AURORA Study-A Transformative Approach Utilizing Behavioral Economics, Education, and Data Science to Support Patients Initiating PrEP With Retention-in-care and Medication Persistence
Conditions: HIV Infections
Sponsor: WV Health Right, Inc.

 
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PrEP Protocol Outline 
 
August 30, 2023 
 
AURORA Study-A Transformative Approach Utilizing Behavioral Economics, Education, and Data 
Science to Support Patients Initiating PrEP with Retention-in-care and Medication Persistence 
 
Cover Page with signature page 
 
Protocol Team 
W. David Hardy, MD, AAHIVS (Principal Investigator) 
Adjunct Clinical Professor of Medicine 
Division of Infectious Diseases 
Keck School of Medicine of USC 
 
Angie Settle, DNP, APRN,BC, FNP 
CEO, WV Health Right 
 
 
Kelly Pillinger, PharmD, BCPS, BCIDP 
PRIME Education, LLC 
 
 
Jeffrey Carter, PhD 
PRIME Education, LLC 
 
 
 
 
 
 
 
 
 

 
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List of Abbreviations 
 CAB-LA - Long-Acting Injectable Cabotegravir  
 EHR – Electronic Health Record  
 FTC – Emtricitabine 
 TDF – Tenofovir disoproxil 
 TAF - Tenofovir alafenamide 
 HCP – Health Care Provider  
 HIV – Human Immunodeficiency Virus  
 PrEP – Pre-Exposure Prophylaxis  
 PROs – Patient Reported Outcomes 
 PWID – Persons who inject drugs   
 WVHR – West Virginia Health Right  
1. PROTOCOL SUMMARY 
Title 
A Transformative Approach Utilizing Behavioral Economics, Education, 
and Data Science to Support Patients Initiating PrEP with Retention-in-
care and Medication Adherence and Persistence 
Funder 
ViiV Healthcare  
Study Design 
Observational Cohort Study  
Study Population 
Patients >18 y/o who are newly started on PrEP at WVHR and have 
access to a smart phone with data.  
Study Size 
n = 105 (70 CAB-LA injection participants and 
35 oral PrEP participants)  

 
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Study Duration 
12 months  
Study Site(s) 
West Virginia Health Right  
Intervention 
Description 
Participants will have been prescribed CAB-LA, daily FTC/TDF, or daily 
FTC/TAF in accordance with the WVHR standard of care by a licensed 
HCP prior to enrolling in the study. Those receiving CAB-LA will be in 
one arm and those receiving oral PrEP will be in the other arm of the 
study.  
Study Aim 
To determine the persistence of injectable PrEP compared to oral PrEP   
Primary Objectives  To evaluate medication persistence in patients receiving CAB-LA 
injections vs oral PrEP and who engage with a digital health 
companion program 
Secondary 
Objective 1 
Evaluate retention-in-care in patients receiving CAB-LA vs oral 
PrEP 
Secondary 
Objective 2 
Evaluate PROs (including PrEP medication satisfaction, PrEP 
acceptance, PrEP-Related Stigma, and reasons for PrEP 
discontinuation) in patients receiving CAB-LA vs oral PrEP 
Secondary 
Objective 3 
Evaluate the acceptability, appropriateness, and helpfulness of a 
digital health companion program for PrEP 
Secondary 
Objective 4 
Evaluate the acceptability, barriers to, and facilitators for 
implementation of CAB-LA PrEP 
 
2. INTRODUCTION 
2.1. Background 
2.1.1. Numerous studies have found that medication persistence with oral PrEP (defined 
as continued use of PrEP over time) tends to be short, with many patients 
discontinuing oral PrEP within about 6-12 months. Moreover, PrEP persistence has 
been found to be shorter among underserved populations with heath inequities—
including Medicaid patients, patients in rural areas, transgender patients, and Black 
and Latinx patients. The introduction of long-acting, injectable cabotegravir (CAB-
LA) for PrEP is viewed by many as an opportunity to overcome adherence 

 
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challenges. Moreover, based on its administration by a healthcare professional 
(HCP) every two months, the implementation for CAB-LA in real-world settings 
affords HCPs new opportunities to engage with patients, especially those with high 
unmet needs, which may influence PrEP persistence, retention-in-care, and 
patient-reported outcomes (PROs). To support adoption of CAB-LA for HIV PrEP, 
real-world studies are urgently needed to evaluate the impact of CAB-LA on 
outcomes that are critical to successful HIV prevention, such as adherence, 
persistence, retention-in-care, and PROs. Additionally, given its mode of 
administration, studies are needed to elucidate barriers to as well as facilitators for 
the implementation of CAB-LA PrEP in clinical settings. For people living with HIV, 
findings from the CUSTOMIZE study shed light on patient and provider 
perspectives on implementation of CAB+RPV LA for treatment of HIV. These 
insights from diverse   settings of HIV treatment can serve as a springboard for 
evidence generation on the real-world use of CAB-LA for PrEP. Recognizing the 
need to support clinics in implementing and streamlining the delivery of PrEP, 
PRIME recently partnered with West Virginia Health Right (WVHR) in an 
implementation science initiative. Through this initiative, significant advances were 
made in overcoming barriers related to PrEP access. Specifically, the initiative 
directly resulted in a landmark decision by the Director of the West Virginia 
Medicaid program to remove all prior authorization requirements for CAB-LA for 
PrEP after attending the PRIME program. Building on this momentum and reduced 
barriers to CAB-LA access in WV, we propose to evaluate the implementation of 
CAB-LA supported by a novel PrEP mobile health app among underserved 
populations receiving care at WVHR. WVHR is a 501(c)3 non-profit, patient-
centered, medical home that provides comprehensive primary and specialty care 
to >40,000 uninsured, underinsured, and underserved adults. Among services 
provided, WVHR provides HIV prevention care, harm reduction services, behavioral 
health care, and transgender health care—which is the only transgender health 
program in the region. Its in-house pharmacy fills >90,000 prescriptions annually, 

 
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including access to free medications for uninsured patients. Additionally, WVHR 
utilizes a mobile health clinic to care for hard-to-reach populations. WVHR is in 
Kanawha County, which is designated by the CDC as one of the top vulnerable 
areas of rapid spread of HIV due to injection drug use.  Due to its location, services 
provided, and focus on uninsured/underinsured individuals, the populations cared 
for by WVHR encompass those with high unmet needs and PrEP-related disparities, 
including women, persons who inject drugs (PWID), transgender persons, persons 
in rural areas, and persons with low-income. Importantly, WVHR is committed to 
sustaining the HIV prevention initiative after the proposed study has concluded, as 
stated in the letter from Chief Executive Officer, Angie Settle, DNP, APRN, BC, FNP 
2.2. Study Rationale 
2.2.1. The digital health companion intervention that will be utilized in this research 
project is based on combining the principles of behavioral health economics, 
patient education, and data science to drive positive behavior change in PrEP 
adherence, persistence and retention-in-care. Prior research supports the 
acceptability and effectiveness of mobile health interventions for adherence to oral 
PrEP. For example, a PrEP adherence mobile app (“Dot”), which was tailored for 
culturally-diverse MSM, was found to have high user acceptability and resulted in 
increased adherence to daily PrEP over the 6-week intervention. Other mobile 
interventions have similarly been found to be effective in supporting PrEP 
adherence in key populations, including in MSM (PrEPmate, Viral combat) and 
cisgender women (AEGiS/iTAB). Importantly, surveys show that 86% of Medicaid 
beneficiaries own smartphones and that approximately one-quarter to one-half 
use their smartphone for a variety of health purposes, such as filling prescriptions, 
measuring health goals, monitoring health issues, and receiving reminders about 
prescription drugs. Thus, there is an important opportunity to evaluate mobile 
health interventions for PrEP among low-income, Medicaid populations, and to 
expand the use of mobile interventions for supporting persistence to long-acting 
injectable PrEP. 

 
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2.3. Hypothesis 
2.3.1. This study is designed to test the hypothesis that, compared to oral PrEP, use of 
CAB-LA in underserved populations in a real-world setting supported by a digital 
health companion program will be associated with greater medication adherence, 
persistence, retention-in-care, and improved PROs. 
3. STUDY OBJECTIVES 
3.1. Study Goal 
3.1.1. The study will evaluate the extent to which real-world use of CAB-LA for PrEP in 
underserved populations impacts PrEP adherence, persistence, retention-in-care, 
and PROs compared with oral PrEP. Additionally, the study will examine 
implementation of a digital health companion program that leverages education 
and behavioral economics to support patients on PrEP, and assess clinician 
perspectives as well as barriers to, and facilitators for implementation of CAB-LA in 
a patient-centered medical home. 
3.2. Primary Objective 
3.2.1. To evaluate medication adherence and persistence in patients receiving CAB-LA vs 
oral PrEP and who engage with a digital health companion program 
3.3. Secondary Objectives 
3.3.1. Evaluate retention-in-care in patients receiving CAB-LA vs oral PrEP 
3.3.2. Evaluate PROs (including PrEP Medication Satisfaction, PrEP Acceptance, PrEP-
Related Stigma, and reasons for PrEP discontinuation) in patients receiving CAB-LA 
vs oral PrEP 
3.3.3. Evaluate the acceptability, appropriateness, and helpfulness of a digital health 
companion program for PrEP 
3.3.4. Evaluate the acceptability, barriers to, and facilitators for implementation of CAB-
LA 
4. STUDY DESIGN 
4.1. Study Design 

 
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4.1.1. The research project follows a hybrid effectiveness-implementation research 
design, with the primary aim focused on evaluation of PrEP adherence, persistence 
and retention-in-care with CAB-LA compared with oral PrEP, and secondary aims 
focused on evaluating patient-reported outcomes (PROs), implementation of a 
digital health intervention to support adherence and persistence, and evaluating 
contextual factors around implementation of CAB-LA. The project is in the initial 
implementation stage, with CAB-LA beginning to be rolled out at WVHR after the 
recent state Medicaid decision to drop prior authorization requirements for CAB-
LA. The proposed study will utilize a digital health intervention with behavioral 
health economics and patient education from PRIME and Reciprocity to evaluate 
the adoption and implementation for PrEP adherence and persistence. The 
implementation aims of the study will leverage the RE-AIM framework as follows: 
Assessment of the digital health intervention will focus primarily on individual-level 
dimensions of RE-AIM, including reach and effectiveness. For example, in assessing 
reach of the digital health intervention, participant demographics will be compared 
to the intended audience to evaluate the extent to which populations with high 
unmet needs were engaged. Conversely, assessment of the implementation of 
CAB-LA will focus on system-level dimensions of RE-AIM, such as qualitative 
assessments of barriers to and facilitators for implementation of CAB-LA. 
Furthermore, evaluation of implementation outcomes will be based on the Proctor 
et al. conceptual framework, using specific measures developed by Weiner et al. to 
assess acceptability, appropriateness, and feasibility of the intervention. In 
addition, evaluation of PROs will be informed by a review of validated instruments, 
including HIVSTQ (HIV Treatment Satisfaction Questionnaire), SMSQ (Study 
Medication Satisfaction Questionnaire), I-TAQ (Injection Treatment Acceptance 
Questionnaire),  ACCEPT (Chronic Treatment Acceptance Questionnaire), and the 
PrEP Stigma Scale, with survey items tailored to evaluate PrEP acceptance, 
satisfaction, and perceptions of PrEP-related stigma for both the CAB-LA and oral 
PrEP arms.  

 
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4.2. Study Schema  
 
  
 
 
Primary outcome measure: Proportion of patients  reporting persistence at months 3 
and end of study, validated by medication possession ratio between the CAB-LA and 
Oral PrEP cohorts. Adherence assessedby estimating the proportion of participants 
who missed one or more injections or received injections outside the 7 day window 
and the proportion of participants who reported missing days of oral PrEP or with gaps 
> 90 days  
Secondary outcome measure 1: retention in care in patients receiving CAB-LA vs oral 
PrEP defined as the proportion of patients presenting for their follow-up appointments 
within 30 days of their scheduled visit at months 3, 9 and 12 for the Oral PrEP cohort 
and at months 3, 9, and 11 for the CAB-LA cohort 
 
Secondary outcome measure 2: patient-reported outcomes including PrEP medication 
satisfaction, PrEP acceptance, and PrEP-related stigma, and barriers to adherence and 
reasons for PrEP discontinuation assessed through brief behavioral surveys 
 
Secondary outcome measure 3: implementation outcomes including patient 
acceptability (AIM), appropriateness (IAM), and helpfulness of the education modules 
within the digital health program assessed using a Likert scale and health literacy 
evaluation 
 
Secondary outcome measure 4: clinician acceptability, appropriateness, and feasibility 
of implementing long-acting cabotegravir injections (AIM, IAM, FIM), and barriers to 
and facilitators for implementation of CAB-LA 
CAB-LA PrEP Arm 
n = 70 
 
PrEP injections at months 
0, 1, 3, 5, 7, 9 and 11 
 
Education modules at 
months 2, 4, 6, 8, and 10 
Oral PrEP Arm 
n = 35 
 
PrEP prescription fills at months 
0, 3, 6, 9, and 12 
 
Education modules at months 2, 
4, 6, 8, and 10 
Patients >18 y/o who are newly started on PrEP therapy at WVHR and have 
access to a smart phone with data (N=105)   
I. 
Participants will have been prescribed CAB-LA, daily FTC/TDF, or daily 
FTC/TAF in accordance with the WVHR standard of care by a licensed 
HCP prior to enrolling in the study 
II. 
Not receiving HIV PrEP care outside of WVHR 
III. 
No positive HIV diagnosis 
IV. 
No contraindications to oral or injectable PrEP therapy 

 
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5. STUDY POPULATION 
5.1. Inclusion Criteria 
5.1.1. >18 y/o  
5.1.2. Initiation of PrEP with CAB-LA, daily FTC/TDF, or daily FTC/TAF prescribed in 
accordance with the WVHR standard of care practices (based practices on CDC 
PrEP 2021 Clinical Practice Guidelines) by a licensed HCP 
5.1.3. PrEP dispensed by WVHR pharmacy 
5.1.4. Access to a smart phone  
5.2. Exclusion Criteria 
5.2.1. <18 y/o  
5.2.2. Receiving HIV PrEP care outside of WVHR  
5.2.3. Positive HIV diagnosis  
5.2.4. Contraindication to oral or injectable PrEP therapy  
5.2.5. Receiving oral bridging therapy prior to injectable PrEP therapy 
5.2.6. Confirmed pregnancy  
5.2.7. Vulnerable populations  
5.3. Study Sample 
5.3.1. n = 105 (70 CAB-LA intervention participants vs 35 oral PrEP participants)  
5.4. Screening and Enrollment 
5.4.1. Patients will be enrolled on a rolling basis via HCPs at WVHR. HCPs will verify 
participant’s eligibility for the study.  
 
 

 
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6. STUDY INTERVENTIONS AND PROCEDURES 
6.1. Study Procedures and Interventions Table (Figure 6a) 
 
 
6.2. Description of Study Procedures  
Before any screening procedure is performed, informed consent will be obtained. Labs 
will be taken at baseline and months 3, 5, 7, 9, and 11 for the CAB-LA cohort and at 
baseline and months 3, 6, 9, and 12 for the Oral PrEP cohort (only collected through 
standard of care). Participants will complete a baseline evaluation and be introduced to 
a support group at baseline. Patients will complete assessments within the TheraPay 
App. Clinicians will complete assessments outside of the app. Patients in both cohorts 
will complete baseline demographic surveys in month 0, patient reported outcomes 
(PRO) data collection set 1 in months 1, 5, and 11 and PRO data collection set 2 in 
months 3, 9, and 12.  Patients in the CAB-LA PrEP cohort will complete persistence 
assessments in months 1, 3, 5, 7, 9, and 11. Patients in the Oral PrEP cohort will 
complete persistence assessments every month from months 1 through 12. Clinic staff 
will complete surveys at baseline, month 6, month 12, and at the end of the study.  The 

 
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schedule of assessments for the CAB-LA PrEP cohort, Oral PrEP cohort, and clinicians is 
presented in figure 6a. Instruments are in Appendix B for the CAB-LA cohort, in 
Appendix C for the Oral PrEP cohort, and Appendix D for clinicians. Patient incentives 
for completing the assessment activities are outlined in Appendix E.  
6.2.1. Baseline Patient Demographic Survey 
6.2.2. Medication Persistence 
6.2.2.1. Definition: Continue to take medicines over time independent of adherence 
to the PrEP medication regimen.  
6.2.3. Persistence Assessment CAB-LA 
6.2.3.1. The proportion of participants who received at least one PrEP injection who 
remained on injectable PrEP or oral bridging at months 3 and 11 measured by 
the self-report assessment and validated with claims data.   
6.2.4. Persistence Assessment Oral PrEP 
6.2.4.1. The proportion of participants who initiated oral PrEP who remained on oral 
PrEP at months 3 and 12 measured by the self-report assessment and 
validated with claims data period. 
6.2.5. Adherence 
6.2.5.1. Definition: Taking PrEP in line with medical advice/using PrEP appropriately 
(critical for efficacy) .  
6.2.6. Adherence Assessment CAB-LA 
6.2.6.1. Adherence to the dosing schedule will be assessed at month 3 (early 
adherence) and end of study by:  
A) Estimating the number of individuals who missed one or more consecutive 
injections without taking daily oral bridging PrEP while not on CAB-LA 
injections and mean and median number of injections missed during a 6- and 
a 12-month period.  
6.2.7. B) Estimating the number of individuals who received the injections seven or more 
days later than their scheduled injection visit and the mean and median duration of 
delayed injections.Adherence Assessment Oral PrEP 

 
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6.2.7.1. Adherence to the dosing schedule will be assessed at months 3 (early 
adherence) and 12 by: 
 A) Estimating the number of individuals who reported three or more days of 
oral PrEP missed and the mean and median number of days they missed.  
B) Estimating the number of individuals who had a gap of >90 days between 
the end of the days of supply of a dispensing and the start date of the next fill. 
6.2.8. Patient Reported Outcomes 
6.2.8.1. Patient Reported Outcomes Set 1: PrEP Medication Satisfaction, PrEP-Related 
Stigma, Acceptability of Intervention Measure (AIM) 
6.2.8.2. Patient Reported Outcomes Set 2: PrEP Acceptance, Intervention 
Appropriateness Measure (IAM) 
6.2.8.3. Helpfulness of the education modules and Health Literacy Evaluation 
6.2.9. Clinician Instruments 
6.2.9.1. Baseline Provider Survey 
6.2.9.1.1. 
Information About You and Your Patients 
6.2.9.1.2. 
Acceptability of Intervention Measure (AIM) 
6.2.9.1.3. 
Intervention Appropriateness Measure (IAM) 
6.2.9.1.4. 
Feasibility of Intervention Measure (FIM) 
6.2.9.1.5. 
Barriers and Facilitators for Implementation of Long-Acting      
            Cabotegravir for PrEP 
6.2.9.2. Follow-up Provider Survey 
6.2.9.2.1. 
Information About You and Your Patients 
6.2.9.2.2. 
Acceptability of Intervention Measure (AIM) 
6.2.9.2.3. 
Intervention Appropriateness Measure (IAM) 
6.2.9.2.4. 
Feasibility of Intervention Measure (FIM) 
6.2.9.2.5. 
Barriers and Facilitators for Implementation of Long-Acting  
            Cabotegravir for PrEP 
6.3. Standard of Care Visits 

 
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6.3.1. The standard of care for patient visits will not be affected. The patients will only be 
given additional surveys to complete.  
6.4. Follow-Up Visits 
6.4.1. CAB-LA PrEP cohort: 2nd PrEP injection at month 1; follow-up labs and PrEP 
injections in months 3, 5, 7, 9, and 11.  
6.4.2. Oral PrEP cohort: follow-up labs and prescription refills in months 3, 6, 9, and 12. 
6.5. Switching between PrEP regimens 
6.5.1. To be included in final data analysis, participants cannot switch between PrEP 
regimens before 6-months duration of initial PrEP.  
6.6. PrEP Discontinuation 
6.6.1. Participants will be deemed as having discontinued PrEP if they miss more than 3 
consecutive months for PrEP.   
6.6.2. Participants will be called, texted and emailed for three consecutive months before 
considered them as discontinued. 
6.7. STI Screening and Management 
6.7.1. Participants will receive STI screening at baseline and at every follow up clinic visit. 
Participants will be screened if they present with any type of symptoms that 
warrant STI testing. If a participant tests positive for an STI other than HIV, they will 
receive guideline-directed therapy at the discretion of their HCP at WVHR.  
6.8. Suspected or Confirmed HIV Infection 
6.8.1. HIV screening will occur a minimum as recommended for every 2 months with 
CAB-LA (same time as injections) and every 3 months for oral PrEP.  
6.9. PrEP Choice Counselling  
6.9.1. Patients will be counseled on the benefits and risks of both oral PrEP and PrEP 
injections. The selection of PrEP option will be done as the standard of care 
through shared-decision with the patient.  
6.10. Possible Participant Pathways  

 
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6.10.1. There will only be two observational cohort arms. Patients will either be placed 
into the injectable PrEP arm or the oral PrEP arm based on their baseline 
prescription.  
6.11. Adherence Strategies 
6.11.1. Patients on oral PrEP will be encouraged to set a daily reminder on their smart 
phone as an alarm at the time their dose is due.   
6.11.2. Patients on injectable PrEP will set a monthly calendar reminder on the day/time 
their injection is due. 
6.12. Retention Strategies 
6.12.1. Follow-up appointments will be set up and conveyed at each appointment. 
6.12.2. Reminder calls will be made by a staff member a few days before the 
appointment. 
6.13. Interventions: PrEP Initiation and Digital Health Companion Program 
6.13.1. Participants will be enrolled in the CAB-LA and Oral PrEP cohorts. Participants in 
the CAB-LA cohort will receive their first dose of the PrEP injection at month 0. 
Injections will also be administered in months 1, 3, 5, 7, 9, and 11. Participants in 
the Oral PrEP cohort will have their prescription filled at month 0, 3, 6, 9, and 12. 
The schedule of dosing is presented in Figure 6a.  
6.13.2. Participants in both cohorts will complete education modules and health literacy 
evaluations in the TheraPay App in months 2, 4, 6, 8, and 10 as presented in Figure 
6a. Education Modules include PrEP Medicines (month 2), Protecting Yourself from 
HIV, STIs, and other infections (month 4),  Building a Support System for HIV 
Prevention Month 6: Being an Active Participant in Your Own Care (month 8), and 
Overcoming Stigma and Becoming a Health Advocate (month 10).  
6.14. STATISTICAL ANALYSIS 
6.14.1. Study Endpoints 
6.14.1.1. 
Medication Adherence and Persistence 
Medication persistence is defined as continuing to take PrEP over time 
independent of adherence to the medication regimen. The proportion of 

 
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patients reporting receipt of CAB-LA or oral PrEP at months 3 (early) and end of 
study (late) will be measured through patient questionnaires and validation 
protocols. Medication adherence is defined as taking PrEP in line with medical 
advice.  
6.14.1.2. 
Retention-in-Care 
Retention-in-care is defined as the proportion of patients presenting for their 
follow-up appointments within 30 days of their scheduled visit at months 3, 9, 
and 12 after PrEP initiation in the oral PrEP cohort and months 3, 9, and 11 for 
the CAB-LA cohort.  
6.14.1.3. 
Patient-reported Outcomes 
Patient-reported outcomes will be assessed through surveys. Medication 
satisfaction will be measured by the HIV Treatment Satisfaction Questionnaire 
(HIVSTQ) adapted for PrEP and PrEP stigma will be measured by the PrEP 
Stigma Scale at months 1, 5, and 11. PrEP acceptance will be measured by the 
Modified Injection Treatment Acceptance Questionnaire (Modified I-TAQ) at 
months 3, 9, and 12. Barriers to adherence to oral PrEP and reasons for PrEP 
discontinuation will be assessed through brief behavioral surveys every 
month after the initiation of PrEP. Barriers to adherence to CAB-LA injections 
and reasons for PrEP discontinuation will be assessed through brief behavioral 
surveys at months 1, 3, 5, 7, 9, and 11.  
 
6.14.1.4. 
Implementation Outcomes for the Mobile App 
Acceptability of the mobile app to support patients in taking PrEP will be 
measured by the Acceptability of Intervention Measure (AIM) at months 1, 5, 
and 11. Appropriateness of the mobile app to support patients in taking PrEP will 
be measured by the Intervention Appropriateness Measure (IAM) at months 3, 
9, and 12.  
6.14.1.5. 
Clinic Staff Acceptability, Appropriateness, and Feasibility of Providing 
Long-acting Cabotegravir Injections 

 
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Acceptability of the process for providing long-acting cabotegravir injections will 
be assessed by the Acceptability of Intervention Measure (AIM). Appropriateness 
of the process for providing long-acting cabotegravir injections will be assessed by 
the Intervention Appropriateness Measure (IAM). Feasibility of long-term use of 
cabotegravir injections will be assessed by the Feasibility of Intervention Measure 
(FIM). Willingness to sustain provision of long-acting cabotegravir injections and 
barriers to and facilitators for provision of long-acting cabotegravir injections will 
be assessed through a brief survey. The clinic staff surveys will be administered at 
baseline, month 6, month 12, and end of study. 
 
7. Statistical Analyses  
Baseline analyses will include tabulations of demographic and clinical variables of the 
study participants. Chi-square tests and t-tests will be used to compare these groups to 
determine if baseline differences exist. The distribution of each continuous variable will 
be inspected for outliers to determine whether a parametric or non-parametric 
approach should be applied. The Wilcoxon ranked sum test will be used for any variable 
that does not meet the statistical assumptions of the t-test. Variables found to be 
associated with persistence or adherence following univariate analysis will be included 
in multivariate models. 
To assess the co-primary endpoint of persistence at 3 months and end of study, the 
proportion of participants reporting continued receipt of injections in the CAB-LA cohort 
and the proportion of patients reporting continued use of PrEP by mouth in the oral 
PrEP cohort on the persistence assessment will be compared using chi square tests or 
Fisher’s exact tests. Self-reported persistence will be validated by the medication 
possession ratio (MPR).  MPR is defined as the number of days of medication dispensed 
during the study period divided by the number of days that the person should have 
received therapy. The percent of CAB-LA participants with MPRs ≥ 1.0 will be compared 
to the percent of oral PrEP participants with MPRs ≥ 1.0 using chi square tests or Fisher’s 
exact tests. To assess the co-primary endpoint of adherence, chi square tests or Fisher’s 

 
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exact tests will be used to compare the percent of CAB-LA participants who reported 
missing one or more injections during the study period to the percent of oral PrEP 
participants who reported three or more missed days of oral PrEP. The percent of CAB-
LA participants who received any injections seven or more days later than their 
scheduled injection or oral PrEP participants who had a gap of >90 days between the 
end of the days of supply of a dispensing and the start date of the next fill will be 
compared.  
Sample Size 
 Assuming adherence proportions of .90 and .65 and sample sizes of 70 and 35 in the 
CAB-LA and oral PrEP arms respectively, the 95% confidence interval for the difference 
between the CAB-LA proportion and the oral PrEP proportion is .0771 to .4229. 
8. SAFETY MONITORING AND ADVERSE EVENT REPORTING 
8.1. An adverse event (AE) is defined as any untoward medical occurrence whether thought 
to have been caused by the investigational medical product or the Study or not, and a 
Serious Adverse Event (SAE) shall mean any adverse event which is fatal, life 
threatening, disabling or incapacitating, requires in-patient treatment or prolongs  
existing hospitalization, is a congenital anomaly in the off-spring of the patient or which 
may require intervention to prevent the previously stated outcomes.  
8.2. All AEs should be reported via FEARS by the health care providers. All SAEs and medical 
device incidents considered related to CAB-LA should be reported to GSK within 24 
hours of awareness. All pregnancies associated with CAB-LA (initial notification 
followed by outcome of the mother and infant) should be reported to GSK within 1 
week of awareness.  
8.3. Participants will be counselled by HCPs at WVHR on the common ADEs to be aware of 
and when the participants should contact their HCP. Common ADEs can also be found 
in the FDA package insert. Participants will be counselled that If they become pregnant 
or suspect they might be pregnant, they should contact their HCP. All investigators and 
health care providers are strongly encouraged to report all pregnancies exposed to 
Cabotegravir to the Antiretroviral Pregnancy Registry (APR) as soon as the pregnancy is 

 
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identified. Pregnancies can be reported to the Registry at SM_APR@APRegistry.com via 
the data forms available at www.APRegistry.com 
9. HUMAN PARTICIPANTS AND DATA PROTECTION 
9.1. TheraPay App 
9.1.1. The TheraPay requires a username and password to access the program and data 
stored by the application. Only survey completed by enrolled participants will be 
stored within the application along with name, phone number, and email address. 
 
10. TIMELINES 
10.1. Patients will be enrolled until the n value of 105 is met.  
2-3 months 
3-6 months* 
12 months 
3 months 
Development of study protocol, 
educational modules and survey 
instruments 
Participant enrollment 
(rolling basis) 
Study period 
Data analysis and 
publication 
submission 
 
11. PRESENTATION AND PUBLICATION PLANS 
12. REFERENCES 
12.1. Huang YLA, Tao G, Smith DK, Hoover KW. Persistence with Human Immunodeficiency 
Virus Pre-exposure Prophylaxis in the United States, 2012-2017. Clin Infect Dis. 
2021;72(3):379-385. 
12.2. Keyes J, Crouse EC, DeJesus E, Rolle C-P. Determinants of pre-exposure prophylaxis 
(PrEP) persistence in a high-risk population in Central Florida. J Investig Med. 
2021;69(2):397 LP - 401. 
12.3. Spinelli MA, Scott HM, Vittinghoff E, et al. Missed Visits Associated with Future 
Preexposure Prophylaxis (PrEP) Discontinuation among PrEP Users in a Municipal 
Primary Care Health Network. Open Forum Infect Dis. 2019;6(4). 
12.4. Krakower D, Maloney KM, Powell VE, et al. Patterns and clinical consequences of 
discontinuing HIV preexposure prophylaxis during primary care. J Int AIDS Soc. 
2019;22(2):1-9. 
12.5. Czarnogorski M, Garris C, D’Amico R, et al. CUSTOMIZE: overall results from a hybrid III 
implementation-effectiveness study examining implementation of cabotegravir and 

 
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20 
rilpivirine long-acting injectable for HIV treatment in US healthcare settings; final 
patient and provider data. In: International AIDS Society Conferences on HIV Science. ; 
2021. 
12.6. Garris C, Stassek L, D’Amico R, et al. Qualitative Patient-Participant Perspectives on 
Implementation of Monthly Cabotegravir and Ripilvirine Long-Acting (CAB+RPV LA) 
Injectable in the United States (CUSTOMIZE). IDWeek 2021. Abstract 883. 
12.7. West Virginia Bureau for Medical Services. Preferred Drug List and Coverage Detail.s. 
Available at https://dhhr.wv.gov/bms/BMS Pharmacy/pages/preferred-drug-list.aspx. 
Accessed 09/06/2022. 
12.8. Centers for Disease Control and Prevention. Vulnerable Counties and Jurisdictions 
Experiencing or At-Risk of Outbreaks. Available at 
https://www.cdc.gov/pwid/vulnerable-counties-data.html. Accessed 09/06/2022. 
12.9. Centers for Disease Control and Prevention. HIV in the United States and Dependent 
Areas. Available at https://www.cdc.gov/hiv/statistics/overview/ataglance.html. 
Accessed 09/06/2022. 
12.10. 
Schneider KE, White RH, O’Rourke A, et al. Awareness of and Interest in Oral Pre-
Exposure Prophylaxis (PrEP) for HIV Prevention and Interest in Hypothetical Forms of 
PrEP among People who Inject Drugs in Rural West Virginia. AIDS Care. 2021;33(6):721-
728. 
12.11. 
Weitzman PF, Zhou Y, Kogelman L, Rodarte S, Vicente SR, Levkoff SE. MHealth for 
pre-exposure prophylaxis adherence by young adult men who have sex with men. 
mHealth. 2021;7(6). 
12.12. 
Garrison LE, Haberer JE. Pre-exposure Prophylaxis Uptake, Adherence, and 
Persistence: A Narrative Review of Interventions in the U.S. Am J Prev Med. 2021;61(5 
Suppl 1):S73-S86. 
12.13. 
Deloitte. Medicaid and Digital Health: Findings from the Deloitte 2018 Survey of 
US Health Care Consumers. Available at 
https://www2.deloitte.com/us/en/insights/industry/public-sector/mobile-health- care-
app-features-for-patients.html. Accessed 09/06/2022.  

 
[220084][4078] Version 8.10.23b 
21 
12.14. 
Woodcock A, Bradley C. Validation of the HIV treatment satisfaction 
questionnaire (HIVTSQ). Qual life Res an Int J Qual life Asp Treat care Rehabil. 
2001;10(6):517-531. 
12.15. 
 Arnould B, Gilet H, Patrick DL, Acquadro C. Item Reduction, Scoring, and First 
Validation of the ACCEPTance by the Patients of their Treatment (ACCEPT©) 
Questionnaire. Patient. 2017;10(1):81-92. 
12.16. 
Klein H, Washington TA. The Pre-Exposure Prophylaxis (PrEP) Stigma Scale: 
Preliminary findings from a pilot study. Int public Heal J. 2019;11(2):185-195. 
12.17. 
Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly 
developed implementation outcome measures. Implement Sci. 2017;12(1):1-12. 
12.18. 
Reciprocity Health. Available at https://www.reciprocityhealth.com/. Accessed 
09/06/2022. 
12.19. 
Fallon S, Molnar K, Taneva E, Simone L, Carter J, Sapir T. Tackling the HIV 
Epidemic in South Florida: Patient Insights on Approaches for HIV Counseling, Testing, 
and Access to Prevention or Treatment. Poster presentation at ID Week iNNOVATE RFP 
CAB LA for PrEP. October 21-25, 2020. 
12.20. 
Felzien G, McIntosh S, Taneva E, et al. Do Patients and Healthcare Professionals 
See Eye-to-Eye on the Usefulness of Strategies for Promoting HIV Care? Poster 
presentation at ID Week. Washington, DC; October 2–6, 2019. 
12.21. 
Taneva E, Simone L, Carter J, Sapir T, Brinson C, Wohl D. Taneva E, Simone L, 
Carter J, Sapir T, Brinson C, Wohl DA. Impact of Quality-Driven Interventions and Action 
Plans on Retention-in-care in 11 HIV Clinics. Poster presentation at the American 
Conference for the Treatment of HIV (ACTHIV). Miami, FL; April 1. 
12.22. 
Wohl D, Brinson C, Hicks C, et al. Real-World Insights into Quality Improvement 
across 11 HIV Clinics in the US. Presentation at ID Week 2018. San Francisco, CA; 
October 3-7, 2018. 
12.23. 
Glasgow RE, Harden SM, Gaglio B, et al. RE-AIM planning and evaluation 
framework: Adapting to new science and practice with a 20-year review. Front Public 
Heal. 2019;7(MAR). 

 
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12.24. 
Proctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research: 
Conceptual distinctions, measurement challenges, and research agenda. Adm Policy 
Ment Heal Ment Heal Serv Res. 2011;38(2):65-76. 
13. APPENDICES 
13.1.1. Informed Consent 
13.1.2. CAB-LA PrEP ARM Instruments  
13.1.2.1. 
Baseline Demographic Survey 
13.1.2.2. 
Persistence Assessment  
13.1.2.3. 
Patient Reported Outcomes Set 1: PrEP Medication Satisfaction, PrEP-
Related Stigma, Acceptability of Intervention Measure (AIM) 
13.1.2.4. 
Patient Reported Outcomes Set 2: PrEP Acceptance, Intervention 
Appropriateness Measure (IAM) 
13.1.2.5. 
Health Literacy Evaluations 
13.1.3. Oral PrEP ARM Instruments 
13.1.3.1. 
Baseline Demographic Survey 
13.1.3.2. 
Persistence Assessment  
13.1.3.3. 
Patient Reported Outcomes Set 1: PrEP Medication Satisfaction, PrEP-
Related Stigma, Acceptability of Intervention Measure (AIM) 
13.1.3.4. 
Patient Reported Outcomes Set 2: PrEP Acceptance, Intervention 
Appropriateness Measure (IAM) 
13.1.3.5. 
Health Literacy Evaluations 
13.1.4. Clinician Instruments 
13.1.4.1. 
Baseline Provider Survey 
13.1.4.2. 
Acceptability of Intervention Measure (AIM) 
13.1.4.3. 
Intervention Appropriateness Measure (IAM) 
13.1.4.4. 
Feasibility of Intervention Measure (FIM) 
13.1.4.5. 
Follow-up Provider Survey 
13.1.5. Incentive Mapping 
13.1.6. List of Tables 
13.1.6.1. 
Study Procedures 
13.1.7. List of Figures 
13.1.7.1. 
Study Schema 

 
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13.1.7.2. 
Study Timelines 
13.1.8. Forms for Safety Reporting 
 

 
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1.  PROTOCOL SUMMARY 
 
Title 
A Transformative Approach Utilizing Behavioral Economics, Education, 
and Data Science to Support Patients Initiating PrEP with Retention-in-
care and Medication Persistence 
Funder 
ViiV Healthcare  
Study Design 
Observational Cohort Study 
Study Population 
Patients >18 y/o who are newly started on PrEP  at WVHR and have 
access to a smart phone with data.  
Study Size 
n = 105 (70 CAB-LA intervention participants and 
35 oral PrEP participants)  
Study Duration 
12 months  
Study Site(s) 
West Virginia Health Right  
Intervention 
Description 
Participants will have been prescribed CAB-LA, daily FTC/TDF, or daily 
FTC/TAF in accordance with the WVHR standard of care by a licensed 
HCP prior to enrolling in the study. Those receiving CAB-LA will be in 
one arm and those receiving oral therapy will be in the other arm of 
the study.  
Study Aim 
To determine the persistence in injectable PrEP  compared to Oral 
PrEP therapy  
Primary Objectives  To evaluate medication persistence in patients receiving CAB-LA 
vs oral PrEP and who engage with a digital health companion 
program 
Secondary 
Objective 1 
Evaluate Retention-in-care in patients receiving CAB-LA vs oral 
PrEP 
Secondary 
Objective 2 
Evaluate PROs (including PrEP medication satisfaction, PrEP 
acceptance, stigma, and reasons for PrEP discontinuation) in 
patients receiving CAB-LA vs oral PrEP 
Secondary 
Objective 3 
Evaluate the acceptability, appropriateness, and helpfulness of a 
digital health companion program for PrEP 

 
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Secondary 
Objective 4 
Evaluate the acceptability, barriers to, and facilitators for 
implementation of CAB-LA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Study Schema Figure 
 
 
Figure showing study components and flow – organize by participant cohort (i.e. oral, LA, no 
PrEP) 
 

 
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Study Outcomes Table  
 
Primary or Secondary 
Endpoint 
Definitions 
Type of 
Endpoint 
Assessment 
Timepoint 
Data Source 
Intervention 
or Approach 
Tool/Instrument 
for Endpoint 
1. Primary Endpoint: PrEP 
adherence and Persistence  
 
Proportion of patients 
reporting receipt of CAB-
LA injections or use of 
oral PrEP at 3 months 
after PrEP initiation and 
end of study 
Quantitative 
M3 and end 
of study 
Participant survey 
and EHR  
Participant 
survey and EHR 
Survey and 
Medication 
Retention Ratio   
2. Secondary Endpoint: 
Retention-in-care  
The proportion of 
patients presenting for 
their follow-up 
appointments within 30 
days of their scheduled 
visit at months 3, 9 and 
12 after PrEP initiation 
for the Oral PrEP arm 
and months 3, 9, and 11 
for the CAB-LA arm. 
Quantitative 
M3, M9, 
M11, M12 
Participant survey 
and EHR 
Participant 
survey and EHR 
Survey  
3. Secondary Endpoint: PROs 
PRO Set #1: 
PrEP Medication 
Satisfaction; PrEP-
Related Stigma  
 
PRO Set #2: PrEP 
Acceptance   
------------------------------ 
Barriers to adherence to 
CAB-LA injections and 
Qualitative  
M1, M5, M11 
(PRO Set #1),  
 
M3, M9, M12 
(PRO Set #2) 
 
Barriers to 
adherence in 
oral PrEP 
arm: M1, M2, 
M3, M4, M5, 
Participant Survey  
Patient 
questionnaire 
Survey  

 
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oral PrEP, and reasons 
for PrEP 
discontinuation will be 
assessed through brief 
behavioral surveys 
M6, M7, M8, 
M9, M10, 
M11, M12 
 
Barriers to 
adherence in 
CAB-LA PrEP 
arm: M1, M3, 
M5, M7, M9, 
M11 
4. Secondary Endpoint: 
Implementation Outcomes 
Acceptability of 
Intervention Measure 
(AIM) and Intervention 
Appropriateness 
Measure (IAM) 
 
Health literacy 
evaluation and 
helpfulness of the 
education modules 
within the digital health 
program assessed 
through a brief survey 
Qualitative  
M3, M9, M12 
Participant Survey  
Patient 
questionnaire 
Survey 
5. Secondary Endpoint: 
Clinician Acceptability, 
Appropriateness, and 
Feasibility  
Acceptability of 
Intervention Measure 
(AIM), Intervention 
Appropriateness 
Measure (IAM), and 
Feasibility of 
Intervention Measure 
(FIM)  
 
Qualitative 
M0, M6, 
M12, and End 
of Study 
Clinician Survey, 
Interview   
Clinician Survey, 
Interview   
Clinician Survey, 
Interview   

 
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Willingness to sustain 
provision of CAB-LA, 
barriers to and 
facilitators for 
provision of CAB-LA 
assessed through a brief 
survey 
 
 
 

 
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Appendix A: Informed Consent 
SUMMARY 
We are asking you to be in a research study to determine the helpfulness of using a cell phone 
application in supporting patients wanting to participate in HIV prevention care. TheraPay 
Rewards is a mobile and web program that tracks the care and rewards patients for doing 
activities such participating in education activities and completing surveys about their care. The 
app provides information on what activities the patient needs to do to earn rewards. It also 
sends reminders along the way. This will help us understand if the overall patient experience 
and satisfaction improves when compared to the traditional care and education approaches. 
This form explains what you need to know to decide whether you want to participate in this 
program 
 
What will I be expected to do in this study? 
You will have to download the TheraPay app. Also, consent to us telling notifying you of when 
education and surveys will be available for you to complete. In order to receive rewards you 
would be required to complete the education and surveys during the specified times that they 
are designated to be completed. 
 
Are there any risks to being in the study? 
There is minimal risk. The level of risk you might experience in everyday life, is associated with 
this study. The risks primarily reside in your personal information being compromised. Payment 
occurs in the form of rewards added to a reloadable smart rewards card from TheraPay. This 
reward card will be sent in the mail to you. 
 
Side effects associated with PrEP are possible. To find further information about possible side 
effects, read the drug label or package insert or talk to your health care provider. If you 
experience side effects associated with PrEP, contact your healthcare provider. If you become 
pregnant or suspect that you might be pregnant, contact your healthcare provider.  
 
Will I benefit from being in the study? 
You will not benefit directly from the study. We hope to learn how to best communicate and 
support patients with HIV prevention care activities for patients in the future. 
 
Will my study information be kept safe? 
Yes. All your health information is kept private and not shared with anyone. To learn more, go 
online to: TheraPay’s Privacy Policy at www.therapayrewards.com/privacy-policy. The Therapay 
app will not connect with your contacts or social media. 
 
Is there any cost for me from being in this study? 
There is no cost to you for being in the study. You will be responsible for the cost of your 
regular care. Additionally, there may be costs for data usage relating to the TheraPay 
application. 
 

 
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Will I get any money or gifts for being in this study? 
Participants will be rewarded for completing tasks assigned to them while receiving care for HIV 
prevention. You will receive your rewards card (similar to a debit card) in the mail in 1 to 2 
weeks after registering for TheraPay. You will get information about the activities and rewards 
you qualify for via the TheraPay Rewards app, emails, and text messages. A $5-30 credit per 
task will be issued to your gift card. You will need to complete approximately 20-25 tasks over 
12-months. A maximum of $265 will be loaded onto the card. 
 
Other information 
Your information collected as part of this research will not be share with without unique 
identifiers being removed. You can contact Rhonda Francis, 304-414-5922 if you have questions 
about this study.  
 
Giving consent 
We will ask you to sign this document. By signing this document, you are agreeing participation 
in this study. Make sure you understand what the study is about before you sign. 
 
 HIPAA Authorization - For the Use of Patient Information for Research 
The purpose of this section of the form is to give your permission to the research team to 
obtain and use your Protected Health Information (PHI) or patient information. Your patient 
information will be used to do the research described earlier in this form. State and federal 
privacy laws protect your patient information. These laws say that, in most cases, your health 
care provider can release your identifiable patient information to the research team only if you 
give permission by signing this form. 
 
You do not have to sign this form. If you do not, you will not be allowed to join the research 
study. Your decision to not sign this form will not affect any other treatment, health care, 
enrollment in health plans or eligibility for benefits. 
 
“Patient information” means the health information in your medical or other healthcare 
records. It also includes information in your records that can identify you. For example, it can 
include your name, address, phone number, birthdate, and medical record number. 
 
By signing this form, you are giving permission to the following organization(s) to disclose 
your patient information for this research. 
• West Virginia Health Right  
• Reciprocity Health, Inc. 
 
Patient information that will be released for research use This permission is for the health 
care provided to you during the following time period: From the time of enrollment for a 
duration of approximately 12-months. 
The information that will be released and used for this research is described below: 
• First Name (You will share this with the app) 
• Last Name (You will share this with the app) 

 
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• DOB (You will share this with the app) 
• Email (You will share this with the app) 
• Mobile Number (You will share this with the app) 
• Gender (You will share this with the app) 
• Address (You will share this with the app) 
• Confirmation of tasks (You will share this with the app) 
• HIV Prevention Care Information (Will be shared) 
 
How your patient information will be used? 
 
1. Who may get your patient information? 
• The group funding the study, known as the sponsor of this research. “Sponsor” includes any 
persons or companies that are working with or for the sponsor, or that are owned by the 
sponsor 
 
2. Why your patient information will be used and/or given to others 
• To do the research 
• To study the results, and 
• To see if the research was done right 
 
If the results of this study are made public, information that identifies you will not be used. The 
researcher will use your patient information only in the ways that are described in this research 
consent form and this HIPAA Authorization. You can ask questions about what the research 
team will do with your information and how they will protect it. 
 
The privacy laws do not always require the people who get your information to keep your 
information confidential. After your information has been given to others, there is a risk that it 
could be shared without your permission. This permission for the researchers to obtain your 
patient information ends when the research ends and any required monitoring of the study is 
finished. 
 
Canceling your permission 
You may change your mind at any time. To take back your permission, you must send your 
written request to: 
 
Rhonda Francis 
WV Health Right  
1520 East Washington Street 
Charleston, WV 25311 
Phone: 304-414-5922 
 
If you take back your permission, the research team may still keep and use any patient 
information about you that they already have. But they can’t obtain more health information 

 
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33 
about you for this research unless it is required by a federal agency that is monitoring the 
research. 
 
If you take back your permission, you will need to leave the research study. This means that you 
would not have any more notifications or rewards. Changing your mind will not affect any other 
treatment, payment, health care, enrollment in health plans or eligibility for benefits. 
 
Giving permission 
By signing this document, you are agreeing to participation in this study. You are also agreeing 
that your patient information will be used as we described earlier in this form. We will give you 
a copy of this document for your records. We will keep a copy with the study records. 
 
If you have any questions about the study after you sign this document, you can contact the 
study team using the information provided above. I have read this consent and HIPAA 
Authorization form describing the research study and how my patient information will be used. 
I have had a chance to ask questions and I have received answers to my questions. I agree to be 
in this study. I also agree to the use of my patient information for this research. 
 
______________________________________________________________________________ 
Printed Name of Research Subject 
 
______________________________________________________________________________ 
Signature of Research Subject Date of signature 
 
______________________________________________________________________________ 
Printed Name of Person Obtaining Consent 
 
______________________________________________________________________________ 
Signature of Person Obtaining Consent Date of signature 
 
 
 
 

 
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PrEP Digital Health Companion Clinician Survey 
Informational Sheet 
Introduction: You are being invited to volunteer for a research study. You must read each item 
in this before you agree to take part in this study.  This form will give you more information 
about this study. You should not continue with the survey if you have questions after reading 
the information sheet.  
Purpose of the research: The intent of this study is to gather valuable insights on unmet needs 
and challenges in PrEP and to gauge Health Care Provider’s (HCP’s) views on potential 
solutions for overcoming specific barriers such utilization of a digital health companion. From 
the information collected and studied, we plan to learn more about the quality of care for 
patients HIV prevention needs.  About 10 clinicians will complete this survey. 
What you will do in this research: You are being asked to volunteer as a participant for a short 
survey. The survey will take approximately 5-10 minutes. You will complete one survey 
intended to obtain your viewpoint about the healthcare experiences of your patients with 
influenza. 
Risks: There are no foreseeable risks for you because the information being collected will not 
be linked back to your name or your specific patients. 
Benefits: Your answers to questions will help inform future clinical education for providers in 
HIV prevention care. You will receive a de-identified summary report of aggregate responses 
through a live virtual continuation education presentation. The de-identified data collected for 
this project may be published in a peer-reviewed manuscript or presented in a national 
conference to inform other providers the barriers in care for patients. 
Compensation: A $50 gift card will be offered for completion of this survey 
Confidentiality: Your responses will be kept confidential. When research results are reported, 
responses will be deidentified and aggregated.  
Participation and withdrawal: Your participation in this survey is completely voluntary. You 
may refuse to participate, which will disenroll. At any time during the survey you exit and cease 
your participation. However, once answers have been submitted, they cannot be retracted as 
the data is deidentified.  
 
To Contact the Researcher: If you have questions or concerns about this research, please 
contact:  Dr. Jeff Carter: Phone: 954-718-6055 ext 23; Address: 114 5th Ave, 14th Floor 
New York, NY 10011 Email: j.carter@primeinc.org.  
 
By continuing to complete the online survey form you are consenting to participate in the 
survey.  
 
Please save a copy of this communication for your records. 
 
 

 
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Appendix B: CAB-LA PrEP Arm Instruments 
Activity Title: Baseline Information About You 
Activity Description: Today we’ll ask you to answer some questions about yourself. The survey 
is 17 questions and should take about 10 minutes to complete.  
Baseline Demographic Survey 
Question 
Question 
# 
What year were you born? [Write in] 
1 
Which of the following best describes your racial/ethnic background? (Select all that apply) 
 African American/Black 
 Asian/Pacific Islander 
 Caucasian/White 
 Hispanic/Latinx 
 Native American/Alaska Native 
 A race or ethnicity not listed: [Write in] 
2 
How do you describe your gender? (Select 1) 
 Female 
 Male 
 Transgender woman 
 Transgender man 
 Non-binary 
 A gender not listed: [Write in] 
3 
How do you describe your sexual orientation? (Select 1) 
 Heterosexual/Straight 
 Gay or Lesbian 
 Bisexual 
 Queer or Sexually Fluid 
 Pansexual 
 A sexual orientation not listed: [Write in] 
4 
What is the highest degree or school level you have completed? (Select 1) 
 Primary school 
 Some high school 
 High school diploma or GED 
 Some college  
 2-year college degree 
 4-year college degree 
 Graduate level degree 
 A school level not listed: [Write in] 
5 
What health coverage are you currently enrolled with? (Select up to 2) 
 Medicaid 
 Medicare 
 Affordable Care Act 
6 

 
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 Uninsured 
 Private health insurance 
 A health coverage not listed: [Write in] 
Why are you using pre-exposure prophylaxis (PrEP) to prevent HIV? [Select all that apply] 
 Reduce acquisition of HIV from sex 
 Reduce acquisition of HIV from IV drug use 
7 
The next 5 questions ask about your food, housing, and transportation routines from the past 12 
months. If you have concerns and need support, please check in with your provider at your next visit 
or call 2-1-1 for immediate support. 
In the last 12 months, was there a time when you were not able to pay the mortgage or 
rent on time? 
 No 
 Yes  
 Not applicable 
8 
In the last 12 months, was there a time when you did not have a steady place to sleep or 
slept in a shelter (including now)? 
 No 
 Yes 
9 
In the last 12 months, have you or the people you live with been unable to get utilities 
(heat, electricity) when it was really needed? 
 No 
 Yes 
10 
Within the past 12 months, the food you bought just didn’t last and you didn’t have money 
to get more. 
 Never true 
 Sometimes true 
 Often true 
11 
Within the past 12 months, has lack of transportation kept you from medical appointments, 
getting your medicines, non-medical meetings or appointments, work, or from getting 
things that you need?  
 No 
 Yes 
12 
Do you feel physically and emotionally safe where you currently live? 
 Yes 
 No 
13 
During the past 30 days, have you used any of the following? 
 
An illegal drug (such as by snorting it or injecting it) 
 
Pain killer to get high (like OxyContin, sometimes called Oxy or OC) or Percocet 
(sometimes called Percs) 
 
Prescription drugs not prescribed to you 
 No 
 Yes 
14 
People who experience discrimination may be at higher risk of negative health outcomes. Sharing your 
experiences with discrimination in everyday life and in healthcare settings may help researchers learn 
how to reduce negative health outcomes associated with discrimination.  
 

 
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The next 3 statements describe how others may treat you.  
 
In your day-to-day life, how often do any of these happen to you? 
You are treated with less respect than other people are. 
 Never 
 Less than once a year 
 A few times a year 
 A few times a month 
 At least once a week 
 Almost every day 
 
15 
People act as if they’re better than you. 
 Never 
 Less than once a year 
 A few times a year 
 A few times a month 
 At least once a week 
 Almost every day 
 
16 
What do you think is the main reason for these experiences? (Select 1) 
 Your gender 
 Your sexual orientation 
 Your race 
 Your religion 
 Some aspect of your physical appearance 
 Your education or income level 
 Other: [Write in] 
17 
End Message: Thank you for completing this survey! 
 
Persistence Assessment 
Activity Title: Are You Still Taking PrEP? 
Activity Description: In this short survey, we’ll ask you some questions about your PrEP journey 
and any challenges you may have encountered. 
Activity:  
1. Are you still getting PrEP medicine by an injection from your healthcare provider? 
 Yes, I am taking PrEP (branching logic to question 4) 
 No, I stopped taking PrEP (branching logic to question 2) 
 
2. If you stopped taking PrEP, which of the following best describes the reason(s) why? 
[Select up to 2] 
 I no longer feel I needed to take PrEP (branching logic to question 3 if selected) 
 It was too difficult to take to take PrEP as prescribed with my lifestyle 
 I felt I was being judged by others for taking PrEP 
 I experienced side effects from taking PrEP 

 
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38 
 I take too many medications 
 There were too many appointments as part of my PrEP care 
 I tested positive for HIV 
 Other: [Fill in the blank] 
 
3. Which of the following best describes why you no longer feel you need to take PrEP? 
 I am no longer having sex 
 I am in a monogamous relationship 
 I am no longer using injectable drugs 
 My partners and I are all regularly using condoms and getting tested for HIV  
 Other: [Fill in the blank] 
 
4. If you are still taking PrEP, what challenges have you experienced? 
 Have not experienced any challenges 
 Keeping up with clinical visits and laboratory testing 
 Concerns about side effects  
 Finding transportation to my appointments 
 Stigma or discrimination from family, friends, or partner(s)  
 Stigma or discrimination from healthcare professionals 
 Other: [Fill in the blank] 
 
5. Did a healthcare provider (for example, a doctor, nurse or pharmacist) or navigator 
ever ask you what may make it difficult for you to take PrEP? (Month 1 & 11) 
 Yes 
 No 
 Unsure 
Activity Type: Patient Reported Outcomes – Set 1 
Activity Title: Your Experiences With PrEP  
Activity Description: This month we’ll ask you to answer questions about your experience using 
PrEP and your thoughts about PrEP-related stigma. We’ll also ask some questions about your 
experience using this mobile app to support you taking PrEP. The survey is 3 parts with a total 
of 24 questions. It should take you 10-15 minutes to complete. 
Activity: 
Part 1. Tell us about your experience using PrEP  
The following questions are related to the PrEP medicine you use to protect you from HIV 
infection and your experience over the past 4 weeks. Please answer each question by selecting 
a number on each of the scales.  
1. How satisfied are you with your current medicine for PrEP? 
 
Very satisfied 
 
Satisfied 

 
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39 
 
Neither satisfied or dissatisfied 
 
Dissatisfied 
 
Very dissatisfied 
2. How bothered are you by any side effects from the medicine you use for PrEP? 
 
Very unbothered 
 
Unbothered 
 
Neither unbothered or bothered 
 
Bothered 
 
Very bothered 
 
I have not experienced any side effects in the last 4 weeks 
3. How satisfied are you with the convenience of PrEP recently? 
 
Very satisfied 
 
Satisfied 
 
Neither satisfied or dissatisfied 
 
Dissatisfied 
 
Very dissatisfied 
4. How satisfied are you with the discreetness of PrEP recently? 
 
Very satisfied 
 
Satisfied 
 
Neither satisfied or dissatisfied 
 
Dissatisfied 
 
Very dissatisfied 
5. How satisfied are you with your understanding of using PrEP to prevent HIV? 
 
Very satisfied 
 
Satisfied 
 
Neither satisfied or dissatisfied 
 
Dissatisfied 
 
Very dissatisfied 
6. How satisfied are you with the extent to which PrEP fits in with your lifestyle? 
 
Very satisfied 
 
Satisfied 
 
Neither satisfied or dissatisfied 
 
Dissatisfied 
 
Very dissatisfied 
7. Would you recommend this type of PrEP to someone else who wants to protect themselves from HIV? 

 
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40 
 
Yes, I would definitely recommend this type of PrEP 
 
Yes, I would recommend this type of PrEP 
 
Not sure if I would recommend or not recommend this type of PrEP 
 
No, I would not recommend this type of PrEP 
 
No, I would definitely not recommend this type of PrEP  
  
8. How satisfied would you be to continue your present form of PrEP? 
 
Very satisfied 
 
Satisfied 
 
Neither satisfied or dissatisfied 
 
Dissatisfied 
 
Very dissatisfied 
Part 2. What are your thoughts about PrEP-related stigma? 
Stigma is a negative and unfair belief about someone because of a particular characteristic or attribute. 
Please answer the following statements to the best of your ability.  
 
Indicate how much you agree with the following: 
 
Completely 
agree 
Agree 
Neither agree 
or disagree 
Disagree 
Completely 
disagree 
I feel ashamed to go to the 
doctor for PrEP 
injections/shots. 
( )  
( )  
( )  
( )  
( )  
People experience negative 
judgment because they take 
PrEP. 
( )  
( )  
( )  
( )  
( )  
Someone using PrEP should 
keep their PrEP injection 
appointments hidden. 
( )  
( )  
( )  
( )  
( )  
 
 
Completely  
agree 
Agree 
Neither 
agree or 
disagree 
Disagree 
Completely 
disagree 
Someone taking PrEP would be 
seen by others as slutty. 
( )  
( )  
( )  
( )  
( )  

 
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41 
People taking PrEP receive praise 
for being responsible. 
( )  
( )  
( )  
( )  
( )  
My friends would be supportive of 
me taking PrEP. 
( )  
( )  
( )  
( )  
( )  
 
 
Completely 
agree 
Agree 
Neither 
agree or 
disagree 
Disagree 
Completely 
disagree 
Someone taking PrEP would be 
treated unfairly by their doctors. 
( )  
( )  
( )  
( )  
( )  
People experience problems when 
they tell their sex partner(s) they 
are taking PrEP.  
( )  
( )  
( )  
( )  
( )  
I feel proud to take PrEP. 
( )  
( )  
( )  
( )  
( )  
  
 
Completely 
agree 
Agree 
Neither 
agree or 
disagree 
Disagree 
Completely 
disagree 
People on PrEP are taking care of 
their health. 
( )  
( )  
( )  
( )  
( )  
My family would be supportive of 
me taking PrEP. 
( )  
( )  
( )  
( )  
( )  
 
Part 3. What is your experience using the TheraPay mobile app? 
Please assess your experience using the TheraPay mobile app to support you in your journey using PrEP.  
 
Completely 
agree 
Agree 
Neither 
agree nor 
disagree 
Disagree 
Completely 
disagree 
1. The TheraPay mobile app meets my approval. 
1 
2  
3  
4  
5  
2. The TheraPay mobile app is appealing to me. 
1 
2  
3  
4  
5  
3. I like the TheraPay mobile app. 
1 
2  
3  
4  
5  
4. I welcome the TheraPay mobile app. 
1 
2  
3  
4  
5  
 
End Message: Thank you for completing this survey! We will ask you these same questions 
again later to see how your responses have changed. 

 
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42 
 
 
Patient Reported Outcomes – Set 2 
Activity Title: Your Experiences With PrEP  
Activity Description: This month we’ll ask you to answer questions about your experience using 
PrEP (pre-exposure prophylaxis). We’ll also ask some questions about your experience using 
this mobile app to support you taking PrEP. The survey is two parts with a total of 16 questions. 
It should take you 8-12 minutes to complete. 
Part 1. Tell us about your experience using PrEP  
 
Question 
Question #  
CAB LA Arm  
[14] 
Sub-concept 
Over the past 4 weeks, how confident were you that PrEP 
prevented you from acquiring HIV? 
 
Very confident 
 
Quite confident 
 
Somewhat confident 
 
A little confident 
 
Not at all confident 
 
1 
Perceived efficacy 
[CAB-LA arm] Over the past 4 weeks, did you experience any side 
effects, including injection site side effects (such as redness, 
bruising, or swelling) from the PrEP injection? 
 
No (branching logic to question 5) 
 
Yes (branching logic to show 3) 
 
2 
Acceptance of side 
effects 
Over the past 4 weeks, how acceptable or unacceptable did you 
find the side effects from PrEP? 
 
Very acceptable 
 
Acceptable 
 
Neither acceptable or unacceptable 
 
Unacceptable 
 
Very unacceptable 
 
3 
(branching 
logic) 
Acceptance of side 
effects 
Over the past 4 weeks, did the side effects of the PrEP medication 
interfere with your physical activity (such as lifting things, 
walking, jogging), your leisure or free time activities (such as 
gardening, reading, dancing, visiting friends), or your daily 
activities (such as shopping, working, house work, yard work)? 
 
No, not at all 
 
Yes, a little 
 
Yes, somewhat 
 
Yes, quite a bit 
 
Yes, very much 
4 (branching 
logic) 
Acceptance of side 
effects 
[CAB LA arm] Over the past 4 weeks, did you experience any pain 
when getting your PrEP injection? 
5 
Acceptance of side 
effects 

 
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43 
 
No (branching logic to question 7) 
 
Yes (branching logic to question 6) 
[CAB LA arm] Over the past 4 weeks, how acceptable or 
unacceptable did you find the pain you experienced when getting 
your PrEP injection? 
 
Very acceptable 
 
Acceptable 
 
Neither acceptable or unacceptable 
 
Unacceptable 
 
Very unacceptable 
 
6 
(branching 
logic) 
Acceptance of side 
effects 
[CAB LA arm] Over the past 4 weeks, how acceptable or 
unacceptable did you find the time it took to get the PrEP 
injection at your doctor’s office? 
 
 
Very acceptable 
 
Acceptable 
 
Neither acceptable or unacceptable 
 
Unacceptable 
 
Very unacceptable 
 
 
7 
Convenience 
[CAB LA arm] Over the past 4 weeks, how acceptable or 
unacceptable did you find the number of times you had to get 
your PrEP injection? 
 
 
Very acceptable 
 
Acceptable 
 
Neither acceptable or unacceptable 
 
Unacceptable 
 
Very unacceptable 
 
8 
Convenience 
[CAB LA arm] Over the past 4 weeks, how easy or difficult was it 
to remember to go to your appointments for your PrEP 
injection?   
 
 
Very easy 
 
Easy 
 
Neither easy or difficult 
 
Difficult 
 
Very difficult 
 
9 
Convenience 

 
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44 
[CAB LA arm] Over the past 4 weeks, how easy or difficult was it 
to fit in getting the PrEP injection into your daily life? 
 
 
Very easy 
 
Easy 
 
Neither easy or difficult 
 
Difficult 
 
Very difficult 
 
10 
Convenience 
Over the past 4 weeks, did you ever feel like you needed to hide 
your attendance to PrEP injection appointments so others would 
not see you? 
 
No, not at all 
 
Yes, occasionally 
 
Yes, often 
 
Yes, quite often 
 
Yes, all the time 
11 
Convenience 
Over the past 4 weeks, how convenient or inconvenient did you 
find taking the PrEP? 
 
Very convenient 
 
Convenient 
 
Neither convenient or inconvenient 
 
Inconvenient 
 
Very inconvenient 
 
12 
Convenience 
[CAB LA arm] In the future, would you choose to continue using 
the PrEP injection to protect yourself from HIV infection? 
 
 
Yes definitely  
 
Yes probably  
 
I don’t know 
 
Probably not 
 
Definitely not 
 
13 
Overall Acceptance 
[CAB LA arm] In the future, would you choose to switch to using 
the PrEP pill to protect yourself from HIV infection? 
 
 
Definitely not 
 
Probably not 
 
I don’t know 
 
Yes, probably  
 
Yes, definitely  
 
14 
Overall Acceptance 
Thinking about all aspects of using PrEP over the past 4 weeks, 
how acceptable or unacceptable did you find the medicine? 
 
Very acceptable 
 
Acceptable 
 
Neither acceptable or unacceptable 
 
Unacceptable 
 
Very unacceptable 
15 
Overall Acceptance 

 
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45 
Overall, over the past 4 weeks, how acceptable or unacceptable 
did you find taking all of your medicines, including PrEP and any 
other pills, tablets, or injections?  
 
Very acceptable 
 
Acceptable 
 
Neither acceptable or unacceptable 
 
Unacceptable 
 
Very unacceptable 
 
16 
Overall Acceptance 
 
 
Part 2. What is your experience using this mobile app? 
Please assess how appropriate the use of a mobile app has been to support you in your journey 
using PrEP.  
 
Completely 
agree 
Agree 
Neither 
agree 
nor 
disagree 
Disagree Completely 
disagree 
1. Using a mobile app to support me 
using PrEP seems fitting. 
1 
2  
3  
4  
5  
2. Using a mobile app to support me 
using PrEP seems suitable. 
1 
2  
3  
4  
5  
3. Using a mobile app seems 
applicable. 
1 
2  
3  
4  
5  
4. Using a mobile app to support me 
using PrEP seems like a good match. 
1 
2  
3  
4  
5  
 
End Message: Thank you for completing this survey! We will ask you these same questions 
again later to see how your responses have changed. 
Health Literacy Evaluation  - Month 2 
Activity Description: Was the pop quiz on PrEP medicine helpful? What did you learn? 
Activity:  
1. How helpful was the pop quiz reviewing important facts about PrEP? 
 
 
                       Very helpful           Somewhat helpful 
Not helpful 
2. True/False: A person who takes PrEP will also need to use condoms to prevent other STIs. 

 
[220084][4078] Version 8.10.23b 
46 
□ True 
 
That’s correct! PrEP only protects against HIV. Condoms will protect you against 
other sexually transmitted infections, such as syphilis, gonorrhea, or chlamydia. 
Condoms will also protect against unintended pregnancy. 
 
□ False 
 
Not quite. PrEP only protects against HIV. Condoms will protect you against 
other sexually transmitted infections, such as syphilis, gonorrhea, or chlamydia. 
Condoms will also protect against unintended pregnancy. 
 
Health Literacy Evaluation – Month 4  
Activity Description: Was the video on protecting yourself helpful? What did you learn? 
Activity:  
1. How helpful was the video on sexual health, safer IV drug use, and protecting yourself? 
 
2. True/False: All body parts used for sex should be tested for HIV & sexually transmitted 
infections (STIs). 
□ True 
That’s correct! In many cases, this means you should have three body parts tested – (1) 
the throat; (2) the front (vagina, front hole, penis, urethra); and (3) the back (anus and 
rectum). 
 
□ False 
Not quite. All body parts used for sex should be tested for STIs. In many cases, this 
means you should have three body parts tested – (1) the throat; (2) the front (vagina, 
front hole, penis, urethra); and (3) the butt hole and rectum. 
 
3. True/False: All sexually transmitted infections (STIs) will cause symptoms. 
a. True 
Not quite. Many STIs do not cause any symptoms that you would notice. It is important 
to get regular testing. 
 
b. False 
That’s correct! Many STIs do not cause any symptoms that you would notice. It is 
important to get regular testing. 
 
Health Literacy Evaluation – Month 6 

 
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47 
Activity Description: Was the video on “Building a Support System for HIV Prevention” helpful? What 
did you learn? 
Activity:  
1. How helpful was the video on building your support system? 
 
2. True/False: West Virginia Health Right has services available if you are facing stressors or 
challenges. 
□ True 
That’s right! There are many services available including telehealth appointments, 
health education classes, support for alcohol or drug addiction, LGBTQIA+ health, help 
from social workers, family planning services, dental and vision care, primary health 
care, behavioral or mental health care, pharmacy, and testing and screening for 
different health concerns. You can contact WVHR at 304-414-5930 for more 
information. 
 
□ False 
Not quite. There are many services available including telehealth appointments, health 
education classes, support for alcohol or drug addiction, LGBTQIA+ health, help from 
social workers, family planning services, dental and vision care, primary health care, 
behavioral or mental health care, pharmacy, and testing and screening for different 
health concerns. You can contact WVHR at 304-414-5930 for more information. 
 
3. True/False: A support person could be a partner, family member, friend, peer navigator, or 
social worker. 
 True 
That’s correct. Any one of these people could help support you. It’s your choice and 
completely up to you who you want to bring on your support team. 
 
 False 
Not quite. Any one of these people could help support you. It’s your choice and completely 
up to you who you want to bring on your support team. 
 
Health Literacy Evaluation – Month 8 
Activity Description: Was the article on “Being an Active Participant in Your Own Care” helpful? What 
did you learn? 
Activity:  

 
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48 
1. How helpful was the article on being an active participant in your own care? 
 
2. Which of the following best describes shared decision-making? 
 When your doctor makes a decision about your healthcare that they feel is in your 
best interest 
 
Not quite. Shared decision-making is a process where you and your healthcare providers 
work together to make decisions that reflect what’s most important to you while 
making sure your medications are safe and effective. 
 
 When you and your doctor work together to make a decision about your healthcare 
that considers your values, goals and concerns 
 
That’s right! Shared decision-making is a process where you and your healthcare 
providers work together to make decisions that reflect what’s most important to you 
while making sure your medications are safe and effective. 
 
 When your doctor works with another member of the care team (such as a nurse or 
social worker) to make a decision about your healthcare 
Not quite. Shared decision-making is a process where you and your healthcare providers 
work together to make decisions that reflect what’s most important to you while 
making sure your medications are safe and effective. 
 
3. True/False: Asking questions during your appointments is an important part of shared 
decision-making.  
 True 
That’s right! By asking your healthcare provider questions, you can get all of the 
information you need to make decisions about your health.  
 
 False 
Not quite. By asking your healthcare provider questions, you can get all of the 
information you need to make decisions about your health. 
Health Literacy Evaluation – Month 8 
Activity Description: Was the video on “Overcoming Stigma and Becoming a Health Advocate” helpful? 
What did you learn? 
Activity:  

 
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49 
1. How helpful was the video on overcoming stigma and becoming a health advocate? 
 
2. True/False: Stigma is when someone views a person or themselves in a negative way because 
of their unique identity, circumstances, and/or experiences.  
□ True 
That’s right! Stigma is a negative and unfair belief about someone because of a 
particular characteristic or attribute. 
 
□ False 
Not quite. Stigma is a negative and unfair belief about someone because of a particular 
characteristic or attribute. 
 
3. True/False: Sharing your experience with PrEP can help fight stigma surrounding it. 
□ True 
That’s right! Calling out biases and finding support within a community can help break 
the stigma cycle. 
 
□ False 
Not quite. Calling out biases and finding support within a community can help break the 
stigma cycle. 
 
 

 
[220084][4078] Version 8.10.23b 
50 
 
Appendix C: Oral PrEP Arm Instruments 
Activity Title: Baseline Information About You 
Activity Description: Today we’ll ask you to answer some questions about yourself. The survey 
is 17 questions and should take about 10 minutes to complete.  
Baseline Demographic Survey 
Question 
Question # 
What year were you born? [Write in] 
1 
Which of the following best describes your racial/ethnic background? (Select all that 
apply) 
 African American/Black 
 Asian/Pacific Islander 
 Caucasian/White 
 Hispanic/Latinx 
 Native American/Alaska Native 
 A race or ethnicity not listed: [Write in] 
2 
How do you describe your gender? (Select 1) 
 Female 
 Male 
 Transgender woman 
 Transgender man 
 Non-binary 
 A gender not listed: [Write in] 
3 
How do you describe your sexual orientation? (Select 1) 
 Heterosexual/Straight 
 Gay or Lesbian 
 Bisexual 
 Queer or Sexually Fluid 
 Pansexual 
 A sexual orientation not listed: [Write in] 
4 
What is the highest degree or school level you have completed? (Select 1) 
 Primary school 
 Some high school 
 High school diploma or GED 
 Some college  
 2-year college degree 
 4-year college degree 
 Graduate level degree 
 An school level not listed: [Write in] 
5 
What health coverage are you currently enrolled with? (Select up to 2) 
 Medicaid 
 Medicare 
 Affordable Care Act 
 Uninsured 
 Private health insurance 
6 

 
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51 
 A health coverage not listed: [Write in] 
Why are using pre-exposure prophylaxis (PrEP) to prevent HIV? [Select all that apply] 
 Reduce acquisition of HIV from sex 
 Reduce acquisition of HIV from IV drug use 
7 
The next 5 questions ask about your food, housing, and transportation routines from the past 12 months. 
If you have concerns and need support, please check in with your provider at your next visit or call 2-1-1 
for immediate support. 
In the last 12 months, was there a time when you were not able to pay the mortgage or 
rent on time? 
 No 
 Yes 
 Not applicable 
8 
In the last 12 months, was there a time when you did not have a steady place to sleep or 
slept in a shelter (including now)? 
 No 
 Yes 
9 
In the last 12 months, have you or the people you live with been unable to get utilities 
(heat, electricity) when it was really needed? 
 No 
 Yes 
10 
Within the past 12 months, the food you bought just didn’t last and you didn’t have 
money to get more. 
 Never true 
 Sometimes true 
 Often true 
11 
Within the past 12 months, has lack of transportation kept you from medical 
appointments, getting your medicines, non-medical meetings or appointments, work, or 
from getting things that you need?  
 No 
 Yes 
12 
Do you feel physically and emotionally safe where you currently live? 
 Yes 
 No 
13 
During the past 30 days, have you used any of the following? 
 
An illegal drug (such as by snorting it or injecting it) 
 
Pain killer to get high (like OxyContin, sometimes called Oxy or OC) or Percocet 
(sometimes called Percs) 
 
Prescription drugs not prescribed to you 
 No 
 Yes 
14 
People who experience discrimination may be at higher risk of negative health outcomes. Sharing your 
experiences with discrimination in everyday life and in healthcare settings may help researchers learn how to 
reduce negative health outcomes associated with discrimination.  
 
The next 3 statements describe how others may treat you.  
 

 
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52 
In your day-to-day life, how often do any of these happen to you? 
You are treated with less respect than other people are. 
 Never 
 Less than once a year 
 A few times a year 
 A few times a month 
 At least once a week 
 Almost every day 
 
15 
People act as if they’re better than you. 
 Never 
 Less than once a year 
 A few times a year 
 A few times a month 
 At least once a week 
 Almost every day 
 
16 
What do you think is the main reason for these experiences? (Select 1) 
 Your gender 
 Your sexual orientation 
 Your race 
 Your religion 
 Some aspect of your physical appearance 
 Your education or income level 
 Other: [Write in] 
17 
End Message: Thank you for completing this survey! 
 
Persistence Assessment 
Activity Title: Are You Still Taking PrEP? 
Activity Description: In this short survey, we’ll ask you some questions about your PrEP journey 
and any challenges you may have encountered. 
Activity:  
1. Are you still taking PrEP medicine by mouth? 
 Yes, I am taking PrEP (branching logic to question 4) 
 No, I stopped taking PrEP (branching logic to questions 2) 
 
2. Over the past week, how many days did you miss taking PrEP? 
 0 
 1 
 2 
 3 
 4 
 5 
 6 

 
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53 
 7 
3. If you stopped taking PrEP, which of the following best describes the reason(s) why? 
[Select up to 2] 
 I no longer feel I needed to take PrEP (branching logic to question 3 if selected) 
 It was too difficult to take PrEP with my schedule 
 I did not want people to know I was taking it or I felt I was being judged by 
others for taking PrEP 
 I did not like the side effects  
 I take too many medications 
 There were too many appointments as part of my PrEP care 
 I tested positive for HIV 
 Other: [Fill in the blank] 
 
4. Which of the following best describes why you no longer feel you need to take PrEP? 
 I am no longer having sex 
 I am in a monogamous relationship 
 I am no longer using injectable drugs 
 My partners and I are all regularly using condoms and getting tested for HIV  
 Other: [Fill in the blank] 
 
5. If you are still taking PrEP, what challenges have you experienced? [Select up to 2] 
 Have not experienced any challenges 
 Remembering to take PrEP every day 
 Keeping up with clinical visits and laboratory testing 
 Concerns about side effects 
 Finding transportation to my appointments 
 Stigma or discrimination from family, friends, or partner(s)  
 Stigma or discrimination from healthcare professionals 
 Other: [Fill in the blank] 
 
6. Did a healthcare provider (for example, a doctor, nurse, or pharmacist) or navigator 
ever ask you what may make it difficult for you to take PrEP?  
 Yes 
 No 
 Unsure 
End Message: Thank you for completing this survey! 
 
 
Patient Reported Outcomes – Set 1 
Activity Title: Your Experiences with PrEP  

 
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Activity Description: This month we’ll ask you to answer questions about your experience using 
PrEP and your thoughts about PrEP-related stigma. We’ll also ask some questions about your 
experience using this mobile app to support you taking PrEP. The survey is 3 parts with a total 
of 24 questions. It should take you 10-15 minutes to complete. 
Activity: 
Part 1. Tell us about your experience using PrEP  
The following questions are related to the PrEP medicine you use to protect you from HIV 
infection and your experience over the past 4 weeks. Please answer each question by selecting 
a number on each of the scales.  
1. How satisfied are you with your current medicine for PrEP? 
 
Very satisfied 
 
Satisfied 
 
Neither satisfied or dissatisfied 
 
Dissatisfied 
 
Very dissatisfied 
2. How bothered are you by any side effects from the medicine you use for PrEP? 
 
Very unbothered 
 
Unbothered 
 
Neither unbothered or bothered 
 
Bothered 
 
Very bothered 
 
I have not experienced any side effects in the last 4 weeks 
3. How satisfied are you with the convenience of PrEP recently? 
 
Very satisfied 
 
Satisfied 
 
Neither satisfied or dissatisfied 
 
Dissatisfied 
 
Very dissatisfied 
4. How satisfied are you with the discreetness of PrEP recently? 
 
Very satisfied 
 
Satisfied 
 
Neither satisfied or dissatisfied 
 
Dissatisfied 
 
Very dissatisfied 
5. How satisfied are you with your understanding of using PrEP to prevent HIV? 
 
Very satisfied 
 
Satisfied 

 
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55 
 
Neither satisfied or dissatisfied 
 
Dissatisfied 
 
Very dissatisfied 
6. How satisfied are you with the extent to which PrEP fits in with your lifestyle? 
 
Very satisfied 
 
Satisfied 
 
Neither satisfied or dissatisfied 
 
Dissatisfied 
 
Very dissatisfied 
 
7. Would you recommend this type of PrEP to someone else who wants to protect themselves from HIV? 
 
Yes, I would definitely recommend this type of PrEP 
 
Yes, I would recommend this type of PrEP 
 
Not sure if I would recommend or not recommend this type of PrEP 
 
No, I would not recommend this type of PrEP 
 
No, I would definitely not recommend this type of PrEP  
 
8. How satisfied would you be to continue your present form of PrEP? 
 
Very satisfied 
 
Satisfied 
 
Neither satisfied or dissatisfied 
 
Dissatisfied 
 
Very dissatisfied 
 
Part 2. What are your thoughts about PrEP-related stigma? 
Stigma is a negative and unfair belief about someone because of a particular characteristic or attribute. 
Please answer the following statements to the best of your ability.  
 
Indicate how much you agree with the following: 
 
Completely 
agree 
Agree 
Neither Agree 
or Disagree 
Disagree 
Completely 
disagree 
I feel ashamed to take PrEP 
pills in front of others. 
( )  
( )  
( )  
( )  
( )  
People experience negative 
judgment because they take 
PrEP. 
( )  
( )  
( )  
( )  
( )  

 
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56 
Someone taking PrEP should 
keep their pills hidden. 
( )  
( )  
( )  
( )  
( )  
 
 
Completely 
agree 
Agree 
Neither 
agree or 
disagree 
Disagree 
Completely 
disagree 
Someone taking PrEP would be 
seen by others as slutty. 
( )  
( )  
( )  
( )  
( )  
People taking PrEP receive praise 
for being responsible. 
( )  
( )  
( )  
( )  
( )  
My friends would be supportive of 
me taking PrEP. 
( )  
( )  
( )  
( )  
( )  
 
 
Completely 
agree 
Agree 
Neither 
agree or 
disagree 
Disagree 
Completely 
disagree 
Someone taking PrEP would be 
treated unfairly by their doctors. 
( )  
( )  
( )  
( )  
( )  
People experience problems when 
they tell their sex partner(s) they 
are taking PrEP.  
( )  
( )  
( )  
( )  
( )  
I feel proud to take PrEP. 
( )  
( )  
( )  
( )  
( )  
  
 
Completely 
agree 
Agree 
Neither 
agree or 
disagree 
Disagree 
Completely 
disagree 
 
 
 
 
 
 
People on PrEP are taking care of 
their health. 
( )  
( )  
( )  
( )  
( )  
My family would be supportive of 
me taking PrEP. 
( )  
( )  
( )  
( )  
( )  
 

 
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57 
Part 3. What is your experience using the TheraPay mobile app? 
Please assess your experience using the TheraPay mobile app to support you in your journey using PrEP.  
 
Completely 
agree 
Agree 
Neither 
agree nor 
disagree 
Disagree 
Completely 
disagree 
1. The TheraPay mobile app meets my approval. 
1 
2  
3  
4  
5  
2. The TheraPay mobile app is appealing to me. 
1 
2  
3  
4  
5  
3. I like the TheraPay mobile app. 
1 
2  
3  
4  
5  
4. I welcome the TheraPay mobile app. 
1 
2  
3  
4  
5  
 
Patient Reported Outcomes – Set 2 
Activity Title: Your Experiences With PrEP  
Activity Description: This month we’ll ask you to answer questions about your experience using 
PrEP (pre-exposure prophylaxis). We’ll also ask some questions about your experience using 
this mobile app to support you taking PrEP. The survey is two parts with a total of 16 questions. 
It should take you 8-12 minutes to complete. 
 
Part 1. Tell us about your experience using PrEP  
Question 
Question # 
Oral PrEP Arm  
[13] 
Sub-concept 
Over the past 4 weeks, how confident were you that PrEP prevented 
you from acquiring HIV? 
 
Very confident 
 
Quite confident 
 
Somewhat confident 
 
A little confident 
 
Not at all confident 
 
1 
Perceived efficacy 
[Oral PrEP arm] Over the past 4 weeks, did you experience any side 
effects from the PrEP pill? 
 
No (branching logic to question 5) 
 
Yes (branching logic to show 3) 
2 
Acceptance of side 
effects 
Over the past 4 weeks, how acceptable or unacceptable did you find 
the side effects from PrEP? 
 
Very acceptable 
 
Acceptable 
 
Neither acceptable or unacceptable 
 
Unacceptable 
 
Very unacceptable 
3 
(branching 
logic) 
Acceptance of side 
effects 
Over the past 4 weeks, did the side effects of the PrEP medication 
interfere with your physical activity (such as lifting things, walking, 
jogging), your leisure or free time activities (such as gardening, 
reading, dancing, visiting friends), or your daily activities (such as 
shopping, working, house work, yard work)? 
 
No, not at all 
4 
(branching 
logic) 
Acceptance of side 
effects 

 
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58 
 
Yes, a little 
 
Yes, somewhat 
 
Yes, quite a bit 
 
Yes, very much 
[Oral PrEP arm] Over the past 4 weeks, did you ever feel like you 
needed to hide your PrEP pills so others would not see them?  
 
No, not at all 
 
Yes, occasionally 
 
Yes, often 
 
Yes, quite often 
 
Yes, all the time 
5 
N/A 
 
[Oral PrEP arm] Over the past 4 weeks, how acceptable or 
unacceptable did you find the time it took to take your PrEP pill 
every day? 
 
 
Very acceptable 
 
Acceptable 
 
Neither acceptable or unacceptable 
 
Unacceptable 
 
Very unacceptable 
 
6 
Convenience 
[Oral PrEP arm] Over the past 4 weeks, how acceptable or 
unacceptable did you find the number of times you had to take your 
PrEP pill? 
 
 
Very acceptable 
 
Acceptable 
 
Neither acceptable or unacceptable 
 
Unacceptable 
 
Very unacceptable 
7 
Convenience 
[Oral PrEP arm] Over the past 4 weeks, how easy or difficult was it 
to remember to take your PrEP pills? 
 
 
Very easy 
 
Easy 
 
Neither easy or difficult 
 
Difficult 
 
Very difficult 
 
8 
Convenience 
[Oral PrEP arm] Over the past 4 weeks, how easy or difficult was it to 
fit in taking the PrEP pill into your daily life? 
 
Very easy 
 
Easy 
 
Neither easy or difficult 
 
Difficult 
 
Very difficult 
 
9 
Convenience 
Over the past 4 weeks, how convenient or inconvenient did you find 
taking the PrEP? 
 
Very convenient 
10 
Convenience 

 
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59 
 
Convenient 
 
Neither convenient or inconvenient 
 
Inconvenient 
 
Very inconvenient 
[Oral PrEP arm] In the future, would you choose to continue using 
the PrEP pill to protect yourself from HIV infection? 
 
Yes, definitely  
 
Yes, probably  
 
I don’t know 
 
Probably not 
 
Definitely not 
 
11 
Overall Acceptance 
[Oral PrEP arm] In the future, would you choose to switch to using 
the PrEP injection to protect yourself from HIV infection? 
 
 
Definitely not 
 
Probably not 
 
I don’t know 
 
Yes, probably  
 
Yes, definitely  
 
12 
Overall Acceptance 
Thinking about all aspects of using PrEP over the past 4 weeks, how 
acceptable or unacceptable did you find the medicine? 
 
Very acceptable 
 
Acceptable 
 
Neither acceptable or unacceptable 
 
Unacceptable 
 
Very unacceptable 
13 
Overall Acceptance 
Overall, over the past 4 weeks, how acceptable or unacceptable did 
you find taking all of your medicines, including PrEP and any other 
pills, tablets, or injections?  
 
Very acceptable 
 
Acceptable 
 
Neither acceptable or unacceptable 
 
Unacceptable 
 
Very unacceptable 
14 
Overall Acceptance 
 
Part 2. What is your experience using this mobile app? 
Please assess how appropriate the use of a mobile app has been to support you in your journey 
using PrEP.  
 
Completely 
agree 
Agree 
Neither 
agree 
nor 
disagree 
Disagree Completely 
disagree 
1. Using a mobile app to support me 
using PrEP seems fitting. 
1 
2  
3  
4  
5  

 
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60 
2. Using a mobile app to support me 
using PrEP seems suitable. 
1 
2  
3  
4  
5  
3. Using a mobile app seems 
applicable. 
1 
2  
3  
4  
5  
4. Using a mobile app to support me 
using PrEP seems like a good match. 
1 
2  
3  
4  
5  
 
End Message: Thank you for completing this survey! We will ask you these same questions 
again later to see how your responses have changed. 
 
Health Literacy Evaluation  - Month 2 
Activity Description: Was the pop quiz on PrEP medicine helpful? What did you learn? 
Activity:  
1. How helpful was the pop quiz reviewing important facts about PrEP? 
 
2. True/False: A person who takes PrEP will also need to use condoms to prevent other STIs. 
□ True 
 
That’s correct! PrEP only protects against HIV. Condoms will protect you against 
other sexually transmitted infections, such as syphilis, gonorrhea, or chlamydia. 
Condoms will also protect against unintended pregnancy. 
 
□ False 
 
Not quite. PrEP only protects against HIV. Condoms will protect you against 
other sexually transmitted infections, such as syphilis, gonorrhea, or chlamydia. 
Condoms will also protect against unintended pregnancy. 
 
Health Literacy Evaluation – Month 4  
Activity Description: Was the video on protecting yourself helpful? What did you learn? 
Activity:  
1. How helpful was the video on sexual health, safer IV drug use, and protecting yourself? 

 
[220084][4078] Version 8.10.23b 
61 
 
2. True/False: All body parts used for sex should be tested for HIV & sexually transmitted 
infections (STIs). 
□ True 
That’s correct! In many cases, this means you should have three body parts tested – (1) 
the throat; (2) the front (vagina, front hole, penis, urethra); and (3) the back (anus and 
rectum). 
 
□ False 
Not quite. All body parts used for sex should be tested for STIs. In many cases, this 
means you should have three body parts tested – (1) the throat; (2) the front (vagina, 
front hole, penis, urethra); and (3) the butt hole and rectum. 
 
3. True/False: All sexually transmitted infections (STIs) will cause symptoms. 
a. True 
Not quite. Many STIs do not cause any symptoms that you would notice. It is important 
to get regular testing. 
 
b. False 
That’s correct! Many STIs do not cause any symptoms that you would notice. It is 
important to get regular testing. 
 
Health Literacy Evaluation – Month 6 
Activity Description: Was the video on “Building a Support System for HIV Prevention” helpful? What 
did you learn? 
Activity:  
1. How helpful was the video on building your support system? 
 
2. True/False: West Virginia Health Right has services available if you are facing stressors or 
challenges. 
□ True 

 
[220084][4078] Version 8.10.23b 
62 
That’s right! There are many services available including telehealth appointments, 
health education classes, support for alcohol or drug addiction, LGBTQIA+ health, help 
from social workers, family planning services, dental and vision care, primary health 
care, behavioral or mental health care, pharmacy, and testing and screening for 
different health concerns. You can contact WVHR at 304-414-5930 for more 
information. 
 
□ False 
Not quite. There are many services available including telehealth appointments, health 
education classes, support for alcohol or drug addiction, LGBTQIA+ health, help from 
social workers, family planning services, dental and vision care, primary health care, 
behavioral or mental health care, pharmacy, and testing and screening for different 
health concerns. You can contact WVHR at 304-414-5930 for more information. 
 
3. True/False: A support person could be a partner, family member, friend, peer navigator, or 
social worker. 
 True 
That’s correct. Any one of these people could help support you. It’s your choice and 
completely up to you who you want to bring on your support team. 
 
 False 
Not quite. Any one of these people could help support you. It’s your choice and completely 
up to you who you want to bring on your support team. 
 
Health Literacy Evaluation – Month 8 
Activity Description: Was the article on “Being an Active Participant in Your Own Care” helpful? What 
did you learn? 
Activity:  
1. How helpful was the article on being an active participant in your own care? 
 
2. Which of the following best describes shared decision-making? 
 When your doctor makes a decision about your healthcare that they feel is in your 
best interest 
 
Not quite. Shared decision-making is a process where you and your healthcare providers 
work together to make decisions that reflect what’s most important to you while 
making sure your medications are safe and effective. 

 
[220084][4078] Version 8.10.23b 
63 
 
 When you and your doctor work together to make a decision about your healthcare 
that considers your values, goals and concerns 
 
That’s right! Shared decision-making is a process where you and your healthcare 
providers work together to make decisions that reflect what’s most important to you 
while making sure your medications are safe and effective. 
 
 When your doctor works with another member of the care team (such as a nurse or 
social worker) to make a decision about your healthcare 
Not quite. Shared decision-making is a process where you and your healthcare providers 
work together to make decisions that reflect what’s most important to you while 
making sure your medications are safe and effective. 
 
3. True/False: Asking questions during your appointments is an important part of shared 
decision-making.  
 True 
That’s right! By asking your healthcare provider questions, you can get all of the 
information you need to make decisions about your health.  
 
 False 
Not quite. By asking your healthcare provider questions, you can get all of the 
information you need to make decisions about your health. 
 
Health Literacy Evaluation – Month 8 
Activity Description: Was the video on “Overcoming Stigma and Becoming a Health Advocate” helpful? 
What did you learn? 
Activity:  
1. How helpful was the video on overcoming stigma and becoming a health advocate? 
 
2. True/False: Stigma is when someone views a person or themselves in a negative way because 
of their unique identity, circumstances, and/or experiences.  
□ True 
That’s right! Stigma is a negative and unfair belief about someone because of a 
particular characteristic or attribute. 
 

 
[220084][4078] Version 8.10.23b 
64 
□ False 
Not quite. Stigma is a negative and unfair belief about someone because of a particular 
characteristic or attribute. 
 
3. True/False: Sharing your experience with PrEP can help fight stigma surrounding it. 
□ True 
That’s right! Calling out biases and finding support within a community can help break 
the stigma cycle. 
 
□ False 
Not quite. Calling out biases and finding support within a community can help break the 
stigma cycle. 
 
Appendix D: Clinician Instruments 
 
PROVIDER SURVEY (Note: baseline survey) 
Thank you for agreeing to be part of this quality improvement project to improve care for those 
individuals taking PrEP. Your responses will remain confidential and anonymous.  
Part 1. Information About You and Your Patients 
1. What year were you born? [Write in] 
 
2. How do you describe your gender (response optional)? [Select 1] 
 Female 
 Male 
 Transgender woman 
 Transgender man 
 Non-binary 
 Prefer not to answer 
 A gender not listed: [Write in] 
 
 
3. Which of the following best describes your racial/ethnic background (response optional)? (Select all 
that apply) 
 African American/Black 
 Asian/Pacific Islander 
 Caucasian/White 

 
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65 
 Hispanic/Latinx 
 Native American/Alaska Native 
 A race or ethnicity not listed: [Write in] 
 
4. What is your role within the interprofessional team? [Select 1] 
 Physician  
 Physician assistant 
 Nurse practitioner 
 Nurse 
 Medical assistant 
 Pharmacist 
 Case manager 
 Social worker 
 Clinic administrative staff 
 A role on the interprofessional team not listed: [Write in] 
 
5. What is your role in the clinic for providing long-acting cabotegravir to your patients? (Select all that 
apply) 
 Prescribing  
 Medication procurement and/or dispensing 
 Administering injections 
 Patient scheduling 
 Coordinating clinic flow (i.e., room availability, nurse scheduling, availability of injection 
during appointment, etc) 
 Providing wraparound services (i.e., transportation, housing support, mental health 
resources, etc.) 
 Patient counseling 
 A role not listed: [write in] 
 
Part 2. Acceptability, Appropriateness, and Feasibility of Implementing Long-Acting Cabotegravir 
Injections 
Acceptability of Intervention Measure (AIM) 
 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. Our clinic process for providing long-
acting cabotegravir injections to our clients 
meets my approval. 
□ 
□ 
□ 
□ 
□ 

 
[220084][4078] Version 8.10.23b 
66 
2. Our clinic process for providing long-
acting cabotegravir injections to our clients 
is appealing to me. 
□ 
□ 
□ 
□ 
□ 
3. I like our clinic process for providing long-
acting cabotegravir injections to our clients. 
□ 
□ 
□ 
□ 
□ 
4. I welcome our clinic process for providing 
long-acting cabotegravir injections to our 
clients. 
□ 
□ 
□ 
□ 
□ 
 
Intervention Appropriateness Measure (IAM) 
 
Completely 
disagree 
Disagree 
Neither 
agree 
nor 
disagree 
Agree 
Completely 
agree 
1. Our clinic process for providing long-
acting cabotegravir injections to our clients 
seems fitting. 
□ 
□ 
□ 
□ 
□ 
2. Our clinic process for providing long-
acting cabotegravir injections to our clients 
seems suitable. 
□ 
□ 
□ 
□ 
□ 
3. Our clinic process for providing long-
acting cabotegravir injections to our clients 
seems applicable. 
□ 
□ 
□ 
□ 
□ 
4. Our clinic process for providing long-
acting cabotegravir injections to our clients 
seems like a good match. 
□ 
□ 
□ 
□ 
□ 
 
Feasibility of Intervention Measure (FIM) 
 
 
Completely 
disagree 
Disagree 
Neither 
agree 
nor 
disagree 
Agree 
Completely 
agree 
1. Long-term use of cabotegravir injections 
in our clinic seem implementable. 
□ 
□ 
□ 
□ 
□ 
2. Long-term use of cabotegravir injections 
in our clinic seem possible. 
□ 
□ 
□ 
□ 
□ 

 
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67 
3. Long-term use of cabotegravir injections 
in our clinic seem doable. 
□ 
□ 
□ 
□ 
□ 
4. Long-term use of cabotegravir injections 
in our clinic seem easy to continue. 
□ 
□ 
□ 
□ 
□ 
 
Part 3. Barriers and Facilitators for Implementation of Long-Acting Cabotegravir for PrEP 
1. Please rate your confidence in initiating and monitoring long-acting cabotegravir for PrEP.  
 Very high 
 High 
 Moderate 
 Low 
 Very low 
 Not applicable 
 
2. Please rate your confidence in administering long-acting cabotegravir for PrEP.  
 Very high 
 High 
 Moderate 
 Low 
 Very low 
 Not applicable 
 
3. Please rate your confidence in counseling patients in HIV prevention, addressing barriers to 
using PrEP, and supporting persistence. 
 Very high 
 High 
 Moderate 
 Low 
 Very low 
 Not applicable 
Please indicate how much you agree with the following: 
 
Strongly 
agree 
Agree 
Neutral 
Disagree 
Strongly 
disagree 
4. People experience negative 
judgment because they take 
PrEP. 
( )  
( )  
( )  
( )  
( )  
5. Someone taking PrEP would be 
seen by others as slutty. 
( )  
( )  
( )  
( )  
( )  

 
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68 
6. People taking PrEP receive 
praise for being responsible. 
( )  
( )  
( )  
( )  
( )  
7. Someone taking PrEP would be 
treated unfairly by their 
doctors. 
( )  
( )  
( )  
( )  
( )  
 
8. What barriers do you foresee in the implementation of long-acting cabotegravir for PrEP? 
[Select up to 2] 
 Patient’s ability to keep bimonthly appointments 
 Patient’s transportation for bimonthly appointments 
 Flagging/Clinic awareness of missed visits 
 Staffing resourcing for clinic flow 
 Rescheduling missed injections 
 Patients acquiring HIV due to missed dose/visit 
 Management of patients with other needs 
 Patient injection/soreness 
 
9. Which structural changes or resources may help facilitate long-acting cabotegravir 
implementation in your clinic? [Select up to 2] 
 Increased coordination with other departments (i.e., pharmacy) 
 Purchasing new refrigerators 
 Finding room space or working around room availability 
 Adjusting or extending staff working hours 
 Use of different staff for injections 
 Making transportation arrangements for patient participants 
 Expanding hours for injection visits (i.e., visits in morning or during lunch breaks) 
 Accommodating patients needing to reschedule injection visits (i.e. using walk-in visits, 
same-day appointments) 
 Other: [write in] 
 
10. How helpful do you think your clients will find the TheraPay mobile health app in supporting 
persistence with PrEP? 
 Very helpful 
 Somewhat helpful 
 Neither helpful or unhelpful 
 Somewhat unhelpful 
 Very unhelpful 
 
11. Do you have a preference for prescribing long-acting cabotegravir or daily oral PrEP? 

 
[220084][4078] Version 8.10.23b 
69 
 Prefer long-acting cabotegravir 
 Prefer oral daily PrEP 
 No preference 
 
12. How likely is it that your clinic will continue to offer cabotegravir following the completion of 
this study? 
 Very likely 
 Somewhat likely 
 Neutral 
 Somewhat unlikely 
 Very unlikely 
Thank you for taking the time to complete this survey. Please provide your work email address. Your 
email will not be tied to your survey responses and will only be used for the purposes of this quality 
improvement initiative.  
 Work email address: [Write in] 
THANK YOU FOR COMPLETING THIS SURVEY. 
PROVIDER SURVEY (Note: 6 months, 12 months and end of study) 
Thank you for agreeing to be part of this quality improvement project to improve care for those 
individuals taking PrEP. Your responses will remain confidential and anonymous.  
Part 1. Information About You and Your Patients 
6. What year were you born? [Write in] 
 
7. How do you describe your gender? [Select 1] 
 Female 
 Male 
 Transgender woman 
 Transgender man 
 Non-binary 
 Prefer not to answer 
 A gender not listed: [Write in] 
 
8. Which of the following best describes your racial/ethnic background? (Select all that apply) 
 African American/Black 
 Asian/Pacific Islander 
 Caucasian/White 

 
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70 
 Hispanic/Latinx 
 Native American/Alaska Native 
 A race or ethnicity not listed: [Write in] 
 
9. What is your role within the interprofessional team? [Select 1] 
 Physician  
 Physician assistant 
 Nurse practitioner 
 Nurse 
 Medical assistant 
 Pharmacist 
 Case manager 
 Social worker 
 Clinic administrative staff 
 A role on the interprofessional team not listed: [Write in] 
 
10. What is your role in the clinic for providing long-acting cabotegravir to your patients? (Select all that 
apply) 
 Prescribing  
 Medication procurement and/or dispensing 
 Administering injections 
 Patient scheduling 
 Coordinating clinic flow (i.e., room availability, nurse scheduling, availability of injection 
during appointment, etc) 
 Providing wraparound services (i.e., transportation, housing support, mental health 
resources, etc.) 
 Patient counseling 
 A role not listed: [write in] 
 
Part 2. Acceptability, Appropriateness, and Feasibility of Implementing Long-Acting Cabotegravir 
Injections 
Acceptability of Intervention Measure (AIM) 
 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. Our clinic process for providing long-
acting cabotegravir injections to our clients 
meets my approval. 
□ 
□ 
□ 
□ 
□ 

 
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71 
2. Our clinic process for providing long-
acting cabotegravir injections to our clients 
is appealing to me. 
□ 
□ 
□ 
□ 
□ 
3. I like our clinic process for providing long-
acting cabotegravir injections to our clients. 
□ 
□ 
□ 
□ 
□ 
4. I welcome our clinic process for providing 
long-acting cabotegravir injections to our 
clients. 
□ 
□ 
□ 
□ 
□ 
 
Intervention Appropriateness Measure (IAM) 
 
Completely 
disagree 
Disagree 
Neither 
agree 
nor 
disagree 
Agree 
Completely 
agree 
1. Our clinic process for providing long-
acting cabotegravir injections to our clients 
seems fitting. 
□ 
□ 
□ 
□ 
□ 
2. Our clinic process for providing long-
acting cabotegravir injections to our clients 
seems suitable. 
□ 
□ 
□ 
□ 
□ 
3. Our clinic process for providing long-
acting cabotegravir injections to our clients 
seems applicable. 
□ 
□ 
□ 
□ 
□ 
4. Our clinic process for providing long-
acting cabotegravir injections to our clients 
seems like a good match. 
□ 
□ 
□ 
□ 
□ 
 
Feasibility of Intervention Measure (FIM) 
 
Completely 
disagree 
Disagree 
Neither 
agree 
nor 
disagree 
Agree 
Completely 
agree 
1. Long-term use of cabotegravir injections 
in our clinic seem implementable. 
□ 
□ 
□ 
□ 
□ 
2. Long-term use of cabotegravir injections 
in our clinic seem possible. 
□ 
□ 
□ 
□ 
□ 
3. Long-term use of cabotegravir injections 
in our clinic seem doable. 
□ 
□ 
□ 
□ 
□ 
4. Long-term use of cabotegravir injections 
in our clinic seem easy to continue. 
□ 
□ 
□ 
□ 
□ 
 

 
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Part 3. Barriers and Facilitators for Implementation of Long-Acting Cabotegravir for PrEP 
13. Please rate your confidence in initiating and monitoring long-acting cabotegravir for PrEP.  
 Very high 
 High 
 Moderate 
 Low 
 Very low 
 Not applicable 
 
14. Please rate your confidence in administering long-acting cabotegravir for PrEP.  
 Very high 
 High 
 Moderate 
 Low 
 Very low 
 Not applicable 
 
15. Please rate your confidence in counseling patients in HIV prevention, addressing barriers to using 
PrEP, and supporting persistence. 
 Very high 
 High 
 Moderate 
 Low 
 Very low 
 Not applicable 
 
16. Please rate the impact of providing long-acting cabotegravir injections for PrEP on your workload in 
clinic.  
 Large increase in workload 
 Moderate increase in workload 
 No change in workload 
 Moderate decrease in workload 
 Large decrease in workload 
 
17. What barriers have you observed with the implementation of long-acting cabotegravir for PrEP? 
[Select up to 2] 
 Patient’s ability to keep bimonthly appointments 
 Patient’s transportation for bimonthly appointments 
 Flagging/Clinic awareness of missed visits 
 Staffing resourcing for clinic flow 
 Rescheduling missed injections 

 
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 Patients acquiring HIV due to missed dose/visit 
 Management of patients with other needs 
 Patient injection/soreness 
 
18. Which structural changes or resources have been most helpful in facilitating long-acting 
cabotegravir implementation in your clinic? [Select up to 2] 
 Increased coordination with other departments (i.e., pharmacy) 
 Purchasing new refrigerators 
 Finding room space or working around room availability 
 Adjusting or extending staff working hours 
 Use of different staff for injections 
 Making transportation arrangements for patient participants 
 Expanding hours for injection visits (i.e., visits in morning or during lunch breaks) 
 Accommodating patients needing to reschedule injection visits (i.e. using walk-in visits, 
same-day appointments) 
 Other: [write in] 
 
19. How could the process for use of long-acting cabotegravir injections for PrEP be improved? [Select 
up to 2] 
 Increased clinic staff 
 Redistribution of clinic duties to allow dedicated healthcare providers more time to support 
long-acting cabotegravir processes 
 Regular evaluation of LA-CAB processes for efficacy and potential problems 
 Additional staff education/training 
 Improve documentation/EMR 
 Improve communication and care coordination within the clinical team 
 Improve communication with clients using PrEP (i.e. reminders of upcoming appointments, 
rescheduling of missed appointments) 
 Other: [fill in blank] 
 
20. For participants who stopped taking long-acting injectable PrEP, which of the following best 
describes the most common reason(s) why? [Select up to 2]  
 They no longer have an indication or need for PrEP  
 They found it too difficult to take PrEP as prescribed with their lifestyle 
 They felt stigmatized by others for taking PrEP 
 They experienced side effects from taking PrEP 
 They take too many medications 
 They felt there were too many appointments as part of PrEP care 
 They tested positive for HIV 
 

 
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21. How helpful do you think your clients find the TheraPay mobile health app in supporting persistence 
with PrEP? 
 Very helpful 
 Somewhat helpful 
 Neither helpful or unhelpful 
 Somewhat unhelpful 
 Very unhelpful 
 
22. Do you have a preference for prescribing long-acting cabotegravir or daily oral PrEP? 
 Prefer long-acting cabotegravir 
 Prefer oral daily PrEP 
 No preference 
 
23. How likely is it that your clinic will continue to offer cabotegravir following the completion of this 
study? 
 Very likely 
 Somewhat likely 
 Neutral 
 Somewhat unlikely 
 Very unlikely 
Thank you for taking the time to complete this survey. Please provide your work email address. Your 
email will not be tied to your survey responses and will only be used for the purposes of this quality 
improvement initiative.  
 Work email address: [Write in] 
THANK YOU FOR COMPLETING THIS SURVEY. 
 
 
 

 
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Appendix E: Incentive Mapping 
 
Incentive Mapping for CAB-LA Arm 
 
Incentive Mapping for Oral PrEP Arm 
 
 
 
Time Frame
Activity
Incentive
Month 0
Baseline Demographic Survey
$20
Month 1
Persistence assessment
$5
PRO Survey #1
$10
Month 2
Health Literacy Survey
$10
Month 3
PRO Survey #2
$10
Persistence assessment
$10
Month 4
Health Literacy Survey
$10
Month 5
Persistence assessment
$15
PRO Survey #1
$15
Month 6
Health Literacy Survey
$10
Month 7
Persistence assessment
$15
Month 8
Health Literacy Survey
$10
Month 9
Persistence assessment
$15
PRO Survey #2
$20
Month 10
Health Literacy Survey
$10
Month 11
Persistence assessment
$25
PRO Survey #1
$25
Month 12
PRO Survey #2
$30
Time Frame
Activity
Incentive
Month 0
Baseline Demographic Survey
$20
Month 1
Persistence assessment
$5
PRO Survey #1
$10
Month 2
Health Literacy Survey
$5
Persistence assessment
$5
Month 3
PRO Survey #2
$10
Persistence assessment
$10
Month 4
Health Literacy Survey
$5
Persistence assessment
$10
Month 5
Persistence assessment
$10
PRO Survey #1
$10
Month 6
Health Literacy Survey
$5
Persistence assessment
$10
Month 7
Persistence assessment
$10
Month 8
Health Literacy Survey
$5
Persistence assessment
$10
Month 9
PRO Survey #2
$15
Persistence assessment
$15
Month 10
Health Literacy Survey
$5
Persistence assessment
$15
Month 11
Persistence assessment
$15
PRO Survey #1
$20
Month 12
Persistence assessment
$15
PRO Survey #2
$25

 
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Appendix F: Overview of TheraPay App Screens for Aurora PrEP Study  
 
 
WVHR CAB LA PrEP DEMO 2023 
Screenshots 
 
 
 
Opening Screen (this is the first screen members see after going through the sign-up process) 
 
 
 
Multiple Plan Carousel screen shows the different Plans for which a Highmark Healthy 
Rewards member is enrolled, the number of activities in the Plan, and 
the total rewards available in the Plan.  
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Overview screen shows all tasks each person is eligible within each plan, examples of the 
tasks in each plan are in the screenshots below. Tasks that have expired are marked by a red 
“x”, tasks that are open have an open check box, tasks that are still locked have a padlock 
image.  
 
 
               
 
 
 
 
 
 
 
 

 
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Up Next shows you only the open tasks, or in other words, all the activities that are available 
for you to complete now. Tasks will open on certain dates, or when previous tasks are 
completed that unlock the next task. 
                  
                
When members tap either the circles (in the Overview page) or the tiles (in the Up Next 
page), each one comes with more details. The screens below are for those pages. 
  
   

 
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In the My Money section, the member can see what their balance is on their card, any 
transactions from their card, and any special offers available to them. 
 
 
The My Progress Page shows how much progress a member has made against their activities 
and how much is still available. 
 
 
 
 
 
 
 
 
 
 

 
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Generic Push Notifications identify accomplishments, validations, and funds received.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix G: Study Schema 
 
 
Primary outcome measure: mean patient-reported adherence and persistence 
at months 3 and end of study, validated by medication ratio between the CAB-
LA and Oral PrEP cohorts  
 
Secondary outcome measure 1: retention in care in patients receiving CAB-LA 
vs oral PrEP defined as the proportion of patients presenting for their follow-
up appointments within 30 days of their scheduled visit at months 3, 9 and 12 
for the Oral PrEP cohort and at months 3, 9, and 11 for the CAB-LA cohort 
 
Secondary outcome measure 2: patient-reported outcomes including PrEP 
medication satisfaction, PrEP acceptance, and PrEP-related stigma, and 
barriers to adherence and reasons for PrEP discontinuation assessed through 
brief behavioral surveys 
 
Secondary outcome measure 3: implementation outcomes including patient 
acceptability (AIM), appropriateness (IAM), and helpfulness of the education 
modules within the digital health program assessed using a Likert scale and 
health literacy evaluation 
 
Secondary outcome measure 4: clinician acceptability, appropriateness, and 
feasibility of implementing long-acting cabotegravir injections (AIM, IAM, FIM), 
and barriers to and facilitators for implementation of CAB-LA 
CAB-LA PrEP Arm 
n = 70 
 
PrEP injections at months 
0, 1, 3, 5, 7, 9 and 11 
 
Education modules at 
months 2, 4, 6, 8, and 10 
Oral PrEP Arm 
n = 35 
 
PrEP prescription fills at months 
0, 3, 6, 9, and 12 
 
Education modules at months 2, 
4, 6, 8, and 10 
Patients >18 y/o who are newly started on PrEP therapy at WVHR and have 
access to a smart phone with data (N=105)   
V. 
Participants will have been prescribed CAB-LA, daily FTC/TDF, or daily 
FTC/TAF in accordance with the WVHR standard of care by a licensed 
HCP prior to enrolling in the study 
VI. 
Not receiving HIV PrEP care outside of WVHR 
VII. 
No positive HIV diagnosis 
VIII. 
No contraindications to oral or injectable PrEP therapy 

 
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Appendix H: Study Timelines 
 
 
  
 
Appendix I: Forms for Safety Reporting 
WV HealthRight will use GSK/ViiV reporting forms (for SAE, medical device incident and pregnancies. 
Completed forms will be sent to the GSK PV Operations group. 
SAFETY DATA EXCHANGE 
Adverse Event and Serious Adverse Event Definitions  
For the purposes of this Agreement, an Adverse Event (AE) shall mean any untoward medical 
occurrence whether thought to have been caused by the ViiV IMP or the Study or not, and a 
Serious Adverse Event (SAE) shall mean any adverse event which is fatal, life threatening, 
disabling or incapacitating, requires in-patient treatment or prolongs existing hospitalization, is 
a congenital anomaly in the off-spring of the patient or which may require intervention to 
prevent the previously stated outcomes.  
End of Study 
AIM, IAM, FIM, 
Follow-up 
Provider Survey 

 
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Medical Device Incident Definition 
 For the purposes of this Agreement a medical device incident is an inadequacy of a medical 
device with respect to its identity, quality, durability, reliability, safety, or performance. Device 
incidents include malfunctions, use errors, and/or deficiencies of the information supplied by 
the manufacturer. Device deficiencies/incidents may result in an SAE (including death or serious 
deterioration in health of a subject, or other non-participant person) or a non-serious AE, or 
lead to an SAE or AE if appropriate action had not been taken or, intervention had not occurred. 
The requirement to report medical device incidents applies to any incident occurring in 
association with a medical device provided in a ViiV commercial pack for the ViiV IMP(s) or any 
other known ViiV medicinal product.  
 
Reporting Clinical Safety Information to GSK on behalf of ViiV  
The Sponsor shall require the Participating Institution to report all Serious Adverse Events, 
Pregnancy Exposures and Medical Device Incidents disclosed by Study Subjects, or identified 
from review of Medical Records/Questionnaires during the course of the Study, for which the 
Participating Institution considers there to be a reasonable possibility of causal relationship 
with the ViiV IMP or any other known ViiV Product within 24 hours of first becoming aware of 
the event, regardless of Sponsor/designee expectedness assessments. Sponsor shall require of 
Participating Institutions that if the Participating Institution is unable to confirm whether ViiV is 
the manufacturer of the relevant product, Participating Institution shall nonetheless report the 
event to ViiV.  
 
Routing of Clinical Safety Data to GSK  
Notwithstanding Section 23 [‘NOTICES’] of the Agreement, such reports and information as 
outlined above, including Investigator causality assessments against all concerned ViiV 
Products(s) and English translations of all information where reporting is from a non-English 
speaking country, shall be sent to the: GSK PV Operations Group at email: OAX37649@gsk.com 
OR if Sponsor is unable to email the report, Sponsor may send the report via facsimile 

 
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88 
number+44-208 1814780. Should SPONSOR experience difficulty submitting a report, contact 
the ViiV individual listed in Section 23 “Notices”.  
 
Requesting Follow up information:  
The Sponsor shall require the Participating Institution to provide GSK’s safety department with 
details of whom GSK or ViiV shall address requests for follow up information from this Study, 
and further agrees to update such contact details as necessary. At the time of this Agreement, 
all such requests should be addressed to: David Hardy wdavidhardymd@gmail.com Sponsor 
shall require the Participating Institution shall submit to GSK (as specified above) such further 
detailed information relating there to as GSK shall request within 24 hours of it becoming 
available.