Conditions: HIV Infections
Keywords: HIV CABENUVA Intramuscular Cabotegravir Rilpivirine
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 44
Healthy volunteers: no

Brief summary:
GLACIER (Giving Long Acting CABENUVA in an Infusion center/ASA) is an interventional study examining the administration of CABENUVA (Cabotegravir long acting \[LA\] plus Rilpivirine LA) intramuscular (IM) in infusion centers/ASAs in United States. In this study, the intervention is the process of using an infusion center/ASA as the location to receive the CABENUVA IM injections. The acceptability and feasibility of the IC/ASA to deliver CABENUVA IM injections will be assessed from the perspectives of the participants, HIV care providers and IC/ASA staff. In this study, Month 1 is the Baseline visit. CABENUVA is a registered trademark of ViiV Healthcare.

Detailed description:

Arms:
arm 1: Eligible participants received CABENUVA injections intramuscularly at infusion centers/ASAs monthly or every-2-months.

Interventions: intervention 1: CABENUVA
Intervention descriptions: intervention 1: CABENUVA will be administered IM at infusion centers/ASAs

Protocol document:
Prot_000.pdf: 
TMF-15719318 
CONFIDENTIAL 
ViiV Healthcare group of companies 
 
214747 
 
 
Protocol Amendment 06 
 
1 
 
TITLE PAGE 
Information Type: ViiV Healthcare Interventional Study Protocol 
Title: 
A Phase 4, open-label, single arm study to optimize 
implementation of CABENUVA for the treatment of HIV-1, 
for administration in U.S. community-based infusion centers or 
other alternate sites of administration 
Protocol Number: 
214747 / Amendment 06 
Compound 
Number: 
GSK1265744, CABENUVA 
Brief Title:  An implementation study using CABENUVA for the treatment of HIV-1, 
administered in infusion centers or other alternate sites of administration in the U.S. 
Development Phase 
Phase 4 
Acronym:  GLACIER - Giving Long Acting CABENUVA in an Infusion centER 
Sponsor Name and Legal Registered Address (excluding US): 
ViiV Healthcare UK Limited 
980 Great West Road 
Brentford 
Middlesex, TW8 9GS 
UK 
US IND Sponsor Legal Registered Address:  
410 Blackwell Street,  
Durham, NC 27701 
Fax Number:  1 919 237 9294 
 
Marketing Authorisation Holder: 
ViiV Healthcare Company 
Regulatory Agency Identifying Number(s):   IND: 109,678 
Medical Monitor Name and Contact Information will be provided separately 
Sponsor Signatory: 
Sherene Shakib Min, MD, MPH 
VP, Head of Clinical Development 
ViiV Research & Development 
 
Approval Date:  29 Mar 2023 
Copyright 2023 ViiV Healthcare Company.  All rights reserved.  Unauthorized copying 
or use of this information is prohibited 


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PROTOCOL AMENDMENT SUMMARY OF CHANGE TABLE 
DOCUMENT HISTORY 
 
Document 
Date 
DNG Number 
Amendment 06 
29 Mar 2023 
TMF-15719318 
Amendment 05 
14 November 2022 
TMF-15061935 
Amendment 04 
6 October 2022 
TMF-15019036 
Amendment 03 
20 July 2022 
TMF-14758153 
Amendment 02 
16 March 2022 
TMF-14150714 
Amendment 01 
19 Nov 2021 
TMF-14150714 
Original Protocol 
11 April 2021 
2020N443730_00 
 
Amendment 01: Overall Rationale for Amendment 1 (See Annex 5: Protocol 
Amendments) 
Amendment 02: Overall Rationale for Amendment 02 (See Annex 5: Protocol 
Amendments) 
Amendment 03: Overall Rationale for Amendment 3 (See Annex 5: Protocol 
Amendments) 
Amendment 04: Overall Rationale for Amendment 4 (See Annex 5: Protocol 
Amendments) 
Amendment 05: Overall Rationale for Amendment 5 (See Annex 5: Protocol 
Amendments) 
Amendment 06: Overall Rationale for Amendment 6  
Section # and 
Name 
Description of Change 
Brief Rationale 
Global Change 
Added Alternate Sites of 
Administration (ASA) 
Add another type of site for 
CABENUVA administration 
Section 10.1: 
Clinical safety 
laboratory 
assessments 
Revised to state labs should 
be drawn prior to the first 
study injections. 
If an IC/ASA will have labs 
drawn off-site, added clarity 
on when the labs should be 
drawn prior to 
Baseline/Month 1 Visit 
Added clarity to the SOA 
regarding the collection of labs 
prior to the Baseline/Month 1 
Visit 


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Section # and 
Name 
Description of Change 
Brief Rationale 
Annex 1: 
Schedule of 
Activities 
Added link to Section 10.1 
for Baseline/Month lab 
assessments 
Clarity  
Annex 5.1: 
Protocol 
Amendments 
Moved the Table of Changes 
from Protocol Amendment 
05 to Annex 5.1  
Moved according to the Protocol 
template 
 
 


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TABLE OF CONTENTS 
PAGE 
1. 
ABSTRACT .............................................................................................................. 8 
2. 
BACKGROUND AND RATIONALE ........................................................................ 11 
2.1. 
Background ................................................................................................ 11 
2.2. 
Rationale .................................................................................................... 11 
2.3. 
Benefit/Risk Assessment ............................................................................ 12 
3. 
OBJECTIVES AND ENDPOINTS ........................................................................... 13 
4. 
RESEARCH DESIGN ............................................................................................. 19 
4.1. 
Study Design .............................................................................................. 19 
4.2. 
Study Population ......................................................................................... 21 
4.2.1. 
Eligibility Criteria .......................................................................... 21 
4.3. 
Study Groups and Duration ........................................................................ 22 
4.3.1. 
Participants with HIV-1 ................................................................. 22 
4.3.2. 
HIV Care Providers ...................................................................... 23 
4.3.3. 
Infusion Center Staff .................................................................... 24 
5. 
IMPLEMENTATION RESEARCH METHODS ........................................................ 25 
5.1. 
Formative Evaluation Procedures ............................................................... 25 
5.1.1. 
Expert Panel ................................................................................ 25 
5.1.2. 
Implementation Assessments ...................................................... 26 
5.1.3. 
Timepoint Definitions for Completion of Questionnaires 
and Interviews ............................................................................. 29 
5.1.4. 
Primary Endpoint ......................................................................... 30 
5.1.5. 
Blueprint and Plan of Treatment .................................................. 30 
5.1.6. 
Scale-up ...................................................................................... 31 
5.2. 
Scientific Rationale for Study Design and Research Methods ..................... 32 
5.2.1. 
Implementation Frameworks ........................................................ 32 
6. 
STATISTICAL CONSIDERATIONS ........................................................................ 33 
6.1. 
Study Size .................................................................................................. 34 
6.2. 
Essential Analysis ....................................................................................... 37 
6.3. 
Secondary Analysis .................................................................................... 39 
6.4. 
Other/Tertiary Endpoints ............................................................................. 40 
6.5. 
Limitations of the Research Methods .......................................................... 41 
7. 
PROTECTION OF HUMAN SUBJECTS ................................................................ 41 
7.1. 
Ethical Approval and Participant Consent ................................................... 41 
7.2. 
Participant Confidentiality ........................................................................... 41 
7.3. 
Informed Consent Process ......................................................................... 42 
7.4. 
Quality Control / Study Monitoring .............................................................. 42 
8. 
CABENUVA AND CONCOMITANT THERAPY ...................................................... 43 
8.1. 
Missed CANENUVA Injections .................................................................... 43 
8.2. 
Treatment of an Overdose .......................................................................... 43 
8.3. 
Concomitant Therapy.................................................................................. 44 


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9. 
DISCONTINUATION OF CABENUVA AND PARTICIPANT 
DISCONTINUATIONS ............................................................................................ 44 
9.1. 
Discontinuation of CABENUVA ................................................................... 44 
9.2. 
Temporary Discontinuation ......................................................................... 45 
9.3. 
Participant Discontinuation / Withdrawal from the Study ............................. 45 
9.4. 
Lost to Follow-up ........................................................................................ 45 
10. MANAGEMENT AND REPORTING OF ADVERSE EVENTS AND SAFETY 
ASSESSMENTS .................................................................................................... 46 
10.1. 
Clinical safety laboratory assessments ....................................................... 46 
10.2. 
Liver Chemistry Monitoring ......................................................................... 47 
10.3. 
Adverse Events (AEs), Pregnancy Exposure and Incident Reporting .......... 47 
10.3.1. 
Specific Adverse Events to be Documented in this Study ............ 48 
10.3.2. 
Time Period and Frequency for Collecting AE and SAE 
Information ................................................................................... 49 
10.3.3. 
Methods of Detecting AEs and SAEs ........................................... 49 
10.3.4. 
Follow-up of AEs and SAEs ......................................................... 49 
10.3.5. 
Regulatory Reporting Requirements for SAEs ............................. 49 
10.3.6. 
Adverse Event Follow-up with the HIV Care Provider .................. 50 
10.3.7. 
Causality Assessments ................................................................ 50 
10.3.8. 
Serious Post-Injection Reactions ................................................. 51 
10.3.9. 
Injection Site Reactions ............................................................... 51 
10.3.10. Reporting of AEs and Timelines ................................................... 52 
10.3.11. Pregnancy ................................................................................... 53 
10.3.12. Cardiovascular and Death Events ................................................ 54 
10.3.13. Medical Device Deficiency ........................................................... 55 
11. REFERENCES ....................................................................................................... 56 
ANNEX 1: SCHEDULE OF ACTIVITIES ....................................................................... 58 
ANNEX 2. LIST OF STAND-ALONE DOCUMENTS ...................................................... 65 
ANNEX 3: AE AND SAE DEFINITIONS ........................................................................ 66 
Annex 3.1   Definition of an Adverse Event ............................................................ 66 
Annex 3.2   Definition of an SAE ............................................................................ 67 
Annex 3.3   Definition of a Cardiovascular Event .................................................... 69 
Annex 3.4   Recording and Follow-up of AEs and SAEs ......................................... 69 
Annex 3.5   Reporting of SAEs to ViiV/GSK ........................................................... 71 
ANNEX 4: CONTACT INFORMATION FOR REPORTING OF AES AND SAES 
AND PREGNANCIES ............................................................................................. 73 
ANNEX 5: PROTOCOL AMENDMENTS ....................................................................... 74 
Annex 5.1  Protocol Amendment 05 (14 November 2022 ....................................... 74 
Annex 5.2  Protocol Amendment 04 (6 October 2022) ........................................... 74 
Annex 5.3  Protocol Amendment 03 (20July2022) .................................................. 76 
Annex 5.4   Protocol Amendment 02 (16 March 2022) ........................................... 79 
Annex 5.5  Protocol Amendment 01 (19 November 2021) ...................................... 82 
 
 


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LIST OF ABBREVIATIONS  
ADRs 
Adverse drug reactions 
AE 
Adverse event 
AIF 
Alternate Injection Facility 
AIM 
Acceptability of Intervention Measure 
ALT 
Alanine aminotransferase 
APR 
Antiretroviral Pregnancy Registry  
ARV 
Antiretroviral Products 
ASA 
Alternate Site of Administration 
AST 
Aspartate aminotransferase 
BMI 
Body Mass Index 
c/mL 
Copies/milliliter 
CABENUVA 
Cabotegravir LA plus rilpivirine LA 
CFIR 
Consolidated Framework for Implementation Research 
CI 
Confidence Interval 
CRO 
Clinical research organization 
CSR 
Clinical study report 
DAIDS 
Division of acquired immune deficiency syndrome 
DBR 
Database release 
DDI 
Drug-Drug Interaction 
ECG 
Electrocardiogram 
EDURANT 
Rilpivirine 
eCRF 
Electronic case report form 
FDA 
Food and Drug Administration 
FIM 
Feasibility of Intervention Measure 
FPFV 
First participant first visit 
GCP 
Good Clinical Practice 
GSK 
GlaxoSmithKline 
HCP 
Healthcare Provider 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
Human immunodeficiency virus 
IC 
Infusion Center 
ICH 
International Conference on Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use 
ICF 
Informed Consent Form  
IM 
Intramuscular 
IRB 
Institutional Review Board 
ISR 
Injection Site Reaction 
LAR 
Legally Authorized Representative 
LMP 
Last Menses Period  
LPFV 
Last participant first visit 
M 
Month 
MedDRA 
Medical Dictionary for Regulatory Activities 
PLWHIV 
People Living with HIV 
POCBP 
Participants of Child-bearing potential 


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POT 
Plan of Treatment 
PPD 
Pharmaceutical Product Development Inc 
PVG 
Pharmacovigilance 
Q1 
Quarter 1 
Q4 
Quarter 4 
QTc 
Corrected QT interval  
QUERI 
Quality Enhancement Research Initiative 
REP 
Replicating Effective Programs 
RNA 
Ribonucleic acid 
SAE 
Serious adverse event 
SGOT 
Serum Glutamic-Oxaloacetic Transaminase 
SGPT 
Serum Glutamic-Pyruvic Transaminase 
SoA 
Schedule of Activities 
SRM 
Study Reference Manual 
SUSAR 
Suspected unexpected serious adverse reactions 
US 
United States 
USPI 
United States Prescribing Information 
VHC 
ViiV Healthcare 
VOCABRIA 
Cabotegravir 
WHO 
World Health Organization 
 
 
 
Trademark Information 
Trademarks of ViiV Healthcare  
 
Trademarks not owned by ViiV 
Healthcare 
CABENUVA 
 
EDURANT 
VOCABRIA 
 
 
 
 
 
 
 
 


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1. 
ABSTRACT 
Background/Rationale:  CABENUVA is a 2-drug co-packaged product of cabotegravir 
plus rilpivirine, both administered as long-acting (LA) intramuscular (IM) once-monthly 
or every 2-monthly injections is a newly approved treatment for human 
immunodeficiency virus (HIV).  Clinical trial results have shown that CABENUVA 
administered either once monthly or once  every 2-months is non-inferior to the daily oral 
treatment for HIV. 
CABENUVA treatment will require a paradigm shift in how HIV care is delivered, 
especially in the United States (US).  People living with HIV (PLWHIV) will no longer 
be able to only see their providers one to two times a year for a prescription refill and 
monitoring visit but will instead attend appointments for their injections once a month.  
As a result, implementation of CABENUVA in HIV clinical settings in the U.S. poses 
new health delivery challenges and may require a shift in resources and openness to new 
ways of delivering and receiving treatment.  Expanding where the treatment can be 
administered, using alternative injection facilities, such as infusion centers (IC) or other 
alternate sites of administration (ASA), has the potential to address workload capacity 
with this paradigm shift, and may positively impact treatment engagement and retention 
for PLWHIV.  ICs/ASAs are an appealing option that will help ease the burden of 
additional appointments, administrative work, and drug ordering in HIV specialty clinics 
and provide PLWHIV greater flexibility in where they receive their monthly or every 2-
month injections. 
In this study, the intervention is the process of using an infusion center as the location to 
receive the CABENUVA IM injections.  The acceptability and feasibility of the IC/ASAs 
to deliver CABENUVA IM injections, will be assessed from the perspectives of the 
participants, HIV care providers (which could potentially include other Provider clinical 
staff) and IC/ASA staff.  The main objective of this post-approval study is to develop, 
evaluate and scale-up an implementation blueprint for IM administration of CABENUVA 
for HIV-1 treatment at ICs/ASAs. 
Study Design:  This is a Phase 4, single arm, open-label, multi-center study examining 
the administration of CABENUVA IM in infusion centers (ICs) or alternate sites of 
administration (ASA) in the United States.  Additional Infusion Centers (ICs) or ASAs 
(initiating approximately between November 2022 to Q2 2023) will increase the 
geographical area in the US and to scale-up of the implementation blueprint.   
Participants enrolled in the study will receive commercially available CABENUVA via 
prescription from their HIV care provider.  Participants will be monitored according to 
usual standard care at their physician’s discretion.  No more than 120 participants will be 
recruited.  CABENUVA injections will be administered at the ICs/ASAs for 8 months. 
The study has two main components.  The first component is to conduct a formative 
evaluation of the feasibility and acceptability of the IC/ASA model by participants, 
IC/ASA staff and HIV providers and the development of the implementation blueprint.  
The second component involves a scale-up of the optimized implementation blueprint 
across all ICs/ASAs in this study.   


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An Expert Panel will meet to generate an implementation blueprint to guide successful 
implementation prior to the first participant first visit (FPFV).  The blueprint will be 
optimized over the first 6 months and will be used as a foundation for the enrolment of 
the remaining participants.  As the Expert Panel will complete their assessments 
Q4 2022, following this timepoint, key IC/ASA staff members involved in decision 
making and/or overseeing daily operations at the IC/ASA, will be given the opportunity 
to review and revise both the optimized blueprint and the POT.  The blueprint and POT 
will be reviewed and/or revised as necessary pre-study, at 3-4 months into the study to 
ensure experience with participants, and at the end of study.   
Some HIV care providers manage their patients in conjunction with other clinic staff 
members who work with the ICs/ASAs and may be better to complete some study 
assessments.  Thus, in Protocol Amendment 4, the completion of study questionnaires 
and potential interviews to be completed by the HIV Care Providers could potentially be 
completed by other clinical staff members.  
• Note: the potential for other clinical staff to complete HIV Care Provider 
questionnaires and potential interviews, will hereafter be represented by HIV Care 
Providers/clinical staff. 
Objectives: The primary objective is to evaluate the feasibility of CABENUVA 
administration at infusion centers from participants.   
Secondary objectives include: 
• To evaluate feasibility of CABENUVA administration at infusion centers from 
HIV care providers/clinical staff and IC/ASA staff 
• To evaluate feasibility of the process of administering CABENUVA at the 
infusion center 
• To evaluate acceptability of CABENUVA administration at infusion centers from 
HIV care providers/clinical staff, participants, and IC/ASA staff 
• To evaluate feasibility, acceptability and the process of CABENUVA 
administration at infusion centers from the Expert Panel 
• To evaluate perceptions, facilitators, and barriers/concerns by HIV care 
providers/clinical staff, participants, and IC/ASA staff  
• To assess the preference of participants on the location to receive CABENUVA 
• To assess the advantages to receive or refer participants to receive CABENUVA 
at the infusion center from participants and HIV care providers/clinical staff 
• To assess the disadvantages about receiving CABENUVA at the infusion center 
from participants and HIV care providers/clinical staff 
• To evaluate the acceptability of receiving and referring participants for 
CABENUVA injections at infusion centers from participants and HIV care 
providers/clinical staff 


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• To evaluate the usefulness of blueprint intervention by IC/ASA staff and the Plan 
of Treatment (POT) for HIV care providers/clinical staff 
• To evaluate overall opinion of receiving and administering the injection at an 
infusion center by IC/ASA staff, participants and HIV care providers/clinical staff 
• To evaluate fidelity to treatment and dosing window 
Analysis Methods:  Implementation science methodology will be used in this study to 
assess the acceptability and feasibility of an IC/ASA for the delivery of CABENUVA IM 
injections.  This study will evaluate the acceptability and feasibility of our 
implementation strategy using the Feasibility of Intervention Measure (FIM) and the 
Acceptability of Intervention Measure (AIM).   
In addition to the FIM and AIM, other quantitative questionnaires will be included to 
address additional constructs related to the study objectives.  These questions will cover 
constructs related to perceptions, facilitators, barriers, usefulness of the blueprint 
advantages, disadvantages, and processes related to CABENUVA administration at 
ICs/ASAs.  These additional quantitative questionnaires will measure endpoints that are 
not directly captured by the AIM and FIM. 
The primary endpoint in terms of feasibility is the percentage of participants that agree or 
completely agree (a score of 4 or higher) across all items on the FIM at Month 8.  For 
FIM of participants, HIV care providers/clinical staff and IC/ASA staff at each specified 
timepoint, the sample percentage and associated 95% confidence interval will be 
presented.   
In addition to summary of FIM scores of participants at different timepoints, the change 
in FIM scores of each item will be analysed, and the shift table for each item of FIM will 
be given to display the number of participants who completely disagree (scale=1), 
disagree (scale=2), neither agree or disagree (scale=3), agree (scale=4), completely agree 
(scale=5) at Baseline/Month 1 and the shift of these quantities at each timepoint that 
follows.   
The feasibility composite score will be further refined based on the standard process 
outlined in the blueprint.  The exact components of feasibility composite score will be 
informed by the Expert Panel process to ensure it matches the critical variables identified 
by all members of the panel. 
Subgroup analysis will be performed to evaluate the effect of contextual factors on the 
variability of responses to feasibility.  These factors include, but not limited to, 
demographic, baseline characteristics, prior clinical experience, initiation method (oral 
lead in or direct to injection or receiving continuation dose), the number of injections 
received prior to enrollment and injection option (monthly or every 2-months) for 
participants, provider type, site type and setting (urban, suburban, rural) for IC/ASA staff, 
and affiliation for HIV care providers/clinical staff.  
The analysis methods for the secondary endpoints of acceptability, and fidelity will be 
similar to that of the feasibility endpoints. 


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2. 
BACKGROUND AND RATIONALE 
2.1. 
Background 
CABENUVA is a 2-drug co-packaged product of cabotegravir plus rilpivirine, both 
administered as long-acting (LA) intramuscular (IM) injections, is a newly approved 
treatment for human immunodeficiency virus (HIV).  Clinical trial results have shown 
that CABENUVA administered once monthly and once every 2-months is non-inferior to 
the daily oral treatment for HIV [Margolis, 2017; Swindells, 2020; Orkin, 2020; Overton, 
2020].  Forty-seven percent of healthcare provides (HCPs) believed that “some” patients 
(25–50%) would be appropriate while nearly one-quarter of HCPs (23%) felt that “many” 
patients (more than 50%) would be appropriate candidates for LA antiretroviral therapy 
(ART) [Murray, 2020].  This treatment will require a paradigm shift in how HIV care is 
delivered, especially in the United States (US).  People living with HIV (PLWHIV) will 
no longer be able to only see their providers one to two times a year for a prescription 
refill and monitoring visit but will instead attend appointments for their injections once a 
month or once every 2 months.  As a result, implementation of CABENUVA in HIV 
clinical settings in the U.S. poses new health delivery challenges and may require a shift 
in resources and openness to new ways of delivering and receiving treatment.  Expanding 
where the treatment can be administered, using alternative injection facilities (AIFs), 
ICs/ASAs has the potential to address workload capacity with this paradigm shift, and 
may positively impact treatment engagement and retention for PLWHIV. 
ICs/ASAs are an appealing option that will help ease the burden of additional 
appointments, administrative work, and drug ordering in HIV specialty clinics and 
provide PLWHIV greater flexibility in where they receive their monthly or every 2-
month injections.  These facilities have an existing infrastructure that supports a wide 
range of treatments and can likely be adopted for administration of CABENUVA.  
Infusion centers exist across the US and have an informal network of sharing information 
both within the same company of infusion centers, as well as across companies.   
Now that CABENUVA is commercially available in the United States, rapidly addressing 
needs to scale-up availability of the treatment will be important to ensure that those who 
want the treatment have access to it in a way that works for them and their providers.  
AIFs, like infusion centers, are a natural option for administering CABENUVA, as they 
routinely administer injectable treatments to a diverse patient population, have trained 
medical staff onsite, and have existing infrastructure to ensure communication between 
the IC/ASA, PLWHIV, and HIV providers.  Additionally, these centers are not diagnosis 
specific, which allows for an added level of privacy during treatment appointments.  
Generating and testing acceptability and feasibility of an implementation blueprint to 
understand how this might work in routine care post-approval is an important next step to 
ensure that implementation of CABENUVA at infusion centers provides optimal care and 
experience for HIV care providers/clinical staff, PLWHIV, and infusion center staff. 
2.2. 
Rationale 
This post-approval, Phase 4 study will use an Expert Panel consisting of selected HIV 
care providers that may refer their PLWHIV to an IC/ASA, key IC/ASA staff members 


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involved in decision making and/or oversight of daily operations and ViiV Healthcare 
(VHC) to collaboratively develop an implementation blueprint and a plan of treatment 
(POT) to establish best practices and standard operating procedures for the administration 
of CABENUVA at ICs/ASAs (see Section 5.1 for full descriptions of the blueprint and 
POT).  The blueprint will be used to guide the development and/or refinement of the POT 
which will be reviewed prior to the HIV care provider’s first patient with HIV-1 enrolled 
in the study at the IC/ASA.   
Implementation science methodology will be used to assess the acceptability and 
feasibility of an IC/ASA for the delivery of CABENUVA IM injections.  In this study, 
the intervention is the process of using an infusion center as the location to receive the 
CABENUVA IM injections.  The acceptability and feasibility of the IC/ASA to deliver 
CABENUVA IM injections, will be assessed from the perspectives of the participants, 
HIV care providers/clinical staff and IC/ASA staff.   
The intention of this post-approval study is to develop, evaluate and scale-up an 
implementation blueprint for IM administration of CABENUVA for HIV-1 treatment at 
ICs/ASAs.  The study has two main components.  The first component is to conduct a 
formative evaluation of the feasibility and acceptability of the IC/ASA model by 
participants, IC/ASA staff and HIV providers and the development of the implementation 
blueprint.  The second component involves a scale-up of the implementation blueprint 
across all ICs/ASAs in this study.   
An Expert Panel will meet to generate an implementation blueprint to guide successful 
implementation prior to the first participant first visit (FPFV).  The blueprint will be 
optimized over the first 6 months and will be used as a foundation for the enrolment of 
the remaining participants.  The Expert Panel will complete all assessments in Q4 2022.  
The optimized blueprint will be reviewed and potentially revised by key IC/ASA staff 
members involved in decision making and overseeing daily operations at the IC/ASA. 
Participants enrolled in the study will receive commercially available CABENUVA via 
prescription from their HIV care provider.  Participants will be monitored according to 
usual standard care at their physician’s discretion. 
As a result, this study will examine the impact of the implementation blueprint and POT 
in enhancing the uptake of infusion centers by HIV care providers/clinical staff and 
patients with HIV-1 as the location they use to provide CABENUVA IM injections for 
their PLWHIV.  
2.3. 
Benefit/Risk Assessment 
Refer to the most recent USPI CABENUVA USPI for more detailed information about 
the known and expected benefits and risks and reasonably expected adverse events (AEs) 
of CABENUVA CABENUVA USPI. 


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3. 
OBJECTIVES AND ENDPOINTS 
Objectives 
Endpoints 
Primary 
To evaluate feasibility of CABENUVA 
administration at infusion centers from 
participants  
• Proportion of participants that agree or 
completely agree (a score of 4 or higher) 
across all items on the FIM at Month 8 
Secondary  
To evaluate feasibility of CABENUVA 
administration at infusion centers from 
participants, HIV care providers/clinical staff 
and IC/ASA staff 
• Proportion of participants that agree or 
completely agree (a score of 4 or higher) 
across all items on the FIM at Month 1, 
Month 3 
• Proportion of HIV care providers/clinical 
staff that agree or completely agree (a 
score of 4 or higher) across all items on 
the FIM at Month 1, Month 4 and at 
Month 8 
• Proportion of IC/ASA Staff that agree or 
completely agree (a score of 4 or higher) 
across all items on the FIM prior to Month 
1, at Month 3, and Month 8 
• Change over time in the FIM at Month 3 
and Month 8 with participants 
• Change over time in the FIM at Month 4 
and Month 8 with HIV care 
providers/clinical staff 
• Change over time in the FIM at Month 3, 
and Month 8 with IC/ASA staff 
• Summary of other quantitative 
questionnaires assessed with participants 
at Month 1, Month 3, and Month 8 
• Summary of other quantitative 
questionnaires assessed with HIV care 
providers/clinical staff at Month 1, Month 4 
and Month 8 
• Summary of other quantitative 
questionnaires assessed with IC/ASA staff 
prior to Month 1, at Month 3, and at Month 
8 


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Objectives 
Endpoints 
• Qualitative interviews assessed at Month 8 
with participants, HIV care 
providers/clinical staff and IC/ASA staff 
To evaluate feasibility of the process of 
administering CABENUVA at the infusion 
center 
• Summary of composite score of the 
feasibility process indications through 
Month 8  
• Change over time through Month 8 in the 
composite score and each item of 
composite score. 
To evaluate acceptability of CABENUVA 
administration at infusion centers from HIV 
care providers/clinical staff, participants, and 
IC/ASA staff 
• Proportion of HIV care providers/clinical 
staff that agree or completely agree (a 
score of 4 or higher) across all items on 
the AIM at Month 1, Month 4 and Month 8 
• Proportion of participants that agree or 
completely agree (a score of 4 or higher) 
across all items on the AIM at Month 1, 
Month 3and Month 8 
• Proportion of IC/ASA staff that agree or 
completely agree (a score of 4 or higher) 
across all items on the AIM prior to 
Month 1, at Month 3, and Month 8 
• Change of HIV care providers/clinical staff 
over time in the AIM at Month 4 and Month 
8 
• Change of participants and IC/ASA staff 
respectively over time in the AIM at 
Month 3, and Month 8 
• Summary of other quantitative 
questionnaires assessed with HIV care 
providers/clinical staff at Month 1, Month 4 
and Month 8 
• Summary of other quantitative 
questionnaires assessed at Month 1, 
Month 3, and Month 8 with participants  
• Summary of other quantitative 
questionnaires assessed prior to Month 1, 
at Month 3 and Month 8 with IC/ASA staff 
• Qualitative interviews assessed at Month 8 
with participants, HIV care 


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Objectives 
Endpoints 
providers/clinical staff and IC/ASA staff 
To evaluate feasibility, acceptability and the 
process of CABENUVA administration at 
infusion centers from the Expert Panel 
• Proportion of Expert Panel that agree or 
completely agree (a score of 4 or higher) 
across all items on the FIM and AIM 
respectively prior to FPFV, and at Month 3 
and Month 6 
• Change of Expert Panel over time in FIM 
and AIM respectively through Month 6 
• Summary of other quantitative 
questionnaires assessed with Expert Panel 
prior to FPFV, and at Month 3 and Month 6 
• Qualitative interviews assessed with 
Expert Panel prior to FPFV and at Month 6  
To evaluate perceptions, facilitators, and 
barriers/concerns by participants, HIV care 
providers/clinical staff, and IC/ASA staff 
• Summary of participant other quantitative 
questionnaires at Month 1, Month 3 and 
Month 8 
• Summary of IC/ASA staff other 
quantitative questionnaires prior to Month 
1, at Month 3, and Month 8 
• Summary of HIV care provider/clinical staff 
other quantitative questionnaires at 
Month 1, Month 4, and Month 8  
• Qualitative interviews assessed at Month 8 
with HIV care providers/clinical staff, 
participants and IC/ASA staff 
To assess the preference of participants on 
the location to receive CABENUVA 
• Summary of preference on the location to 
receive CABENUVA at Month 1, Month 3, 
and Month 8 assessed by participant other 
quantitative questionnaires  
• Qualitative interviews assessed at Month 8 
with participants  
To assess the advantages to receive or refer 
participants to receive CABENUVA at the 
infusion center from participants and HIV care 
providers/clinical staff 
• Summary of advantages of receiving 
CABENUVA at IC/ASA at Month 1, Month 
3, and Month 8 assessed by participant 
other quantitative questionnaires  
• Summary of advantage to referring 


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Objectives 
Endpoints 
participants to the IC/ASA to receive 
CABENUVA at Month 1, Month 4, and 
Month 8 assessed by HIV care 
provider/clinical staff other quantitative 
questionnaires 
• Qualitative interviews assessed at Month 8 
with participants and HIV care 
providers/clinical staff  
To assess the disadvantages about receiving 
CABENUVA at the infusion center from 
participants and HIV care providers/clinical 
staff 
• Summary of disadvantages of receiving 
CABENUVA at ICs/ASAs from participant 
other quantitative questionnaires at Month 
1, Month 3, and Month 8  
• Summary of disadvantage of referring 
participants to IC/ASA for CABENUVA 
injections from HIV care providers/clinical 
staff other quantitative questionnaires at 
Month 1, Month 4 and Month 8 
• Qualitative interviews assessed at Month 8 
with participants and HIV care 
providers/clinical staff 
To evaluate the acceptability of receiving and 
referring participants for CABENUVA injections 
at infusion centers from participants and HIV 
care providers/clinical staff 
• Summary of acceptability of the process of 
receiving injections at ICs/ASAs from 
participant other quantitative 
questionnaires at Month 1, Month 3 and 
Month 8 
• Summary of acceptability of the process of 
referring participants to the infusion center 
for CABENUVA by HIV care 
providers/clinical staff other quantitative 
questionnaires at Month 1, Month 4, and 
Month 8 
• Qualitative interviews assessed at Month 8 
with participants and HIV care providers 
To evaluate the usefulness of blueprint 
intervention by IC/ASA staff and the POT for 
HIV care providers/clinical staff 
• Summary of usefulness of the blueprint 
intervention by IC/ASA staff other 
quantitative questionnaires prior to Month 
1, at Month 3 and Month 8 


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Objectives 
Endpoints 
• Summary of usefulness of the POT by HIV 
care providers/clinical staff other 
quantitative questionnaires at Month 4 and 
Month 8  
• Qualitative interviews assessed at Month 8 
with HIV care providers/clinical staff and 
IC/ASA staff 
To evaluate overall opinion of receiving and 
administering the injection at an infusion 
center by IC/ASA staff, participants and HIV 
care providers/clinical staff 
• Summary of the overall opinion of 
administering the injection at an IC/ASA by 
IC/ASA staff other quantitative 
questionnaires prior to Month 1, at 
Month 3, and Month 8 
• Summary of overall opinion of receiving 
CABENUVA at an infusion center by 
participant other quantitative 
questionnaires at Month 1, Month 3, and 
Month 8. 
• Summary of overall opinion of referring 
patients to an IC/ASA center for 
CABENUVA injections by HIV care 
provider/clinical staff via other quantitative 
questionnaires at Month 1, Month 4 and 
Month 8 
• Qualitative interviews at Month 8 with 
participants, HIV care providers/clinical 
staff and IC/ASA staff  
To evaluate fidelity to treatment and dosing 
window 
• Proportion of injections occurring within 
target window from target date ( 7 days 
of target date) through Month 8 
Other / Tertiary 
CCI


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Objectives 
Endpoints 
 
 
 
CCI


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4. 
RESEARCH DESIGN  
This study will be conducted in accordance with the protocol and with: 
• Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences (CIOMS) International Ethical Guidelines 
• Applicable ICH Good Clinical Practice (GCP) Guidelines 
• Applicable laws and regulations 
4.1. 
Study Design 
This is a Phase 4, single arm, open-label, multi-center study examining the administration 
of CABENUVA IM in infusion centers in the United States.  This study is being 
conducted following FDA approval and commercial availability of CABENUVA in the 
U.S.   
Eligible and consenting participants will be followed for 8 months to evaluate and scale-
up an implementation blueprint for IM administration of CABENUVA for HIV-1 
treatment at ICs/ASAs.  The total study duration for participants is approximately 8 
months from the time of enrollment and receipt of the first study related administration of 
CABENUVA IM injections at the IC/ASA.  For a detailed Schedule of Activities (SoA) 
refer to Annex 1: Schedule of Activities.  CABENUVA dosing adherence information 
and schematics can be found in the Study Reference Manual (SRM). 
 
 


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Figure 1 
Study Design Schematic 
 
 
Expert Panel questionnaires completed prior to the first participants first visit at the Month 1 visit.  The Expert Panel will 
complete their review and optimization of the blueprint in Q4 2022.  Thus, the ICs/ASAs initiating between approximately 
from November 2022 and Q1 2023 will use the optimized version of the blueprint and key IC/ASA staff will be allowed to 
modify prior to site enrollment, at 3-4 months and at the Month 8 visit. 
Questionnaires include the FIM, AIM and other quantitative questionnaires 
Participant assessments are completed based on Month regardless of monthly versus every-2-month dosing  
Note,  Study design may not include all potential patterns of dosing.  Talk to the HIV Care Provider or the Medical 
Monitor if you have any questions on the injection schedule. 
 


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4.2. 
Study Population 
During the recruitment period, the aim is to recruit no more than 120 participants who 
have been prescribed CABENUVA by their HIV care provider.  
After signing an informed consent, participants will complete Baseline's assessments to 
confirm participant eligibility.  Each participant being screened for study enrolment 
evaluation will be assigned a participant number at the Baseline visit.   
4.2.1. 
Eligibility Criteria 
4.2.1.1. 
Inclusion Criteria 
AGE:  
1 
Adults (18 years old) at the time of signing the informed consent. 
Type of Participant and Disease Characteristics 
2 
 HIV-1 infected and have been prescribed CABNEUVA per the USPI.  Participants 
can be enrolled:  
• If they have been taking oral VOCABRIA + EDURANT or other ART for 
approximately 1 month (at least 28 days) prior to Baseline/Month 1, or 
• Already taking CABENUVA prior to Baseline/Month 1 and the last injections 
were within a 1 month  7-day window or for every 2-month injections, the 
timing will vary they are receiving the initiation injections (1 month  7-day) or 
the continuation injections (2 months  7 days) per the USPI, or 
• Prescribed direct to inject and receive their 1st injection without an oral lead in at 
the Infusion Center on the last day of any other antiretroviral therapy.  
Informed Consent 
3 
Capable of giving signed informed consent as described in Section 7.3 which 
includes compliance with the requirements and restrictions listed in the informed 
consent form (ICF) and in this protocol. 
Other 
4 
Agreement to receive CABENUVA IM injections at participating infusion center.   
4.2.1.2. 
Exclusion Criteria 
Participants may be excluded from the study, in consultation with the HIV care 
provider, based on information from the most current Prescribing Information 
[CABENUVA USPI] at the time of study enrolment. 
1. Contraindications, as per the current Prescribing Information [CABENUVA USPI]  
• Previous hypersensitivity reaction to cabotegravir or rilpivirine.  
• Contraindicated co-administered drugs: 


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o Anticonvulsants: Carbamazepine, oxcarbazepine, phenobarbital, 
phenytoin 
o Antimycobacterials: Rifabutin, rifampin, rifapentine 
o Glucocorticoid (systemic): Dexamethasone (more than a single-dose 
treatment) 
o Herbal product: St John’s wort (Hypericum perforatum) 
2. New health condition / prohibited medication reported 
• After discussion with the referring HIV care provider a decision was made not to 
enter participant into the study 
3. Other Reason at the discretion of the HIV care provider or IC/ASA staff 
4.3. 
Study Groups and Duration 
This study will include the following groups: An Expert Panel, HIV care providers, 
virologically suppressed PLWHIV seeking to start or continue CABENUVA for 
treatment for HIV-1, and the IC/ASA staff.  A CABENUVA POT will be agreed between 
the HIV care provider and the IC/ASA prior to study participants receiving their first 
study related injections at the IC/ASA. 
Assessments can be found in Annex 1: Schedule of Activities and in the POT.   
4.3.1. 
Participants with HIV-1 
PLWHIV are allowed in the study if they have been prescribed CABENUVA per the 
USPI [CABENUVA USPI] and meet all eligibility criteria (Section 4.2.1) at the 
Baseline/Month 1 visit.  Participants meeting all eligibility criteria will sign the informed 
consent form at the IC/ASA and will enter into the study.   
If a participant plans to miss the injections by more than 7 days, in consultation with the 
HIV care provider, oral VOCABRIA + EDURANT or other ART regimens should be 
taken daily to replace up to 2 consecutive planned missed monthly injection visits or 
every 2-month injection visit-doses.  Dosing of oral bridging in the event of missed doses 
will be in accordance with the most recent CABENUVA prescribing information 
[CABENUVA USPI]. 
In consultation with the HIV care provider, participants may switch from monthly 
injections to an every-2-month continuation injection schedule, or from a 2-month 
continuation injection schedule to a monthly continuation dosing schedule.  When 
switching dosing regimens, follow all instructions as outlined in the most current 
Prescribing Information [CABENUVA USPI].  The total duration of study participants is 
approximately 8 months from the time of enrolment. and receipt of the first study related 
administration of CABENUVA IM injections at the IC/ASA.  A participant is considered 
to have completed the study if he/she has finished all Month 8 assessments. 


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4.3.2. 
HIV Care Providers  
Selected HIV care providers will be included on the Expert Panel.  The Expert Panel will 
meet prior to Baseline/Month 1, and as required over the first 6 months, and per the SoA 
(Annex 1: Schedule of Activities) to develop the CABENUVA implementation blueprint 
as described in Section 5.1.  The Expert Panel will complete the Month 6 review and 
revision of the blueprint within 2 to 4 weeks of the last site initiation visits of the 
additional ICs/ASAs.   
Any HIV care provider will be allowed to refer PLWHIV to approximately 35 designated 
ICs/ASAs.  Once an HIV care provider has identified a PLWHIV who would benefit 
from receiving CABENUVA or is already receiving CABENUVA and the patient agrees 
to receive the CABENUVA IM injections given at the IC/ASA, the provider will send a 
referral to the IC/ASA.  The IC/ASA will conduct insurance verification.  Once insurance 
verification is approved and reviewed with the patient, the IC/ASA will inform the HIV 
care provider and the patient will initiate treatment per the CABENUVA USPI. 
HIV care providers will manage all medical and clinical aspects of their PLWHIV during 
the study including management of adverse events.  The HIV care provider can request 
the following procedures to take place at the IC/ASA (i.e., local labs, vital signs) at any 
time. 
• Prior to their HIV care providers first participant first visit (FPFV), providers will 
work with the IC/ASA to review and complete the POT for their patients.  The 
HIV care provider will be notified that IC/ASA staff, clinical research 
organization (CRO) staff and/or the Medical Monitor may request additional 
information, including medical records if required, on CABENUVA-related AEs, 
AEs leading to withdrawal of CABENUVA and study withdrawals, SAEs, or 
other assessments (e.g., follow-up on liver chemistry elevations, pregnancies).  
HIV care providers will be notified of all adverse events and will be requested to 
provide a causality assessment.  
• During the oral lead-in phase (for those initiating CABENUVA for the first time) 
and for the duration of the study, the HIV care providers will remain responsible 
for the medical management of their PLWHIV.   
• HIV care providers will be notified by the IC/ASA of all planned and any 
unplanned missed visits.  The HIV care provider will determine when to start oral 
therapy for planned missed doses, or restart CABENUVA according to the most 
current USPI. 
• If the IC/ASA or the HIV care provider cannot contact the participant following 
missed injections of CABENUVA, this should be documented in the participants 
medical record, and if an injection is not administered within the allotted window 
period, such participants will be removed from the study and the clinical 
management of the participant will remain with the HIV care provider  
Some HIV care providers manage their patients in conjunction with other clinic staff 
members who work with ICs/ASAs and may be better to complete some study 
assessments.  Thus, in Protocol Amendment 4, the completion of study questionnaires 


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and potential interviews to be completed by the HIV Care Providers could potentially be 
completed by other clinical staff members. 
Up to approximately 20 HIV care providers/clinical staff who refer their PLWHIV to a 
study IC/ASA, and after the HIV care provider’s first patient is enrolled into the study, 
the HIV care provider/clinical staff may be asked to complete questionnaires per the SoA 
(Annex 1: Schedule of Activities).   
The duration of study participation for each HIV care provider/clinical staff is 
approximately 8 months after their last PLWHIV has their first visit (LPFV) and received 
CABENUVA IM injections at a participating IC/ASA. 
4.3.3. 
Infusion Center Staff 
Key IC/ASA staff members involved in decision making and/or overseeing daily 
operations at the IC/ASA will participate in the Expert Panel.  IC/ASA staff that are not 
part of the Expert Panel will complete assessments per the SoA (Annex 1) and in the 
POT.  Baseline questionnaires should be completed by IC/ASA staff, prior to the first 
participant enrolled at their center. 
Insurance verification will be done by the ICs/ASAs for all referred PLWHIV that are 
new to CABENUVA.  The IC/ASA staff is responsible for promptly informing the 
PLWHIV and HIV care provider of the outcome of the insurance verification.   
• The IC/ASA and the referring HIV care provider will review and individualize the 
POT for each participant prior to their first injections, if required.  The IC/ASA 
center will explain that medical records may be collected for SAEs or other events 
for their PLWHIV enrolled at their center.  
• At the first study-related injection visit (M1), the IC/ASA staff will obtain the 
participant's informed consent prior to enrolling in the study.  After consent is 
obtained, the IC/ASA staff will administer CABENUVA IM injections as per the 
most current approved prescribing information in the CABENUVA USPI.  
• The IC/ASA will be responsible for scheduling the monthly or every 2-month 
injections, reminding participants when they are scheduled to receive their 
injections, and rescheduling missed injections  
The IC/ASA will immediately notify the participant's HIV care provider for any of 
the following reasons:    
• The participant has missed a dose and/or is outside the dosing window (7 days) 
• The IC/ASA cannot contact the participant to reschedule a missed appointment 
• The IC/ASA learns of an AE or SAE.  The IC/ASA staff will be responsible for 
reporting all AEs/SAEs (refer to Section 10.3), to the HIV care provider.  All 
events should be kept in the participant source documentation.  
• Participant has started a new medication with the potential for drug-drug 
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The HIV care provider will manage all medical and clinical follow-up required, 
including management of adverse events. 
Every injection visit will be recorded as a study visit.  Additional participant contacts will 
not need to be documented as a study visit; however, the results of the viral load or other 
assessments are to be entered into the electronic Case Report Forms (eCRF).   
The IC/ASA staff are responsible for the completion of all eCRF forms.  Refer to Section 
10.3.10, Table 3 for AE/SAE and pregnancy reporting timelines.  
Total duration of study participation for IC/ASA staff is approximately 8 months from 
the time of enrollment of the last participant at that IC/ASA site. 
5. 
IMPLEMENTATION RESEARCH METHODS 
5.1. 
Formative Evaluation Procedures 
HIV care providers will refer their PLWHIV that are interested in receiving 
CABENUVA injections at a participating IC/ASA.  Participants of the study will be 
required to receive all their monthly or every 2-month injections at the IC/ASA, unless 
the injection is given at the HIV care providers office, as part of a routine care visit.   
5.1.1. 
Expert Panel  
The Expert Panel (approximately 10 members) will convene prior to any participant 
enrolment and will develop a CABENUVA implementation blueprint and an IC POT for 
the study.  The pre-determined panel will be comprised of key IC/ASA staff members 
involved in decision making and/or overseeing daily operations at the IC/ASA, selected 
HIV care providers and VHC.  VHC will provide oversight, and participate on the Expert 
Panel, when appropriate to ensure critical components of the process are addressed and 
that the blueprint is complying with the protocol, and the delivery of the study objectives 
and endpoints.  IC/ASA Staff and HIV care provider membership of this panel will be 
chosen after completion of feasibility, and members will be asked to remain on the panel 
for the duration of the Expert Panel.   
Prior to any participant enrollment in the study, the Expert Panel members will 
participate in a brief baseline qualitative interview and a meeting to design the blueprint, 
which will provide guidance to any IC/ASA about the overall process and 
implementation strategies to support CABENUVA initiation and continuation injections 
and will be used for the development and/or refinement of the POT.  Templated analysis 
will occur for rapid coding both instream during the interviews as well as afterwards, if 
necessary, to capture additional information.  Data from all stakeholder interviews will be 
summarized for top level key constructs noted across interviews.   
At the Expert Panel first meeting, the qualitative interview data will be discussed, 
elements for the blueprint that will be used to develop the IC/ASA POT will be 
identified.  This blueprint and POT will direct the entire spectrum of users (participants, 
HIV care providers, IC/ASA staff) on processes including clinical procedures and 
facilitative communication.  This process will follow an evidence-based qualitative 
improvement process (e.g., identifying potential barriers to implementation, generating a 
plan to address it, and ultimately testing through implementation) paired with a nominal 


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group technique.  The nominal group technique involves the ability to ask the Expert 
Panel to rank order different recommendations anonymously then discuss the triaged 
barriers and create an implementation blueprint to test in each cluster or iteration of the 
process.  At the end of the initial meeting, an implementation blueprint draft will be 
prepared and will serve as the foundation for the IC/ASA POT for guiding successful 
implementation.   
Additionally, as part of the blueprint and the POT, the Expert Panel will define which 
labs (i.e, HIV-1 RNA, CD4 cell counts, liver chemistries, or other labs) or other 
procedures are required, and at what timepoints.  The HIV care provider and the IC/ASA 
can add additional labs to the POT, if required, for the clinical management of their 
PLWHIV. 
After agreement on the initial blueprint, the participating IC/ASA sites and HIV care 
providers will begin to deploy the implementation blueprint, including the POT, and 
begin referring appropriate candidates for enrollment for CABENUVA treatment at the 
participating ICs/ASAs.   
The Expert Panel will meet per the SoA (Annex 1: Schedule of Activities) and/or as 
required over the first 6 months, after the first participant was referred, to refine and 
optimize the blueprint and POT if needed.  The revised blueprint and POT will then guide 
the care of the referred PLWHIV.   
At approximately Month 6, the members of the Expert Panel will complete all 
assessments per the SoA (Annex 1: Schedule of Activities), or as required, over the first 6 
months.  The Expert Panel will meet for a final time at Month 6 to analyze key outcomes 
and to optimize the final blueprint.   
As the additional ICs/ASAs are joining the study at the completion of the Expert Panel 
(approximately November 2022 to Q1 2023), the additional sites may revise the 
implementation blueprint outside of the Expert Panel.  There will be a review of the 
blueprint and POT pre-study, at 3-4 months into the study to ensure IC/ASA experience, 
and at the end of study. 
5.1.2. 
Implementation Assessments 
Implementation outcomes align with the specified aims and Proctor and colleague’s 
[Proctor, 2011] implementation outcome recommendations.  Assessments for the Expert 
Panel, HIV care providers/clinical staff, participants and the IC/ASA staff will be 
administered as outlined in Table 1 and in Annex 1.  Baseline assessments for the Expert 
Panel and the IC/ASA Staff should be completed prior to the first participant is enrolled.  
Implementation assessments may also be gathered from IC/ASA staff members who are 
administering CABENUVA outside of this study. 
A baseline analysis and one or more interim analysis will be conducted to provide early 
evaluation of the implementation science primary and key secondary objectives.  The 
timing of the interim/s will be based on when a sufficient number of IC/ASA staff and/or 
study participant questionnaires and interviews have been completed. 
Per Protocol Amendment 4, HIV care providers/clinical staff will be asked to complete 
questionnaires and interviews. 


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Table 1 
Implementation Assessments 
Outcome 
Assessment Level 
Measurement 
Time point 
Feasibility  
Expert Panel*† 
FIM 
Other quantitative 
questionnaires 
Qualitative Interview 
Prior to FPFV, M3, M6 
Prior to FPFV, M3, M6 
 
Prior to FPFV, M6 
HIV Care Providers/ 
Clinical Staff 
FIM 
Other quantitative 
questionnaires 
Qualitative Interview 
M1, M4, M8 
M1, M4, M8 
 
M8 
Participants 
FIM 
Other quantitative 
questionnaires 
Qualitative Interview 
M1, M3, M8 
M1, M3, M8 
 
M8 
IC/ASA Staff 
FIM 
Other quantitative 
questionnaires 
Qualitative Interview 
Prior to M1, M3, M8 
Prior to M1, M3, M8 
 
M8 
Cross study 
Consent Rate 
Show Rate 
Participant Notification 
Provider Notification 
Return rate 
M1- M8 
M1- M8 
M1- M8 
M1- M8 
M1- M8 
Acceptability 
Expert Panel*† 
AIM 
Other quantitative 
questionnaires 
Qualitative Interview 
Prior to FPFV, M3, M6 
Prior to FPFV. M3, M6 
 
Prior to FPFV, M6 
HIV Care Providers/ 
Clinical Staff 
AIM 
Other quantitative 
questionnaires 
Qualitative Interview 
M1, M4, M8 
M1, M4, M8 
 
M8 
Participants 
AIM 
Other quantitative 
questionnaires 
Qualitative Interview 
M1, M3, M8 
M1, M3, M8 
 
M8 
IC Staff 
AIM 
Other quantitative 
questionnaires 
Qualitative Interview 
Prior to M1, M3, M8 
Prior to M1, M3, M8 
 
M8 
Fidelity 
Participants 
Adherence to Target 
date (7 days) 
Monthly 
Process 
evaluation 
HIV Care Providers/ 
Clinical Staff, 
Participants, IC/ASA Staff 
Qualitative Interview 
M8 
CCI


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Outcome 
Assessment Level 
Measurement 
Time point 
Perceptions, 
Facilitators, and 
Barriers/Concerns,  
HIV Care Providers/ 
Clinical Staff 
Qualitative Interview 
Other quantitative 
questionnaires 
M8 
M1, M4, M8 
Participants 
Qualitative Interview 
Other quantitative 
questionnaires 
M8 
M1, M3, M8 
IC/ASA Staff 
Qualitative Interview 
Other quantitative 
questionnaires 
M8 
Prior to M1, M3, M8 
Preferences 
Participants 
Qualitative Interview 
Other quantitative 
questionnaires  
M8 
M1, M3, M8 
Advantages and 
Disadvantages 
HIV Care Providers/ 
Clinical Staff 
Qualitative Interview  
Other quantitative 
questionnaires 
M8 
M1, M4, M8 
Participants 
Qualitative Interview 
Other quantitative 
questionnaires 
M8 
M1, M3, M8 
Acceptability of 
receiving and 
referring patients 
HIV Care Providers/ 
Clinical Staff 
Qualitative Interview 
Other quantitative 
questionnaires 
M8 
M1, M4, M8 
Participants 
Qualitative Interview 
Other quantitative 
questionnaires 
M8 
M1, M3, M8 
Usefulness of the 
blueprint and POT 
HIV Care Providers/ 
Clinical Staff 
Qualitative Interview 
Other quantitative 
questionnaires 
M8 
M4, M8 
IC/ASA Staff 
Qualitative Interview 
Other quantitative 
questionnaires 
M8 
Prior to M1, M3, M8 
Overall opinion of 
receiving and 
administering the 
injections at an IC 
HIV Care Providers/ 
Clinical Staff 
Qualitative Interview  
Other quantitative 
questionnaires 
M8 
M1, M4, M8 
Participants 
Qualitative Interview 
Other quantitative 
questionnaires 
M8 
M1, M3, M8 
IC/ASA Staff 
Qualitative Interview 
Other quantitative 
questionnaires 
M8 
Prior to M1, M3, M8 
Abbreviations: AIM: Acceptability of Intervention Measure; ASA: Alternate Sites for Administration; FIM: 
Feasibility of Intervention Measure; FPFV = First participant first visit, IC = Infusion Center; M: Month 
*Expert Panel includes selected HIV Care Providers and Key IC Staff 
†The Expert Panel will meet as required over the first 6 months to discuss any iterations that are needed to 
refine and optimize the blueprint. 
Only HIV care providers/clinical staff that had patients enrolled into the study will be included in 
assessments post Baseline/Month 1.   


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5.1.3. 
Timepoint Definitions for Completion of Questionnaires and 
Interviews 
Participants:   
• Baseline/Month 1 is defined as the date when a participant signs ICF and 
completes Baseline/Month 1 protocol procedures prior to receiving the first study 
related CABENUVA injections at the IC/ASA. 
• All additional study visits, including those where questionnaires and/or interviews 
are administered at Months 3, and 8, will be anchored off of each participants 
Month 1 visit, so it will reflect the Months on study, regardless of what injection 
schedule they are on and regardless of whether they have missed any injections 
and received oral bridging. 
Expert Panel:  
• Panel members will meet prior to Baseline/Month 1 to design the Blueprint and 
refine the POT 
• Baseline/Month 1 is defined as the date when a participant signs ICF and 
completes protocol procedures and receives the first study related CABENUVA 
injections at any infusion center 
• Month 3 and Month 6 assessments are to be completed after approximately 10 
participants (across all ICs/ASAs) have completed their Month 3 and Month 6 
study visits at any IC/ASA site 
HIV Care Providers/Clinical Staff: 
• Baseline/Month 1 is defined when the HIV care provider’s first patient referred to 
the IC/ASA is enrolled into the study and receives their first injections of 
CABENUVA at the IC/ASA.  HIV care providers/clinical staff  will be asked to 
complete the Baseline/Month 1 questionnaire within 4 weeks of their first referred 
patient enrolled. 
• Month 4 and Month 8 assessments are to be completed when the HIV care 
provider’s first referred patient completes the Month 4 or Month 8 study visits, 
respectively  
― Questionnaires and/or interviews can be completed up to 2 weeks before 
or after the Month 4 or Month 8 study visits 
IC/ASA Staff: 
• Baseline/Month 1 questionnaires should be completed prior to enrollment of the 
first participant at each infusion center  
• Month 1 for each IC/ASA is defined when the first participant enrolls into the 
study at that specific IC/ASA and the participant is administered the first study 
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• Month 2 for potential interviews of approximately 5 IC/ASA staff will be defined 
after at least 1 participant, at their respective IC/ASA site, has completed their 
Month 2 study visits  
• Month 3 and Month 8 will be defined after at least 1 participant, at their 
respective IC/ASA site, has completed their Month 3 or 8 study visits, 
respectively  
― Questionnaires and/or interviews can be completed up to 2 weeks before 
or after the Month 2, Month 3, or Month 8 study visits. 
The full SoA can be found in Annex 1: Schedule of Activities.   
5.1.4. 
Primary Endpoint 
The primary endpoint is participant feasibility at Month 8.  The secondary endpoints 
include the feasibility in HIV care providers/clinical staff and IC/ASA staff, acceptability 
in all groups (HIV care providers/clinical staff, IC/ASA staff, and participants), as well as 
fidelity.  Other feasibility measures as shown in Table 1 will be informed by Pai and 
colleagues [Pai, 2017].  In addition to the quantitative feasibility thresholds, we will 
incorporate data from stakeholder discussions and qualitative data prior to making a final 
rating of success. 
5.1.5. 
Blueprint and Plan of Treatment 
The Expert Panel will construct a blueprint that all ICs/ASAs will follow.  The blueprint 
is similar to standard operating procedures and is intended to provide an overview of 
essential features of implementing CABENUVA as administered via an IC/ASA.  This 
will include procedures and optimal strategies for successful implementation.  This may 
include, but is not limited to:  
• Referral process 
• Time for Insurance processing/Notification of Patient  
• When to order/obtain labs on participants receiving CABENUVA treatment at an 
IC/ASA? 
• Point of service for labs (i.e. at infusion center, at clinic, at an external lab)? 
• How often do HIV care providers want their participants to be seen in their clinic 
while getting CABENUVA at the IC/ASA? 
• How is the HIV care provider notified that the participant received a dose or 
missed a dose? 
• Communication plan for AEs, SAEs, and medical management of AEs/SAEs. 
• What happens when a participant misses a scheduled dose? 
• Scheduling/Rescheduling 
• Appointment Reminders 


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As the Expert Panel will complete their assessments Q4 2022, following this timepoint, 
key IC/ASA staff members involved in decision making and/or overseeing daily 
operations at the IC/ASA, will be given the opportunity to review and revise both the 
blueprint and the POT.  The blueprint and POT will be reviewed and/or revised as 
necessary pre-study, at 3-4 months into the study to ensure experience with participants 
and at the end of study. 
Part of the blueprint will involve a POT, which outlines key information needed to ensure 
the IC/ASA and HIV care providers have communicated necessary information on new 
referrals for CABENUVA.  A typical process for incorporating a new product into 
routine care at ICs/ASAs involves development and/or refinement of a POT, which they 
iterate as needed until the process works seamlessly for communication and engagement 
between HIV care providers, participants, and IC/ASA staff.  The blueprint and POT will 
be iterated to include any IC/ASA letters or other means of advertisements that contacts 
HIV care providers in the community to refer their PLWHIV to them.  This process will 
be documented and incorporated into a final blueprint at the end of the study.  Once the 
initial POT is agreed upon, the IC/ASA will begin incremental real word roll-out into 
their centers that were not previously participating in the study.  Documentation will 
occur around how ICs/ASAs measures success and the impact to further iterate the 
blueprint or not.   
POTs are often unique to the IC/ASA, however, the POT developed in this study will be 
used as a model moving forward for all participating ICs/ASAs.  A POT may include, but 
is not limited to, the following:  
• Patient information (e.g., name, height, weight, year of birth) 
• Diagnosis 
• Pre-medication 
• Dose and frequency of treatment 
• Insurance information 
• Preferred form of communication 
• Additional requests from referring physicians 
5.1.6. 
Scale-up 
The blueprint that was determined to achieve optimal performance through formative 
evaluation will be used to support successful scale-up of CABENUVA IM injections 
across all ICs/ASAs.  Data collected to capture the scale-up will be collected on 
additional participants that enroll to receive CABENUVA, as well as HIV care providers 
that opt into participating in the study, as outlined in Table 1.  The blueprint will be used 
to help other alternate administration facilities set up similar models of care and service 
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5.2. 
Scientific Rationale for Study Design and Research Methods 
The study design is based on the well-established Quality Enhancement Research 
Initiative (QUERI) Four Phase Framework for Implementation Projects [QUERI, 2013].  
These studies are designed to produce valid evidence on operations and impact in a 
rigorous manner while allowing for continued refinement of program design.  The 
formulative evidence of this study maps onto Phase 2 in the QUERI framework in which 
a small clinical trial is conducted to refine and evaluate an implementation program (e.g., 
the process of referring and engaging PLWHIV choosing to receive CABENUVA IM 
injections at an infusion center).  The scale-up of this study maps onto the QUERI 
framework Phase 3, which involves regional roll-out of projects.  This type of design 
allows for real world testing while collecting data on real-time refinements of the 
implementation strategy, measurement of impact on key patient and provider outcomes, 
while having an opportunity to examine what real world scale-up would look like.  The 
measurement follows gold standard implementation outcome guidelines to ensure valid 
measurement of the intended effect.   
Data from advisory boards has demonstrated a preference for having AIFs to expand 
access to CABENUVA when it becomes available in routine care.  To accommodate the 
anticipated increased visits in routine care that are associated with the CABENUVA, an 
expanded capacity for delivery is needed.  Shifting to delivering HIV treatment in AIFs is 
one option to expand uptake of this new treatment.  Research shows that just because an 
effective treatment exists, translation into routine care is slow and often never occurs 
[Bauer, 2019].  As a result, understanding how to efficiently incorporate AIFs into HIV 
care, as well as stakeholder views on this option, could serve as a critical step in uptake 
and sustainment of this novel HIV treatment in the community.   
5.2.1. 
Implementation Frameworks 
To support the QUERI phased design used in this implementation study, per 
implementation methodology it is also guided by 3 gold standard frameworks (covering 
process, determinants and evaluation): Replicating Effective Programs (REP) [Kilbourne, 
2007], the Consolidated Framework for Implementation Research (CFIR) [Damschroder, 
2009] and the Proctor [Proctor, 2011] outcomes framework.   
REP will be used to guide the process of the study.  REP is based on the United States 
Center for Disease Control REP project, which developed systematic and effective 
strategies to prepare HIV treatments for dissemination [Kilbourne, 2007].  REP provides 
a conceptual framework on processes needed to prepare effective interventions for use in 
community settings.  The four steps of REP (see Figure 2; pre-conditions, pre 
implementation, implementation, and maintenance and evolution) ensure key factors are 
thoroughly addressed that are crucial to implementation of effective interventions in 
healthcare settings.  REP is intended to be flexible and adapted to the context in which 
implementation is intended to occur with a new effective intervention. 


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Figure 2 
Replicating Effective Programs 
 
CFIR will serve as the main determinant’s framework guiding examination of factors 
influencing CABENUVA implementation and the qualitative interviews.  This 
framework provides a menu of constructs that can be used to systematically assess 
potential barrier and facilitators to implementation.  Lastly, the Proctor outcomes will 
also be used to guide measurement decisions to ensure the appropriate outcomes are 
measured across the two frameworks [Proctor, 2011].  Notably, acceptability, feasibility, 
and fidelity will be focused on in the proposed study. 
6. 
STATISTICAL CONSIDERATIONS  
The statistical analysis plan will be finalized prior to database release, and it will include 
a more technical and detailed description of the statistical analyses described in this 
section.  This section is a summary of the planned statistical analyses of the most 
important endpoints including primary and key secondary endpoints.  The learnings over 
the first 6 months will will be used to inform the final data analyses. 
A baseline analysis will be planned to gain insights on the initial assessment of 
implementation science data on primary and key secondary objectives.  It is expected that 
this analysis will be performed with baseline questionnaire data needed from participants 
and IC/ASA staff. 
One or more interim analysis will be conducted to provide early evaluation of the 
implementation science primary and key secondary objectives.  No changes to the study 
conduct will occur. 
The timing of the interim/s will be based on when a sufficient number of IC/ASA staff 
and/or study participant questionnaires and interviews have been completed. 
No formal criteria for stopping or amending the study based on interim analysis results 
will be made.  
A Statistical Analysis Plan will describe the planned baseline/interim analysis in greater 
detail individually.  There is potential analysis for a small number of interviews (N  5) 
with IC/ASA staff at Month 2 to gain an understanding of what is occurring at ICs/ASAs 
during early implementation.   
All interviews will be audio recorded, professionally transcribed by a third-party vendor, 
and reviewed for quality assurance purposes.  Analyses will be done via qualitative rapid 


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coding in Excel and targeted at capturing key concepts of interest for assessing the 
blueprint and POT (including any recommended changes prior to the Month 3 and 
Month 6 assessments). 
6.1. 
Study Size 
This study will include up to 120 participants prescribed CABENUVA by their HIV care 
providers, who will be referred to approximately 35 study infusion centers to receive their 
injections and will be enrolled.  Approximately 20 referring HIV care providers/clinical 
staff will be selected to complete appropriate questionnaires.  Approximately 5 IC/ASA 
staff at each of the IC/ASA locations will be selected to complete the questionnaires.  
Approximately 20 participants will be selected for the Month 8 interview.  In addition, 
approximately 10 referring HIV care providers/clinical staff and 10 IC/ASA staff will be 
selected to conduct interviews.   
The Expert Panel will review the questionnaire data and real-time feedback from the 
Infusion Centers to determine if the blueprint and/or the POT will need to be updated.  
Approximately 10 participants across all ICs/ASAs should have completed the Month 3 
assessments prior to the Expert Panel meetings at Month 3 and Month 6. 
The Acceptability of Intervention Measure (AIM) and the Feasibility of Intervention 
Measure (FIM) are employed to evaluate the acceptability and feasibility of our 
implementation strategy.  The AIM and FIM are validated implementation outcome 
measures [Weiner, 2017a; Weiner, 2017b].  Higher scores for AIM and FIM indicate 
greater acceptability and feasibility.  For these two types of measures, we focus on the 
proportion of participants that agree or completely agree (a score of 4 or higher) across 
all items.  The following power and sample size discussion is based on the primary 
endpoint of feasibility score.  Suppose that the indicators for feasibility success are set at 
80%, then we want to detect a proportion of participants that agree or completely agree (a 
score of 4 or higher) across all items on FIM, which is 80% or higher.  The following 
analysis shows how sensitive the statistical power is to the number of participants 
enrolled. 
Assuming the true proportion of participants that agree or completely agree on FIM 
across all items is 90%>80%, Figure 3 shows the relationship between the study power to 
detect such a proportion and the sample size.  In order to have 80% study power, a 
sample size of 82 participants is needed.  If 106 or more participants are enrolled, we 
would have >85% power to detect such a percentage.  To have 90% power, a minimum 
sample size of 112 participants would be recommended. 
Note: "Enrolled" means a HIV-1 participant agrees to participate in this clinical study, 
following completion of an informed consent process and provided they meet the 
baseline eligibility criteria for participation.  If required, a legally acceptable 
representative may provide the participants agreement to participate in the clinical study 
and sign the ICF. 


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Figure 3 
Relationship between Study Power and Sample Size 
 
Further, if we consider a series of possible true percentage, Figure 4 summarizes 
corresponding minimum sample size needed to achieve three target powers (80%, 85%, 
90%).  For instance, if the true percentage is a little higher than 90%, which we 
considered above, say, 93%, then a sample size of 44 participants is required to achieve 
80% power.  And approximately 50 and 63 participants are needed to have 85% and 90% 
power respectively. 
Figure 4 
Relationship between Minimum Sample Size Required and the 
Assumed Percentage 
 


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Considering the real-world uptake of CABENUVA is evolving, we might expect some 
potential low enrollment scenarios at the end of the recruitment period, which could 
impact the study power significantly due to insufficient sample size available.  Under the 
assumption that the true proportion of participants that agree or completely agree on FIM 
across all items is 0.90, 0.93 or 0.95, Figure 5 below demonstrates how the study power 
will vary as the enrollment of participants ranges from 30 to 80.  If the true percentage is 
0.95, the study power is still relatively high and above 70% for all possible sample size in 
this range, while the power might be lower than 70% for sample size within 30-42 but 
keep above 50% for all cases if the true percentage decreased to 0.93.  When the true 
percentage is 0.90, the study power will maintain below the statistically desired 80% as 
the sample size increases from 30 to 80.  In this case, at least 64 participants are needed 
to achieve 60% or above power.  
Figure 5 
Sensitivity of Study Power to Relatively Small Sample Size 
 
Table 2 below provides more details on the associated study power to some selected 
sample size in the range 30-80 with the true percentage equal to 0.90. 


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Table 2 
Relationship between Study Power and Sample Size with Range 30-
80  
True Percentage 
Sample Size 
Power 
0.90 
30 
0.41 
0.90 
36 
0.29 
0.90 
42 
0.38 
0.90 
48 
0.47 
0.90 
54 
0.54 
0.90 
60 
0.61 
0.90 
66 
0.66 
0.90 
72 
0.71 
0.90 
78 
0.75 
0.90 
80 
0.72 
 
6.2. 
Essential Analysis 
The primary endpoint in terms of feasibility is the percentage of participants that agree or 
completely agree (a score of 4 or higher) across all items on the FIM [Weiner, 2017b] at 
Month 8.  For FIM of each study group, the sample percentage and associated 95% 
confidence interval (CI) will be presented.   
One of the secondary endpoints is the change in FIM scores of participants over time at 
Month 3, and Month 8.  In addition to summary of FIM scores at different timepoints, the 
shift table for each item of FIM will be given to display the number of participants who 
completely disagree (scale=1), disagree (scale=2), neither agree or disagree (scale=3), 
agree (scale=4), completely agree (scale=5) at Baseline/Month 1 and the shift of these 
quantities at each timepoint that follows. 
The feasibility composite score will be further refined based on the standard process 
outlined in the blueprint.  The components that are planned to be evaluated at Month 1 
through Month 8 and as part of the composite score are outlined below.  The intention is 
to have a sub-score from the following measures, however, information from the Expert 
Panel will be used to finalize the proposed composite scores prior to data analysis: 
1. FIM Score: Proportion of HIV care providers/clinical staff, participants, and IC/ASA 
Staff respectively that agree or completely agree (a score of 4 or higher) across all 
items on the FIM. 
• Numerator: Number of HIV care providers/clinical staff, participants, and 
IC/ASA Staff respectively that agree or completely agree on FIM (a score of 4 
or greater) across all items 
• Denominator: Total number of HIV care providers/clinical staff, participants, 
and IC/ASA Staff respectively 
2. Consent Rate: Proportion of participants that provide consent to participate in the 
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• Numerator: Number of participants consented 
• Denominator: Number of participants referred to the IC/ASA to receive 
CABENUVA IM injections   
3. Show Rate: Proportion of scheduled injection appointments that are not missed 
a. Numerator: Number of scheduled injection appointments that result in shows 
b. Denominator: Number of confirmed scheduled injection appointments for 
participants 
4. Participant Notification: Proportion of contacts the participant receives from the 
infusion center for missed appointments out of the standard number they should be 
contacted 
a. Numerator: Number of documented times that a participant is contacted by 
infusion center staff regarding a missed appointment 
b. Denominator: Standard number of times that a participant is contacted regarding a 
missed appointment, according to infusion center policy 
5. HIV Care Provider Notification:  
a. 1) Proportion of participants whose information regarding test results are 
communicated to their HIV Care Provider  
― Numerator: Number of participants whose information was communicated to 
the appropriate HIV care provider 
― Denominator: Total number of participants in the study 
b. 2) Proportion of all appointments missed that are communicated to the HIV care 
provider 
― Numerator: Number of missed appointments that are communicated to the 
appropriate HIV care provider 
― Denominator: Total number of missed appointments 
6. Return Rate at Visit N: Proportion of participants that completed any injection at 
Visit N after the completion of (N-1)th injection visit  
a. Numerator: Number of participants who returned to the infusion center and 
completed an injection at Visit N 
b. Denominator: Number of participants who completed an injection at the infusion 
center at the previous visit (N-1) 
― This definition is for any scheduled post-baseline visit.  When N=1, the previous 
visit (N-1) is the baseline visit. 
The estimates of these quantitative measures will be given and corresponding 95% CIs 
will also be presented. 
The feasibility composite score will be informed by the Expert Panel process to ensure it 
matches the critical variables identified by all members of the panel.  Summary details of 
feasibility composite score will be included in the statistical analysis plan. 


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To evaluate the effect of contextual factors on the variability of responses to 
implementation science measurements. subgroup analysis will be undertaken at specified 
assessment timepoints, which include, but not limited to, demographic, baseline 
characteristics, prior clinical experience, initiation method (oral lead in or direct to 
injection or receiving continuation dose), the number of injections received prior to 
enrollment and injection option (monthly or every 2-months) for participants, provider 
type, site type and setting (urban, suburban, rural) for IC/ASA staff, and affiliation for 
HIV care providers. 
6.3. 
Secondary Analysis 
A key secondary outcome is Acceptability:  
AIM Score: Proportion of HIV care providers/clinical staff, participants, and IC/ASA 
Staff respectively that agree or completely agree (a score of 4 or higher) across all items 
on the Acceptability of Intervention Measure (AIM).  The score will be calculated 
approximately at Month 1, Month 4 and Month 8 for HIV care providers/clinical staff, 
and at prior to Month 1/Month 1, Month 3, and Month 8 for participants and IC/ASA 
Staff.   
• Numerators: Numbers of HIV care providers/clinical staff, participants, and 
IC/ASA Staff respectively that agree or completely agree (a score of 4 or higher) 
on AIM across all items 
• Denominators: Total numbers of HIV care providers/clinical staff, participants, 
and I/ASA C Staff respectively 
Other secondary outcomes to be evaluated include:  
• Fidelity: Proportion of injections occurring within target window from target date 
(7 days of target date)  
• Feasibility, acceptability and the process of CABENUVA administration at 
infusion centers from the Expert Panel 
• Perceptions, facilitators, and barriers/concerns by HIV care providers/clinical 
staff, participants, and IC/ASA staff 
• Preference of participants on the location to receive CABENUVA 
• Advantages to receive or refer participants to receive CABENUVA at the infusion 
center from participants and HIV care providers/clinical staff 
• Disadvantages about receiving CABENUVA at the infusion center from 
participants and HIV care providers/clinical staff 
• Acceptability of receiving and referring participants for CABENUVA injections 
at infusion centers from participants and HIV care providers/clinical staff 
• Usefulness of blueprint intervention by IC/ASA staff and the POT for HIV care 
providers/clinical staff 
• Overall opinion of receiving and administering the injection at an infusion center 
by IC/ASA staff, participants and HIV care providers/clinical staff 


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Estimates and associated 95% CI of the quantitative measures above will be presented. 
Qualitative interview data will be summarized by a third party and reported as part of the 
overall study results (clinical study report (CSR)).  Details of these analyses will be 
described in a separate analysis plan provided by the CRO partner under GSK’s 
oversight. 
6.4. 
Other/Tertiary Endpoints 
CCI


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6.5. 
Limitations of the Research Methods 
This is a single-arm study for gathering information on the feasibility and acceptability of 
utilizing an IC/ASA to administer CABENUVA in the US.  As such there are geographic 
limitations.  The study is deliberately non-stratified to reduce limitations on recruitment.   
Thus, this approach may result in some characteristics under- or overrepresented within 
the participants and limited diversity in terms of demographics or introduction of 
confounding factors. 
7. 
PROTECTION OF HUMAN SUBJECTS 
7.1. 
Ethical Approval and Participant Consent 
The protocol, protocol amendments, ICF, and other relevant documents (e.g., 
advertisements) must be submitted to an Institutional Review Board (IRB) and reviewed 
and approved by the IRB before the study is initiated.  
Any amendments to the protocol will require IRB approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an 
immediate hazard to study participants.  
Protocols and any substantial amendments to the protocol will require health authority 
approval prior to initiation except for changes necessary to eliminate an immediate 
hazard to study participants. 
The IC/ASA will be responsible for the following: 
• Providing written summaries of the status of the study to the IRB annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB 
• Notifying the IRB of SAEs or other significant safety findings as required by IRB 
procedures 
• Providing oversight of the conduct of the study at the ICs/ASAs and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB, and all other applicable local 
regulations 
7.2. 
Participant Confidentiality 
Participants will be assigned a unique identifier.  Any participant records or datasets that 
are transferred to the sponsor will contain the identifier only; participant names or any 
information which would make the participant identifiable will not be transferred.  
The participant must be informed that their personal study-related data will be used by 
the sponsor in accordance with local data protection law.  The level of disclosure must 
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also be explained to the participant who will be required to give consent for their data to 
be used as described in the informed consent.  
The participant must be informed that their medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the sponsor, by 
appropriate IRB members, and by inspectors from regulatory authorities. 
All IC/ASA study staff will ensure protection of participant personal data and will not 
include participant names on any sponsor forms, reports, publications, or in any other 
disclosures, except where required by laws. 
7.3. 
Informed Consent Process 
The IC/ASA will explain the nature of the study to the participant or their legally 
authorized representative and answer all questions regarding the study.  
• Participants must be informed that their participation is voluntary.  Participants or 
their legally authorized representative will be required to sign a statement of 
informed consent that meets the requirements of 21 CFR 50, local regulations, 
ICH guidelines, Health Insurance Portability and Accountability Act (HIPAA) 
requirements, where applicable, and the IRB.  
• The medical record must include a statement that written informed consent was 
obtained before the participant was enrolled in the study and the date the written 
consent was obtained.  The IC/ASA authorized person obtaining the informed 
consent must also sign the ICF. 
• Participants must be re-consented to the most current version of the ICF during 
their participation in the study.  
• A copy of the ICF must be provided to the participant or their legally authorized 
representative.  
ViiV Healthcare (alone or working with others) may use participant’s coded study data 
and other information to carry out this study; understand the results of this study; learn 
more about CABENUVA or about the study disease; and publish the results of these 
research efforts.   
7.4. 
Quality Control / Study Monitoring 
In accordance with applicable regulations including GCP, study monitors will contact the 
ICs/ASAs prior to the start of the study to review with the IC/ASA staff the protocol, 
study requirements, and their responsibilities to satisfy regulatory, ethical, and VHC 
requirements. 
When reviewing data collection procedures, the discussion will also include 
identification, agreement and documentation of data items for which the eCRF will serve 
as the source document.  The study monitors will monitor the study and IC/ASA site 
activity to verify that the: 
• Data are authentic, accurate, and complete. 


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• Safety and rights of participants are being protected. 
• Study is conducted in accordance with the currently approved protocol and any 
other study agreements, GCP, and all applicable regulatory requirements. 
• The IC/ASA staff and the head of the IC/ASA (where applicable) agrees to allow 
the monitor direct access to all relevant documents. 
8. 
CABENUVA AND CONCOMITANT THERAPY 
The protocol only requires that the participant is initiating or continuing CABENUVA 
IM injections, dosed in accordance with the approved label [CABENUVA USPI, 
EDURANT USPI, VOCABRIA USPI]; no CABENUVA is provided by VHC.  No dose 
reductions, modifications, or changes in the frequency of any components of 
CABENUVA will be allowed during the study beyond what is allowed within the 
approved CABENUVA label 
The IC/ASA will refer to the most recent CABENUVA USPI, for the preparation and 
administration of CABENUVA [CABENUVA USPI]. 
8.1. 
Missed CANENUVA Injections 
Adherence to the CABENUVA monthly or every 2-monthly injection dosing schedule is 
required.  If a participant misses a scheduled injection visit, the referring HIV care 
provider must be notified.  The HIV care provider is responsible for all medical 
management decision for participants after a missed dose, as described in the most recent 
USPI [CABENUVA USPI].  The IC/ASA staff should also notify the Medical Monitor of 
missed injections; however, the Medical Monitor is not responsible for decisions 
regarding medical management of missed injections.   
Any changes in a participant’s ART must be recorded in the eCRF.  This includes oral 
dosing of VOCABRIA and EDURANT or other ART regimens to ensure anti-viral 
coverage during a planned or unplanned missed visit. 
Participants receiving CABENUVA are anticipated to be at risk for development of 
virologic resistance if ART is interrupted.  The time period during which participants are 
at risk for development of virologic resistance may be determined by the period between 
when drug levels fall below therapeutic values and when they fall below levels which 
exert selective pressure on HIV.  This time period will vary by ART agent and is 
dependent upon effective concentration, inhibitory concentration, and half-life.  Plasma 
concentrations of both drugs (cabotegravir, rilpivirine) may be measurable for more than 
one year following IM injections.   
8.2. 
Treatment of an Overdose 
At the IC/ASA, an SOP will be developed for the management of treatment overdose 
following prescribing label information [CABENUVA USPI].  For this study, any dose 
of CABENUVA greater than listed in the prescribing information will be considered an 
overdose.  All overdoses and any treatment for the overdosage should be recorded in the 
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There is no known specific treatment for overdose with cabotegravir or rilpivirine.  If 
overdose occurs, contact the PPD Medical Monitor immediately while monitoring the 
participant and apply standard supportive treatment as required, including monitoring of 
vital signs as well as observation of the clinical status of the patient, and record in the 
participants source documentation.  Consider the prolonged exposure to cabotegravir and 
rilpivirine (components of CABENUVA) following injections when assessing treatment 
needs and recovery.   
In the event of an overdose, the IC/ASA should: 
1. Contact both the HIV care provider and the PPD Medical Monitor 
immediately.   
2. Document the quantity of the excess dose as well as the duration of the 
overdosing in the eCRF. 
3. Document any signs or symptoms the IC/ASA assess as related to the overdose in 
the eCRF  
Decisions regarding dose interruptions or modifications will be made by the HIV care 
provider and may consult with the Medical Monitor based on the clinical evaluation of 
the participant. 
8.3. 
Concomitant Therapy 
HIV care providers and IC/ASA staff will monitor concomitant medications, referring to 
the most recent USPI [CABENUVA USPI], paying special attention to the 
contraindicated medications and medications with a potential for drug-drug interactions.   
The IC/ASA will note all new concomitant medications and send to the HIV care 
provider.  The IC/ASA should consult with the HIV care provider if any new 
contraindicated or concomitant medications with the potential for drug interactions are 
noted prior to administering CABENUVA.  Contraindicated or concomitant medications 
with the potential for drug interactions must be recorded in the eCRF at each visit.  The 
Medical Monitor should be contacted if there are any questions regarding concomitant or 
prior therapy. 
9. 
DISCONTINUATION OF CABENUVA AND PARTICIPANT 
DISCONTINUATIONS 
9.1. 
Discontinuation of CABENUVA 
It may be necessary for a participant to permanently discontinue CABENUVA.  If 
CABENUVA is permanently discontinued, the participant will not remain in the study.  
See the SoA (Annex 1: Schedule of Activities) and the POT for data to be collected at the 
time of discontinuation of CABENUVA.  All study and CABENUVA discontinuations 
will be captured in the eCRF. 
A participant may have to discontinue CABENUVA due to moderate to severe (as 
clinically determined by the IC/ASA and/or HIV care provider) COVID-19 infection 


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(suspect, probable, or confirmed using the most recent version of the World Health 
Organization (WHO) case definition [WHO, 2020]. 
All study and CABENUVA discontinuations will be recorded. 
9.2. 
Temporary Discontinuation  
The referring HIV care providers will determine if a temporary discontinuation is 
appropriate for their PLWHIV, per the most recent USPI for CABENUVA 
[CABENUVA USPI].  The IC/ASA will capture temporary discontinuations and restart 
information in the eCRF.  If the participant does not restart CABENUVA they will no 
longer be eligible to continue the study.  
If the referring HIV care provider determines a temporary discontinuation of 
CABENUVA is appropriate, he/she is responsible for all medical management 
decisions regarding ART coverage during this time.  The IC/ASA staff should also 
notify the Medical Monitor of temporary discontinuations; however, the Medical Monitor 
is not responsible for decisions regarding medical management of missed injections.   
Any changes in a participant’s ART must be recorded in the eCRF.  This includes oral 
dosing of VOCABRIA and EDURANT or other ART regimens to ensure anti-viral 
coverage during a planned or unplanned missed visit. 
9.3. 
Participant Discontinuation / Withdrawal from the Study 
A participant may discontinue CABENUVA and withdraw from the study at any time at 
their own request or may be withdrawn at any time at the discretion of the IC/ASA or 
HIV care providers for safety (i.e., AE, SAE), behavioural, or compliance reasons (i.e., 
protocol deviation).   
At the time of discontinuing from the study, if possible, an early discontinuation visit 
should be conducted, as shown in the SoA (Annex 1: Schedule of Activities) and the 
POT.  The SoA includes the data to be collected at the time of study discontinuation and 
follow-up and for any further evaluations that need to be completed. 
If the participant withdraws consent for disclosure of future information, the sponsor may 
retain and continue to use any data collected before such a withdrawal of consent.  
9.4. 
Lost to Follow-up 
A participant will be considered lost to follow-up if they fail to return for one or more 
scheduled visits and is unable to be contacted by the IC/ASA or the HIV care provider.  
The following actions must be taken if a participant fails to return to the IC/ASA for a 
required study visit: 
• The IC/ASA must immediately contact the HIV care provider if a participant has 
missed a visit. 


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• The IC/ASA must attempt to contact the participant and reschedule the missed 
visit as soon as possible and counsel the participant on the importance of 
maintaining the assigned visit schedule and ascertain whether or not the 
participant wishes to and/or should continue receiving monthly or every 2-
monthly injections at the IC/ASA.   
• Before a participant is deemed lost to follow up, the IC/ASA and HIV care 
provider must make every effort to regain contact with the participant.  These 
contact attempts should be documented in the participant’s medical record. 
• Should the participant continue to be unreachable, they will be considered to have 
withdrawn from the study with a primary reason of “Lost to Follow-up”.  
10. 
MANAGEMENT AND REPORTING OF ADVERSE 
EVENTS AND SAFETY ASSESSMENTS 
Planned time points for all safety assessments are provided in the SoA, Annex 1 and in 
the POT.  Definitions of AEs, SAEs and CV events can be found in Annex 3. 
All AEs, SAEs and clinical laboratory abnormalities should be graded using the Division 
of AIDS (DAIDS) table for grading the severity of adult and pediatric adverse events 
[DAIDS, 2017]. 
10.1. 
Clinical safety laboratory assessments 
All Baseline/Month 1 lab assessments should be drawn prior to the 1st study injections.  If 
labs will be taken off-site from the IC/ASA, then the study participant should sign the 
ICF and receive a requisition for a blood draw at another location (i.e., Quest, Labcorp).  
Labs should be drawn 7-10 days prior to the Baseline/Month 1 visit.  Confirmation that 
labs were drawn prior to the 1st study injections are mandatory, relevant labs should be 
added to the eCRF.  If a potential participant has had labs drawn with 10 days of the 
Month 1/Baseline visit, and the HCP is willing to share that data, this data can then be 
used and added to the eCRF. 
Local laboratory assessments for this study will be performed as per the blueprint and the 
POT at local laboratories.  All laboratory reports will be shared with the HIV care 
provider.  See the SRM for additional information. 
• The HIV care provider will determine if any laboratory tests have values 
considered clinically significantly abnormal and will be responsible for the 
participant clinical management.  The IC/ASA and HIV care provider will agree 
if follow-up labs are to be collected at the IC/ASA.  The PPD Medical Monitor 
should be informed of abnormal laboratory tests considered clinically significant.   
• The IC/ASA should document this review and record any HIV care provider 
determination of clinically significant changes occurring during the study as an 
AE/SAE.  The PPD Medical Monitor should be informed.  The laboratory reports 
must be filed with the source documents.  
• If any laboratory test results require a change in participant management or are 
considered clinically significant by the HIV care provider, then the results must 


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be recorded in the eCRF as appropriate (e.g., abnormal lab results that are 
considered an SAE, CABENUVA related or required CABENUVA to be 
discontinued). 
• If laboratory values from non-protocol specified laboratory tests performed at the 
HIV care provider’s local laboratory require a change in participant management 
or are considered clinically significant by the provider then the results must be 
recorded in the eCRF as appropriate (e.g., abnormal lab results that are considered 
an SAE, CABENUVA-related AE, requires CABENUVA to be discontinued, or 
COVID-19 related). 
It is expected that at a minimum, HIV-1 RNA and liver chemistries will be analyzed.  
Other lab assessments will be determined by the Expert Panel (e.g., absolute CD4 cell 
counts) and the POT between the HIV care provider and the IC/ASA. 
• Liver chemistries should include: 
o Aspartate Aminotransferase (AST)/ Serum Glutamic-Oxaloacetic 
Transaminase (SGOT) 
o Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase 
(SGPT) 
o Alkaline Phosphatase 
o Total and direct Bilirubin 
Additional tests may be performed at any time during the study as determined necessary 
by the HIV care provider. 
10.2. 
Liver Chemistry Monitoring 
The HIV care provider and the Medical Monitor must be contacted at onset of liver 
chemistry elevations to discuss participant safety.  Liver event documents (i.e., “Liver 
Event eCRF” and updates, “Liver Imaging eCRF” and/or “Liver Biopsy eCRF”, as 
applicable) should be completed as soon as possible.  See the SRM for more information 
on liver events.  Safety contact information can be found in Annex 4. 
The decision whether to discontinue CABENUVA for abnormal liver tests should be 
made by HIV care provider.  The POT between the IC/ASA and the HIV care provider 
will include the monitoring of liver chemistries and communications between the 
IC/ASA, HIV care provider, and the PPD Medical Monitor.  The PPD Medical Monitor 
may request additional information regarding the results of and/or the monitoring of liver 
chemistries.  Additional information can be found in Section 10.1 and in the SRM. 
10.3. 
Adverse Events (AEs), Pregnancy Exposure and Incident 
Reporting 
Clinical safety data will be collected as outlined in the eCRF.  The complete definitions 
of adverse events (AE) or serious adverse events (SAEs) can be found in Annex 3.  For 
AEs, only those that are considered related to CABENUVA, or that caused the 


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participant to discontinue the study are required to be reported to PPD PVG (See 
Section 10.3.1).  All AEs will be reported to the HIV care provider.   
AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, 
or the participant's legally authorized representative (LAR)) be collected and stored in the 
participants source documentation. 
The IC/ASA staff and any qualified designees are responsible for detecting, 
documenting, and reporting events that meet the definition of an AE or SAE and remain 
responsible for following up AEs that are serious, considered related to CABENUVA or 
that cause the participant to discontinue CABENUVA from the time of the informed 
consent to participants withdrawal or completions of the study.   
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Section 10.3.10. 
Please call the PPD safety hotline located in  Annex 4 for AE/SAE assistance (i.e., is this 
event an SAE?) and for eCRF entry assistance. 
10.3.1. 
Specific Adverse Events to be Documented in this Study 
Please refer to the most current USPIs for CABENUVA, VOCABRIA and EDURANT 
for additional safety information [CABENUVA USPI; EDURANT USPI, VOCABRIA 
USPI]. 
AEs and SAEs that are required to be recorded as defined in the eCRF include:  
• AEs/Adverse drug reactions* (ADRs) reported at the Baseline/Month 1 visit that 
are considered related to oral VOCABRIA or EDURANT or from the time of the 
last injections 
• AEs/ADRs considered related to CABENUVA  
• All AEs, whether considered related or not, that cause the participant to 
discontinue CABENUVA  
• All SAEs whether related to CABENUVA or not 
• All CV events listed in Annex 3 
• COVID-19 related adverse events 
*An adverse drug reaction (ADR) is defined as a noxious and unintended response to a 
medication related to any doses where there is at least a reasonable possibility, or the 
relationship cannot be ruled out, that it is related to CABENUVA. 
Non serious AEs that are considered not related to CABENUVA or do not lead to 
withdrawal, should be documented in the source documents but will not be documented 
in the eCRF, as this information has been extensively collected in treatment clinical trials, 
no further information is needed to characterize these events. 


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10.3.2. Time Period and Frequency for Collecting AE and SAE Information 
The IC/ASA staff are obliged to collect and report AE information from the time of 
informed consent to the participants withdrawal or completion from the study. 
AEs that begin during the oral lead-in and are considered related to VOCABRIA or 
EDURANT will be recorded as a VOCABRIA or EDURANT-related AE after obtaining 
the informed consent.  
For participants that are already receiving CABENUVA injections prior to enrolling in 
the study, any CABENUVA related AEs reported after their last injections will be 
recorded after obtaining the informed consent. 
• All other events that begin before the administration of CABENUVA IM 
injections but after obtaining informed consent will be recorded as Medical 
History/Current Medical Conditions not as AEs. 
All SAEs will be recorded and reported to PPD PVG immediately and under no 
circumstance should this exceed 24 hours, as indicated in Section 10.3.10, Table 3.  The 
IC/ASA will submit any updated SAE data to PPD PVG (Annex 4)within 24 hours of it 
being available. 
The IC/ASA should send all participant reported AEs/SAEs to the HIV care provider and 
request a causality assessment.  The HIV care provider is responsible to the medical 
management of any AE/SAEs. 
The IC/ASA is not obligated to actively seek information on AEs or SAEs after 
conclusion of the study participation.  However, if the IC/ASA learns of any SAE, 
including a death, at any time after a participant has been discharged from the study, and 
he/she considers the event to be reasonably related to the study intervention or study 
participation, the IC/ASA staff must promptly notify PPD PVG. 
10.3.3. 
Methods of Detecting AEs and SAEs 
Care will be taken not to introduce bias when detecting AEs and/or SAEs.  Open-ended 
and nonleading verbal questioning of the participant is the preferred method to inquire 
about any adverse event occurrence. 
10.3.4. 
Follow-up of AEs and SAEs 
After the initial AE/SAE report, the HIV care provider and/or the IC/ASA is required to 
proactively follow each participant at subsequent visits/contacts.  All SAEs will be 
followed until the event is resolved, stabilized, otherwise explained, or the participant is 
lost to follow-up (as defined in Section 9.4).  Further information on follow-up 
procedures is given in the SRM. 
10.3.5. 
Regulatory Reporting Requirements for SAEs 
The definition of SAEs can be found in Annex 3. 


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Prompt notification by the IC/ASA staff to PPD of SAEs is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the 
safety of VOCABRIA, EDURANT and/or CABENUVA are met.  All SAEs need to 
be reported and recorded to PPD within 24 hours of IC/ASA awareness of the event.  The 
primary mechanism for reporting SAEs to PPD will be the eCRF, which will send an 
automated, electronic safety alert to PPD.  If the electronic system is unavailable, the 
IC/ASA will use the paper SAE form and fax it to PPD. 
The sponsor has a legal responsibility to notify both the local regulatory authority and 
other regulatory agencies about the safety of VOCABRIA, EDURANT and/or 
CABENUVA.  The sponsor will comply with country-specific regulatory requirements 
relating to safety reporting to the regulatory authority, Institutional Review Boards 
(IRBs), ICs/ASAs and the referring HIV care providers. 
The IC/ASA which receives a safety report describing an SAE or other specific safety 
information (e.g., summary or listing of SAEs) from the sponsor will review and then file 
it along with the required study documents and will notify the IRB, if appropriate 
according to local requirements. 
Safety reports must be prepared for suspected unexpected serious adverse reactions 
(SUSAR) according to local regulatory requirements and sponsor policy and forwarded 
to participating HIV care providers as necessary. 
10.3.6. 
Adverse Event Follow-up with the HIV Care Provider 
The IC/ASA should send all AEs and SAEs to the HIV care provider for follow-up 
medical management and to confirm or determine relatedness to CABENUVA.   
10.3.7. 
Causality Assessments 
The causality assessment to CABENUVA is one of the criteria used when determining 
regulatory reporting requirements.   
Please refer to the most recent USPIs for CABENUVA, VOCABRIA and EDURANT for 
additional safety information [CABENUVA USPI; EDURANT USPI; VOCABRIA 
USPI]. 
• For each AE/SAE, the IC/ASA physician must document in the medical notes that 
he/she has reviewed the AE/SAE reported and has provided an initial assessment of 
causality.  All AE/SAEs, along with the initial assessment of causality to 
CABENUVA, should be sent to the referring HIV care provider. 
• There may be situations in which an SAE has occurred, and the IC/ASA physician 
has minimal information to include in the initial report to PPD PVG.  However, it is 
very important that the IC/ASA physician always make an assessment of 
causality for every event before the initial transmission of the SAE data to PPD 
PVG. 
• The HIV care provider is expected to provide a causality assessment.  The HIV care 
provider’s assessment will determine the final causality to CABENUVA.   


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• When a causal relationship is determined by the HIV care provider to be related 
to CABENUVA, this must be recorded as a treatment related AE or SAE as soon 
as possible.  The PPD Medical Monitor should be informed of these events. 
• If the HIV care provider does not provide a causality, it will remain as the IC/ASA 
physician’s initial determination. 
• In the case that the IC/ASA physician determines a non-serious AE that hasn’t 
resulted in discontinuation or withdrawal is not related to CABENUVA, the AE 
would not be entered into the eCRF.  However, if the referring HIV care provider 
determines that the non-serious AE is related to CABENUVA, the IC/ASA staff will 
enter the AE into the eCRF. 
• The IC/ASA staff may change causality as confirmed by the referring HIV care 
provider or when additional follow-up information is available, in which case an SAE 
follow-up report is sent to PPD (via the automated eCRF email) with the updated 
causality assessment included. 
10.3.8. 
Serious Post-Injection Reactions  
Per the current CABENVUA USPI [CABENUVA USPI], participants should be 
observed briefly (approximately 10 minutes) after the injection.  Serious post-injection 
reactions include dyspnea, agitation, abdominal cramping, flushing, sweating, oral 
numbness, and changes in blood pressure).  These events may have been associated with 
inadvertent (partial) intravenous administration.  For more information, please refer to the 
most recent CABENUVA USPI.  These events should be considered as a serious adverse 
event and reported to PPD PVG as described in Section 10.3.10.  
If a participant experiences a serious post-injection reaction, monitor and treat as 
clinically indicated.  In case of a serious post-injection reaction after administration of 
CABENUVA, an ECG may be obtained if medically required.  The ECG should be 
included in the participants source documents. 
The HIV care provider will determine whether the participant should continue to receive 
CABENUVA and remain in the study.  The Medical Monitor should be made aware of 
these events. 
10.3.9. 
Injection Site Reactions 
Injection site reactions (ISRs) are considered drug related as they are related to the 
administration of CABENUVA.  ISRs may include redness, itching, pain or swelling or 
discomfort at the site of the reaction.  All ISRs must be recorded in the eCRF. 
As ISRs have been well characterized throughout the development program of 
CABENUVA and are considered common adverse drug reactions for CABENUVA, 
therefore only serious ISRs and ISRs leading to discontinuation are required to be 
reported to PPD PVG as described in Section 10.3.10. 


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10.3.10. 
Reporting of AEs and Timelines  
If the eCRF is down at the time of notification of these events, complete the applicable 
AE/SAE paper forms or other safety event eCRF and fax the completed forms to PPD 
PVG.  All SAEs should be reported to PPD PVG immediately and under no circumstance 
should this exceed 24 hours.  Please see Annex 4 for safety contact information the SRM 
for additional information on the follow-up of safety events. 
AE or SAE information must include relationship to CABENUVA.  Specific events 
requiring safety follow-up are: 
• SAEs reported at the Baseline/Month 1 visit that are considered related to oral 
VOCABRIA or EDURANT or from the last injection 
• All SAEs (Annex 3) whether related to CABENUVA or not 
The non-serious AEs listed below will require reporting within 3 days to PPD PVG and 
will use the same automated safety alerts within the eCRF.   
• AEs/Adverse drug reactions (ADRs) (Annex 3) reported at the Baseline/Month 1 
visit that are considered related to oral VOCABRIA or EDURANT or from the 
last injection 
• AEs/ADRs considered related to CABENUVA  
o Note: non-serious injection site reactions do not have to be reported to 
PPD 
• All AEs, whether considered related or not, that cause the participant to 
discontinue CABENUVA (including ISRs) 
• Cardiovascular AEs considered related to CABENUVA  
Safety reporting timeline requirements for AE and SAE is summarized in Table 3.  


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Table 3 
Reporting of Serious Adverse Events and Other Events 
 
Initial Reports 
Follow-up Information on a Previous 
Report 
Type of Event 
Time Frame 
Documents 
Time Frame 
Documents 
All SAEs 
24 hours 
“SAE eCRF”   
24 hours 
Update “SAE eCRF”  
 
Cardiovascular (CV)a or 
death event 
Initial and follow-
up reports to be 
completed when 
the CV event or 
death is 
reportedb  
‘AE/SAE eCRF’ and 
“CV events” and/or 
“death” eCRF  
Initial and follow-up 
reports to be 
completed when the 
CV event or death is 
reportedb 
‘Updated AE/SAE 
eCRF’ and Update 
“CV events” and/or 
“death” eCRF  
Pregnancy 
24 hours 
“Pregnancy 
Notification Form” 
and SAE (if required) 
Within 24 hours of 
IC/ASA staff 
awareness of 
pregnancy outcome 
“Pregnancy Follow-up 
Form” and SAE (if 
required) 
Non serious ADRsc  
3 days 
eCRF 
3 days 
eCRF 
AEs leading to 
withdrawal 
3 days 
eCRF 
3 days 
eCRF 
a. 
CV events are noted in Annex 3. 
b. 
Additional details and time frames for reporting supplementary information for cardiovascular and death 
events are provided in Section 10.3.12. 
c. 
See Section 10.3.1 for additional information of what AE/ADRs need to be collected. 
10.3.11. 
Pregnancy 
Pregnancy status at enrolment should be confirmed in all participants of child-bearing 
potential (POCBP) by asking their pregnancy status and/or when was the last menses 
period (LMP).  If a participant states they are pregnant, or the LMP was >4 weeks, call 
the HIV care provider to confirm if CABENUVA should be administered.  This 
confirmation from the HIV care provider should be stored in the participants source 
documentation. 
Pregnancy testing will be managed by the HIV care provider.  For POCBP, IC/ASA staff 
should verbally ask about pregnancy status at each visit by asking when was the LMP.  If 
the LMP was >4 weeks, call the HIV care provider before injecting CABENUVA. 
If a pregnancy is reported, the IC/ASA will work with the HIV care provider to 
record pregnancy information on the appropriate form and submit it to PPD within 
24 hours of learning of the pregnancy and should follow the procedure outlined in 
SRM.   
Whilst pregnancies are not part of the study nor documented within eCRF, they will 
however be reported to the sponsor within 24 hours of awareness.  All pregnancies 
will be followed up until outcome (including premature terminations and complications) 
for both mother and child. 
The IC/ASA staff will be provided with necessary “pregnancy notification” and 
“pregnancy follow up” forms and supported by clinical monitor and/or GSK/ViiV 
medical team in complying with regular pregnancy reporting procedures.  Pregnancies 


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will also be reported to the Antiretroviral Pregnancy Registry (APR) by GSK global 
safety.  The IC/ASA staff should not report to APR, to avoid duplication. 
• 
Any participant who becomes pregnant while participating in the study will be 
assessed by their HIV care provider whether to continue or discontinue 
CABENUVA and whether to remain in the study.  Pregnancy information will 
be collected from Day 1 and followed for 52 weeks, including any post-study 
SAEs possibly related to CABENUVA should be reported promptly.   
The pregnancy must be followed up to determine outcome (including premature 
termination) and status of mother and child(ren).  Pregnancy complications and elective 
terminations for medical reasons must be reported as an AE or SAE.  Abnormal 
pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, ectopic pregnancy) are considered SAEs. 
Any SAE occurring in association with a pregnancy should be brought to the IC/ASA 
attention after the participant has completed the study and considered by the HIV care 
provider as possibly related to CABENUVA, must be promptly reported to ViiV/GSK. 
• 
ViiV/GSK’s central safety department will also forward this information to the 
Antiretroviral Pregnancy Registry.  The international registry is jointly sponsored by 
manufacturers or licensees of antiretroviral (ARV) products.  Additional information 
and a list of participating manufacturers/licensees are available from 
http://apregistry.com/index.htm. 
Prior to the enrolment of pregnant participants or the continuation of CABENUVA 
following pregnancy, the following must occur: 
• HIV care provider confirms CABENUVA can be continued and this 
documentation is stored in the participants source documents. 
• The IC/ASA, along with the HIV care provider, agrees to monitor the outcome of 
the pregnancy and the status of the participant and her offspring. 
10.3.12. 
Cardiovascular and Death Events 
All deaths will be reported and recorded as SAEs.  In addition, all deaths will be required 
to have the eCRF death forms completed by the IC/ASA.  These sections include 
questions regarding the death (including sudden cardiac death and non-cardiovascular 
death).  
The Death eCRF is provided immediately after the occurrence or outcome of death is 
reported.  Initial and follow-up reports regarding death must be completed within one 
week of when the death is reported. 
For any CV events detailed in ANNEX 3, whether or not they are considered SAEs, 
specific CV sections of the eCRF will be required to be completed.  These sections 
include questions regarding the CV event (including sudden cardiac death).  
The CV CRFs are presented as queries in response to reporting of certain CV Medical 
Dictionary for Regulatory Activities (MedDRA) terms.  The CV information should be 


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recorded in the specific cardiovascular section of the CRF within one week of receipt of a 
CV Event data query prompting its completion.   
10.3.13. 
Medical Device Deficiency  
The vial adaptor, syringe, and needles provided commercially in the study are classed as 
medical devices by the FDA.  If a medical device deficiency or incident is noted during 
the study, please follow the instructions found in the CABENUVA packaging for 
reporting the incident. 
 


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11. 
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65-76 
Quality Enhancement Research Initiative (QUERI) Implementation Guide. Updated 
2013. https://www.queri.research.va.gov/implementation/ImplementationGuide.pdf 
Swindells S, Andrade-Villanueva J-F, Richmond GJ, et al. Long-acting cabotegravir and 
rilpivirine for maintenance of HIV-1 suppression. N Engl J Med 2020; 382:1112-23. 


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U.S. Department of Health and Human Services, National Institutes of Health, National 
Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS 
(DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 
2.1. [March 2017]. Available from: 
https://rsc.tech-res.com/docs/default-source/safety/daids-ae-grading-table-mar2017.pdf 
U.S. Department of Health and Human Services. Food and Drug Administration (FDA). 
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 
Pandemic - Guidance for Industry, Investigators, and Institutional Review Boards. March 
2020. Available at: https://www.fda.gov/media/136238/download. Accessed April 6, 
2020. 
VOCABRIA Prescribing Information (VOCABRIA USPI). 
Weiner, B. J., Lewis, C. C. N., Stanick, C., et al. (2017b). Acceptability of Intervention 
Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of 
Intervention Measure (FIM) (appears in: Psychometric Assessment of Three Newly 
Developed Implementation Outcome Measures). Copyright: Creative Common License. 
Weiner, B. J., Lewis, C. C., Stanick, C. et al. (2017a). Psychometric assessment of three 
newly developed implementation outcome measures. Implementation Science, 12(1), 1-
12. 
WHO Case Definition - March 20, 2020 Version 
(https://www.who.int/publicationsdetail/global-surveillance-for-human-infection-with-
novel-coronavirus-(2019-ncov)). 
 


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ANNEX 1: SCHEDULE OF ACTIVITIES 
Procedure1 
Baseline/ 
Month 12 
Treatment Period (Months) 
E.D.3 
Notes 
2 
3 
4 
5 
6 
7 
8 
1. 
The timing and number of planned study assessments may be altered during the study based on newly available data.  
2. 
The following sequence of events must be followed for participants at the Baseline/Month 1 visit: 1) Informed consent form (ICF) Consent 2) Confirm Inclusion and Exclusion 
criteria 3) complete questionnaires and assessments, 4) Receive first study related intramuscular (IM) injections at the IC/ASA.  Baseline is defined as the Month 1 visit. 
3. E.D = early discontinuation/ withdrawal: This visit should only be conducted if the participant discontinues from the study, and the discontinuation/withdrawal reason should be 
recorded. 
NOTE: Carefully follow the Instructions for Use when preparing and administering CABENUVA IM to avoid accidental intravenous administration 
Clinical and Other Assessments 
Informed consent 
X 
 
 
 
 
 
 
 
 
Written informed consent must be obtained from 
each potentially eligible participant by IC/ASA 
personnel prior to the initiation of any Baseline 
procedures as outlined in this protocol. 
Inclusion and 
exclusion criteria 
X 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria will be fully assessed at 
the Baseline/Month 1 Visit. 
Demography 
X 
 
 
 
 
 
 
 
 
 
Pregnancy Status 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Ask POCBP at each visit if they are pregnant and 
ask for the date of their LMP.  See Section 10.3.11 
for additional information. 
For participants on every 2 monthly injections, 
pregnancy status should be confirmed only at 
IC/ASA visits 


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Procedure1 
Baseline/ 
Month 12 
Treatment Period (Months) 
E.D.3 
Notes 
2 
3 
4 
5 
6 
7 
8 
Height and weight 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Height will only be collected at Baseline. 
BMI will be calculated within the eCRF.  
If possible, the same scale should be used 
consistently throughout the study and participants 
should be asked to remove any excess clothing 
(i.e., coats and shoes).  
For participants on every 2 monthly injections, 
weight would be collected only at IC/ASA visits 
Vital signs: blood 
pressure, heart rate 
X 
Vital signs will be measured according to the POT with the HIV care provider.  All vital 
signs collected must be stored in the participants source documentation at the IC/ASA. 
Vital signs are to be measured after resting in a 
semi-supine position for at least 5 minutes. 
For participants on every 2 monthly injections, vital 
signs would be collected only at IC/ASA visits 
Laboratory 
assessments (HIV1-
RNA, liver 
chemistries, other 
labs per POT) 
X 
 
 
 
 
 
 
X 
X 
The Baseline/Month 1 labs should be collected 
prior to the first study injection (at the 
Baseline/Month 1 visit.  See Section 10.1 for 
additional information 
The HIV care provider is responsible for monitoring 
and any follow-up of elevated HIV-1 RNA and liver 
chemistries in their PLWHIV and to let the IC/ASA 
know if there are any changes to the monthly or 
every 2-month injections.  The HIV care provider 
can request that the IC/ASA draw labs at any time 
or they can perform local labs as required. 
Additional Lab assessments may be obtained per blueprint and the POT with 
the HIV care provider.  All lab reports must be stored in the participants 
source documentation at the IC/ASA. 
Fasting is not required unless otherwise required for a specific lab test. 
Study Treatment:  All injections will be administered according to the CABENUVA USPI. 
CABENUVA IM Injections initiated at IC/ASA, post oral lead-in (1st injections of CABENUVA at the IC/ASA) 
The final oral doses of VOCABRIA + EDURANT, or 
other ART, should be taken on the same day when 
injections with CABENUVA are started. 
Questionnaires and procedures should be 
conducted prior to the injections. 


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Procedure1 
Baseline/ 
Month 12 
Treatment Period (Months) 
E.D.3 
Notes 
2 
3 
4 
5 
6 
7 
8 
Monthly Dosing (post 
oral lead-in) 
X 
X 
X 
X 
X 
X 
X 
X 
 
IM dosing is expected to occur on the same date of 
the month as determined by Dose 1 - Treatment 
Target Date.  Dosing window is (+ or -) a 7-day 
window 
Every 2-month 
Dosing  
X 
X 
 
X 
 
X 
 
X 
 
Dosing window for every 2-months is +/ - 7-days. 
CABENUVA IM Continuation injections: for those already receiving CABENUVA injections, and who are to get their 
subsequent injections at the IC/ASA 
Note:  To avoid having participants whose last injections are at Month 7 return to the IC/ASA at Month 8, the end of study 
assessments (Month 8) will be completed at Month 7.  Questionnaires and potential interviews will be completed at Month 8 
Questionnaires and interviews should be 
conducted prior to the injections. 
Monthly Dosing 
X 
X 
X 
X 
X 
X 
X 
X 
 
The first study related CABENUVA injections at the 
IC/ASA should be started within 1 month (7-day) 
after the last injections. 
For participants switching from an every-2-month 
continuation injection schedule to a monthly 
continuation dosing schedule, follow the dosing 
instructions in the most recent USPI for 
CABENUVA, pl. 
Every 2-month dosing 
(participants already 
receiving every 2-
month dosing) 
X 
 
X 
 
X 
 
X 
 
 
Dosing window for every 2-month dosing is  7-
days. 
For participants switching from a monthly 
continuation injection schedule to an every-2-
month continuation injection dosing schedule follow 
the dosing instructions in the most recent USPI for 
CABENUVA.,  


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Procedure1 
Baseline/ 
Month 12 
Treatment Period (Months) 
E.D.3 
Notes 
2 
3 
4 
5 
6 
7 
8 
Concomitant 
medication review 
X 
======================================================  
X 
The IC/ASA will note all new concomitant 
medications and send to the HIV care provider.  
Contraindicated medications and concomitant 
medications with a potential for a DDI per 
CABENUVA USPI will be recorded. 
Adverse Event (AE) 
Review 
X 
======================================================  
X 
See Section 10 for more information on the DAIDS 
grading scale, Section 10.3.7 for guidelines on 
assessment of causality, and Section 10.3.10 for 
AE reporting requirements   
Refer to the Annex 3 for definitions of AEs. 
Serious AEs (SAEs) 
X 
=====================================================  
X 
See Section 10 for more information on the DAIDS 
grading scale, Section 10.3.7 for guidelines on 
assessment of causality, and Section 10.3.10 for 
SAE reporting requirements.  
Refer to the Annex 3 for definitions of SAEs  
Questionnaires and Interviews: Questionnaires and Interviews should be completed before receiving CABENUVA IM injections 
Participants 
Baseline/Month 1 is defined as the date when a participant signs ICF and completes Baseline/Month 1 protocol procedures prior to receiving the first study related CABENUVA 
injections at the IC/ASA 
All additional study visits, including those where questionnaires and/or interviews are administered at Months 3 and 8 will be anchored off of each participants Month 1 visit, so it will 
reflect the Months on study, regardless of what dosing regimen the participant is on (e.g., monthly or every 2 monthly) and regardless of whether they have missed any injections 
and received oral bridging. 


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Procedure1 
Baseline/ 
Month 12 
Treatment Period (Months) 
E.D.3 
Notes 
2 
3 
4 
5 
6 
7 
8 
Participant 
Questionnaires  
X 
 
X 
 
 
 
 
X 
X 
At Month 1, Questionnaires should be completed 
after signing the ICF and before receiving 
CABENUVA IM injections or within 14 days 
following the Month 1 visit. 
Questionnaires should be completed before 
receiving CABENUVA IM injections or  14 days 
following the last visit. 
Participant Interviews  
 
 
 
 
 
 
 
X 
X 
Interviews will be completed at the participants last 
study Visit: Month 8 or early withdrawal visit.  
Interviews can be completed 2 weeks before or 2 
weeks following the last visit. 
Interviews should be completed before receiving 
CABENUVA IM injections if interviews are 
completed the day the injections are administered. 
Expert Panel: will consist of key IC/ASA staff members involved in decision making and/or oversee daily operations at the IC/ASA, selected HIV care providers that may refer 
PLWHIV, and ViiV Healthcare (VHC).  Panel members will meet prior to Baseline/Month 1 to design the Blueprint (Section 5.1.1) 
Baseline/Month 1 is defined as the date when a participant signs ICF, completes protocol procedures and receives the first study related CABENUVA injections at any infusion 
center. 
Month 3 and Month 6 assessments are to be completed after approximately 10 participants (across all ICs/ASA) have completed their Month 3 and Month 6 study visits at any 
IC/ASA site 
Expert Panel 
Questionnaires 
X (Prior to 
Month 1) 
 
X 
 
 
X 
 
 
 
FIM, AIM (FIM and AIM also completed prior to 
FPFV at the Baseline/Month 1 visit) 
Meetings will be held as required over the first 6 
months to discuss any iterations that are needed to 
refine and optimize the blueprint. 


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Procedure1 
Baseline/ 
Month 12 
Treatment Period (Months) 
E.D.3 
Notes 
2 
3 
4 
5 
6 
7 
8 
Expert Panel 
Interviews 
X (Prior to 
Month 1) 
 
 
 
 
X 
 
 
 
FIM, AIM (FIM and AIM also completed prior to 
FPFV at the Baseline/Month 1 visit) 
Meetings will be held as required over the first 6 
months to discuss any iterations that are needed to 
refine and optimize the blueprint. 
HIV Care Providers/Clinical Staff 
Baseline/Month 1 is defined when the HIV care provider’s first patient referred to the IC/ASA is enrolled into the study and receives their first study related injections of CABENUVA.  
HIV care providers/clinical staff will be asked to complete the Baseline/Month 1 questionnaire within 4 weeks of their first referred patient enrolled. 
Month 4 and Month 8 assessments are to be completed when the HIV care provider’s first referred patient completes the Month 4 or Month 8 study visits, respectively.  
Questionnaires and/or interviews can be completed up to 2 weeks before or after the Month 4 or Month 8 study visits 
HIV Care Providers/ 
Clinical Staff 
Questionnaires 
X (Within 
4 weeks) 
 
 
X 
 
 
 
X 
 
HIV care providers/clinical staff should complete 
questionnaires within 4 weeks following their first 
patient’s enrolment into the study.  
Only HIV care providers/clinical staff that had 
patients enrolled into the study will be included in 
assessments post Baseline/Month 1.   
HIV Care Providers/ 
Clinical Staff 
Interviews 
 
 
 
 
 
 
 
X 
 
Infusion Center Staff: Baseline questionnaires should be completed prior to the first participant enrolled 
Baseline/Month 1 questionnaires should be completed prior to enrolment of the first participant at each infusion center. 
Month 1 for each IC/ASA is defined when the first participant enrolls into the study at that specific IC/ASA and the participant is administered the first study related injections of 
CABENUVA. 
Month 2 for potential interviews of approximately 5 IC/ASA staff will be defined after at least 1 participant, at their respective IC/ASA site, has completed their Month 2 study visits 
Month 3 and Month 8 will be defined after at least 1 participant, at their respective IC/ASA site, has completed their Month 3, or 8 study visits, respectively.  Questionnaires and/or 
interviews can be completed up to 2 weeks before or after to the Month 3 or Month 8 study visits. 


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Procedure1 
Baseline/ 
Month 12 
Treatment Period (Months) 
E.D.3 
Notes 
2 
3 
4 
5 
6 
7 
8 
IC Staff 
Questionnaires 
X (Prior to 
Month 1) 
 
X  
 
 
 
 
X 
 
Month 1/Baseline questionnaires should be 
completed prior to the first participant enrolled at 
that IC/ASA.  
Questionnaires at other months should be 
completed within  14 days of the scheduled 
month. 
IC Staff Interviews  
 
X 
 
 
 
 
 
X 
 
Month 1/Baseline questionnaires should be 
completed prior to the first participant enrolled at 
that IC/ASA.   
Questionnaires at other months should be 
completed within  14 days of the scheduled 
month. 
 
 


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ANNEX 2. LIST OF STAND-ALONE DOCUMENTS 
Study Blueprint 
Plan of Treatment (PoT) 
Study Reference Manual (SRM) 
 


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Annex 3: AE and SAE Definitions 
Annex 3.1   Definition of an Adverse Event  
AE Definition 
• An AE is any untoward medical occurrence in a clinical study participant, temporally 
associated with the use of CABENUVA, whether or not considered related to the 
CABENUVA. 
• 
NOTE: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of CABENUVA. 
Definition of Unsolicited and Solicited AE 
• An unsolicited AE is an AE that was not solicited and that is communicated by a 
participant or their legally authorized representative (LAR) who has signed the 
informed consent.  Unsolicited AEs include serious and nonserious AEs.  Only AEs 
that are considered related to CABENUVA or lead to discontinuation of 
CABENUVA will be recorded.   
• Potential unsolicited AEs may be medically attended (i.e., symptoms or illnesses 
requiring hospitalization, emergency room visit, or visit to/by a healthcare provider).  
The participants or their LAR(s) will be instructed to contact the HIV care provider 
and/or the IC/ASA staff as soon as possible to report medically attended event(s), as 
well as any events that, although not medically attended, are of concern to the 
participant or LAR.  Detailed information about reported unsolicited medically 
attended AEs will be collected by qualified IC/ASA site personnel, communicated 
to the HIV care provider, documented in the participant’s source documentation, and 
recorded in the participant’s records if related to CABENUVA or leads to 
discontinuation. 
• Unsolicited AEs that are not medically attended nor perceived as a concern by 
participant or their LAR(s) will be collected during the visit with the participants or 
their LAR(s) and by review of available medical records at the next visit.  Any 
unsolicited CABENUVA-related AEs reported during a visit must be documented in 
the participant’s source documentation, communicated to the HIV care provider, and 
recorded in the eCRF by the IC/ASA if the event is considered related to 
CABENUVA or leads to discontinuation.  
Events Meeting the AE Definitions 
• Any abnormal laboratory test results that are collected (hematology, clinical 
chemistry, or urinalysis) or other safety assessments (e.g., electrocardiogram (ECG), 
radiological scans, vital signs measurements) considered clinically significant and 
CABENUVA related in the medical and scientific judgment of the HIV care provider 
and/or IC/ASA physician. 


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AE Definition 
• Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition.  If the IC/ASA staff are 
alerted to this, these events should be recorded. 
• New conditions detected or diagnosed after CABENUVA administration at the 
IC/ASA that are considered CABENUVA related or lead to the discontinuation of 
CABENUVA even though it may have been present before the start of the study. 
• Signs, symptoms, or the clinical sequelae of a suspected CABENUVA interaction. 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of CABENUVA 
or a contraindicated or concomitant medication with the potential drug-drug 
interactions.  Overdose per se will not be reported as an AE/SAE unless it is an 
intentional overdose taken with possible suicidal/self-harming intent. Such 
overdoses should be reported regardless of sequelae. 
• The signs, symptoms, and/or clinical sequelae resulting from lack of efficacy will be 
reported as AE or SAE if they fulfil the definition of an AE or SAE. “Lack of 
efficacy” or “failure of expected pharmacological action” also constitutes an AE or 
SAE. 
Events NOT Meeting the AE Definition  
• Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments which are associated with the underlying disease, unless judged by the 
HIV care provider to be more severe than expected for the participant’s condition. 
• The disease being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the participant’s 
condition. 
• Medical or surgical procedure (e.g., endoscopy, appendectomy): the condition that 
leads to the procedure is the AE. 
• Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present 
or detected at the start of the study that do not worsen. 
Annex 3.2   Definition of an SAE 
An SAE is defined as any serious AE that meets one of the following criteria: 
• Results in death 
• Is life-threatening 
The term “life-threatening” in the definition of “serious” refers to an event in which the 
participant was at risk of death at the time of the event.  It does not refer to an event that 
hypothetically might have caused death if it had been more severe. 


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An SAE is defined as any serious AE that meets one of the following criteria: 
• Requires inpatient hospitalization or prolongation of existing hospitalization 
• In general, hospitalization signifies that the participant has been admitted 
(usually involving at least an overnight stay) to the hospital or emergency ward 
for observation and/or treatment that would not have been appropriate in the 
physician’s office or outpatient setting.   
• Complications that occur during hospitalization are AEs.  If a complication 
prolongs hospitalization or fulfils any other serious criteria, the event is serious.  
When in doubt as to whether “hospitalization” occurred or was necessary, the 
AE should be considered serious. 
• Hospitalization for elective treatment of a pre-existing condition that did not 
worsen from baseline is not considered an AE. 
• Results in persistent or significant disability/incapacity 
• The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions. 
• This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (e.g., sprained ankle) that may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption. 
• Is a congenital anomaly/birth defect 
• Other situations: 
• Possible Hy’s Law case: alanine aminotransferase ≥ 3 x upper limit of normal 
(ULN) AND total bilirubin ≥ 2 x ULN (>35% direct bilirubin) or international 
normalized ratio (INR) > 1.5 must be reported as SAE 
• Medical or scientific judgment should be exercised by the HIV care providers 
and/or the IC/ASA physician in deciding whether SAE reporting is appropriate 
in other situations, such as significant medical events that may jeopardize the 
participant or may require medical or surgical intervention to prevent one of the 
other outcomes listed in the above definition.  These events should usually be 
considered serious. 
o Examples of such events include invasive or malignant cancers, intensive 
treatment for allergic bronchospasm, blood dyscrasias, convulsions, or 
development of intervention dependency or intervention abuse. 


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Annex 3.3   Definition of a Cardiovascular Event 
Cardiovascular Events (CV) Definition: 
IC/ASA staff will be required to fill out the specific CV event page of the CRF for the 
following AEs and SAEs: 
• Myocardial infarction/unstable angina 
• Congestive heart failure 
• Arrhythmias 
• Valvulopathy 
• Pulmonary hypertension 
• Cerebrovascular events/stroke and transient ischemic attack 
• Peripheral arterial thromboembolism 
• Deep venous thrombosis/pulmonary embolism 
• Revascularization 
Annex 3.4   Recording and Follow-up of AEs and SAEs 
AE and SAE Recording 
• When a CABENUVA-related AE, AE leading to withdrawal, or any SAE occurs, it 
is the responsibility of the HIV care provider to review all documentation (e.g., 
hospital progress notes, laboratory and diagnostics reports) related to the event. 
• The IC/ASA will then record all relevant AE/SAE (VOCABRIA or EDURANT 
related AEs, CABENUVA-related AEs, AEs leading to withdrawal, all SAEs) 
information. 
• If an event is not an AE per definition above, then it cannot be an SAE even if serious 
conditions are met (e.g., hospitalization for signs/symptoms of the disease under 
study, death due to progression of disease, etc.). 
• It is not acceptable for the IC/ASA or HIV care provider to send photocopies of the 
participant’s medical records to the Medical Monitor or the Sponsor in lieu of 
completion of the eCRF required forms. 
• There may be instances when copies of medical records for certain cases are 
requested.  In this case, all participant identifiers, with the exception of the 
participant number, will be redacted on the copies of the medical records before 
submission. 
• The IC/ASA staff, working with the HIV care provider, will attempt to establish a 
diagnosis of the event based on signs, symptoms, and/or other clinical information.  
Whenever possible, the diagnosis (not the individual signs/symptoms) will be 


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AE and SAE Recording 
documented as the AE/SAE and recorded in the eCRF if it is a VOCABRIA-, 
EDURANT, or CABENUVA-related AE, an AE leading to withdrawal, or an SAE. 
Assessment of Intensity 
All AEs and SAEs reported during the study should be evaluated by the IC/ASA 
physician, working with the HIV care provider, and if an AE/SAE is determined as a 
CABENUVA related AE, leads to discontinuation, or is an SAE, it will be graded in the 
eCRF. 
The IC/ASA staff will capture the SAE causality in the participant’s source notes in a 
timely manner, and the IC/ASA staff or an appropriately delegated team member will 
enter the causality into the eCRF.  CRAs will monitor the participant source 
documentation to confirm that SAE causality is being documented in a timely manner. 
• 
Mild:  An event that is easily tolerated by the participant, causes minimal 
discomfort, and does not interfere with everyday activities. 
• 
Moderate:  An event that is sufficiently discomforting to interfere with normal 
everyday activities. 
• 
Severe:  An event that prevents normal everyday activities – an AE that is assessed 
as severe will not be confused with an SAE.  Severity is a category utilized for rating 
the intensity of an event, and both AEs and SAEs can be assessed as severe. 
Assessment of Causality 
• 
The IC/ASA physician, working with the HIV care provider, is obligated to assess 
the relationship between CABENUVA and each occurrence of each AE and SAE 
reported.  Prior to a participant enrolling in the study, if an AE or SAE should be 
reported and if it is related to oral VOCABRIA or EDURANT, it should be 
documented in the eCRF. 
• A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than that a relationship 
cannot be ruled out. 
• The IC/ASA physician, working with the HIV care provider, will use clinical 
judgment to determine the relationship. 
• Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to CABENUVA 
administration, will be considered and investigated. 
• The HIV care provider and/or IC/ASA physician will also consult the USPIs for 
CABENUVA, VOCABRIA, and EDURANT in their assessment  
• For each AE and SAE, the IC/ASA physician must document in the medical notes 
that they have reviewed the AE/SAE and have provided an assessment of causality 
and have retrieved all required source documentation as available. 


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AE and SAE Recording 
• There may be situations in which an SAE has occurred, and the IC/ASA has minimal 
information to include in the initial report to ViiV Healthcare (VHC).  However, it 
is very important that the IC/ASA physician, working with the HIV care 
provider, always makes an assessment of causality for every event before the 
initial transmission of the SAE data to VHC. 
• The HIV care provider may change their opinion of causality in light of follow-up 
information, and the IC/ASA should send an SAE follow-up report with the updated 
causality assessment. 
• 
The causality assessment is one of the criteria used when determining regulatory 
reporting requirements. 
Follow-up of AE and SAE 
• The HIV care provider will medically and clinically manage the follow-up of each 
AE and SAE.  If this follow-up information is shared with the IC/ASA, this should 
be recorded.  Information regarding the causality of the AE or SAE can be updated 
based on these investigations by the HIV care provider.  
• If a participant dies during participation in the study, the IC/ASA will provide VHC 
with a copy of any postmortem findings including histopathology, if this is available 
to them.  
• New or updated information will be recorded. 
• 
The IC/ASA will submit any updated SAE data to VHC within 24 hours of receipt 
of the information. 
Annex 3.5   Reporting of SAEs to ViiV/GSK 
SAE Reporting to ViiV/GSK via Electronic Data Collection Tool 
• The primary mechanism for reporting SAEs to PPD and to VHC will be the 
electronic data collection tool. 
• If the electronic system is unavailable, then the IC/ASA will use the paper SAE data 
collection tool to report the event within 24 hours. 
• The IC/ASA will enter the SAE data into the electronic system as soon as it becomes 
available. 
• The IC/ASA physician or a medically qualified sub-physician, working with the HIV 
care provider, must show evidence within the source documents of the review and 
verification of the relationship of each SAE to CABENUVA, VOCABRIA, or 
EDURANT. 
• After the study is completed at a given site, the electronic data collection tool will be 
taken off-line to prevent the entry of new data or changes to existing data. 


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SAE Reporting to ViiV/GSK via Electronic Data Collection Tool 
• If an IC/ASA receives a report of a new SAE from a study participant or receives 
updated data on a previously reported SAE after the electronic data collection tool 
has been taken offline, then the IC/ASA can report this information on a paper SAE 
form (see table below) or to the Medical Monitor by telephone. 
• 
Contacts for SAE reporting can be found in SRM. 
SAE Reporting to ViiV/GSK via Paper Data Collection Tool 
• The IC/ASA staff will complete, scan, and upload the applicable AE/SAE or other 
safety event CRF to SharePoint and will then email Evidera/PPD and 
wilsafety@ppd.com to inform them that an AE/SAE or other safety event has 
occurred and that the applicable form has been uploaded to the specific SharePoint 
folder. AE or SAE information must include the relationship to CABENUVA, and 
the IC/ASA will contact the participant’s HIV care provider urgently to discuss this 
assessment. 
• Evidera/PPD project managers (PMs) and the PPD Pharmacovigilance (PVG) team 
will receive automatic notifications when CRFs are uploaded and will review all 
AE/SAE and other safety event CRFs within one business day.  
• Evidera/PPD PMs will contact the PPD PVG team to ensure that they have received 
the notification.  
• 
The PPD PVG team will inform the GSK/ViiV medical monitor(s), safety team, and 
applicable team members of the event via email and will provide the necessary 
documentation within 24 hours of awareness. The GSK/ViiV medical monitors will 
be given access to the SharePoint site. The safety documents will be viewable 
through SharePoint and will not need to be downloaded.  
 
 


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Annex 4: Contact Information for Reporting of AEs and SAEs 
and Pregnancies 
Study contacts  
Available 24/24 hours and 7/7 days 
PPD Clinical Safety and Pharmacovigilance (PPD PVG) 
SAE Hotline for North America 
Phone   1-800-201-8725 
Fax:      1-888-488-9697 
Email:   WIL Safety (SM) wilsafety@ppd.com 
 
Additional contacts can be found in the SRM. 
 


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Annex 5: Protocol Amendments  
The Protocol Amendment Summary of Changes Table for the current amendment is 
located directly before the Table of Contents (TOC). 
Annex 5.1  Protocol Amendment 05 (14 November 2022 
The primary and only purpose of this amendment is to update the Sponsor address on the 
Title Page 
Section # and 
Name 
Description of Change 
Brief Rationale 
Title Page 
Updated Sponsor Address 
Location Moved 
Annex 5.1 
Moved the Table of Changes 
from Protocol Amendment 
04 to Annex 5.1  
Moved according to the Protocol 
template 
Annex 5.2  Protocol Amendment 04 (6 October 2022) 
The primary and only purpose of this amendment is to update the Sponsor address on the 
Title Page 
The primary purpose of this amendment is to support the additional Infusion Centers 
The primary purpose of this amendment is to support the additional Infusion Centers 
being added to the study to broaden the geographical area within the US and to scale-up 
the implementation blueprint.  The additional ICs will be initiated between approximately 
November 2022 – 1st Quarter 2023.  Other changes include deletion of Exclusion 
Criteria 4 in Section 4.2.1 to allow participants into the study regardless of how many 
prior (pre-study) injections of CABENUVA they have received at the IC site and to 
remove the recruitment period of 12 months as the recruitment period for some sites may 
be longer than or less than 12 months.   
Section # and 
Name 
Description of Change 
Brief Rationale 
Global Change to 
Sections listed 
below 
Added other clinical staff to 
also be allowed to complete 
questionnaires and 
interviews, represented as 
HIV Care Provider/clinical 
staff 
Some HIV care providers manage 
their patients in conjunction with 
other clinic staff members who, 
work with ICs and may be better 
to complete some study 
assessments 
• Global change to Section 1 Abstract, Section 2.1 Background, Section 2.2 Rationale, 
Section 3. Objectives and Endpoints, Section 4.1. Study Design, Section 4.3.2 HIV 
Care Providers, Section 5.1.2 Implementation Assessments, Section 5.1.3 Timepoint 
Definitions, Section 5.1.4 Primary Endpoint, Section 6. Statistical Considerations, 


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Section # and 
Name 
Description of Change 
Brief Rationale 
Section 6.1 Study Size, Section 6.2 Essential Analysis, Section 6.3 Secondary 
Analysis, Annex 1 Schedule of Activities 
Global Change to 
Sections listed 
below 
Expert Panel expected 
completion is expected in late 
2022 
Clarification for the additional 
ICs, how the optimized blueprint 
and POT will be revised outside 
the Expert Panel 
• Global change to Section 1 Abstract; Section 2.2 Rationale, Section 4.1 Study 
Design, Section 4.3.2 HIV Care Providers, Section 5.1.1 Expert Panel, Section 5.1.5 
Blueprint and Plan of Treatment 
Through-out 
Minor editorial and 
document formatting 
revisions 
Minor and therefore have not been 
summarized 
Section 1 
Abstract  
 
Moved the Study Design 
section up within the abstract 
Added text regarding the 
additional ICs  
 
 
Removed all text regarding a 
12-month recruitment period 
Revised order for readability in 
light of the changes made  
Increased the approximate number 
of IC sites to include the 
additional ICs 
 
The recruitment period for some 
sites may be longer than or less 
than 12 months 
Section 4.1 Study 
Design 
Modified schema 
In the Participants design removed 
one set of the questionnaire/ 
interview symbols for clarity 
Added footnote to explain how the 
blueprint will be revised outside of 
the Expert Panel 
Section 4.2 Study 
Population 
Removed all text regarding a 
12-month recruitment period 
The recruitment period for some 
sites may be longer than or less 
than 12 months 
Section 4.2.1.2 
Exclusion Criteria 
Removed Exclusion 
Criteria 4 
To allow participants into the 
study regardless of how many 
prior (pre-study) injections of 
CABENUVA they have received 
at the IC 
Section 4.3.2 HIV 
Care Providers  
 
Revision to number of IC 
sites  
 
Increased the approximate number 
of IC sites to include the 
additional ICs  


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Section # and 
Name 
Description of Change 
Brief Rationale 
Section 4.3.3 
Infusion Center 
Staff 
Minor text changes 
Clarification of text 
Section 5.1.1 
Expert Panel 
Added text regarding the 
additional ICs entering the 
study 
New information 
Section 5.1.2 
Implementation 
Assessments 
Section 6 
Statistical 
Considerations 
Added baseline analysis 
To gain insights on the initial 
assessment of implementation 
science data on primary and key 
secondary objectives 
Section 6.1 Study 
Size 
Revision to number of IC 
sites 
 
Removed all text regarding a 
12-month recruitment period 
Increased the approximate number 
of IC sites to include the 
additional ICs 
The recruitment period for some 
sites may be longer than or less 
than 12 months 
Annex 1 
Schedule of 
Activities  
Corrected several errors in 
text and in the Month of 
assessment 
 
Clarifications 
Annex 5 Protocol 
Amendments 
Moved Protocol 
Amendment 3 Table of 
Changes to Annex 5 
 
 
Annex 5.3  Protocol Amendment 03 (20July2022) 
Overall Rationale for Amendment 3  
The primary purposes of this amendment are to update Inclusion Criteria 2 in Section 
4.2.1 so that it matches the prescribing information in the CABENUVA USPI and to 
clarify the Schedule of Activities for those participants whose last study injections of 
CABENUVA at the Infusion Center falls on Month 7. 


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Section # and 
Name 
Description of Change 
Brief Rationale 
Section 1 
Abstract; Global 
change 
Change “first study 
administration of 
CABENUVA at the Infusion 
Center (IC)” to “first study 
related administration of 
CABENUVA at the IC” 
Revised to align with the new 
Exclusion Criteria 4, excluding 
participants who have received 
more than 3 injections of 
CABENUVA at the IC 
Section 4.1 Study 
Design; Global 
Change 
Remove the location of the 
ICs 
Removed as the study may recruit 
additional sites 
Section 4.1 Study 
Design 
Revision for clarify 
Added timeline for participants 
entering the study already on 
every 2-month dosing  
Section 4.2.1.1 
Inclusion Criteria 
Revised Inclusion Criteria 2 
Revised Inclusion Criteria to align 
with the CABENUBA USPI 
Section 4.2.1.2 
Exclusion Criteria 
Added new exclusion for 
those that have received more 
than 3 non-study 
CABENUVA injections at an 
IC 
Ensure that all participants have a 
similar starting point when 
answering questionnaires at 
Baseline. 
Section 4.3.1 
Participants with 
HIV-1 
Revision of text 
Modified the first paragraph and 
removed the next 2 paragraphs as 
they repeated the text in the new 
paragraph and in Inclusion 
Criteria 2  
Section 4.3.1 
Participants with 
HIV-1; global 
change 
Removed strikethrough text: 
A participant is considered to 
have completed the study if 
he/she has finished all Month 
8 assessments and receive 
their last injections of 
CABENUVA at the IC  
Clarification, as study participants 
can continue to receive 
CABENUVA at the IC after the 
Month 8 assessments 
Section 4.3.2 HIV 
Care Providers 
and Section 6.1 
Study Size 
Revision to number of IC 
sites 
Increased the approximate number 
of ICs as the study may increase 
the number of IC site 
Section 4.3.2 HIV 
Care Providers 
Removed strikethrough text: 
Once insurance verification 
is approved and reviewed 
with the patient, the IC will 
inform the HIV care provider 
Revised to ensure compliance 
with the CABENUVA USPI 


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Section # and 
Name 
Description of Change 
Brief Rationale 
and the patient will initiate 
treatment with the oral lead-
in of VOCABRIA + 
EDURANT per the 
CABENUVA USPI 
Section 4.3.3 
Infusion Center 
Staff 
Removed strikethrough text: 
Completed questionnaires 
will not be collected in the 
eCRF 
Removed as study is moving to 
new system for collecting case 
report forms, and this will include 
IC staff questionnaires. 
Section 5.1 
Formative 
Evaluation 
Procedures 
Text revised 
Repetitious text was deleted 
Section 5.1.1 
Expert Panel 
Text revised 
Changed maintenance injections 
to continuation injections per the 
USPI 
Section 5.1.2 
Implement 
Assessments 
Revised text to align with 
changes in Section 6 
Wording on when an interim 
analysis may be conducted was 
revised for flexibility 
Section 5.1.3 
Timepoint 
Definitions for 
Completion of the 
Questionnaires 
and Interviews 
Deleted the Month 6 
assessment  
IC questionnaire Month 6 
questionnaire assessment was 
removed as this was revised in 
Protocol Amendment 2  
Section 6 
Statistical 
Considerations 
Revised text 
Flexibility was added on the 
number and when an interim 
analysis may be conducted  
Section 6.2 
Essential 
Analysis 
Revised text  
Additional sub-groups were 
included to align with the revised 
Inclusion and Exclusion criteria, 
initiation methods and the number 
of injections received prior to 
enrolment  
Section 8 
CABENUVA and 
Concomitant 
Therapy 
Revised text 
 
 
Deleted sentence 
Text was clarified to ensure that 
all participants were receiving 
CABENUVA per the USPI 
Sentence removed regarding the 
collection points for 
questionnaires 


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Section # and 
Name 
Description of Change 
Brief Rationale 
Annex 1 
Schedule of 
Activities 
Update to include 
information on participants 
whose last study injections 
fall at Month 7 and not at 
Month 8 
 
 
Deleted specific instructions 
for changing injection 
schedule in a participant 
To avoid having participants 
whose last injections are at Month 
7 return to the IC at Month 8, the 
end of study assessments (Month 
8) will be completed at Month 7.  
Questionnaires will be completed 
at Month 8 
Text revised to ensure the HIV 
care provider and IC Staff follow 
the CABENUVA USPI 
Through-out 
Minor editorial and 
document formatting 
revisions 
Minor and therefore have not been 
summarized 
 
Annex 5.4   Protocol Amendment 02 (16 March 2022) 
Overall Rationale for Amendment 02 
The primary purposes of this amendment were to add changes so that the protocol reflects 
the most recent USPI.  The main change was to add in every 2-month dosing.  
Additionally, the objectives and endpoints for the study were reassessed and modified. 
Section # and 
Name 
Description of Change 
Brief Rationale 
Through-out:  
Removed the 2021year of the 
CABENUVA USPI  
 
Added text to reflect the 
addition of every 2-month 
dosing regimen 
Year removed to ensure protocol 
reflects most current USPI. 
 
Every 2-month dosing was 
recently approved by the FDA; 
therefore, the protocol will allow 
enrolment of participants on 
monthly or every 2 month dosing. 
Section 3 
Objectives and 
Endpoints 
 
 
 
Primary, secondary and 
tertiary were modified 
FIM changed from Month 12 
to Month 8  
The real-world strategies for 
CABENUVA uptake have shifted 
mid-study which is causing a shift 
in study approach to recruitment. 
This will be challenging to track 
and likely be a confounding 
variable for these endpoints. 
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Section # and 
Name 
Description of Change 
Brief Rationale 
All 12-month endpoints 
changed to 8 months.  For 
participants, all assessments 
changed to reflect that the 
data will be collected at 1,3 
and 8 months.  For IC staff; 
1, 3, 8 and for HIV Care 
providers, 1, 4 and 8.  No 
changes to expert panel 
assessments. 
Section 4.1 Study 
Design 
Schema and study length 
updated 
Updated version includes 
participants on every 2-Month 
dosing regimen.  Additionally, 
updated the timing of assessments 
and the length of time each 
participant is in the study was 
updated to reflect the reduction in 
timeline from 12 months to 8 
months. 
Section 4.2.1.2 
Study Population 
Sentence changes to read, 
“Participants may be 
excluded from the study, in 
consultation with the HIV 
care provider, based on 
information from the most 
current Prescribing 
Information 
Sentence restructured for clarity. 
Section 4.3.1 
Participants with 
HIV-1  
Added text to include every 
2-month dosing and added a 
paragraph around switching 
to another dosing regimen 
(monthly or every 2-
monthly) 
Updates to include every 2-Month 
dosing. 
Section 5.1. 
Formative 
Evaluation 
Process 
Added changes to reflect 
every 2-month dosing 
regimen and revised some 
sentences for clarification. 
Updates to include every 2-Month 
dosing. 
Section 5.1.1 
Expert Panel   
Sentences restructured for 
clarity. 
Clarification  
Section 5.1.2 
Table 1;   
FIM Changed from Month 12 
to Month 8 throughout the 
document.   
CABENUVA uptake in the real 
world has changed since the initial 
protocol was developed. The 


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Section # and 
Name 
Description of Change 
Brief Rationale 
All 12-month endpoints 
changed to 8 months 
throughout the document.   
For participants throughout 
the document, all 
assessments changed to 
reflect that the data will be 
collected at 1,3 and 8 
months; 
For IC staff; throughout the 
document, Month 1, 3, 8 and 
for HIV Care providers, 1, 4 
and 8.  No change to expert 
panel assessments. 
Table 1 timepoints were 
updated.  M6 changed to M4.  
M12 changed to M8. 
Preferences, advantages, 
disadvantages, acceptability 
of receiving and referring 
patients updated to include 
MM1, MM4, MM8 
duration of the study was changed 
to limit the recruitment period to 
12 months and the treatment 
period to 8 months. Monthly 
assessments have been modified 
to capture timepoints in the study 
that align with these shortened 
time periods. 
 
 
 
 
 
 
The real-world strategies for 
CABENUVA uptake have shifted 
mid-study which is causing a shift 
in study approach to recruitment. 
This will be challenging to track 
and likely be a confounding 
variable for these endpoints 
Section 5.1.4 
Primary Endpoint 
Per the revision in Section 3, 
 
 
 
Alignment with Section 3  
Section 6.1 
Sample Size 
Update to text, figures and 
tables to reflect a potential 
lower sample size 
CABENUVA uptake is not as fast 
as anticipated, which has resulted 
in slower than anticipated 
recruitment 
Section 6.3 
Secondary 
Analysis 
Per the revision in Section 3, 
 
 
 to Section 6.4 
Alignment with Section 3 
Section 8.1 
Missed 
CABENUVA 
Injections 
Added text to reflect every 2-
month dosing regimen 
Updated to include every 2-Month 
dosing 
Section 9.4 Lost 
to Follow-up 
Added text to reflect every 2-
month dosing regimen 
Updated to include every 2-Month 
dosing 
CCI
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Section # and 
Name 
Description of Change 
Brief Rationale 
Annex 1 
Schedule of 
Activities 
Added additional text to 
reflect every 2-month 
regimen and added 
Questionnaire completion 
windows for each dosing 
regimen 
Updated to include every 2-Month 
dosing 
Annex 5 
Protocol Amendment 1 
revisions table moved 
Compliance with current protocol 
template 
Through-out 
Minor editorial and 
document formatting 
revisions 
Minor and therefore have not been 
summarized 
 
Annex 5.5  Protocol Amendment 01 (19 November 2021) 
Overall Rationale for Amendment 1  
The primary purposes of this amendment were to add additional secondary endpoints and 
revising safety Section 10 for ease of reading and to enhance the understanding of what 
adverse events (AEs) and serious adverse events (SAEs) are required to be recorded in 
the electronic case report form (eCRF) and what safety events are required to be reported 
to meet regulatory reporting requirements.   
Section # and 
Name 
Description of Change 
Brief Rationale 
Section 1 Abstract 
Removed the words “with HIV” 
from participants  
New secondary objectives added 
 
 
New text added to define the other 
quantitative questionnaires 
New text added to include sub-
group analysis including 
participants, human 
immunodeficiency virus (HIV) 
care providers and infusion center 
(IC) Staff 
Consistency of the use of “participant” 
thought-out the protocol 
Change was made in the abstract to 
reflect the changes in Section 3 
Objectives and Endpoints 
Clarification of other questionnaires in 
addition to the Feasibility of Intervention 
Measure (FIM) and Acceptability of 
Intervention Measure (AIM) 
New text and type of analysis added 
Section 2.1 
Background 
Defined HCPs as healthcare 
providers 
Clarification 
Section 2.3 
Benefit/Risk 
Assessment 
Clarification that the United States 
Prescribing Information (USPI) 
contains both the expected benefits 
and the risks of CABENUVA  
New section added 


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Section # and 
Name 
Description of Change 
Brief Rationale 
Section 3 Objectives 
and Endpoints 
Additional secondary objectives 
and endpoints were added.  For 
clarity with the additional 
secondary objectives, most 
objectives and endpoints were re-
written and combined.  
The tertiary objective “To evaluate 
feasibility of CABENUVA 
administration at infusion centers 
from participants with HIV-1” was 
moved to a secondary objective. 
The tertiary objective “To further 
evaluate trends in feasibility of 
CABENUVA administration at 
infusion centers (via score from 
HIV care providers, participants, 
and IC staff)” was incorporated 
into a secondary endpoint 
 
 
 
 
 
The tertiary endpoint for semi-
structured interviews (SSIs) was 
moved and modified to a secondary 
endpoint.  
 
 
 
 
 
 
Objectives and endpoints added to reflect 
data which will impact feasibility and 
acceptability.  Clarifying text was added 
regarding the other quantitative 
questionnaires and the qualitative 
interview. 
 
 
 
 
 
 
 
 
 
 
 
 
Removed the mention of injection site 
reaction (ISRs) and post-injection 
reactions as those are already being 
captured under CABENUVA related 
events 
Section 4.1 Study 
Design 
Revised Schema to incorporate 
potential interviews with IC staff at 
Month 2 and added 2 footnotes 
The number of participants 
changed from 106 to 120. 
Updated based on change in this 
amendment and clarifications provided 
within the footnotes 
Correction on the sample size   
Section 4.2 Study 
Population 
Text removed: This number will be 
given sequentially in chronological 
order of participant presentation 
according to a numeric roster 
provided by GlaxoSmithKline 
(GSK). 
Text removed as there is no 
randomization in this study 
Section 4.2.1.1 
Inclusion Criteria 
Clarification that “within one 
month” is defined as 28 days 
Clarification to align with the USPI 
Section 4.2.1.2 
Exclusion Criteria 
Added 3 exclusion criteria based 
on information from the 
CABENUVA USPI: 
Contraindications, new health 
condition/prohibited medications 
and Other reasons 
Added to aid the IC staff in making 
exclusionary decisions 
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Section # and 
Name 
Description of Change 
Brief Rationale 
Section 4.3.2 HIV 
Care Providers  
Change in number of IC sites from 
23 to 24 
Text added to include participants 
who are already receiving 
CABENUVA 
Additional clarification that the 
HIV care provider will manage all 
adverse events (AEs) and will be 
requested to make AE/serious 
adverse event (SAE) causality 
assessments 
Text added through-out this section 
regarding the oral lead-in and for 
missed injections during the study 
An additional IC location was added 
 
Clarification of study populations 
 
 
Clarifications on the expected HIV care 
provider oversight of AE/SAEs 
 
 
 
Clarifications 
Section 4.3.3 
Infusion Center Staff 
Updated text to align with changes 
made in Section 10 
Removed 2 bullets on serious post 
injection reactions and ISRs as 
these are captured under AEs 
related to CABENUVA 
Added a reference to Section 
10.3.10 Reporting of AEs and 
Timelines  
Revised to align with the updated 
information in Section 10 
Removal of redundant text  
Removed specific references to 
Section 10 to reduce potential 
inconsistencies between sections 
Alignment with the revised safety 
Section 10 
Section 5.1.2 
Implementation 
Assessments 
Implementation Assessments table 
updated to reflect changes made in 
Objectives and Endpoints. 
Alignment with Section 3 
Section 5.1.3 
Timepoint 
Definitions for 
Completion of 
Questionnaires and 
Interviews  
Added text to define when the 
potential Month 2 interviews would 
be conducted with IC staff 
Added text to align with the potential 
Month 2 interviews  
Section 5.1.5 
Blueprint and Plan of 
Treatment 
Added text to specify medical 
management of AEs and SAEs  
Clarification 
Section 5.1.6 Scale-
Up 
Added text that the blueprint will 
be used to help other alternate 
administration facilities set up 
similar models of care and service 
delivery.   
Clarification of the use for the study 
blueprint 
Section 6 Statistical 
Considerations 
Text modified to state that the 
statistical analysis plan will be 
finalized prior to database release 
(DBR) and not prior to FPFV 
Text added to clarify the time of 
interim analysis (Month 3 and/or 
Month 6) and the number of 
Clarification on when the statistical 
analysis plan will be finalized 
 
 
Clarification of planned interim analysis 
and a reduction from 50 – 60 participants 
to at least 25 participants  
 


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Name 
Description of Change 
Brief Rationale 
participants (~25) at which these 
will occur. 
Text added to explain the 
possibility of a small number of 
interviews with IC staff at Month 2 
Added text about interview 
procedures and how the interview 
analysis will take place 
 
Additional interviews added to gain an 
understanding of what is occurring at ICs 
during early implementation.   
 
Clarification on interview process 
Section 6.1 Study 
Size 
Updated the number of ICs from 23 
to 24 
Text added to clarify the number of 
HIV care providers, IC staff and 
participants completing interviews 
Update 
 
Clarification 
Section 6.2 Essential 
analysis 
Due to moving some of the 
tertiary/other endpoints regarding 
FIM to secondary, text was updated 
to reflect this in several places. 
New text was added on the 
evaluation of the contextual factors 
on the variability of responses 
Updated text  
 
 
 
New text 
Section 6.3 
Secondary Analysis 
Added the additional secondary 
outcomes 
Added how the qualitative 
interview data will be summarized 
and details of this analysis will be 
included within a separate analysis 
plan 
New text 
Section 6.4 
Other/Tertiary 
Endpoints 
Other/Tertiary endpoints updated to 
reflect changes made in Objectives and 
Endpoints 
 
Clarification 
Section 7.1 Ethical 
Approval and 
Participant Consent  
Subject changed to Participant in 
the header 
Update 
Section 7.4 Quality 
Control / Study 
Monitoring 
The IC Investigator has been 
changed to IC staff. 
Updated for clarity 
Section 8.2 
Treatment of an 
Overdose 
Added the Medical Monitor must 
be contacted, and that signs and 
symptoms related to the overdose 
be recorded in the electronic case 
report form (eCRF) 
Clarification 
Section 10 
Management and 
Reporting of Adverse 
Section 10 was revised, edited and 
sections were added or moved to 
Revisions to the safety section: New and 
revised sections added for additional 
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Section # and 
Name 
Description of Change 
Brief Rationale 
Events and Safety 
Assessments 
improve the information flow 
throughout this section 
Added within the Section Header 
text that this section also has 
information for safety assessments 
and reporting requirements 
Added text that the definitions of 
AEs, SAEs and cardiovascular 
(CV) events were added to 
Annex 3 AE and SAE Definitions 
Added text that the grading of all 
AEs, SAEs and lab abnormalities 
should be graded by Division of 
acquired immune deficiency 
syndrome (DAIDS) 
clarifications and to ensure understanding 
of the information  
Clarification  
 
 
 
New Annex 
 
 
 
 
New grading information included 
 
Original Protocol 
Section 10 
Management and 
Reporting of Adverse 
Events to new 
Section 10.3.4 
Follow-up of AEs 
and SAEs 
Text from original protocol 
Section 10 was moved to new 
Section 10.3.4 to ensure the follow-
up of AEs and SAEs is clear 
Revisions to the safety sections 
Original Protocol 
Section 10.1 Safety 
Assessments and 
Section 10.2.3 
Reporting of AEs and 
timelines and moved 
to new Section 10.3.2 
Time Period and 
Frequency for 
Collecting AE and 
SAE Information 
Heading name and number revised  
Added Pharmaceutical Product 
Development Inc (PPD) 
Pharmacovigilance (PVG) to 
collect all SAEs 
Text added for the HIV care 
provider to provide causality for 
safety events 
Clarified reporting AE/SAEs after 
study conclusions 
Revisions to the safety sections 
Clarified where all SAEs will be reported 
 
Clarification of HIV care provider 
responsibilities 
 
Clarification of safety reporting 
Original Protocol 
Section 10.1.1 moved 
to new Section 10.1 
Clinical safety 
laboratory 
assessments  
Heading number change 
New text added regarding causality 
assessment for lab abnormalities 
Added text to clarify how abnormal 
labs should be recorded in the 
eCRF. 
Revisions to safety section and 
Clarifications  
New text added 
Original Protocol 
Section 10.1.2 moved 
to new Section 10.2 
Liver Chemistry 
Monitoring 
Heading number change 
Added text for the completion of 
liver event eCRF pages  
Added a reference to Annex 4 for 
PPD safety contact information 
Revisions to safety section 
New text added 
 
New Annex added 
 
Original Protocol 
Section 10.2 moved 
to new Section 10.3 
Adverse Events 
Deleted the definition of AEs as 
now included within new Annex 3 
Text from original Protocol Section 
10.2.1 Definition of Adverse 
Revisions to safety section  
 
 


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Section # and 
Name 
Description of Change 
Brief Rationale 
(AEs), Pregnancy 
Exposure and 
Incident Reports 
Events was added and revised in 
new Section 10.3 (collection and 
storage of AEs in source 
documentation and detecting, 
documenting and reporting events) 
Removed text on causality and 
moved and revised this text in new 
Section 10.3.7 Causality 
Assessments 
Added a reference to Annex 4 for 
PPD safety contact information 
 
 
 
 
 
 
 
 
 
New Annex 4 reference 
Original Protocol 
Section 10.2.1 
Definition of 
Adverse Events 
moved to Section 
10.3 Adverse Events 
(AEs), Pregnancy 
Exposure and 
Incident Reports, 
Section 10.3.6 
Adverse Event 
Follow-up with the 
HIV Care Provider 
and Annex 3 AE and 
SAE Definitions 
Text from original Protocol Section 
10.2.1 added and revised into new 
Section 10.3 (collection and 
storage of safety events in source 
documentation and detecting, 
documenting and reporting events) 
Sentence was moved to Section 
10.3.6 to ensure the appropriate 
follow-up by the IC staff to the 
HIV care providers 
Removed the text about defining 
AEs as this was moved and revised 
in Annex 3 
Revisions to safety sections 
 
 
 
 
 
 
 
 
New Annex 3 added 
Original Protocol 
Section 10.2.2 
Adverse Events to be 
Documented in this 
Study moved to new 
Section 10.3.1 
Specific Adverse 
Events to be 
Documented in this 
study 
Heading number change and text 
revised to include the word 
“Specific” 
Added all CV events and COVID-
19 related AEs are to be 
documented 
Added a paragraph regarding non 
serious AEs that are considered not 
related to CABENUVA or do not 
lead to withdrawal, these AEs 
should be documented and stored 
in the source documentation but 
will not be documented in the 
eCRF, as this information has been 
extensively collected in treatment 
clinical trials, no further 
information is needed to 
characterize these events. 
Deleted paragraph regarding 
AE/SAE follow-up as duplicative 
with other safety sections 
Revisions to safety sections 
 
 
New text added 
 
 
Revisions to safety sections 
Original Protocol 
Section 10.2.2.1 
Adverse Drug 
Section deleted and the definition 
of adverse drug reactions (ADRs) 
was added to Section 10.3.1 
Revisions to safety sections 


TMF-15719318 
CONFIDENTIAL 
 
 
214747 
 
 
Protocol Amendment 06 
 
88 
 
Section # and 
Name 
Description of Change 
Brief Rationale 
Reaction moved to 
new Section 10.3.1 
Specific Adverse 
Events to be 
Documented in this 
Study 
Original Protocol 
Section 10.2.2.2 
moved to Section 
10.3.8 Serious Post-
Injection Reactions 
Heading number change 
Added text for serious post-
injection reactions reporting 
requirement to PPD PVG 
Revisions to the safety sections  
Clarification of reporting requirements 
Original Protocol 
Section 10.2.2.3 
moved to Section 
10.3.9 Injection site 
reactions 
Heading number change 
Text added for safety reporting 
requirements 
Revisions to the safety sections 
Clarification that all ISRs should be 
recorded in the eCRF, however only 
serious ISRs or those leading to 
withdrawal need to be reported to PPD 
PVG 
Original Protocol 
Section 10.2.2.4 
Serious Adverse 
Events moved to 
Section 10.3.5 
Regulatory Reporting 
Requirements for 
SAEs and Annex 3 
AE and SAE 
definitions 
New Section added and contains 
text from original Protocol 10.2.2.4 
Removed the text about defining 
SAEs as this was moved and 
revised in Annex 3 
Revisions to safety sections  
 
New Annex 3 added 
Original Protocol 
Section 10.2.3 
Reporting of AEs and 
timelines moved to 
Section 10.3.2 Time 
Period and 
Frequency for 
Collecting AE and 
SAE Information and 
Section 10.3.10 
Reporting of AEs and 
Timelines 
Heading number and name change 
One sentence was moved to 
Section 10.3.2 (obligations of the 
IC staff to collect and report AEs) 
New text and a table were added to 
Section 10.3.10 regarding the 
specific safety events and the 
timelines for reporting these events 
to PPD PVG  
Revisions to the safety sections  
 
 
 
New text to clarify reporting 
requirements 
Original Protocol 
Section 10.2.4 
Pregnancy moved to 
Section 10.3.11 
Pregnancy  
Heading number change 
Added text that participants of 
child-bearing potential (POCBP) 
should be asked their pregnancy 
status at each visit and date of last 
menses period (LMP) 
Removed text regarding the 
pregnancy specific addendum 
 
 
Revisions to the Safety sections 
Clarification and added text to the 
schedule of activities (SOA) to further 
support  
 
The protocol is being conducted in 
accordance to the currently approved 
USPI, which does not contraindicate or 
have a warning and precaution against 
the use of CABENUVA during 
pregnancy.  It is a HIV care providers 


TMF-15719318 
CONFIDENTIAL 
 
 
214747 
 
 
Protocol Amendment 06 
 
89 
 
Section # and 
Name 
Description of Change 
Brief Rationale 
 
 
 
 
 
Added text that pregnancies will be 
followed and will include the 
reporting of any post-study SAEs 
Deleted text that the Sponsor needs 
to provide written approval 
decision, after considering whether the 
expected benefit justifies the potential 
risk to the fetus to prescribe or have a 
patient remain on CABENUVA while 
pregnant. 
 
Clarification of reporting requirements 
 
Not required in this study 
 
Original Protocol 
Section 10.2.5 Death 
Events moved to new 
Section 10.3.12 
Cardiovascular and 
Death Events 
Heading name and number change 
Text added that all deaths will be 
recorded and reported as a SAE 
Added new text about 
cardiovascular events and the 
recording and reporting 
requirements 
Added reference to Annex 3 AE 
and SAE Definitions 
Revisions to the Safety sections 
Clarification 
 
New text added 
 
 
 
New Annex added 
Section 10.3.3 
Methods of Detecting 
AEs and SAEs 
New Section on how to reduce bias 
with the collection of AEs and 
SAEs 
Revisions to the safety sections 
Section 10.3.7 
Causality 
Assessments 
New Section added to clarify the 
requirement for the relatedness of 
any safety event to CABENUVA 
Revisions to the safety sections 
Section 10.3.13 
Medical Devise 
Deficiency 
New Section added for the Food 
and Drug Administration (FDA) 
regulatory reporting requirements 
for a medical device incident 
Added the FDA spontaneous incident 
reporting requirement 
Section 11 
References 
New reference added 
Added reference for the DAIDS grading 
scale that was added to Section 10 
Management and Reporting of Adverse 
Events and Safety Assessments 
Annex 1 Schedule of 
Activities 
Added a check for pregnancy status 
at each monthly visit 
Additional labs at the Month 12 
visit have been added 
Added that fasting is not required 
unless otherwise required for a 
specific lab test 
If the early discontinuation (ED) 
visit is not at a scheduled study 
visit, participants would not receive 
CABENUVA injections.  If the ED 
visit is at a scheduled study visit, 
injections would be captured there 
New text added 
 
Updated  
 
 
Clarification 
 
 
 
Clarification by removing the X for 
injections at the ED visit  
 
 


TMF-15719318 
CONFIDENTIAL 
 
 
214747 
 
 
Protocol Amendment 06 
 
90 
 
Section # and 
Name 
Description of Change 
Brief Rationale 
AEs and SAEs comments: added 
links to the relevant Safety sections 
Removed the row for the collection 
of ISRs or post-injection reactions 
as these are included within AEs or 
SAEs. 
Added the potential Month 2 IC 
staff interviews and defined the 
timepoint this could be completed 
 
Revised to ensure consistency in 
information 
Deleted row for clarification on the 
collection of AEs related to 
CABENUVA 
 
Month 2 potential interviews added 
Annex 2.  List of 
Stand-Alone 
documents 
Added Study Blueprint  
Study Specific Pharmacovigilance 
Plan (sPVP) is removed. 
Blueprint is shared with the IC ‘ 
sPVP Document was no longer required 
since this is an interventional study 
Annex 3 AE and 
SAE Definitions 
New Annex added 
Moved the AE and SAE definitions from 
the SRM into the protocol and added in 
the CV definitions 
Annex 4: Contact 
Information for 
Reporting of AEs and 
SAEs and 
Pregnancies 
New Annex Added 
Added PPD PVG and Safety contact 
information  
Through-out 
Minor editorial and document 
formatting revisions 
Minor and therefore have not been 
summarized 
 


Signature Page for  214747 TMF-15719318 v2.0
Signature Page for TMF-15719318 v2.0
Reason for signing: Approved
Name:
Role: Approver
Date of signature: 29-Mar-2023 08:39:17 GMT+0000
PPD

SAP_001.pdf: 
Statistical Analysis Plan 
Study ID:  214747
Official Title of Study: A Phase 4, open-label, single arm study to optimize 
implementation of CABENUVA for the treatment of HIV-1, for administration in U.S. 
community-based infusion centers or other alternate sites of administration
NCT number: NCT04982445 
Date of Document: 05-MAR-2024 (This date was redacted on Page 38, 92 and 152, as 
part of signature [Personal Information] in the document)


A Phase 4, Open-label, Single-arm Study to 
Optimize Implementation of CABENUVA 
for the Treatment of HIV-1, for 
Administration in US Community-based 
Infusion Centers or other Alternative Sites 
of Administration 
Statistical Analysis Plan for Clinical Analyses 
EVA-30466 | October 05, 2023 | Version 1.0 
Prepared For: 
I Statistician  
, Clinical Development Lead 
 GSK 
, Global Implementation Research, ViiV Healthcare 
Prepared By: 
PhD, MPH 
 MSc 
Project Contact: 
PPD
PPD
PPD
PPD
PPD
PPD
PPD


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
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Statistical Analysis Plan (SAP) Signature Page 
SAP Title: 
A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for the 
Treatment of HIV-1, for Administration in US Community-based Infusion Centers or other 
alternate sites of administration. Statistical Analysis Plan for Clinical Analyses. 
SAP Date and Version: October 05 2023; Version 1.0 
This SAP with the title, number, and version indicated above has been reviewed and approved by the 
Evidera Principal Investigators and Project Managers. 
___________________ 
Date 
___________________ 
Date 
___________________ 
Date 
___________________ 
Date 
PPD


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Table of Contents 
1 
INTRODUCTION ...................................................................................................................................... 1 
2 
STUDY DESIGN ....................................................................................................................................... 1 
2.1 Study Population............................................................................................................................ 2 
2.1.1 Eligibility Criteria ................................................................................................................. 3 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................. 4 
3.1 Primary Objectives ......................................................................................................................... 4 
3.2 Secondary Objectives .................................................................................................................... 5 
3.3 Tertiary Objectives ......................................................................................................................... 5 
3.3.1 Safety and Effectiveness of CABENUVA............................................................................... 5 
3.3.2 Discontinuation of CABENUVA and Participant Discontinuations ....................................... 6 
3.3.3 The Use of Oral Bridging for Missed CABENUVA Injection .................................................. 7 
4 
STATISTICAL METHODS .......................................................................................................................... 7 
4.1 General Statistical Considerations ................................................................................................. 7 
4.1.1 Descriptive Summary Statistics ........................................................................................... 7 
4.1.2 Baseline Definition .............................................................................................................. 8 
4.1.3 Missing Data Handling ......................................................................................................... 8 
4.1.4 Power and Sample Size ..................................................................................................... 10 
4.2 Analysis Sets ................................................................................................................................ 10 
4.2.1 Enrolled Set ....................................................................................................................... 10 
4.2.2 Safety Set .......................................................................................................................... 10 
4.3 Disposition ................................................................................................................................... 11 
4.3.1 Study Disposition ............................................................................................................... 11 
4.3.2 Protocol Deviations ........................................................................................................... 12 
4.4 Demographics and Baseline Characteristics ................................................................................ 13 
4.5 Medical History ............................................................................................................................ 14 
4.6 Prior and Concomitant Medications/Therapies, and Study Treatments ...................................... 14 
4.6.1 Prohibited Medications ..................................................................................................... 14 
4.6.2 Prior Medications or Antiretroviral Therapies ................................................................... 14 
4.6.3 Concomitant Medications or Antiretroviral Therapies ...................................................... 14 
4.6.4 Study Treatment Initiation Method .................................................................................. 15 
4.6.5 Study Treatments .............................................................................................................. 15 
4.7 Analysis of Clinical Study Endpoints ............................................................................................. 15 
4.7.1 Safety Analysis ................................................................................................................... 15 
4.7.2 Clinical Laboratory Assessments ....................................................................................... 18 
4.7.3 Changes in Vital Signs ........................................................................................................ 19 
4.7.4 Effectiveness ..................................................................................................................... 19 


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4.7.5 Use of Oral Bridging .......................................................................................................... 20 
4.7.6 Impact of COVID-19 Pandemic .......................................................................................... 20 
4.7.7 Changes from Planned Analysis ......................................................................................... 20 
5 
LIMITATIONS ON RESEARCH METHODS ................................................................................................ 20 
6 
REFERENCES ......................................................................................................................................... 21 
7 
APPENDICES ......................................................................................................................................... 22 
7.1 Schedule of Activities (SoA) ......................................................................................................... 22 
7.2 Protocol Deviations Rules Document .......................................................................................... 25 
7.3 Tables and Listings ....................................................................................................................... 25 
7.3.1 Tables ................................................................................................................................ 25 
7.3.2 Listings ............................................................................................................................... 27 
 
 
 


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List of Tables 
Table 1. 
Clinical Objectives and Endpoints ............................................................................................. 4 
List of Figures 
Figure 1. 
Study Design Schematic ............................................................................................................ 2 
 
 
 
 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
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List of Abbreviations 
Abbreviation 
Definition 
ADR 
Adverse drug reaction 
AE 
Adverse event 
ALP 
Alkaline phosphatase 
ALT 
Alanine aminotransferase 
ART 
Antiretroviral therapy 
ASA 
Alternative site of administration 
AST 
Aspartate aminotransferase 
BMI 
Body mass index 
CAB 
CABENUVA 
CI 
Confidence interval 
DBL 
Database lock 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
HIV 
Human immunodeficiency virus 
IC 
Infusion center 
ICF 
Informed consent form 
IM 
Intramuscular 
IQR 
Interquartile range 
MedDRA 
Medical Dictionary for Regulatory Activities 
PLWHIV 
People living with human immunodeficiency virus 
POT 
Plan of treatment 
PT 
Preferred term 
Q1M 
Once monthly 
Q2M 
Once every -2 -months 
RNA 
Ribonucleic acid 
RPV 
EDURANT 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SD 
Standard deviation  
SGOT 
Serum glutamic-oxaloacetic transaminase 
SGPT 
Serum glutamic-pyruvic transaminase 
SoA 
Schedule of activities 
SOC 
System organ class 
SRM 
Study reference manual 
ULN 
Upper limit of normal 
USPI 
United States prescribing information 
 


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1 Introduction 
CABENUVA is a two-drug, co-packaged product of cabotegravir plus rilpivirine, both administered as long-
acting, intramuscular (IM) injections once every month or once every 2 months. CABENUVA is an 
approved treatment for human immunodeficiency virus (HIV). Clinical trial results have shown that 
CABENUVA, administered once monthly or once every 2-months, is a non-inferior alternative to the daily 
oral treatment for HIV. 
Long-acting injectable treatments require changes in how HIV care is delivered. People living with human 
immunodeficiency virus (PLWHIV) need to attend appointments once a month or once every 2 months 
for their injections, increasing office visits over their normal monitoring visits. This poses new healthcare 
delivery challenges, including a shift in resources to this alternative means of delivering and receiving 
treatment—thus requiring the expansion of alternative injection facilities to include infusion centers (ICs) 
or other alternative sites of administration (ASAs). This has the potential to increase the workload for 
these facilities; however, it also has the potential to positively impact treatment engagement and 
retention for PLWHIV. 
ICs/ASAs are an appealing option that will help ease the burden of additional appointments, 
administrative work, and drug ordering in HIV specialty clinics, as well as provide greater flexibility to 
PLWHIV in deciding where they receive their monthly or every-2-monthly injections. In this study, the 
intervention itself is the process of using an IC/ASA as the location to receive the CABENUVA IM 
injections. 
The scope of this statistical analysis plan (SAP) is to examine the safety and effectiveness of CABENUVA 
IM injections in real-world settings through ICs/ASAs. This SAP details the planned analyses for the 
tertiary objectives that are related to the safety and effectiveness of CABENUVA, as outlined in Table 1 in 
Section 3. It implements the study’s clinical objectives and endpoints and specifies the needed summary 
tables and other statistical results of the lab tests, other clinical metrics, CABENUVA-related adverse 
events (AEs), all AEs leading to participant discontinuation, all cardiovascular events, COVID-19 related, 
and all serious AEs (SAEs). Two analysis sets will be used for the study analyses: the Enrolled Set and the 
Safety Set. The Enrolled Set will include all participants who provided a signed informed consent form 
(ICF), met the eligibility criteria, and were enrolled in the study. The Safety Set will consist of all 
participants in the Enrolled Set who received at least one on-study CABENUVA injection(s). 
2 Study Design 
This is a phase 4, single-arm, open-label, multicenter study examining the administration of CABENUVA 
IM in ICs/ASAs across the US. This study is being conducted following FDA approval and commercial 
availability of CABENUVA in the US. 
This study will include no more than 120 eligible and consenting participants to receive monthly injections 
or every-2-monthly injections of CABENUVA for HIV-1 treatment at ICs/ASAs. The total study duration for 
each participant is approximately 8 months, from the time of their enrollment and receipt of the first 


A P h as e 4, O p e n -l a b el, Si n gl e- ar m St u dy t o O pti miz e I m pl e m e nt ati o n of C A B E N U V A f or 
t h e Tr e at m e nt of HI V- 1, f or A d mi nistr ati o n i n U S C om m u nity- b as e d I nf usi o n C e nt ers 
 
 
P r o pri et ary a n d C o nfi d e nti al | P a g e 2 
r o pri et ary a n d C o nfi d e nti al | P a g e 2 
w w w. evi d er a.c o m 
 
st u dy-r el at e d a d mi nistr atio n of C A B E N U V A I M i nj e cti o ns at t h e I C/ AS A. F or a d et ail e d Sc h e d ul e of 
Activiti es ( S o A), r ef er t o A p p e n dix 7. 1. C A B E N U V A d osi n g a d h er e nc e is d escri b e d i n t h e US pr escri bi n g 
i nf or m ati o n ( US PI) if C A B E N UV A i nj ecti o ns w er e miss e d. 
Fi g ur e 1.  St u dy D esi g n Sc h e m atic 
Fi g ur e 1.  St u dy D esi g n Sc h e m atic 
  
 
P artici p a nt ass ess m e nts ar e c o m pl et e d b as e d o n M o nt h r e g ar d l ess of m o nt hly ( Q 1 M) vs. ev ery- 2- m o nt hly ( Q 2 M) d osi n g.  
N ot e: St u dy d esi g n m ay n ot i ncl u d e all p ot e nti al p att e r ns of d osi n g. 
2. 1  St u d y P o p ul ati o n 
T h e st u dy ai ms t o r ecr uit n o m or e t h a n 1 2 0 p artici p a nts w h o h av e b e e n pr escri b e d C A B E N U V A by t h eir 
HI V c ar e pr ovi d er. D uri n g t h eir firs t visit t o t h e I C/ AS A, aft er si g ni n g a n I C F, p artici p a nts will c o m pl et e 
b as eli n e ass ess m e nts t o c o nfir m p artici p a nt eli gi bil ity a n d t h e n r ec eiv e t h eir M o nt h 1 i nj ecti o ns. I n 
s u bs e q u e nt m o nt hs, p artici p a nts ar e m e dic ally m a n ag e d by t h eir HI V c ar e pr ovi d ers a n d r ec eiv e t h eir 
o nc e- a- m o nt h or ev ery- 2- m o nt hs  i nj ecti o ns at t h e I C/ AS A. 
Ov er ti m e, p artici p a nt tr e at m e nt disc o nti n u ati o n as w ell as miss e d i nj ecti o ns ar e ex p ect e d. PL W HI V ar e 
all o w e d i n t h e st u dy if t h ey h av e b e e n pr escri b e d C A B E N U V A p er t h e U S PI  a n d m e et all eli gi bility crit eri a 
( S ecti o n 2. 1. 1) at t h e B as eli n e/ M o nt h 1 visit. P artici p a nts w h o si g n t h e I C F a n d m e et all eli gi bility crit eri a 
will e nt er t h e st u dy. 
If a p artici p a nt pl a ns t o miss t h e i nj ecti o ns by m or e t h a n 7 d ays, i n c o ns ult ati o n wit h t h e HI V c ar e 
pr ovi d er, or al C A B E N U V A pl us E D U R A N T ( C A B + R P V) or ot h er a ntir etr ovir al t h er a py ( A R T) r e gi m e ns 
s h o ul d b e t ak e n d aily t o r e pl ac e u p t o t w o c o ns ec utiv e pl a n n e d miss e d m o nt hly i n j ecti o n visits or ev ery-
2- m o nt h i nj ecti o n visit- d os es. D osi n g of or al bri d gi n g i n t h e ev e nt of miss e d d os es will b e i n acc or d a nc e 
wit h t h e m ost r ec e nt C A B E N U V A US PI. 
I n c o ns ult ati o n wit h t h e HI V c ar e provi d er, p artici p a nts m ay s witc h fr o m  m o nt hly i nj ecti o ns t o a n ev ery- 2-
m o nt h c o nti n u ati o n i nj ecti o n sc h e d ul e, or fr o m a 2- m o nt h c o nti n u ati o n i nj ecti o n sc h e d ul e t o a m o nt hly 
c o nti n u ati o n d osi n g sc h e d ul e. W h e n s witc hi n g d osi n g r e gi m e ns, all i nstr ucti o ns o utli n e d i n t h e m ost 
c urr e nt US PI will b e f oll o w e d. T h e t ot al d ur ati o n f or st u dy p artici p a nts is a p pr oxi m at ely 8 m o nt hs fr o m 
L e g e n d:                  I nt er vi e ws                           Q u esti o n n air es 
   


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
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the time of enrollment and receipt of the first study-related administration of CABENUVA IM injections at 
the IC/ASA. A participant is considered to have completed the study if they have finished all Month 8 
assessments. 
2.1.1 Eligibility Criteria 
The eligibility criteria below are the most current as of the writing of the SAP. 
2.1.1.1 Inclusion Criteria 
Age 
1. Adults (t18 years old) at the time of signing the ICF 
Type of Participant and Disease Characteristics 
2. PLWHIV-1, prescribed CABNEUVA per the USPI. Participants can be enrolled: 
x 
If they have been taking oral CAB + RPV or other ART for approximately 1 month (at least 28 days) 
prior to Baseline/Month 1, or 
x 
Already taking CABENUVA prior to Baseline/Month 1 and the last injections were within a 1-
month r 7-day window, or for every-2-month injections, the timing will vary depending on when 
they are receiving the initiation injections (1 month r 7 days) or the continuation injections (2 
months r 7 days) per the USPI, or 
x 
Prescribed direct to inject and receive their first injection without an oral lead-in at the IC/ASA on 
the last day of any other ART 
Informed Consent 
3. Capable of giving signed informed consent as described in the protocol, which includes 
compliance with the requirements and restrictions listed in the ICF and in the protocol. 
Other 
4. Agree to receive CABENUVA IM injections at participating ICs/ASAs. 
2.1.1.2 Exclusion Criteria 
Participants may be excluded from the study, in consultation with the HIV care provider, based on 
information from the most current CABENUVA USPI at the time of study enrollment. 
Contraindications, as per the current CABENUVA USPI 
x 
Previous hypersensitivity reaction to cabotegravir or rilpivirine 
x 
Contraindicated co-administered drugs: 
o Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin 
o Antimycobacterials: rifabutin, rifampin, rifapentine 
o Glucocorticoid (systemic): dexamethasone (more than a single-dose treatment) 
o Herbal product: St John’s wort (Hypericum perforatum) 


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New health condition / prohibited medication reported 
x 
After discussion with the referring HIV care provider, a decision may be made not to enter 
participant into the study 
Other reason at the discretion of the HIV care provider or IC/ASA staff 
3 Objectives and Endpoints 
The scope of this SAP is limited to the clinical objectives and endpoints related to the safety and 
effectiveness of CABENUVA as set forth in the protocol (see Table 1). 
Table 1. 
Clinical Objectives and Endpoints 
Clinical Objectives 
Endpoints 
3.1 Primary Objectives 
The primary objectives are beyond the scope of this clinical SAP. Three additional implementation 
research SAPs are planned and will cover the primary objectives, one each for participant type 
(participants living with HIV, healthcare providers and expert panel members, and infusion center staff). 
CCI


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3.2 Secondary Objectives 
The secondary objectives are beyond the scope of this clinical SAP. Three additional implementation 
research SAPs are planned and will cover the secondary objectives, one each for participant type 
(participants living with HIV, healthcare providers and expert panel members, and infusion center staff). 
3.3 Tertiary Objectives 
CCI


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CCI


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4 Statistical Methods 
4.1 General Statistical Considerations 
Data will be analyzed on the nominal scheduled visits as recorded in the eCRF. Visit windowing will be 
used as required. 
4.1.1 Descriptive Summary Statistics 
If the number of non-missing observations is zero (i.e., n=0), then only n is displayed, no other statistics. 
Two-sided 95% confidence intervals (CIs) will be provided using normal approximation. But when normal 
approximation is deemed to be inappropriate, exact methods will be used instead. 
4.1.1.1 Categorical Data 
Tabulations for categorical data will be displayed in the form n (%) with non-zero percentages enclosed 
with parentheses. 
CCI


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The number of distinct participants with non-missing observations (n) at all levels of categories will be 
presented. If no participants are reported for a particular level of a category, n will be presented as zero. 
If for all levels of a category, data are missing for at least one participant, a “Missing” category level will 
be presented. 
Percentages (%) will be presented when there is at least one non-missing observation. Percentages will 
not be presented for the “Missing” category level. Percentages >99.9% will be displayed as 100%; in other 
cases, they will be rounded to and displayed with one decimal place. Generally, the denominator for 
percentages will be the number of participants in the analysis group of interest for the specified analysis 
set. Other denominators will be described in a footnote when applicable. 
4.1.1.2 Continuous Data 
The following summary statistics will be reported for continuous data: 
x 
n: number of distinct participants with non-missing observations 
x 
Mean (standard deviation [SD]): arithmetic mean, SD) 
x 
Median 
x 
Interquartile range (IQR; i.e., 25th percentile [Q1] - 75th percentile [Q3]) 
x 
Min, Max: minimum, maximum 
If n=1, SD will be displayed as “N/A” (i.e., not applicable) and CIs as “NE” (i.e., not estimable). SD will be 
rounded and displayed with two more decimal places than the reported value. All mean, median, Q1, and 
Q3 values will be rounded and displayed to one more decimal place than the reported value. CI values will 
be rounded and displayed to one more decimal place than the parameter estimate. Min and max values 
will be displayed consistent with the number of decimal places in the reported value. 
4.1.2 Baseline Definition 
Baseline will be defined as the date when a participant signs the ICF and completes the Baseline/Month 1 
protocol procedures prior to receiving the first study-related CABENUVA injections at the IC/ASA. 
All additional study visits will be anchored from each participant’s Baseline/Month 1 visit, and will 
therefore reflect the months on study, regardless of what injection schedule they are on and regardless 
of whether they have missed any injections and received oral bridging. 
Change from baseline will be calculated as the difference between the baseline and post-baseline values, 
which have the same number of decimal places. Percent change from baseline will be calculated by 
dividing change from baseline by non-zero baseline value, rounded and reported to one decimal place. 
4.1.3 Missing Data Handling 
For the purposes of classifying medications/therapies as prior or concomitant, or for AEs as pre-
treatment, on-treatment, or post-treatment, incomplete dates may be imputed. 
Details for handing missing AE relatedness, severity, seriousness, etc. are discussed in Section 4.7.1.1. 


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No other missing data will be imputed. 
4.1.3.1 Imputation of Incomplete Dates 
4.1.3.1.1 
General Dates, including Start/Stop Dates of Concomitant Medications/Therapies 
A partial event start date, or partial start dates of prior and concomitant medications/therapies, will be 
assumed to be the earliest possible date consistent with the partial date. 
x 
If the day is missing, it will be assumed to be the first day of the month 
x 
If the month is missing, it will be assumed to be January 
x 
If the entire date is missing, assume exposure prior to dosing start and date will not be imputed 
If the month and the year of the start date is the same month and year of the CABENUVA treatment start 
date, then the following imputation rules apply: 
x 
If the stop date contains a full date and is earlier than the CABENUVA treatment start date, then 
the set start date = 1st of month 
x 
Else, the set start date = the CABENUVA treatment start date 
If the year of the start date is the same year of the CABENUVA treatment start date, then the following 
imputation rules apply: 
x 
If the stop date contains a full date and is earlier than the CABENUVA treatment start date, then 
the set start date = January 1 
x 
Else, the set start date = the CABENUVA treatment start date 
Partial event or medication/therapy stop dates will be assumed to be the latest possible date consistent 
with the partial date. 
x 
If the day is missing, it will be assumed to be the last day of the month 
x 
If the month is missing, it will be assumed to be December 
x 
If the entire date is missing, there will be no imputation 
Note that if the concomitant medications/therapies end date is present, the imputed onset date will 
always be on or prior to the end date. 
4.1.3.1.2 
Onset and End Dates of Adverse Event  
Incomplete AE onset and end dates will be imputed, respectively, as the earliest and latest possible date 
consistent with the partial date and assigned treatment period (pre-study, pre-treatment or on-
treatment), where: 
x 
Pre-study: The onset of the AE is on or after the CABENUVA treatment start date, but prior to 
enrollment in the study 
x 
Post-enrollment, pre-treatment: The onset of the AE is prior to the on-study CABENUVA 
treatment start date 


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x 
Post-enrollment, on-treatment: The onset of the AE is on or after the on-study CABENUVA 
treatment start date 
If the event start day is missing, assume the first day of the month. If the month or entire start date are 
missing, assume the event occurred on January 1 if the year of the start date is not the year of the 
CABENUVA treatment start. If the year of the start date is  the year of CABENUVA treatment start, then 
the following imputation rules apply: 
x 
If the stop date contains a full date and is earlier than the CABENUVA treatment start date, then 
the set start date = January 1 
x 
Else, the set start date = the CABENUVA treatment start date 
If the event end day is missing, assume the last day of the month. If the month or entire end date are 
missing, there will be no imputation. 
Events that that begin on or after the date of on-study CABENUVA treatment initiation will be considered 
treatment-emergent events.  
Note that if the AE end date is present, the imputed onset date will always be on or prior to the end date. 
4.1.4 Power and Sample Size 
The study sample size of up to 120 participants is based on the primary objective “To evaluate feasibility 
of CABENUVA administration at infusion centers/ASAs from participants” with an endpoint defined as 
“the proportion of participants that agree or completely agree (a score of 4 or higher) across all items on 
the Feasibility of Intervention Measure (FIM) at Month 8”. Sample size calculations were not powered to 
evaluate clinical or safety outcomes. 
4.2 Analysis Sets 
4.2.1 Enrolled Set 
"Enrolled" participants will include PLWHIV-1 who have agreed to participate in this clinical study, 
following the completion of the informed consent process, and have met the baseline eligibility criteria. If 
required, a legally acceptable representative may provide the participant’s agreement to participate in 
the clinical study and sign the ICF. 
The Enrolled Set will include all participants who provided a signed ICF, met the eligibility criteria, and 
were enrolled in the study. Some participants may meet the eligibility criteria but may not be enrolled for 
other reasons. 
4.2.2 Safety Set 
The Safety Set will consist of all participants in the Enrolled Set who received at least one on-study 
CABENUVA injection(s). 


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4.3 Disposition 
4.3.1 Study Disposition 
The study disposition will be summarized as the number and percentage of participants in each analysis 
set (i.e., Enrolled Set and Safety Set): 
x 
Screen failed, and reason(s) such as: 
 
AE 
 
Did not meet inclusion/exclusion criteria 
 
Referring physician decision and reason specified 
 
Protocol deviation 
 
Study terminated by sponsor 
 
Withdrawal by participant and reason specified 
x 
Met entry criteria but not enrolled 
x 
Consented/reconsented, and enrolled 
x 
Ongoing at the time of analysis 
x 
Completed the study 
x 
Discontinued treatment 
o AE 
o Lack of efficacy 
o Referring physician decision and reason specified 
o Protocol deviation 
o Sponsor terminated site 
o Sponsor terminated treatment 
o Study terminated by sponsor 
o Withdrawal by participant and reason specified 
x 
Discontinued study 
o AE 
o Lack of efficacy 
o Referring physician decision and reason specified 
o Protocol deviation 
o Sponsor terminated site 
o Sponsor terminated treatment 


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o Study terminated by sponsor 
o Withdrawal by participant and reason specified 
x 
Lost to follow-up 
o Participant relocated 
o Participant incarcerated 
A listing of all inclusion and exclusion criteria deviations will be provided for all participants in the Enrolled 
Set. 
4.3.1.1 Lost to Follow-up 
A participant will be considered lost to follow-up if they fail to return for one or more scheduled visits and 
is unable to be contacted by the IC/ASA or the HIV care provider. 
The following actions must be taken if a participant fails to return to the IC/ASA for a required study visit: 
x 
The IC/ASA must immediately contact the HIV care provider if a participant has missed a visit. 
x 
The IC/ASA must attempt to contact the participant and reschedule the missed visit as soon as 
possible and counsel the participant on the importance of maintaining the assigned visit schedule 
and ascertain whether or not the participant wishes to and/or should continue receiving monthly 
or every-2-monthly injections at the IC/ASA. 
x 
Before a participant is deemed lost to follow-up, the IC/ASA and HIV care provider must make 
every effort to regain contact with the participant. These contact attempts should be 
documented in the participant’s medical record. 
x 
Should the participant continue to be unreachable, they will be considered to have withdrawn 
from the study with a primary reason of “Lost to Follow-up.” 
4.3.2 Protocol Deviations 
Protocol deviations will be recorded within the Clinical Trial Management System and undergo cross-
functional team review prior to final database lock (DBL). The Study Deviation Rules Document contains 
all potential protocol deviations, classified by Clinical Trial Management System subtype (see Section 7.2). 
Important protocol deviations can be related to study eligibility criteria, study conduct, participant 
management, or participant assessments. Prior to DBL, important protocol deviations will be identified 
and documented based on a review of potential protocol deviations. The potential protocol deviations 
will be identified through programmatic checks of study data, as well as through review of selected data 
listings. 
Protocol deviations may include the following: 
x 
Prohibited medication use 
x 
Prohibited ART 
x 
Non-compliance with study treatment 


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x 
Non-compliance with protocol procedures 
x 
Other protocol deviation 
The number and percentage of participants with important protocol deviations will be summarized by 
type of deviation for the Enrolled Set. Individual protocol deviations will also be presented in a list. 
4.4 Demographics and Baseline Characteristics 
Descriptive summaries of demographic and selected baseline characteristics will be presented for 
participants in the Safety Set. Demographic and baseline characteristics data will include: 
x 
Age at informed consent, and the age categories as follows: 
o 18 to <20 years 
o 20 to <50 years 
o ≥50 years 
x 
Sex assigned at birth 
x 
Gender identity at informed consent 
x 
Child-bearing potential at informed consent, and 
o Pregnancy status at informed consent (when applicable) 
x 
Race 
x 
Ethnicity 
x 
Height at baseline 
x 
Weight at baseline 
x 
Body mass index (BMI) and BMI categories at baseline as follows2 
o Severely Underweight: <16 kg/m2 
o Underweight: 16 to <18 kg/m2 
o Normal Weight: 18 to <25 kg/m2 
o Overweight: 25 to <30 kg/m2 
o Obesity Class I: 30 to <35 kg/m2 
o Obesity Class II: 35 to <40 kg/m2 
o Obesity Class III: ≥40 kg/m2 
x 
Vital signs at baseline 
x 
History of tobacco use reported at baseline 
A participant’s age in years will be estimated using the year of informed consent and year of birth. 
BMI will be calculated as (body weight in kilograms) / (height in meters)2. 


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Participant demographics and baseline characteristics will also be presented in a listing. 
4.5 Medical History 
Medical history will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 
25.0 or higher. The number and percentage of participants by system organ class (SOC) and preferred 
term (PT) will be summarized. 
Percentages will be calculated based on the number of participants in the Enrolled Set.  
Participant medical history data, including specific details, will also be presented in a listing. 
4.6 Prior and Concomitant Medications/Therapies, and Study 
Treatments 
All medications will be coded according to the WHO Drug Dictionary  version 2022 MAR or higher, and 
the GSK Drug Dictionary: Proprietary sponsor medication dictionary version 5.0 or higher. 
A prior medication or ART will be defined as any medication/therapy that is taken or starts prior to the 
first dose of the study drug (whether stopped or continued after the first dose). A concomitant 
medication or ART will be defined as any medication/therapy taken on or after the date of first dose of 
study drug. Furthermore, a medication/therapy could be flagged as both a prior and concomitant 
medication if it was started prior to the first dose and continued after first dose of study medication. 
4.6.1 Prohibited Medications 
Prohibited medications, as described in the USPI include: 
x 
Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin 
x 
Antimycobacterials: rifabutin, rifampin, rifapentine 
x 
Glucocorticoid (systemic): dexamethasone (more than a single-dose treatment) 
x 
Herbal product: St John’s wort (Hypericum perforatum) 
Reported use of prohibited medications will be listed for the Enrolled Set. 
4.6.2 Prior Medications or Antiretroviral Therapies 
Prior medications/therapies will be summarized for participants in the Enrolled Set. The total number of 
prior medications/therapies, as well as the number and percentages of participants with at least one prior 
medication/therapy will be presented and listed by Anatomical Therapeutic Chemical level 1 classification 
and PT. 
Prior medications/therapies will be presented in a listing. 
4.6.3 Concomitant Medications or Antiretroviral Therapies 
Concomitant medications/therapies will be summarized for participants in the Safety Set. The total 
number of concomitant medications/therapies, as well as the number and percentages of participants 


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with at least one concomitant medication/therapies, will be presented and listed by Anatomical 
Therapeutic Chemical level 1 classification and PT. 
Concomitant medications/therapies will be presented in a listing. 
4.6.4 Study Treatment Initiation Method 
Study treatment initiation methods as described in the protocol include the following: 
x 
Have been taking oral CAB + RPV or other ART for approximately 1 month (at least 28 days) prior 
to Baseline/Month 1, or 
x 
Had already been receiving CABENUVA prior to Baseline/Month 1 and the last injections were 
within a 1-month r 7-day window or for every-2-month injections, the timing will vary they are 
receiving the initiation injections (1 month r 7 days) or the continuation injections (2 months r 7 
days) per the USPI, or 
x 
Had been prescribed direct to inject and received first injection without an oral lead-in at the 
IC/ASA on the last day of any other ART. 
Initiation methods will be summarized and listed for all participants in the Safety Set. 
4.6.5 Study Treatments 
4.6.5.1 Duration of Exposure 
Duration of exposure will be defined as the total number of days a participant is exposed to CABENUVA 
and will be presented as the total number of days from the first dose date to the last dose date (date of 
last dose minus the date of first dose + 1) as recorded for study discontinuation. If the last dose date for 
study discontinuation is not reported, the last available visit date or when lost to follow-up, the date of 
last contact will be used. For participants receiving CABENUVA prior to enrolling in the study, exposure 
will be counted from the date that therapy was initiated (which would predate study entry). 
Because missed doses may occur during the study, exposure to the study drug will also be characterized 
by cumulative dose, which will be defined as the cumulative dose of CABENUVA injections administered 
to the participants. 
A summary of each participant’s exposure will be presented in a listing. 
4.7 Analysis of Clinical Study Endpoints 
4.7.1 Safety Analysis 
All safety analyses will be presented for participants in the Safety Set.  
4.7.1.1 Adverse Events  
Treatment-emergent AEs are being collected in this study; i.e., all events that began on or after the date 
of on-study CABENUVA treatment initiation. Hereafter, these events will be referred to as AEs.  


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All AEs, AEs related to CABENUVA, AEs leading to CABENUVA discontinuation or study withdrawal, SAEs, 
and COVID-19 AEs will be classified by SOC and PT according to MedDRA version 25.0 or higher. AEs will 
be graded according to the DAIDS Table for Grading Adult and Pediatric Adverse Events, corrected version 
2.1 dated July 2017. 
Incidence will be reported for the overall cohort, as well as separately for the monthly and every-2-
monthly injection groups. The number and percentage of participants experiencing at least one AE will be 
reported, along with DAID severity grade, AE category (injection site reaction, cardiovascular, liver, 
COVID-19, and pregnancy-related), action taken with study treatment, and outcome of event. If a 
participant switches between the monthly and every-2-monthly injection groups during the study, the 
participant will be summarized under the treatment group within which they began the study. 
The overall incidence is defined as the number of patients in the Safety Set with at least one AE occurring 
after study enrollment divided by the total number of patients in the Safety Set. The AE data will be 
categorized and presented by SOC and PT.  
If any summary table does not contain any AEs, then the summary table will be produced with a 
statement indicating that there are no AEs to report. 
The DAID grading severity of events will be presented in the overall table, as well as the AE sub-tables. 
The possible severities are “Grade 1 – 
,” “Grade 2 – 
,” “Grade 3 – 
,” “Grade 4 – 
,” and “Grade 5 – 
”. If a participant reported multiple occurrences of the 
same AE, only the most severe grading will be presented. AEs that are missing severity will be presented 
in tables as “
” but will be presented in the data listing with a missing severity. The AE data will be 
categorized and presented by SOC, PT, and severity in a separate table. 
The seriousness of an AE will be independently assessed by the investigator from the severity of the AE. 
An SAE will be defined as any untoward medical occurrence that at any dose results in death, is life-
threatening, results in a congenital anomaly/birth defect, requires in-patient hospitalization or 
prolongation, or results in significant disability/incapacity. Important medical events that may not result 
in death, be life-threatening, or require hospitalization may be considered SAEs when, based upon 
medical judgment, they may jeopardize the participant and may require medical or surgical intervention 
to prevent one of the outcomes listed above. All SAEs will be presented in a table with the number and 
percentage of participants who experienced the event. The summary table will be displayed by SOC and 
PT.  
Similarly, the following types of AE will be summarized in separate tables, if applicable: 
x 
Baseline AEs reported at the Baseline/Month 1 visit beginning before informed consent and 
during the oral lead-in/injections that are considered related to oral CAB + RPV or the last 
CABENUVA injection 
x 
Treatment-related AEs  
x 
AEs leading to discontinuation 
x 
Injection site reactions 
CCI
CCI
CCI
CCI
CCI
CCI


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x 
Cardiovascular events 
x 
Liver monitoring/stopping events 
x 
Pregnancy-related AEs 
x 
COVID-19-related AEs 
Other non-serious AEs that are considered not related to CABENUVA or do not lead to withdrawal are not 
documented in the eCRF, and therefore will not be summarized. 
4.7.1.1.1 Baseline AEs 
For participants taking CABENUVA prior to enrollment in the study, any previous AEs related to oral CAB + 
RPV lead in or previous injection beginning before informed consent will be recorded and reported 
separately from events occurring during the study. 
4.7.1.1.2 Treatment-related AEs  
AEs that are considered related to study treatment will be summarized in separate tables.  
4.7.1.1.3 Adverse Events Leading to Discontinuation 
AEs that are associated with discontinuation of treatment will be summarized in separate tables and 
listings. 
4.7.1.1.4 Injection Site Reactions 
Injections site reactions, such as redness, itching, pain or swelling or discomfort, will be recorded and 
summarized in a table as well as in listings. 
4.7.1.1.5 Cardiovascular Event Status 
Type of event and specific event characteristics for arrhythmias, congestive heart failure, stroke/transient 
ischemic attack, deep vein thrombosis/pulmonary embolism, myocardial infarction, peripheral arterial 
thromboembolism, pulmonary hypertension, revascularization, and valvulopathy will be collected and 
reported. 
Participants may have a standard 12-lead electrocardiogram (ECG) performed during the study as 
clinically indicated for a cardiovascular event. ECG overall interpretation will be summarized. ECG data 
(e.g., result, significance, abnormalities present) will be presented in a listing. 
4.7.1.1.6 Liver Monitoring / Stopping Events 
Start and stopping dates/times of liver events, any available liver labs, imaging, and/or biopsies, and 
patient exposures near the time of the event will be recorded and summarized. Alcohol intake at onset of 
liver events will be presented in a table for participants in the Safety Set. 
4.7.1.1.7 Pregnancy Status at Baseline and Pregnancy-related Adverse Events 
Child-bearing potential and pregnancy status at baseline will be reported as part of baseline information 
in a table. Individuals who become pregnant over the course of the study will be reported in a separate 


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listing. Any participant who becomes pregnant while participating in the study will be assessed by their 
HIV care provider whether to continue or discontinue CABENUVA and whether to remain in the study. 
While pregnancy characteristics and outcomes are not part of the study nor documented within the 
eCRF, the reported occurrence of pregnancy during the study will be reported to the sponsor within 24 
hours of awareness. All pregnancies will then be followed up by Sponsor until outcome (including 
premature terminations and complications) for both mother and child. Pregnancy information will be 
collected by the Sponsor from Day 1 and followed for 52 weeks, including any post-study SAEs possibly 
related to CABENUVA. 
Pregnancy-related AEs (pregnancy complications, elective termination for medical reasons, spontaneous 
abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy) will be captured in the AE form 
and reported in a separate listing.  
4.7.1.1.8 COVID-19-related Adverse Events 
Any AEs that are also coded with a COVID-19 infection will be reported in a separate table and listing. 
4.7.1.1.9 Serious Post-injection Reactions 
Any serious post-injection reactions, including dyspnea, agitation, abdominal cramping, flushing, 
sweating, oral numbness, and changes in blood pressure, will be recorded and will be presented in a 
listing. 
4.7.2 Clinical Laboratory Assessments 
Clinical laboratory values performed by local laboratories will be assessed at planned study visits. A 
summary table will present the count and percentage of subjects who have an abnormal value at each 
visit and overall. 
When there are multiple values within a planned visit for a particular laboratory assessment, the 
observation closest to the analysis visit target study day should be used. If there are multiple assessments 
equidistant from the target study day, then the mean of these values will be used. 
HIV-1 RNA and liver chemistries will be summarized. In addition, given adequate sample sizes, other lab 
assessments may be summarized to include: 
x 
Hematology 
x 
Chemistry 
x 
CD4 
Liver laboratory tests will be included with chemistry lab tests. 
Summaries of hepatobiliary laboratory events including possible Hy’s law cases will be provided. Possible 
Hy’s law cases are defined as any elevated ALT ≥3 × upper limit of normal (ULN), total bilirubin ≥2 × ULN, 
and ALP <2 × ULN/missing. Total bilirubin ≥2 × ULN can be within 28 days following the ALT elevation and 
if direct bilirubin is available on the same day, it must be ≥35% of total bilirubin. ALP <2 × ULN/missing 


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means it is satisfied unless the ALP is ≥2 x ULN at the time of bilirubin elevation. The summary will be 
produced for worst-case post-baseline only. 
In addition to liver chemistries, liver biopsy and imaging will also be presented in a listing. 
Harmonization of Local Laboratory Values 
Harmonization of local laboratory value has been referenced in various publications due to differences in 
the test measurements. Normal laboratory reference interval values vary based on several factors, 
including the demographics of the healthy population from which specimens were obtained and the 
specific methods and/or instruments used to assay these specimens. Laboratories that are accredited by 
the College of American Pathologists are required to establish and/or validate their own reference values. 
Thus, any given result should be interpreted based on the reference value of the laboratory in which the 
test was done. This study will receive the results from different laboratory centers. Therefore, the 
laboratory results should be interpreted based on the reference value of the laboratory in which the test 
was done since there is no central laboratory involved.  
4.7.3 Changes in Vital Signs 
Summary tables presenting observed values and changes from baseline for each visit will be presented 
for vital sign data, including systolic/diastolic blood pressure (mmHg), heart rate (beats/min), as well as 
height (cm), weight (kg), and BMI (kg/m2). Vital signs will be assessed in a semi-supine position. 
Vital signs, height, weight, and BMI will be presented in a listing. 
4.7.4 Effectiveness 
A summary of HIV-1 RNA results per visit will be provided. If HIV-1 RNA data is documented at 
unscheduled or early withdrawal visits, the data will be assigned to the closest scheduled visit. However, 
if data from a scheduled visit is already available from the same timepoint, this data is prioritized and data 
from the unscheduled/early withdrawal visit will not be used for analysis. All documented data on HIV-1 
RNA (at scheduled and unscheduled visits) will be presented in the listings.  
The number and percentage classified as virologically suppressed and confirmed virologic failure will as 
be reported as defined below.  
Virological Suppression 
Virological suppression will be defined as observing plasma HIV-1 RNA <50 copies/mL. 
The proportion of participants with virologic suppression will be summarized using the Safety Set. 95% CIs 
will be calculated using Clopper-Pearson exact CI as appropriate for large and small sample sizes. 
Confirmed Virologic Failure 
Confirmed virologic failure will be defined as observing two consecutive plasma HIV-1 RNA ≥200 
copies/mL. 


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The proportion of participants with confirmed virologic failure will be summarized using the Safety Set. 
95% CIs will be calculated using Clopper-Pearson exact CI. 
4.7.5 Use of Oral Bridging 
When a participant plans for a missed injection, the participants may elect for oral bridging. Dosing of oral 
bridging in the event of missed doses will be in accordance with the most recent CABENUVA USPI. 
A single occurrence of oral bridging will be defined as the period between two adjacent CABENUVA 
injections. If the participant is on oral bridging at the end of the study period, then the last occurrence of 
oral bridging is counted as between the last CABENUVA injection and the end of the study period. The 
duration of each oral bridging instance will be derived as the duration from start to end date of the use of 
oral HIV medication between two adjacent CABENUVA injections. 
The number of occurrences and duration of each occurrence of oral bridging will be summarized in a 
table using the Safety Set. 
Participants who have used oral bridging at least once will be summarized. This includes both the 
participants on a monthly injection schedule and an every-2-month injection schedule. 
Frequency of the oral bridging occurrences will be summarized in a table and a histogram. This includes 
both the participants on a monthly injection schedule and an every-2-month injection schedule, while the 
max frequency for the former is eight and for the latter is four. 
The missed injection rate at each visit for participants on oral bridging (proportion of participants who 
missed injection at scheduled visit N+1 while on oral bridging after visit N) will be summarized. Missed 
injection rate will be defined as one minus the adherence rate. 
4.7.6 Impact of COVID-19 Pandemic 
Incidence, severity, and outcome of COVID-19 diagnoses, changes to prescribing related to COVID-19, 
visit impact (e.g., missed visits, altered visit type), and study impact (e.g., need for remote visits, 
discontinuation of study treatment, discontinuation of study) will be listed. 
4.7.7 Changes from Planned Analysis 
As the data are analyzed, some deviation from expectations may occur. In instances where these 
deviations would make the proposed analyses inappropriate, modifications to the SAP—along with 
justifications for these changes—will be made and noted in the final report. 
5 Limitations on Research Methods 
This is a single-arm, real-world study for gathering information on the feasibility and acceptability of 
utilizing an IC/ASA to administer CABENUVA in the US. As such, participants may not necessarily be 
representative of the general population and certain demographics may be over- or under-represented. 


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6 References 
1. 
World Health Organization. Global Surveillance for human infection with novel coronavirus (2019-
nCoV): interim guidance, 31 January 2020. 2020. 2020. 
https://apps.who.int/iris/handle/10665/330857 
2. 
Jan A, Weir CB. BMI Classification Percentile and Cut Off Points. StatPearls: Treasure Island, FL, 
USA. 2021; 
 


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7 Appendices 
7.1 Schedule of Activities (SoA) 
Procedure1 
Baseline/ 
Month 12 
Treatment Period (Months) 
E.D.3 
Notes 
2 
3 
4 
5 
6 
7 
8 
1. 
The timing and number of planned study assessments may be altered during the study based on newly available data.  
2. 
The following sequence of events must be followed for participants at the Baseline/Month 1 visit: 1) informed consent form (ICF) Consent 2) confirm inclusion and 
exclusion criteria 3) complete questionnaires and assessments, 4) receive first study-related intramuscular (IM) injections at the IC/ASA. Baseline is defined as the Month 1 
visit. 
3. 
E.D. = early discontinuation/withdrawal: This visit should only be conducted if the participant discontinues from the study, and the discontinuation/withdrawal reason 
should be recorded. 
NOTE: Carefully follow the Instructions for Use when preparing and administering CABENUVA IM to avoid accidental intravenous administration 
Clinical and Other Assessments 
Informed Consent 
X 
 
 
 
 
 
 
 
 
Written informed consent must be obtained from 
each potentially eligible participant by IC/ASA 
personnel prior to the initiation of any Baseline 
procedures as outlined in this protocol. 
Inclusion and 
Exclusion Criteria 
X 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria will be fully assessed 
at the Baseline/Month 1 Visit. 
Demography 
X 
 
 
 
 
 
 
 
 
 
Pregnancy Status 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Ask POCBP at each visit if they are pregnant and 
ask for the date of their LMP. See Protocol 
Section 10.3.11 for additional information. 
For participants on every-2-month injections, 
pregnancy status should be confirmed only at 
IC/ASA visits. 
Height and Weight 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Height will only be collected at Baseline. BMI will 
be calculated within the eCRF.  
If possible, the same scale should be used 
consistently throughout the study and 
participants should be asked to remove any 
excess clothing (i.e., coats and shoes).  


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For participants on every-2-month injections, 
weight will be collected only at IC/ASA visits. 
Vital Signs: Blood 
Pressure, Heart Rate 
X 
Vital signs will be measured according to the POT with the HIV care provider. All vital 
signs collected must be stored in the participants source documentation at the 
IC/ASA. 
Vital signs are to be measured after resting in a 
semi-supine position for at least 5 minutes. 
For participants on every-2-month injections, vital 
signs will be collected only at IC/ASA visits. 
Laboratory 
Assessments (HIV1-
RNA, Liver 
Chemistries, Other 
Labs Per POT) 
X 
 
 
 
 
 
 
X 
X 
The Baseline/Month 1 labs should be collected 
prior to the first study injection (at the 
Baseline/Month 1 visit). See Section 10.1 for 
additional information 
The HIV care provider is responsible for 
monitoring and any follow-up of elevated HIV-1 
RNA and liver chemistries in their PLWHIV and to 
let the IC/ASA know if there are any changes to 
the monthly or every-2-month injections. The HIV 
care provider can request that the IC/ASA draw 
labs at any time or they can perform local labs as 
required. 
Additional lab assessments may be obtained per blueprint and the POT with 
the HIV care provider. All lab reports must be stored in the participants 
source documentation at the IC. 
Fasting is not required unless otherwise required for a specific lab test. 
Study Treatment: All injections will be administered according to the CABENUVA USPI 
CABENUVA IM Injections initiated at IC/ASA, post oral lead-in (1st injections of CABENUVA at the IC/ASA) 
The final oral doses of CAB + RPV, or other ART, 
should be taken on the same day when injections 
with CABENUVA are started. 
Questionnaires and procedures should be 
conducted prior to the injections. 
Monthly Dosing (Post 
Oral Lead-In) 
X 
X 
X 
X 
X 
X 
X 
X 
 
IM dosing is expected to occur on the same date 
of the month as determined by Dose 1 - 
Treatment Target Date. Dosing window is ± 7 
days. 
Every-2-month 
Dosing  
X 
X 
 
X 
 
X 
 
X 
 
Dosing window for every-2-months is ± 7 days. 
CABENUVA IM Continuation injections: For those already receiving CABENUVA injections, and who are to get their 
subsequent injections at the IC/ASA. 
Questionnaires and interviews should be 
conducted prior to the injections. 


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Note: To avoid having participants whose last injections are at Month 7 return to the IC/ASA at Month 8, the end of study 
assessments (Month 8) will be completed at Month 7. Questionnaires and potential interviews will be completed at 
Month 8. 
Monthly Dosing 
X 
X 
X 
X 
X 
X 
X 
X 
 
The first study-related CABENUVA injections at 
the IC/ASA should be started within 1 month (±7 
days) after the last injections. 
For participants switching from an every-2-month 
continuation injection schedule to a monthly 
continuation dosing schedule, follow the dosing 
instructions in the most recent USPI for 
CABENUVA. 
Every-2-month 
Dosing (Participants 
Already Receiving 
Every-2-month 
Dosing) 
X 
 
X 
 
X 
 
X 
 
 
Dosing window for every-2-month dosing is ±7 
days. 
For participants switching from a monthly 
continuation injection schedule to an every-2-
month continuation injection dosing schedule 
follow the dosing instructions in the most recent 
USPI for CABENUVA. 
Concomitant 
Medication Review 
X 
======================================================  
X 
The IC/ASA will note all new concomitant 
medications and send to the HIV care provider. 
Contraindicated medications and concomitant 
medications with a potential for a DDI per 
CABENUNVA USPI will be recorded. 
Adverse Event (AE) 
Review 
X 
======================================================  
X 
See Protocol Section 10 for more information on 
the DAIDS grading scale, Protocol Section 10.3.7 
for guidelines on assessment of causality, and 
Protocol Section 10.3.10 for AE reporting 
requirements. 
Refer to the Protocol Annex 3 for definitions of 
AEs. 
Serious AEs (SAEs) 
X 
=====================================================  
X 
See Protocol Section 10 for more information on 
the DAIDS grading scale, Protocol Section 10.3.7 
for guidelines on assessment of causality, and 
Protocol Section 10.3.10 for SAE reporting 
requirements.  
Refer to the Protocol Annex 3 for definitions of 
SAEs  


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Abbreviations: AE = adverse event; ART = antiretroviral therapy; ASA = alternative site of administration; DDI = drug-drug interaction; E.D. = early discontinuation/withdrawal; HIV = 
human immunodeficiency virus; IC = infusion center; ICF = informed consent form; IM = intramuscular; LMP = last menstrual period; POCBP = person of child-bearing potential; 
PLWHIV = People living with human immunodeficiency virus; POT = plan of treatment; RNA = ribonucleic acid; SAE = serious adverse event; USPI = United States prescribing 
information 
7.2 Protocol Deviations Rules Document 
[At DBL, will be placed in this appendix.] 
7.3 Tables and Listings 
EVA 30466- Clinical 
Table Shells_Final_V    
EVA 30466- Clinical 
Listing Shells_Final_V       
7.3.1 Tables  
Table 14.1.1 Summary of Participant Disposition (Enrolled Set) 
Table 14.1.2 Summary of Important Protocol Deviations (Enrolled Set) 
Table 14.1.3 Summary of Demographics and Baseline Characteristics (Enrolled Set) 
Table 14.1.4 Summary of Medical History (Enrolled Set) 
Table 14.1.5 Summary of Prior Medications (Excluding ARTs) (Enrolled Set) 
Table 14.1.6 Summary of Prior Antiretroviral Therapies (Enrolled Set) 
Table 14.1.7 Summary of Concomitant Medications (Excluding ARTs) (Safety Set) 
Table 14.1.8 Summary of Concomitant Antiretroviral Therapies (Safety Set) 
Table 14.1.9 Summary of Study Treatment Exposure Prior to Enrollment (Safety Set) 
Table 14.2.1 Summary of HIV-1 RNA Over Time (Safety Set) 


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Table 14.2.2 Summary of HIV-1 RNA Changes from Baseline (Safety Set) 
Table 14.3.1 Summary of Study Treatment Exposure (Safety Set) 
Table 14.3.2 Summary of CAB + RPV Exposure (Safety Set) 
Table 14.3.3 Summary of Missed CABENUVA Injections (Safety Set) 
Table 14.3.4 Summary of Oral Bridging (Safety Set) 
Table 14.3.5 Summary of Baseline Adverse Events (Safety Set) 
Table 14.3.5.1 Summary of Baseline Adverse Events by SOC and PT (Safety Set) 
Table 14.3.6 Summary of Adverse Events (Safety Set) 
Table 14.3.6.1 Summary of Adverse Events by SOC and PT (Safety Set) 
Table 14.3.7 Summary of Injection Site Reaction Adverse Events (Safety Set) 
Table 14.3.8 Summary of Treatment-Related Adverse Events (Safety Set) 
Table 14.3.8.1 Summary of Treatment-Related Adverse Events by SOC and PT (Safety Set) 
Table 14.3.9 Summary of Adverse Events Leading to Treatment Discontinuation or Study Withdrawal (Safety Set) 
Table 14.3.9.1 Summary of Adverse Events Leading to Treatment Discontinuation or Study Withdrawal by SOC and PT (Safety Set) 
Table 14.3.10 Summary of Serious Adverse Events (Safety Set) 
Table 14.3.10.1 Summary of Serious Adverse Events by SOC and PT (Safety Set) 
Table 14.3.11 Summary of Cardiovascular Event Status (Safety Set) 
Table 14.3.12 Summary of Liver Monitoring / Stopping Events (Safety Set) 
Table 14.3.13 Summary of Hepatobiliary Laboratory Abnormalities (Safety Set) 


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Table 14.3.14 Summary of Clinically Significant or Abnormal Lab Values (Safety Set) 
Table 14.3.14.x Summary of Clinically Significant or Abnormal Lab Values by Lab Parameter (Safety Set) 
Table 14.3.15 Summary of CD4 Results and Changes from Baseline (Safety Set) 
Table 14.3.16 Summary of Vital Sign Changes from Baseline (Safety Set) 
Table 14.3.17 Summary COVID-19 Adverse Events (Safety Set) 
Table 14.3.17.1 Summary COVID-19 Adverse Events by SOC and PT (Safety Set) 
Table 14.3.18 Summary of COVID-19 Study Impacts 
7.3.2 Listings 
Listing 16.1.1 Participant Disposition (Enrolled Set) 
Listing 16.1.2 Screen Failures (Enrolled Set) 
Listing 16.1.3 CABENUVA Discontinuation (Safety Set) 
Listing 16.1.4 Protocol Deviations (Enrolled Set)  
Listing 16.1.5 Prohibited Medications (Enrolled Set) 
Listing 16.1.6 Demographics and Baseline Characteristics (Enrolled Set)  
Listing 16.1.7 Medical History (Enrolled Set)  
Listing 16.1.8 Cardiovascular Risk Factors (Safety Set) 
Listing 16.1.9 Prior Antiretroviral Therapy (Enrolled Set)  
Listing 16.1.10 Current Antiretroviral Therapy (Safety Set) 
Listing 16.1.11 Prior Concomitant Medications (Excluding ARTs) (Enrolled Set) 


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Listing 16.1.12 Current Concomitant Medications (Excluding ARTs) (Safety Set) 
Listing 16.3.1 Study Treatment Initiation Method (Safety Set)  
Listing 16.3.2 Study Treatment Administration (Safety Set)  
Listing 16.3.3 Study Treatment Change in Regimen (Safety Set)  
Listing 16.3.4 Missed CABENUVA Injections (Safety Set) 
Listing 16.3.5 Use of Oral Bridging (Safety Set) 
Listing 16.3.6 Baseline Adverse Events (Safety Set)  
Listing 16.3.7 Adverse Events (Safety Set) 
Listing 16.3.8 Injection Site Reaction Adverse Events (Safety Set) 
Listing 16.3.9 Adverse Events Leading to Study Discontinuation (Safety Set)  
Listing 16.3.10 Serious Adverse Events (Safety Set) 
Listing 16.3.11 Liver Monitoring / Stopping Events (Safety Set) 
Listing 16.3.12 Pregnancies Occurring During Study (Safety Set) 
Listing 16.3.13 Pregnancy-Related Adverse Events (Safety set)  
Listing 16.3.14 HIV-1 RNA Clinical Lab Results (Safety Set) 
Listing 16.3.15 Liver Chemistry Clinical Lab Results (Safety Set) 
Listing 16.3.16 Other Clinically Significant or Abnormal Value Clinical Lab Results (Safety Set) 
Listing 16.3.17 Vital Signs and Anthropometrics (Safety Set) 
Listing 16.3.18 12-Lead ECG Results (Safety Set)  


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Listing 16.3.19 COVID-19 Adverse Events (Safety set) 
Listing 16.3.20 COVID-19 Study Impact (Safety Set) 


A Phase 4, Open-label, Single-arm Study to 
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US Community-based Infusion Centers or 
Alternate Sites of Administration 
Statistical Analysis Plan: Infusion Center or Alternate Site of 
Administration Staff 
EVA-30466 | March 4th, 2024| Version 4 
Prepared For: 
, GSK 
, PhD | 
, Global Implementation Research, ViiV Healthcare 
Prepared By: 
, PhD 
PhD MPH 
 PhD, MPH 
Project Contact: 
PPD
PPD
PPD
PPD
PPD
PPD
PPD


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Statistical Analysis Plan (SAP) Signature Page 
SAP Title: 
A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for the 
Treatment of HIV-1, for Administration in US Community-based Infusion Centers or 
Alternative Site of Administration. Statistical Analysis Plan: Infusion Center or Alternative Site 
of Administration Staff 
SAP Date and Version: March 4th, 2024; Version 4.0 
This SAP with the title, number, and version indicated above has been reviewed and approved by the 
Evidera Principal Investigators and Project Managers. 
___________________ 
Date 
___________________ 
Date 
___________________ 
    Date 
___________________ 
Date 
PPD


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Table of Contents 
1 
INTRODUCTION ...................................................................................................................................... 1 
2 
STUDY DESIGN ....................................................................................................................................... 3 
2.1 Description of the IC/ASA Staff Questionnaire and Schedule for Completion ............................... 3 
2.1.1 Feasibility of Intervention Measure .................................................................................... 4 
2.1.2 Acceptability of Intervention Measure ................................................................................ 4 
2.1.3 IC/ASA Staff Additional Questionnaire ................................................................................ 4 
2.2 Windows for Questionnaire Completion ....................................................................................... 4 
2.3 Conditions for Inclusion in Analytic Dataset .................................................................................. 5 
2.4 Implementation Science-Related Protocol Deviations................................................................... 6 
3 
STATISTICAL METHODS .......................................................................................................................... 6 
3.1 Missing Data Handling Scheme ...................................................................................................... 6 
3.2 Cross-sectional Univariate Distributions of Study Variables and Features of Score 
Distributions .................................................................................................................................. 7 
3.3 Distributions of Study Variables and Features of Score Distributions, Change from Baseline/ 
Month 1 for FIM and AIM .............................................................................................................. 7 
4 
QUALITATIVE ANALYSIS .......................................................................................................................... 7 
5 
IC/ACA SITE METRICS ............................................................................................................................. 7 
6 
REFERENCES ........................................................................................................................................... 9 
7 
TABLE SHELLS: BASELINE, MONTH 3, MONTH 8, AND CHANGE ............................................................ 10 
7 
TABLE SHELLS: IC/ASA METRICS ........................................................................................................... 40 
8 
FIGURES ............................................................................................................................................... 44 
APPENDIX A. MISSING DATA ........................................................................................................................ 48 
 
 
 


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List of Tables 
Table A. Objectives and Endpoints for IC/ASA Staff ....................................................................................... 2 
Table B. Questionnaire Administration for IC/ASA Staff ................................................................................ 3 
Table 1.1.1. IC/ASA Staff Roles, Attitudes, and Anticipated Procedures in Implementing CABENUVA 
via IC/ASAs, Baseline (N=XX) ................................................................................................... 10 
Table 1.1.2. IC/ASA Staff Roles, Attitudes, and Anticipated Procedures in Implementing CABENUVA 
via IC/ASAs, Month 3 (N=XX) .................................................................................................. 13 
Table 1.1.3. IC/ASA Staff Roles, Attitudes, and Anticipated Procedures in Implementing CABENUVA 
via IC/ASAs, Month 8 (N=XX) .................................................................................................. 15 
Table 1.2.1. IC/ASA Staff Concerns about CABENUVA Administration – Baseline (N=XX) ........................... 16 
Table 1.2.2. IC/ASA Staff Concerns about CABENUVA Administration – Month 3 (N=XX) ........................... 17 
Table 1.2.3. IC/ASA Staff Concerns about CABENUVA Administration – Month 8 (N=XX) ........................... 19 
Table 1.3.1. IC/ASA Staff Feedback on IC/ASA Administration Blueprint, Month 3 (N=XX) ......................... 19 
Table 1.3.2. IC/ASA Staff Feedback on IC/ASA Administration Blueprint, Month 8 ..................................... 20 
Table 2.1. IC/ASA Staff Responding “Agree” or “Completely Agree” On All FIM Items at Baseline, 
Month 3, and Month 8: Proportions and Change .................................................................. 20 
Table 2.2. IC/ASA Staff Responding “Agree” or “Completely Agree” On All AIM Items at Baseline, 
Month 3, and Month 8: Proportions and Change .................................................................. 21 
Table 3.1. IC/ASA Staff, Distributional Characteristics of Feasibility of Intervention Measure (FIM), 
N=XX ....................................................................................................................................... 22 
Table 3.2. IC/ASA Staff, Distributional Characteristics of Acceptability of Intervention Measure (AIM), 
N=XX ....................................................................................................................................... 23 
Table 4.1. IC/ASA Staff, Univariate Distribution of Feasibility of Intervention Measure (FIM), N=XX .......... 24 
Table 4.2. IC/ASA Staff, Univariate Distribution of Acceptability of Intervention Measure (AIM), N=XX ..... 25 
Table 5.1. IC/ASA Staff, Distributional Characteristics of Change in Feasibility of Intervention Measure 
(FIM), N=XX ............................................................................................................................. 26 
Table 5.2. IC/ASA Staff, Distributional Characteristics of Change in Acceptability of Intervention 
Measure (AIM), N=XX ............................................................................................................. 27 
Table 6.1. IC/ASA Staff, Shift of Feasibility of Intervention Measure (FIM) Response Frequency by 
Item, N=XX .............................................................................................................................. 28 
Table 6.2. IC/ASA Staff, Shift of Acceptability of Intervention Measure (AIM) Response Frequency by 
Item, N=XX .............................................................................................................................. 33 
Table 7.1 IC/ASA Metric Reporting .............................................................................................................. 40 
Table 7.2 IC/ASA Metric Reporting - Palmetto ............................................................................................ 42 
Table 7.3 IC/ASA Metric Reporting - Medix ................................................................................................. 42 
Table 7.4 IC/ASA Metric Reporting - Infusion Associates ............................................................................ 42 
Table 8. Distributional Characteristics of the Feasibility Composite Score .................................................. 42 
Table 9. Implementation Science-Related Protocol Deviations, N=XX ........................................................ 43 
Table A1. Summary of Missing Data ............................................................................................................ 48 


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Table A2. Summary of Free-text Responses ................................................................................................ 48 
 
 
List of Figures 
Figure 1. Bar Chart Showing Mean IC/ASA Staff FIM and AIM Responses at Baseline, Month 3, and 
Month 8 .................................................................................................................................. 44 
Figure 2. Bar Chart Showing Proportion of IC/ASA Staff Responding “Agree” or “Completely Agree” 
on All FIM Items at Baseline, Month 3, and Month 8 ............................................................. 45 
Figure 3. Bar Chart Showing Proportion of IC/ASA Staff Responding “Agree” or “Completely Agree” 
on All AIM Items at Baseline, Month 3, and Month 8 ............................................................. 45 
Figure 4. Bar Chart Showing Change in Proportion of IC/ASA Staff Responding “Agree” or 
“Completely Agree” on All FIM Items, Baseline to Month 3, Baseline to Month 8, and 
Month 3 to Month 8 ............................................................................................................... 46 
Figure 5. Bar Chart Showing Change in Proportion of IC/ASA Staff Responding “Agree” or 
“Completely Agree” on All AIM Items, Baseline to Month 3, Baseline to Month 8, and 
Month 3 to Month 8 ............................................................................................................... 47 
 
 
 


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List of Abbreviations 
Abbreviation 
Definition 
AIM 
Acceptability of Intervention Measure 
BL 
Baseline 
ASA 
Alternative site of administration 
CI 
Confidence interval 
FDA 
Food and Drug Administration 
EDC 
Electronic data capture 
FIM 
Feasibility of Intervention Measure 
FPFV 
First participant first visit 
HIV 
Human immunodeficiency virus 
IC 
Infusion center 
IM 
Intramuscular 
M3 
Month 3 
M8 
Month 8 
OCR 
Optical character recognition 
PDF 
Portable document format 
PLWHIV 
Participants living with human immunodeficiency virus 
QAP 
Qualitative analysis plan 
SAP 
Statistical analysis plan 
SD 
Standard deviation  
SoA 
Schedule of Activities 
 


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1 
Introduction 
CABENUVA is a two-drug, co-packaged product of cabotegravir plus rilpivirine, both administered as long-
acting, intramuscular (IM) injections, once-monthly or every two months; it is an approved treatment for 
human immunodeficiency virus (HIV). Clinical trial results have shown that CABENUVA administered once-
monthly or every two months is non-inferior to the daily oral treatment for HIV. 
Long-acting injectable treatments require changes in how HIV care is delivered. People living with HIV 
must attend appointments for their injections once a month or every two months, rather than seeing 
their providers several times per year for a prescription refill and monitoring visits. This poses new 
healthcare delivery challenges, including a shift in resources to this alternative means of delivering and 
receiving treatment—thus requiring the expansion of alternative injection facilities to include infusion 
centers (ICs) or alternate sites of administration (ASAs). This has the potential to impact workload 
capacity for these facilities, though it also has the potential to positively impact treatment engagement 
and retention for people living with HIV. 
ICs/ASAs are an appealing option that can ease the burden of additional appointments, administrative 
work, and drug ordering in HIV specialty clinics, as well as provide people living with HIV with greater 
flexibility in where they receive their monthly or every two months injections. In this study, the 
intervention itself is the process of using an IC/ASA as the location to receive the CABENUVA IM 
injections. Specifically, the acceptability and feasibility of injection delivery at ICs/ASAs will be assessed 
from the perspectives of the participants living with HIV (PLWHIV), HIV care providers/clinical staff, and 
IC/ASA staff. 
This statistical analysis plan (SAP) describes analyses for the acceptability and feasibility of an IC/ASA to 
deliver CABENUVA IM injections, as reported by IC/ASA staff. It also encompasses a tailored questionnaire 
that asks IC/ASA staff about their attitudes, concerns, and anticipated/implemented procedures regarding 
the use of CABENUVA/long-acting injectables administered by ICs/ASAs. 
This is one of four SAPs for the following protocol: Phase 4, open-label, single arm study to optimize 
implementation of CABENUVA for the treatment of HIV-1, for administration in U.S. community-based 
infusion centers or alternate sites of administration. The three additional SAPs are:  
(1) analyses for HIV care providers and Expert Panel, A Phase 4, open-label, single arm study to optimize 
implementation of CABENUVA for the treatment of HIV-1, for administration in U.S. community-based 
infusion centers or alternate sites of administration, Statistical Analysis Plan: HIV Care Providers and key 
personal who are involved in the patients’ care (Clinical Staff) & Expert Panel;  
(2) analyses of the participant questionnaires and clinical data, A Phase 4, open-label, single arm study to 
optimize implementation of CABENUVA for the treatment of HIV-1, for administration in U.S. community-
based infusion centers or alternate sites of administration, Statistical Analysis Plan: Participants living with 
HIV for Implementation Science Questionnaires; and  


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(3) an additional SAP for clinical characteristics /analyses for PLWHIV, A Phase 4, open-label, single arm 
study to optimize implementation of CABENUVA for the treatment of HIV-1, for administration in U.S. 
community-based infusion centers or alternate sites of administration: Statistical Analysis Plan for Clinical 
Analyses. 
While there are no primary objectives involving IC/ASA staff for this study, this SAP will describe the 
planned analyses for the secondary objectives related to IC/ASA staff as outlined in Table A. Additionally, 
this plan will not incorporate the planned qualitative interview analyses at the end of study.  These 
analyses are described in detail in the qualitative analysis plan (QAP) (currently under development). 
Table A. Objectives and Endpoints for IC/ASA Staff 
Objectives 
Endpoints 
Secondary  
To evaluate feasibility of 
CABENUVA administration at 
infusion centers or alternate sites 
of administration from IC/ASA staff 
Proportion of IC/ASA staff that agree or completely agree (a score of 4 or higher) 
across all items on the FIM prior to Month 1, at Month 3, and Month 8 
Change over time in the FIM at Month 3, and Month 8 with IC/ASA staff 
Summary of other quantitative questionnaires assessed with IC/ASA staff prior to 
Month 1, at Month 3, and Month 8 
Qualitative interviews assessed at Month 8 with IC/ASA staff (QAP) 
To evaluate acceptability of 
CABENUVA administration at 
infusion centers or alternate sites 
of administration from IC/ASA staff 
Proportion of IC/ASA staff that agree or completely agree (a score of 4 or higher) 
across all items on the AIM prior to Month 1, at Month 3, and Month 8 
Change of IC/ASA staff respectively over time in the AIM at Month 3, and Month 8 
Summary of other quantitative questionnaires assessed prior to Month 1, at Month 
3and Month 8 with IC/ASA staff 
Qualitative interviews assessed at Month 8 with IC/ASA staff (QAP) 
To evaluate perceptions, 
facilitators, and barriers/concerns 
by IC/ASA staff 
Summary of IC/ASA staff other quantitative questionnaires prior to Month 1, at 
Month 3, and Month 8 
Qualitative interviews assessed at Month 8 with IC/ASA staff (QAP) 
To evaluate the usefulness of 
blueprint intervention by IC/ASA 
staff 
Summary of usefulness of the blueprint intervention by IC/ASA staff other quantitative 
questionnaires prior to Month 1, at Month 3 and Month 8 
Qualitative interviews assessed at Month 8 with IC/ASA staff (QAP) 
To evaluate overall opinion of 
receiving and administering the 
injection at an infusion center or 
alternate site of administration by 
IC/ASA staff 
Summary of the overall opinion of administering the injection at an IC/ASA by IC/ASA 
staff other quantitative questionnaires prior to Month 1, at Month 3, and Month 8 
Qualitative interviews at Month 8 with IC/ASA staff (QAP) 
To evaluate fidelity to treatment 
and dosing window 
Proportion of injections occurring within target window from target date (± 7 days of 
target date) through Month 8 
Other / Tertiary 
Abbreviations: AIM = Acceptability of Intervention Measure; ASA=Alternative Site of Administration; FIM = Feasibility of 
Intervention Measure; IC = infusion center; QAP = Qualitative Analysis Plan 
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2 
Study Design 
This is a Phase 4, single-arm, open-label, multi-center study examining the administration of CABENUVA 
IM in ICs/ASAs in the United States. This study is being conducted following Food and Drug Administration 
(FDA) approval and commercial availability of CABENUVA. Eligible and consenting participants will be 
followed for eight months to evaluate an implementation blueprint for IM administration of CABENUVA 
for HIV-1 treatment at ICs/ASAs. The total duration for study participants is approximately eight months 
from the time of enrollment and receipt of the first administration of CABENUVA IM injections at the 
IC/ASA. 
Relevant to this SAP, key IC/ASA staff members involved in decision making and/or overseeing daily 
operations at the IC/ASA will be asked to complete questionnaires per the Schedule of Activities (SoA; see 
ANNEX 1 in protocol), as follows: 
x 
Baseline/Month 1 questionnaires should be completed prior to enrollment of the first participant 
at each IC/ASA 
x 
Baseline/Month 1 for each IC/ASA is defined when the first participant enrolls into the study at 
that specific IC/ASA, and the participant is administered the first injections of CABENUVA 
x 
Months 3 and 8 will be defined after at least one participant, at their respective IC/ASA, has 
completed their Month 3, or 8 study visits, respectively 
o Questionnaires can be completed up to two weeks before or after the Month 3 or 8 study 
visits 
Total duration of study participation for IC/ASA staff for completing questionnaires is approximately eight 
months from the time of enrollment of the last participant at that IC/ASA. IC/ASA staff questionnaires 
consist of the Feasibility of Intervention Measure (FIM) and the Acceptability of Intervention Measure 
(AIM), as well as a tailored questionnaire. 
2.1 Description of the IC/ASA Staff Questionnaire and Schedule for 
Completion 
The IC/ASA staff questionnaire consists of two validated instruments and tailored items written for this 
study. The validated instruments are the FIM and AIM, described below. The tailored items ask IC/ASA 
staff about a number of topics, including, but not limited to, their role, experience, and views on the 
CABENUVA/long-acting injectable model, as well as using ICs/ASAs to implement that model. 
IC/ASA staff will be asked to complete a questionnaire at Baseline/ Month 1 (prior to first participant first 
visit [FPFV] at respective ICs/ASAs), and at Months 3 and 8 (see above). 
Table B. Questionnaire Administration for IC/ASA Staff 
Questionnaire 
Baseline/ Month 1 
Month 3 
Month 8 
Feasibility of Intervention Measure 
x 
x 
x 
Acceptability of Intervention Measure 
x 
x 
x 


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Questionnaire 
Baseline/ Month 1 
Month 3 
Month 8 
IC Staff Tailored Items 
x 
x 
x 
Abbreviation: IC/ASA = infusion center/ alternate site of administration 
2.1.1 Feasibility of Intervention Measure  
The FIM (four items) is employed to evaluate the feasibility of an implementation strategy and assess 
perceived intervention feasibility. Items are measured on a five-point rating scale (1=
, 
2=
, 3=
, 4=
, 5=
). The FIM has been validated with 
other implementation outcome measures.1 Higher scores indicate greater feasibility. There are no 
reverse-scored items on the FIM and the mean score for feasibility of the intervention is calculated by 
averaging the responses from the four items. 
2.1.2 Acceptability of Intervention Measure 
The AIM (four items) is employed to evaluate the acceptability of an implementation strategy and 
assesses perceived intervention acceptability. The items are measured on a five-point rating scale 
(1=
, 2=
, 3=
, 4=
, 5=
). The 
AIM was validated with a suite of implementation outcome measures.1 Higher scores indicate greater 
acceptability. There are no reverse-scored items on the AIM and the mean score for acceptability of the 
intervention is calculated by averaging the responses from the four items. 
2.1.3 IC/ASA Staff Additional Questionnaire 
The tailored IC/ASA staff questionnaire was developed specifically for this study and contains items 
regarding the staff member’s role at the IC/ASA, as well as their attitudes, concerns, and 
anticipated/implemented procedures regarding the use of CABENUVA/long-acting injectable 
administered by IC/ASAs. The Baseline/ Month 1 IC/ASA staff questionnaire has 33 items, and the Month 
3 questionnaire has 40 items (including the FIM and AIM), using several different response scales. Data 
Management 
The Baseline/ Month 1 IC/ASA staff questionnaires will be completed on paper, uploaded in portable 
document format (PDF), sent to Evidera via SharePoint, then processed in DF Discovery. Subsequent 
questionnaires will be handled by electronic data capture (EDC). Queries will focus on issues with optical 
character recognition (OCR; legibility), missing data, or DF Discovery form elements required to include 
the data. Missing pages will be queried (by e-mail) to the IC/ASA staff member, to verify that all pages 
were scanned. If data is still missing, follow-up queries will be initiated by the study team with respective 
IC/ASA staff. Queries remaining open from unresponsive IC/ASA staff may be closed with GSK/ViiV review 
and approval. 
2.2 Windows for Questionnaire Completion  
Baseline/Month 1 questionnaires should be completed prior to enrollment of the first participant at each 
infusion center/alternative site of administration. Questionnaires at other months should be completed 
within +/- 14 days of the scheduled month. 
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Month 1 for each IC/ASA is defined when the first participant enrolls into the study at that specific IC/ASA 
and the participant is administered the first study related injections of CABENUVA. 
Month 2 for potential interviews of approximately 5 IC/ASA staff is defined as after at least 1 participant, 
at their respective IC/ASA site, has completed their Month 2 study visits. 
Month 3 and Month 8 is defined as after at least 1 participant, at their respective IC/ASA site, has 
completed their Month 3, or 8 study visits, respectively. 
 
2.3 Conditions for Inclusion in Analytic Dataset  
Duplicate Questionnaires  
In the instance that duplicate questionnaires are present for the same participant at the same visit, the 
temporally first-administered questionnaire will be included in the analytical dataset if it is fully 
completed. If the first questionnaire is not fully completed and the temporally second-administered 
questionnaire is fully completed, then the second questionnaire will be included in the analytical 
dataset. If neither questionnaire is fully completed, the temporally first-administered questionnaire will 
be included in the analytical dataset.    
Multiple Responses Regarding the Blueprint Questionnaire  
In the instance that IC/ASA staff have multiple responses pertaining to the study Blueprint, the temporally 
first-offered responses following that participant receiving the Blueprint will be included in the analytical 
dataset. 
 
IC/ASA Staff who were Discontinued: 
For IC/ASA Staff who were discontinued/withdrawn from the study by the site or did not have a patient 
enroll/reach by month 3: 
 
1. IC/ASA participants who were removed by their respective IC/ASA site prior to month 3 patient 
enrollment will have their month 3 questionnaires removed from the analytic dataset.  
 
2. IC/ASA participants who did not have a patient at their clinic reach Baseline/ Month 1 will have their 
month 3 questionnaires removed from the analytic dataset. 
 
Out-of-Window Questionnaires 
Questionnaires will not be excluded for being out of temporal window (see Section 2). A sensitivity 
analysis will be performed for all analyses described in the current SAP that pertain to FIM or AIM items, 
with all out-of-window questionnaires removed. Results of these analyses will be compared to the main 
analyses, and the magnitude of differences will be summarized descriptively. 
 


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2.4 Implementation Science-Related Protocol Deviations 
Implementation science-related protocol deviations will be reported, where numerators equal the 
number of IC/ASA staff experiencing the respective deviation type, and denominators equal the number 
of IC/ASA staff in analytic dataset. Deviations reported will include, but are not limited to, the following: 
questionnaires with missing data, questionnaires completed but not required at respective time point, 
questionnaires completed out of window (early), questionnaire completed out of window (late), and 
duplicate questionnaire completed. Missing data is considered a deviation if any item is missing, and the 
participant has not dropped out of the study. See section 2.3 and 3.1 for how deviations affect inclusion 
in analytic dataset. 
 
 
3 
Statistical Methods 
This SAP has been developed to guide the analyses for the data collected and assumes that all data will be 
collected in adherence to the protocol developed by GSK/ViiV. The analysis population for this SAP is all 
responding IC/ASA staff who complete any portion of any questionnaire at any point in the study. As the 
data are analyzed, some deviation from expectations may occur. In instances where these deviations 
would make the proposed analyzes inappropriate, modifications to the SAP—along with justifications for 
these changes—will be made and noted in the final report. 
Continuous and interval-like variables will be summarized using descriptive statistics (e.g., n, mean, 
standard deviation [SD], median, minimum, maximum, first and third quartiles, and confidence intervals 
[CI]). Data in tables will be tabulated relative to the source data. Mean, median, and quartiles will be 
tabulated to one more decimal place than the source data; minimum/maximum values will have the same 
decimal places as source data; percentages will be rounded to one decimal place after calculation. SD and 
CIs will be tabulated to two more decimal places than the source data. Categorical variables will be 
reported as frequency counts, the percentage of IC/ASA staff in corresponding categories, and 95% CIs. 
Subgroup analysis will be performed to evaluate the effect of contextual factors on the variability of 
responses to feasibility and acceptability, for example stratifying by practice size. Other subgroup / 
sensitivity analyses may be added subsequent to completion of Baseline/ Month 1 data collections. 
For the analyses of the proportion of IC/ASA staff responding agree or completely agree on all FIM items, 
this will include the IC/ASA staff members who select response option 4 
 or 5 
 
 for all four FIM items at a given time point, out of all IC/ASA staff who completed all four FIM 
items at that respective timepoint. The same definition applies to the analogous analysis for the AIM. 
3.1 Missing Data Handling Scheme 
Missing data at the multi-item scale level for standardized scales (FIM and AIM) will be addressed with 
standard proration rules2: if at least 50% of the items are completed the scale will be scored by taking the 
mean of the completed items, unless otherwise specified for a particular outcome. Following this, 
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partially completed FIM and AIM administrations will be scored if two, three, or four items are 
completed, and will not be scored if only one item is completed. Items not completed will be logged as 
missing data.  No missing data will be imputed. Table shells for missing data from FIM and AIM scales can 
be found in Appendix A. 
3.2 Cross-sectional Univariate Distributions of Study Variables and 
Features of Score Distributions 
For questions with ordinal responses, a univariate distribution of every item will be tabulated. Standard 
distributional statistics will be tabulated for interval-like (ordinal) variables, including mean, SD, median, 
percentage missing, range (minimum and maximum of responses), percentage of the sample at the 
ceiling (highest possible score) and floor (lowest possible score), first and third quartiles, and 95% CIs. For 
questions with descriptive responses, a frequency distribution of all responses will be presented with n 
(%). 
3.3 Distributions of Study Variables and Features of Score 
Distributions, Change from Baseline/ Month 1 for FIM and AIM 
The univariate distribution of item change scores (Month 3 minus Baseline/ Month 1, Month 8 minus 
Baseline/ Month 1, and Month 8 minus Month 3) will be tabulated for the FIM and AIM, both in terms of 
distributional characteristics of change and frequency of responses. Distributional characteristic tables 
will include the SD of the change distribution, median change, first and third quartiles, and 95% CIs. 
Change analyses will be limited to those IC/ASA staff completing questionnaires at Baseline/ Month 1 and 
each respective timepoint. Categorical data for the FIM and AIM from IC/ASA staff questionnaires will be 
presented in shift analyses showing the frequency of change by the degree of shift across response 
categories and will be presented for Baseline/ Month 1 to Month 3, Baseline/ Month 1 to Month 8, and 
Month 3 to Month 8. 
4 
Qualitative Analysis 
Qualitative analyses will be described in the qualitative analysis plan. 
5 
IC/ACA Site Metrics 
Metrics as reported by IC/ASA sites will be described (Section 7). Metrics will include consent rate, 
participant show rate, rate of notifications from HIV care providers and participants, participant return 
visit rate, reach (proportion of eligible individuals that participate in receiving injections at the IC/ASA), 
adoption (proportion of clinics contacted by the IC/ASA that initiate referrals for the injections), and 
fidelity (proportion of injections occurring within target window from target date). Metrics will be 
described for each site and aggregated across sites. Tables will display the rate, numerator and 
denominator used to calculate the rate, and the CI of the estimate. 


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A feasibility composite score will be derived from the following data: 1) FIM score; 2) consent rate; 3) 
show rate; 4) participant notification (appointment level); 5) HIV care provider notification (appointment 
level); and 6) return rate. The mean for each component of the composite score will be calculated across 
all data collections for that score and each component mean will then be multiplied by 100. The mean of 
these scores will then be calculated, producing a composite score where each component receives equal 
weight and the scale range is 0 - 100.  The univariate distribution of feasibility composite score will be 
tabulated. The distributional characteristic table will include the mean and SD of the distribution, median, 
first and third quartiles, and 95% Cis using clinics as the unit of observation. Cronbach’s alpha coefficient 
will be calculated to assess if the items consistently measure feasibility of implementation as a scale.  
 
 


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6 
References 
1. 
Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed 
implementation outcome measures. Implement Sci. 2017;12(1):108. 
2. 
Cella D. Manual of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement 
System—Version 4. Evanston, IL: Center on Outcomes, Research & Education (CORE), Evanston 
Northwestern Healthcare and Northwestern University; 1997. 
 
 
 
 


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7 
Table Shells: Baseline, Month 3, Month 8, and 
Change 
Table 1.1.1. IC/ASA Staff Roles, Attitudes, and Anticipated Procedures in Implementing CABENUVA 
via IC/ASAs, Baseline (N=XX) 
Question 
Number of 
Participants 
at Baseline 
Response 
n (%) 
1.What is your role at the 
infusion center?1,2 
XX 
Front Desk Staff 
n (%) 
Nurse Manager 
n (%) 
Clinic Nurse 
n (%) 
Physician 
n (%) 
Nurse Practitioner 
n (%) 
Pharmacist 
n (%) 
Patient Services 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
2. How concerned are you 
from a personal safety 
perspective about 
administering CABENUVA 
to PLWHIV?3 
XX 
Extremely Concerned 
n (%) 
Moderately Concerned 
n (%) 
Somewhat concerned 
n (%) 
Slightly concerned 
n (%) 
Not concerned at all 
n (%) 
Missing 
n (%) 
3. What are your concerns 
about treating PLWHIV or 
administering 
CABENUVA?1,2  
XX 
Treating HIV positive patients 
n (%) 
Scheduling/Rescheduling in the correct 
treatment window 
n (%) 
Difficulty of giving the gluteal medial injection 
n (%) 
Ability to provide adequate privacy for patients 
n (%) 
Volume of patients we may need to treat on 
CABENUVA 
n (%) 
I have no concerns at all 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
4. CABEBUVA must be 
administered within a two-
week treatment window 
every month.  
4a. How easy or difficult do 
you think the appointment 
scheduling will be?3 
XX 
Extremely easy 
n (%) 
Very easy 
n (%) 
Somewhat easy 
n (%) 
Neutral 
n (%) 
Somewhat challenging 
n (%) 
Very challenging 
n (%) 
Extremely challenging 
n (%) 


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Question 
Number of 
Participants 
at Baseline 
Response 
n (%) 
Missing 
n (%) 
4. CABEBUVA must be 
administered within a two-
week treatment window 
every month.  
4b. How easy or difficult do 
you think the appointment 
re-scheduling will be?3  
XX 
Extremely easy 
n (%) 
Very easy 
n (%) 
Somewhat easy 
n (%) 
Neutral 
n (%) 
Somewhat difficult 
n (%) 
Very difficult 
n (%) 
Extremely difficult 
n (%) 
Missing 
n (%) 
5. How will you notify a 
provider when a patient 
gets CABENUVA on time?1,2  
XX 
Phone call 
n (%) 
Email 
n (%) 
Fax 
n (%) 
Postal Letter 
n (%) 
Secure electronic medical record message 
n (%) 
Depends on provider preference 
n (%) 
No communication necessary 
n (%) 
Missing 
n (%) 
6. How will you notify 
providers if a patient 
misses a CABENUVA visit or 
gets it out of window?1,2 
XX 
Phone call 
n (%) 
Email 
n (%) 
Fax 
n (%) 
Postal Letter 
n (%) 
Secure electronic medical record message 
n (%) 
Depends on provider preference 
n (%) 
No communication necessary 
n (%) 
Missing 
n (%) 
7. In your opinion, how 
easy or difficult do you 
think the CABENUVA 
administration will be to 
implement in your current 
work-flow?3 
XX 
Extremely easy 
n (%) 
Very easy 
n (%) 
Somewhat easy 
n (%) 
Neutral 
n (%) 
Somewhat difficult 
n (%) 
Very difficult 
n (%) 
Extremely difficult 
n (%) 
Missing 
n (%) 
8. How many CABENUVA 
patients do you think your 
infusion center can handle 
in an average week?3 
XX 
0 – 2 patients 
n (%) 
3 – 5 patients 
n (%) 
6 – 10 patients 
n (%) 
11 – 15 patients 
n (%) 
16 – 25 patients 
n (%) 


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Question 
Number of 
Participants 
at Baseline 
Response 
n (%) 
26+ patients 
n (%) 
Missing 
n (%) 
9. Overall, what is your 
opinion about 
administering CABENUVA 
for PLWHIV at your 
infusion center?3 
XX 
Extremely positive 
n (%) 
Very positive 
n (%) 
Somewhat positive 
n (%) 
Neutral 
n (%) 
Somewhat negative 
n (%) 
Very negative 
n (%) 
Extremely negative 
n (%) 
Missing 
n (%) 
1 Select all that apply  
2 Within each question, response choices will be ordered by percent endorsing, descending, and ties will go in order presented to 
respondents. For items with more than 5 response options, the top 5 selected response options within each item at baseline will 
be bolded in tables for subsequent timepoints. 
3 Select one response  
Abbreviations: IC = infusion center; ASA = alternative site of administration; HIV = human immunodeficiency virus; PLWHIV = 
participants living with human immunodeficiency virus 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey at the respective 
timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint. 
Cell percentages do not include missing and responses from participants who completed items which violated the prescribed skip 
pattern were omitted 
*”Other” responses and open-ended text responses will be presented in an appendix 
 
 
 


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Table 1.1.2. IC/ASA Staff Roles, Attitudes, and Anticipated Procedures in Implementing CABENUVA 
via IC/ASAs, Month 3 (N=XX) 
Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
1. How concerned are you 
from a personal safety 
perspective about 
administering CABENUVA to 
people with HIV?1  
XX 
Extremely concerned 
n (%) 
Moderately concerned 
n (%) 
Somewhat concerned 
n (%) 
Slightly concerned 
n (%) 
Not concerned at all (skip to 2) 
n (%) 
Unsure/not applicable to role (skip to 2) 
n (%) 
Missing 
n (%) 
1a. What are your concerns 
about treating people with HIV 
or administering 
CABENUVA?2,3  
XX 
Treating HIV positive patients 
n (%) 
Scheduling/Rescheduling in the correct 
treatment window 
n (%) 
Difficulty of giving the gluteal injection 
n (%) 
Ability to provide adequate privacy for patients 
n (%) 
Volume of patients we may need to treat on 
CABENUVA 
n (%) 
I have no concerns at all 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
2. CABENUVA must be 
administered within a two-
week treatment window (+/-7 
days relative to the target 
treatment date). 
2a. How easy or difficult has it 
been to schedule 
appointments for CABENUVA 
injections?1  
XX 
Extremely easy 
n (%) 
Very easy 
n (%) 
Somewhat easy 
n (%) 
Neither easy nor difficult 
n (%) 
Somewhat difficult 
n (%) 
Very difficult 
n (%) 
Extremely difficult 
n (%) 
Unsure/not applicable to role (skip to 3) 
n (%) 
Missing 
n (%) 
2b. How easy or difficult has it 
been to reschedule 
appointments for CABENUVA 
injections?1,4  
XX 
Extremely easy 
n (%) 
Very easy 
n (%) 
Somewhat easy 
n (%) 
Neither easy nor difficult 
n (%) 
Somewhat difficult 
n (%) 
Very difficult 
n (%) 
Extremely difficult 
n (%) 
Unsure/not applicable to role (skip to 3) 
n (%) 
Missing 
n (%) 
XX 
Phone call 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
3. How does your center notify 
providers when a patient gets 
CABENUVA on time?2,3  
Email 
n (%) 
Fax/FastFax 
n (%) 
Postal Letter 
n (%) 
Secure electronic medical record message 
n (%) 
Depends on provider preference 
n (%) 
No communication necessary 
n (%) 
Unsure/not applicable to role 
n (%) 
Missing 
n (%) 
4a. How does your infusion 
center notify providers if a 
patient misses a CABENUVA 
visit or is out of window?2,3  
XX 
Phone call 
n (%) 
Email 
n (%) 
Fax/FastFax 
n (%) 
Postal Letter 
n (%) 
Secure electronic medical record message 
n (%) 
Depends on provider preference 
n (%) 
No communication necessary 
n (%) 
Unsure/not applicable to role (skip to 5) 
n (%) 
Missing 
n (%) 
4b. How does your infusion 
center notify providers if a 
patient falls out of their 
window for their CABENUVA 
injection?2,3,5  
XX 
Phone call 
n (%) 
Email 
n (%) 
Fax/FastFax 
n (%) 
Postal Letter 
n (%) 
Secure electronic medical record message 
n (%) 
Depends on provider preference 
n (%) 
No communication necessary 
n (%) 
Unsure/not applicable to role 
n (%) 
Missing 
n (%) 
5. In your opinion, how easy or 
difficult has CABENUVA 
administration been to 
implement in your current 
work-flow?1  
XX 
Extremely easy 
n (%) 
Very easy 
n (%) 
Somewhat easy 
n (%) 
Neither easy nor difficult 
n (%) 
Somewhat difficult 
n (%) 
Very difficult 
n (%) 
Extremely difficult 
n (%) 
Missing 
n (%) 
6. About how many 
CABENUVA patients does your 
infusion center currently see?1  
XX 
0 – 2 patients 
n (%) 
3 – 5 patients 
n (%) 
6 – 10 patients 
n (%) 
11 – 15 patients 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
16 – 25 patients 
n (%) 
26+ patients 
n (%) 
Unsure/not applicable to role 
n (%) 
Missing 
n (%) 
7. How many CABENUVA 
patients do you think your 
infusion center can handle in 
an average week?1  
XX 
0 – 2 patients 
n (%) 
3 – 5 patients 
n (%) 
6 – 10 patients 
n (%) 
11 – 15 patients 
n (%) 
16 – 25 patients 
n (%) 
26+ patients 
n (%) 
Unsure/not applicable to role 
n (%) 
Missing 
n (%) 
8. Overall, what is your opinion 
about administering 
CABENUVA for PLWHIV at your 
infusion center?1 
XX 
Extremely positive 
n (%) 
Very positive 
n (%) 
Somewhat positive 
n (%) 
Neither positive nor negative 
n (%) 
Somewhat negative 
n (%) 
Very negative 
n (%) 
Extremely negative 
n (%) 
Missing 
n (%) 
1 Select one response 
2 Select all that apply 
3 Within each question, response choices will be ordered by percent endorsing, descending, and ties will go in order presented to 
respondents. For items with more than 5 response options, the top 5 selected response options within each item at baseline will 
be bolded in tables for subsequent timepoints. 
4Only administered to respondents who did not endorse “Unsure/not applicable to role” for item 2a. 
5Only administered to respondents who did not endorse “Unsure/not applicable to role” for item 4a. 
Abbreviations: IC = infusion center; ASA = alternative site of administration; HIV = human immunodeficiency virus; PLWHIV = 
participants living with human immunodeficiency virus 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey at the respective 
timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint. 
Cell percentages do not include missing and responses from participants who completed items which violated the prescribed skip 
pattern were omitted.  
*”Other” responses and open-ended text responses will be presented in an appendix 
 
Table 1.1.3. IC/ASA Staff Roles, Attitudes, and Anticipated Procedures in Implementing CABENUVA 
via IC/ASAs, Month 8 (N=XX) 
 


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Table 1.2.1. IC/ASA Staff Concerns about CABENUVA Administration – Baseline (N=XX) 
Item 
Number of 
Participants at 
Baseline 
Missing 
Extremely 
concerned 
Moderately 
concerned 
Somewhat 
concerned 
Slightly 
concerned 
Not at all 
concerned 
1. Patients’ 
willingness to travel 
to an infusion 
center for each 
injection visit 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2. Timely reporting 
to the provider 
when a patient 
receives CABENUVA 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3. Timely reporting 
to the provider 
when a patient 
misses a CABENUVA 
visit 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4. Timely reporting 
of adverse events to 
HIV providers  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
5. Frequency of lab 
draws at the 
infusion center  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
6. Management of 
reporting of adverse 
events  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
7. Management of 
reporting abnormal 
lab results with HIV 
providers  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
8. Understanding of 
when to bridge 
patients with oral 
medication for 
planned missed 
doses 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
9. Understanding of 
how to bridge 
patients with oral 
medication for 
planned missed 
doses  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
10. Management of 
patient injection-
related 
pain/soreness  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 


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Item 
Number of 
Participants at 
Baseline 
Missing 
Extremely 
concerned 
Moderately 
concerned 
Somewhat 
concerned 
Slightly 
concerned 
Not at all 
concerned 
11. Answering 
patient questions 
between visits  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
12. Managing 
patients who 
present to 
CABENUVA 
appointments with 
other care needs 
that need to be 
addressed  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
13. Management of 
scheduling 
appointments 
during correct 
treatment windows 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
14. Management of 
rescheduling 
appointments 
during correct 
treatment windows  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
15. Management of 
confirming patient 
insurance coverage  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
16. Patient 
insurance coverage 
clearing for 
payment  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
NOTE: all items are ‘select one response’; Table will be sorted from highest to lowest percentage of IC/ASA staff indicating 
extremely concerned, followed by moderately concerned, somewhat concerned, slightly concerned, and not at all concerned 
Abbreviation: IC = infusion center; ASA = alternative site of administration; HIV = human immunodeficiency virus 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey at the respective 
timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint. Cell percentages do not include missing. 
 
Table 1.2.2. IC/ASA Staff Concerns about CABENUVA Administration – Month 3 (N=XX) 
 
Number of 
Participants 
at Month 3 
Missing 
Extremely 
concerned 
Moderately 
concerned 
Somewhat 
concerned 
Slightly 
concerned 
Not at all 
concerned 
1. Patients’ willingness to travel 
to an infusion center on a 
monthly basis  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2. Timely reporting to the 
provider when a patient receives 
CABENUVA  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 


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Number of 
Participants 
at Month 3 
Missing 
Extremely 
concerned 
Moderately 
concerned 
Somewhat 
concerned 
Slightly 
concerned 
Not at all 
concerned 
3. Timely reporting to the 
provider when a patient misses 
a CABENUVA visit 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4. Timely reporting of adverse 
events to HIV providers  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
5. Frequency of lab draws at the 
infusion center  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
6. Management of reporting of 
adverse events  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
7. Management of reporting 
abnormal lab results with HIV 
providers  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
8. Understanding of when 
patients should receive oral 
medication for planned missed 
doses  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
9. Understanding of how to 
provide patients with oral 
medication for planned missed 
doses  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
10. Management of patient 
injection-related pain/soreness  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
11. Answering patient questions 
between visits  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
12. Managing patients who 
present to CABENUVA 
appointments with other care 
needs that need to be 
addressed  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
13. Management of scheduling 
appointments during correct 
treatment windows  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
14. Management of 
rescheduling appointments 
during correct treatment 
windows  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
15. Management of confirming 
patient insurance coverage  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
16. Patient insurance coverage 
clearing for payment 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
NOTE: all items are ‘select one response’; Table will be sorted from highest to lowest percentage, at baseline, of IC/ASA Staff 
indicating extremely concerned, followed by moderately concerned, somewhat concerned, slightly concerned, and not at all 
concerned. The top 5 items in terms of percent indicating extremely concerned at baseline will be bolded at all subsequent time 
points. Tables reporting subsequent time points will be sorted the same as baseline table. 
Abbreviation: IC = infusion center; ASA = alternative site of administration; HIV = human immunodeficiency virus 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey at the respective 


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timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint. Cell percentages do not include missing. 
Table 1.2.3. IC/ASA Staff Concerns about CABENUVA Administration – Month 8 (N=XX) 
 
Table 1.3.1. IC/ASA Staff Feedback on IC/ASA Administration Blueprint, Month 3 (N=XX) 
Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
1. In which format did you receive the 
blueprint?1,2  
XX 
PowerPoint 
n (%) 
Word document 
n (%) 
Both 
n (%) 
I did not receive the blueprint (skip 
remaining) 
n (%) 
Missing 
n (%) 
2. Which format do you prefer for the 
blueprint?1,2 
XX 
PowerPoint 
n (%) 
Word document 
n (%) 
Either format 
n (%) 
Missing 
n (%) 
3. How often do you use or refer to 
the blueprint?1  
XX 
Extremely often 
n (%) 
Very often 
n (%) 
Somewhat often 
n (%) 
Seldom 
n (%) 
I have never used or referred to the 
blueprint (skip remaining) 
n (%) 
Missing 
n (%) 
4. How useful is the blueprint?1  
XX 
Extremely useful 
n (%) 
Very useful 
n (%) 
Somewhat useful 
n (%) 
Neutral 
n (%) 
Not very useful 
n (%) 
Not at all useful 
n (%) 
Missing 
n (%) 
5. The blueprint contains the 
information I need to administer 
CABENUVA at my infusion center.1  
XX 
Strongly agree 
n (%) 
Agree 
n (%) 
Neither agree nor disagree 
n (%) 
Disagree 
n (%) 
Strongly disagree 
n (%) 
Missing 
n (%) 
6. There is information I need for 
administering CABENUVA in my 
XX 
Strongly agree (go to 6a) 
n (%) 
Agree (go to 6a) 
n (%) 
Neither agree nor disagree (go to 7) 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
infusion center that is missing from 
the blueprint.1  
Disagree (go to 7) 
n (%) 
Strongly disagree (go to 7) 
n (%) 
Missing 
n (%) 
6a. What do you think is missing from 
the blueprint?1,3,4 
XX 
Open-ended text* 
n (%) 
Missing 
n (%) 
7. What is your overall opinion of the 
blueprint?1,5 
XX 
Extremely positive 
n (%) 
Very positive 
n (%) 
Somewhat positive 
n (%) 
Neutral 
n (%) 
Somewhat negative 
n (%) 
Very negative 
n (%) 
Extremely negative 
n (%) 
Missing 
n (%) 
1 Select one response 
2 Within each question, response choices will be ordered by percent endorsing, descending, and ties will go in order presented to 
respondents. 
3Only administered to respondents who endorsed “Agree” or “Strongly agree” for item 6. 
4Open-ended text responses indicating N/A were not included in analyses 
5Only administered to respondents who endorsed “Neither agree nor disagree” or “Disagree” for item 6. 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey at the respective 
timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint. *”Other” responses and open-ended text responses will be presented in an appendix 
Cell percentages do not include missing and responses from participants who completed items which violated the prescribed skip 
pattern were omitted. 
Abbreviations: IC = infusion center; ASA = alternative site of administration 
Table 1.3.2. IC/ASA Staff Feedback on IC/ASA Administration Blueprint, Month 8 
 
Table 2.1. IC/ASA Staff Responding “Agree” or “Completely Agree” On All FIM Items at Baseline, 
Month 3, and Month 8: Proportions and Change 
  
Number completing 
all 4 FIM items 
Number endorsing 4 
or 5 on all FIM Items 
% endorsing all FIM 
Items 
% Point Change 
Baseline1 
XX 
XX 
XX% 
- 
Month 31 
XX 
XX 
XX% 
- 
Month 81 
XX 
XX 
XX% 
- 
Baseline to Month 32 
XX 
BL=XX M3=XX 
BL=XX%; M3=XX% 
XX% 
Baseline to Month 82 
XX 
BL=XX; M8=XX 
BL=XX%; M8=XX% 
XX% 
Month 3 to Month 82 
XX 
M3=XX; M8=XX 
M3=XX%; M8=XX% 
XX% 


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1For each cross-sectional time point row, numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 
items 
2Each change row is limited to those completing all 4 items at both respective timepoints, which may differ from reporting at 
each individual timepoint; numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items. 
Abbreviations: IC = infusion center; ASA = alternative site of administration; FIM = Feasibility of Intervention Measure; 
BL=baseline; M3 = Month 3; M8 = Month 8 
Responses: 4= 
 5= 
 
 
Table 2.2. IC/ASA Staff Responding “Agree” or “Completely Agree” On All AIM Items at Baseline, 
Month 3, and Month 8: Proportions and Change 
 
Number completing 
all 4 AIM items 
Number endorsing 4 
or 5 on all AIM Items 
% endorsing all AIM 
Items 
% Point Change 
Baseline1 
XX 
XX 
XX% 
- 
Month 31 
XX 
XX 
XX% 
- 
Month 81 
XX 
XX 
XX% 
- 
Baseline to Month 32 
XX 
BL=XX; M3=XX 
BL=XX%; M3=XX% 
XX% 
Baseline to Month 82 
XX 
BL=XX; M8=XX 
BL=XX%; M8=XX% 
XX% 
Month 3 to Month 82 
XX 
M3=XX; M8=XX 
M3=XX%; M8=XX% 
XX% 
1For each cross-sectional time point row, numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 
items 
2Each change row is limited to those completing all 4 items at both respective timepoints, which may differ from reporting at 
each individual timepoint; numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items. 
Abbreviations: IC = infusion center; ASA = alternative site of administration; AIM = Acceptability of Intervention Measure; 
BL=baseline; M3 = Month 3; M8 = Month 8 
Responses: 4= 
; 5= 
  
 
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Table 3.1. IC/ASA Staff, Distributional Characteristics of Feasibility of Intervention Measure (FIM), N=XX 
Item/ Scale 
Time 
Point 
 Number of 
Participants 
Missing 
Mean 
SD 
Median 
(Q1, Q3) 
Range 
(–Min, 
Max) 
Percent 
Missing 
Percent 
Floor 
Percent 
Ceiling 
95% CI 
(Lower, 
Upper) 
FIM Mean Score 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
1. Administering 
CABENUVA seems 
implementable in my 
infusion center. 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
2. Administering 
CABENUVA seems 
possible in my infusion 
center. 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
3. Administering 
CABENUVA seems doable 
in my infusion center. 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
4. Administering 
CABENUVA seems easy to 
implement in my infusion 
center. 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
Abbreviations: BL=Baseline; CI = Confidence interval; FIM = Feasibility of Intervention Measure; IC/ASA = Infusion center/alternate site of administration; M3 = Month 3; M8 = 
Month 8; SD = standard deviation. 
Percent Floor for the mean score is the percent of respondents with a score of 1 (
) out of all respondents replying to at least two FIM items at a given time point. 
Percent Ceiling for the mean score is the percent of respondents with a score of 5 (
) out of all respondents replying to at least one two items at a given time point. 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item; Missing % = the number of 
participants who were eligible to complete a survey the respective timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a 
survey at the respective timepoint. Missing for the mean score counts any instance where a respondent completed one FIM item, not reaching the minimum of 2 items required to 
calculate a mean FIM score. 
Cell percentages do not include missing. 
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Table 3.2. IC/ASA Staff, Distributional Characteristics of Acceptability of Intervention Measure (AIM), N=XX 
Item/ Scale 
Time 
Point 
Number of 
Participants 
Missing 
Mean 
SD 
Median 
(Q1, Q3) 
Range 
(–Min, 
Max) 
Percent 
Missing 
Percent 
Floor 
Percent 
Ceiling 
95% CI 
(Lower, 
Upper) 
AIM Mean Score 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X,X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
1. The idea of providing 
CABENUVA at my infusion 
center meets my 
approval. 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
2. The idea of providing 
CABENUVA at my infusion 
center is appealing to me. 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
3. I like the idea of 
providing CABENUVA for 
PLWHIV in my infusion 
center. 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
4. I welcome providing 
CABENUVA for PLWHIV in 
my infusion center. 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
Abbreviations: AIM = Acceptability of Intervention Measure; BL=Baseline; CI = Confidence interval; IC/ASA = Infusion center/alternate site of administration; M3 = Month 3; M8 = 
Month 8; PLWHIV = Participants living with human immunodeficiency virus; SD = Standard deviation; CABENUVA = Cabotegravir Long-Acting + Rilpivirine Long-Acting;. 
Percent Floor for the mean score is the percent of respondents with a score of 1 (
) out of all respondents replying to at least two AIM items at a given time point. 
Percent Ceiling for the mean score is the percent of respondents with a score of 5 (
) out of all respondents replying to at least two AIM items at a given time point. 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item; Missing % = the number of 
participants who were eligible to complete a survey the respective timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a 
survey at the respective timepoint. Missing for the mean score counts any instance where a respondent completed one AIM item, not reaching the minimum of 2 items required 
to calculate a mean AIM score. 
Cell percentages do not include missing. 
 
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Table 4.1. IC/ASA Staff, Univariate Distribution of Feasibility of Intervention Measure (FIM), N=XX 
Items 
Time Point 
Number of 
Participants 
Missing 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. Administering CABENUVA 
seems implementable in my 
infusion center. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2. Administering CABENUVA 
seems possible in my infusion 
center. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3. Administering CABENUVA 
seems doable in my infusion 
center. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4. Administering CABENUVA 
seems easy to implement in my 
infusion center. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
Abbreviations: BL = Baseline; IC/ASA = Infusion center/alternate site of administration; M3 = Month 3; M8 = Month 8 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item; Missing % = the number of 
participants who were eligible to complete a survey at the respective timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a 
survey at the respective timepoint. Cell percentages do not include missing. 
 


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Table 4.2. IC/ASA Staff, Univariate Distribution of Acceptability of Intervention Measure (AIM), N=XX 
Items 
Time Point 
Number of 
Participants 
Missing 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. The idea of providing 
CABENUVA at my infusion 
center meets my approval. 
BL 
xx 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
xx 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
xx 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2. The idea of providing 
CABENUVA at my infusion 
center is appealing to me. 
BL 
xx 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
xx 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
xx 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3. I like the idea of providing 
CABENUVA for PLWHIV in my 
infusion center. 
BL 
xx 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
xx 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
xx 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4. I welcome providing 
CABENUVA for PLWHIV in my 
infusion center. 
BL 
xx 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
xx 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
xx 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
Abbreviations: BL = Baseline; IC/ASA = Infusion center/alternate site of administration; M3 = Month 3; M8 = Month 8; PLWHIV = participants living with human immunodeficiency 
virus 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item; Missing % = the number of 
participants who were eligible to complete a survey at the respective timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a 
survey at the respective timepoint. Cell percentages do not include missing. 
 


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Table 5.1. IC/ASA Staff, Distributional Characteristics of Change in Feasibility of Intervention Measure (FIM), N=XX 
Item/Scale 
Time  
Point 
Number of 
Participants1 
Missing 
Mean 
Change 
SD 
Median 
(Q1, Q3) 
Range 
(–Min, Max) 
95% CI 
(Lower, Upper) 
FIM Mean Score 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X,X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
1. Administering CABENUVA 
seems implementable in my 
infusion center. 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
2. Administering CABENUVA 
seems possible in my 
infusion center. 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
3. Administering CABENUVA 
seems doable in my infusion 
center. 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
4. Administering CABENUVA 
seems easy to implement in 
my infusion center. 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
1 Only includes IC/ASA Staff who completed surveys at respective months 
Abbreviations: BL=Baseline; CI = Confidence interval; IC/ASA = Infusion center/alternate site of administration; FIM = Feasibility of Intervention Measure; M3 = Month 3; M8 = 
Month 8; SD = Standard deviation 
NOTE: Missing for individual item counts = the number of participants who were eligible to complete a survey at the respective timepoint but did not complete respective item; 
Missing % = the number of participants who were eligible to complete a survey at the respective timepoint but did NOT complete the respective item / the number of people who 
were eligible to complete a survey at the respective timepoint. 
Missing for the mean score counts any instance where a respondent completed one FIM item, not reaching the minimum of 2 items required to calculate a mean FIM score. 
Cell percentages do not include missing. 
 


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Table 5.2. IC/ASA Staff, Distributional Characteristics of Change in Acceptability of Intervention Measure (AIM), N=XX 
Item/Scale 
Time  
Point 
Number of 
Participants1 
Missing 
Mean 
Change 
SD 
Median 
(Q1, Q3) 
Range 
(–Min, Max) 
95% CI 
(Lower, Upper) 
AIM Mean Score 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X,X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
1. The idea of providing 
CABENUVA at my infusion 
center meets my approval. 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
2. The idea of providing 
CABENUVA at my infusion 
center is appealing to me. 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
3. I like the idea of providing 
CABENUVA for PLWHIV in 
my infusion center. 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
4. I welcome providing 
CABENUVA for PLWHIV in 
my infusion center. 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
1 Only includes IC/ASA Staff who completed surveys at respective months 
Abbreviations: AIM = Acceptability of Intervention Measure; BL=Baseline; CI = Confidence interval; IC/ASA = Infusion center/alternate site of administration; M3 = Month 3; M8 = 
Month 8; PLWHIV = participants living with human immunodeficiency virus; SD = standard deviation 
NOTE: Missing for individual item counts = the number of participants who were eligible to complete a survey at the respective timepoint but did not complete respective item; Missing % = the number 
of participants who were eligible to complete a survey at the respective timepoint but did NOT complete the respective item / the number of people who were eligible to complete a survey at the 
respective timepoint.  
Missing for the mean score counts any instance where a respondent completed one AIM item, not reaching the minimum of 2 items required to calculate a mean AIM score. 
Cell percentages do not include missing. 


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Table 6.1. IC/ASA Staff, Shift of Feasibility of Intervention Measure (FIM) Response Frequency by Item, N=XX  
1.Administering CABENUVA seems implementable in my infusion center. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  


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N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
2. Administering CABENUVA seems possible in my infusion center. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
3. Administering CABENUVA seems doable in my infusion center. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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4. Administering CABENUVA seems easy to implement in my infusion center. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 


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N=(xx) 
  
  
  
Month 8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Abbreviations: FIM = Feasibility of Intervention Measure; IC = infusion center; ASA = alternative site of administration 
1Missing  at T1, completed at T2 
2Missing  at T2, completed at T1 
Percentage calculations:  
Non-missing cell %: 
numerator = number selecting respective combination of Time 1 and Time 2 responses  
denominator = number of participants responding within Time 1 response category at Time 1 
Table 6.2. IC/ASA Staff, Shift of Acceptability of Intervention Measure (AIM) Response Frequency by Item, N=XX  
1. The idea of providing CABENUVA at my infusion center meets my approval. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
2. The idea of providing CABENUVA at my infusion center is appealing to me. 
  
Baseline  


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Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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Month 
8 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
3. I like the idea of providing CABENUVA for PLWHIV in my infusion center. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
4. I welcome providing CABENUVA for PLWHIV in my infusion center. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Abbreviations: FIM = Feasibility of Intervention Measure; IC = infusion center; ASA = alternative site of administration; PLWHIV = participants living with human immunodeficiency 
virus 
1Missing  at T1, completed at T2 
2Missing  at T2, completed at T1 
Percentage calculations:  


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Non-missing cell %: 
numerator = number selecting respective combination of Time 1 and Time 2 responses  
denominator = number of participants responding within Time 1 response category at Time 1 


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7 Table Shells: IC/ASA Metrics 
Table 7.1 IC/ASA Metric Reporting 
Item 
 
Numerator (N) 
Denominator (N) 
Proportion 
(%) 
95% CI1 
Consent Rate: Proportion of participants that provide 
consent to participate in the study  
Numerator: Number of participants consented 
Denominator: Number of participants referred to the 
IC/ASA to receive CABENUVA IM injections   
XX 
XX 
XX 
(XX%-XX%) 
Show Rate: Proportion of scheduled injection 
appointments that are not missed2,3 
Numerator: Number of scheduled injection 
appointments that result in shows 
Denominator: Number of confirmed scheduled 
injection appointments for participants 
XX 
XX 
XX 
(XX% -XX%) 
Participant Notification – Appointment level: 
Proportion of missed appointments in which the 
infusion center contacts the participant3,4  
Numerator: Number of missed appointments for 
which the participant was contacted 
Denominator: Number of missed appointments 
XX 
XX 
XX 
(XX% -XX%) 
HIV Care Provider Notification: Proportion of all 
appointments missed that are communicated to the 
HIV care provider3,4 
Numerator: Number of missed appointments that 
are communicated to the appropriate HIV care 
provider 
Denominator: Total number of missed appointments 
XX 
XX 
XX 
(XX% -XX%) 
Return Rate at Visit N: Proportion of participants that 
completed any injection at Visit N after the 
completion of (N-1)th injection visit5  
Numerator: Number of participants who returned to 
the IC/ASA and completed an injection at Visit N 
Denominator: Number of participants who 
completed an injection at the IC/ASA at the previous 
visit (N-1) 
― This definition is for any scheduled post-baseline 
visit.  When N=1, the previous visit (N-1) is the 
baseline visit. 
XX 
XX 
XX 
(XX% -XX%) 
Reach: Proportion of participants receiving injections 
at the infusion center/ASA as compared to the 
number of eligible participants through Month 8  
Numerator: Number of participants receiving their 
first injection 
Denominator: Number of eligible participants6 
XX 
XX 
XX 
(XX% -XX%) 


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Item 
 
Numerator (N) 
Denominator (N) 
Proportion 
(%) 
95% CI1 
Adoption (Clinic level): Proportion of clinics contacted 
by the infusion center/ASA that initiate referrals for 
the injections  
Numerator: Number clinics initiation a referral 
Denominator: Number of clinical contacted to refer 
XX 
XX 
XX 
(XX% -XX%) 
Adoption Provider level 
Numerator: Number providers who initiated a 
referral 
Denominator: Number of providers contacted by IC 
XX 
XX 
XX 
(XX% -XX%) 
Fidelity: Proportion of injections occurring within 
target window from target date (+/-7 days of target 
date)7 
Numerator: Number injections in window 
Denominator: Number of injections7 
XX 
XX 
XX 
(XX% -XX%) 
1 Based on the normal approximation to the binomial distribution. Upper bound capped at 100% and lower bound capped at 0%. 
2 Injection appointments that result in shows were defined as an injection at visit N occurring during the target window. Baseline 
visits were excluded as no scheduled date was recorded. Participants who withdrew during the target window were counted as 
no shows. 
3 Missed appointments were defined as any appointment for which no injection occurred among participants who reached the 
target window prior to study discontinuation. 
4 No missed dose forms were completed, therefore participant and HIV care provider notification could not be determined. 
5 Return rate was determined by counting the number of participants receiving an injection at visit N based on the number 
expected according to the number of participants at the previous visit. 
6 Eligible participants included consented, declined study participation, not scheduled/lost to follow-up after referral. Eligible 
participants excluded those not receiving CABENUVA due to lack/change of insurance or cancellation by HCP, not enrolled due to 
site closure, not attending infusion center, and unknown and was prescribed CABENUVA every other month (before permitted in 
study) and <18 years of age. 
7 Target dates for injections were determined in accordance with the methodology implemented in the PLWHIV outputs. 
Abbreviations: CI = Confidence interval; HIV = human immunodeficiency virus; IC/ASA = infusion center/ alternate site of 
administration; IM = intramuscular; N/A = Not available; NE= Not estimable  
 
 


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Table 7.2 IC/ASA Metric Reporting - Palmetto 
 
Table 7.3 IC/ASA Metric Reporting - Medix 
 
Table 7.4 IC/ASA Metric Reporting - Infusion Associates 
 
Table 8. Distributional Characteristics of the Feasibility Composite Score 
 
Number of 
Clinics1 
Missing 
Mean  
SD 
Median 
(Q1, Q3) 
Range 
(Min, 
Max) 
95% CI 
(Lower, 
Upper) 
Cronbach's 
α2 
Feasibility 
Composite 
Score3 
XX 
XX 
XX.X 
XX 
XX (X.X, 
X.X) 
(X.X, 
X.X) 
(X.X,X.X) 
X.XX 
FIM Score4 
XX 
XX 
XX.X 
XX 
XX (X.X, 
X.X) 
(X.X, 
X.X) 
(X.X,X.X) 
X.XX 
Consent Rate 
XX 
XX 
XX.X 
XX 
XX (X.X, 
X.X) 
(X.X, 
X.X) 
(X.X,X.X) 
X.XX 
Show Rate 
XX 
XX 
XX.X 
XX 
XX (X.X, 
X.X) 
(X.X, 
X.X) 
(X.X,X.X) 
X.XX 
Return Rate 
XX 
XX 
XX.X 
XX 
XX (X.X, 
X.X) 
(X.X, 
X.X) 
(X.X,X.X) 
X.XX 
Feasibility composite score includes FIM score, consent rate, show rate, participant notification appointment level, HIV care 
provider notification, and return rate across the entire study period within each clinic. 
Participants are assigned to clinics based on the initial referral. 
1 Includes only clinics consenting one or more participants. 
2 Standardized Cronbach's α. For components, Cronbach's alpha if item deleted is presented. 
3 Feasibility composite score includes FIM score, consent rate, show rate, and return rate across the entire study period within 
each clinic. Participant notification appointment level, and HIV care provider notification were excluded as no missed dose forms 
were completed. 
4 Based on proportion of PLWHIV endorsing all FIM items at a level of 4 or 5 at any timepoint. 
Participants are assigned to clinics based on the initial referral. 
Abbreviations: CI = Confidence interval; FIM = Feasibility of Intervention Measure;  SD = Standard deviation 
 


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Table 9. Implementation Science-Related Protocol Deviations, N=XX 
Protocol Deviation 
IS-related Protocol 
Deviations For IC/ASA Staff  
(N= XX) 
 
n(%) 
Total Sample IS-related Protocol Deviations 
xx (xx.x) 
Questionnaire missing data 
xx (xx.x) 
Questionnaire completed but not required 
xx (xx.x) 
Questionnaire completed out of window (early) 
xx (xx.x) 
Questionnaire completed out of window (late) 
xx (xx.x) 
Duplicate questionnaire completed 
xx (xx.x) 
Placeholder, other possible deviation 
xx (xx.x) 
Abbreviations: IC/ASA = infusion center/ alternate site of administration  
1Deviations associated with incomplete IS questionnaires are for those initiated but not completed 
Note: Numerators equal the number of IC/ASA staff experiencing respective deviation type, denominators equal the number of 
IC/ASA staff in analytic dataset 
 
 
 
 


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8 
Figures 
Figure 1. Bar Chart Showing Mean IC/ASA Staff FIM and AIM Responses at Baseline, Month 3, and 
Month 8 
 
Abbreviations: IC/ASA = Infusion center/ alternate site of administration; FIM = Feasibility of Intervention Measure ; AIM = 
Acceptability of Intervention Measure; BL=Baseline; M3 = Month 3; M8 = Month 8 
Error Bars = Standard error 
 
 
 
0
1
2
3
4
5
Mean FIM
Mean AIM
Mean Response
Bl
M3
M8


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Figure 2. Bar Chart Showing Proportion of IC/ASA Staff Responding “Agree” or “Completely Agree” 
on All FIM Items at Baseline, Month 3, and Month 8 
 
Abbreviations: IC/ASA = Infusion center/alternate site of administration; FIM = Feasibility of Intervention Measure; BL=Baseline; 
M3 = Month 3; M8 = Month 8 
Responses: 4=
 5=
 
For each time point, numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items 
Error Bars = Standard error 
 
Figure 3. Bar Chart Showing Proportion of IC/ASA Staff Responding “Agree” or “Completely Agree” 
on All AIM Items at Baseline, Month 3, and Month 8 
 
Abbreviations: IC/ASA = Infusion center/alternate site of administration; AIM = Acceptability of Intervention Measure; 
BL=Baseline; M3 = Month 3; M8 = Month 8 
Responses: 4=
, 5=
 
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Bl
M3
M8
% Responding 4 or 5
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Bl
M3
M8
% Responding 4 or 5
CCI
CCI
CCI
CCI


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For each time point, numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items 
Error Bars = Standard error 
Figure 4. Bar Chart Showing Change in Proportion of IC/ASA Staff Responding “Agree” or 
“Completely Agree” on All FIM Items, Baseline to Month 3, Baseline to Month 8, and 
Month 3 to Month 8 
 
Abbreviations: IC/ASA = Infusion center/alternate site of administration; FIM = Feasibility of Intervention Measure; BL=baseline; 
M3 = Month 3; M8 = Month 8 
Responses: 4=
 5=
 
Note: Each bar is limited to those completing all 4 items at both respective timepoints; numerator = number responding ‘4’ or ‘5’, 
denominator = number completing all 4 items 
Error Bars = Standard error 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
BL to M3
BL to M8
M3 to M8
Change in Responding 4 or 5, 
Percentage Points
CCI
CCI


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Figure 5. Bar Chart Showing Change in Proportion of IC/ASA Staff Responding “Agree” or 
“Completely Agree” on All AIM Items, Baseline to Month 3, Baseline to Month 8, and 
Month 3 to Month 8 
 
Abbreviations: IC/ASA = Infusion center/alternate site of administration; AIM = Acceptability of Intervention Measure; 
BL=baseline; M3 = Month 3; M8 = Month 8 
Responses: 4=
 5=
 
Note: Each bar  is limited to those completing all 4 items at both respective timepoints; numerator = number responding ‘4’ or 
‘5’, denominator = number completing all 4 items 
Error Bars = Standard error 
 
 
 
 
 
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
BL to M3
BL to M8
M3 to M8
Change in Responding 4 or 5, 
Percentage Points
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Appendix A. Missing Data 
Table A1. Summary of Missing Data 
Timepoint 
Item 
Completed n(%) 
Missing n(%) 
Baseline 
N=XX 
FIM Item 1 
n (%) 
n (%) 
FIM Item 2 
n (%) 
n (%) 
FIM Item 3 
n (%) 
n (%) 
FIM Item 4 
n (%) 
n (%) 
AIM  Item 1 
n (%) 
n (%) 
AIM Item 2 
n (%) 
n (%) 
AIM Item 3 
n (%) 
n (%) 
AIM Item 4 
n (%) 
n (%) 
Month 3 
N=XX 
FIM Item 1 
n (%) 
n (%) 
FIM Item 2 
n (%) 
n (%) 
FIM Item 3 
n (%) 
n (%) 
FIM Item 4 
n (%) 
n (%) 
AIM  Item 1 
n (%) 
n (%) 
AIM Item 2 
n (%) 
n (%) 
AIM Item 3 
n (%) 
n (%) 
AIM Item 4 
n (%) 
n (%) 
Month 8 
N=XX 
FIM Item 1 
n (%) 
n (%) 
FIM Item 2 
n (%) 
n (%) 
FIM Item 3 
n (%) 
n (%) 
FIM Item 4 
n (%) 
n (%) 
AIM  Item 1 
n (%) 
n (%) 
AIM Item 2 
n (%) 
n (%) 
AIM Item 3 
n (%) 
n (%) 
AIM Item 4 
n (%) 
n (%) 
Abbreviations: AIM = Acceptability of Intervention Measure; FIM = Feasibility of Intervention Measure 
 
Table A1. Summary of Free-text Responses 
  


A Phase 4, Open-label, Single-arm Study to 
Optimize Implementation of CABENUVA for 
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US Community-based Infusion Centers or 
Alternate Sites of Administration:  
Statistical Analysis Plan: Participants Living with HIV for 
Implementation Science Questionnaires 
EVA-30466 | March 4, 2024 | Version 4.0 
Prepared For:         
, GSK 
, PhD | 
, Global Implementation Research, ViiV Healthcare 
Prepared By: 
, PhD 
, PhD MPH 
, PhD MPH 
Project Contact: 
  
PPD
PPD
PPD
PPD
PPD
PPD
PPD


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Statistical Analysis Plan (SAP) Signature Page 
SAP Title: 
A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for the 
Treatment of HIV-1, for Administration in US Community-based Infusion Centers or 
Alternative Site of Administration. Statistical Analysis Plan: Participants Living with HIV for 
Implementation Science Questionnaires. 
SAP Date and Version: March 4th, 2024; Version 4.0 
This SAP with the title, number, and version indicated above has been reviewed and approved by the 
Evidera Principal Investigators and Project Managers. 
___________________ 
Date 
___________________ 
Date 
___________________ 
    Date 
___________________ 
Date 
PPD


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Table of Contents 
1 
INTRODUCTION ...................................................................................................................................... 1 
2 
STUDY DESIGN ....................................................................................................................................... 3 
2.1 Description of the PLWHIV Questionnaire and Schedule for Completion ..................................... 4 
2.1.1 Feasibility of Intervention Measure .................................................................................... 4 
2.1.2 Acceptability of Intervention Measure ................................................................................ 4 
2.1.3 PLWHIV Additional Questionnaire ....................................................................................... 4 
2.1.4 Data Management .............................................................................................................. 5 
2.2 Windows for Questionnaire Completion ....................................................................................... 5 
2.3 Conditions for Inclusion in Analytic Dataset .................................................................................. 5 
2.4 Implementation Science-Related Protocol Deviations................................................................... 5 
3 
STATISTICAL METHODS .......................................................................................................................... 6 
3.1 Missing Data Handling Scheme ...................................................................................................... 6 
3.2 Cross-sectional Univariate Distributions of Study Variables and Features of Score 
Distributions .................................................................................................................................. 7 
3.3 Distributions of Study Variables and Features of Score Distributions, Change from Baseline/ 
Month 1 for FIM and AIM .............................................................................................................. 7 
4 
FIDELITY TO TREATMENT IN DOSING WINDOW ..................................................................................... 7 
5 QUALITATIVE ANALYSIS ............................................................................................................................... 7 
5 
REFERENCES ........................................................................................................................................... 8 
6 
TABLE SHELLS: BASELINE, MONTH 3, MONTH 8, AND CHANGE .............................................................. 9 
7 
TABLE SHELLS: ADHERENCE.................................................................................................................. 47 
8 
FIGURES ............................................................................................................................................... 50 
APPENDIX A. MISSING DATA ........................................................................................................................ 54 
 
 
 


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List of Tables 
Table A. Objectives and Endpoints for Participants ....................................................................................... 2 
Table B. Questionnaire Administration for PLWHIV ...................................................................................... 4 
Table 1. PLWHIV Characteristics Baseline (N=XX) .......................................................................................... 9 
Table 1.2.1. PLWHIV Medication Regimen: Experience, Practices, and Views, Baseline (N=XX) ................. 10 
Table 1.2.2. PLWHIV Medication Regimen: Experience, Practices, and Views, Month 3 (N=XX) ................. 15 
Table 1.2.3. PLWHIV Medication Regimen: Experience, Practices, and Views, Month 8 ............................ 17 
Table 1.3.1. PLWHIV Views on IC Administration Model, Baseline (N=XX) .................................................. 17 
Table 1.3.2. PLWHIV Views on IC Administration Model, Month 3 (N=XX) ................................................. 22 
Table 1.3.3. PLWHIV Views on IC Administration Model, Month 8 ............................................................. 32 
Table 2.1. PLWHIV Responding “Agree” or “Completely Agree” On All FIM Items at Baseline, Month 
3, and Month 8: Proportions and Change .............................................................................. 32 
Table 2.2. PLWHIV Responding “Agree” or “Completely Agree” On All AIM Items at Baseline, Month 
3, and Month 8: Proportions and Change .............................................................................. 32 
Table 3.1. PLWHIV, Distributional Characteristics of Feasibility of Intervention Measure (FIM), N=XX ...... 33 
Table 3.2. PLWHIV, Distributional Characteristics of Acceptability of Intervention Measure (AIM), 
N=XX ....................................................................................................................................... 34 
Table 4.1. PLWHIV, Univariate Distribution of Feasibility of Intervention Measure (FIM), N=XX ................ 35 
Table 4.2. PLWHIV, Univariate Distribution of Acceptability of Intervention Measure (AIM), N=XX ........... 36 
Table 5.1. PLWHIV, Distributional Characteristics of Change in Feasibility of Intervention Measure 
(FIM), N=XX ............................................................................................................................. 37 
Table 5.2. PLWHIV, Distributional Characteristics of Change in Acceptability of Intervention Measure 
(AIM) ....................................................................................................................................... 38 
Table 6.1. PLWHIV, Shift of Feasibility of Intervention Measure (FIM) Response Frequency by Item, 
N=XX ....................................................................................................................................... 39 
Table 6.2. PLWHIV, Shift of Acceptability of Intervention Measure (AIM) Response Frequency by 
Item, N=XX .............................................................................................................................. 43 
Table 7. Implementation Science-Related Protocol Deviations, N=XX ........................................................ 47 
Table 8. CABENUVA Adherence, Safety Set ................................................................................................. 47 
Table 9. CABENUVA Adherence: days from the target dosing date at each study visit, Safety Set ............. 48 
Table A1. Summary of Missing Data ............................................................................................................ 54 
Table A2. Summary of Free-text Responses ................................................................................................ 54 
 
 
 


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List of Figures 
Figure 1. Bar Chart Showing Mean PLWHIV FIM and AIM Responses at Baseline, Month 3, and Month 
8 .............................................................................................................................................. 50 
Figure 2. Bar Chart Showing Proportion of PLWHIV Responding “Agree” or Completely Agree” on All 
FIM Items at Baseline, Month 3, and Month 8 ....................................................................... 51 
Figure 3. Bar Chart Showing Proportion of PLWHIV Responding “Agree” or Completely Agree” on All 
AIM Items at Baseline, Month 3, and Month 8....................................................................... 51 
Figure 4. Bar Chart Showing Change in Proportion of PLWHIV Responding “Agree” or Completely 
Agree” on All FIM Items, Baseline to Month 3, Baseline to Month 8, and Month 3 to 
Month 8 .................................................................................................................................. 52 
Figure 5. Bar Chart Showing Change in Proportion of PLWHIV Responding “Agree” or Completely 
Agree” on All AIM Items, Baseline to Month 3, Baseline to Month 8, and Month 3 to 
Month 8 .................................................................................................................................. 53 
 
 
 
 


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List of Abbreviations 
Abbreviation 
Definition 
AIM 
Acceptability of Intervention Measure 
ART 
Antiretroviral therapy 
ASA 
Alternative site of administration 
BL 
Baseline 
CI 
Confidence interval 
EDC 
Electronic data capture 
FDA 
Food and Drug Administration 
FIM 
Feasibility of Intervention Measure 
HIV 
Human immunodeficiency virus 
IC 
Infusion center 
IM 
Intramuscular 
M3 
Month 3 
M8 
Month 8 
OCR 
Optical character recognition 
PDF 
Portable document format 
PLWHIV 
Participants living with human immunodeficiency virus 
QAP 
Qualitative analysis plan 
SAP 
Statistical analysis plan 
SD 
Standard deviation  
SoA 
Schedule of Activities 
 
 


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1 
Introduction 
CABENUVA is a two-drug, co-packaged product of cabotegravir plus rilpivirine, both administered as long-
acting, intramuscular (IM) injections once-monthly or every two months; it is an approved treatment for 
human immunodeficiency virus (HIV). Clinical trial results have shown that CABENUVA administered once-
monthly or every two months is non-inferior to daily oral treatment for HIV. 
Long-acting injectable treatments require changes in how HIV care is delivered. People living with HIV 
must attend appointments for their injections once a month or every two months, rather than seeing 
their providers several times per year for a prescription refill and monitoring visits. This poses new 
healthcare delivery challenges, including a shift in resources to this alternative means of delivering and 
receiving treatment—thus requiring the expansion of alternative injection facilities to include infusion 
centers (ICs) or alternate sites of administration (ASAs). This has the potential to impact workload 
capacity for these facilities, though it also has the potential to positively impact treatment engagement 
and retention for people living with HIV. 
ICs/ASAs are an appealing option that can ease the burden of additional appointments, administrative 
work, and drug ordering in HIV specialty clinics, as well as provide people living with HIV with greater 
flexibility in where they receive their monthly or every two months injections. In this study, the 
intervention itself is the process of using an IC/ASA as the location to receive the CABENUVA IM 
injections. Specifically, the acceptability and feasibility of injection delivery at ICs/ASAs will be assessed 
from the perspectives of the participants living with HIV (PLWHIV), HIV care providers/clinical staff, and 
IC/ASA staff. 
This statistical analysis plan (SAP) describes analyses for the acceptability and feasibility of an IC/ASA to 
deliver CABENUVA IM injections, as reported by study PLWHIV. It also encompasses a tailored 
questionnaire that asks PLWHIV about their experiences regarding their medication regimen, as well as 
their overall health, education, and employment status.  
This is one of four SAPs for the following protocol: Phase 4, open-label, single arm study to optimize 
implementation of CABENUVA for the treatment of HIV-1, for administration in US community-based 
infusion centers or alternate sites of administration. The three additional SAPs are:  
(1) an additional SAP for clinical characteristics/analyses for PLWHIV, A Phase 4, open-label, single arm 
study to optimize implementation of CABENUVA for the treatment of HIV-1, for administration in US 
community-based infusion centers or alternate sites of administration: Statistical Analysis Plan for Clinical 
Analyses,  
(2) analyses for HIV care providers and Expert Panel, A Phase 4, open-label, single arm study to optimize 
implementation of CABENUVA for the treatment of HIV-1, for administration in US community-based 
infusion centers or alternate sites of administration, Statistical Analysis Plan: HIV Care Providers and key 
personal who are involved in the patients’ care (Clinical Staff) & Expert Panel; and  


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(3) analyses for IC/ASA staff, A Phase 4, open-label, single arm study to optimize implementation of 
CABENUVA for the treatment of HIV-1, for administration in US community-based infusion centers or 
alternate sites of administration, Statistical Analysis Plan: Infusion Center Staff. 
This SAP will describe the planned analyses for the primary and secondary quantitative objectives related 
to implementation science for PLWHIV as outlined in Table A. Additionally, this plan will not incorporate 
the planned qualitative interview analyses at the end of study.  These analyses are detailed in the 
qualitative analysis plan (QAP) (currently under development). 
Table A. Objectives and Endpoints for Participants 
Objectives 
Endpoints 
Primary 
To evaluate feasibility of CABENUVA 
administration at infusion centers or 
alternate sites of administration from 
participants  
Proportion of participants that agree or completely agree (a score of 4 or higher) 
across all items on the FIM at Month 8 
Secondary  
To evaluate feasibility of CABENUVA 
administration at infusion centers or 
alternate sites of administration from 
participants 
Proportion of participants that agree or completely agree (a score of 4 or higher) 
across all items on the FIM at Month 1, Month 3 
Change over time in the FIM at Month 3 and Month 8 with participants 
Summary of other quantitative questionnaires assessed with participants at Month 
1, Month 3, and Month 8 
Qualitative interviews assessed at Month 8 with participants (QAP) 
To evaluate feasibility of the process 
of administering CABENUVA at the 
infusion center/ ASA 
Summary of composite score of the feasibility process indications through Month 8  
Change over time through Month 8 in the composite score and each item of 
composite score. 
To evaluate acceptability of 
CABENUVA administration at infusion 
centers or alternate sites of 
administration from participants 
Proportion of participants that agree or completely agree (a score of 4 or higher) 
across all items on the AIM at Month 1, Month 3and Month 8 
Change of participants over time in the AIM at Month 3 and Month 8 
Summary of other quantitative questionnaires assessed at Month 1, Month 3, and 
Month 8 with participants  
Qualitative interviews assessed at Month 8 with participants (QAP) 
To evaluate perceptions, facilitators, 
and barriers/concerns by participants 
Summary of participant other quantitative questionnaires at Month 1, Month 3 and 
Month 8 
Qualitative interviews assessed at Month 8 with participants (QAP) 
To assess the preference of 
participants on the location to receive 
CABENUVA 
Summary of preference on the location to receive CABENUVA at Month 1, Month 3, 
and Month 8 assessed by participant other quantitative questionnaires  
Qualitative interviews assessed at Month 8 with participants (QAP) 
To assess the advantages to receive or 
refer participants to receive 
CABENUVA at the infusion center or 
alternate site of administration from 
participants 
Summary of advantages of receiving CABENUVA at IC/ASA at Month 1, Month 3, and 
Month 8 assessed by participant other quantitative questionnaires  
Qualitative interviews assessed at Month 8 with participants (QAP) 
To assess the disadvantages about 
receiving CABENUVA at the infusion 
Summary of disadvantages of receiving CABENUVA at ICs/ASAs from participant 
other quantitative questionnaires at Month 1, Month 3, and Month 8  
Qualitative interviews assessed at Month 8 with participants (QAP) 


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Objectives 
Endpoints 
center or alternate site of 
administration from participants 
To evaluate the acceptability of 
receiving and referring participants 
for CABENUVA injections at infusion 
centers or alternate sites of 
administration from participants 
Summary of acceptability of the process of receiving injections at ICs/ASAs from 
participant other quantitative questionnaires at Month 1, Month 3and Month 8 
Qualitative interviews assessed at Month 8 with participants (QAP) 
To evaluate overall opinion of 
receiving and administering the 
injection at an infusion center or 
alternate site of administration by 
participants 
Summary of overall opinion of receiving CABENUVA at an infusion center or 
alternate site of administration by participant other quantitative questionnaires at 
Month 1, Month 3, and Month 8. 
Qualitative interviews at Month 8 with participants (QAP) 
Abbreviations: AIM = Acceptability of Intervention Measure; ASA=Alternative Site of Administration; FIM = Feasibility of 
Intervention Measure; IC = infusion center; QAP = Qualitative Analysis Plan 
2 
Study Design 
This is a Phase 4, single-arm, open-label, multi-center study examining the administration of CABENUVA 
IM in ICs/ASAs in the United States. This study is being conducted following Food and Drug Administration 
(FDA) approval and commercial availability of CABENUVA. Eligible and consenting PLWHIV will be 
followed for eight months to evaluate an implementation blueprint for IM administration of CABENUVA 
for HIV-1 treatment at ICs/ASAs. The total duration for study PLWHIV is approximately eight months from 
the time of enrollment and receipt of the first administration of CABENUVA IM injections at the IC/ASA. 
Relevant to this SAP, up to 120 PLWHIV who have been prescribed CABENUVA by their HIV care provider 
will be asked to complete questionnaires per the Schedule of Activities (SoA; see ANNEX 1 in protocol), as 
follows: 
x 
Baseline/Month 1 questionnaires should be completed prior to receiving the first CABENUVA 
injections 
x 
Baseline/Month 1 for each PLWHIV is defined as the date when a PLWHIV signs the informed 
consent form and completes Baseline/Month 1 protocol procedures prior to receiving the first 
CABENUVA injections at the IC/ASA 
x 
Months 3 and 8 will be anchored off of each PLWHIV Baseline/Month 1 visit, so it will reflect the 
Months on study, regardless of what dose they are on and regardless of whether they have 
missed any injections and received oral bridging. 
PLWHIV questionnaires consist of the Feasibility of Intervention Measure (FIM) and the Acceptability of 
Intervention Measure (AIM), as well as a tailored questionnaire. 


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2.1 
Description of the PLWHIV Questionnaire and Schedule for 
Completion 
The PLWHIV questionnaire consists of two validated instruments and tailored items written for this study. 
The validated instruments are the FIM and AIM, described below. The tailored items ask PLWHIV about a 
number of topics, including preferences and attitudes regarding their medication regimen. 
PLWHIV will be asked to complete a questionnaire at Baseline/ Month 1 and at Months 3 and 8 (see table 
above). 
Table B. Questionnaire Administration for PLWHIV 
Questionnaire 
Baseline/ Month 1 
Month 3 
Month 8 
Feasibility of Intervention Measure 
x 
x 
x 
Acceptability of Intervention Measure 
x 
x 
x 
PLWHIV Tailored Items 
x 
x 
x 
Abbreviation: PLWHIV = participants living with human immunodeficiency virus 
2.1.1 Feasibility of Intervention Measure 
The FIM (four items) is employed to evaluate the feasibility of an implementation strategy and assess 
perceived intervention feasibility. Items are measured on a five-point rating scale (1=
, 
2=
, 3=
, 4=
, 5=
). The FIM was validated with 
other implementation outcome measures.1 Higher scores indicate greater feasibility. There are no 
reverse-scored items on the FIM, and the mean score for feasibility of the intervention is calculated by 
averaging the responses from the four items. 
2.1.2 Acceptability of Intervention Measure 
The AIM (four items) is employed to evaluate the acceptability of an implementation strategy and 
assesses perceived intervention acceptability. The items are measured on a five-point rating scale 
(1=
, 2=
, 3=
, 4=
, 5=
). The 
AIM was validated with a suite of implementation outcome measures.1 Higher scores indicate greater 
acceptability. There are no reverse-scored items on the AIM, and the mean score for acceptability of the 
intervention is calculated by averaging the responses from the four items. 
2.1.3 PLWHIV Additional Questionnaire 
The tailored PLWHIV questionnaire was developed specifically for this study and contains items regarding 
the reasons for switching to CABENUVA, adherence to their previous oral HIV medication, preferences 
and attitudes regarding their medication regimen, and perceived advantages and disadvantages of 
receiving injections at the IC/ASA. The Baseline/ Month 1 PLWHIV questionnaire has 34 items (including 
the FIM and AIM), and the Month 3 and Month 8 questionnaires have 39 items, will be a hybrid of paper 
and CRF (Medidata). 
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2.1.4 Data Management 
The Baseline/ Month 1 PLWHIV questionnaires will be collected by electronic data capture (EDC) via 
MediData rave using tablets at the study sites. Subsequent questionnaires will also be collected by EDC. 
Any questionnaires completed on paper, due to issues with EDC devices for example, will be entered into 
the EDC at the sites by clinical staff. Queries will focus on issues of missing data. Missing surveys will be 
queried (by e-mail) to the IC/ASA staff member, to verify that surveys were completed. If data are still 
missing, follow-up queries will be initiated by the study team with respective IC/ASA staff. Queries 
remaining open from unresponsive IC/ASA staff may be closed with GSK/ViiV review and approval.  
2.2 Windows for Questionnaire Completion  
Baseline/Month 1 is defined as the date when a participant signs the Informed Consent Form (ICF) and 
completes Baseline/Month 1 protocol procedures prior to receiving the first study related CABENUVA 
injections at the IC/ASA 
All additional study visits, including those where questionnaires and/or interviews are administered at 
Months 3 and 8 will be anchored off of each participant’s Month 1 visit, so it will reflect the months on 
study, regardless of what dosing regimen the participant is on (e.g., monthly or every 2 months) and 
regardless of whether they have missed any injections and received oral bridging. 
At Month 1, questionnaires should be completed after signing the ICF and before receiving CABENUVA 
intramuscular (IM) injections or within 14 days following the Month 1 visit. Questionnaires should be 
completed before receiving CABENUVA IM injections or +/- 14 days following the last visit. 
2.3 Conditions for Inclusion in Analytic Dataset 
Duplicate Questionnaires  
In the instance that duplicate questionnaires are present for the same participant at the same visit, the 
temporally first-administered questionnaire will be included in the analytical dataset if it is fully 
completed. If the first questionnaire is not fully completed and the temporally second-administered 
questionnaire is fully completed, then the second questionnaire will be included in the analytical 
dataset. If neither questionnaire is fully completed, the temporally first-administered questionnaire will 
be included in the analytical dataset.    
Out-of-Window Questionnaires 
Questionnaires will not be excluded for being out of temporal window (see Section 2). A sensitivity 
analysis will be performed for all analyses described in the current SAP that pertain to FIM or AIM items, 
with all out-of-window questionnaires removed. Results of these analyses will be compared to the main 
analyses, and the magnitude of differences will be summarized descriptively. 
2.4 Implementation Science-Related Protocol Deviations 
Implementation science-related protocol deviations will be reported, where numerators equal the 
number of PLWHIV experiencing the respective deviation type, and denominators equal the number of 
PLWHIV in analytic dataset. Deviations reported will include, but are not limited to, the following: 


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questionnaires with missing data, questionnaires completed but not required at respective time point, 
questionnaires completed out of window (early), questionnaire completed out of window (late), and 
duplicate questionnaire completed. Missing data is considered a deviation if any item is missing, and the 
participant has not dropped out of the study. See section 2.3 and 3.1 for how deviations affect inclusion 
in analytic dataset. 
 
 
3 
Statistical Methods 
This SAP has been developed to guide the analyses for the data collected and assumes that all data will be 
collected in adherence to the protocol developed by GSK/ViiV. The analysis population is all PLWHIV who 
complete any portion of any questionnaire at any point in the study. As the data are analyzed, some 
deviation from expectations may occur. In instances where these deviations would make the proposed 
analyzes inappropriate, modifications to the SAP—along with justifications for these changes—will be 
made and noted in the final report. 
Continuous and interval-like variables will be summarized using descriptive statistics (e.g., n, mean, 
standard deviation [SD], median, minimum, maximum, first and third quartiles, and confidence intervals 
[CIs]). Data in tables will be tabulated relative to the source data. Mean, median, and quartiles will be 
tabulated to one more decimal place than the source data; minimum/maximum values will have the same 
decimal places as source data; percentages will be rounded to one decimal place after calculation. SD and 
CIs will be tabulated to two more decimal places than the source data. Categorical variables will be 
reported as frequency counts, the percentage of PLWHIV in corresponding categories, and 95% CIs. 
Subgroup analysis will be performed to evaluate the effect of contextual factors on the variability of 
responses to feasibility and acceptability. These factors may include, but are not limited to, demographic, 
baseline characteristics, prior clinical experience, initiation method (oral lead in or direct to injection or 
receiving continuation dose), the number of injections received prior to enrollment and injection option 
(monthly or every two months) for PLWHIV. Once specified these will be added to this SAP.  
For the analyses of the proportion of PLWHIV responding agree or completely agree on all FIM items, this 
will include the PLWHIV who select response option 4 (
) or 5 
 for all four FIM 
items at a given time point, out of all PLWHIV who completed all four FIM items at that respective 
timepoint. The same definition applies to the analogous analysis for the AIM. 
3.1 
Missing Data Handling Scheme 
Missing data at the multi-item scale level for standardized scales (FIM and AIM) will be addressed with 
standard proration rules2: if at least 50% of the items are completed the scale will be scored by taking the 
mean of the completed items, unless otherwise specified for a particular outcome. Following this, 
partially completed FIM and AIM administrations will be scored if two, three, or four items are 
completed, and will not be scored if only one item is completed. Items not completed will be logged as 
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missing data. No missing data will be imputed. Table shells for missing data from FIM and AIM scales can 
be found in Appendix A. 
3.2 
Cross-sectional Univariate Distributions of Study Variables and 
Features of Score Distributions 
For questions with ordinal responses, a univariate distribution of every item will be tabulated. Standard 
distributional statistics will be tabulated for interval-like (ordinal) variables, including mean, SD, median, 
percentage missing, range (minimum and maximum of responses), percentage of the sample at the 
ceiling (highest possible score) and floor (lowest possible score), first and third quartiles, and 95% CIs. For 
questions with descriptive responses, a frequency distribution of all responses will be presented with n 
(%). 
3.3 
Distributions of Study Variables and Features of Score 
Distributions, Change from Baseline/ Month 1 for FIM and AIM 
The univariate distribution of item change scores (Month 3 minus Baseline/ Month 1, Month 8 minus 
Baseline/ Month 1, and Month 8 minus Month 3) will be tabulated for the FIM and AIM, both in terms of 
distributional characteristics of change and frequency of responses. Distributional characteristic tables 
will include the SD of the change distribution, median change, first and third quartiles, and 95% CIs. 
Change analyses will be limited to those PLWHIV completing questionnaires at Baseline/ Month 1 and 
each respective timepoint. Categorical data for the FIM and AIM will be presented in shift analyses 
showing the frequency of change by the degree of shift across response categories and will be presented 
for Baseline/ Month 1 to Month 3, Baseline/ Month 1 to Month 8, and Month 3 to Month 8. 
4 
Fidelity to Treatment in Dosing Window 
The fidelity to treatment in dosing window will be described in terms of the number and percentage of 
participants with CABENUVA injections not completed within the +/-7 day window of target dosing date, 
grouped by the number of missed injections. The distributional characteristics (mean, standard deviation, 
median, first and third quartiles minimum, and maximum) of the number of days from the target dosing 
date will also be summarized by visit. Fidelity to treatment in dosing window will be described separately 
for participants receiving monthly and bi-monthly injections. 
5 Qualitative Analysis 
Qualitative analyses will be described in the Qualitative Analysis Plan. 
 
 


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5 
References 
1. 
Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed 
implementation outcome measures. Implement Sci. 2017;12(1):108. 
2. 
Cella D. Manual of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement 
System—Version 4. Evanston, IL: Center on Outcomes, Research & Education (CORE), Evanston 
Northwestern Healthcare and Northwestern University; 1997. 
 
 
 
 


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6 
Table Shells: Baseline, Month 3, Month 8, and 
Change 
Table 1. PLWHIV Characteristics Baseline (N=XX) 
Question 
Number of 
Participants 
at Baseline 
Response / Statistic 
Value 
1. What is your age? 
XX 
Mean (SD) 
XX.X (X.X) 
Median (Q1-Q3) 
XX (XX-XX) 
Range (–Min, Max) 
(XX, XX) 
Missing 
X 
2. I consider my current state of health to be … 1 
XX 
Excellent 
n (%) 
Very Good 
n (%) 
Good 
n (%) 
Fair 
n (%) 
Poor 
n (%) 
Missing 
n (%) 
3. What is the highest level of education 
you have completed (select one response)?1 
XX 
Less than high school  
n (%) 
High School or equivalent  
n (%) 
Bachelor’s degree  
n (%) 
Master’s degree  
n (%) 
Doctoral degree 
n (%) 
Other 
n (%) 
Prefer not to answer 
n (%) 
Missing 
n (%) 
4. What is your employment status?2,3 
XX 
Employed full-time 
n (%) 
Employed part-time 
n (%) 
Student 
n (%) 
Not currently employed  
n (%) 
Retired 
n (%) 
Not working due to my health 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
1 Select one response 
2 Select all that apply 
3 Within each question, response choices will be ordered by percent endorsing, descending, and ties will go in order presented to 
respondents.  
Abbreviation: PLWHIV = participants living with human immunodeficiency virus; SD = standard deviation 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey the respective 
timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint. 


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Cell percentages do not include missing. 
* ”Other” responses and open-ended text responses will be presented in an appendix 
 
Table 1.2.1. PLWHIV Medication Regimen: Experience, Practices, and Views, Baseline (N=XX) 
Question 
Number of 
Participants 
at Baseline 
Response 
n (%) 
1. How often do you 
typically see your HIV 
doctor?1  
XX 
Once every 3 months 
n (%) 
Once every 4 months 
n (%) 
Once every 6 months 
n (%) 
Once every 12 months 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
2. Have you received 
CABENUVA injections 
before today?1  
XX 
No, I have not received CABENUVA injections prior to today. (Go to 
Q4) 
n (%) 
Yes, I’ve received CABEUNVA injections prior to today. (provide Q3 
as pop-up) 
n (%) 
I am not sure. (Go to Q3) 
n (%) 
Missing 
n (%) 
3. How many 
CABENUVA injections 
have you had in the 
past?1 
XX 
1 injection 
n (%) 
2 injections 
n (%) 
3 or more injections 
n (%) 
Missing 
n (%) 
4. What is the primary 
reason why you 
decided to switch your 
ART regimen to 
CABENUVA?1,2   
XX 
It was difficult for me to remember to take my previous HIV 
medications everyday 
n (%) 
I was concerned about the long-term side effects of my previous 
HIV medications 
n (%) 
I was not tolerating my prior HIV medications well because of side 
effects  
n (%) 
I was tired of taking my medication every day 
n (%) 
I experience(d) anxiety or stress about others seeing my daily pills 
and finding out that I have HIV  
n (%) 
I do not want my HIV treatment to remind me of my HIV status 
every day  
n (%) 
I experience(d) anxiety or stress about missing a dose of my HIV 
medications  
n (%) 
I wanted a treatment option that is more convenient for my life 
n (%) 
My HIV doctor suggested that I switch 
n (%) 
I worried that my viral load was not suppressed with my prior oral 
HIV medications 
n (%) 
I had difficulty swallowing my oral HIV treatment 
n (%) 
Other* 
n (%) 
Missing 
n (%) 


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Question 
Number of 
Participants 
at Baseline 
Response 
n (%) 
5. What other 
reason(s) did you have 
for switching your ART 
regimen to 
CABENUVA?2,3  
XX 
It was difficult for me to remember to take my previous HIV 
medications everyday 
n (%) 
I was concerned about the long-term side effects of my previous 
HIV medications 
n (%) 
I was not tolerating my prior HIV medications well because of side 
effects  
n (%) 
I was tired of taking my medication every day 
n (%) 
I experience(d) anxiety or stress about others seeing my daily pills 
and finding out that I have HIV  
n (%) 
I do not want my HIV treatment to remind me of my HIV status 
every day  
n (%) 
I experience(d) anxiety or stress about missing a dose of my HIV 
medications  
n (%) 
I wanted a treatment option that is more convenient for my life 
n (%) 
My HIV doctor suggested that I switch 
n (%) 
I worried that my viral load was not suppressed with my prior oral 
HIV medications 
n (%) 
I had difficulty swallowing my oral HIV treatment 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
6.  Prior to deciding to 
switch to CABENUVA, 
did you have any 
problems with taking 
your daily oral HIV 
medications?2,3  
XX 
I experienced side effects with my daily HIV medications 
n (%) 
I had problems remembering to take my daily HIV medications 
n (%) 
I was concerned about running out of my daily HIV medications 
n (%) 
I take too many oral medications and would prefer to take fewer all 
together 
n (%) 
I had anxiety about taking my daily HIV medications 
n (%) 
I felt that I had to hide my daily HIV medications from others 
n (%) 
My daily HIV medications reminded me of my HIV status 
n (%) 
My daily HIV medication routine was not convenient for me 
n (%) 
I had difficulty with paying for my daily HIV medications 
n (%) 
I had difficulty swallowing my daily pills (for any reason) 
n (%) 
I worried about potential interaction with other treatments 
n (%) 
I worried about the food requirement when taking my daily HIV 
medication 
n (%) 
I had difficulty/worry about getting to the pharmacy to get my daily 
HIV medications 
n (%) 
I had difficulty/worry about wait times at the pharmacy to get my 
daily HIV medications 
n (%) 
I had difficulty/worry about the pharmacy not having my daily HIV 
medications in stock 
n (%) 
Other* 
n (%) 


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Question 
Number of 
Participants 
at Baseline 
Response 
n (%) 
I did not have any problems with my prior daily HIV medications 
n (%) 
Missing 
n (%) 


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Question 
Number of 
Participants 
at Baseline 
Response 
n (%) 
7. When you were 
taking daily oral HIV 
medication, how often 
did you not take your 
HIV medicine during a 
typical week?1   
XX 
Never 
n (%) 
Less than once per week 
n (%) 
Once or twice per week 
n (%) 
Three or four times per week 
n (%) 
More than five times per week 
n (%) 
Missing 
n (%) 
8. What were your 
reasons for not taking 
your daily oral HIV 
medicine?2,3  
XX 
Forgot 
n (%) 
Social plans interfered with usual dosing time 
n (%) 
Work schedule interfered with usual dosing time 
n (%) 
Travel/vacation (either work or pleasure) 
n (%) 
To avoid side effects 
n (%) 
Did not feel well 
n (%) 
Ran out of medication 
n (%) 
Changed medication 
n (%) 
I never forgot to take my daily oral meds 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
9.What are/were your 
biggest concerns about 
receiving CABENUVA at 
an infusion center?2,3  
XX 
The infusion center managing my pain or soreness from CABENUVA 
n (%) 
The infusion center managing the side effects from CABENUVA 
n (%) 
My doctor not knowing if I have a bad reaction 
n (%) 
The infusion center not aware of my other medical history 
n (%) 
Infusion center not aware of my other medications and possible 
interactions 
n (%) 
Scheduling upcoming CABENUVA visits 
n (%) 
Rescheduling missed CABENUVA visits 
n (%) 
Forgetting my appointments for the CABENUVA visits 
n (%) 
Frequency of the required visits to the infusion center clinic as well 
as my primary HIV doctor 
n (%) 
Transportation to the infusion center for the CABENUVA visits 
n (%) 
Parking at the infusion center for CABENUVA visits 
n (%) 
The infusion center hours for CABENUVA visits 
n (%) 
Childcare during CABENUVA visits 
n (%) 
Infusion Center not being an HIV-specific clinic 
n (%) 
Others at the clinic may find out that I am HIV positive 
n (%) 
Other* 
n (%) 
No current worries about receiving CABENUVA at an infusion center 
n (%) 
Missing 
n (%) 


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Question 
Number of 
Participants 
at Baseline 
Response 
n (%) 
10. Where would you 
prefer to receive 
CABENUVA?1,2  
XX 
At my HIV doctor’s clinic 
n (%) 
At an infusion center 
n (%) 
At home 
n (%) 
At a pharmacy 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
11. How interested would you be in these other ways of receiving your CABENUVA injections, if available in the future? 
11a. At home, 
administered by a 
partner as two 
injections in your 
gluteal (buttocks) 
muscle (same type of 
injections you have 
been/will be receiving 
in this study)1  
XX 
Very interested 
n (%) 
Moderately interested 
n (%) 
Somewhat interested 
n (%) 
A little interested 
n (%) 
Not at all interested 
n (%) 
Missing 
n (%) 
11b. At home, 
administered by a 
partner as two 
injections in your 
thigh1  
XX 
Very interested 
n (%) 
Moderately interested 
n (%) 
Somewhat interested 
n (%) 
A little interested 
n (%) 
Not at all interested 
n (%) 
Missing 
n (%) 
11c. At home, self-
administered by you as 
two injections in your 
thigh1  
XX 
Very interested 
n (%) 
Moderately interested 
n (%) 
Somewhat interested 
n (%) 
A little interested 
n (%) 
Not at all interested 
n (%) 
Missing 
n (%) 
1 Select one response 
2 Within each question, response choices will be ordered by percent endorsing descending, ties will go in order presented to 
respondents. For items with more than 5 response options, the top 5 selected response options within each item at baseline will 
be bolded in tables for subsequent timepoints. 
3 Select all that apply 
Abbreviations: ART = antiretroviral therapy; HIV = human immunodeficiency virus; PLWHIV = participants living with human 
immunodeficiency virus. 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey the respective 
timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint. 
Cell percentages do not include missing. Cell percentages do not include missing. 
* ”Other” responses and open-ended text responses will be presented in an appendix 
 
 


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Table 1.2.2. PLWHIV Medication Regimen: Experience, Practices, and Views, Month 3 (N=XX) 
Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
1. Do you have any 
concerns about continuing 
to receive CABENUVA at 
an infusion center?1  
XX 
Yes (go to Q2) 
n (%) 
No (go to Q3) 
n (%) 
Missing 
n (%) 
2. What are your biggest 
concerns about continuing 
to receive CABENUVA at 
an infusion center?2,3 
XX 
The infusion center managing my pain or soreness from CABENUVA 
n (%) 
The infusion center managing the side effects from CABENUVA 
n (%) 
My doctor not knowing if I have a bad reaction 
n (%) 
The infusion center not aware of my other medical history 
n (%) 
Infusion center not aware of my other medications and possible 
interactions 
n (%) 
Scheduling upcoming CABENUVA visits 
n (%) 
Rescheduling missed CABENUVA visits 
n (%) 
Forgetting my appointments for the CABENUVA visits 
n (%) 
Frequency of the required visits to the infusion center clinic as well 
as my primary HIV provider 
n (%) 
Transportation to the infusion center for the CABENUVA visits 
n (%) 
Parking at the infusion center for CABENUVA visits 
n (%) 
The infusion center hours for CABENUVA visits 
n (%) 
Childcare during CABENUVA visits 
n (%) 
Infusion center not being an HIV-specific clinic 
n (%) 


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Others at the infusion center may find out that I am HIV positive 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
3. Where would you 
prefer to receive 
CABENUVA?1,3  
XX 
At my HIV provider’s clinic 
n (%) 
At an infusion center 
n (%) 
At home 
n (%) 
At a pharmacy 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
4. How interested would you be in these other ways of receiving your CABENUVA injections, if available in the future? 
4a. At home, administered 
by a partner as two 
injections in your gluteal 
(buttocks) muscle (same 
type of injections you 
have been receiving in this 
study)1 
XX 
Very interested 
n (%) 
Moderately interested 
n (%) 
Somewhat interested 
n (%) 
A little interested 
n (%) 
Not at all interested 
n (%) 
Missing 
n (%) 
4b. At home, 
administered by a partner 
as two injections in your 
thigh1 
XX 
Very interested 
n (%) 
Moderately interested 
n (%) 
Somewhat interested 
n (%) 
A little interested 
n (%) 
Not at all interested 
n (%) 
Missing 
n (%) 
4c. At home, self-
administered by you as 
two injections in your 
thigh1 
XXX 
Very interested 
n (%) 
Moderately interested 
n (%) 
Somewhat interested 
n (%) 
A little interested 
n (%) 
Not at all interested 
n (%) 


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Missing 
n (%) 
1 Select one response 
2 Select all that apply 
3 Within each question, response choices will be ordered by percent endorsing, descending, ties will go in order presented to 
respondents. or items with more than 5 response options, the top 5 selected response options within each item at baseline will 
be bolded in tables for subsequent timepoints. 
Abbreviation: HIV = human immunodeficiency virus; PLWHIV = participants living with human immunodeficiency virus 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey the respective 
timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint. 
Cell percentages do not include missing and responses from participants who completed items which violated the prescribed skip 
pattern were omitted*”Other” responses and open-ended text responses will be presented in an appendix 
 
Table 1.2.3. PLWHIV Medication Regimen: Experience, Practices, and Views, Month 8 
 
Table 1.3.1. PLWHIV Views on IC Administration Model, Baseline (N=XX) 
Question 
Number of 
Participants 
at Baseline 
Response 
n (%) 
1. How acceptable is it 
to you to come to the 
infusion center for 
CABENUVA?1  
XX 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
A little acceptable 
n (%) 
Neutral 
n (%) 
A little unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Missing 
n (%) 
2. What are the 
advantages of going to 
the infusion center to 
receive CABENUVA?2,3 
XX 
Convenient location of the infusion center 
n (%) 
Ease of parking at the infusion center  
n (%) 
Convenient hours for the infusion center  
n (%) 
More privacy at the infusion center  
n (%) 
I like that people do not know what medication I am there 
to receive 
n (%) 
Reduced stigma 
n (%) 


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Question 
Number of 
Participants 
at Baseline 
Response 
n (%) 
Injections are not available at my provider’s office 
n (%) 
Other* 
n (%) 
No advantages of receiving CABENUVA at the infusion 
center 
n (%) 
Missing 
n (%) 
3. What are the 
disadvantages of going 
to the infusion center 
to receive 
CABENUVA?2,3 
XX 
Inconvenient location of the infusion center 
n (%) 
Unfamiliar with routine at the infusion center 
n (%) 
Unfamiliar with the infusion center staff 
n (%) 
Inconvenient hours for the infusion center 
n (%) 
Less privacy at the infusion center 
n (%) 
Decreased contact with my HIV provider 
n (%) 
Difficulty scheduling and rescheduling appointments 
n (%) 
Too many appointments between the IC and the HIV 
doctors 
n (%) 
Too many lab draws 
n (%) 
Infusion center doesn’t know how to manage the pain or 
side effects of CABENUVA 
n (%) 
I don’t want other people at the infusion center to know I 
have HIV 
n (%) 
Other* 
n (%) 
No disadvantages of receiving CABENUVA at the infusion 
center 
n (%) 
Missing 
n (%) 
4.How convenient is it 
for you to get to the 
infusion center for your 
CABENUVA visits?1 
XX 
Very Convenient  
n (%) 
Somewhat convenient 
n (%) 
A little convenient 
n (%) 
Neutral 
n (%) 
A little inconvenient 
n (%) 


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Question 
Number of 
Participants 
at Baseline 
Response 
n (%) 
Somewhat inconvenient 
n (%) 
Very inconvenient 
n (%) 
Missing 
n (%) 
5. How long does it 
typically take you to get 
to the infusion center?1 
XX 
1-15 minutes 
n (%) 
16-30 minutes 
n (%) 
31-45 minutes 
n (%) 
46-60 minutes 
n (%) 
More than 60 minutes 
n (%) 
Missing 
n (%) 
6. How acceptable to 
you is the time it 
typically takes you to 
get to the infusion 
center?1 
XX 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
A little acceptable 
n (%) 
Neutral 
n (%) 
A little unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Missing 
n (%) 
7. How much time do 
you expect to spend in 
the infusion center for 
each CABENUVA visit?1 
XX 
1-15 minutes 
n (%) 
16-30 minutes 
n (%) 
31-45 minutes 
n (%) 
46-60 minutes 
n (%) 
More than 60 minutes 
n (%) 
Missing 
n (%) 
8. How concerned are 
you about unwanted 
disclosure of your HIV 
status when attending 
XX 
Very concerned 
n (%) 
Moderately concerned 
n (%) 


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Question 
Number of 
Participants 
at Baseline 
Response 
n (%) 
appointments at your 
HIV providers office?1 
Somewhat concerned 
n (%) 
A little concerned 
n (%) 
Not at all concerned 
n (%) 
Missing 
n (%) 
9. How concerned are 
you about unwanted 
disclosure of your HIV 
status when attending 
appointments at the 
infusion center?1 
XX 
Very concerned 
n (%) 
Moderately concerned 
n (%) 
Somewhat concerned 
n (%) 
A little concerned 
n (%) 
Not at all concerned 
n (%) 
Missing 
n (%) 
10. How acceptable is it 
to go to two separate 
places for your care 
(that is, the infusion 
center for CABENUVA 
and to your clinic for 
your regular HIV 
appointments)?1 
XX 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
A little acceptable 
n (%) 
Neutral 
n (%) 
A little unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Missing 
n (%) 
11. How acceptable is it 
for you to get labs 
drawn at the infusion 
center?1 
XX 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
A little acceptable 
n (%) 
Neutral 
n (%) 
A little unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 


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Question 
Number of 
Participants 
at Baseline 
Response 
n (%) 
Missing 
n (%) 
12. How acceptable 
was the insurance 
verification process at 
the infusion center?1 
XX 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
A little acceptable 
n (%) 
Neutral 
n (%) 
A little unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Missing 
n (%) 
13. What is your overall 
opinion about going to 
an infusion center to 
receive CABENUVA?1 
XX 
Very positive 
n (%) 
Somewhat positive 
n (%) 
A little positive 
n (%) 
Neutral 
n (%) 
A little negative 
n (%) 
Somewhat negative 
n (%) 
Very negative 
n (%) 
Missing 
n (%) 
1 Select one response 
2 Select all that apply 
3Within each question, response choices will be ordered by percent endorsing, descending, ties will go in order presented to 
respondents. For items with more than 5 response options, the top 5 selected response options within each item at baseline will 
be bolded in tables for subsequent timepoints. 
Abbreviation: HIV = human immunodeficiency virus; PLWHIV = participants living with human immunodeficiency virus 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey the respective 
timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint. 
Cell percentages do not include missing and responses from participants who completed items which violated the prescribed skip 
pattern were omitted. 
 *”Other” responses and open-ended text responses will be presented in an appendix. 
 
 
 


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Table 1.3.2. PLWHIV Views on IC Administration Model, Month 3 (N=XX) 
Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
1. How acceptable is it to 
you to come to the infusion 
center for CABENUVA?1 
XX 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
A little acceptable 
n (%) 
Neutral 
n (%) 
A little unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Missing 
n (%) 
2. What are the advantages 
of going to the infusion 
center to receive 
CABENUVA?2,3 
XX 
Convenient location of the infusion center 
n (%) 
Ease of parking at the infusion center 
n (%) 
Convenient hours for the infusion center 
n (%) 
Ease of scheduling and rescheduling 
appointments at the infusion center 
n (%) 
More privacy at the infusion center 
n (%) 
I like that people do not know what 
medication I am there to receive 
n (%) 
Reduced stigma at the infusion center 
n (%) 
Injections are not available at my provider’s 
office 
n (%) 
No advantages of receiving CABENUVA at 
the infusion center 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
3. What are the 
disadvantages of going to 
the infusion center to 
receive CABENUVA?2,3 
XX 
Inconvenient location of the infusion center 
n (%) 
Difficulty of parking at the infusion center 
n (%) 
Unfamiliar with routine at the infusion 
center 
n (%) 
Unfamiliar with the infusion center staff 
n (%) 
Inconvenient hours for the infusion center 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
Less privacy at the infusion center 
n (%) 
More stigma at the infusion center 
n (%) 
Decreased contact with my HIV provider 
n (%) 
Difficulty scheduling and rescheduling 
appointments at the infusion center 
n (%) 
Too many appointments between the 
infusion center and my HIV providers 
n (%) 
Too many lab draws 
n (%) 
Infusion center doesn’t know how to 
manage the pain or side effects of 
CABENUVA 
n (%) 
I don’t want other people at the infusion 
center to know I have HIV 
n (%) 
No disadvantages of receiving CABENUVA at 
the infusion center 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
4. How convenient is it for 
you to get to the infusion 
center for your CABENUVA 
visits?1 
XX 
Very convenient 
n (%) 
Somewhat convenient 
n (%) 
A little convenient 
n (%) 
Neutral 
n (%) 
A little inconvenient 
n (%) 
Somewhat inconvenient 
n (%) 
Very inconvenient 
n (%) 
Missing 
n (%) 
5. How long does it typically 
take you to get to the 
infusion center?1 
XX 
1-15 minutes 
n (%) 
16-30 minutes 
n (%) 
31-45 minutes 
n (%) 
46-60 minutes 
n (%) 
More than 60 minutes 
n (%) 
Missing 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
6. How acceptable is the 
time it typically takes you to 
get to the infusion center?1 
XX 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
A little acceptable 
n (%) 
Neutral 
n (%) 
A little unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Missing 
n (%) 
7. Not including your first 
visit, how much time have 
you been spending at the 
infusion center for your 
CABENUVA visits?1 
XX 
1-15 minutes 
n (%) 
16-30 minutes 
n (%) 
31-45 minutes 
n (%) 
46-60 minutes 
n (%) 
More than 60 minutes 
n (%) 
Missing 
n (%) 
8. How acceptable is the 
amount of time you spend 
at the infusion center for 
your CABENUVA visits?1 
XX 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
A little acceptable 
n (%) 
Neutral 
n (%) 
A little unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Missing 
n (%) 
9. How easy or difficult was 
it to schedule your monthly 
injection visits at the 
infusion center?1 
XX 
Extremely easy 
n (%) 
Very easy 
n (%) 
Somewhat easy 
n (%) 
Neutral 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
Somewhat difficult 
n (%) 
Very difficult 
n (%) 
Extremely difficult 
n (%) 
Missing 
n (%) 
10. How easy or difficult 
was it to reschedule your 
injection visits at the 
infusion center, if needed?1 
XX 
Extremely easy 
n (%) 
Very easy 
n (%) 
Somewhat easy 
n (%) 
Neutral 
n (%) 
Somewhat difficult 
n (%) 
Very difficult 
n (%) 
Extremely difficult 
n (%) 
I have not had to reschedule any visits yet 
n (%) 
Missing 
n (%) 
11. How satisfied are you 
with the appointment 
reminders you receive from 
the infusion center?1 
XX 
Extremely satisfied 
n (%) 
Very satisfied 
n (%) 
Somewhat satisfied 
n (%) 
Neutral 
n (%) 
Somewhat dissatisfied 
n (%) 
Very dissatisfied 
n (%) 
Extremely dissatisfied 
n (%) 
Missing 
n (%) 
12. How satisfied are you 
with the convenience of the 
infusion center hours 
available for your injection 
appointments?1 
XX 
Extremely satisfied 
n (%) 
Very satisfied 
n (%) 
Somewhat satisfied 
n (%) 
Neutral 
n (%) 
Somewhat dissatisfied 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
Very dissatisfied 
n (%) 
Extremely dissatisfied 
n (%) 
Missing 
n (%) 
13. Which appointment 
times would be most helpful 
to you for getting the 
CABENUVA treatment at the 
infusion center?2,3 
XX 
Standard business hours during weekdays 
(e.g., 8am – 5pm) 
n (%) 
Early morning during weekdays (e.g., before 
8am) 
n (%) 
Evenings during weekdays (e.g., after 5pm) 
n (%) 
Weekend mornings 
n (%) 
Weekend afternoons 
n (%) 
Weekend evenings 
n (%) 
Missing 
n (%) 
14. If you had questions 
about CABENUVA treatment 
in-between appointments 
(other than appointment 
scheduling or rescheduling), 
who did you reach out to 
for answers to your 
question(s)?2,3 
XX 
Staff at the infusion center 
n (%) 
My regular HIV provider 
n (%) 
Other staff at my regular HIV provider’s 
office 
n (%) 
Other people with HIV 
n (%) 
Social media 
n (%) 
No questions to date 
n (%) 
Missing 
n (%) 
14a. If “staff at the infusion 
center” selected, how 
satisfied were you with the 
infusion center staff’s ability 
to answer your 
question(s)?1 
XX 
Extremely satisfied 
n (%) 
Very satisfied 
n (%) 
Somewhat satisfied 
n (%) 
Neutral 
n (%) 
Somewhat dissatisfied 
n (%) 
Very dissatisfied 
n (%) 
Extremely dissatisfied 
n (%) 
Missing 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
15. How acceptable is it for 
you to get labs drawn at the 
infusion center?1 
XX 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
A little acceptable 
n (%) 
Neutral 
n (%) 
A little unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Missing 
n (%) 
16. How acceptable is it to 
go to two separate places 
for your care (that is, the 
infusion center for 
CABENUVA and to your 
clinic for your regular HIV 
appointments)?1 
XX 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
A little acceptable 
n (%) 
Neutral 
n (%) 
A little unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Missing 
n (%) 
17. We know that people 
can be treated differently 
due to factors including, but 
not limited to, HIV status, 
gender, and race. Have you 
been treated differently, or 
experienced stigma or 
discrimination at the 
infusion center?1 
XX 
Yes 
n (%) 
No (skip to question #30) 
n (%) 
Prefer not to answer 
n (%) 
Missing 
n (%) 
17a. If yes, how has your 
experience at the infusion 
center compared to your 
experience at your HIV 
provider’s office/clinic?1 
XX 
A lot worse 
n (%) 
Somewhat worse 
n (%) 
A little worse 
n (%) 
About the same 
n (%) 
A little better 
n (%) 
Somewhat better 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
A lot better 
n (%) 
Missing 
n (%) 
18. Do you believe you have 
been treated differently 
based on any of the 
following factors:2,3 
XX 
Age 
n (%) 
Race/ethnicity 
n (%) 
Sex 
n (%) 
Gender identity 
n (%) 
Sexual preference 
n (%) 
HIV status 
n (%) 
Religion 
n (%) 
Physical appearance 
n (%) 
Housing status 
n (%) 
Due to pregnancy/being pregnant 
n (%) 
Other* 
n (%) 
None of the above 
n (%) 
Extremely comfortable 
n (%) 
Missing 
n (%) 
19. How comfortable are 
you with the infusion center 
managing your CABENUVA 
injections?1 
XX 
Very comfortable 
n (%) 
Somewhat comfortable 
n (%) 
Neutral 
n (%) 
Somewhat uncomfortable 
n (%) 
Very uncomfortable 
n (%) 
Extremely uncomfortable 
n (%) 
Extremely welcome 
n (%) 
Missing 
n (%) 
20. How welcome do you 
feel at the infusion center?1 
XX 
Very welcome 
n (%) 
Somewhat welcome 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
Neutral 
n (%) 
Somewhat unwelcome 
n (%) 
Very unwelcome 
n (%) 
Extremely unwelcome 
n (%) 
Extremely respectful 
n (%) 
Missing 
n (%) 
21. How respectful are the 
infusion center staff when 
you are there for your 
injections?1 
XX 
Very respectful 
n (%) 
Somewhat respectful 
n (%) 
Neutral 
n (%) 
Somewhat disrespectful 
n (%) 
Very disrespectful 
n (%) 
Extremely disrespectful 
n (%) 
Missing 
n (%) 
22. How satisfied are you 
with the level of privacy at 
the infusion center for 
receiving your injections?1 
XX 
Extremely satisfied 
n (%) 
Very satisfied 
n (%) 
Somewhat satisfied 
n (%) 
Neutral 
n (%) 
Somewhat dissatisfied 
n (%) 
Very dissatisfied 
n (%) 
Extremely dissatisfied 
n (%) 
Missing 
n (%) 
23. How concerned are you 
about unwanted disclosure 
of your HIV status when 
attending appointments at 
your HIV provider’s office?1 
XX 
Very concerned 
n (%) 
Moderately concerned 
n (%) 
Somewhat concerned 
n (%) 
A little concerned 
n (%) 
Not at all concerned 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
Missing 
n (%) 
24. How concerned are you 
about unwanted disclosure 
of your HIV status when 
attending appointments at 
the infusion center? 1 
XX 
Very concerned 
n (%) 
Moderately concerned 
n (%) 
Somewhat concerned 
n (%) 
A little concerned 
n (%) 
Not at all concerned 
n (%) 
Extremely satisfied 
n (%) 
Missing 
n (%) 
25. How satisfied are you 
with the level of care you 
are receiving at the infusion 
center? 1 
XX 
Very satisfied 
n (%) 
Somewhat satisfied 
n (%) 
Neutral 
n (%) 
Somewhat dissatisfied 
n (%) 
Very dissatisfied 
n (%) 
Extremely dissatisfied 
n (%) 
Missing 
n (%) 
26. What is your overall 
opinion about going to an 
infusion center to receive 
CABENUVA?1 
XX 
Extremely positive 
n (%) 
Somewhat positive 
n (%) 
A little positive 
n (%) 
Neutral 
n (%) 
A little negative 
n (%) 
Somewhat negative 
n (%) 
Very negative 
n (%) 
Missing 
n (%) 
27. How does your total 
monthly out of pocket cost 
for CABENUVA (how much 
you have to pay) compare 
with how much you paid 
XX 
Significantly more cost now 
n (%) 
Somewhat more cost now 
n (%) 
About the same cost now 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
monthly for your previous 
oral HIV medication?1 
If you are receiving 
CABENUVA injections every 
2 months: Divide your out 
of pocket cost for 
CABENUVA in half to obtain 
your monthly out of pocket 
cost for comparison to your 
monthly cost for oral HIV 
medication. 
A little less cost now 
n (%) 
A lot less cost now 
n (%) 
Don’t know/Unsure/Not applicable 
n (%) 
Missing 
n (%) 
28. How satisfied are you 
with how much you are 
paying (out of pocket cost) 
for your CABENUVA 
injections?1 
XX 
Extremely satisfied 
n (%) 
Very satisfied 
n (%) 
Somewhat satisfied 
n (%) 
Neutral 
n (%) 
Somewhat dissatisfied 
n (%) 
Very dissatisfied 
n (%) 
Extremely dissatisfied 
n (%) 
Missing 
n (%) 
 
1 Select one response 
2 Select all that apply 
3Within each question, response choices will be ordered by percent endorsing, descending, ties will go in order presented to 
respondents. or items with more than 5 response options, the top 5 selected response options within each item at baseline will 
be bolded in tables for subsequent timepoints. 
Abbreviations: HIV = human immunodeficiency virus; PLWHIV = participants living with human immunodeficiency virus 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey the respective 
timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint.  
Cell percentages do not include missing and responses from participants who completed items which violated the prescribed skip 
pattern were omitted. 
 *”Other” responses and open-ended text responses will be presented in an appendix. 


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Table 1.3.3. PLWHIV Views on IC Administration Model, Month 8 
 
Table 2.1. PLWHIV Responding “Agree” or “Completely Agree” On All FIM Items at Baseline, Month 
3, and Month 8: Proportions and Change 
  
Number completing 
all 4 FIM items 
Number endorsing 4 
or 5 on all FIM Items 
% endorsing all FIM 
Items 
% Point Change 
Baseline1 
XX 
XX 
XX% 
- 
Month 31 
XX 
XX 
XX% 
- 
Month 81 
XX 
XX 
XX% 
- 
Baseline to Month 32 
XX 
BL=XX; M3=XX 
BL=XX%; M3=XX% 
XX% 
Baseline to Month 82 
XX 
BL=XX; M8=XX 
BL=XX%; M8=XX% 
XX% 
Month 3 to Month 82 
XX 
M3=XX; M8=XX 
M3=XX%; M8=XX% 
XX% 
1For each cross-sectional time point row, numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 
items 
2Each change row is limited to those completing all 4 items at both respective timepoints, which may differ from reporting at 
each individual timepoint: numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items. 
Abbreviations: PLWHIV = Participants living with human immunodeficiency virus; BL = Baseline; FIM = Feasibility of Intervention 
Measure; M3 = Month 3; M8 = Month 8 
Responses: 4= 
 5= 
. 
 
Table 2.2. PLWHIV Responding “Agree” or “Completely Agree” On All AIM Items at Baseline, 
Month 3, and Month 8: Proportions and Change 
  
Number completing 
all 4 AIM items 
Number endorsing 4 
or 5 on all AIM Items 
% endorsing all AIM 
Items 
% Point Change 
Baseline1 
XX 
XX 
XX% 
- 
Month 31 
XX 
XX 
XX% 
- 
Month 81 
XX 
XX 
XX% 
- 
Baseline to Month 32 
XX 
BL=XX; M3=XX 
BL=XX%; M3=XX% 
XX% 
Baseline to Month 82 
XX 
BL=XX; M8=XX 
BL=XX%; M8=XX% 
XX% 
Month 3 to Month 82 
XX 
M3=XX; M8=XX 
M3=XX%; M8=XX% 
XX% 
1For each cross-sectional time point row, numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 
items 
2Each change row is limited to those completing all 4 items at both respective timepoints, which may differ from reporting at 
each individual timepoint; numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items 
Abbreviations: PLWHIV = Participants living with human immunodeficiency virus; AIM = Acceptability of Intervention Measure; BL 
= Baseline; M3 = Month 3; M8 = Month 8 
Responses: 4= 
 5= 
  
 
 
 
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Table 3.1. PLWHIV, Distributional Characteristics of Feasibility of Intervention Measure (FIM), N=XX 
Item/ Scale 
Time 
Point 
Number 
of 
Particip
ants 
Missing 
Mean 
SD 
Median 
(Q1, Q3) 
Range 
(–Min, 
Max) 
Percent 
Missing 
Percent 
Floor 
Percent 
Ceiling 
95% CI 
(Lower, 
Upper) 
FIM Mean Score 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X,X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
1. Administering 
CABENUVA seems 
implementable in my 
infusion center. 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
2. Administering 
CABENUVA seems 
possible in my infusion 
center. 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
3. Administering 
CABENUVA seems 
doable in my infusion 
center. 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
4. Administering 
CABENUVA seems easy 
to implement in my 
infusion center. 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
Abbreviations: BL = Baseline; CI = confidence interval; FIM = Feasibility of Intervention Measure; M3 = Month 3; M8 = Month 8; PLWHIV = Participants living with human 
immunodeficiency virus; SD = standard deviation. 
Percent Floor for the mean score is the percent of respondents with a score of 1 (
) out of all respondents replying to at least two FIM items at a given time point. 
Percent Ceiling for the mean score is the percent of respondents with a score of 5 (
) out of all respondents replying to at least two FIM items at a given time point. 
NOTE: Missing for individual item counts = the number of participants who were eligible to complete a survey at the respective timepoint but did not complete respective item; 
Missing % = the number of participants who were eligible to complete a survey at the respective timepoint but did NOT complete the respective item / the number of people who 
filled out any portion of a survey the respective timepoint. Missing for the mean score counts any instance where a respondent completed one FIM item, not reaching the 
minimum of 2 items required to calculate a mean FIM score. 
Cell percentages do not include missing. 
 
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Table 3.2. PLWHIV, Distributional Characteristics of Acceptability of Intervention Measure (AIM), N=XX 
Item/ Scale 
Time 
Point 
Number of 
Participants 
Missing 
Mean 
SD 
Median 
(Q1, Q3) 
Range 
(–Min, 
Max) 
Percent 
Missing 
Percent 
Floor 
Percent 
Ceiling 
95% CI 
(Lower, 
Upper) 
AIM Mean Score 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X,X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
1. The idea of providing 
CABENUVA at my infusion 
center meets my 
approval. 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
2. The idea of providing 
CABENUVA at my infusion 
center is appealing to me. 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
3. I like the idea of 
providing CABENUVA for 
PLWHIV in my infusion 
center. 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
4. I welcome providing 
CABENUVA for PLWHIV in 
my infusion center. 
BL 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
XX% 
XX% 
XX% 
(X.X, X.X) 
Abbreviations: AIM = Acceptability of Intervention Measure; BL = Baseline; CI = confidence interval; M3 = Month 3; M8 = Month 8; PLWHIV = Participants living with human 
immunodeficiency virus; SD = standard deviation. 
Percent Floor for the mean score is the percent of respondents with a score of 1 
 out of all respondents replying to at least two AIM items at a given time point. 
Percent Ceiling for the mean score is the percent of respondents with a score of 5 
 out of all respondents replying to at least two AIM items at a given time point. 
NOTE: Missing for individual item counts = the number of participants who were eligible to complete a survey at the respective timepoint but did not complete respective item; 
Missing % = the number of participants who were eligible to complete a survey at the respective timepoint but did NOT complete the respective item / the number of people who 
filled out any portion of a survey the respective timepoint.  Missing for the mean score counts any instance where a respondent completed one AIM item, not reaching the 
minimum of 2 items required to calculate a mean AIM score. 
Cell percentages do not include missing. 
 
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Table 4.1. PLWHIV, Univariate Distribution of Feasibility of Intervention Measure (FIM), N=XX 
Items 
Time Point 
Number of Participants 
Missing 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. Administering CABENUVA 
seems implementable in my 
infusion center. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2. Administering CABENUVA 
seems possible in my infusion 
center. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3. Administering CABENUVA 
seems doable in my infusion 
center. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4. Administering CABENUVA 
seems easy to implement in 
my infusion center. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
Abbreviations: BL = Baseline; M3 = Month 3; M8 = Month 8; PLWHIV = participants living with human immunodeficiency virus. 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item; Missing % = the number of 
participants who were eligible to complete a survey the respective timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a 
survey at the respective timepoint. 
Cell percentages do not include missing. 
 


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Table 4.2. PLWHIV, Univariate Distribution of Acceptability of Intervention Measure (AIM), N=XX 
Items 
Time Point 
Number of 
Participants 
Missing 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. The idea of providing 
CABENUVA at my infusion 
center meets my approval. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2. The idea of providing 
CABENUVA at my infusion 
center is appealing to me. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3. I like the idea of 
providing CABENUVA for 
PLWHIV in my infusion 
center. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4. I welcome providing 
CABENUVA for PLWHIV in 
my infusion center. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
Abbreviations: BL = Baseline; M3 = Month 3; M8 = Month 8; PLWHIV = participants living with human immunodeficiency virus. 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item; Missing % = the number of 
participants who were eligible to complete a survey the respective timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a 
survey at the respective timepoint. 
Cell percentages do not include missing. 
 


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Table 5.1. PLWHIV, Distributional Characteristics of Change in Feasibility of Intervention Measure (FIM), N=XX 
Item/Scale 
Time  
Point 
Number of 
Participants1 
Missing 
Mean 
Change  
SD 
Median 
(Q1, Q3) 
Range 
(Min, Max) 
95% CI 
(Lower, 
Upper) 
FIM Mean Score 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X,X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
1. Administering 
CABENUVA seems 
implementable in my 
infusion center. 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
2. Administering 
CABENUVA seems 
possible in my infusion 
center. 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
3. Administering 
CABENUVA seems doable 
in my infusion center. 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
4. Administering 
CABENUVA seems easy to 
implement in my infusion 
center. 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
1 Only includes PLWHIV who completed surveys at respective months 
Abbreviations: BL = Baseline; CI = confidence interval; FIM = Feasibility of Intervention Measure; M3 = Month 3; M8 = Month 8; PLWHIV = participants living with human 
immunodeficiency virus; SD = standard deviation 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item; Missing % = the number of 
participants who were eligible to complete a survey the respective timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a 
survey at the respective timepoint. 
Cell percentages do not include missing. 
 


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Table 5.2. PLWHIV, Distributional Characteristics of Change in Acceptability of Intervention Measure (AIM) 
Item/Scale 
Time  
Point 
Number of 
Participants1 
Missing 
Mean  
Change 
SD 
Median 
(Q1, Q3) 
Range 
(–Min, Max) 
95% CI 
(Lower, Upper) 
AIM Mean Score 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X,X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
1. The idea of providing 
CABENUVA at my infusion 
center meets my approval. 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
2. The idea of providing 
CABENUVA at my infusion 
center is appealing to me. 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
3. I like the idea of 
providing CABENUVA for 
PLWHIV in my infusion 
center. 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
4. I welcome providing 
CABENUVA for PLWHIV in 
my infusion center. 
BL to M3 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
BL to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
(X.X, X.X) 
(X.X, X.X) 
M3 to M8 
XX 
XX 
XX 
XX 
XX (X.X, X.X) 
 (X.X, X.X) 
(X.X, X.X) 
1 Only includes PLWHIV who completed surveys at respective months 
Abbreviations: AIM = Acceptability of Intervention Measure; BL = Baseline; CI = confidence interval; M3 = Month 3; M8 = Month 8; PLWHIV = participants living with human 
immunodeficiency virus; SD = standard deviation 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item; Missing % = the number of 
participants who were eligible to complete a survey the respective timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a 
survey at the respective timepoint. 
Cell percentages do not include missing. 


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Table 6.1. PLWHIV, Shift of Feasibility of Intervention Measure (FIM) Response Frequency by Item, 
N=XX  
1.Administering CABENUVA seems implementable in my infusion center. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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2. Administering CABENUVA seems possible in my infusion center. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
3. Administering CABENUVA seems doable in my infusion center. 
  
Baseline  


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Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
4. Administering CABENUVA seems easy to implement in my infusion center. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 


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N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
1Missing  at T1, completed at T2 
2Missing  at T2, completed at T1 
Abbreviations: PLWHIV = participants living with human immunodeficiency virus; BL = baseline; FIM = Feasibility of Intervention 
Measure; 
Percentage calculations:  
Non-missing cell %: 
numerator = number selecting respective combination of Time 1 and Time 2 responses  
denominator = number of participants responding within Time 1 response category at Time 1 


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Table 6.2. PLWHIV, Shift of Acceptability of Intervention Measure (AIM) Response Frequency by 
Item, N=XX  
1. The idea of providing CABENUVA at my infusion center meets my approval. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
2. The idea of providing CABENUVA at my infusion center is appealing to me. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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3. I like the idea of providing CABENUVA for PLWHIV in my infusion center. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
4. I welcome providing CABENUVA for PLWHIV in my infusion center. 
  
Baseline  


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Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
1Missing  at T1, completed at T2 
2Missing  at T2, completed at T1 
Abbreviations: PLWHIV = participants living with human immunodeficiency virus; AIM = Acceptability of Intervention Measure 
Percentage calculations:  
Non-missing cell %: 


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numerator = number selecting respective combination of Time 1 and Time 2 responses  
denominator = number of participants responding within Time 1 response category at Time 1 
 
Table 7. Implementation Science-Related Protocol Deviations, N=XX 
Protocol Deviation 
IS-related Protocol 
Deviations For PLWHIV 
(N= XX) 
 
n(%) 
Total Sample IS-related Protocol Deviations 
xx (xx.x) 
Questionnaire incomplete1 
xx (xx.x)  
Questionnaire completed but not required 
xx (xx.x)  
Questionnaire completed out of window (early) 
 xx (xx.x) 
Questionnaire completed out of window (late) 
 xx (xx.x) 
Duplicate questionnaire completed 
xx (xx.x)  
Placeholder, other possible deviation 
xx (xx.x)  
Abbreviations: PLWHIV = Participants living with human immunodeficiency virus 
1Deviations associated with incomplete IS questionnaires are for those initiated but not completed 
Note: Numerators equal the number of PLWHIV experiencing respective deviation type, denominators equal the number of 
PLWHIV in analytic dataset 
 
 
7 
Table Shells: Adherence 
Table 8. CABENUVA Adherence, Safety Set 
  
  
CABENUVA 
Monthly 
Injection 
(N=XX) 
n (%) 
CABENUVA 
Bi-monthly 
Injection 
(N=XX) 
n (%) 
Number of participants 
with the following 
number of CABENUVA 
injections NOT completed 
within +/-7 day windows 
of scheduled dates. 
0 
xx (xx.x) 
xx (xx.x) 
1 
xx (xx.x) 
xx (xx.x) 
2 
xx (xx.x) 
xx (xx.x) 
3 
xx (xx.x) 
xx (xx.x) 
4 
xx (xx.x) 
xx (xx.x) 
5 
xx (xx.x) 
xx (xx.x) 
6 
xx (xx.x) 
xx (xx.x) 


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7 
xx (xx.x) 
xx (xx.x) 
If a participant switches between monthly and bi-monthly injection groups during the study, the participant will be summarized 
under the treatment group within which they began the study 
Baseline target dosing date was determined as follows: 
 The last date of VOCABRIA + ENDURANT for patients on oral lead-in. 
 Previous injection date + 1 month for participants on monthly CABENUVA regimen prior to the study. 
 Previous injection date + 2 months for participants on a bi-monthly CABENUVA regimen prior to the study. For participants on a 
planned bi-monthly CABENUVA regimen prior to the study receiving their first dose (loading dose), target date was injection date 
+ 1 month. 
 Date of first injection for participants on neither oral lead-in nor previously using CABENUVA. 
Target dosing date for follow-up visits were determined as follows: 
 Day of the month of baseline injection + 1 month for participants on monthly CABENUVA regimen. 
 Day of the month of baseline injection + 2 months for participants on a bi-monthly CABENUVA regimen. 
 For target injection dates occurring on the 29, 30th, or 31st in months without that day, the last day of the month was used. 
As fidelity is to be determined based on total number of injections given during the course of the study, injections not occurring 
due to participant withdrawal, loss-to-follow-up or missed injections prior to study discontinuation were set to missing. 
 
 
Table 9. CABENUVA Adherence: days from the target dosing date at each study visit, Safety Set 
  
  
CABENUVA 
Monthly 
Injection 
(N=XX) 
CABENUVA Bi-
monthly 
Injection 
(N=XX) 
Month 1 
(days) 
n 
XX 
XX 
Mean (SD) 
XX.XX (XX.XX) 
XX.XX (XX.XX) 
Median (Q1, Q3) 
XX.XX (XX, XX) 
XX.XX (XX, XX) 
Min, Max 
XX.XX, XX.XX 
XX.XX, XX.XX 
Month 2 
(days) 
n 
XX 
XX 
Mean (SD) 
XX.XX (XX.XX) 
XX.XX (XX.XX) 
Median (Q1, Q3) 
XX.XX (XX, XX) 
XX.XX (XX, XX) 
Min, Max 
XX.XX, XX.XX 
XX.XX, XX.XX 
Month 3 
(days) 
n 
XX 
XX 
Mean (SD) 
XX.XX (XX.XX) 
XX.XX (XX.XX) 
Median (Q1, Q3) 
XX.XX (XX, XX) 
XX.XX (XX, XX) 
Min, Max 
XX.XX, XX.XX 
XX.XX, XX.XX 
Month 4 
(days) 
n 
XX 
XX 
Mean (SD) 
XX.XX (XX.XX) 
XX.XX (XX.XX) 
Median (Q1, Q3) 
XX.XX (XX, XX) 
XX.XX (XX, XX) 
Min, Max 
XX.XX, XX.XX 
XX.XX, XX.XX 
n 
XX 
XX 


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Month 5 
(days) 
Mean (SD) 
XX.XX (XX.XX) 
XX.XX (XX.XX) 
Median (Q1, Q3) 
XX.XX (XX, XX) 
XX.XX (XX, XX) 
Min, Max 
XX.XX, XX.XX 
XX.XX, XX.XX 
Month 6 
(days) 
n 
XX 
XX 
Mean (SD) 
XX.XX (XX.XX) 
XX.XX (XX.XX) 
Median (Q1, Q3) 
XX.XX (XX, XX) 
XX.XX (XX, XX) 
Min, Max 
XX.XX, XX.XX 
XX.XX, XX.XX 
Month 7 
(days) 
N 
XX 
XX 
Mean (SD) 
XX.XX (XX.XX) 
XX.XX (XX.XX) 
Median (Q1, Q3) 
XX.XX (XX, XX) 
XX.XX (XX, XX) 
Min, Max 
XX.XX, XX.XX 
XX.XX, XX.XX 
Month 8 
(days) 
N 
XX 
XX 
Mean (SD) 
XX.XX (XX.XX) 
XX.XX (XX.XX) 
Median (Q1, Q3) 
XX.XX (XX, XX) 
XX.XX (XX, XX) 
Min, Max 
XX.XX, XX.XX 
XX.XX, XX.XX 
If a participant switches between monthly and bi-monthly injection groups during the study, the participant will be summarized 
under the treatment group within which they began the study 
Baseline target dosing date was determined as follows: 
 The last date of VOCABRIA + ENDURANT for patients on oral lead-in. 
 Previous injection date + 1 month for participants on monthly CABENUVA regimen prior to the study. 
 Previous injection date + 2 months for participants on a bi-monthly CABENUVA regimen prior to the study. For participants on a 
planned bi-monthly CABENUVA regimen prior to the study receiving their first dose (loading dose), target date was injection date 
+ 1 month. 
 Date of first injection for participants on neither oral lead-in nor previously using CABENUVA. 
Target dosing date for follow-up visits were determined as follows: 
 Day of the month of baseline injection + 1 month for participants on monthly CABENUVA regimen. 
 Day of the month of baseline injection + 2 months for participants on a bi-monthly CABENUVA regimen. 
 For target injection dates occurring on the 29, 30th, or 31st in months without that day, the last day of the month was used. 
As fidelity is to be determined based on total number of injections given during the course of the study, injections not occurring 
due to participant withdrawal, loss-to-follow-up or missed injections prior to study discontinuation were set to missing. 
 
 


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8 
Figures 
Figure 1. Bar Chart Showing Mean PLWHIV FIM and AIM Responses at Baseline, Month 3, and 
Month 8 
 
Abbreviations: PLWHIV = Participants living with human immunodeficiency virus; FIM = Feasibility of Intervention Measure; AIM = 
Acceptability of Intervention Measure; BL=Baseline; M3 = Month 3; M8 = Month 8 
Error Bars = Standard error 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
0
1
2
3
4
5
Mean FIM
Mean AIM
Mean Response
Bl
M3
M8


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Figure 2. Bar Chart Showing Proportion of PLWHIV Responding “Agree” or Completely Agree” on 
All FIM Items at Baseline, Month 3, and Month 8 
 
Abbreviations: PLWHIV = Participants living with human immunodeficiency virus; FIM = Feasibility of Intervention Measure; 
BL=Baseline; M3 = Month 3; M8 = Month 8 
Responses: 4=
 5=
 
For each time point, numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items 
Error Bars = Standard error 
 
Figure 3. Bar Chart Showing Proportion of PLWHIV Responding “Agree” or Completely Agree” on 
All AIM Items at Baseline, Month 3, and Month 8 
 
Abbreviations: PLWHIV = Participants living with human immunodeficiency virus; AIM = Acceptability of Intervention Measure; 
BL=Baseline; M3 = Month 3; M8 = Month 8 
Responses: 4=
 5=
 
For each time point, numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items 
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Bl
M3
M8
% Responding 4 or 5
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Bl
M3
M8
% Responding 4 or 5
CCI
CCI
CCI
CCI


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Error Bars = Standard error 
 
Figure 4. Bar Chart Showing Change in Proportion of PLWHIV Responding “Agree” or Completely 
Agree” on All FIM Items, Baseline to Month 3, Baseline to Month 8, and Month 3 to 
Month 8 
 
Abbreviations: PLWHIV = Participants living with human immunodeficiency virus; FIM = Feasibility of Intervention Measure; 
BL=Baseline; M3 = Month 3; M8 = Month 8 
Responses: 4=
 5=
 
Note: Each bar is limited to those completing all 4 items at both respective timepoints; numerator = number responding ‘4’ or ‘5’, 
denominator = number completing all 4 items 
Error Bars = Standard error 
 
 
 
 
 
 
 
 
 
 
 
 
 
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
BL to M3
BL to M8
M3 to M8
Change in Responding 4 or 5, 
Percentage Points
CCI
CCI


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Figure 5. Bar Chart Showing Change in Proportion of PLWHIV Responding “Agree” or Completely 
Agree” on All AIM Items, Baseline to Month 3, Baseline to Month 8, and Month 3 to 
Month 8 
 
Abbreviations: PLWHIV = Participants living with human immunodeficiency virus; AIM = Acceptability of Intervention Measure; 
BL=Baseline; M3 = Month 3; M8 = Month 8 
Responses: 4=
 5=
 
Note: Each bar is limited to those completing all 4 items at both respective timepoints; numerator = number responding ‘4’ or ‘5’, 
denominator = number completing all 4 items 
Error Bars = Standard error 
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
BL to M3
BL to M8
M3 to M8
Change in Responding 4 or 5, 
Percentage Points
CCI
CCI


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Appendix A. Missing Data 
Table A1. Summary of Missing Data 
Timepoint 
Item 
Completed n(%) 
Missing n(%) 
Baseline 
N=XX 
FIM Item 1 
n (%) 
n (%) 
FIM Item 2 
n (%) 
n (%) 
FIM Item 3 
n (%) 
n (%) 
FIM Item 4 
n (%) 
n (%) 
AIM Item 1 
n (%) 
n (%) 
AIM Item 2 
n (%) 
n (%) 
AIM Item 3 
n (%) 
n (%) 
AIM Item 4 
n (%) 
n (%) 
Month 3 
N=XX 
FIM Item 1 
n (%) 
n (%) 
FIM Item 2 
n (%) 
n (%) 
FIM Item 3 
n (%) 
n (%) 
FIM Item 4 
n (%) 
n (%) 
AIM Item 1 
n (%) 
n (%) 
AIM Item 2 
n (%) 
n (%) 
AIM Item 3 
n (%) 
n (%) 
AIM Item 4 
n (%) 
n (%) 
Month 8 
N=XX 
FIM Item 1 
n (%) 
n (%) 
FIM Item 2 
n (%) 
n (%) 
FIM Item 3 
n (%) 
n (%) 
FIM Item 4 
n (%) 
n (%) 
AIM Item 1 
n (%) 
n (%) 
AIM Item 2 
n (%) 
n (%) 
AIM Item 3 
n (%) 
n (%) 
AIM Item 4 
n (%) 
n (%) 
Abbreviations: AIM = Acceptability of Intervention Measure; FIM = Feasibility of Intervention Measure 
 
Table A2. Summary of Free-text Responses 
 


A Phase 4, Open-label, Single-arm Study to 
Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in 
US Community-based Infusion Centers or 
other Alternate Sites of Administration 
Statistical Analysis Plan: HIV Care Providers and Key Personal 
Involved in the Patients’ Care (Clinical Staff) and Expert Panel 
EVA-30466 | March 4, 2024 | Version 3.0 
Prepared For: 
, GSK 
, PhD | 
, Global Implementation Research, ViiV Healthcare 
Prepared By:  
 PhD  
, PhD MPH 
, PhD MPH 
Project Contact: 
  
PPD
PPD
PPD
PPD
PPD
PPD
PPD


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in US Community-based Infusion Centers or 
Alternate Sites of Administration    
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Statistical Analysis Plan (SAP) Signature Page 
SAP Title: 
A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for the 
Treatment of HIV-1, for Administration in US Community-based Infusion Centers or other 
Alternate Sites of Administration.  
Statistical Analysis Plan: HIV Care Providers and Key Personal Involved in the Patients’ Care 
(Clinical Staff) and Expert Panel 
SAP Date and Version: March 4th, 2024; Version 3.0 
This SAP with the title, number, and version indicated above has been reviewed and approved by the 
Evidera Principal Investigators and Project Managers. 
___________________ 
Date 
___________________ 
Date 
___________________ 
    Date 
___________________ 
Date 
PPD


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Table of Contents 
1 
INTRODUCTION ...................................................................................................................................... 1 
2 
STUDY DESIGN ....................................................................................................................................... 3 
2.1 Description of the HIV Care Provider/Clinical Staff and Expert Panel Questionnaire and 
Schedule for Completion ............................................................................................................... 4 
2.1.1 Feasibility of Intervention Measure .................................................................................... 5 
2.1.2 Acceptability of Intervention Measure ................................................................................ 5 
2.1.3 HIV Care Provider/Clinical Staff Additional Questionnaire .................................................. 5 
2.1.4 Expert Panel Additional Questionnaire ............................................................................... 5 
3 
STATISTICAL METHODS .......................................................................................................................... 5 
3.1 Missing Data Handling Scheme ...................................................................................................... 6 
3.2 Cross-sectional Univariate Distributions of Study Variables and Features of Score 
Distributions .................................................................................................................................. 7 
3.3 Distributions of Study Variables and Features of Score Distributions, Change from Baseline 
for FIM and AIM ............................................................................................................................. 7 
4 
QUALITATIVE ANALYSIS .......................................................................................................................... 7 
5 
REFERENCES ........................................................................................................................................... 8 
6 
TABLE SHELLS, HIV CARE PROVIDERS/CLINICAL STAFF: BASELINE, MONTH 4, MONTH 8, AND CHANGE . 9 
7 
TABLE SHELLS, EXPERT PANEL: BASELINE, MONTH 3, MONTH 6, AND CHANGE ................................... 59 
8 
FIGURES ............................................................................................................................................. 127 
APPENDIX A. MISSING DATA ...................................................................................................................... 135 
 
 


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List of Tables 
Table A. Objectives and Endpoints for HIV Care Providers/Clinical Staff and the Expert Panel ..................... 2 
Table B. Questionnaire Administration for HIV Care Provider/Clinical Staff and Expert Panel ...................... 4 
Table 1. HIV Care Provider, Practice and Experience- Baseline (N= XX) ........................................................ 9 
Table 1.2.1. HIV Care Provider/Clinical Staff, Experience with CABENUVA - Baseline, (N= XX) ................... 11 
Table 1.2.2. HIV Care Provider/Clinical Staff Experience with CABENUVA – Month 4 (N=XX) ..................... 13 
Table 1.2.3. HIV Care Provider/Clinical Staff Experience with CABENUVA – Month 8 (N=XX) ..................... 17 
Table 1.3.1. HIV Care Provider/Clinical Staff Prospective Preferences with CABENUVA – Baseline 
(N=XX) ..................................................................................................................................... 21 
Table 1.3.2. HIV Care Provider/Clinical Staff Preferences with CABENUVA – Month 4 ............................... 23 
Table 1.3.3. HIV Care Provider/Clinical Staff Preferences with CABENUVA – Month 8 ............................... 27 
Table 1.4.1. HIV Care Provider/Clinical Staff Concerns about CABENUVA Administration - Baseline 
(N=XX) ..................................................................................................................................... 32 
Table 1.4.2. HIV Care Provider/Clinical Staff Concerns about CABENUVA Administration – Month 4 
(N=XX) ..................................................................................................................................... 34 
Table 1.4.3. HIV Care Provider/Clinical Staff Concerns about CABENUVA Administration - Month 8 
(N=XX) ..................................................................................................................................... 36 
Table 2.1. HIV Care Providers/Clinical Staff Responding “Agree” or Completely Agree” On All FIM 
Items at Baseline, Month 4, and Month 8: Proportions and Change ..................................... 39 
Table 2.2. HIV Care Providers/Clinical Staff Responding “Agree” or Completely Agree” On All AIM 
Items at Baseline, Month 4, and Month 8: Proportions and Change ..................................... 39 
Table 3.1. HIV Care Provider/Clinical Staff, Distributional Characteristics of Feasibility of Intervention 
Measure (FIM), N=XX.............................................................................................................. 40 
Table 3.2. HIV Care Provider/Clinical Staff, Distributional Characteristics of Acceptability of 
Intervention Measure (AIM), N=XX ........................................................................................ 41 
Table 4.1. HIV Care Provider/Clinical Staff, Univariate Distribution of Feasibility of Intervention 
Measure (FIM), N=XX.............................................................................................................. 42 
Table 4.2. HIV Care Provide/ Clinical Staff, Univariate Distribution of Acceptability of Intervention 
Measure (AIM), N=XX ............................................................................................................. 43 
Table 5.1. HIV Care Provider/Clinical Staff, Distributional Characteristics of Change in Feasibility of 
Intervention Measure (FIM), N=XX ......................................................................................... 44 
Table 5.2. HIV Care Provider/Clinical Staff, Distributional Characteristics of Change in Acceptability of 
Intervention Measure (AIM), N=XX ........................................................................................ 45 
Table 6.1. HIV Care Provider/Clinical Staff, Shift of Feasibility of Intervention Measure (FIM) Response 
Frequency by item, N=XX ....................................................................................................... 46 
Table 6.2. HIV Care Provider, Shift of Acceptability of Intervention Measure (AIM) Response 
Frequency by item, N=XX ....................................................................................................... 52 
Table 7. Implementation Science-Related Protocol Deviations, HIV Care Provider/Clinical Staff N=XX ...... 58 
Table 8.1. Expert Panel, Preferences for CABENUVA Administration Moving to Infusion Center, HIV 
Care Providers and IC Staff - Baseline, (N= XX) ....................................................................... 59 


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Table 8.2.1. Expert Panel, Assessment of CABENUVA Administration Moving to Infusion Center, HIV 
Care Providers – Month 3, (N= XX) ......................................................................................... 63 
Table 8.2.2. Expert Panel, Assessment of CABENUVA Administration Moving to Infusion Center, HIV 
Care Providers – Month 6, (N= XX) ......................................................................................... 74 
Table 8.2.3. Expert Panel, Impact of CABENUVA Administration Moving to Infusion Center, HIV Care 
Providers – Month 6, (N= XX) ................................................................................................. 87 
Table 8.3.1. Expert Panel, Assessment of CABENUVA Administration Moving to Infusion Center, IC 
Staff – Month 3, (N= XX) ......................................................................................................... 89 
Table 8.3.2. Expert Panel, Assessment of CABENUVA Administration Moving to Infusion Center, IC 
Staff – Month 6, (N= XX) ....................................................................................................... 100 
Table 9.1. Expert Panel Responding “Agree” or Completely Agree” On All FIM Items at Baseline, 
Month 3, and Month 6: Proportions and Change ................................................................ 111 
Table 9.2. Expert Panel Responding “Agree” or Completely Agree” On All AIM Items at Baseline, 
Month 3, and Month 6: Proportions and Change ................................................................ 111 
Table 10.1. Expert Panel, Distributional Characteristics of Feasibility of Intervention Measure (FIM), 
N=XX ..................................................................................................................................... 113 
Table 10.2. Expert Panel, Distributional Characteristics of Acceptability of Intervention Measure 
(AIM), N=XX .......................................................................................................................... 114 
Table 11.1. Expert Panel, Univariate Distribution of Feasibility of Intervention Measure (FIM), N=XX ..... 115 
Table 11.2. Expert Panel, Univariate Distribution of Acceptability of Intervention Measure (AIM), 
N=XX ..................................................................................................................................... 116 
Table 12.1. Expert Panel, Distributional Characteristics of Change in Feasibility of Intervention 
Measure (FIM), N=XX............................................................................................................ 117 
Table 12.2. Expert Panel, Distributional Characteristics of Change in Acceptability of Intervention 
Measure (AIM), N=XX ........................................................................................................... 118 
Table 13.1. Expert Panel, Shift of Feasibility of Intervention Measure (FIM) Response Frequency by 
item, N=XX ............................................................................................................................ 119 
Table 13.2. Expert Panel, Shift of Acceptability of Intervention Measure (AIM) Response ....................... 123 
Table 14. Implementation Science-Related Protocol Deviations ............................................................... 127 
Table A1. Summary of Missing Data, HCP Providers/Clinical Staff ............................................................ 135 
Table A2. Summary of Free-text Responses, HIV Care Provider/Clinical Staff ........................................... 135 
Table A3. Summary of Missing Data, Expert Panel .................................................................................... 136 
Table A4. Summary of Free-text Responses, Expert Panel ........................................................................ 136 
 
 
 
 


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List of Figures 
Figure 1. Bar Chart Showing Mean HIV Care Providers/Clinical Staff FIM and AIM Responses at 
Baseline, Month 4 and Month 8 ........................................................................................... 127 
Figure 2. Bar chart showing proportion of HIV Care Providers/Clinical Staff Responding “Agree” or 
Completely Agree” On All FIM Items at Baseline, Month 4, and Month 8 ........................... 128 
Figure 3. Bar chart showing proportion of HIV Care Providers/Clinical Staff Responding “Agree” or 
Completely Agree” On All AIM Items at Baseline, Month 4, and Month 8 ........................... 129 
Figure 4. Bar chart showing change in Proportion of HIV Care Providers/Clinical Staff Responding 
“Agree” or Completely Agree” On All FIM Items, Baseline to Month 4, Baseline to 
Month 8, and Month 4 to Month 8 ...................................................................................... 129 
Figure 5. Bar chart showing change in Proportion of HIV Care Providers/Clinical Staff Responding 
“Agree” or Completely Agree” On All AIM Items, Baseline to Month 4, Baseline to 
Month 8, and Month 4 to Month 8 ...................................................................................... 130 
Figure 6. Bar Chart Showing Mean Expert Panel FIM and AIM Responses at Baseline, Month 3, and 
Month 6 ................................................................................................................................ 131 
Figure 7. Bar chart showing proportion of Expert Panel Responding “Agree” or Completely Agree” On 
All FIM Items at Baseline, Month 3, and Month 6 ................................................................ 132 
Figure 8. Bar chart showing proportion of Expert Panel Responding “Agree” or Completely Agree” On 
All AIM Items at Baseline, Month 3, and Month 6 ................................................................ 132 
Figure 9. Bar chart showing change in Proportion of Expert Panel Responding “Agree” or Completely 
Agree” On All FIM Items, Baseline to Month 3, Baseline to Month 6, and Month 3 to 
Month 6 ................................................................................................................................ 133 
Figure 10. Bar chart showing change in Proportion of Expert Panel Responding “Agree” or 
Completely Agree” On All AIM Items, Baseline to Month 3, Baseline to Month 6, and 
Month 3 to Month 6 ............................................................................................................. 134 
 
 
 


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List of Abbreviations 
Abbreviation 
Definition 
AE 
Adverse event 
AIDS 
Acquired immunodeficiency syndrome 
AIM 
Acceptability of Intervention Measure 
ART 
Antiretroviral therapy 
ASA 
Alternative site of administration 
BL 
Baseline 
CI 
Confidence interval 
eCRF 
Electronic case report form 
FDA 
Food and Drug Administration 
FIM 
Feasibility of Intervention Measure 
FPFV 
First participant first visit 
HIV 
Human immunodeficiency virus 
HMO 
Health Maintenance Organization 
IC 
Infusion center 
IM 
Intramuscular 
M3 
Month 3 
M4 
Month 4 
M6 
Month 6 
M8 
Month 8 
OCR 
Optical character recognition 
PDF 
Portable document format 
PLWHIV 
Participants living with human immunodeficiency virus 
POT 
Plan of treatment 
QAP 
Qualitative analysis plan 
SAP 
Statistical analysis plan 
SD 
Standard deviation  
SoA 
Schedule of Activities 
 
 


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1 Introduction 
CABENUVA is a two-drug, co-packaged product of cabotegravir plus rilpivirine, both administered as long-
acting, intramuscular (IM) injections once-monthly or every two months; it is an approved treatment for 
human immunodeficiency virus (HIV). Clinical trial results have shown that CABENUVA administered once-
monthly or every two months is non-inferior to daily oral treatment for HIV. 
Long-acting injectable treatments require changes in how HIV care is delivered. People living with HIV 
must attend appointments for their injections once a month or every two months, rather than seeing 
their providers several times per year for a prescription refill and monitoring visits. This poses new 
healthcare delivery challenges, including a shift in resources to this alternative means of delivering and 
receiving treatment —thus requiring the expansion of alternative injection facilities to include infusion 
centers (ICs) or alternate sites of administration (ASA). This has the potential to impact workload capacity 
for these facilities, though it also has the potential to positively impact treatment engagement and 
retention for people living with HIV. 
ICs/ASA are an appealing option that can ease the burden of additional appointments, administrative 
work, and drug ordering in HIV specialty clinics, as well as provide people living with HIV with greater 
flexibility in where they receive their once monthly or every two monthly injections. In this study, the 
intervention itself is the process of using an IC/ASA as the location to receive the CABENUVA IM 
injections. Specifically, the acceptability and feasibility of injection delivery at ICs/ASAs will be assessed 
from the perspectives of the participants living with HIV (PLWHIV), HIV care providers/clinical staff, and 
IC/ASA staff. 
This statistical analysis plan (SAP) describes analyses for the acceptability and feasibility of an IC/ASA to 
deliver CABENUVA IM injections, as reported by HIV care providers/clinical staff, as well as a tailored 
questionnaire that asks HIV care providers/clinical staff about their general practice history as well as 
their experience, attitudes, and expectations regarding the IC model of administration of CABENUVA.  
This SAP will also evaluate the feasibility, acceptability, and the process of CABENUVA administrations at 
ICs from the Expert Panel. The Expert Panel will generate an implementation blueprint and consist of HIV 
care providers referring patients living with HIV to an IC/ASA, IC staff members involved in decision-
making and/or oversight of daily operations, and ViiV.  
This is one of four SAPs for the following protocol: Phase 4, open-label, single arm study to optimize 
implementation of CABENUVA for the treatment of HIV-1, for administration in US community-based 
infusion centers or alternate sites of administration. The three additional SAPs are:  
(1) analyses for the IC staff questionnaires, A Phase 4, open-label, single arm study to optimize 
implementation of CABENUVA for the treatment of HIV-1, for administration in US community-based 
infusion centers or alternate sites of administration, Statistical Analysis Plan: IC Staff;  
(2) analyses of questionnaires for PLWHIV, A Phase 4, open-label, single arm study to optimize 
implementation of CABENUVA for the treatment of HIV-1, for administration in US community-based 


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infusion centers or alternate sites of administration, Statistical Analysis Plan: Participants living with HIV 
for Implementation Science Questionnaires; and  
(3) analyses for clinical data  for PLWHIV, A Phase 4, open-label, single arm study to optimize 
implementation of CABENUVA for the treatment of HIV-1, for administration in US community-based 
infusion centers or alternate sites of administration: Statistical Analysis Plan for Clinical Analyses. 
While there are no primary objectives involving HIV care providers/clinical staff or the Expert Panel for 
this study, this SAP will describe the planned secondary quantitative objectives related to HIV care 
providers/Expert Panel as outlined in Table A. Additionally, this plan does not incorporate the qualitative 
interview analyses at the end of study. These analyses will be detailed in a separate qualitative analysis 
plan (QAP) (currently under development).  
Table A. Objectives and Endpoints for HIV Care Providers/Clinical Staff and the Expert Panel 
Objectives 
Endpoints 
To evaluate feasibility of CABENUVA 
administration at infusion centers or 
alternate sites of administration HIV 
care providers/ clinical staff 
Proportion of HIV care providers/clinical staff that agree or completely agree (a score 
of 4 or higher) across all items on the FIM at Month 1, Month 4 and at Month 8 
Change over time in the FIM at Month 4 and Month 8 with HIV care providers/clinical 
staff 
Summary of other quantitative questionnaires assessed with HIV care providers/ 
clinical staff at Month 1, Month 4 and Month 8 
Qualitative interviews assessed at Month 8 with HIV care providers/ clinical staff 
(QAP) 
To evaluate acceptability of 
CABENUVA administration at infusion 
centers or alternate sites of 
administration from HIV care 
providers/clinical staff 
Proportion of HIV care providers/clinical staff that agree or completely agree (a score 
of 4 or higher) across all items on the AIM at Month 1, Month 4 and Month 8 
Change of HIV care providers/clinical staff over time in the AIM at Month 4 and 
Month 8 
Summary of other quantitative questionnaires assessed with HIV care 
providers/clinical staff at Month 1, Month 4 and Month 8 
Qualitative interviews assessed at Month 8 with HIV care providers/clinical staff 
(QAP) 
To evaluate feasibility, acceptability 
and the process of CABENUVA 
administration at infusion centers or 
alternate sites of administration from 
the Expert Panel 
Proportion of Expert Panel that agree or completely agree (a score of 4 or higher) 
across all items on the FIM and AIM respectively prior to FPFV, and at Month 3 and 
Month 6 
Change of Expert Panel over time in FIM and AIM respectively through Month 6 
Summary of other quantitative questionnaires assessed with Expert Panel prior to 
FPFV, and at Month 3 and Month 6 
Qualitative interviews assessed with Expert Panel prior to FPFV and at Month 6 (QAP) 
To evaluate perceptions, facilitators, 
and barriers/concerns by HIV care 
providers/clinical staff 
Qualitative interviews assessed at Month 8 with HIV care providers/clinical staff 
(QAP) 
Summary of HIV care provider/clinical staff other quantitative questionnaires at 
Month 1, Month 4, and Month 8 
To assess the advantages to receive or 
refer participants to receive 
CABENUVA at the infusion center or 
alternate sites of administration or 
Qualitative interviews assessed at Month 8 with HIV care providers/clinical staff 
(QAP) 
Summary of advantage to referring participants to the IC/ASA to receive CABENUVA 
at Month 1, Month 4, and Month 8 assessed by HIV care provider other quantitative 
questionnaires  


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Objectives 
Endpoints 
alternate site of administration from 
HIV care providers/clinical staff 
To assess the disadvantages about 
receiving CABENUVA at the infusion 
center or alternate sites of 
administration or alternate site of 
administration from HIV care 
providers/clinical staff 
Summary of disadvantage of referring participants to IC/ASA for CABENUVA 
injections from HIV care providers/clinical staff other quantitative questionnaires at 
Month 1, Month 4 and Month 8 
Qualitative interviews assessed at Month 8 with HIV care providers/clinical staff 
(QAP) 
To evaluate the acceptability of 
receiving and referring participants for 
CABENUVA injections at infusion 
centers or alternate sites of 
administration from HIV care 
providers/clinical staff 
Summary of acceptability of the process of referring participants to the infusion 
center or alternate sites of administration for CABENUVA by HIV care 
providers/clinical staff other quantitative questionnaires at Month 1, Month 4, and 
Month 8 
Qualitative interviews assessed at Month 8 with HIV care providers/clinical staff 
(QAP) 
To evaluate the usefulness of the POT 
for HIV care providers/clinical staff 
Summary of usefulness of the POT by HIV care providers/ clinical staff other 
quantitative questionnaires at Month 4 and Month 8  
Qualitative interviews assessed at Month 8 with HIV care providers/clinical staff 
(QAP) 
To evaluate overall opinion of 
receiving and administering the 
injection at an infusion center or 
alternate sites of administration by HIV 
care providers/clinical staff 
Qualitative interviews at Month 8 with 00000HIV care providers/clinical staff (QAP) 
Summary of overall opinion of referring patients to an IC center for CABENUVA 
injections by HIV care provider/clinical staff via other quantitative questionnaires at 
Month 1, Month 4 and Month 8 
Abbreviations: AIM = Acceptability of Intervention Measure; ASA=Alternative Site of Administration; FIM = Feasibility of 
Intervention Measure; FPFV = first participant first visit; HIV = human immunodeficiency virus; IC = infusion center; POT = plan of 
treatment; QAP = qualitative analysis plan 
2 Study Design 
This is a Phase 4, single arm, open-label, multi-center study examining the administration of CABENUVA 
IM in IC/ASAs in the United States. This study is being conducted following Food and Drug Administration 
(FDA) approval and commercial availability of CABENUVA. Eligible and consenting participants will be 
followed for eight months to evaluate an implementation blueprint for IM administration of CABENUVA 
for HIV-1 treatment at ICs/ASAs. The total duration for study participants is approximately eight months 
from the time of enrollment and receipt of the first administration of CABENUVA IM injections at the 
ICs/ASA.  
Relevant to this SAP, approximately 20 HIV care providers/clinical staff who refer their patients living with 
HIV to a study ICs/ASA to receive CABENUVA will be asked to complete questionnaires per the Schedule 
of Activities (SoA, see ANNEX 1 in protocol) after the HIV care provider’s first referred patient is enrolled 
into the study. This study also has an Expert Panel, consisting of approximately 10 members, which will 
consist of key ICs/ASA staff members involved in decision making and/or oversee daily operations at the 
ICs/ASA, selected HIV care providers that may refer PLWHIV, and ViiV. Panel members will meet prior to 
Baseline/Month 1 to design the Blueprint. 


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The duration of study participation for each HIV care provider/clinical staff is approximately 8 months 
after their last PLWHIV has their first visit (last participant first visit) and receives CABENUVA IM injections 
at a participating ICs/ASA. HIV care provider/clinical staff and Expert Panel questionnaires consist of the 
Feasibility of Intervention Measure (FIM) and the Acceptability of Intervention Measure (AIM) and 
additional tailored questions. HIV care providers/clinical staff will be asked to complete the 
Baseline/Month 1 questionnaire within four weeks of their first referred participant’s first visit (FPFV) in 
the study at any study site. Month 4 and Month 8 assessments are to be completed when the HIV care 
provider’s/clinical staff first referred patient completes the Month 4 or Month 8 study visits, respectively. 
Questionnaires can be completed up to two weeks before or after the Month 4 or Month 8 study visits. 
The Expert Panel will be asked to complete the Baseline/Month 1 questionnaire prior to the FPFV, defined 
as the date when a participant signs the informed consent form, completes protocol procedures, and 
receives the first CABENUVA injections at any IC/ASA. Month 3 and Month 6 assessments are to be 
completed after approximately 10 participants (across all ICs/ASAs) have completed their Month 3 and 
Month 6 study visits at any IC/ASA site.   
2.1 
Description of the HIV Care Provider/Clinical Staff and Expert 
Panel Questionnaire and Schedule for Completion 
The HIV care provider/clinical staff questionnaire consists of two validated instruments and tailored items 
written for this study. The validated instruments are the FIM and AIM, described below. The tailored 
items ask HIV care providers/clinical staff about several topics including, but not limited to, their practice, 
experience, and views on the CABENUVA / long-acting injectable model, as well as using ICs/ASAs to 
implement that model. The Expert Panel questionnaire also consists of the FIM and AIM and tailored 
items. Two different versions of the FIM and AIM will be used for the Expert Panel: one for HIV care 
providers/clinical staff and one for IC/ASA staff. Across FIM and AIM versions, the stem of each item has 
slightly different wording, reflecting the different roles of HIV care providers/clinical staff and IC/ASA 
staff. Response options are the same across versions. Due to the small numbers on the Expert Panel, the 
FIM and AIM will be summarized in all tables together, though the differences in the wording for 
underlying groups, due to their different roles, should be noted.  The tailored items will ask the Expert 
Panel about the specifics of the implementation of the study.  
A feasibility composite score for HIV care providers/clinical staff and Expert Panel, to be determined, will 
be added to this SAP. The exact components of the feasibility composite score will be informed by the 
Expert Panel process to ensure it matches the critical variables identified by all members of the panel. 
Table B. Questionnaire Administration for HIV Care Provider/Clinical Staff and Expert Panel 
Questionnaire 
Baseline 
Month 3 
Month 4 
Month 6 
Month 8 
HIV Care Provider Tailored Items, HIV Care Provider/ 
Clinical Staff 
x 
 
x 
 
x* 
Feasibility of Intervention Measure, HIV Care Provider/ 
Clinical Staff 
x 
 
x 
 
x 
Acceptability of Intervention Measure, HIV Care Provider/ 
Clinical Staff 
x 
 
x 
 
x 
Feasibility of Intervention Measure, Expert Panel 
x 
x 
 
x 
 


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Questionnaire 
Baseline 
Month 3 
Month 4 
Month 6 
Month 8 
Acceptability of Intervention Measure, Expert Panel 
x 
x 
 
x 
 
Abbreviation: HIV = human immunodeficiency virus 
2.1.1 Feasibility of Intervention Measure 
The FIM is employed to evaluate the feasibility of an implementation strategy. This four-item measure 
assesses perceived intervention feasibility. The items are measured on a five-point rating scale 
(1=
, 2=
 3=
, 4=
 and 5=
. 
The FIM was validated with other implementation outcome measures.1 Higher scores indicate greater 
feasibility. There are no reverse-scored items on the FIM, and the mean score for feasibility of the 
intervention is calculated by averaging the responses from four items. 
2.1.2 Acceptability of Intervention Measure 
The AIM is employed to evaluate the acceptability of an implementation strategy. This four-item measure 
assesses perceived intervention acceptability. The items are measured on a five-point rating scale 
(1=
, 2=
 3=
, 4=
 and 5=
). 
The AIM was validated with a suite of implementation outcome measures.1 Higher scores indicate greater 
acceptability. There are no reverse-scored items on the AIM, and the mean score for acceptability of the 
intervention is calculated by averaging the responses from four items. 
2.1.3 HIV Care Provider/Clinical Staff Additional Questionnaire 
The tailored HIV care provider/clinical staff questionnaire was developed specifically for this study and 
contains items regarding the provider’s practice and experience, as well as their attitudes, expectations, 
and concerns regarding the use of CABENUVA/long-acting injectable administered by ICs/ASAs. The 
baseline HIV care provider/clinical staff questionnaire has 38 items (including the FIM and AIM) using 
several different response scales. 
2.1.4 Expert Panel Additional Questionnaire 
The tailored Expert Panel questionnaire items were developed specifically for this study and contain items 
regarding the Expert Panel’s preferences and assessment for CABENUVA administration. The baseline 
questionnaire has 18 items using several different response scales.  
3 Statistical Methods 
This SAP has been developed to guide the analyses for the data collected and assumes that all data will be 
collected in adherence to the protocol developed by GSK/ViiV. There are two analysis populations 
discussed in this SAP: (1) all responding HIV care providers/clinical staff who complete any portion of any 
questionnaire at any point in the study and (2) all responding members of the Expert Panel comprised of 
key IC/ASA staff members involved in decision making and/or oversee daily operations at the IC/ASA, 
selected HIV care providers, and ViiV members who complete any portion of any questionnaire at any 
point in the study.  As the data are analyzed, some deviation from expectations may occur. In instances 
where these deviations would make the proposed analyses inappropriate, modifications to the analysis 
CCI
CCI
CCI
CCI
CCI
CCI
CCI
CCI
CCI
CCI


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plan, along with justifications for these changes, will be made and noted in the final report. Given the 
small sample size of HIV care providers/clinical staff and the Expert Panel, the planned analyses will be 
descriptive. 
Continuous and interval-like variables will be summarized using descriptive statistics (e.g., n, mean, 
standard deviation [SD], median, minimum, maximum, first and third quartiles, and 95% confidence 
intervals [CI]). Data in tables will be tabulated relative to the source data. Mean, median, quartiles, and 
percentages will be tabulated to one more decimal place than the source data; minimum/maximum 
values will have the same decimal places as source data; percentages will be rounded to one decimal 
place after calculation. SD and CIs will be tabulated to two more decimal places than the source data. 
Categorical variables will be reported as frequency counts, the percentage of HIV care providers/clinical 
staff and Expert Panel in corresponding categories, and 95% CIs. 
Subgroup analysis will be performed to evaluate the effect of contextual factors on the variability of 
responses to feasibility, and acceptability. These factors will include, but are not limited to, affiliation for 
HIV care providers. Once specified these will be added to this SAP. No subgroup analyses will be 
performed for the Expert Panel due to insufficient sample size. 
For the analyses of the proportion of HIV care providers/clinical staff  and Expert Panel members 
responding agree or completely agree on all FIM items, this will include the HIV care providers/clinical 
staff and Expert Panel members who select response option 4 
 or 5 
 for all 
four FIM items at a given time point, out of all HIV care providers/clinical staff and Expert Panel members 
who completed all four FIM items at that respective timepoint. The same definition applies to the 
analogous analysis for the AIM. 
Table shells for analyses of HIV care providers/clinical staff can be found in Section 6, and for the Expert 
Panel can be found in Section 7. 
3.1 
Missing Data Handling Scheme 
HIV care provider/clinical staff and Expert Panel member questionnaires will be completed in a hybrid, 
eCRF (Medidata) and on paper, converted to portable document format (PDF), and sent to Evidera via 
DataFax. Forms received will be quality checked for missing data and illegible responses by the study 
team. Queries will focus on issues with optical character recognition (OCR; legibility), missing data, or 
DataFax form elements required to include the data. Missing pages will be queried by e-mail to the HIV 
care provider/clinical staff and Expert Panel member to verify that all pages were scanned. If data are still 
missing, follow-up queries will be initiated by the study team with respective HIV care providers/clinical 
staff and Expert Panel member. Queries remaining open from unresponsive HIV care providers/clinical 
staff or Expert Panel members may be closed with GSK/ViiV review and approval. Missing data at the 
multi-item scale level for standardized scales (FIM and AIM) will be addressed with standard proration 
rules2: if at least 50% of the items are completed the scale will be scored by taking the mean of the 
completed items, unless otherwise specified for a particular outcome. Following this, partially completed 
FIM and AIM administrations will be scored if two, three, or four items are completed, and will not be 
scored if only one item is completed. Items not completed will be logged as missing data.  Summaries will 
CCI
CCI


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be produced on all available data, no missing data will be imputed. Table shells for missing data from FIM 
and AIM scales can be found in Appendix A. 
3.2 
Cross-sectional Univariate Distributions of Study Variables and 
Features of Score Distributions 
For questions with ordinal responses, a univariate distribution of every item will be tabulated. Standard 
distributional statistics will be tabulated for interval-like (ordinal) variables, including mean, SD, median, 
percentage missing, range (minimum and maximum of responses), percentage of the sample at the 
ceiling (highest possible score) and floor (lowest possible score), first and third quartiles, and 95% CIs. For 
questions with descriptive responses, a frequency distribution of all responses will be presented with 
n(%). 
3.3 
Distributions of Study Variables and Features of Score 
Distributions, Change from Baseline for FIM and AIM 
The univariate distribution of item change scores for HIV care providers/clinical staff (Month 4 minus 
Baseline, Month 8 minus Baseline, and Month 8 minus Month 4) and the Expert Panel (Month 3 minus 
Baseline, Month 6 minus baseline, and Month 6 minus Month 3) will be tabulated for the FIM and the 
AIM, both in terms of distributional characteristics of change and in terms of frequency of responses. 
Distributional characteristic tables will include the SD of the change distribution, median change, first and 
third quartiles, and 95% CIs. Change analyses will be limited to those HIV care providers/clinical staff 
completing questionnaires at baseline and respective timepoints. Categorical data for the FIM and AIM 
from the HIV care provider/clinical staff and Expert Panel member questionnaires will be presented in 
shift analyses showing the frequency of change by the degree of shift across response categories, and will 
be presented for Baseline to Month 4, Baseline to Month 8, and Month 4 to Month 8 for HIV care 
providers/clinical staff and Baseline to Month 3, Baseline to Month 6 and Month 3 to Month 6 for the 
Expert Panel.  
4 Qualitative Analysis 
Qualitative analyses will be described in a separate qualitative analysis plan.  
 
 


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5 
References 
1. 
Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed 
implementation outcome measures. Implement Sci. 2017;12(1):108. 
2. 
Cella D. Manual of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement 
System—Version 4. Evanston, IL: Center on Outcomes, Research & Education (CORE), Evanston 
Northwestern Healthcare and Northwestern University; 1997. 
 
 
 


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6 Table Shells, HIV Care Providers/Clinical Staff: 
Baseline, Month 4, Month 8, and Change 
Table 1. HIV Care Provider, Practice and Experience- Baseline (N= XX) 
Question 
Number of 
Participants at 
Baseline 
Response/Statistic 
Value 
1. What type of 
clinic/practice do 
you work in (select 
the answer that is 
most fitting)?1,2 
XX 
Hospital-based setting, non-university affiliated 
n (%) 
University or Medical School Based Hospital (employed by or 
primarily affiliated with an academic institution) 
n (%) 
Federally Qualified Health Center 
n (%) 
Private Practice/Solo or Group Practice   
n (%) 
General Class HMO/Integrated Network (e.g., Kaiser 
Permanente, Geisinger) 
n (%) 
AIDS Health Care Foundation 
n (%) 
VA Medical Center or other VA facility (e.g., outpatient clinic) 
n (%) 
AIDS Service Organization with Clinical Services 
n (%) 
Other*  
n (%) 
Missing 
n (%) 
2. How many 
patients are served 
by your 
clinic/practice?1  
XX 
 <200 PLWHIV 
n (%) 
201-500 PLWHIV 
n (%) 
501-1000 PLWHIV 
n (%) 
1001-2000 PLWHIV 
n (%) 
2001-3000 PLWHIV 
n (%) 
3001-4000 PLWHIV 
n (%) 
More than 4000 PLWHIV 
n (%) 
Missing 
n (%) 
2a. How many 
patients in your 
practice are 
currently on 
CABENUVA?1 
XX 
1-10 PLWHIV 
n (%) 
11-25 PLWHIV 
n (%) 
26-50 PLWHIV 
n (%) 
51-100 PLWHIV 
n (%) 
More than 100 
n (%) 
Missing 
n (%) 
1 Select one response 
2Within each question, response choices will be ordered by percent endorsing, descending, and ties will go in order presented to 
respondents.  
 
Abbreviations: AIDS = acquired immunodeficiency syndrome; HIV = human immunodeficiency virus; HMO 
= health maintenance organization; PLWHIV = participants living with human immunodeficiency virus; VA 
= Veteran’s Affairs 


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NOTE: Missing = the number of participants who completed any portion of a survey at any time but did not complete respective 
item; Missing % = the number of participants who filled out any portion of a survey at any time but did NOT complete the 
respective item / the number of people who filled out any portion of a survey at any time.  
Cell percentages do not include missing 
*”Other” responses and open-ended text responses will be presented in an appendix 


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Table 1.2.1. HIV Care Provider/Clinical Staff, Experience with CABENUVA - Baseline, (N= XX) 
Question 
Number of 
Participants at 
Baseline 
Response 
n (%) 
1. How acceptable 
was the overall 
process of 
interacting with the 
infusion center so 
far?1 
N=XX 
Very acceptable 
XX (XX.X%) 
Somewhat acceptable 
XX (XX.X%) 
A little acceptable 
XX (XX.X%) 
Neutral 
XX (XX.X%) 
A little unacceptable 
XX (XX.X%) 
Somewhat unacceptable 
XX (XX.X%) 
Very unacceptable 
XX (XX.X%) 
I have not interacted with the infusion center yet. 
XX (XX.X%) 
Missing 
XX (XX.X%) 
2. How acceptable 
was the process of 
obtaining or 
dispensing oral 
lead in 
medication?1 
N=XX 
Very acceptable 
XX (XX.X%) 
Somewhat acceptable 
XX (XX.X%) 
A little acceptable 
XX (XX.X%) 
Neutral 
XX (XX.X%) 
A little unacceptable 
XX (XX.X%) 
Somewhat unacceptable 
XX (XX.X%) 
Very unacceptable 
XX (XX.X%) 
Missing 
XX (XX.X%) 
3. How do you 
prefer to be 
notified if a patient 
N=XX 
Email 
XX (XX.X%) 
Fax 
XX (XX.X%) 


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receives 
CABENUVA on 
time?1,3 
Phone call 
XX (XX.X%) 
Postal Letter 
XX (XX.X%) 
Secure electronic medical record (EMR) message 
XX (XX.X%) 
No communication necessary 
XX (XX.X%) 
Missing 
XX (XX.X%) 
4. How do you 
prefer to be 
notified if a patient 
misses or receives 
CABENUVA out of 
window at the 
infusion center?1,3 
N=XX 
Email 
XX (XX.X%) 
Secure electronic medical record (EMR) message 
XX (XX.X%) 
Phone call 
XX (XX.X%) 
Fax 
XX (XX.X%) 
Postal Letter 
XX (XX.X%) 
No communication necessary 
XX (XX.X%) 
Missing 
XX (XX.X%) 
5. Where do you 
expect that 
patients in your 
care will receive 
CABENUVA?2,3 
N=XX 
In my clinic, by my healthcare staff 
XX (XX.X%) 
Infusion Center 
XX (XX.X%) 
Home-nursing visits 
XX (XX.X%) 
At a pharmacy 
XX (XX.X%) 
Through a mobile van service 
XX (XX.X%) 
Other* 
XX (XX.X%) 
Missing 
XX (XX.X%) 
6. How often do 
you/your clinic buy 
and bill any other 
medications?1 
N=XX 
Always 
XX (XX.X%) 
Often 
XX (XX.X%) 
Occasionally 
XX (XX.X%) 


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Rarely 
XX (XX.X%) 
Never 
XX (XX.X%) 
Missing 
XX (XX.X%) 
7. How often have 
you referred your 
patients to an 
infusion center 
before for any 
reason?1 
N=XX 
Always 
XX (XX.X%) 
Often 
XX (XX.X%) 
Occasionally 
XX (XX.X%) 
Rarely 
XX (XX.X%) 
Never 
XX (XX.X%) 
Missing 
XX (XX.X%) 
1 Select one response 
2 Select all that apply 
3 Within each question, response choices will be ordered by percent endorsing, descending, and ties will go in order presented to respondents. For items with more than 5 response options, the top 5 
selected response options within each item at baseline will be bolded in tables for subsequent timepoints. 
Abbreviations: HIV = Human immunodeficiency virus 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item; Missing % = the number of participants who were 
eligible to complete a survey at the respective timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the respective timepoint. 
Cell percentages do not include missing 
Table 1.2.2. HIV Care Provider/Clinical Staff Experience with CABENUVA – Month 4 (N=XX) 
Question 
Number of 
Participants at 
Month 4 
Response 
n (%) 
1. How acceptable 
was the overall 
process of 
interacting with 
N=XX 
Very acceptable 
XX (XX.X%) 
Somewhat acceptable 
XX (XX.X%) 
A little acceptable 
XX (XX.X%) 


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the infusion center 
so far?1 
Neutral 
XX (XX.X%) 
A little unacceptable 
XX (XX.X%) 
Somewhat unacceptable 
XX (XX.X%) 
Very unacceptable 
XX (XX.X%) 
I have not interacted with the infusion center 
yet. 
XX (XX.X%) 
Missing 
XX (XX.X%) 
2. How acceptable 
was the process of 
obtaining or 
dispensing oral 
lead in 
medication?1 
N=XX 
Very acceptable 
XX (XX.X%) 
Somewhat acceptable 
XX (XX.X%) 
A little acceptable 
XX (XX.X%) 
Neutral 
XX (XX.X%) 
A little unacceptable 
XX (XX.X%) 
Somewhat unacceptable 
XX (XX.X%) 
Very unacceptable 
XX (XX.X%) 
I was not involved in this process 
XX (XX.X%) 
Missing 
XX (XX.X%) 
3. How are you 
notified if a patient 
receives 
CABENUVA on 
time?2,3 
N=XX 
Email 
XX (XX.X%) 
Fax 
XX (XX.X%) 
Phone call 
XX (XX.X%) 
Postal Letter 
XX (XX.X%) 
Secure electronic medical record (EMR) 
message  
XX (XX.X%) 
No communication necessary 
XX (XX.X%) 
Missing 
XX (XX.X%) 


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4. How are you 
notified if a patient 
misses or receives 
CABENUVA out of 
window at the 
infusion center?2,3 
N=XX 
Email 
XX (XX.X%) 
Phone call 
XX (XX.X%) 
Fax 
XX (XX.X%) 
No communication necessary 
XX (XX.X%) 
Postal Letter 
XX (XX.X%) 
Secure electronic medical record (EMR) message 
XX (XX.X%) 
Missing 
XX (XX.X%) 
5. Where do 
patients in your 
care receive 
CABENUVA?2,3 
N=XX 
In my clinic, by my healthcare staff 
XX (XX.X%) 
Infusion Center 
XX (XX.X%) 
Home-nursing visits 
XX (XX.X%) 
At a pharmacy 
XX (XX.X%) 
Through a mobile van service 
XX (XX.X%) 
Other* 
XX (XX.X%) 
Missing 
XX (XX.X%) 
6. Do you recall 
seeing or 
completing the 
plan of treatment 
(POT)? 1 
N=XX 
No or not sure (skip all remaining questions) 
XX (XX.X%) 
Yes 
XX (XX.X%) 
Missing 
XX (XX.X%) 
7. The information 
included in the 
plan of treatment 
(POT) is 
comprehensive 
enough for the 
infusion center to 
administer 
N=XX 
Strongly Agree 
XX (XX.X%) 
Agree 
XX (XX.X%) 
Occasionally 
XX (XX.X%) 
Neither agree nor disagree 
XX (XX.X%) 
Disagree 
XX (XX.X%) 


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CABENUVA to 
patients.1 
Strongly disagree 
XX (XX.X%) 
Missing 
XX (XX.X%) 
8. The plan of 
treatment (POT) 
has all of the 
information I think 
it should have for 
the infusion center 
to administer 
CABENUVA.1 
N=XX 
Strongly Agree 
XX (XX.X%) 
Agree 
XX (XX.X%) 
Occasionally 
XX (XX.X%) 
Neither agree nor disagree 
XX (XX.X%) 
Disagree 
XX (XX.X%) 
Strongly disagree 
XX (XX.X%) 
Missing 
XX (XX.X%) 
9. What do you 
think is missing 
from or could be 
improved about 
the plan of 
treatment (POT)? 1 
N=XX 
Open-ended text* 
XX (XX.X%) 
1 Select one response 
2 Select all that apply 
3 Within each question, response choices will be ordered by percent endorsing, descending, and ties will go in order presented to respondents. For items with more than 5 response options, the top 5 
selected response options within each item at baseline will be bolded in tables for subsequent timepoints. 
Abbreviations: HIV = Human immunodeficiency virus 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item; Missing % = the number of participants who were 
eligible to complete a survey at the respective timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the respective timepoint. 
Cell percentages do not include missing 
* Responses and open-ended text responses will be presented in an appendix 


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Table 1.2.3. HIV Care Provider/Clinical Staff Experience with CABENUVA – Month 8 (N=XX) 
Question 
Number of 
Participants at 
Month 4 
Response 
n (%) 
1. How acceptable 
was the overall 
process of 
interacting with 
the infusion center 
so far?1 
N=XX 
Very acceptable 
XX (XX.X%) 
Somewhat acceptable 
XX (XX.X%) 
A little acceptable 
XX (XX.X%) 
Neutral 
XX (XX.X%) 
A little unacceptable 
XX (XX.X%) 
Somewhat unacceptable 
XX (XX.X%) 
Very unacceptable 
XX (XX.X%) 
I have not interacted with the infusion center 
yet. 
XX (XX.X%) 
Missing 
XX (XX.X%) 
2. How acceptable 
was the process of 
obtaining or 
dispensing oral 
lead in 
medication?1 
N=XX 
Very acceptable 
XX (XX.X%) 
Somewhat acceptable 
XX (XX.X%) 
A little acceptable 
XX (XX.X%) 
Neutral 
XX (XX.X%) 
A little unacceptable 
XX (XX.X%) 
Somewhat unacceptable 
XX (XX.X%) 
Very unacceptable 
XX (XX.X%) 
I was not involved in this process 
XX (XX.X%) 
Missing 
XX (XX.X%) 
N=XX 
Email 
XX (XX.X%) 


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3. How are you 
notified if a patient 
receives 
CABENUVA on 
time?2,3 
Fax 
XX (XX.X%) 
Phone call 
XX (XX.X%) 
Postal Letter 
XX (XX.X%) 
Secure electronic medical record (EMR) 
message  
XX (XX.X%) 
No communication necessary 
XX (XX.X%) 
Missing 
XX (XX.X%) 
4. How are you 
notified if a patient 
misses or receives 
CABENUVA out of 
window at the 
infusion center?2,3 
N=XX 
Email 
XX (XX.X%) 
Phone call 
XX (XX.X%) 
Fax 
XX (XX.X%) 
No communication necessary 
XX (XX.X%) 
Postal Letter 
XX (XX.X%) 
Secure electronic medical record (EMR) message 
XX (XX.X%) 
Missing 
XX (XX.X%) 
5. Where do 
patients in your 
care receive 
CABENUVA?2,3 
N=XX 
In my clinic, by my healthcare staff 
XX (XX.X%) 
Infusion Center 
XX (XX.X%) 
Home-nursing visits 
XX (XX.X%) 
At a pharmacy 
XX (XX.X%) 
Through a mobile van service 
XX (XX.X%) 
Other* 
XX (XX.X%) 
Missing 
XX (XX.X%) 
6. Do you recall 
seeing or 
completing the 
N=XX 
No or not sure (skip all remaining questions) 
XX (XX.X%) 
Yes 
XX (XX.X%) 


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plan of treatment 
(POT)? 1 
Missing 
XX (XX.X%) 
7. The information 
included in the 
plan of treatment 
(POT) is 
comprehensive 
enough for the 
infusion center to 
administer 
CABENUVA to 
patients.1 
N=XX 
Strongly Agree 
XX (XX.X%) 
Agree 
XX (XX.X%) 
Occasionally 
XX (XX.X%) 
Neither agree nor disagree 
XX (XX.X%) 
Disagree 
XX (XX.X%) 
Strongly disagree 
XX (XX.X%) 
Missing 
XX (XX.X%) 
8. The plan of 
treatment (POT) 
has all of the 
information I think 
it should have for 
the infusion center 
to administer 
CABENUVA.1 
N=XX 
Strongly Agree 
XX (XX.X%) 
Agree 
XX (XX.X%) 
Occasionally 
XX (XX.X%) 
Neither agree nor disagree 
XX (XX.X%) 
Disagree 
XX (XX.X%) 
Strongly disagree 
XX (XX.X%) 
Missing 
XX (XX.X%) 
9. What do you 
think is missing 
from or could be 
improved about 
the plan of 
treatment (POT)? 1 
N=XX 
Open-ended text* 
XX (XX.X%) 
1 Select one response 
2 Select all that apply 
3 Within each question, response choices will be ordered by percent endorsing, descending, and ties will go in order presented to respondents. For items with more than 5 response options, the top 5 
selected response options within each item at baseline will be bolded in tables for subsequent timepoints. 
Abbreviations: HIV = Human immunodeficiency virus 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item; Missing % = the number of participants who were 
eligible to complete a survey at the respective timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the respective timepoint. 
Cell percentages do not include missing 


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*”Other” responses and open-ended text responses will be presented in an appendix 


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Table 1.3.1. HIV Care Provider/Clinical Staff Prospective Preferences with CABENUVA – Baseline 
(N=XX) 
Item 
Number of 
Participants at 
Baseline  
Response 
n (%) 
1. What types of 
patients do you 
plan to refer to 
an infusion 
center to 
receive 
CABENUVA?1,2  
XX 
All patients 
n (%) 
Patients who want to start CABENUVA but prefer not to come to 
the HIV clinic for each injection visit 
n (%) 
Patients who have had difficulty maintaining their daily oral 
treatment regimen 
n (%) 
Patients who have concerns about disclosure of their HIV status to 
others  
n (%) 
Patients who feel stigmatized by their HIV 
n (%) 
Patients with more chaotic lifestyles (variable work schedules, 
frequent travel, balancing work and school)  
n (%) 
Patients with more structured lifestyles 
n (%) 
Newly diagnosed (<2 years since diagnosis) 
n (%) 
Treatment experienced  
n (%) 
Patients already receiving CABENUVA 
n (%) 
Younger patients (<35 years old) 
n (%) 
Older patients (>50 years old) 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
2. What are the 
potential 
advantages of 
referring 
patients to an 
infusion center 
for CABENUVA 
from your 
perspective?1,2  
XX 
Infusions centers have more clinic space 
n (%) 
Infusion centers have more time to add visits to their schedules 
n (%) 
Infusion centers have more staff to manage 
scheduling/rescheduling appointments 
n (%) 
Infusion centers have more staff to administer it 
n (%) 
Infusion centers have the space to store the medication 
n (%) 
Infusion centers manage acquisition of the medication 
n (%) 
Infusion center handles the logistics of administration 
n (%) 
Infusion centers manage the insurance verification process 
n (%) 
Infusion centers manage the insurance reimbursement 
n (%) 
Convenience for the patient 
n (%) 
Financial considerations for my clinic 
n (%) 
Financial considerations for my clinic 
n (%) 
Missing 
n (%) 
3. What are the 
potential 
disadvantages of 
referring 
patients to an 
infusion center 
XX 
Concern I won’t be aware when my patient receives CABENUVA 
n (%) 
Concern I won’t be aware if my patient does not receive 
CABENUVA on time 
n (%) 
Concern about adverse event management 
n (%) 
Concern about management of injection site reactions 
n (%) 


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Item 
Number of 
Participants at 
Baseline  
Response 
n (%) 
for CABENUVA 
from your 
perspective?1,2 
Concern about reduced involvement in management of HIV-
related care 
n (%) 
Inconvenience for patients; having to go to two locations (clinic for 
routine visits, infusion center for injections) 
n (%) 
Concern patient won’t want to go to infusion center 
n (%) 
Concern about stigma patient may experience receiving an 
CABENUVA at infusion center 
n (%) 
Missed opportunity for revenue for my HIV clinic 
n (%) 
Issues with infusion centers handling the logistics associated with 
insurance verification and approval 
n (%) 
Issues with infusion centers handling the logistics associated with 
insurance reimbursement 
n (%) 
Fear of losing my patient to another provider 
n (%) 
Other*  
n (%) 
Missing 
n (%) 
4. If your patient 
is receiving 
CABENUVA at an 
infusion center, 
how often do 
you want to see 
them in your 
clinic for follow-
up?3  
XX 
Once every month 
n (%) 
Once after the first injection at the infusion center, then every 3 
months 
n (%) 
Once after the first injection at the infusion center, then every 6 
months 
n (%) 
Once every 3 months 
n (%) 
Once every 6 months 
n (%) 
Once a year 
n (%) 
Other*  
n (%) 
Missing 
n (%) 
5. If your patient 
is receiving 
CABENUVA at an 
infusion center, 
how often do 
you want to 
them to get 
routine labs?3 
XX 
Once every month 
n (%) 
Once after the first injection at the infusion center, then every 3 
months 
n (%) 
Once after the first injection at the infusion center, then every 6 
months 
n (%) 
Once every 3 months 
n (%) 
Once every 6 months 
n (%) 
Once a year 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
1 Select all that apply 
2 Within each question, response choices will be ordered by percent endorsing, descending, and ties will go in order presented to 
respondents. For items with more than 5 response options, the top 5 selected response options within each item at baseline will 
be bolded in tables for subsequent timepoints. 
Abbreviation: HIV = human immunodeficiency virus 
3 Select one response 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in US Community-based Infusion Centers 
 
 
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NOTE: Missing = the number of participants who completed any portion of a survey at any time but did not complete respective 
item; Missing % = the number of participants who filled out any portion of a survey at any time but did NOT complete the 
respective item / the number of people who filled out any portion of a survey at any time. 
Cell percentages do not include missing 
*”Other” responses and open-ended text responses will be presented in an appendix 
 
Table 1.3.2. HIV Care Provider/Clinical Staff Preferences with CABENUVA – Month 4 
Question 
Number of 
Participants 
at Month 4 
Response 
n (%) 
1. How many patients have 
you referred to a Palmetto 
infusion center to receive 
CABENUVA injections? 
XX 
1 patient 
n (%) 
2 patients 
n (%) 
3 patients 
n (%) 
4 patients 
n (%) 
5 or more patients 
n (%) 
Missing 
n (%) 
2. How many patients in 
your care have received at 
least one CABENUVA 
injection at a Palmetto 
infusion center? 
XX 
0 patients 
n (%) 
1 patient 
n (%) 
2 patients 
n (%) 
3 patients 
n (%) 
4 patients 
n (%) 
5 or more patients 
n (%) 
Missing 
n (%) 
3. How many patients in 
your care have ever received 
at least one CABENUVA 
injection outside of a 
research study at your 
clinic/practice? 
XX 
0 patients 
n (%) 
1 patient 
n (%) 
2 patients 
n (%) 
3 patients 
n (%) 
4 patients 
n (%) 
5 patients 
n (%) 
6 patients 
n (%) 
7 patients 
n (%) 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in US Community-based Infusion Centers 
 
 
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8 patients 
n (%) 
9 patients 
n (%) 
10 or more patients 
n (%) 
Missing 
n (%) 
4. What types of patients 
have you referred to an 
infusion center to receive 
CABENUVA?1,2  
XX 
All patients 
n (%) 
Patients who want to start CABENUVA but 
prefer not to come to the HIV clinic for each 
injection visits 
n (%) 
Patients who have had difficulty maintaining 
their daily oral treatment regimen 
n (%) 
Patients who have concerns about disclosure 
of their HIV status to others  
n (%) 
Patients who feel stigmatized by their HIV 
n (%) 
Patients with more chaotic lifestyles (variable 
work schedules, frequent travel, balancing 
work and school)  
n (%) 
Patients with more structured lifestyles 
n (%) 
Newly diagnosed (<2 years since diagnosis) 
n (%) 
Treatment experienced  
n (%) 
Patients already receiving CABENUVA 
n (%) 
Younger patients (<35 years old) 
n (%) 
Older patients (>50 years old) 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
5. What are the advantages 
of referring patients to an 
infusion center for 
CABENUVA from your 
perspective?1,2  
XX 
Infusions centers have more clinic space 
n (%) 
Infusion centers have more time to add visits 
to their schedules 
n (%) 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in US Community-based Infusion Centers 
 
 
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Infusion centers have more staff to manage 
scheduling/rescheduling appointments 
n (%) 
Infusion centers have more staff to administer 
it 
n (%) 
Infusion centers have the space to store the 
medication 
n (%) 
Infusion centers manage acquisition of the 
medication 
n (%) 
Infusion center handles the logistics of 
administration 
n (%) 
Infusion centers manage the insurance 
verification process 
n (%) 
Infusion centers manage the insurance 
reimbursement 
n (%) 
Convenience for the patient 
n (%) 
Financial considerations for my clinic 
n (%) 
Other 
n (%) 
Missing 
n (%) 
6. What are the 
disadvantages of referring 
patients to an infusion 
center for CABENUVA from 
your perspective?1,2 
XX 
Concern I won’t be aware when my patient 
receives CABENUVA 
n (%) 
Concern I won’t be aware if my patient does 
not receive CABENUVA on time 
n (%) 
Concern about adverse event management 
n (%) 
Concern about management of injection site 
reactions 
n (%) 
Concern about reduced involvement in 
management of HIV-related care 
n (%) 
Inconvenience for patients; having to go to 
two locations (clinic for routine visits, infusion 
center for injections) 
n (%) 
Concern patient won’t want to go to infusion 
center 
n (%) 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in US Community-based Infusion Centers 
 
 
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Concern about stigma patient may experience 
receiving an CABENUVA at infusion center 
n (%) 
Missed opportunity for revenue for my HIV 
clinic 
n (%) 
Issues with infusion centers handling the 
logistics associated with insurance verification 
and approval 
n (%) 
Issues with infusion centers handling the 
logistics associated with insurance 
reimbursement 
n (%) 
Fear of losing my patient to another provider 
n (%) 
Other*  
n (%) 
Missing 
n (%) 
7. If a patient in your care is 
receiving CABENUVA at an 
infusion center, how often 
do you see them/expect to 
see them in your clinic for 
follow-up?3  
XX 
Once every month 
n (%) 
Once after the first injection at the infusion 
center, then every 3 months 
n (%) 
Once after the first injection at the infusion 
center, then every 6 months 
n (%) 
Once every 3 months 
n (%) 
Once every 6 months 
n (%) 
Once a year 
n (%) 
Other*  
n (%) 
Missing 
n (%) 
8. If a patient in your care is 
receiving CABENUVA at an 
infusion center, how often 
do they get/expect to get 
routine labs?3 
XX 
Once every month 
n (%) 
Once after the first injection at the infusion 
center, then every 3 months 
n (%) 
Once after the first injection at the infusion 
center, then every 6 months 
n (%) 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in US Community-based Infusion Centers 
 
 
Proprietary and Confidential | Page 27 
www.evidera.com 
 
Once every 3 months 
n (%) 
Once every 6 months 
n (%) 
Once a year 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
1 Select one response 
2 Select all that apply 
3 Within each question, response choices will be ordered by percent endorsing, descending, and ties will go in order presented to 
respondents. For items with more than 5 response options, the top 5 selected response options within each item at baseline will 
be bolded in tables for subsequent timepoints. 
Abbreviations: HIV = Human immunodeficiency virus 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey at the respective 
timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint. 
Cell percentages do not include missing 
*”Other” responses and open-ended text responses will be presented in an appendix 
 
 
Table 1.3.3. HIV Care Provider/Clinical Staff Preferences with CABENUVA – Month 8 
Question 
Number of 
Participants 
at Month 8 
Response 
n (%) 
1. How many patients have 
you referred to a Palmetto 
infusion center to receive 
CABENUVA injections? 
XX 
1 patient 
n (%) 
2 patients 
n (%) 
3 patients 
n (%) 
4 patients 
n (%) 
5 or more patients 
n (%) 
Missing 
n (%) 
2. How many patients in 
your care have received at 
least one CABENUVA 
injection at a Palmetto 
infusion center? 
XX 
0 patients 
n (%) 
1 patient 
n (%) 
2 patients 
n (%) 
3 patients 
n (%) 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in US Community-based Infusion Centers 
 
 
Proprietary and Confidential | Page 28 
www.evidera.com 
 
4 patients 
n (%) 
5 or more patients 
n (%) 
Missing 
n (%) 
3. How many patients in 
your care have ever 
received at least one 
CABENUVA injection 
outside of a research study 
at your clinic/practice? 
XX 
0 patients 
n (%) 
1 patient 
n (%) 
2 patients 
n (%) 
3 patients 
n (%) 
4 patients 
n (%) 
5 patients 
n (%) 
6 patients 
n (%) 
7 patients 
n (%) 
8 patients 
n (%) 
9 patients 
n (%) 
10 or more patients 
n (%) 
Missing 
n (%) 
4. What types of patients 
have you referred to an 
infusion center to receive 
CABENUVA?1,2  
XX 
All patients 
n (%) 
Patients who want to start CABENUVA but 
prefer not to come to the HIV clinic 
n (%) 
Patients who have had difficulty 
maintaining their daily oral treatment 
regimen 
n (%) 
Patients who have concerns about 
disclosure of their HIV status to others  
n (%) 
Patients who feel stigmatized by their HIV 
n (%) 
Patients with more chaotic lifestyles 
(variable work schedules, frequent travel, 
balancing work and school)  
n (%) 
Patients with more structured lifestyles 
n (%) 
Newly diagnosed (<2 years since diagnosis) 
n (%) 
Treatment experienced  
n (%) 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in US Community-based Infusion Centers 
 
 
Proprietary and Confidential | Page 29 
www.evidera.com 
 
Patients already receiving CABENUVA 
n (%) 
Younger patients (<35 years old) 
n (%) 
Older patients (>50 years old) 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
5. What are the 
advantages of referring 
patients to an infusion 
center for CABENUVA from 
your perspective?1,2  
XX 
Infusions centers have more clinic space 
n (%) 
Infusion centers have more time to add 
visits to their schedules 
n (%) 
Infusion centers have more staff to manage 
scheduling/rescheduling appointments 
n (%) 
Infusion centers have more staff to 
administer it 
n (%) 
Infusion centers have the space to store the 
medication 
n (%) 
Infusion centers manage acquisition of the 
medication 
n (%) 
Infusion center handles the logistics of 
administration 
n (%) 
Infusion centers manage the insurance 
verification process 
n (%) 
Infusion centers manage the insurance 
reimbursement 
n (%) 
Convenience for the patient 
n (%) 
Financial considerations for my clinic 
n (%) 
Other 
n (%) 
Missing 
n (%) 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in US Community-based Infusion Centers 
 
 
Proprietary and Confidential | Page 30 
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6. What are the 
disadvantages of referring 
patients to an infusion 
center for CABENUVA from 
your perspective?1,2 
XX 
Concern I won’t be aware when my patient 
receives CABENUVA 
n (%) 
Concern I won’t be aware if my patient 
does not receive CABENUVA on time 
n (%) 
Concern about adverse event management 
n (%) 
Concern about management of injection 
site reactions 
n (%) 
Concern about reduced involvement in 
management of HIV-related care 
n (%) 
Inconvenience for patients; having to go to 
two locations (clinic for routine visits, 
infusion center for injections) 
n (%) 
Concern patient won’t want to go to 
infusion center 
n (%) 
Concern about stigma patient may 
experience receiving an CABENUVA at 
infusion center 
n (%) 
Missed opportunity for revenue for my HIV 
clinic 
n (%) 
Issues with infusion centers handling the 
logistics associated with insurance 
verification and approval 
n (%) 
Issues with infusion centers handling the 
logistics associated with insurance 
reimbursement 
n (%) 
Fear of losing my patient to another 
provider 
n (%) 
Other*  
n (%) 
Missing 
n (%) 
7. If a patient in your care 
is receiving CABENUVA at 
an infusion center, how 
often do you see 
them/expect to see them 
in your clinic for follow-
up?3  
XX 
Once every month 
n (%) 
Once after the first injection at the infusion 
center, then every 3 months 
n (%) 
Once after the first injection at the infusion 
center, then every 6 months 
n (%) 
Once every 3 months 
n (%) 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in US Community-based Infusion Centers 
 
 
Proprietary and Confidential | Page 31 
www.evidera.com 
 
Once every 6 months 
n (%) 
Once a year 
n (%) 
Other*  
n (%) 
Missing 
n (%) 
8. If a patient in your care 
is receiving CABENUVA at 
an infusion center, how 
often do they get/expect 
to get routine labs?3 
XX 
Once every month 
n (%) 
Once after the first injection at the infusion 
center, then every 3 months 
n (%) 
Once after the first injection at the infusion 
center, then every 6 months 
n (%) 
Once every 3 months 
n (%) 
Once every 6 months 
n (%) 
Once a year 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
9. Overall, how satisfied 
are you with the 
experience of referring 
patients to receive 
CABENUVA at an infusion 
center? 
XX 
Extremely satisfied 
n (%) 
Very satisfied 
n (%) 
Somewhat satisfied 
n (%) 
Neutral 
n (%) 
Somewhat dissatisfied 
n (%) 
Very dissatisfied 
n (%) 
Extremely dissatisfied 
n (%) 
I was not involved in this process 
n (%) 
Missing 
n (%) 
10. How likely are you to 
continue to refer patients 
to receive CABENUVA at an 
infusion center moving 
forward? 
XX 
Extremely likely 
n (%) 
Very likely 
n (%) 
Somewhat likely 
n (%) 
Neutral 
n (%) 
Somewhat unlikely 
n (%) 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in US Community-based Infusion Centers 
 
 
Proprietary and Confidential | Page 32 
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Very unlikely 
n (%) 
Extremely unlikely 
n (%) 
I was not involved in this process 
n (%) 
Missing 
n (%) 
1 Select one response 
2 Select all that apply 
3 Within each question, response choices will be ordered by percent endorsing, descending, and ties will go in order presented 
to respondents. For items with more than 5 response options, the top 5 selected response options within each item at baseline 
will be bolded in tables for subsequent timepoints. 
Abbreviations: HIV = Human immunodeficiency virus 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey at the respective 
timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint. 
Cell percentages do not include missing 
*”Other” responses and open-ended text responses will be presented in an appendix 
 
 
Table 1.4.1. HIV Care Provider/Clinical Staff Concerns about CABENUVA Administration - Baseline 
(N=XX) 
Items 
Number of 
Participants 
at Baseline 
Missing  
Extremely 
concerned 
Moderately 
concerned 
Somewhat 
concerned 
Slightly 
concerned 
Not at all 
concerned 
1. Managing the oral lead-in 
phase of CABENUVA treatment 
before starting injections  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2. Being informed (in a timely 
manner) when a patient 
receives CABENUVA  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3. Infusion center managing 
post-injection reactions 
appropriately  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4. Infusion center’s ability to 
manage patients presenting to 
CABENUVA appointments with 
other care needs that need to 
be addressed  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
5. Infusion center’s ability to 
schedule/reschedule missed 
CABENUVA visits within correct 
treatment window  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
6. Being informed (in a timely 
manner) when a patient needs 
oral therapy for planned missed 
CABENUVA visits  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
7. Being informed (in a timely 
manner) when a patient misses 
a CABENUVA visit 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
8. Infusion Center’s (lack of) 
persistence to follow up with 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in US Community-based Infusion Centers 
 
 
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Items 
Number of 
Participants 
at Baseline 
Missing  
Extremely 
concerned 
Moderately 
concerned 
Somewhat 
concerned 
Slightly 
concerned 
Not at all 
concerned 
patients on missed 
appointments  
9. Patients not being 
virologically suppressed due to 
missed injections  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
10. Risk of drug resistance for 
patients not adherent to 
injections  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
11. Being informed (in a timely 
manner) of adverse events  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
12. Being informed of 
laboratory results (e.g., CD4, VL, 
LFTs)  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
13. Infusion Center not taking 
adequate steps to address 
privacy concerns for PLWHIV  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
14. Worried that my patient will 
feel stigmatized at the infusion 
center  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
15. Patients’ willingness to 
travel to an infusion for each 
injection visit  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
16. Patient reluctance to 
receive care at infusion center 
due to perception of severity of 
illness  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
NOTE: all items are ‘select one response’; Table will be sorted from highest to lowest percentage of providers indicating 
extremely concerned, followed by moderately concerned, somewhat concerned, slightly concerned, and not at all concerned.  
NOTE: Missing = the number of participants who completed any portion of a survey at any time but did not complete respective 
item; Missing % = the number of participants who filled out any portion of a survey at any time but did NOT complete the 
respective item / the number of people who filled out any portion of a survey at any time. 
Cell percentages do not include missing 
 
Instructions to respondents: 
Survey Completion Instructions: “We want to understand any concerns or barriers to successful administration of long-acting 
CABENUVA injections at an infusion center. For each item, please indicate how concerned you would be about each of the 
following challenges potentially being a barrier based on your current expectations and knowledge.” 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in US Community-based Infusion Centers 
 
 
Proprietary and Confidential | Page 34 
www.evidera.com 
 
 
 
Table 1.4.2. HIV Care Provider/Clinical Staff Concerns about CABENUVA Administration – Month 4 
(N=XX) 
Items 
Number of 
Participants at 
Month 4 
Missing    
Extremely 
concerned 
Moderately 
concerned 
Somewhat 
concerned 
Slightly 
concerned 
Not at all 
concerned 
1. Managing the oral 
lead-in phase of 
CABENUVA 
treatment before 
starting injections  
XX 
n (%)   
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2. Being informed 
(in a timely manner) 
when a patient 
receives CABENUVA  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3. Infusion center 
managing post-
injection reactions 
appropriately  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4. Infusion center’s 
ability to manage 
patients presenting 
to CABENUVA 
appointments with 
other care needs 
that need to be 
addressed  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
5. Infusion center’s 
ability to 
schedule/reschedule 
missed CABENUVA 
visits within correct 
treatment window  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
6. Being informed 
(in a timely manner) 
when a patient 
needs oral therapy 
for planned missed 
CABENUVA visits  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
7. Being informed 
(in a timely manner) 
when a patient 
misses a CABENUVA 
visit 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in US Community-based Infusion Centers 
 
 
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8. Infusion Center’s 
(lack of) persistence 
to follow up with 
patients on missed 
appointments  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
9. Patients not being 
virologically 
suppressed due to 
missed injections  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
10. Risk of drug 
resistance for 
patients not 
adherent to 
injections  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
11. Being informed 
(in a timely manner) 
of adverse events  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
12. Being informed 
of laboratory results 
(e.g., CD4, VL, LFTs, 
etc.)  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
13. Infusion Center 
not taking adequate 
steps to address 
privacy concerns for 
PLWHIV  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
14. Worried that my 
patient will feel 
stigmatized at the 
infusion center  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
15. Patients’ 
willingness to travel 
to an infusion center 
for each injection 
visit  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
16. Patient 
reluctance to 
receive care at 
infusion center due 
to perception of 
severity of illness  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
NOTE: all items are ‘select one response’; Table will be sorted from highest to lowest percentage, at baseline, of providers 
indicating extremely concerned, followed by moderately concerned, somewhat concerned, slightly concerned and not at all 
concerned. The top 5 items in terms of percent indicating extremely concerned at baseline will be bolded at all subsequent time 
points 
NOTE: Missing = the number of participants who completed any portion of a survey at any time but did not complete respective 
item; Missing % = the number of participants who filled out any portion of a survey at any time but did NOT complete the 
respective item / the number of people who filled out any portion of a survey at any time. 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in US Community-based Infusion Centers 
 
 
Proprietary and Confidential | Page 36 
www.evidera.com 
 
Cell percentages do not include missing 
 
Instructions to respondents: 
Survey Completion Instructions: “We want to understand any concerns or barriers to successful administration of long-acting 
CABENUVA injections at an infusion center. For each item, please indicate how concerned you would be about each of the 
following challenges potentially being a barrier based on your current expectations and knowledge.” 
 
Table 1.4.3. HIV Care Provider/Clinical Staff Concerns about CABENUVA Administration - Month 8 
(N=XX) 
Items 
Number of 
Participants at 
Month 4 
Missing    
Extremely 
concerned 
Moderately 
concerned 
Somewhat 
concerned 
Slightly 
concerned 
Not at all 
concerned 
1. Managing the oral 
lead-in phase of 
CABENUVA 
treatment before 
starting injections  
XX 
n (%)   
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2. Being informed 
(in a timely manner) 
when a patient 
receives CABENUVA  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3. Infusion center 
managing post-
injection reactions 
appropriately  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4. Infusion center’s 
ability to manage 
patients presenting 
to CABENUVA 
appointments with 
other care needs 
that need to be 
addressed  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
5. Infusion center’s 
ability to 
schedule/reschedule 
missed CABENUVA 
visits within correct 
treatment window  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
6. Being informed 
(in a timely manner) 
when a patient 
needs oral therapy 
for planned missed 
CABENUVA visits  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for 
the Treatment of HIV-1, for Administration in US Community-based Infusion Centers 
 
 
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www.evidera.com 
 
7. Being informed 
(in a timely manner) 
when a patient 
misses a CABENUVA 
visit 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
8. Infusion Center’s 
(lack of) persistence 
to follow up with 
patients on missed 
appointments  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
9. Patients not being 
virologically 
suppressed due to 
missed injections  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
10. Risk of drug 
resistance for 
patients not 
adherent to 
injections  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
11. Being informed 
(in a timely manner) 
of adverse events  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
12. Being informed 
of laboratory results 
(e.g., CD4, VL, LFTs, 
etc.)  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
13. Infusion Center 
not taking adequate 
steps to address 
privacy concerns for 
PLWHIV  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
14. Worried that my 
patient will feel 
stigmatized at the 
infusion center  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
15. Patients’ 
willingness to travel 
to an infusion center 
for each injection 
visit  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
16. Patient 
reluctance to 
receive care at 
infusion center due 
to perception of 
severity of illness  
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
NOTE: all items are ‘select one response’; Table will be sorted from highest to lowest percentage, at baseline, of providers 
indicating extremely concerned, followed by moderately concerned, somewhat concerned, slightly concerned and not at all 


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concerned. The top 5 items in terms of percent indicating extremely concerned at baseline will be bolded at all subsequent time 
points 
NOTE: Missing = the number of participants who completed any portion of a survey at any time but did not complete respective 
item; Missing % = the number of participants who filled out any portion of a survey at any time but did NOT complete the 
respective item / the number of people who filled out any portion of a survey at any time. 
Cell percentages do not include missing 
 
Instructions to respondents: 
Survey Completion Instructions: “We want to understand any concerns or barriers to successful administration of long-acting 
CABENUVA injections at an infusion center. For each item, please indicate how concerned you would be about each of the 
following challenges potentially being a barrier based on your current expectations and knowledge.” 
 
 
 
 


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Table 2.1. HIV Care Providers/Clinical Staff Responding “Agree” or Completely Agree” On All FIM 
Items at Baseline, Month 4, and Month 8: Proportions and Change 
 
Number 
completing all 4 
FIM items 
Number endorsing  
‘4’ or ‘5’ on all FIM 
Items 
% endorsing all FIM Items 
Percentage Point 
Change 
Baseline1 
XX 
XX 
XX% 
- 
Month 41 
XX 
XX 
XX% 
- 
Month 81 
XX 
XX 
XX% 
- 
Baseline to Month 42 
XX 
BL=XX; M4=XX 
BL=XX%; M4=XX% 
XX% 
Baseline to Month 82 
XX 
BL=XX; M8=XX 
BL=XX%; M8=XX% 
XX% 
Month 4 to Month 82 
XX 
M4=XX; M8=XX 
M4=XX%; M8=XX% 
XX% 
1For each cross-sectional time point row, numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 
items 
2Each change row is limited to those completing all 4 items at both respective timepoints: numerator = number responding ‘4’ or 
‘5’, denominator = number completing all 4 items 
Abbreviations: FIM = Feasibility of Intervention Measure; BL=baseline; M4 = Month 4; M8 = Month 8 
Responses: 4= 
 5= 
 
Note: Reporting for change includes only those who completed surveys at both respective time points, which may differ from 
reporting at each individual timepoint 
 
Table 2.2. HIV Care Providers/Clinical Staff Responding “Agree” or Completely Agree” On All AIM 
Items at Baseline, Month 4, and Month 8: Proportions and Change 
 
Number completing all 
4 AIM items 
Number endorsing  ‘4’ 
or ‘5’ on all AIM Items 
% endorsing all AIM 
Items1 
Percentage Point 
Change2 
Baseline1 
XX 
XX 
XX% 
- 
Month 41 
XX 
XX 
XX% 
- 
Month 81 
XX 
XX 
XX% 
- 
Baseline to Month 42 
XX 
BL=XX; M4=XX 
BL=XX%; M4=XX% 
XX% 
Baseline to Month 82 
XX 
BL=XX; M8=XX 
BL=XX%; M8=XX% 
XX% 
Month 4 to Month 82 
XX 
M4=XX; M8=XX 
M4=XX%; M8=XX% 
XX% 
Responses: 4= 
 5= 
  
Note: Reporting for change includes only those who completed surveys at both respective time points, which may differ from 
reporting at each individual timepoint 
1For each cross-sectional time point row, numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 
items 
2Each change row is limited to those completing all 4 items at both respective timepoints; numerator = number responding ‘4’ or 
‘5’, denominator = number completing all 4 items 
Abbreviations: AIM = Acceptability of Intervention Measure; BL=baseline; M4 = Month 4; M8 = Month 8 
 
 
CCI
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CCI
CCI


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Table 3.1. HIV Care Provider/Clinical Staff, Distributional Characteristics of Feasibility of Intervention Measure (FIM), N=XX 
Item/ Scale 
Time Point 
Number of 
Participants  
Missing  
Mean 
SD 
Median 
(Q1, Q3) 
Range 
(Max ,Min) 
Percent 
Missing 
Percent 
Floor 
Percent 
Ceiling 
95% CI 
(Lower, Upper) 
FIM Mean Score 
BL 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.XX) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.XXX, X.XXX) 
M4 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.XXX, X.XXX) 
M8 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.XXX, X.XXX) 
1. Infusion Center 
administered CABENUVA 
seems implementable for 
the patients in our 
clinic/practice. 
BL 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M4 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
2. Infusion Center 
administered CABENUVA 
seems possible for the 
patients in our 
clinic/practice. 
BL 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M4 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
3. Infusion Center 
administered CABENUVA 
seems doable for the 
patients in our 
clinic/practice. 
BL 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M4 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
4. Infusion Center 
administered CABENUVA 
seems easy to implement 
for the patients in our 
clinic/practice. 
BL 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M4 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
Abbreviations: BL = Baseline; CI = confidence interval; FIM = Feasibility of Intervention Measure; M4 = Month 4; M8 = Month 8; SD = standard deviation; BL = Baseline; M4 = Month 
4; M8 = Month 8. 
Percent Floor for the mean score is the percent of respondents with a score of 1 
 out of all respondents replying to at least two FIM item at a given time point. 
Percent Ceiling for the mean score is the percent of respondents with a score of 5 
 out of all respondents replying to at least two FIM item at a given time point. 
NOTE: Missing for individual item counts = the number of participants who completed any portion of a survey at any time but did not complete respective item; Missing % = the 
number of participants who filled out any portion of a survey at any time but did NOT complete the respective item / the number of people who filled out any portion of a survey 
at any time. Missing for the mean score counts any instance where a respondent completed one FIM item, not reaching the minimum of 2 items required to calculate a mean FIM 
score. 
Cell percentages do not include missing 
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Table 3.2. HIV Care Provider/Clinical Staff, Distributional Characteristics of Acceptability of Intervention Measure (AIM), N=XX 
Item/ Scale 
Time 
Point 
Number of 
Participants  
Missing  
Mean 
SD 
Median 
(Q1, Q3) 
Range 
(Max ,Min) 
Percent 
Missing 
Percent 
Floor 
Percent 
Ceiling 
95% CI 
(Lower, 
Upper) 
AIM Mean Score 
BL 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.XX) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.XXX, 
X.XXX) 
M4 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.XXX, 
X.XXX) 
M8 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.XXX, 
X.XXX) 
1. The idea of providing 
CABENUVA at my infusion center 
meets my approval. 
BL 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M4 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
2. The idea of providing 
CABENUVA at my infusion center 
is appealing to me. 
BL 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M4 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
3. I like the idea of providing 
CABENUVA for PLWHIV in my 
infusion center. 
BL 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M4 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
4. I welcome providing CABENUVA 
for PLWHIV in my infusion center. 
BL 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M4 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
Abbreviations: AIM = Acceptability of Intervention Measure; BL = Baseline; CI = confidence interval; M4 = Month 4; M8 = Month 8; PLWHIV = participants living with human 
immunodeficiency virus; SD = standard deviation; BL = Baseline; M3 = Month 3; M8 = Month 8. 
Percent Floor for the mean score is the percent of respondents with a score of 1 
 out of all respondents replying to at least two AIM item at a given time point. 
Percent Ceiling for the mean score is the percent of respondents with a score of 5 
 out of all respondents replying to at least two AIM item at a given time point. 
NOTE: Missing for individual item counts = the number of participants who completed any portion of a survey at any time but did not complete respective item; Missing % = the 
number of participants who filled out any portion of a survey at any time but did NOT complete the respective item / the number of people who filled out any portion of a survey at 
any time. Missing for the mean score counts any instance where a respondent completed one AIM item, not reaching the minimum of 2 items required to calculate a mean AIM 
score. 
Cell percentages do not include missing 
 
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Table 4.1. HIV Care Provider/Clinical Staff, Univariate Distribution of Feasibility of Intervention Measure (FIM), N=XX 
Item 
Time Point 
Number of 
Participants  
Missing   
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. Infusion Center administered CABENUVA 
seems implementable for the patients in our 
clinic/practice. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M4 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2. Infusion Center administered CABENUVA 
seems possible for the patients in our 
clinic/practice. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M4 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3. Infusion Center administered CABENUVA 
seems doable for the patients in our 
clinic/practice. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M4 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4. Infusion Center administered CABENUVA 
seems easy to implement for the patients in our 
clinic/practice. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M4 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
Abbreviations: BL = Baseline; HIV = human immunodeficiency virus; M4 = Month 4; M8 = Month 8 
NOTE: NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item; Missing % = the number 
of participants who were eligible to complete a survey at the respective timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a 
survey at the respective timepoint.. 
Cell percentages do not include missing 
 


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Table 4.2. HIV Care Provide/ Clinical Staff, Univariate Distribution of Acceptability of Intervention Measure (AIM), N=XX 
Items 
Time Point 
Number of 
Participants 
Missing 
Completely 
disagree 
Disagree 
Neither agree 
nor disagree 
Agree 
Completely 
agree 
1. The idea of an infusion center 
providing CABENUVA meets my 
approval. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M4 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
2. The idea of an infusion center 
providing CABENUVA is appealing to me. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M4 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
3. I like the idea of an infusion center 
providing CABENUVA for PLWHIV in our 
clinic/practice. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M4 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
4. I welcome an infusion center 
providing CABENUVA for PLWHIV in our 
clinic/practice. 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M4 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M8 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
Abbreviations: BL = Baseline; HIV = human immunodeficiency virus; M4 = Month 4; M8 = Month 8; PLWHIV = participants living with human immunodeficiency virus 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item; Missing % = the number of 
participants who were eligible to complete a survey at the respective timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a 
survey at the respective timepoint.. 
Cell percentages do not include missing 
 


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Table 5.1. HIV Care Provider/Clinical Staff, Distributional Characteristics of Change in Feasibility of Intervention Measure (FIM), N=XX 
Item/ Scale 
Time Point 
Number of 
Participants1 
Missing  
Mean 
Change 
SD 
Median 
(Q1, Q3) 
Range  
(Max - Min) 
95% CI 
Lower- 
Upper 
FIM Mean Score 
BL to M4 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.XX) 
(X.X, X.X) 
(X.XXX - X.XXX) 
BL to M8 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.XX) 
(X.X, X.X) 
(X.XXX - X.XXX) 
M4 to M8 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.XX) 
(X.X, X.X) 
(X.XXX - X.XXX) 
1. Infusion Center administered 
CABENUVA seems implementable for 
the patients in our clinic/practice. 
BL to M4 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
BL to M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
M4 to M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
2. Infusion Center administered 
CABENUVA seems possible for the 
patients in our clinic/practice. 
BL to M4 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
BL to M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
M4 to M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
3. Infusion Center administered 
CABENUVA seems doable for the 
patients in our clinic/practice. 
BL to M4 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
BL to M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
M4 to M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
4. Infusion Center administered 
CABENUVA seems easy to implement 
for the patients in our clinic/practice. 
BL to M4 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
BL to M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
M4 to M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
1 Only includes Providers who completed surveys at respective months 
Abbreviations: BL = Baseline; CI = confidence interval; FIM = Feasibility of Intervention Measure; M4 = Month 4; M8 = Month 8; SD = standard deviation 
NOTE: Missing for individual item counts = the number of participants who were eligible to complete a survey at the respective timepoint but did not complete respective item; 
Missing % = the number of participants who were eligible to complete a survey at the respective timepoint but did NOT complete the respective item / the number of people who 
were eligible to complete a survey at the respective timepoint. Missing for the mean score counts any instance where a respondent completed one FIM item, not reaching the 
minimum of 2 items required to calculate a mean FIM score. 
Cell percentages do not include missing 


A Phase 4, Open-label, Single-arm Study to Optimize Implementation of CABENUVA for the Treatment of HIV-1, for 
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Table 5.2. HIV Care Provider/Clinical Staff, Distributional Characteristics of Change in Acceptability of Intervention Measure (AIM), N=XX 
Item/ Scale 
Time Point 
Number of 
Participants1 
Missing  
Mean 
Change 
SD 
Median 
(Q1, Q3) 
Range  
(Max - Min) 
95% CI 
Lower- 
Upper 
AIM Mean Score 
BL to M4 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.XX) 
(X.X, X.X) 
(X.XXX - X.XXX) 
BL to M8 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.XX) 
(X.X, X.X) 
(X.XXX - X.XXX) 
M4 to M8 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.XX) 
(X.X, X.X) 
(X.XXX - X.XXX) 
1. The idea of an infusion center providing 
CABENUVA meets my approval. 
BL to M4 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
BL to M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
M4 to M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
2. The idea of an infusion center providing 
CABENUVA is appealing to me. 
BL to M4 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
BL to M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
M4 to M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
3. I like the idea of an infusion center 
providing CABENUVA for PLWHIV in our 
clinic/practice. 
BL to M4 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
BL to M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
M4 to M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
4. I welcome an infusion center providing 
CABENUVA for PLWHIV in our 
clinic/practice. 
BL to M4 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
BL to M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
M4 to M8 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
(X.XX - X.XX) 
1 Only includes Providers who completed surveys at respective months 
Abbreviations: AIM = Acceptability of Intervention Measure; BL = Baseline; CI = confidence interval; M4 = Month 4; M8 = Month 8; PLWHIV = participants living with human 
immunodeficiency virus; SD = standard deviation 
NOTE: Missing for individual item counts = the number of participants who were eligible to complete a survey at the respective timepoint but did not complete respective item; 
Missing % = the number of participants who were eligible to complete a survey at the respective timepoint but did NOT complete the respective item / the number of people who 
were eligible to complete a survey at the respective timepoint. Missing for the mean score counts any instance where a respondent completed one AIM item, not reaching the 
minimum of 2 items required to calculate a mean AIM score. 
Cell percentages do not include missing 


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Table 6.1. HIV Care Provider/Clinical Staff, Shift of Feasibility of Intervention Measure (FIM) Response Frequency by item, N=XX  
1.Infusion Center administered CABENUVA seems implementable for the patients in our clinic/practice. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
4 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 4  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
2. Infusion Center administered CABENUVA seems possible for the patients in our clinic/practice. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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Month 
4 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 4  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
3. Infusion Center administered CABENUVA seems doable for the patients in our clinic/practice. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
4 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 4  


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Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
4. Infusion Center administered CABENUVA seems easy to implement for the patients in our clinic/practice. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
4 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  


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Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 4  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
1Missing at T1, completed at T2 
2Missing at T2, completed at T1 
Abbreviations: HIV = Human immunodeficiency virus; FIM = Feasibility of Intervention Measure 
Percentage calculations:  
Non-missing cell %: 
numerator = number selecting respective combination of Time 1 and Time 2 responses  
denominator = number of participants responding within Time 1 response category at Time 1 


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Table 6.2. HIV Care Provider, Shift of Acceptability of Intervention Measure (AIM) Response Frequency by item, N=XX  
1. The idea of an infusion center providing CABENUVA meets my approval. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
4 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 4  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
2. The idea of an infusion center providing CABENUVA is appealing to me. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  


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Month 
4 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 4  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
3. I like the idea of an infusion center providing CABENUVA for PLWHIV in our clinic/practice. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
4 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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Month 4  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
4. I welcome an infusion center providing CABENUVA for patients in our clinic/practice. 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
4 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 4  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
1Missing  at T1, completed at T2 
2Missing  at T2, completed at T1 
Abbreviations: HIV = Human immunodeficiency virus; AIM = Acceptability of Intervention Measure; PLWHIV = participants living with human immunodeficiency virus 
Percentage calculations:  
Non-missing cell %: 


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numerator = number selecting respective combination of Time 1 and Time 2 responses  
denominator = number of participants responding within Time 1 response category at Time 1 
Table 7. Implementation Science-Related Protocol Deviations, HIV Care Provider/Clinical Staff N=XX 
Protocol Deviation 
IS-related Protocol Deviations Reported for HIV Care Provider/Clinical 
Staff 
n (%)  
IS-related Protocol Deviations 
  
Placeholder sub-category 1 
  
Placeholder sub-category 2 
  
Placeholder sub-category 3 
  
 


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7 Table Shells, Expert Panel: Baseline, Month 3, 
Month 6, and Change 
Table 8.1. Expert Panel, Preferences for CABENUVA Administration Moving to Infusion Center, HIV 
Care Providers and IC Staff - Baseline, (N= XX) 
Question 
Number of Participants 
at Baseline 
Response 
n (%) 
1. What is the preferred 
method for HIV 
providers/clinic staff to 
refer patients to receive 
CABENUVA at an 
infusion Center?1,3 
N=XX 
Phone call 
n (%) 
Email  
n (%) 
Fax 
n (%) 
Secure Electronic Medical Record message 
n (%) 
Other* 
n (%) 
Unsure/ Not applicable to role                             
n (%) 
Missing 
n (%) 
2. What details should 
be included on the 
referral form?2,3 
N=XX 
Patient age 
n (%) 
Patient insurance details 
n (%) 
Current/most recent viral load 
n (%) 
Prior ART regimen 
n (%) 
Duration of Prior ART regimen 
n (%) 
History of prior ART failure 
n (%) 
Allergies 
n (%) 
Relevant medical conditions 
n (%) 
Relevant concomitant medications 
n (%) 
Other* 
n (%) 
Unsure/ Not applicable to role                                                    
n (%) 
Missing 
n (%) 
3. What is your 
preference for who will 
conduct the insurance 
benefit verification?1,3 
N=XX 
HIV Provider/ Clinic Staff 
n (%) 
Infusion Center Staff 
n (%) 
ViiV Connect (reimbursement hub) 
n (%) 
Unsure/ Not applicable to role                                     
n (%) 
Missing 
n (%) 
4. What is the 
expectation for an 
acceptable amount of 
time for the insurance 
benefit verification 
process (e.g. total time 
from patient referral to 
infusion center to 
notification of insurance 
coverage to patient)?1 
N=XX 
<1 business day  
n (%) 
1–2 business days 
n (%) 
3–4 business days 
n (%) 
5–6 business days 
n (%) 
>6 business days 
n (%) 
Unsure/ Not applicable to role                                     
n (%) 
Missing 
n (%) 


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Question 
Number of Participants 
at Baseline 
Response 
n (%) 
5. What is your 
preference for who 
notifies the patient 
about insurance 
coverage? 1,3 
N=XX 
HIV provider/ Clinic Staff 
n (%) 
Infusion Center Staff 
n (%) 
Missing 
n (%) 
6. What is the preferred 
method for contacting 
patients to relay 
insurance coverage 
information? 1,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Secure Electronic Medical Record message  
n (%) 
In person discussion   
n (%) 
Other* 
n (%) 
Unsure/ Not applicable to role 
n (%) 
Missing 
n (%) 
7. What are the 
expected modes of 
communication to 
patients for 
appointment reminders 
for their CABENUVA 
injections? 2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Secure Electronic Medical Record message 
n (%) 
Other* 
n (%) 
Unsure/ Not applicable to role                                                    
n (%) 
Missing 
n (%) 
8. What is your 
preferred mode of 
communication from 
infusion center to HIV 
provider/ clinic staff 
about completed 
CABENUVA injection 
visits? 1,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax  
n (%) 
Secure Electronic Medical Record message 
n (%) 
Other* 
n (%) 
Unsure/ Not applicable to role                                          
n (%) 
Missing 
n (%) 
9. What is your 
preferred mode of 
communication from 
infusion center to HIV 
provider/clinic staff 
about missed 
CABENUVA injection 
visits? 1,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure Electronic Medical Record message 
n (%) 
Other* 
n (%) 
Unsure/ Not applicable to role                                     
n (%) 
Missing 
n (%) 
10. What is the 
preferred process for 
providing oral ART 
therapy when a patient 
will miss one or more 
N=XX 
Infusion center staff contacts referring HIV provider to 
manage 
n (%) 
Infusion center staff notifies referring HIV provider, and 
IC manages the process of acquiring or helping the 
patient to acquire oral therapy 
n (%) 


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Question 
Number of Participants 
at Baseline 
Response 
n (%) 
CABENUVA injection 
visits due to planned 
travel or other reasons? 
1,3 
Other*  
n (%) 
Unsure/ Not applicable to role                                     
n (%) 
Missing 
n (%) 
11. What is your 
preferred mode of 
communication 
between HIV 
provider/clinic staff and 
infusion center when a 
patient decides to 
discontinue CABENUVA 
or discontinue receiving 
injections at the 
infusion center? 1,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure Electronic Medical Record message 
n (%) 
Other* 
n (%) 
Unsure/ Not applicable to role                                     
n (%) 
Missing 
n (%) 
12. What is your 
preferred mode of 
communication about 
adverse events from 
infusion center to HIV 
provider/clinic staff 
(either due to 
CABENUVA injections or 
other events)?1,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure Electronic Medical Record message 
n (%) 
Other* 
n (%) 
Unsure/ Not applicable to role                                     
n (%) 
Missing 
n (%) 
13. What is the 
preferred process for 
managing mild adverse 
events (i.e., Grade 1-2 
injection site reactions) 
1,3 
N=XX 
Infusion center manages the event and notifies referring 
HIV provider 
n (%) 
Infusion center notifies referring HIV provider 
immediately, then manages the event in collaboration 
with HIV provider 
n (%) 
Infusion center notifies referring HIV provider 
immediately, then HIV provider manages the event 
n (%) 
Process may vary depending on the event 
n (%) 
Other* 
n (%) 
Unsure/ Not applicable to role                                     
n (%) 
Missing 
n (%) 
14. What is the 
preferred process for 
managing severe or 
serious adverse events 
(i.e., a vasovagal 
reaction)? 1,3 
N=XX 
Infusion center manages the event and notifies referring 
HIV provider 
n (%) 
Infusion center notifies referring HIV provider 
immediately, then manages the event in collaboration 
with HIV provider 
n (%) 
Infusion center notifies referring HIV provider 
Reimmediately, then HIV provider manages the event 
n (%) 
Process may vary depending on the event 
n (%) 
Other* 
n (%) 
Unsure/ Not applicable to role                                     
n (%) 
Missing 
n (%) 


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Question 
Number of Participants 
at Baseline 
Response 
n (%) 
15. How often do you 
think it is appropriate to 
do routine labs at the 
infusion center? 2 
N=XX 
Never/ not needed 
n (%) 
Every month / at each injection 
n (%) 
Every 2 months  
n (%) 
Every 3 months 
n (%) 
Every 4 months 
n (%) 
Every 6 months 
n (%) 
Yearly 
n (%) 
As needed (i.e., when an adverse event occurs) 
n (%) 
Other* 
n (%) 
Unsure/ Not applicable to role                                                    
n (%) 
Missing 
n (%) 
16. If ad-hoc labs are 
needed (e.g., in the 
case of an adverse 
event), where should 
they be done? 1,3 
N=XX 
HIV provider’s office 
n (%) 
Infusion Center  
n (%) 
External lab 
n (%) 
Other* 
n (%) 
Unsure/ Not applicable to role                                     
n (%) 
Missing 
n (%) 
17. How do you prefer 
that ad hoc labs be 
communicated 
between HIV 
provider/clinic staff and 
infusion center? 1,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax 
n (%) 
Secure Electronic Medical Record message 
n (%) 
Other* 
n (%) 
Unsure/ Not applicable to role                                     
n (%) 
Missing 
n (%) 
18. For patients 
receiving CABENUVA 
injections at the 
infusion center, what is 
the preferred interval of 
time for patients to be 
seen by their HIV 
provider? 2 
N=XX 
Never/ not needed 
n (%) 
Every month  
n (%) 
Every 2 months  
n (%) 
Every 3 months 
n (%) 
Every 4 months 
n (%) 
Every 6 months 
n (%) 
Yearly 
n (%) 
As needed (i.e., when an adverse event occurs) 
n (%) 
Other 
n (%) 
Unsure/ Not applicable to role                                    
n (%) 
Missing 
n (%) 
1 Select one response 
2 Select all that apply 
3 Within each question, where appropriate, response choices will be ordered by percent endorsing, descending, and ties will go in 
order presented to respondents.  


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Abbreviations: ART = antiretroviral therapy; HIV = human immunodeficiency virus; IC = infusion center 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey at the respective 
timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint. 
Cell percentages do not include missingCell percentages do not include missing 
*”Other” responses and open-ended text responses will be presented in an appendix 
 
 
Table 8.2.1. Expert Panel, Assessment of CABENUVA Administration Moving to Infusion Center, HIV 
Care Providers – Month 3, (N= XX) 
Question 
Number of 
Participants at 
Month 3 
Response 
n (%) 
9. Have you submitted a 
referral to the infusion center?1 
N=XX 
 
n (%) 
 
n (%) 
Missing 
n (%) 
9a. If yes, how acceptable has 
the referral process been?1,2 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
9b. If yes, what challenges, if 
any, have you or your staff 
encountered with the referral 
process?2,3,4 
N=XX 
I/my staff have not encountered any challenges with 
the referral process. [If selecting this option please do 
not select any others and proceed to 9c.] 
n (%) 
It was unclear how to initiate the referral. 
n (%) 
It was unclear when to initiate the referral. 
n (%) 
I/my staff did not know where to find the plan of 
treatment (POT) to initiate the referral process. 
n (%) 
I /my staff was not clear on how to complete the plan 
of treatment (POT) as part of the referral process. 
n (%) 
The plan of treatment (POT) does not provide enough 
information for a referral. 
n (%) 
The plan of treatment (POT) required too much 
information for a referral. 
n (%) 
The process of transferring the information to the 
infusion center was difficult due to technology 
limitations (e.g., too much paperwork to fax).  
n (%) 
I did not know to whom to send the plan of treatment 
(POT) and supporting documentation. 
n (%) 
I was not comfortable faxing the documentation 
required for the referral process. 
n (%) 


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I was never informed whether or not my patient was 
eligible to receive CABENUVA injections at the infusion 
center.  
n (%) 
The process to initiate oral cabotegravir and rilpivirine 
was not clear 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
9c. If no, what are the reason(s) 
you have not yet referred a 
patient to the infusion center to 
receive CABENUVA? (Only 
complete this question if you 
have not submitted a referral to 
the infusion center.)2,3,4 
N=XX 
I am not recommending CABENUVA as a treatment 
option for my patients at this time. 
n (%) 
I have not identified a patient that is appropriate for 
receipt of CABENUVA. 
n (%) 
I prefer to administer CABENUVA at my own clinic at 
this time. 
n (%) 
I prefer to administer CABENUVA at my own clinic for 
patients new to CABENUVA prior to referring them to 
the infusion center. 
n (%) 
My patient(s) do not want to receive CABENUVA at an 
infusion center at this time. 
n (%) 
I do not have enough information about the infusion 
centers to recommend it for my patients. 
n (%) 
It was unclear how to initiate the referral. 
n (%) 
It was unclear when to initiate the referral. 
n (%) 
I/my staff did not know where to find the plan of 
treatment (POT) to initiate the referral process. 
n (%) 
I/my staff was not clear on how to complete the plan of 
treatment (POT) as part of the referral process. 
n (%) 
The plan of treatment (POT) does not provide enough 
information for a referral. 
n (%) 
The plan of treatment (POT) required too much 
information for a referral. 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
9d. How likely are you to refer 
(or to continue to refer) 
patients to infusion centers to 
receive CABENUVA?1 
N=XX 
Extremely likely 
n (%) 
Very likely 
n (%) 
Somewhat likely 
n (%) 
Neither likely nor unlikely 
n (%) 
Somewhat unlikely 
n (%) 
Very unlikely 
n (%) 
Extremely unlikely 
n (%) 
Missing 
n (%) 
10. Have you seen the plan of 
treatment (POT) or referral 
form?1,5 
N=XX 
Yes (Go to Q11a.) 
n (%) 
No (Go to Q12.) 
n (%) 
Missing 
n (%) 
N=XX 
Yes (Go to Q11b.) 
n (%) 


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10a. Is there anything missing 
from the plan of treatment 
(POT) or referral form?1 
No (Go to Q11c.) 
n (%) 
Missing 
n (%) 
10b. If yes, what is missing from 
the plan of treatment (POT) or 
referral form?3,4 
N=XX 
Place to provide comments to infusion center 
n (%) 
Documentation of my preferences regarding modality 
of urgent communications  
n (%) 
Documentation of my preferences regarding modality 
of non-urgent communications  
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
10c. Is there anything on the 
plan of treatment (POT) or 
referral form that you feel 
should not be included (or is 
not needed) as part of the 
referral process?3,4 
N=XX 
I think that all of the information on the plan of 
treatment (POT) or referral form is needed or should be 
included as part of a referral. [If selecting this option 
please do not select any others.] 
n (%) 
Patient demographic information 
n (%) 
Patient height 
n (%) 
Patient weight 
n (%) 
Allergies 
n (%) 
Patient diagnosis Z21 asymptomatic human 
immunodeficiency virus (HIV) infection status 
n (%) 
Patient diagnosis B230 HIV disease 
n (%) 
Dose frequency initiation 
n (%) 
Dose frequency continuation 
n (%) 
Lab orders 
n (%) 
End date of oral lead-in drug 
n (%) 
Date of previous injection 
n (%) 
Physician preferred method of contact 
n (%) 
Patient insurance details 
n (%) 
Prior antiretroviral therapy (ART) regimen 
n (%) 
Duration of prior ART regimen 
n (%) 
History of prior ART failure 
n (%) 
Relevant medical conditions 
n (%) 
Current medication list 
n (%) 
Relevant concomitant medications 
n (%) 
Affirmation of HIV diagnosis 
n (%) 
Other*  
n (%) 
Missing 
n (%) 
11. Who has conducted the 
insurance 
verification/confirmation 
process?1,4 
N=XX 
Myself or my office 
n (%) 
Infusion center  
n (%) 
Both myself or my office and the infusion center 
n (%) 
ViiV Connect (reimbursement hub) 
n (%) 
I do not have knowledge of/not involved in this process. 
(Go to Q19.) 
n (%) 


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I have not referred a patient to the infusion center at 
this time and unable to reflect on the processes 
involved. (Go to Q39.) 
n (%) 
Missing 
n (%) 
12. Have there been any 
challenges with the insurance 
verification/ confirmation 
process for your patients 
referred to the infusion 
center?1,6 
N=XX 
Yes (Go to Q13a.) 
n (%) 
No (Go to Q14.) 
n (%) 
I do not have knowledge of/not involved in this process. 
(Go to Q19.) 
n (%) 
Missing 
n (%) 
12a. If yes, what have the 
challenges been with the 
insurance 
verification/confirmation 
process?3,4 
N=XX 
The insurance verification process has been difficult for 
my office and my staff to manage ourselves. 
n (%) 
The insurance verification process has been difficult for 
my office and my staff to coordinate with the infusion 
center. 
n (%) 
The amount of patient information required by 
insurance plans is burdensome. 
n (%) 
The time required to complete the insurance 
verification process is burdensome. 
n (%) 
I did not receive a communication regarding the status 
of the insurance verification/confirmation process 
being conducted by the infusion center. 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
13. On average, how long has 
the insurance 
verification/confirmation 
process been taking for your 
patients referred to the 
infusion center?1 
N=XX 
<1 business day  
n (%) 
1–2 business days 
n (%) 
3–4 business days 
n (%) 
5–6 business days 
n (%) 
7-10 business days 
n (%) 
11-14 business days 
n (%) 
>14 business days 
n (%) 
I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 
14. How acceptable has the 
insurance 
verification/confirmation 
process been overall for your 
patients referred to the 
infusion center?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 
15. Who has been notifying 
patients about the status of 
N=XX 
Myself or my office  
n (%) 
Infusion center (Go to Q19.) 
n (%) 


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their insurance 
confirmation/verification?1,4 
Both myself/ my office and the infusion center 
n (%) 
I do not have knowledge of/not involved in this process. 
(Go to Q19.) 
n (%) 
Missing 
n (%) 
16. How have patients been 
contacted to relay insurance 
coverage information?3,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Secure electronic medical record message 
n (%) 
In-person discussion 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. 
(Go to Q19.) 
n (%) 
Missing 
n (%) 
17. How acceptable has the 
process been for relaying 
insurance coverage information 
to patients?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 
18. How acceptable has the 
communication been between 
yourself (or your office) and the 
infusion center during the oral 
lead-in phase?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
I do not have knowledge of/not involved in this process. 
n (%) 
Not applicable/none of my patients were on oral lead-in 
n (%) 
Missing 
n (%) 
19. How acceptable has the 
communication via FastFax 
been following the completion 
of a patient appointment?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 


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20. How have you requested to 
be notified about non-urgent 
communications?1,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
I don’t remember 
n (%) 
I haven’t requested a specific method for non-urgent 
communications. 
n (%) 
I have not had any non-urgent communications. (Go to 
Q22.) 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
20a. How acceptable has the 
communication been regarding 
non-urgent communications?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
21. Have you had a situation 
that required an urgent 
communication to you or your 
office from the infusion 
center?1 
 
Yes  
n (%) 
No (Go to Q23.) 
n (%) 
I don’t know (Go to Q23.) 
n (%) 
Missing 
n (%) 
21a. How have you requested 
to be notified about urgent 
communications?1,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
I don’t remember 
n (%) 
I haven’t requested a specific method for urgent 
communications.  
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
21b. How acceptable has the 
communication been regarding 
urgent communications?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 


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Missing 
n (%) 
22. Have you had any referred 
patients with an unplanned 
missed CABENUVA injection 
visit?1 
N=XX 
Yes  
n (%) 
No (Go to Q24.) 
n (%) 
I don’t know (Go to Q24.) 
n (%) 
Missing 
n (%) 
22a. How have you requested 
to be notified about unplanned 
missed CABENUVA injection 
visits?1,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
I don’t remember 
n (%) 
I haven’t requested specific communication about 
missed injection visits. 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
22b. How acceptable has the 
communication been regarding 
unplanned missed CABENUVA 
injection visits?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
23. Have you had any referred 
patients with a planned missed 
CABENUVA injection visit?1 
N=XX 
Yes  
n (%) 
No (Go to Q25.) 
n (%) 
I don’t know (Go to Q25.) 
n (%) 
Missing 
n (%) 
23. How have you requested to 
be notified about planned 
missed CABENUVA injection 
visits?1,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
I don’t remember 
n (%) 
I haven’t requested specific communication about 
planned missed injection visits. 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
23b. How acceptable has the 
communication been regarding 
planned missed CABENUVA 
injection visits?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 


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Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
24. Have you had a patient that 
required oral therapy to cover 
missed doses of CABENUVA?1 
N=XX 
Yes  
n (%) 
No (Go to Q26.) 
n (%) 
I don’t know (Go to Q26.) 
n (%) 
Missing 
n (%) 
24a. How acceptable has the 
communication been regarding 
oral therapy to cover missed 
doses of CABENUVA?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
24b. How acceptable has the 
process been coordinating oral 
therapy between your office 
and the infusion center?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
25. Have you had a patient 
experience an adverse event 
(AE) while receiving CABENUVA 
injections at the infusion 
center?1 
N=XX 
Yes  
n (%) 
No (Go to Q27.) 
n (%) 
I don’t know (Go to Q27.) 
n (%) 
Missing 
n (%) 
25a. How have you requested 
to be notified about 
communications regarding 
AEs?1,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
I don’t remember 
n (%) 
I haven’t requested specific communication about AEs.  
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
25b. How acceptable has the 
communication been regarding 
AEs?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 


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Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
 
26. What is your preferred 
process for managing each of 
the following adverse event 
situations (select one response 
per column): 
26a. Managing mild adverse 
events (i.e., Grade 1-2 injection 
site reactions)1,4 
N=XX 
Infusion center manages the event and notifies 
referring HIV provider 
n (%) 
Infusion center notifies referring HIV provider 
immediately, then manages the event in collaboration 
with HIV provider 
n (%) 
Infusion center notifies referring HIV provider 
immediately, then HIV provider manages the event 
n (%) 
Process may vary depending on the event 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
26. What is your preferred 
process for managing each of 
the following adverse event 
situations (select one response 
per column): 
26b. Managing severe or 
serious adverse events (i.e., a 
vasovagal reaction)1,4 
N=XX 
Infusion center manages the event and notifies 
referring HIV provider 
n (%) 
Infusion center notifies referring HIV provider 
immediately, then manages the event in collaboration 
with HIV provider 
n (%) 
Infusion center notifies referring HIV provider 
immediately, then HIV provider manages the event 
n (%) 
Process may vary depending on the event 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
27. Have you had a patient 
discontinue CABENUVA 
injections at the infusion 
center?1 
N=XX 
Yes  
n (%) 
No (Go to Q29.) 
n (%) 
I don’t know (Go to Q29.) 
n (%) 
Missing 
n (%) 
27a. How have you requested 
to be notified about 
communications regarding 
patient discontinuation of 
CABENUVA?1,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
I don’t remember 
n (%) 
I haven’t requested specific communication about 
patient discontinuation of CABENUVA.  
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
27b. How acceptable has the 
communication been regarding 
patient discontinuation of 
CABENUVA?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 


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Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
28. Have you requested labs to 
be conducted at the infusion 
center on the plan of treatment 
(POT)?1 
N=XX N=XX 
Yes  
n (%) 
No (Go to Q30.) 
n (%) 
I don’t know (Go to Q30.) 
n (%) 
Missing 
n (%) 
28a. What timepoints have you 
requested that labs be done at 
the infusion center?1 
 
 
 
 
 
N=XX 
Every month / at each injection 
n (%) 
Every 2 months  
n (%) 
Every 3 months 
n (%) 
Every 4 months 
n (%) 
Every 6 months 
n (%) 
Yearly 
n (%) 
As needed (i.e., when an adverse event occurs) 
n (%) 
Other*  
 n (%) 
Missing 
n (%) 
28b. How have you requested 
to be notified about 
communications regarding labs 
you may have requested via the 
plan of treatment (POT)?1,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax 
n (%) 
Secure electronic medical record message 
n (%) 
I don’t remember  
n (%) 
I haven’t requested specific communication about labs. 
n (%) 
Other*  
 n (%) 
Missing 
n (%) 
28c. How acceptable has the 
communication been regarding 
labs you may have requested 
via the plan of treatment 
(POT)?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
29. If ad-hoc labs are needed 
(e.g., in the case of an adverse 
event), where do you prefer 
they be done?1,4 
N=XX 
My office or lab affiliated with my office 
n (%) 
Infusion center  
n (%) 
External lab 
n (%) 
Other* 
 n (%) 
N=XX 
Yes  
n (%) 
No (Go to Q32.) 
n (%) 


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30. Have you requested ad-hoc 
labs to be conducted via the 
infusion center?1 
I don’t know (Go to Q32.) 
n (%) 
Missing 
n (%) 
30a. How have you requested 
to be notified about 
communications regarding ad-
hoc labs you may have 
requested?1,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax 
n (%) 
Secure electronic medical record message 
n (%) 
I don’t remember 
n (%) 
I haven’t requested specific communication about ad-
hoc labs.  
n (%) 
Other*  
 n (%) 
Missing 
n (%) 
30b. How acceptable has the 
communication been regarding 
ad-hoc labs you might have 
requested?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
31. How often are you typically 
seeing or expect to see your 
patients who are receiving 
CABENUVA at an infusion 
center?1 
N=XX 
Never/not needed 
n (%) 
Every month  
n (%) 
Every 2 months  
n (%) 
Every 3 months 
n (%) 
Every 4 months 
n (%) 
Every 6 months 
n (%) 
Yearly 
n (%) 
As needed (i.e., when an adverse event occurs) 
n (%) 
Missing 
n (%) 
32. On average, how does this 
compare with the frequency of 
visits for these patients prior to 
starting CABENUVA at an 
infusion center?1 
N=XX 
Much more frequently than before  
n (%) 
More frequently than before  
n (%) 
About the same as before 
n (%) 
Less frequently than before 
n (%) 
Much less frequently than before 
n (%) 
Missing 
n (%) 
33. Overall, how have your 
patients described their 
experiences of receiving 
injections at the infusion 
center?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 


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1 Select one response 
2 Select all that apply 
3 Within each question, where appropriate, response choices will be ordered by percent endorsing, descending, and ties will go in 
order presented to respondents. For items with more than 5 response options, the top 5 selected response options within each 
item at baseline will be bolded in tables for subsequent timepoints 
Abbreviations: AE = adverse event; ART = antiretroviral therapy; HIV = human immunodeficiency virus; POT = plan of treatment 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey at the respective 
timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint. 
Cell percentages do not include missing 
*”Other” responses and open-ended text responses will be presented in an appendix 
 
Table 8.2.2. Expert Panel, Assessment of CABENUVA Administration Moving to Infusion Center, HIV 
Care Providers – Month 6, (N= XX) 
Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
9. Have you submitted a 
referral to the infusion center?1 
N=XX 
Yes (Go Q9a and Q9b.) 
n (%) 
No (Go to Q9c.) 
n (%) 
Missing 
n (%) 
9a. If yes, how acceptable has 
the referral process been?1,2 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
I don’t know/haven’t talked to a patient about their 
experiences. 
n (%) 
Missing 
n (%) 
34. Have your patients 
expressed any concerns about 
stigma at the infusion center?1 
 
 
 
N=XX 
Yes  
n (%) 
No 
n (%) 
Missing 
n (%) 
35. Have your patients 
expressed any concerns about 
privacy at the infusion center?1 
N=XX 
Yes 
n (%) 
No 
n (%) 
Missing 
n (%) 
36. Do you have any other 
thoughts or comments about 
your experiences that you’d like 
to share? Please write in your 
response below. 
N=XX 
Open-ended text* 
 - 
Missing 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
Missing 
n (%) 
9b. If yes, what challenges, if 
any, have you or your staff 
encountered with the referral 
process?2,3,4 
N=XX N=XX 
I/my staff have not encountered any challenges with 
the referral process. [If selecting this option please do 
not select any others and proceed to 9c.] 
n (%) 
It was unclear how to initiate the referral. 
n (%) 
It was unclear when to initiate the referral. 
n (%) 
I/my staff did not know where to find the plan of 
treatment (POT) to initiate the referral process. 
n (%) 
I /my staff was not clear on how to complete the plan 
of treatment (POT) as part of the referral process. 
n (%) 
The plan of treatment (POT) does not provide enough 
information for a referral. 
n (%) 
The plan of treatment (POT) required too much 
information for a referral. 
n (%) 
The process of transferring the information to the 
infusion center was difficult due to technology 
limitations (e.g., too much paperwork to fax).  
n (%) 
I did not know to whom to send the plan of treatment 
(POT) and supporting documentation. 
n (%) 
I was not comfortable faxing the documentation 
required for the referral process. 
n (%) 
I was never informed whether or not my patient was 
eligible to receive CABENUVA injections at the infusion 
center.  
n (%) 
The process to initiate oral cabotegravir and rilpivirine 
was not clear 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
9c. If no, what are the reason(s) 
you have not yet referred a 
patient to the infusion center to 
receive CABENUVA? (Only 
complete this question if you 
have not submitted a referral to 
the infusion center.)2,3,4 
N=XX 
I am not recommending CABENUVA as a treatment 
option for my patients at this time. 
n (%) 
I have not identified a patient that is appropriate for 
receipt of CABENUVA. 
n (%) 
I prefer to administer CABENUVA at my own clinic at 
this time. 
n (%) 
I prefer to administer CABENUVA at my own clinic for 
patients new to CABENUVA prior to referring them to 
the infusion center. 
n (%) 
My patient(s) do not want to receive CABENUVA at an 
infusion center at this time. 
n (%) 
I do not have enough information about the infusion 
centers to recommend it for my patients. 
n (%) 
It was unclear how to initiate the referral. 
n (%) 
It was unclear when to initiate the referral. 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
I/my staff did not know where to find the plan of 
treatment (POT) to initiate the referral process. 
n (%) 
I/my staff was not clear on how to complete the plan 
of treatment (POT) as part of the referral process. 
n (%) 
The plan of treatment (POT) does not provide enough 
information for a referral. 
n (%) 
The plan of treatment (POT) required too much 
information for a referral. 
n (%) 
Other* 
n (%) 
Missing 
n (%) 
10. How likely are you to refer 
(or to continue to refer) 
patients to infusion centers to 
receive CABENUVA?1 
N=XX 
Extremely likely 
n (%) 
Very likely 
n (%) 
Somewhat likely 
n (%) 
Neither likely nor unlikely 
n (%) 
Somewhat unlikely 
n (%) 
Very unlikely 
n (%) 
Extremely unlikely 
n (%) 
Missing 
n (%) 
11. Have you seen the plan of 
treatment (POT) or referral 
form?1,5 
N=XX 
Yes (Go to Q11a.) 
n (%) 
No (Go to Q12.) 
n (%) 
Missing 
n (%) 
11a. Is there anything missing 
from the plan of treatment 
(POT) or referral form?1 
N=XX 
Yes (Go to Q11b.) 
n (%) 
No (Go to Q11c.) 
n (%) 
Missing 
n (%) 
11b. If yes, what is missing from 
the plan of treatment (POT) or 
referral form?3,4 
N=XX 
Place to provide comments to infusion center 
n (%) 
Documentation of my preferences regarding modality 
of urgent communications  
n (%) 
Documentation of my preferences regarding modality 
of non-urgent communications  
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
11c. Is there anything on the 
plan of treatment (POT) or 
referral form that you feel 
should not be included (or is 
not needed) as part of the 
referral process?3,4 
N=XX 
I think that all of the information on the plan of 
treatment (POT) or referral form is needed or should 
be included as part of a referral. [If selecting this 
option please do not select any others.] 
n (%) 
Patient demographic information 
n (%) 
Patient height 
n (%) 
Patient weight 
n (%) 
Allergies 
n (%) 
Patient diagnosis Z21 asymptomatic human 
immunodeficiency virus (HIV) infection status 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
Patient diagnosis B230 HIV disease 
n (%) 
Dose frequency initiation 
n (%) 
Dose frequency continuation 
n (%) 
Lab orders 
n (%) 
End date of oral lead-in drug 
n (%) 
Date of previous injection 
n (%) 
Physician preferred method of contact 
n (%) 
Patient insurance details 
n (%) 
Prior antiretroviral therapy (ART) regimen 
n (%) 
Duration of prior ART regimen 
n (%) 
History of prior ART failure 
n (%) 
Relevant medical conditions 
n (%) 
Current medication list 
n (%) 
Relevant concomitant medications 
n (%) 
Affirmation of HIV diagnosis 
n (%) 
Other*  
n (%) 
Missing 
n (%) 
12. Who has conducted the 
insurance 
verification/confirmation 
process?1,4 
N=XX 
Myself or my office 
n (%) 
Infusion center  
n (%) 
Both myself or my office and the infusion center 
n (%) 
ViiV Connect (reimbursement hub) 
n (%) 
I do not have knowledge of/not involved in this 
process. (Go to Q19.) 
n (%) 
I have not referred a patient to the infusion center at 
this time and unable to reflect on the processes 
involved. (Go to Q39.) 
n (%) 
Missing 
n (%) 
13. Have there been any 
challenges with the insurance 
verification/ confirmation 
process for your patients 
referred to the infusion 
center?1,6 
N=XX 
Yes (Go to Q13a.) 
n (%) 
No (Go to Q14.) 
n (%) 
I do not have knowledge of/not involved in this 
process. (Go to Q19.) 
n (%) 
Missing 
n (%) 
13a. If yes, what have the 
challenges been with the 
insurance 
verification/confirmation 
process?3,4 
N=XX 
The insurance verification process has been difficult 
for my office and my staff to manage ourselves. 
n (%) 
The insurance verification process has been difficult 
for my office and my staff to coordinate with the 
infusion center. 
n (%) 
The amount of patient information required by 
insurance plans is burdensome. 
n (%) 
The time required to complete the insurance 
verification process is burdensome. 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
I did not receive a communication regarding the status 
of the insurance verification/confirmation process 
being conducted by the infusion center. 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
14. On average, how long has 
the insurance 
verification/confirmation 
process been taking for your 
patients referred to the 
infusion center?1 
N=XX 
<1 business day  
n (%) 
1–2 business days 
n (%) 
3–4 business days 
n (%) 
5–6 business days 
n (%) 
7-10 business days 
n (%) 
11-14 business days 
n (%) 
>14 business days 
n (%) 
I do not have knowledge of/not involved in this 
process. 
n (%) 
Missing 
n (%) 
15. How acceptable has the 
insurance 
verification/confirmation 
process been overall for your 
patients referred to the 
infusion center?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
I do not have knowledge of/not involved in this 
process. 
n (%) 
Missing 
n (%) 
16. Who has been notifying 
patients about the status of 
their insurance 
confirmation/verification?1,4 
N=XX 
Myself or my office  
n (%) 
Infusion center (Go to Q19.) 
n (%) 
Both myself/ my office and the infusion center 
n (%) 
I do not have knowledge of/not involved in this 
process. (Go to Q19.) 
n (%) 
Missing 
n (%) 
17. How have patients been 
contacted to relay insurance 
coverage information?3,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Secure electronic medical record message 
n (%) 
In-person discussion 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this 
process. (Go to Q19.) 
n (%) 
Missing 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
18. How acceptable has the 
process been for relaying 
insurance coverage information 
to patients?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
I do not have knowledge of/not involved in this 
process. 
n (%) 
Missing 
n (%) 
19. How acceptable has the 
communication been between 
yourself (or your office) and the 
infusion center during the oral 
lead-in phase?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
I do not have knowledge of/not involved in this 
process. 
n (%) 
Not applicable/none of my patients were on oral lead-
in 
n (%) 
Missing 
n (%) 
20. How acceptable has the 
communication via FastFax 
been following the completion 
of a patient appointment?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
I do not have knowledge of/not involved in this 
process. 
n (%) 
Missing 
n (%) 
21. How have you requested to 
be notified about non-urgent 
communications?1,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
I don’t remember 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
I haven’t requested a specific method for non-urgent 
communications. 
n (%) 
I have not had any non-urgent communications. (Go 
to Q22.) 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
21a. How acceptable has the 
communication been regarding 
non-urgent communications?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
22. Have you had a situation 
that required an urgent 
communication to you or your 
office from the infusion 
center?1 
N=XX 
Yes  
n (%) 
No (Go to Q23.) 
n (%) 
I don’t know (Go to Q23.) 
n (%) 
Missing 
n (%) 
22a. How have you requested 
to be notified about urgent 
communications?1,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
I don’t remember 
n (%) 
I haven’t requested a specific method for urgent 
communications.  
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
22b. How acceptable has the 
communication been regarding 
urgent communications?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
23. Have you had any referred 
patients with an unplanned 
N=XX 
Yes  
n (%) 
No (Go to Q24.) 
n (%) 
I don’t know (Go to Q24.) 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
missed CABENUVA injection 
visit?1 
Missing 
n (%) 
23a. How have you requested 
to be notified about unplanned 
missed CABENUVA injection 
visits?1,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
I don’t remember 
n (%) 
I haven’t requested specific communication about 
missed injection visits. 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
23b. How acceptable has the 
communication been regarding 
unplanned missed CABENUVA 
injection visits?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
24. Have you had any referred 
patients with a planned missed 
CABENUVA injection visit?1 
N=XX 
Yes  
n (%) 
No (Go to Q25.) 
n (%) 
I don’t know (Go to Q25.) 
n (%) 
Missing 
n (%) 
24a. How have you requested 
to be notified about planned 
missed CABENUVA injection 
visits?1,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
I don’t remember 
n (%) 
I haven’t requested specific communication about 
planned missed injection visits. 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
24b. How acceptable has the 
communication been regarding 
planned missed CABENUVA 
injection visits?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
25. Have you had a patient that 
required oral therapy to cover 
missed doses of CABENUVA?1 
N=XX 
Yes  
n (%) 
No (Go to Q26.) 
n (%) 
I don’t know (Go to Q26.) 
n (%) 
Missing 
n (%) 
25a. How acceptable has the 
communication been regarding 
oral therapy to cover missed 
doses of CABENUVA?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
25b. How acceptable has the 
process been coordinating oral 
therapy between your office 
and the infusion center?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
26. Have you had a patient 
experience an adverse event 
(AE) while receiving CABENUVA 
injections at the infusion 
center?1 
N=XX 
Yes  
n (%) 
No (Go to Q27.) 
n (%) 
I don’t know (Go to Q27.) 
n (%) 
Missing 
n (%) 
26a. How have you requested 
to be notified about 
communications regarding 
AEs?1,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
I don’t remember 
n (%) 
I haven’t requested specific communication about 
AEs.  
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
N=XX 
Extremely acceptable 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
26b. How acceptable has the 
communication been regarding 
AEs?1 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
 
 
 
27. What is your preferred 
process for managing each of 
the following adverse event 
situations (select one response 
per column): 
 
27a. Managing mild adverse 
events (i.e., Grade 1-2 injection 
site reactions)1,4 
N=XX 
Infusion center manages the event and notifies 
referring HIV provider 
n (%) 
Infusion center notifies referring HIV provider 
immediately, then manages the event in collaboration 
with HIV provider 
n (%) 
Infusion center notifies referring HIV provider 
immediately, then HIV provider manages the event 
n (%) 
Process may vary depending on the event 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
27. What is your preferred 
process for managing each of 
the following adverse event 
situations (select one response 
per column): 
 
27b. Managing severe or 
serious adverse events (i.e., a 
vasovagal reaction)1,4 
N=XX 
Infusion center manages the event and notifies 
referring HIV provider 
n (%) 
Infusion center notifies referring HIV provider 
immediately, then manages the event in collaboration 
with HIV provider 
n (%) 
Infusion center notifies referring HIV provider 
immediately, then HIV provider manages the event 
n (%) 
Process may vary depending on the event 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
28. Have you had a patient 
discontinue CABENUVA 
injections at the infusion 
center?1 
N=XX 
Yes  
n (%) 
No (Go to Q29.) 
n (%) 
I don’t know (Go to Q29.) 
n (%) 
Missing 
n (%) 
28a. How have you requested 
to be notified about 
communications regarding 
patient discontinuation of 
CABENUVA?1,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
I don’t remember 
n (%) 
I haven’t requested specific communication about 
patient discontinuation of CABENUVA.  
n (%) 
Other* 
 n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
Missing 
n (%) 
28b. How acceptable has the 
communication been regarding 
patient discontinuation of 
CABENUVA?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
29. Have you requested labs to 
be conducted at the infusion 
center on the plan of treatment 
(POT)?1 
N=XX 
Yes  
n (%) 
No (Go to Q30.) 
n (%) 
I don’t know (Go to Q30.) 
n (%) 
Missing 
n (%) 
29a. What timepoints have you 
requested that labs be done at 
the infusion center?1 
N=XX 
Every month / at each injection 
n (%) 
Every 2 months  
n (%) 
Every 3 months 
n (%) 
Every 4 months 
n (%) 
Every 6 months 
n (%) 
Yearly 
n (%) 
As needed (i.e., when an adverse event occurs) 
n (%) 
Other*  
 n (%) 
Missing 
n (%) 
29b. How have you requested 
to be notified about 
communications regarding labs 
you may have requested via the 
plan of treatment (POT)?1,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax 
n (%) 
Secure electronic medical record message 
n (%) 
I don’t remember  
n (%) 
I haven’t requested specific communication about 
labs. 
n (%) 
Other*  
 n (%) 
Missing 
n (%) 
29c. How acceptable has the 
communication been regarding 
labs you may have requested 
via the plan of treatment 
(POT)?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
30. If ad-hoc labs are needed 
(e.g., in the case of an adverse 
event), where do you prefer 
they be done?1,4 
N=XX 
My office or lab affiliated with my office 
n (%) 
Infusion center  
n (%) 
External lab 
n (%) 
Other* 
 n (%) 
31. Have you requested ad-hoc 
labs to be conducted via the 
infusion center?1 
N=XX 
Yes  
n (%) 
No (Go to Q32.) 
n (%) 
I don’t know (Go to Q32.) 
n (%) 
Missing 
n (%) 
31a. How have you requested 
to be notified about 
communications regarding ad-
hoc labs you may have 
requested?1,4 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax 
n (%) 
Secure electronic medical record message 
n (%) 
I don’t remember 
n (%) 
I haven’t requested specific communication about ad-
hoc labs.  
n (%) 
Other*  
 n (%) 
Missing 
n (%) 
31b. How acceptable has the 
communication been regarding 
ad-hoc labs you might have 
requested?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
Missing 
n (%) 
32. How often are you typically 
seeing or expect to see your 
patients who are receiving 
CABENUVA at an infusion 
center?1 
N=XX 
Never/not needed 
n (%) 
Every month  
n (%) 
Every 2 months  
n (%) 
Every 3 months 
n (%) 
Every 4 months 
n (%) 
Every 6 months 
n (%) 
Yearly 
n (%) 
As needed (i.e., when an adverse event occurs) 
n (%) 
Missing 
n (%) 
N=XX 
Much more frequently than before  
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
33. On average, how does this 
compare with the frequency of 
visits for these patients prior to 
starting CABENUVA at an 
infusion center?1 
More frequently than before  
n (%) 
About the same as before 
n (%) 
Less frequently than before 
n (%) 
Much less frequently than before 
n (%) 
Missing 
n (%) 
34. More frequent clinic visits 
due to CABENUVA 
administration (at the infusion 
center) will provide a benefit to 
my patients on this regimen in 
terms of improved medical, 
psychological, and/or social 
health.1 
N=XX 
Strongly disagree  
n (%) 
Disagree 
n (%) 
Somewhat disagree 
n (%) 
Neither agree nor disagree 
n (%) 
Somewhat agree 
n (%) 
Agree 
n (%) 
Strongly agree 
n (%) 
Missing 
n (%) 
35. How much has your ability 
to manage your patients’ health 
changed since they started 
receiving CABENUVA at an 
infusion center?1 
N=XX 
Extremely improved 
n (%) 
Very improved 
n (%) 
Somewhat improved 
n (%) 
No change 
n (%) 
Somewhat worsened 
n (%) 
Very worsened 
n (%) 
Extremely worsened 
n (%) 
Missing 
n (%) 
36. Overall, how have your 
patients described their 
experiences of receiving 
injections at the infusion 
center?1 
N=XX 
Extremely acceptable 
n (%) 
Very acceptable 
n (%) 
Somewhat acceptable 
n (%) 
Neither acceptable nor unacceptable 
n (%) 
Somewhat unacceptable 
n (%) 
Very unacceptable 
n (%) 
Extremely unacceptable 
n (%) 
I don’t know/haven’t talked to a patient about their 
experiences. 
n (%) 
Missing 
n (%) 
37. Have your patients 
expressed any concerns about 
stigma at the infusion center?1 
N=XX 
Yes  
n (%) 
No 
n (%) 
Missing 
n (%) 
38. Have your patients 
expressed any concerns about 
privacy at the infusion center?1 
N=XX 
Yes 
n (%) 
No 
n (%) 
Missing 
n (%) 
N=XX 
Open-ended text* 
 - 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
37a/38a. Please explain the 
situation that led to your 
concerns and any changes you 
made to this patient’s care as a 
result. 
Missing 
n (%) 
44. Do you have any other 
thoughts or comments about 
your experiences that you’d like 
to share? Please write in your 
response below. 
N=XX 
Open-ended text* 
 - 
Missing 
n (%) 
1 Select one response 
2 Select all that apply 
3 Within each question, where appropriate, response choices will be ordered by percent endorsing, descending, and ties will go in 
order presented to respondents. For items with more than 5 response options, the top 5 selected response options within each 
item at baseline will be bolded in tables for subsequent timepoints 
Abbreviations: AE = adverse event; ART = antiretroviral therapy; HIV = human immunodeficiency virus; POT = plan of treatment 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey at the respective 
timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint. 
Cell percentages do not include missing 
*”Other” responses and open-ended text responses will be presented in an appendix 
 
Table 8.2.3. Expert Panel, Impact of CABENUVA Administration Moving to Infusion Center, HIV 
Care Providers – Month 6, (N= XX) 
Item/ Scale 
Number of 
Participants at 
Month 6 
Missing   
Negative 
impact 
No impact 
Positive 
impact 
Unknown/too 
early to tell 
39. Current impact to clinic/ 
healthcare organization 
resourcing and capacity 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
40. Expected future impact to 
clinic/ healthcare 
organization resourcing and 
capacity 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
41. Current financial impact 
to clinic/ healthcare 
organization 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
42. Expected future financial 
impact to clinic/ healthcare 
organization 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
43. If you selected negative 
or positive impact in 
questions 39 through 42, 
please explain the impact 
below. 
Open-ended text* 
Abbreviation: HIV = human immunodeficiency virus 


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NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey at the respective 
timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint. 
*Responses will be presented in an appendixCell percentages do not include missing 
*Responses will be presented in an appendix 
 
 
 


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Table 8.3.1. Expert Panel, Assessment of CABENUVA Administration Moving to Infusion Center, IC 
Staff – Month 3, (N= XX) 
Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
9. How acceptable has the 
referral process been?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
 I do not have knowledge of/not involved in this process. (Go to 
Q10.) 
n (%) 
Missing 
n (%) 
9a. What challenges have you 
or your staff encountered with 
the referral process?2,3 
N=XX 
I have not encountered any challenges with the referral 
process. [If selecting this option please do not select any others 
and proceed to 10.] 
n (%) 
It was unclear how to handle the referral. 
n (%) 
The plan of treatment (POT) submitted to initiate the referral 
process was incomplete. 
n (%) 
The process of transferring the information from the HIV 
providers tone of our infusion centers was difficult due to 
technology limitations (e.g., too much paperwork to fax).  
n (%) 
It was difficult to reach the HIV provider to follow-up on missing 
or incomplete information on the plan of treatment (POT). 
n (%) 
The process of initiating oral cabotegravir and rilpivirine has 
been unclear. 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
10. Is there anything missing 
from the plan of treatment 
(POT)/referral form?1 
N=XX 
 Yes (Go to Q10a.) 
n (%) 
 No (Go to Q10b.) 
n (%) 
 I have not seen the plan of treatment/referral form. (Go to 
Q11.)                         
n (%) 
Missing 
n (%) 
10a. If yes, what is missing 
from the POT/referral form?2,3 
N=XX 
Place to provide comments to infusion center 
n (%) 
Documentation of HIV provider preferences regarding modality 
of urgent communications  
n (%) 
Documentation of HIV provider preferences regarding modality 
of non-urgent communications  
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
10b. Is there anything on the 
plan of treatment (POT) or 
referral for that you feel 
N=XX 
I think that all of the information on the plan of treatment 
(POT) or referral form is needed or should be included as part 
of a referral. 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
should not be included (or is 
not needed) as part of the 
referral process?2,3 
[If selecting this option please do not select any others.] 
n (%) 
Patient demographic information 
n (%) 
Patient height 
n (%) 
Patient weight 
n (%) 
Allergies 
n (%) 
Patient diagnosis Z21 asymptomatic human immunodeficiency 
virus (HIV) infection status 
n (%) 
Patient diagnosis B230 HIV disease 
n (%) 
Dose frequency initiation 
n (%) 
Dose frequency continuation 
n (%) 
Lab orders 
n (%) 
End date of oral lead-in drug 
n (%) 
Date of previous injection 
n (%) 
Physician preferred method of contact 
n (%) 
Patient insurance details 
n (%) 
Prior antiretroviral therapy (ART) regimen 
n (%) 
Duration of prior ART regimen 
n (%) 
History of prior ART failure 
n (%) 
Relevant medical conditions 
n (%) 
Current medication list 
n (%) 
Relevant concomitant medications 
n (%) 
Affirmation of HIV diagnosis 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
11. Who has conducted the 
insurance 
verification/confirmation 
process?1,3 
N=XX 
 Patient’s HIV provider 
n (%) 
 Infusion centers  
n (%) 
 Both the infusion centers and the HIV provider 
n (%) 
 ViiV Connect (reimbursement hub) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go to 
Q18.) 
n (%) 
Missing 
n (%) 
12. Have there been any 
challenges with the insurance 
verification/confirmation 
process?1 
N=XX 
 Yes (Go to Q12a.) 
n (%) 
 No (Go to Q13.) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go to 
Q18.) 
n (%) 
Missing 
n (%) 
12a. If yes, what have the 
challenges been with the 
N=XX 
The insurance verification process has been difficult for our 
infusion centers to manage. 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
insurance 
verification/confirmation 
process?2,3 
The insurance verification process has been difficult for our 
infusion centers to coordinate with the HIV provider’s office 
and/or their staff. 
n (%) 
The amount of patient information required by insurance plans 
is burdensome. 
n (%) 
The time required to complete the insurance verification 
process is burdensome. 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
13. On average, how long has 
the insurance 
verification/confirmation 
process been taking for 
patients referred to receive 
CABENUVA?1 
N=XX 
 <1 business day  
n (%) 
 1–2 business days 
n (%) 
 3–4 business days 
n (%) 
 5–6 business days 
n (%) 
 7-10 business days 
n (%) 
 11-14 business days 
n (%) 
 >14 business days 
n (%) 
 I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 
14. How acceptable has the 
insurance 
verification/confirmation 
process been overall?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
 I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 
15. Who has been notifying 
patients about the status of 
their insurance 
confirmation/verification?1,3 
N=XX 
 Patient’s HIV provider (Go to Q18.) 
n (%) 
 Infusion centers 
n (%) 
 Both the infusion centers and the HIV provider 
n (%) 
 I do not have knowledge of/not involved in this process. (Go to 
Q18.) 
n (%) 
Missing 
n (%) 
16. How have patients been 
contacted to relay insurance 
coverage information?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Secure electronic medical record message 
n (%) 
In-person discussion 
n (%) 
Other* 
 n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
I do not have knowledge of/not involved in this process. (Go to 
Q18.) 
n (%) 
Missing 
n (%) 
17. How acceptable has the 
process been for relaying 
insurance coverage 
information to patients?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
 I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 
18. How acceptable has the 
communication been between 
your infusion centers and the 
HIV providers during the oral 
lead-in phase?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
 I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 
19. How receptive have HIV 
providers been to 
communications via FastFax 
for sharing information 
following th19completion of a 
patient appointment?1 
N=XX 
 Extremely receptive 
n (%) 
 Very receptive 
n (%) 
 Somewhat receptive 
n (%) 
 Neither receptive nor unreceptive 
n (%) 
 Somewhat unreceptive 
n (%) 
 Very unreceptive 
n (%) 
 Extremely unreceptive 
n (%) 
 I do not have knowledge of/not involved in this process. (Go to 
Q20.) 
n (%) 
Missing 
n (%) 
19a. Other than FastFax, what 
other communication 
strategies have your infusion 
centers used to share 
information following the 
completion of a patient 
appointment?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Combination of methods (e.g., phone, text, and/or email) 
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
 n (%) 
I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
20. What are the 
communication preferences 
for HIV providers for non-
urgent communications?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
 n (%) 
I do not have knowledge of/not involved in this process. (Go to 
Q21.) 
n (%) 
Missing 
n (%) 
20a. How acceptable has the 
communication been regarding 
non-urgent communications 
with HIV providers?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
21. Have there been any 
situations that required an 
urgent communication to an 
HIV provider from one of your 
infusion centers?1 
N=XX 
 Yes  
n (%) 
 No (Go to Q22.) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go to 
Q22.) 
n (%) 
Missing 
n (%) 
21a. What are the 
communication preferences 
for HIV providers for urgent 
communications?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. (Go to 
Q22.) 
n (%) 
Missing 
n (%) 
21b. How acceptable has the 
communication been regarding 
urgent communications with 
HIV providers?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
22. Have there been any 
patients with an unplanned 
missed CABENUVA injection 
visit at one of your infusion 
centers?1 
N=XX 
 Yes  
n (%) 
 No (Go to Q23.) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go to 
Q23.) 
n (%) 
Missing 
n (%) 
22a. What are the 
communication preferences 
for HIV providers for 
unplanned missed CABENUVA 
injection visits?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. (Go to 
Q23.) 
n (%) 
Missing 
n (%) 
22b. How acceptable has the 
communication been regarding 
unplanned missed CABENUVA 
injection visits with HIV 
providers?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
23. Have there been any 
patients with a planned missed 
CABENUVA injection visit at 
one of your infusion centers?1 
N=XX 
 Yes  
n (%) 
 No (Go to Q24.) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go to 
Q24.) 
n (%) 
Missing 
n (%) 
23a. What are the 
communication preferences 
for HIV providers about 
planned missed CABENUVA 
injection visits?1,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. (Go to 
Q24.) 
n (%) 
Missing 
n (%) 
23b. How acceptable has the 
communication been regarding 
planned missed CABENUVA 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
injection visits with HIV 
providers?1 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
24. Have any patients required 
oral therapy to cover missed 
doses of CABENUVA?1 
N=XX 
 Yes  
n (%) 
 No (Go to Q25) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go to 
Q25.) 
n (%) 
Missing 
n (%) 
24a. How acceptable has the 
communication been regarding 
oral therapy to cover missed 
doses of CABENUVA between 
the infusion center and the HIV 
providers?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
24b. How acceptable has the 
process been coordinating oral 
therapy between the infusion 
centers and HIV providers?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
25. Have any patients 
experienced an adverse event 
(AE) while receiving CABENUVA 
injections at one of your 
infusion centers?1 
N=XX 
 Yes  
n (%) 
 No (Go to Q26.) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go to 
Q26.) 
n (%) 
 
 
25a. What are the 
communication preferences 
for HIV providers to be notified 
about regarding AEs?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. (Go to 
Q26.) 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
Missing 
n (%) 
25b. How acceptable has the 
communication been regarding 
AEs with HIV providers?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
26. What is your preferred 
process for managing each of 
the following adverse event 
situations (select one response 
per column): 
26a. Managing mild adverse 
events (i.e., Grade 1-2 injection 
site reactions)1,3 
N=XX 
Infusion centers manage the event and notify referring HIV 
provider 
n (%) 
Infusion centers notify referring HIV provider immediately, then 
manage the event in collaboration with HIV provider 
n (%) 
Infusion centers notify referring HIV provider immediately, then 
HIV provider manages the event 
n (%) 
Process may vary depending on the event 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 
 
26. What is your preferred 
process for managing each of 
the following adverse event 
situations (select one response 
per column): 
26b. Managing severe or 
serious adverse events (i.e., a 
vasovagal reaction)1,3 
N=XX 
Infusion centers manage the event and notify referring HIV 
provider 
n (%) 
Infusion centers notify referring HIV provider immediately, then 
manage the event in collaboration with HIV provider 
n (%) 
Infusion centers notify referring HIV provider immediately, then 
HIV provider manages the event 
n (%) 
Process may vary depending on the event 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 
27. Have any patients 
discontinued CABENUVA 
injections at one of your 
infusion centers?1 
N=XX 
 Yes  
n (%) 
 No (Go to Q28.) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go to 
Q28.) 
n (%) 
Missing 
n (%) 
27a. What are the 
communication preferences 
for HIV providers regarding 
patient discontinuation of 
CABENUVA?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
I do not have knowledge of/not involved in this process. (Go to 
Q28.) 
n (%) 
Missing 
n (%) 
27b. How acceptable has the 
communication been regarding 
patient discontinuation of 
CABENUVA with HIV 
providers?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
28. Have HIV providers 
requested labs to be 
conducted via the infusion 
centers on the plan of 
treatment (POT)?1 
N=XX 
 Yes  
n (%) 
 No (Go to Q29.) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go to 
Q29.) 
n (%) 
Missing 
n (%) 
28a. What are the 
communication preferences 
for HIV providers regarding 
labs they may have requested 
via the plan of treatment 
(POT)?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. (Go to 
Q29.) 
n (%) 
Missing 
n (%) 
28b. How acceptable has the 
communication been regarding 
labs the HIV provider may have 
requested via the plan of 
treatment (POT)?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
29. If ad-hoc labs are needed 
(e.g., in the case of an adverse 
event), where do the infusion 
centers prefer they are 
done?1,3 
N=XX 
 HIV provider’s office 
n (%) 
 Infusion centers  
n (%) 
 External lab 
n (%) 
 Other* 
n (%) 
Missing 
n (%) 
N=XX 
 Yes  
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
30. Have HIV providers 
requested ad-hoc labs to be 
conducted at the infusion 
centers?1 
 No (Go to Q31.) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go to 
Q31.) 
n (%) 
Missing 
n (%) 
30a. What are the 
communication preferences 
for HIV providers regarding ad-
hoc labs they may have 
requested?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. (Go to 
Q31.) 
n (%) 
Missing 
n (%) 
30b. How acceptable has the 
communication been regarding 
ad-hoc labs requested by HIV 
providers?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
31. Which format do you 
prefer for the blueprint?2,3 
N=XX 
PowerPoint 
n (%) 
Word document or PDF 
n (%) 
Either format 
n (%) 
Missing 
n (%) 
32. In which format did you 
receive the blueprint?2,3 
N=XX 
PowerPoint 
n (%) 
Either Format 
n (%) 
Word document or PDF 
n (%) 
Missing 
n (%) 
33. How often do you use or 
refer to the blueprint?1 
N=XX 
Extremely often 
n (%) 
Very often 
n (%) 
Somewhat often 
n (%) 
Seldom 
n (%) 
I have never used or referred to the blueprint (skip remaining) 
n (%) 
Missing 
n (%) 
 
 
34. How useful is the 
blueprint?1 
N=XX 
Extremely useful 
n (%) 
Very useful 
n (%) 
Somewhat useful 
n (%) 


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Question 
Number of 
Participants 
at Month 3 
Response 
n (%) 
Neutral 
n (%) 
Not very useful 
n (%) 
Not useful at all 
n (%) 
35. The blueprint contains the 
information I need to 
administer CABENUVA at my 
infusion center.1 
N=XX 
 Strongly agree  
n (%) 
 Agree  
n (%) 
 Neither agree nor disagree  
n (%) 
 Disagree 
n (%) 
 Strongly disagree 
n (%) 
Missing 
n (%) 
36. There is information I need 
for administering CABENUVA in 
my infusion center that is 
missing from the blueprint.1 
N=XX 
Strongly agree (go to 36a) 
n (%) 
Agree (go to 36a) 
n (%) 
Neither agree nor disagree 
n (%) 
Disagree 
n (%) 
Strongly disagree 
n (%) 
Missing 
n (%) 
36a. What do you think is 
missing from the blueprint?1 
N=XX 
Open-ended text* 
n (%) 
Missing 
n (%) 
37. What is your overall 
opinion of the blueprint?1 
 
Extremely positive 
n (%) 
Very positive 
n (%) 
Somewhat positive 
n (%) 
Neutral 
n (%) 
Somewhat negative 
n (%) 
Very negative 
n (%) 
Extremely negative 
n (%) 
Missing 
n (%) 
38. Do you have any other 
thoughts or comments about 
your experiences that you’d 
like to share? Please write in 
your response below. 
N=XX 
Open-ended text* 
n (%) 
Missing 
n (%) 
1 Select one response 
2 Select all that apply 
3 Within each question, where appropriate, response choices will be ordered by percent endorsing, descending, and ties will go in order presented to respondents. For items with more than 5 
response options, the top 5 selected response options within each item at baseline will be bolded in tables for subsequent timepoints 
Abbreviations: AE = adverse event; ART = antiretroviral therapy; HIV = human immunodeficiency virus; POT = plan of treatment 
NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item; Missing % = the number of participants who 
were eligible to complete a survey at the respective timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the respective timepoint. 
Cell percentages do not include missing 
*”Other” responses and open-ended text responses will be presented in an appendix 


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Table 8.3.2. Expert Panel, Assessment of CABENUVA Administration Moving to Infusion Center, IC 
Staff – Month 6, (N= XX) 
Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
9. How acceptable has the 
referral process been?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
 I do not have knowledge of/not involved in this process. (Go 
to Q10.) 
n (%) 
Missing 
n (%) 
9a. What challenges have you 
or your staff encountered with 
the referral process?2,3 
N=XX 
I have not encountered any challenges with the referral 
process. [If selecting this option please do not select any 
others and proceed to 10.] 
n (%) 
It was unclear how to handle the referral. 
n (%) 
The plan of treatment (POT) submitted to initiate the 
referral process was incomplete. 
n (%) 
The process of transferring the information from the HIV 
providers tone of our infusion centers was difficult due to 
technology limitations (e.g., too much paperwork to fax).  
n (%) 
It was difficult to reach the HIV provider to follow-up on 
missing or incomplete information on the plan of treatment 
(POT). 
n (%) 
The process of initiating oral cabotegravir and rilpivirine has 
been unclear. 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
10. Is there anything missing 
from the plan of treatment 
(POT)/referral form?1 
N=XX 
 Yes (Go to Q10a.) 
n (%) 
 No (Go to Q10b.) 
n (%) 
 I have not seen the plan of treatment/referral form. (Go to 
Q11.)                         
n (%) 
Missing 
n (%) 
10a. If yes, what is missing from 
the POT/referral form?2,3 
N=XX 
Place to provide comments to infusion center 
n (%) 
Documentation of HIV provider preferences regarding 
modality of urgent communications  
n (%) 
Documentation of HIV provider preferences regarding 
modality of non-urgent communications  
n (%) 
Other* 
 n (%) 
Missing 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
10b. Is there anything on the 
plan of treatment (POT) or 
referral for that you feel should 
not be included (or is not 
needed) as part of the referral 
process?2,3 
N=XX 
I think that all of the information on the plan of treatment 
(POT) or referral form is needed or should be included as 
part of a referral. 
n (%) 
[If selecting this option please do not select any others.] 
n (%) 
Patient demographic information 
n (%) 
Patient height 
n (%) 
Patient weight 
n (%) 
Allergies 
n (%) 
Patient diagnosis Z21 asymptomatic human 
immunodeficiency virus (HIV) infection status 
n (%) 
Patient diagnosis B230 HIV disease 
n (%) 
Dose frequency initiation 
n (%) 
Dose frequency continuation 
n (%) 
Lab orders 
n (%) 
End date of oral lead-in drug 
n (%) 
Date of previous injection 
n (%) 
Physician preferred method of contact 
n (%) 
Patient insurance details 
n (%) 
Prior antiretroviral therapy (ART) regimen 
n (%) 
Duration of prior ART regimen 
n (%) 
History of prior ART failure 
n (%) 
Relevant medical conditions 
n (%) 
Current medication list 
n (%) 
Relevant concomitant medications 
n (%) 
Affirmation of HIV diagnosis 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
11. Who has conducted the 
insurance 
verification/confirmation 
process?1,3 
N=XX 
 Patient’s HIV provider 
n (%) 
 Infusion centers  
n (%) 
 Both the infusion centers and the HIV provider 
n (%) 
 ViiV Connect (reimbursement hub) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go 
to Q18.) 
n (%) 
Missing 
n (%) 
12. Have there been any 
challenges with the insurance 
verification/confirmation 
process?1 
N=XX 
 Yes (Go to Q12a.) 
n (%) 
 No (Go to Q13.) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go 
to Q18.) 
n (%) 
Missing 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
12a. If yes, what have the 
challenges been with the 
insurance 
verification/confirmation 
process?2,3 
N=XX 
The insurance verification process has been difficult for our 
infusion centers to manage. 
n (%) 
The insurance verification process has been difficult for our 
infusion centers to coordinate with the HIV provider’s office 
and/or their staff. 
n (%) 
The amount of patient information required by insurance 
plans is burdensome. 
n (%) 
The time required to complete the insurance verification 
process is burdensome. 
n (%) 
Other* 
 n (%) 
Missing 
n (%) 
13. On average, how long has 
the insurance 
verification/confirmation 
process been taking for 
patients referred to receive 
CABENUVA?1 
N=XX 
 <1 business day  
n (%) 
 1–2 business days 
n (%) 
 3–4 business days 
n (%) 
 5–6 business days 
n (%) 
 7-10 business days 
n (%) 
 11-14 business days 
n (%) 
 >14 business days 
n (%) 
 I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 
14. How acceptable has the 
insurance 
verification/confirmation 
process been overall?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
 I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 
15. Who has been notifying 
patients about the status of 
their insurance 
confirmation/verification?1,3 
N=XX 
 Patient’s HIV provider (Go to Q18.) 
n (%) 
 Infusion centers 
n (%) 
 Both the infusion centers and the HIV provider 
n (%) 
 I do not have knowledge of/not involved in this process. (Go 
to Q18.) 
n (%) 
Missing 
n (%) 
16. How have patients been 
contacted to relay insurance 
coverage information?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Secure electronic medical record message 
n (%) 
In-person discussion 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
Other* 
 n (%) 
I do not have knowledge of/not involved in this process. (Go 
to Q18.) 
n (%) 
Missing 
n (%) 
17. How acceptable has the 
process been for relaying 
insurance coverage information 
to patients?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
 I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 
18. How acceptable has the 
communication been between 
your infusion centers and the 
HIV providers during the oral 
lead-in phase?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
 I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 
19. How receptive have HIV 
providers been to 
communications via FastFax for 
sharing information following 
th19completion of a patient 
appointment?1 
N=XX 
 Extremely receptive 
n (%) 
 Very receptive 
n (%) 
 Somewhat receptive 
n (%) 
 Neither receptive nor unreceptive 
n (%) 
 Somewhat unreceptive 
n (%) 
 Very unreceptive 
n (%) 
 Extremely unreceptive 
n (%) 
 I do not have knowledge of/not involved in this process. (Go 
to Q20.) 
n (%) 
Missing 
n (%) 
19a. Other than FastFax, what 
other communication 
strategies have your infusion 
centers used to share 
information following the 
completion of a patient 
appointment?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Combination of methods (e.g., phone, text, and/or email) 
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
 n (%) 
I do not have knowledge of/not involved in this process. 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
Missing 
n (%) 
20. What are the 
communication preferences for 
HIV providers for non-urgent 
communications?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
 n (%) 
I do not have knowledge of/not involved in this process. (Go 
to Q21.) 
n (%) 
Missing 
n (%) 
20a. How acceptable has the 
communication been regarding 
non-urgent communications 
with HIV providers?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
21. Have there been any 
situations that required an 
urgent communication to an 
HIV provider from one of your 
infusion centers?1 
N=XX 
 Yes  
n (%) 
 No (Go to Q22.) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go 
to Q22.) 
n (%) 
Missing 
n (%) 
21a. What are the 
communication preferences for 
HIV providers for urgent 
communications?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. (Go 
to Q22.) 
n (%) 
Missing 
n (%) 
21b. How acceptable has the 
communication been regarding 
urgent communications with 
HIV providers?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
Missing 
n (%) 
22. Have there been any 
patients with an unplanned 
missed CABENUVA injection 
visit at one of your infusion 
centers?1 
N=XX 
 Yes  
n (%) 
 No (Go to Q23.) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go 
to Q23.) 
n (%) 
Missing 
n (%) 
22a. What are the 
communication preferences for 
HIV providers for unplanned 
missed CABENUVA injection 
visits?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. (Go 
to Q23.) 
n (%) 
Missing 
n (%) 
22b. How acceptable has the 
communication been regarding 
unplanned missed CABENUVA 
injection visits with HIV 
providers?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
23. Have there been any 
patients with a planned missed 
CABENUVA injection visit at 
one of your infusion centers?1 
N=XX 
 Yes  
n (%) 
 No (Go to Q24.) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go 
to Q24.) 
n (%) 
Missing 
n (%) 
23a. What are the 
communication preferences for 
HIV providers about planned 
missed CABENUVA injection 
visits?1,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. (Go 
to Q24.) 
n (%) 
Missing 
n (%) 
23b. How acceptable has the 
communication been regarding 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
planned missed CABENUVA 
injection visits with HIV 
providers?1 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
24. Have any patients required 
oral therapy to cover missed 
doses of CABENUVA?1 
N=XX 
 Yes  
n (%) 
 No (Go to Q25) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go 
to Q25.) 
n (%) 
Missing 
n (%) 
24a. How acceptable has the 
communication been regarding 
oral therapy to cover missed 
doses of CABENUVA between 
the infusion center and the HIV 
providers?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
24b. How acceptable has the 
process been coordinating oral 
therapy between the infusion 
centers and HIV providers?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
25. Have any patients 
experienced an adverse event 
(AE) while receiving CABENUVA 
injections at one of your 
infusion centers?1 
N=XX 
 Yes  
n (%) 
 No (Go to Q26.) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go 
to Q26.) 
n (%) 
 
 
25a. What are the 
communication preferences for 
HIV providers to be notified 
about regarding AEs?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
I do not have knowledge of/not involved in this process. (Go 
to Q26.) 
n (%) 
Missing 
n (%) 
25b. How acceptable has the 
communication been regarding 
AEs with HIV providers?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
26. What is your preferred 
process for managing each of 
the following adverse event 
situations (select one response 
per column): 
26a. Managing mild adverse 
events (i.e., Grade 1-2 injection 
site reactions)1,3 
N=XX 
Infusion centers manage the event and notify referring HIV 
provider 
n (%) 
Infusion centers notify referring HIV provider immediately, 
then manage the event in collaboration with HIV provider 
n (%) 
Infusion centers notify referring HIV provider immediately, 
then HIV provider manages the event 
n (%) 
Process may vary depending on the event 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 
 
26. What is your preferred 
process for managing each of 
the following adverse event 
situations (select one response 
per column): 
26b. Managing severe or 
serious adverse events (i.e., a 
vasovagal reaction)1,3 
N=XX 
Infusion centers manage the event and notify referring HIV 
provider 
n (%) 
Infusion centers notify referring HIV provider immediately, 
then manage the event in collaboration with HIV provider 
n (%) 
Infusion centers notify referring HIV provider immediately, 
then HIV provider manages the event 
n (%) 
Process may vary depending on the event 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. 
n (%) 
Missing 
n (%) 
27. Have any patients 
discontinued CABENUVA 
injections at one of your 
infusion centers?1 
N=XX 
 Yes  
n (%) 
 No (Go to Q28.) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go 
to Q28.) 
n (%) 
Missing 
n (%) 
27a. What are the 
communication preferences for 
HIV providers regarding patient 
discontinuation of 
CABENUVA?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. (Go 
to Q28.) 
n (%) 
Missing 
n (%) 
27b. How acceptable has the 
communication been regarding 
patient discontinuation of 
CABENUVA with HIV 
providers?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
28. Have HIV providers 
requested labs to be conducted 
via the infusion centers on the 
plan of treatment (POT)?1 
N=XX 
 Yes  
n (%) 
 No (Go to Q29.) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go 
to Q29.) 
n (%) 
Missing 
n (%) 
28a. What are the 
communication preferences for 
HIV providers regarding labs 
they may have requested via 
the plan of treatment (POT)?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. (Go 
to Q29.) 
n (%) 
Missing 
n (%) 
28b. How acceptable has the 
communication been regarding 
labs the HIV provider may have 
requested via the plan of 
treatment (POT)?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
29. If ad-hoc labs are needed 
(e.g., in the case of an adverse 
event), where do the infusion 
centers prefer they are 
done?1,3 
N=XX 
 HIV provider’s office 
n (%) 
 Infusion centers  
n (%) 
 External lab 
n (%) 
 Other* 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
Missing 
n (%) 
30. Have HIV providers 
requested ad-hoc labs to be 
conducted at the infusion 
centers?1 
N=XX 
 Yes  
n (%) 
 No (Go to Q31.) 
n (%) 
 I do not have knowledge of/not involved in this process. (Go 
to Q31.) 
n (%) 
Missing 
n (%) 
30a. What are the 
communication preferences for 
HIV providers regarding ad-hoc 
labs they may have 
requested?2,3 
N=XX 
Phone call 
n (%) 
Text 
n (%) 
Email 
n (%) 
Fax   
n (%) 
Secure electronic medical record message 
n (%) 
Other* 
n (%) 
I do not have knowledge of/not involved in this process. (Go 
to Q31.) 
n (%) 
Missing 
n (%) 
30b. How acceptable has the 
communication been regarding 
ad-hoc labs requested by HIV 
providers?1 
N=XX 
 Extremely acceptable 
n (%) 
 Very acceptable 
n (%) 
 Somewhat acceptable 
n (%) 
 Neither acceptable nor unacceptable 
n (%) 
 Somewhat unacceptable 
n (%) 
 Very unacceptable 
n (%) 
 Extremely unacceptable 
n (%) 
Missing 
n (%) 
31. Which format do you prefer 
for the blueprint?2,3 
N=XX 
PowerPoint 
n (%) 
Word document or PDF 
n (%) 
Either format 
n (%) 
Missing 
n (%) 
32. How often do you use or 
refer to the blueprint?1 
N=XX 
Extremely often 
n (%) 
Very often 
n (%) 
Somewhat often 
n (%) 
Seldom 
n (%) 
I have never used or referred to the blueprint (skip all 
remaining questions). 
n (%) 
Missing 
n (%) 
33. How useful is the 
blueprint?1 
N=XX 
 Extremely useful 
n (%) 
 Very useful 
n (%) 
 Somewhat useful 
n (%) 
 Neutral 
n (%) 
 Not very useful 
n (%) 


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Question 
Number of 
Participants at 
Month 6 
Response 
n (%) 
 Not at all useful 
n (%) 
Missing 
n (%) 
34. The blueprint contains the 
information I need to 
administer CABENUVA at our 
infusion centers.1 
N=XX 
 Strongly agree 
n (%) 
 Agree 
n (%) 
 Neither agree nor disagree  
n (%) 
 Disagree 
n (%) 
 Strongly disagree 
n (%) 
Missing 
n (%) 
35. There is information I need 
for administering CABENUVA in 
our infusion centers that 
should be included in the 
blueprint.1 
N=XX 
 Strongly agree (Go to Q36a.) 
n (%) 
 Agree (Go to Q36a.) 
n (%) 
 Neither agree nor disagree  
n (%) 
 Disagree 
n (%) 
 Strongly disagree 
n (%) 
Missing 
n (%) 
35a. What do you think is 
missing from the blueprint? 
N=XX 
Open-ended text* 
 - 
Missing 
n (%) 
36. Are there any process 
details in the blueprint you 
think should be changed?1 
N=XX 
  Yes (Go to Q37a) 
n (%) 
  No (Go to Q38) 
n (%) 
Missing 
n (%) 
36a. What details do you think 
should be changed? 
N=XX 
Open-ended text* 
 - 
Missing 
n (%) 
37. What is your overall opinion 
of the blueprint?1 
N=XX 
 Extremely positive 
n (%) 
 Very positive 
n (%) 
 Somewhat positive 
n (%) 
 Neutral 
n (%) 
 Somewhat negative 
n (%) 
 Very negative 
n (%) 
 Extremely negative  
n (%) 
Missing 
n (%) 
38. Do you have any other 
thoughts or comments about 
your experiences that you’d 
like to share? Please write in 
your response below. 
N=XX 
Open-ended text* 
- 
Missing 
n (%) 
1 Select one response 
2 Select all that apply 
3 Within each question, where appropriate, response choices will be ordered by percent endorsing, descending, and ties will go in 
order presented to respondents. For items with more than 5 response options, the top 5 selected response options within each 
item at baseline will be bolded in tables for subsequent timepoints 
Abbreviations: AE = adverse event; ART = antiretroviral therapy; HIV = human immunodeficiency virus; POT = plan of treatment 


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NOTE: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not 
complete respective item; Missing % = the number of participants who were eligible to complete a survey at the respective 
timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a survey at the 
respective timepoint. 
Cell percentages do not include missing 
*”Other” responses and open-ended text responses will be presented in an appendix 
 
 
 
Table 9.1. Expert Panel Responding “Agree” or Completely Agree” On All FIM Items at Baseline, 
Month 3, and Month 6: Proportions and Change 
  
Number completing all 
4 FIM items  
Number endorsing  ‘4’ 
or ‘5’ on all FIM Items 
% endorsing all FIM 
Items1 
Percentage Point 
Change2 
Baseline1 
XX 
XX 
XX% 
- 
Month 31 
XX 
XX 
XX% 
- 
Month 61 
XX 
XX 
XX% 
- 
Baseline to Month 32 
XX 
BL=XX; M3=XX 
BL=XX%; M3=XX% 
XX% 
Baseline to Month 62 
XX 
BL=XX; M6=XX 
BL=XX%; M6=XX% 
XX% 
Month 3 to Month 62 
XX 
M3=XX; M6=XX 
M3=XX%; M6=XX% 
XX% 
1For each cross-sectional time point row, numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items 
2Each change row is limited to those completing all 4 items at both respective timepoints; numerator = number responding ‘4’ or ‘5’, 
denominator = number completing all 4 items 
Abbreviations: FIM = Feasibility of Intervention Measure; BL= baseline; M3 = Month 3; M6 = Month 6 
Responses: 4= 
 5= 
. 
Note: Reporting for change includes only those who completed surveys at both respective time points, which may differ from 
reporting at each individual timepoint 
 
Table 9.2. Expert Panel Responding “Agree” or Completely Agree” On All AIM Items at Baseline, 
Month 3, and Month 6: Proportions and Change 
  
Number completing all 
4 AIM items  
Number endorsing  ‘4’ 
or ‘5’ on all AIM Items 
% endorsing all AIM 
Items1 
Percentage Point 
Change2 
Baseline1 
XX 
XX 
XX% 
- 
Month 31 
XX 
XX 
XX% 
- 
Month 61 
XX 
XX 
XX% 
- 
Baseline to Month 32 
XX 
BL=XX; M3=XX 
BL=XX%; M3=XX% 
XX% 
Baseline to Month 62 
XX 
BL=XX; M6=XX 
BL=XX%; M6=XX% 
XX% 
Month 3 to Month 62 
XX 
M3=XX; M6=XX 
M3=XX%; M6=XX% 
XX% 
1For each cross-sectional time point row, numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items 
2Each change row is limited to those completing all 4 items at both respective timepoints; numerator = number responding ‘4’ or ‘5’, 
denominator = number completing all 4 items 
Abbreviations: AIM = Acceptability of Intervention Measure; BL=baseline; M3 = Month 3; M6 = Month 6 
Responses: 4= 
 5= 
  
Note: Reporting for change includes only those who completed surveys at both respective time points, which may differ from 
reporting at each individual timepoint 
 
CCI
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Table 10.1. Expert Panel, Distributional Characteristics of Feasibility of Intervention Measure (FIM), N=XX 
Item 
Time 
Point 
Number of 
Participants  
Missing  
Mean 
SD 
Median 
(Q1, Q3) 
Range 
(Max ,Min) 
Percent 
Missing 
Percent 
Floor 
Percent 
Ceiling 
95% CI 
(Lower, Upper) 
FIM Mean Score 
BL 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.XX) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.XXX, X.XXX) 
M3 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.XXX, X.XXX) 
M6 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.XXX, X.XXX) 
FIM Q1 
BL 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M3 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M6 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
FIM Q2 
BL 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M3 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M6 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
FIM Q3 
BL 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M3 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M6 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
FIM Q4 
BL 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M3 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M6 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
Abbreviations: BL= Baseline; CI = confidence interval; FIM = Feasibility of Intervention Measure; M3 = Month 3; M6 = Month 6; SD = standard deviation 
Percent Floor for the mean score is the percent of respondents with a score of 1 
 out of all respondents replying to at least two FIM items at a given time point. 
Percent Ceiling for the mean score is the percent of respondents with a score of 5 
 out of all respondents replying to at least two FIM items at a given time point. 
NOTE 1: FIM item wording differed by the position of the expert panel member. The FIM items presented to HIV care providers/ clinical staff were as follows: 1. Infusion Center 
administered CABENUVA seems implementable for the patients in our clinic/practice; 2. Infusion Center administered CABENUVA seems possible for the patients in our 
clinic/practice; 3. Infusion Center administered CABENUVA seems doable for the patients in our clinic/practice; 4. Infusion Center administered CABENUVA seems easy to 
implement for the patients in our clinic/practice. The FIM items presented to IC Staff were as follows: 1. Administering CABENUVA seems implementable in my infusion center; 2. 
Administering CABENUVA seems possible in my infusion center; 3. Administering CABENUVA seems doable in my infusion center; 4. Administering CABENUVA seems easy to 
implement in my infusion center. 
NOTE 2: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item. Missing for the mean score 
counts any instance where a respondent completed one FIM item, not reaching the minimum of 2 items required to calculate a mean FIM score 
Cell percentages do not include missing 
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Table 10.2. Expert Panel, Distributional Characteristics of Acceptability of Intervention Measure (AIM), N=XX 
Item 
Time 
Point 
Number of 
Participants  
Missing  
Mean 
SD 
Median 
(Q1, Q3) 
Range 
(Max ,Min) 
Percent 
Missing 
Percent 
Floor 
Percent 
Ceiling 
95% CI 
(Lower, Upper) 
AIM Mean 
Score 
BL 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.XX) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.XXX, X.XXX) 
M3 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.XXX, X.XXX) 
M6 
XX 
XX 
X.XX 
X.XXX 
X.XX (X.XX, X.X) 
(X.X, X.X) 
XX% 
XX% 
XX% 
(X.XXX, X.XXX) 
AIM Q1 
BL 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M3 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M6 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
AIM Q2 
BL 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M3 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M6 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
AIM Q3 
BL 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M3 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M6 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
AIM Q4 
BL 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M3 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
M6 
XX 
XX 
X.X 
X.XX 
X.X (X.X, X.X) 
(X, X) 
XX% 
XX% 
XX% 
(X.XX, X.XX) 
Abbreviations: BL= Baseline; CI = confidence interval; AIM = Acceptability of Intervention Measure; M3 = Month 3; M6 = Month 6; SD = standard deviation 
Percent Floor for the mean score is the percent of respondents with a score of 1 
 out of all respondents replying to at least two AIM items at a given time point. 
Percent Ceiling for the mean score is the percent of respondents with a score of 5 
 out of all respondents replying to at least two AIM items at a given time point. 
NOTE 1: NOTE: AIM item wording differed by the position of the expert panel member. The AIM items presented to HIV care providers/ clinical staff were as follows: 1. The idea of 
an infusion center providing CABENUVA meets my approval; 2. The idea of an infusion center providing CABENUVA is appealing to me; 3. I like the idea of an infusion center 
providing CABENUVA for PLWHIV in our clinic/practice; 4. I welcome an infusion center providing CABENUVA for patients in our clinic/practice. The AIM items presented to IC Staff 
were as follows: 1. The idea of providing CABENUVA at my infusion center meets my approval; 2. The idea of providing CABENUVA at my infusion center is appealing to me; 3. I like 
the idea of providing CABENUVA for PLWHIV in my infusion center; 4. I welcome providing CABENUVA for PLWHIV in my infusion center. 
NOTE 2: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item 
Cell percentages do not include missing 
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Table 11.1. Expert Panel, Univariate Distribution of Feasibility of Intervention Measure (FIM), N=XX 
Items 
Time Point 
Number of 
Participants 
Missing 
Completely 
disagree 
Disagree 
Neither agree 
nor disagree 
Agree 
Completely 
agree 
FIM Q1 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M6 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
FIM Q2 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M6 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
FIM Q3 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M6 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
FIM Q4 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M6 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
Abbreviations: BL = Baseline; M3 = Month 3; M6 = Month 6 
NOTE 1: FIM item wording differed by the position of the expert panel member. The FIM items presented to HIV care providers/ clinical staff were as follows: 1. Infusion Center 
administered CABENUVA seems implementable for the patients in our clinic/practice; 2. Infusion Center administered CABENUVA seems possible for the patients in our 
clinic/practice; 3. Infusion Center administered CABENUVA seems doable for the patients in our clinic/practice; 4. Infusion Center administered CABENUVA seems easy to 
implement for the patients in our clinic/practice. The FIM items presented to IC Staff were as follows: 1. Administering CABENUVA seems implementable in my infusion center; 2. 
Administering CABENUVA seems possible in my infusion center; 3. Administering CABENUVA seems doable in my infusion center; 4. Administering CABENUVA seems easy to 
implement in my infusion center. 
NOTE 2: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item 
Cell percentages do not include missing 
 


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Table 11.2. Expert Panel, Univariate Distribution of Acceptability of Intervention Measure (AIM), N=XX 
Items 
Time Point 
Number of 
Participants 
Missing 
Completely 
disagree 
Disagree 
Neither agree 
nor disagree 
Agree 
Completely 
agree 
AIM Q1 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M6 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
AIM Q2 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M6 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
AIM Q3 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M6 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
AIM Q4 
BL 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M3 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
M6 
XX 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
Abbreviations: BL = Baseline; M3 = Month 3; M6 = Month 6; PLWHIV = participants living with human immunodeficiency virus 
NOTE 1: AIM item wording differed by the position of the expert panel member. The AIM items presented to HIV care providers/ clinical staff were as follows: 1. The idea of an 
infusion center providing CABENUVA meets my approval; 2. The idea of an infusion center providing CABENUVA is appealing to me; 3. I like the idea of an infusion center providing 
CABENUVA for PLWHIV in our clinic/practice; 4. I welcome an infusion center providing CABENUVA for patients in our clinic/practice. The AIM items presented to IC Staff were as 
follows: 1. The idea of providing CABENUVA at my infusion center meets my approval; 2. The idea of providing CABENUVA at my infusion center is appealing to me; 3. I like the 
idea of providing CABENUVA for PLWHIV in my infusion center; 4. I welcome providing CABENUVA for PLWHIV in my infusion center. 
NOTE 2: Missing = the number of participants who are eligible to complete a survey at the respective timepoint but did not complete respective item; Missing % = the number of 
participants who were eligible to complete a survey at the respective timepoint but did NOT complete the respective item / the number of people who were eligible to fill out a 
survey at the respective timepoint. 
Cell percentages do not include missing 
 


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Table 12.1. Expert Panel, Distributional Characteristics of Change in Feasibility of Intervention Measure (FIM), N=XX 
Item 
Time Point 
Number of 
Participants1 
Missing 
Mean Change 
SD 
Median 
(Q1, Q3) 
Range 
(Min, Max) 
95% CI 
(Lower, Upper) 
FIM Mean Score 
BL to M3 
XX 
XX 
X.XXX 
X.XXX 
X.XX (X.XX, X.XX) 
(X.X, X.X) 
(X.XXX, X.XXX) 
BL to M6 
XX 
XX 
X.XXX 
X.XXX 
X.XX (X.XX, X.XX) 
(X.X, X.X) 
(X.XXX, X.XXX) 
M3 to M6 
XX 
XX 
X.XXX 
X.XXX 
X.XX (X.XX, X.XX) 
(X.X, X.X) 
(X.XXX, X.XXX) 
FIM Q1 
BL to M3 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
BL to M6 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
M3 to M6 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
FIM Q2 
BL to M3 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
BL to M6 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
M3 to M6 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
FIM Q3 
BL to M3 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
BL to M6 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
M3 to M6 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
FIM Q4 
BL to M3 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
BL to M6 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
M3 to M6 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
1Only includes Expert Panel who completed surveys at respective months 
Abbreviations: FIM = Feasibility of Intervention Measure; BL= Baseline; CI = confidence interval; M3 = Month 3; M6 = Month 6; PLWHIV = participants living with human 
immunodeficiency virus; SD = standard deviation 
NOTE 1: FIM item wording differed by the position of the expert panel member. The FIM items presented to HIV care providers/ clinical staff were as follows: 1. Infusion Center 
administered CABENUVA seems implementable for the patients in our clinic/practice; 2. Infusion Center administered CABENUVA seems possible for the patients in our 
clinic/practice; 3. Infusion Center administered CABENUVA seems doable for the patients in our clinic/practice; 4. Infusion Center administered CABENUVA seems easy to 
implement for the patients in our clinic/practice. The FIM items presented to IC Staff were as follows: 1. Administering CABENUVA seems implementable in my infusion center; 2. 
Administering CABENUVA seems possible in my infusion center; 3. Administering CABENUVA seems doable in my infusion center; 4. Administering CABENUVA seems easy to 
implement in my infusion center. 
NOTE 2: Missing for individual item counts = the number of participants who were eligible to complete a survey at the respective timepoint but did not complete respective item. 
Cell percentages do not include missing 


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Table 12.2. Expert Panel, Distributional Characteristics of Change in Acceptability of Intervention Measure (AIM), N=XX 
Item 
Time Point 
Number of 
Participants1 
Missing 
Mean Change 
SD 
Median 
(Q1, Q3) 
Range  
(Max - Min) 
95% CI 
Lower-Upper 
AIM Mean Score 
BL to M3 
XX 
XX 
X.XXX 
X.XXX 
X.XX (X.XX, X.XX) 
(X.X, X.X) 
(X.XXX, X.XXX) 
BL to M6 
XX 
XX 
X.XXX 
X.XXX 
X.XX (X.XX, X.XX) 
(X.X, X.X) 
(X.XXX, X.XXX) 
M3 to M6 
XX 
XX 
X.XXX 
X.XXX 
X.XX (X.XX, X.XX) 
(X.X, X.X) 
(X.XXX, X.XXX) 
AIM Q1 
BL to M3 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
BL to M6 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
M3 to M6 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
AIM Q2 
BL to M3 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
BL to M6 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
M3 to M6 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
AIM Q3 
BL to M3 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
BL to M6 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
M3 to M6 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
AIM Q4 
BL to M3 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
BL to M6 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
M3 to M6 
XX 
XX 
X.XX 
X.XX 
XX (X.X, X.X) 
(X, X) 
(X.XX, X.XX) 
1Only includes Expert Panel who completed surveys at respective months 
Abbreviations: AIM = Acceptability of Intervention Measure; BL= Baseline; CI = confidence interval; M3 = Month 3; M6 = Month 6; PLWHIV = participants living with human immunodeficiency virus; SD = 
standard deviation 
NOTE 1: AIM item wording differed by the position of the expert panel member. The AIM items presented to HIV care providers/ clinical staff were as follows: 1. The idea of an infusion center providing 
CABENUVA meets my approval; 2. The idea of an infusion center providing CABENUVA is appealing to me; 3. I like the idea of an infusion center providing CABENUVA for PLWHIV in our clinic/practice; 4. 
I welcome an infusion center providing CABENUVA for patients in our clinic/practice. The AIM items presented to IC Staff were as follows: 1. The idea of providing CABENUVA at my infusion center 
meets my approval; 2. The idea of providing CABENUVA at my infusion center is appealing to me; 3. I like the idea of providing CABENUVA for PLWHIV in my infusion center; 4. I welcome providing 
CABENUVA for PLWHIV in my infusion center. 
NOTE 2: Missing for individual item counts = the number of participants who were eligible to complete a survey at the respective timepoint but did not complete respective item. 
Cell percentages do not include missing 


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Table 13.1. Expert Panel, Shift of Feasibility of Intervention Measure (FIM) Response Frequency by 
item, N=XX  
1.FIM Q1 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
6 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
6 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
2.FIM Q2 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
6 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
6 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
3.FIM Q3 


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Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
6 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3 
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
6 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
4.FIM Q4 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 


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Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
Missing1 
(N=XX) 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
6 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3 
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
6 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
1Missing at T1, completed at T2 
2Missing at T2, completed at T1 
Abbreviations: FIM = Feasibility of Intervention Measure 
Percentage calculations: 
Non-missing cell %: 
numerator = number selecting respective combination of Time 1 and Time 2 responses 
denominator = number of participants responding within Time 1 response category at Time 1 
at T1 


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Table 13.2. Expert Panel, Shift of Acceptability of Intervention Measure (AIM) Response  
1.AIM Q1 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3 
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
6 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 


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Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
2.AIM Q2 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
6 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
6 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
3.AIM Q3 


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Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 
Missing1 
(N=XX) 
Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
6 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 3  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
6 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
4.AIM Q4 
  
Baseline  
Completely  
Disagree 
Neither 
Agree 
Completely 


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Disagree 
N=(XX) 
agree nor 
(N=XX) 
Agree 
Missing1 
(N=XX) 
N=(XX)  
  
disagree 
  
(N=XX) 
  
  
N=(XX) 
  
  
Month 
3 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
  
  
  
  
  
  
  
Month 
6 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
  
Month 4  
Completely 
Disagree 
Neither 
Agree 
Completely 
  
Disagree 
N=(xx) 
agree nor 
(N=xx) 
Agree 
  
N=(xx) 
  
disagree 
  
(N=xx) 
Missing 
(N=XX) 
  
  
N=(xx) 
  
  
  
Month 
8 
Completely  
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Neither agree  
nor disagree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Completely  
Agree (N=XX) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
Missing2 (N=XX) 
n(%)  
n(%) 
n(%) 
n(%) 
n(%) 
n(%) 
1Missing at T1, completed at T2 
2Missing at T2, completed at T1 
Abbreviations: FIM = Feasibility of Intervention Measure 
Percentage calculations: 
Non-missing cell %: 
numerator = number selecting respective combination of Time 1 and Time 2 responses 
denominator = number of participants responding within Time 1 response category at Time 1 
 


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Table 14. Implementation Science-Related Protocol Deviations 
Protocol Deviation 
IS-related Protocol Deviations Reported for Expert Panel 
n(%) 
IS-related Protocol Deviations 
  
Placeholder sub-category 1 
  
Placeholder sub-category 2 
  
Placeholder sub-category 3 
  
1 Deviations associated with incomplete IS questionnaires are for those initiated but not completed 
Note: Numerators equal the number of expert panel members experiencing respective deviation type, denominators equal the number of expert panel members in ana
 
 
 
 
 
 
 
 
 
8 Figures 
Figure 1. Bar Chart Showing Mean HIV Care Providers/Clinical Staff FIM and AIM Responses at 
Baseline, Month 4 and Month 8 
 
Abbreviations: FIM = Feasibility of Intervention Measure; AIM = Acceptability of Intervention Measure; BL=baseline; M4 = Month 
4; M8 = Month 8 
Error Bars = Standard error 
0
1
2
3
4
5
Mean FIM
Mean AIM
Mean Response
BL
M4
M8


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Figure 2. Bar chart showing proportion of HIV Care Providers/Clinical Staff Responding “Agree” or 
Completely Agree” On All FIM Items at Baseline, Month 4, and Month 8 
 
Abbreviations: FIM = Feasibility of Intervention Measure; BL=baseline; M4 = Month 4; M8 = Month 8 
Responses: 4=
 5=
 
For each time point, numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items 
Error Bars = Standard error 
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
BL
M4
M8
% Responding 4 or 5
CCI
CCI


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Figure 3. Bar chart showing proportion of HIV Care Providers/Clinical Staff Responding “Agree” or 
Completely Agree” On All AIM Items at Baseline, Month 4, and Month 8 
 
Abbreviations: FIM = Feasibility of Intervention Measure; BL=baseline; M4 = Month 4; M8 = Month 8 
Responses: 4=
 5=
 
For each time point, numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items 
Error Bars = Standard error 
Figure 4. Bar chart showing change in Proportion of HIV Care Providers/Clinical Staff Responding 
“Agree” or Completely Agree” On All FIM Items, Baseline to Month 4, Baseline to Month 
8, and Month 4 to Month 8   
 
Abbreviations: FIM = Feasibility of Intervention Measure; BL=baseline; M4 = Month 4; M8 = Month 8 
Responses: 4=
 5=
 
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
BL
M4
M8
% Responding 4 or 5
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
BL to M4
BL to M8
M4 to M8
Change in Responding 4 or 5, 
Percentage Points
CCI
CCI
CCI
CCI


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Note: Reporting for change includes only those who completed surveys at both respective time points, which may differ from 
reporting at each individual timepoint. Each change row is limited to those completing all 4 items at both respective timepoints; 
numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items 
Error Bars = Standard error 
 
 
Figure 5. Bar chart showing change in Proportion of HIV Care Providers/Clinical Staff Responding 
“Agree” or Completely Agree” On All AIM Items, Baseline to Month 4, Baseline to 
Month 8, and Month 4 to Month 8 
 
Abbreviations: FIM = Feasibility of Intervention Measure; BL=baseline; M4 = Month 4; M8 = Month 8 
Responses: 4=
, 5=
 
Note: Reporting for change includes only those who completed surveys at both respective time points, which may differ from 
reporting at each individual timepoint. Each change row is limited to those completing all 4 items at both respective timepoints; 
numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items 
Error Bars = Standard error 
 
 
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
BL to M4
BL to M8
M4 to M8
Change in Responding 4 or 5, 
Percentage Points
CCI
CCI


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Figure 6. Bar Chart Showing Mean Expert Panel FIM and AIM Responses at Baseline, Month 3, and 
Month 6 
 
Abbreviations: FIM = Feasibility of Intervention Measure; AIM = Acceptability of Intervention Measure; BL=baseline; M3 = Month 
3; M6 = Month 6 
Error Bars = Standard error 
 
 
 
 
0
1
2
3
4
5
Mean FIM
Mean AIM
Mean Response
BL
M3
M6


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Figure 7. Bar chart showing proportion of Expert Panel Responding “Agree” or Completely Agree” 
On All FIM Items at Baseline, Month 3, and Month 6 
 
Abbreviations: FIM = Feasibility of Intervention Measure; BL=baseline; M3 = Month 3; M6 = Month 6 
Responses: 4=
, 5=
 
For each time point, numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items 
Error Bars = Standard error 
 
Figure 8. Bar chart showing proportion of Expert Panel Responding “Agree” or Completely Agree” 
On All AIM Items at Baseline, Month 3, and Month 6 
 
Abbreviations: FIM = Feasibility of Intervention Measure; BL=baseline; M3 = Month 3; M6 = Month 6 
Responses: 4=
, 5=
 
For each time point, numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items 
Error Bars = Standard error 
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
BL
M3
M6
% Responding 4 or 5
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
BL
M3
M6
% Responding 4 or 5
CCI
CCI
CCI
CCI


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Figure 9. Bar chart showing change in Proportion of Expert Panel Responding “Agree” or 
Completely Agree” On All FIM Items, Baseline to Month 3, Baseline to Month 6, and 
Month 3 to Month 6   
 
Abbreviations: FIM = Feasibility of Intervention Measure; BL=baseline; M3 = Month 3; M6 = Month 6 
Responses: 4=
 5=
 
Note: Reporting for change includes only those who completed surveys at both respective time points, which may differ from 
reporting at each individual timepoint. Each change row is limited to those completing all 4 items at both respective timepoints; 
numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items 
Error Bars = Standard error 
 
 
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
BL to M3
BL to M6
M3 to M6
Change in Responding 4 or 5, 
Percentage Points
CCI
CCI


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Figure 10. Bar chart showing change in Proportion of Expert Panel Responding “Agree” or 
Completely Agree” On All AIM Items, Baseline to Month 3, Baseline to Month 6, and 
Month 3 to Month 6 
 
Abbreviations: FIM = Feasibility of Intervention Measure; BL=baseline; M3 = Month 3; M6 = Month 6 
Responses: 4=
 5=
 
Note: Reporting for change includes only those who completed surveys at both respective time points, which may differ from 
reporting at each individual timepoint. Each change row is limited to those completing all 4 items at both respective timepoints; 
numerator = number responding ‘4’ or ‘5’, denominator = number completing all 4 items 
Error Bars = Standard error 
 
 
 
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
BL to M3
BL to M6
M3 to M6
Change in Responding 4 or 5, 
Percentage Points
CCI
CCI


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Appendix A. Missing Data 
Table A1. Summary of Missing Data, HCP Providers/Clinical Staff 
Timepoint 
Item 
Completed n(%) 
Missing n(%) 
Baseline 
N=XX 
FIM Item 1 
n (%) 
n (%) 
FIM Item 2 
n (%) 
n (%) 
FIM Item 3 
n (%) 
n (%) 
FIM Item 4 
n (%) 
n (%) 
AIM  Item 1 
n (%) 
n (%) 
AIM Item 2 
n (%) 
n (%) 
AIM Item 3 
n (%) 
n (%) 
AIM Item 4 
n (%) 
n (%) 
Month 4 
N=XX 
FIM Item 1 
n (%) 
n (%) 
FIM Item 2 
n (%) 
n (%) 
FIM Item 3 
n (%) 
n (%) 
FIM Item 4 
n (%) 
n (%) 
AIM  Item 1 
n (%) 
n (%) 
AIM Item 2 
n (%) 
n (%) 
AIM Item 3 
n (%) 
n (%) 
AIM Item 4 
n (%) 
n (%) 
Month 8 
N=XX 
FIM Item 1 
n (%) 
n (%) 
FIM Item 2 
n (%) 
n (%) 
FIM Item 3 
n (%) 
n (%) 
FIM Item 4 
n (%) 
n (%) 
AIM Item 1 
n (%) 
n (%) 
AIM Item 2 
n (%) 
n (%) 
AIM Item 3 
n (%) 
n (%) 
AIM Item 4 
n (%) 
n (%) 
Abbreviations: AIM = Acceptability of Intervention Measure; FIM = Feasibility of Intervention Measure 
 
Table A2. Summary of Free-text Responses, HIV Care Provider/Clinical Staff 
 
 
 


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Table A3. Summary of Missing Data, Expert Panel 
Timepoint 
Item 
Completed n(%) 
Missing n(%) 
Baseline 
N=XX 
FIM Item 1 
n (%) 
n (%) 
FIM Item 2 
n (%) 
n (%) 
FIM Item 3 
n (%) 
n (%) 
FIM Item 4 
n (%) 
n (%) 
AIM Item 1 
n (%) 
n (%) 
AIM Item 2 
n (%) 
n (%) 
AIM Item 3 
n (%) 
n (%) 
AIM Item 4 
n (%) 
n (%) 
Month 3 
N=XX 
FIM Item 1 
n (%) 
n (%) 
FIM Item 2 
n (%) 
n (%) 
FIM Item 3 
n (%) 
n (%) 
FIM Item 4 
n (%) 
n (%) 
AIM Item 1 
n (%) 
n (%) 
AIM Item 2 
n (%) 
n (%) 
AIM Item 3 
n (%) 
n (%) 
AIM Item 4 
n (%) 
n (%) 
Month 6 
N=XX 
FIM Item 1 
n (%) 
n (%) 
FIM Item 2 
n (%) 
n (%) 
FIM Item 3 
n (%) 
n (%) 
FIM Item 4 
n (%) 
n (%) 
AIM Item 1 
n (%) 
n (%) 
AIM Item 2 
n (%) 
n (%) 
AIM Item 3 
n (%) 
n (%) 
AIM Item 4 
n (%) 
n (%) 
Abbreviations: AIM = Acceptability of Intervention Measure; FIM = Feasibility of Intervention Measure 
 
Table A4. Summary of Free-text Responses, Expert Panel