Implementation and Delivery of Lenacapavir for PrEP in a Community Pharmacy Setting
Phase: PHASE4
Conditions: HIV
Sponsor: Kelley-Ross & Associates, Inc.

DMID Specimen Protocol Template: Minimal Risk 
 
Version 1.0 
 
14 September 2025 
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IMPLEMENTATION AND DELIVERY OF 
LENACAPAVIR FOR PREP IN A COMMUNITY 
PHARMACY SETTING (L4P in Pharm) 
Protocol Number: 002 
 
National Clinical Trial (NCT) Identified Number: TBD 
 
Principal Investigator*: Elyse Tung, PharmD, BCACP 
 
Sponsor: Kelley-Ross Pharmacy Group 
 
Grant Title: INCLUSION: Implementation of Twice-yearly Lenacapavir 
to Address Unmet Needs in HIV Prevention) 
 
Grant Number: IN-US-974-7746 
 
Funded by: Gilead Sciences, Inc. 
 
28 July 2025 
 

DMID Specimen Protocol Template: Minimal Risk 
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i 
Statement of Compliance 
The study will be carried out in accordance with Good Clinical Practice (GCP) as required by 21 
CFR Part 50 Protection of Human Subjects (Informed Consent), 21 CFR Part 54 Financial 
Disclosure by Clinical Investigators, and 21 CRF Part 56 Institutional Review Boards.  

DMID Specimen Protocol Template: Minimal Risk 
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14 September 2025 
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ii 
SIGNATURE PAGE 
The signature below constitutes the approval of this protocol and the attachments and provides 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable US federal regulations and ICH guidelines. 
 
Site Investigator: 
 
Signed: 
 
Date: 
 
 
Elyse Tung, PharmD, BCACP 
Director of Clinical Services 
Kelley-Ross Pharmacy Group 
 
 
 

DMID Specimen Protocol Template: Minimal Risk 
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Table of Contents 
 
 
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iii 
Contents 
1 
Study Schema .................................................................................................................. vii 
1.1 
Subject Schema .................................................................................................... vii 
1.2 
Pharmacist Subject Schema ................................................................................. vii 
2 
Key Roles ........................................................................................................................... 1 
3 
Background Information and Scientific Rationale................................................................ 2 
3.1 
Background Information .......................................................................................... 2 
3.2 
Scientific Rationale ................................................................................................. 2 
4 
Objectives .......................................................................................................................... 3 
4.1 
Study Goal .............................................................................................................. 3 
4.2 
Aim 1 ...................................................................................................................... 3 
4.2.1 
Primary Objective ........................................................................................ 3 
4.2.2 
Secondary Objective ................................................................................... 3 
4.3 
Aim 2 ...................................................................................................................... 4 
4.3.1 
Primary Objective ........................................................................................ 4 
4.3.2 
Secondary Objective ................................................................................... 4 
5 
Study Design ...................................................................................................................... 5 
5.1 
Study Design .......................................................................................................... 5 
6 
Study Population ................................................................................................................ 7 
6.1 
Inclusion Criteria ..................................................................................................... 7 
6.2 
Exclusion Criteria .................................................................................................... 7 
6.2.1 
Additional Cohort Matching Exclusion Criteria ............................................. 7 
6.3 
Study Sample ......................................................................................................... 7 
6.4 
Recruitment ............................................................................................................ 7 
7 
STUDY PROCEDURES/EVALUATIONS ........................................................................... 9 
7.1 
Study Procedures ................................................................................................... 9 
7.2 
Screening and Enrollment ..................................................................................... 10 
7.2.1 
Screening Visit .......................................................................................... 10 
7.3 
Positive STI testing ............................................................................................... 12 
7.4 
Preliminary Positive HIV Test ................................................................................ 12 
7.5 
Initiation L4P Visit (Day 1 Visit) ............................................................................. 12 
7.6 
L4P Day 2 Oral Loading Dose .............................................................................. 14 
7.7 
Follow Up L4P Visits ............................................................................................. 14 
7.8 
Missed Injection Visits ........................................................................................... 15 
7.9 
L4P Discontinuation .............................................................................................. 16 
7.9.1 
Early study discontinuation assessment .................................................... 16 
7.9.2 
Study discontinuation visits ....................................................................... 16 
7.10 
Adherence Strategies ........................................................................................... 18 

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7.11 
Interventions ......................................................................................................... 18 
7.11.1 Pharmacist provider surveys ..................................................................... 18 
7.11.2 Study Participant Surveys ......................................................................... 18 
8 
Statistical Analysis ............................................................................................................ 20 
8.1 
Study Endpoints .................................................................................................... 20 
8.2 
Sample Size Considerations ................................................................................. 21 
8.3 
Analysis Plan ........................................................................................................ 21 
8.3.1 
Aim 1 ......................................................................................................... 21 
8.3.2 
Aim 2 ......................................................................................................... 21 
9 
SAFETY MONITORING AND ADVERSE EVENT REPORTING ...................................... 23 
9.1 
Safety Monitoring .................................................................................................. 23 
9.2 
Adverse Event Reporting ...................................................................................... 23 
9.2.1 
Definition of Adverse Events ..................................................................... 23 
9.2.2 
Time Period and Frequency for Reporting AE and SAE Information .......... 24 
9.2.3 
Method of Detecting AEs and SAEs .......................................................... 24 
9.2.4 
Follow-up of AEs and SAEs ...................................................................... 24 
9.2.5 
Pregnancy ................................................................................................. 25 
10 
Subject Confidentiality ...................................................................................................... 26 
10.1 
Informed Consent ................................................................................................. 26 
10.2 
Incentives ............................................................................................................. 26 
10.3 
Confidentiality ....................................................................................................... 26 
10.4 
Communicable Disease Reporting Requirements ................................................. 28 
10.5 
Study Discontinuation ........................................................................................... 28 
11 
TIMELINES ...................................................................................................................... 29 
12 
Presentation and publication plans ................................................................................... 30 
13 
Literature References ....................................................................................................... 31 
14 
APPENDICES .................................................................................................................. 33 
14.1 
Study Subject Informed Consent........................................................................... 33 
14.2 
Pharmacist Provider Informed Consent ................................................................ 33 
14.3 
Study Participant Surveys ..................................................................................... 33 
14.3.1 Baseline Survey ........................................................................................ 33 
14.3.2 HIVPrev-TSQs .......................................................................................... 37 
14.3.3 HIVPrev-TSQc .......................................................................................... 39 
14.3.4 HIVPrev-TSQ (early discontinuation) ......................................................... 39 
14.4 
Pharmacist Provider Survey .................................................................................. 43 
14.5 
Forms for Safety Data Reporting........................................................................... 44 
14.5.1 FDA Form 3500A ...................................................................................... 44 
 
 
 

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List of Abbreviations 
 
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v 
AE 
AFAB 
AMAB 
APR 
CAB-LA 
CDC 
Adverse event 
Assigned female at birth 
Assigned male at birth 
Antiretroviral Pregnancy Registry 
Long-acting cabotegravir 
Centers for Disease Control 
CFR 
CDTA 
CPA 
Code of Federal Regulation 
Collaborative drug therapy agreement 
Collaborative practice agreement 
DSMB 
ESD 
FDA 
Data and Safety Monitoring Board 
Early Study Discontinuation 
Food and Drug Administration 
FWA 
Federal-Wide Assurance 
GCP 
HIV 
Good Clinical Practice 
Human Immunodeficiency Virus 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IEC 
Independent or Institutional Ethics Committee 
IRB 
L4P 
Institutional Review Board 
Lenacapavir for PrEP 
MSM 
Men who have sex with men 
N 
Number (typically refers to subjects) 
NIH 
National Institutes of Health 
PI 
POC 
PrEP 
Principal Investigator 
Point of care  
Pre-exposure prophylaxis 
SAE 
Serious Adverse Event 
SMC 
Safety Monitoring Committee 
SOP 
STI 
TAF/FTC 
TDF/FTC 
TGW 
Standard Operating Procedure 
Sexually transmitted infection 
Tenofovir alafenamide/emtricitabine 
Tenofovir disoproxil fumarate/emtricitabine 
Transgender women 
WHO 
World Health Organization 
 
 
 
 

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vi 
IMPLEMENTATION AND DELIVERY OF 
LENACAPAVIR FOR PREP IN A COMMUNITY 
PHARMACY SETTING  
(IDLinC) 
 
Title 
Implementation and Delivery of Lenacapavir for PrEP in a 
Community Pharmacy Setting (IDLinC)
Funder 
Gilead Sciences, Inc. 
Study Design 
Prospective, longitudinal, observational, mixed methods study 
with a retrospective matched cohort study 
Study Population 
HIV uninfected people at risk of acquiring HIV infection, age 18 
and older, living in Washington State 
Study Size 
75 participants 
Study Duration 
Approximately 1 year 
Study Site(s) 
Kelley-Ross Pharmacy at the Polyclinic 
Kelley-Ross Capitol Hill Pharmacy
Intervention 
Description 
This is an open-label, single center study to evaluate 
implementation of a pharmacist-managed delivery of L4P in a 
community pharmacy setting and the impact of twice-yearly vs. 
quarterly PrEP visits on STI rates. 
Study Aim 
Aim 1: Evaluate the implementation of a pharmacist-managed 
L4P service in a community pharmacy setting. 
Aim 2: Compare the impact of twice-yearly vs quarterly PrEP 
visits. 
Primary 
Objective 
Aim 1: Evaluate the feasibility of a pharmacist-managed L4P 
service in a community pharmacy setting. 
Aim 2: Evaluate the effect of 6-month versus 3-month PrEP 
monitoring visits. 
Secondary 
Objective 
Aim 1: Evaluate the acceptability and effectiveness of a 
pharmacist managed L4P service. 
Aim 2: Compare visit frequency and STI positivity rates between 
people receiving PrEP visits every 3 months versus every 6 
months 
 

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1 
STUDY SCHEMA 
1.1 
Subject Schema 
 
1.2 
Pharmacist Subject Schema 
 
 
 
 
 
 
 
 

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2 
KEY ROLES 
 
Elyse Tung, PharmD, BCACP 
Director of Clinical Services 
Kelley-Ross Capitol Hill Pharmacy 
400 E Pine St Suite 100B Seattle, WA 98122 
Phone # 206-641-7766 
Fax # 206-641-7767 
Email: etung@kelley-ross.com   
 
Peter Shalit, MD, PhD, FACP, AAHIVS 
Medical Director 
901 Boren Ave Suite 850 Seattle, WA 98104 
Phone # 206-624-0688 
Fax # 206-624-2432 
Email: peter@tribalmed.com 
 
Alexi Duenas, PharmD 
Clinical Pharmacist  
Kelley-Ross Capitol Hill Pharmacy 
400 E Pine St Suite 100B Seattle, WA 98122 
Phone # 206-641-7766 
Fax # 206-641-7767 
Email: aduenas@kelley-ross.com   
 
Jolene Pfulmann 
Pharmacy Technician and Medical Billing Specialist 
Kelley-Ross Capitol Hill Pharmacy 
400 E Pine St Suite 100B Seattle, WA 98122 
Phone # 206-641-7766 
Fax # 206-641-7767 
Email: jpfulmann@kelley-ross.com 
 
Francis Slaughter 
Data Scientist 
Seattle’s LGBTQ+ Center 
400 E Pine St Suite 100 Seattle, WA 98122 
Phone # 206-860-6969 
Email: francis@gaycity.org 

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3 
BACKGROUND INFORMATION AND SCIENTIFIC 
RATIONALE  
3.1 
Background Information  
HIV pre-exposure prophylaxis (PrEP) is a comprehensive prevention strategy that 
utilizes antiretroviral medications in combination with behavioral risk reduction techniques to 
reduce the risk of acquiring HIV in high-risk individuals. For years, pharmacists have 
demonstrated success in managing PrEP through clinic-based protocols called collaborative 
practice agreements (CPAs) or collaborative drug therapy agreements (CDTAs). CPAs and 
CDTAs are formal practice relationships between a pharmacist and a prescriber that allow the 
pharmacist to perform certain functions that are beyond the typical scope of practice but are 
delegable under specified circumstances and allow the pharmacist to perform all functions 
necessary to manage medication therapy. Such functions include ordering and interpreting 
laboratory tests, initiating, managing, and administering medication therapy. CPAs are now legal 
in 48 states. 
 Kelley-Ross Pharmacy in Seattle has managed the U.S.'s first pharmacist-run PrEP 
clinic for 10 years. We have initiated over 5,000 patients on PrEP and currently have over 1,600 
active patients. In 2023, KR became the first pharmacy to offer LA-CAB for PrEP, and we 
presented our results in 2024. Since then, we have initiated 214 people with over 170 people 
still active on LA-CAB. The success and scalability of this program has led multiple pharmacies 
nationwide to replicate the service and inspired legislative changes in 10 states. With the 
upcoming approval of L4P, data on the management of the medication in community 
pharmacies will be needed, particularly the comparison between 3-month versus 6-month PrEP 
monitoring visits. Patients may find quarterly STI screenings burdensome, leading to 
discontinuation. 
3.2 
Scientific Rationale  
Until recently, only oral formulations of PrEP were available. With the availability of long-
acting PrEP injectables, new strategies will need to be developed to deliver this new treatment 
option. Current data shows that the management of oral PrEP in community pharmacy settings 
is feasible and acceptable. The availability of L4P offers an opportunity to expand PrEP access 
outside traditional healthcare settings. However, data on the feasibility and acceptability of L4P 
in community pharmacies is lacking. Community pharmacies are ideal for L4P due to their 
accessibility and the ability to utilize both pharmacy and medical billing for reimbursement of 
medication and clinical services, unlike traditional healthcare settings. Pharmacists are one of 
the most highly accessible healthcare professionals in the community. There are over 60,000 
community pharmacies across the U.S. The study will evaluate implementation outcomes 
(feasibility, acceptability), real-world effectiveness, and whether L4P can be used for same day 
starts or treatment switches. If successful, this model could expand L4P nationwide, reducing 
visit burden and increasing PrEP access. 

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4 
OBJECTIVES 
4.1 
Study Goal 
 
We aim to operate a demonstration project to evaluate the feasibility and 
acceptability of a pharmacist-managed L4P program in a community pharmacy 
setting. The study is divided into 2 aims.  
4.2 
Aim 1 
4.2.1 Primary Objective 
 
The primary objective is to evaluate the feasibility of a pharmacist-
managed L4P service in a community pharmacy setting.  
4.2.1.1 
Feasibility Outcomes 
Feasibility outcomes include retention, adherence, and persistence rates.   
 
Retention rate will be calculated by dividing the number of participants 
present in the study at 1 year by the number of individuals enrolled.  
 
Adherence rate will be collected as the proportion of injections that are 
successfully administered during each target injection window period over 
1 year. 
 
Persistence will be measured as the length of time a person remains on 
L4P for over 1 year.  
 
Sample characteristics will include baseline demographics (age, gender, 
race), housing status, HIV risk factors, PCP, and insurance status. 
4.2.2 Secondary Objective 
 
The secondary objective of Aim 1 is to evaluate the acceptability and 
effectiveness of a pharmacist managed L4P service.  
4.2.2.1 
Acceptability Outcomes  
 
Patient Acceptability: Measured by the HIV-PrevTSQs questionnaire at 
baseline (for those already on an FDA approved PrEP regimen within 3 
months from enrollment), 4-6 weeks and 1 year and HIV-PrevTSQc at 1 
year. 
 
Pharmacist Acceptability: Assessed using the FIM, AIM, and IAM surveys 
at baseline and 1 year. 
4.2.2.2 
Effectiveness Outcomes 
 L4P Initiations: Number of L4P starts by end of 1 year 
 Time to first injection 
 HIV Seroconversions: Rate at the end of 1 year  
 STI Rates: Rate at the end of 1 year 
 Reasons for early discontinuation  
 Adverse Reactions: Rates, including injection site reactions at 1 year.  

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4.3 
Aim 2 
4.3.1 Primary Objective  
 
The primary objective is to evaluate the effect of 6-month versus 3-month 
PrEP monitoring visits.  
4.3.1.1 
Primary Outcome 
 
Retention rate will be calculated by dividing the number of participants 
present in the study at 1 year by the number of individuals enrolled.  
 
4.3.2 Secondary Objective  
 
The secondary objective is to compare visit frequency and STI positivity rates 
between people receiving PrEP visits every 3 months versus every 6 months.  
4.3.3 Secondary Outcome 
 
Visit frequency will be measured as the overall number of PrEP visits and in-
between STI visits per person year. 
 
STI positivity rate will be measured as the number of chlamydia, gonorrhea, 
or syphilis diagnosed per 100 visits. 
 

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5 
STUDY DESIGN 
 
5.1 
Study Design 
We aim to conduct a prospective observational study enrolling 75 subjects into the cohort 
to report on the feasibility and acceptability of a pharmacist-managed L4P in a community 
pharmacy setting. This will be done as a longitudinal, observational, mixed methods study of our 
experiences of operating this service for 1 year using our existing pharmacy clinic models and 
infrastructure. We will also conduct a retrospective cohort study to assess the impact on PrEP 
visits every 3 months vs. every 6 months. All subjects must meet all eligibility criteria to 
participate in the study. Subjects will have the opportunity to start or switch to commercially 
available L4P. PrEP start will be defined as subjects starting PrEP who have not taken PrEP for 
the previous 3 months. All forms of FDA approved PrEP products indicated for each person will 
be offered, and each patient will have an opportunity to participate in the study. Patients 
interested in initiating will be offered the opportunity to enroll and provide informed consent. 
Initiation of L4P will be based on medical, laboratory, and coverage qualifications.  
Patients on L4P will be managed by a pharmacist provider utilizing a CDTA based on the 
DHHS Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and 
FDA approved label for lenacapavir. It will be administered on Day 1, Day 2 (oral loading dose 
only), and every six months thereafter. Subjects will be followed for 12 months, and electronic 
health record data will be collected retrospectively throughout the study duration. Subjects will 
be given a survey 4 to 6 weeks after initiation and at study end. Subjects will have the option to 
discontinue at any time for any reason and standards of care for discontinuation will be followed. 
Any participants who do not meet criteria for management under the CDTA (positive HIV 
screening, pregnancy, or other complicated health conditions) will be referred to their existing 
primary care provider or the clinic medical director for further management. Referral for 
substance abuse, mental health, and primary care services will also be provided. At the end of 
the study, each patient will complete a survey and be offered the option to continue 
commercially available L4P. 
L4P will be administered by the pharmacist provider. A pharmacist training program will 
be created by the study team and completed by all pharmacists providing L4P services. 
Pharmacies are health care settings, and as such, all safety measures will be followed for the 
administration of L4P. These include informed consent and counseling on risks versus benefits, 
post-injection observation, policies, and procedures in place for emergency services and allergic 
reactions. Access to epinephrine and diphenhydramine will be onsite. All pharmacist providers 
will have CPR and blood-borne pathogen training. Pharmacists who choose to enroll in the 
study and provide informed consent will be given at survey at study start and end. The 
pharmacist surveys will be validated psychometric assessments measuring implementation 
outcomes that often considered “leading indicators” of implementation success: Acceptability of 
Intervention (AIM), Intervention Appropriateness Measure (IAM), and Feasibility Intervention 
Measure (FIM). Pharmacists will be reimbursed $100 for completing surveys.  
A pharmacy technician will assist with administrative tasks such as scheduling, billing, 
prior authorizations, benefit verification, and patient assistance programs. Specific attention will 
be given to overcoming billing barriers. Commercial drug product will be utilized in this study. To 

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6 
create a sustainable program after funding ceases, real world reimbursement programs, such 
as insurance and patient assistance programs, will be used to reimburse pharmacist time for 
performing these clinical services and for the reimbursement of commercial drug product. 
Uninsured patients will have an opportunity to participate. The pharmacy technician will assist 
patients in enrolling in state and commercial drug assistance programs to cover service and 
medication costs.  
 
The study intervention is divided into 2 aims. For aim 1, we aim to conduct a prospective 
observational study enrolling 75 subjects into the cohort to report on the feasibility and 
acceptability of a pharmacist-managed L4P in a community pharmacy setting. This will be done 
as a longitudinal, observational, mixed methods study of our experiences of operating this 
service for 1 year. The primary objective is feasibility as measured by retention. Additional 
feasibility outcomes include adherence, persistence and seroconversion collected through EHR 
review. Secondary outcomes include acceptability (as determined by subject and provider 
subject surveys), STI rates, HIV seroconversions, reason for discontinuation, and pharmacist 
providers and patient perspectives on barriers and facilitators. In aim 2, subjects enrolled in the 
L4P cohort will have the option of conducting STI testing every 6 months versus every 3 
months. We will conduct a retrospective matched cohort study to assess the differences in 
retention and STI positivity rates between groups. All participants will be able to get tested in 
between monitoring visits. Primary outcome measure will be adherence to PrEP medication as 
measured by the proportion of people who successfully attend their PrEP monitoring visits over 
12 months. Secondary outcomes include visit frequency and STI positivity rate. Visit frequency 
will be measured as the overall number of PrEP visits and in-between STI visits per person 
year.  

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6 
Study Population 
6.1 
Inclusion Criteria 
Patients who meet all the following criteria are eligible for inclusion in this study:  
 
18 years of age or older at the time of screening 
 
Weight ≥ 35 kg  
 
HIV-negative status  
 
Willing to provide informed consent and undergo all required study procedures 
6.2 
Exclusion Criteria 
Participants who meet any of the following criteria will be excluded from this study: 
 
Unknown or positive HIV status 
 
Coadministration of drugs that significantly decrease lenacapavir concentrations 
according to the FDA package insert. 
 
Any participants that do not meet criteria for management under CDTA 
6.2.1 Additional Cohort Matching Exclusion Criteria  
 
Any subjects on 2-1-1 TDF/FTC PrEP regimen  
 
Any subjects on CAB-LA for PrEP regimen 
6.3 
Study Sample 
 
Aim 1: 75 subjects who meet all the inclusion criteria, none of the exclusion 
criteria, and provide informed consent will be enrolled as study participants 
 
Aim 2: Up to 300 subjects who meet all the inclusion criteria and none of the 
exclusion criteria will be selected as cohort matches 
6.4 
Recruitment 
 
Participants will be recruited through our existing panel of patients, as well as 
obtaining referrals from other PrEP providers. If insufficient recruitment exists, a 
multimedia outreach program of new patients from our local geographical area 
will be utilized. The recruitment strategies are designed to ensure broad 
awareness of the study while minimizing the risk of coercion and respecting 
participant autonomy. 
 
The cohort will be matched with our existing panel of PrEP patients as detailed in 
Section 8.3.2.  
6.4.1 Multimedia Outreach  
 
We will use platforms such as Google, Meta (Instagram), and Tik Tok 
to share IRB-approved advertisements about the study. Posts will 
include brief study description, eligibility criteria and contact 
information for interested individuals. All content will be reviewed and 
approved by the IRB prior to dissemination. We will not use direct 
messaging to contact potential participants.  
 
In-person recruitment will occur at the pharmacy and partner 
organization sites where our target population is likely to be present. 

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Trained study staff will provide brief, IRB-approved information about 
the study and offer flyers. Staff will respect all refusals to engage. As 
part of routine clinical care, all patients receiving HIV prevention 
services will be offered general information about a new PrEP option, 
lenecapavir. If a patient expresses interest in learning more about 
lenacapavir, study staff will provide additional clinical information. At 
that point, staff will also inform the patient about this optional research 
study. Interested individuals will be screened for eligibility and invited 
to participate in the study. Participation in the study is voluntary, and 
declining will not affect access to lenacapvir or services. Study staff 
will follow a standardized, IRB-approved recruitment script and 
consent process to minimize the risk of undue influence. 
 
Telephone recruitment of potential participants will be made with 
people who have previously consented to be contacted by the 
pharmacy. Call will be made by trained study staff using standardized, 
IRB-approved script. No cold-calling or unsolicited outreach will be 
conducted. Voicemails will only be left if the participant has previously 
consented to being contact by phone.  

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7 
STUDY PROCEDURES/EVALUATIONS 
7.1 
Study Procedures 
Study Procedures 
Procedure 
Preenrollment 
Screening 
Day 1 Initiation 
Day 2 
Follow Up L4P 
Early D/C 
End of study 
Pharmacist 
Informed Consent 
 
X 
 
 
 
 
 
Pharmacist training  
X 
 
 
 
 
 
 
FIM, AIM, IAM Survey 
X 
 
 
 
 
 
X 
Subject 
Study Interventions 
Informed Consent 
X 
 
 
 
 
 
 
Patient baseline demographics survey 
 
X 
 
 
 
 
 
HIVPrev-TSQs 
 
 
X 
 
X 
 
X 
HIVPrev-TSQc 
 
 
 
 
 
X 
X 
Electronic health record data collection 
 
X 
X 
X 
X 
X 
X 
Standard of Care per CDC Guidelines 
Medical history collection 
 
X 
 
 
 
 
 
Review of concomitant medications, medical conditions, 
and allergies 
 
X 
X 
 
X 
X 
X 
Patient interview for sexual history and recent risk 
events 
 
X 
X 
 
X 
X 
X 
Screening for STI symptoms 
 
X 
X 
 
X 
X 
X 
STI site testing  
 
X 
X 
 
X 
X 
X 
Assessment for acute signs and symptoms of HIV 
 
X 
X 
 
X 
X 
X 
Patient education on acute signs and symptoms of HIV 
 
 
X 
 
X 
 
 
Rapid HIV- 1/2 Ag/Ab 
 
 
X 
 
X 
X 
X 
4th generation Ag/Ab laboratory test 
 
 
X 
 
X 
X 
X 
HIV-1 RNA qualitative laboratory test 
 
 
X 
 
 
 
 
hCG pregnancy test 
 
 
X 
 
X 
X 
X 
PrEP choice counseling 
 
 
X 
 
X 
X 
X 
Risk reduction counseling 
 
 
X 
 
X 
X 
X 
Review of AEs and SAEs 
 
 
X 
 
X 
X 
X 
Adherence to target injection window period counseling 
 
 
X 
 
X 
X 
X 
In-depth discussion of L4P, patient counseling and 
education 
 
 
X 
 
 
 
 

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Patient attestation of counseling intervention 
 
 
X 
 
 
 
 
Drug dispensation and/or administration 
 
 
X 
X 
X 
 
X 
Recording and documentation of all SAEs 
 
 
X 
X 
X 
X 
X 
7.2 
Screening and Enrollment 
 
Screening will occur by pharmacist providers for all patients who request HIV PrEP 
consultation at Kelley-Ross One-Step PrEPTM clinic. This study will be open to patients 
both newly starting PrEP therapy and those who decide to switch from another PrEP 
regimen to L4P.  
 
Informed consent will be obtained for every study participant before any study 
procedures are initiated.  
 
All standard of care procedures as recommended by CDC PrEP guidelines and FDA 
approved labeling instructions for the medication will be followed.  
 
It is the responsibility of the PI to ensure that the subject is eligible for the study. Once 
eligibility has been confirmed, each subject will be assigned a unique subject number. 
Once a subject number has been assigned to a subject, it will not be reassigned to any 
other subject.  
 
The study will conclude after 1 year of operation from full study enrollment. The 
retrospective cohort study will be conducted after this 1 year of operations.  
 
Patients who choose L4P but decline to participate in the study will be able to access 
L4P through Kelley-Ross One-Step PrEPTM. Declining to be in the study will not preclude 
the individual from receiving care are Kelley-Ross Pharmacy.  
7.2.1 Screening Visit 
 
Written informed consent completed prior to any other assessments.  
 
Medical history taking including information about alcohol use in the past year, 
self-reported sexual risk events, medications used by the participant, allergies, 
recent sexual risk events, interest in using PrEP, self-identification of gender 
identity, sexual orientation, sex assigned at birth, education and employment 
status, housing status, use of tobacco and controlled substances, immunization 
status, height, and weight. 
 
Standard of care procedures for STI site testing, intervals, and symptom 
presentation will be conducted according to the CDC guideline.  
o Site specific testing will be provided based on patient’s needs: rectal 
swab, pharyngeal swab, vaginal swab, or urine sample for gonorrhea and 
chlamydia on a schedule in accordance with FDA labeling.  
o Syphilis testing: Blood sample collection for laboratory analysis. If 
screening is positive, confirmatory testing will be performed by laboratory.  

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11 
o Subjects who test positive for any STI will be treated in accordance with 
local STI guidelines.  
 
All standard of care procedures as recommended by CDC PrEP guidelines and 
FDA approved labeling instructions for commercially available L4P will be 
followed and include:  
o Rapid HIV-1/2 Ag/Ab test (or optimal test approved, per local standard).  
o Laboratory HIV- 1/2 4th generation Ag/Ab confirmatory test 
o HIV-1 RNA testing  
o Any subject with a positive HIV rapid test, laboratory 4th generation HIV 
test, or HIV-1 RNA result will receive counseling and be referred for 
appropriate care per procedures listed in the preliminary positive HIV 
tests (section 7.4).  
o Assessment for acute signs/symptoms of HIV.  
o Pregnancy testing for patients with the ability to conceive.  
o Patient interview for sexual history and recent events 
 
Patients who are not currently receiving PrEP who seek care 
within 72 hours after an isolated sexual or injection related HIV 
exposure will be evaluated and offered nPEP.  
o Risk reduction counseling, including provision of condoms.  
o Subjects will be educated on the signs and symptoms of acute HIV 
infection and will be instructed to call and/or present to the site 
immediately for evaluation and HIV testing.  
 
PrEP Choice Counseling  
o The pharmacist provider will determine the appropriate HIV prevention 
indication per CDC guidelines. The pharmacist provider will discuss all 
FDA-approved oral and injectable options for PrEP therapy deemed 
clinically indicated for the individual.  
o Pharmacist providers will use patient education materials as approved by 
the FDA and according to package labeling. Patients will be given an 
opportunity to ask questions to their satisfaction before choosing their 
preferred therapy.  
o Patients will have the opportunity to choose the PrEP medication best for 
them.  
o All patients will be provided with risk reduction counseling including 
provision of condoms as per standard of care.  

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12 
o Patients who choose L4P will then be offered study enrollment. L4P 
initiation visits may or may not occur on the date of study enrollment, 
pending benefits investigation and enrollment in patient assistance 
programs.  
7.3 
Positive STI testing  
 
Subjects who test positive for any STI will be treated in accordance with local STI 
guidelines.  
7.4 
Preliminary Positive HIV Test 
 
Any individuals with a reactive/positive POC HIV test at screening will not be eligible for 
this study and will promptly receive counseling and referred for appropriate medical care.  
 
Subjects who present to clinic with signs/symptoms of acute HIV, regardless of HIV test 
result, will not be eligible for enrollment until HIV has been ruled out with appropriate 
laboratory testing.  
 
Any subject with a positive HIV rapid test, laboratory 4th generation HIV test, or HIV-1 
RNA result will receive counseling and be referred for appropriate care.  
o The subject will immediately discontinue the study, receive counseling, and be 
referred for appropriate care.  
o Counseling will consist of explanation of test results, emotional support, 
emphasis on the importance of HIV medical care and decrease in risk behaviors, 
and referral to one of the following for appropriate care:  
 
Patient’s designated primary care provider or provider of their choice  
 
Medical Director, Peter Shalit, MD  
 
Public Health- Seattle & King County (PHSKC) Sexual Health Clinic 
 
For newly reactive HIV tests, patients may also be referred to the PHSKC 
One-on-One program.  
7.5 
Initiation L4P Visit (Day 1 Visit)  
 
Commercially available FDA approved L4P drug product will be used.  
 
The Day 1 (Initiation) visit will occur after screening and payment coverage for 
commercially available drug product has been confirmed. This can be through medical 
insurance, pharmacy insurance, patient assistance programs, or patient payment.  
 
Baseline demographics survey will be administered.  
 
HIV-PrevTSQs survey will be administered to all subjects switching from another PrEP 
regimen to L4P. Subjects that have not had any PrEP medication within the last 3 
months will be considered PrEP naïve and are not eligible to take the HIV-PrevTSQs at 
the Day 1 initiation visit.  

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13 
 
Standard of care procedures for STI site testing, intervals, and symptom presentation 
will be conducted according to CDC guidelines.  
o Site specific testing will be provided based on subject’s needs: rectal swab, 
pharyngeal swab, vaginal swab, or urine sample for gonorrhea and chlamydia.  
o Syphilis testing: blood sample collection for laboratory analysis. If screening is 
positive, confirmatory testing will be performed by laboratory.  
o Subjects who test positive for any STI will be treated in accordance with local STI 
guidelines.  
 
All standard of care procedures as recommended by CDC PrEP guidelines and FDA 
approved labeling instructions for commercially available L4P will be followed and 
include:  
o HIV virologic testing:  
 
Rapid HIV- 1/2 Ag/Ab test (or optimal test approved, per local standard).  
 
Laboratory HIV -1/2 4th generation Ag/Ab confirmatory test 
 
HIV-1 RNA testing 
 
Any subject with a positive HIV rapid test, laboratory 4th generation 
HIV test, or HIV-1 RNA result will receive counseling and be 
referred for appropriate care per procedures listed in preliminary 
positive HIV tests (section 6.4). The subject will no longer be 
permitted to participate in the study.  
o Assessment for acute signs/symptoms of HIV 
o Pregnancy testing for subjects with the ability to conceive 
o Risk reduction counseling, including provision of condoms  
o Review of changes in concomitant medications, medical conditions, and allergies 
since last visit  
o Review of AEs and SAEs 
o Subject interview for sexual history and recent risk events  
 
Subjects not receiving PrEP who seek care within 72 hours after an 
isolated sexual or injection related HIV exposure will be evaluated and 
offered nPEP 
o Adherence to target injection window period counseling  
o Subjects will be educated on the signs and symptoms of acute HIV infection and 
will be instructed to call and/or present to the site immediately for evaluation and 
HIV testing  
o Counseling will include an in-depth discussion of FDA approved patient 
information handout from package insert for L4P.  

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14 
o Subjects will be given an opportunity to ask questions to their satisfaction. 
Pharmacist provider will obtain subject attestation of counseling intervention prior 
to initiation.  
o Drug dispensation and administration  
 
L4P injections will be administered according to the FDA approved 
labeling instructions  
 
L4P oral loading dose will be administered according to the FDA 
approved labeling instructions. Day 1 600 mg L4P oral loading dose 
administration will be directly observed by the pharmacist provider at the 
L4P initiation visit. 
 
Day 2 600 mg L4P oral loading dose will be dispensed. Counseling on 
administration will be provided. 
o Serious Adverse Events:  
 
From the time of obtaining informed consent through the first 
administration of L4P, investigators will record all SAEs on FDA Form 
3500. All other untoward medical occurrences observed during the 
screening period, including exacerbation or changes in medical history, 
are to be captured in the electronic health record. See section 7 Safety 
Monitoring and Adverse Event reporting for additional details.  
7.6 
L4P Day 2 Oral Loading Dose  
 
Day 2 600 mg oral L4P dose will be dispensed at the L4P initiation visit.  
 
Pharmacist providers will contact all study subjects to confirm successful administration 
of 600 mg oral L4P the day after L4P initiation visit. Confirmation will be recorded in the 
EHR. 
7.7 
Follow Up L4P Visits 
 
Commercially available L4P drug product will be used.  
 
Administration of commercially available L4P must take place within 24 to 28 weeks after 
the last injection of L4P.  
 
Follow-up visits will occur once payment coverage for commercially available drug 
product has been confirmed. This can be through medical insurance, pharmacy 
insurance, patient insurance programs, or patient payment.  
 
Standard of care procedures for STI site testing, intervals, and symptom presentation 
will be conducted according to the CDC guidelines.  
o Site specific testing will be provided based on subject’s needs: rectal swab, 
pharyngeal swab, vaginal swab, or urine sample for gonorrhea and chlamydia on 
a schedule that is in accordance with CDC guidelines.  

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15 
o Syphilis testing: Blood sample collection for laboratory analysis. If screening is 
positive, confirmatory testing will be performed by the laboratory.  
o Subjects who test positive for any STI will be treated in accordance with local STI 
guidelines.  
 
All standard of care procedures as recommended by CDC PrEP guidelines and FDA 
approved labeling instructions for commercially available CAB-LA for PrEP will be 
followed and include:  
o HIV virologic testing:  
 
Rapid HIV-1/2 Ag/Ab test (or optimal test approved, per local standard).  
 
Laboratory HIV- 1/2 4th generation Ab/Ag confirmatory test  
 
Any subject with a positive HIV- 1/2 4th generation Ab/Ag result will 
receive counseling and be referred for appropriate care per procedures 
listed in preliminary positive HIV tests (section 6.4). The subject will no 
longer be permitted to participate in the study.  
o Assessment for acute signs/symptoms of HIV 
o Pregnancy testing for subjects with the ability to conceive 
o Risk reduction counseling, including provision of condoms  
o Changes in concomitant medications, medical conditions, and allergies since the 
last visit  
o Review of AEs and SAEs 
o Subject interval for sexual history and recent risk events 
o Adherence to target injection window period counseling  
o Subjects will be given an opportunity to ask questions to their satisfaction.  
o Drug dispensation and administration 
 
L4P will be administered according to FDA approved labeling instructions.  
o Serious Adverse Events:  
 
From the time of obtaining informed consent through the first 
administration of L4P, investigators will record all SAEs on the Gilead 
form. All other untoward medical occurrences observed during the 
screening period, including exacerbation or changes in medical history, 
are to be captured in the electronic health record. See section 7 Safety 
Monitoring and Adverse Event reporting for additional details.  
7.8 
Missed Injection Visits 
 
Study participants who miss their injection visit will be contacted on the same day of the 
missed appointment and rescheduled for another visit within their target injection 

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16 
window. Study participants will be contacted three times per standard of care clinic 
procedures to reschedule an injection visit. Any participant who does not respond will be 
considered lost to follow up and is no longer eligible for the study.  
 
If a subject cannot make an appointment within the injection window but can reschedule 
an injection visit outside the injection window, drug will be dispensed and administered 
as indicated by FDA labeling for missed injections. This includes continuing injections, 
bridging with oral L4P, or transitioning to oral PrEP therapy as approved by the FDA and 
detailed in product labeling.  
 
Subjects will be counseled on 
o How to safely continue or restart L4P  
o Need for daily oral PrEP or other effective HIV prevention methods if ongoing risk 
of HIV exposure is anticipated 
7.9 
L4P Discontinuation 
7.9.1 Early study discontinuation assessment   
 
Participants may voluntarily discontinue participation in the study at any time for 
any reason.  
 
Investigators will discontinue individual participation in the study for the following 
reasons: 
o L4P product-related toxicity requiring discontinuation per FDA labeling 
o Request by study participant to discontinue therapy  
o HIV acquisition 
o Initiation of medication contraindicated with L4P, as stated by FDA 
labeling 
 
Counseling will include an in-depth discussion of the following warning and 
precautions, as detailed in FDA labeling, prior to discontinuation:  
o How to safely discontinue or restart L4P  
o Need for daily oral PrEP or other effective HIV prevention methods if 
ongoing risk of HIV exposure is anticipated 
 
If study participants elect to transition to daily oral PrEP, the 
pharmacist provider will offer to retain subject within Kelley-Ross 
One-Step PrEP™ or transition PrEP care to a provider of the 
participants choosing.  
7.9.2 Study discontinuation visits 
 
Study discontinuation visits will occur 12 months from subject enrollment.  

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17 
 
HIV-PrevTSQs and HIV-PrevTSQc will be administered.  
 
At this visit, the subject will choose to continue with commercially available L4P, 
transition to another PrEP regimen, or counseled on how to safely discontinue 
L4P.  
 
Subjects who wish to discontinue L4P should be counseled about:  
o How to safely discontinue or restart L4P for PrEP  
o Need for daily oral PrEP or other effective HIV prevention methods if 
ongoing risk of HIV exposure is anticipated 
 
Standard of care procedures for STI site testing, intervals, and symptom 
presentation will be conducted according to the CDC guideline.  
o Site specific testing will be provided based on subject’s needs: rectal 
swab, pharyngeal swab, vaginal swab, or urine sample for gonorrhea and 
chlamydia on a schedule that is in accordance with CDC guidelines.  
o Syphilis testing: Blood sample collection for laboratory analysis. If 
screening is positive, confirmatory testing will be performed by the 
laboratory.  
o Subjects who test positive for any STI will be treated in accordance with 
local STI guidelines.  
 
All standard of care procedures as recommended by CDC PrEP guidelines and 
FDA approved labeling instructions for commercially available CAB-LA for PrEP 
will be followed and include:  
o HIV virologic testing:  
 
Rapid HIV-1/2 Ag/Ab test (or optimal test approved, per local 
standard).  
 
Laboratory HIV- 1/2 4th generation Ab/Ag confirmatory test  
 
HIV-1 RNA testing  
 
Any subject with a positive HIV-1 RNA result will receive 
counseling and be referred for appropriate care per procedures 
listed in preliminary positive HIV tests (section 6.4). The subject 
will no longer be permitted to participate in the study.  
o Assessment for acute signs/symptoms of HIV 
o Pregnancy testing for subjects with the ability to conceive 
o Risk reduction counseling, including provision of condoms  
o Changes in concomitant medications, medical conditions, and allergies 
since the last visit  
o Review of AEs and SAEs 

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18 
o Subject interval for sexual history and recent risk events 
o Adherence to target injection window period counseling  
o Subjects will be given an opportunity to ask questions to their satisfaction.  
o Drug dispensation and administration 
 
L4P will be administered according to FDA approved labeling 
instructions.  
o Serious Adverse Events:  
 
From the time of obtaining informed consent through the first 
administration of L4P, investigators will record all SAEs on FDA 
form 3500. All other untoward medical occurrences observed 
during the screening period, including exacerbation or changes in 
medical history, are to be captured in the electronic health record. 
See section 7 Safety Monitoring and Adverse Event reporting for 
additional details.  
7.10 Adherence Strategies 
 
Subject adherence to target injection date will be monitored through our electronic health 
record.  
 
If an injection is missed, an alert to staff will be made by the EHR and procedures for 
missed injections (Section 6.8) will be followed.  
7.11 Interventions 
7.11.1 Aim 1:  
7.11.1.1 Pharmacist provider surveys 
 
Investigators will administer FIM, AIM, and IAM surveys to pharmacist 
providers prior to training and 1 year after service implementation of L4P. 
Surveys are detailed in the appendix (Section 14.4)  
7.11.1.2 Study Participant Surveys 
 
Study participant surveys will be administered according to the following 
schedule  
o At L4P initiation visit: All study subjects will complete the baseline 
demographics survey. The HIV-PrevTSQs will be administered to 
patients on a PrEP regimen within the last 90 days prior to enrollment. 
Any subjects who have not had PrEP in the last 90 days will not be 
eligible for this survey.  

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19 
o Four to six weeks after first L4P injection: HIV-PrevTSQs for all 
participants remaining in the study 
o 12 months after study enrollment: HIV-PrevTSQs and HIV-PrevTSQc 
for all participants remaining in the study 
 
Surveys are detailed in the appendix (Section 14)  
 
7.11.2 Aim 2:  
7.11.2.1 Retrospective Case Control Matched Cohort 
 
The 75 subjects who provided informed consent will be retrospectively case 
control matched to a cohort of people for age, gender identity, insurance 
status, postal code, predictors of STI risk, number of partners, genders of 
partners, condomless sex, receptive anal sex. Adjustments will be made to 
matching ratio if all matches are not found.  
 
Data collected through retrospective chart review of the case control matched 
cohort will include visit frequency and outcome of bacterial STI acquisition. 
Bacterial STI acquisition includes acquiring one or more of the following STI’s 
gonorrhea, chlamydia, syphilis.  
 
This aim involves a retrospective chart review of matched control subjects. 
Access to protected health information (PHI) is necessary to identify eligible 
cases and appropriate matched controls, and to extract relevant clinical 
variables. This research poses no more than minimal risk to privacy since 
PHI will be accessed only by study personnel, stored securely, and will be de-
identified or destroyed at the earliest opportunity consistent with the research 
aims. Therefore, a waiver of written HIPAA authorization for the matched 
cohort is needed. 
 
If, for any reason, a subject’s record is flagged as restricted or if the IRB or 
requires exclusion, those records will not be included in the research dataset, 
and no PHI from those individuals will be retained or used. All other records 
will be handled according to the study’s HIPAA protections and de-
identification procedures. 
 
 

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8 
STATISTICAL ANALYSIS 
 
8.1 
Study Endpoints 
 
Primary Endpoints 
 
Aim 1 
 
Retention rate will be calculated by dividing the number of participants 
present in the study at 1 year by the number of individuals enrolled.  
 
Adherence rate will be collected as the proportion of injections that are 
successfully administered during each target injection window period over 
1 year. 
 
Persistence will be measured as the length of time a person remains on 
L4P for over 1 year.  
 
Aim 2 
 
Retention rate will be calculated by dividing the number of participants 
present in the study at 1 year by the number of individuals enrolled.  
 
Secondary Endpoints 
 
Aim 1 
 
Patient Acceptability: Measured by the HIV-PrevTSQs questionnaire at 
baseline (for those already on an FDA approved PrEP regimen within 3 
months from enrollment), 4-6 weeks and 1 year and HIV-PrevTSQc at 1 
year. 
 
Pharmacist Acceptability: Assessed using the FIM, AIM, and IAM surveys 
at 1 year. 
 
L4P Initiations: Number of L4P starts by end of 1 year 
 
HIV Seroconversions: Incidence of HIV seroconversions as defined by 
HIV RNA by PCR  
 
STI Rates: Rate at the end of 1 year 
 
Reasons for early discontinuation  
 
Aim 2 
 
Visit frequency will be measured as the overall number of PrEP visits and 
in-between STI visits per person year. 
 
STI positivity rate will be measured as the number of chlamydia, 
gonorrhea, or syphilis diagnosed per 100 visits. 
 

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8.2 
Sample Size Considerations 
 
We aim to enroll 75 patient participants into this program during the first year. We 
hypothesize that at least 50% of participants will remain on L4P at 12 months. Using 
a 95% confidence interval (CI) with a critical value of 1.96, our standard error is 0.0577, 
resulting in an estimated CI range of 0.387 to 0.613. If retention falls below 50%, we will 
reassess the feasibility of scaling the intervention. 
 
 
For the retrospective cohort analysis, we will compare the L4P group to patients on a 
different PrEP formulation during the same 18-month period as detailed by section 6.2.1. 
We will perform a matched cohort study and then further confirm our findings using 
propensity score matching.  
8.3 
Analysis Plan 
8.3.1 Aim 1 
 
Statistical analyses will be conducted using both descriptive and comparative 
methods to assess the study’s primary and secondary outcomes. Descriptive 
statistics will be used to summarize baseline and outcome variables. Categorical 
variables, including demographics, HIV risk factors, housing status, retention, 
and adherence will be summarized using frequencies, medians, and modes to 
describe central tendencies. Proportions will be presented with corresponding 
confidence intervals. Ordinal variables, such as Likert-scale survey responses, 
will be assessed using medians and interquartile ranges to evaluate distributions. 
Continuous variables, such as age, will be analyzed using measures of central 
tendency and variability, including the mean, median, standard deviation, and 
range.  
 
 
Comparative analyses will be performed to evaluate differences between 
subgroups. Differences in retention and adherence will be assessed using Chi-
squared or Fishers exact tests for categorical variables, as appropriate. Ordinal 
and continuous variables, such as Likert scale responses, will be compared 
using non-parametric methods, including the Mann-Whitney U test or Kruskal-
Wallis test, depending on the number of comparison groups.  
8.3.2 Aim 2 
 
We will attempt to match our cohort on 1:4 6-month follow-up to 3-month follow-
up.  We will match on covariates chosen a priori based on previous studies. 
Covariates will include the following: age, gender identity, insurance status, 
postal code, predictors of STI risk, number of partners, genders of partners, 
condomless sex, receptive anal sex. Adjustments will be made to matching ratio 
if all matches are not found. 

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22 
 
To provide more robust results, we will use propensity score matching to 
approximate the effect of randomization by balancing observed covariates 
between study groups. As done in the matched retrospective cohort we will 
select a group of comparison patients who had 3-month follow up who are most 
like our participants who had 6-month follow up. Following the methods laid out 
by Montaño et. al., we will include all collected variables in our propensity score 
model, related to PrEP eligibility, sexual behavior, STI risk, recent STI diagnoses, 
and demographic characteristics. We will then match on propensity score. The 
period for patients in the 3-month follow up group who will be matched on 
propensity score will be those who were enrolled in the center at time of study 
initiation to its conclusion. 
 
 
We will initially analyze results using conditional logistic regression using the 
binary outcome of bacterial STI acquired or not. We will compare those in the 6-
month follow-up group to those in the 3-month follow-up group with the outcome 
of bacterial STI acquisition at any point during the study period. Bacterial STI 
acquisition includes acquiring one or more of the following STI’s gonorrhea, 
chlamydia, syphilis. We will exclude 6-month follow up participants who left the 
study prematurely and their corresponding matches. This analysis will be done 
for both retrospective cohort 1:M match as well as propensity score. 
 
 
As a secondary analysis we use Poisson regression to compare incidence of 
bacterial STI acquisition between 6-month follow-up group to those in the 3-
month follow-up group. This analysis will be done on time to event and thus will 
not exclude those who dropped out of study prematurely and instead include 
them as person time.  
 
 
Data cleaning, matching and analyses will be conducted using R statistical 
software (version 4.4.0 or later) 

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9 
SAFETY MONITORING AND ADVERSE EVENT 
REPORTING 
9.1 
Safety Monitoring 
 
Close cooperation between study team members will be necessary to monitor 
participant safety and to respond to safety events in a timely manner. The team 
will have regularly scheduled conference calls during the study and additional ad 
hoc calls will be convened if required.  
 
All pharmacist providers are responsible for continuous close monitoring and 
management of AEs. Sites will have detailed SOPs describing methods for AE 
reporting to ensure that AEs are reported and managed in accordance with the 
protocol. In the case of drug-related toxicities, pharmacy providers will follow the 
FDA package insert and CDC PrEP guidelines. Information on the identified and 
potential risks with L4P and the recognized adverse events can be found in the 
FDA package insert for L4P. 
 
All safety measures will be followed for the administration of L4P. These include 
informed consent, counseling on risks versus benefits, patient observation for 10 
minutes post-injection, policies and procedures in place for emergency services, 
and allergic reactions. Access to epinephrine and diphenhydramine will be onsite. 
All pharmacist providers will have CPR and blood-borne pathogen training.   
9.2 
Adverse Event Reporting 
9.2.1 Definition of Adverse Events 
 
An adverse event (AE) is defined as any untoward medical occurrence in a 
patient or clinical investigation participant, temporally associated with the 
use of a medicinal product, whether or not considered related to the 
medicinal product. An AE can therefore be any unfavorable and 
unintended sign, symptom, or disease temporally associated with the use 
of a medicinal product.  
 
A serious adverse event (SAE) is defined as any untoward medical 
occurrence that, at any dose, results in death, is life threatening, requires 
hospitalization or prolongation of existing hospitalization, results in 
disability/incapacity, is a congenital abnormality/birth defect, or other 
situations. Medical or scientific judgment should be exercised in deciding 
whether reporting is appropriate in other situations, such as important 
medical events that may not be immediately life-threatening or result in 
death or hospitalization but may jeopardize the subject or may require 
medical or surgical intervention to prevent one of the other outcomes listed 
in the above definition. These should also be considered serious. 

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24 
 
All persons with study involvement are responsible for detecting, 
documenting, and reporting events that meet the definition of AE or SAE 
and are responsible for following up with AEs that are considered serious, 
considered related to the study intervention or the study, or cause the 
participant to discontinue.  
9.2.2 Time Period and Frequency for Reporting AE and SAE 
Information  
 
All AE information will be collected from the first injection visit (Day 1) until 
either patient discontinuation or study end; whichever comes first at all 
specified timepoints (see Table 1).  
 
All SAE information will be collected from signing of informed consent form 
until either patient discontinuation or study end, whichever comes first at all 
specified timepoints (see Table 1). 
 
Medical occurrences that begin after obtaining informed consent and prior to 
the first injection visit (Day 1) will be recorded within the patient’s electronic 
health record.  
 
All SAEs considered related to L4P will be recorded and reported to the 
sponsor within 24 hours of notification. Any updated information about the 
SAE will be submitted to the sponsor within 24 hours of it being available. 
Email is the preferred method for communication of SAEs. If email is not 
available, communication will be submitted by facsimile.  
 
Investigators are not obligated to actively seek AE or SAE data after the 
study conclusion; however, if the investigator learns of any SAE, including a 
death, at any time after the participant is no longer enrolled in the study, and 
they consider the event to be reasonably related to the study intervention or 
participation, the investigator must notify the sponsor.  
9.2.3  Method of Detecting AEs and SAEs 
 
AEs and SAEs will be detected through patient interview at all specified time 
points (Table 1). Care will be taken not to introduce bias when detecting AE 
and/or SAE with open-ended and non-leading verbal questioning as the 
preferred method.  
9.2.4 Follow-up of AEs and SAEs 
 
After the initial AE/SAE report, the investigator is required to proactively 
follow each participant at subsequent visits/contacts. All SAEs will be 

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25 
followed until the event is resolved, stabilized, or otherwise explained, or the 
participant is lost to follow-up. 
9.2.5 Pregnancy 
 
Women of childbearing potential must have a negative pregnancy test at the 
initiation visit. Pregnancy testing will also be conducted as described in the 
Study Procedures (Table 1) and at any time during the study when pregnancy 
is suspected. If a pregnancy is reported, the investigator will inform Gilead 
within 7 days of learning of the pregnancy and the participant will no longer 
be eligible to participate in the study. Pregnancies will be reported to the 
Antiretroviral Pregnancy Registry (APR).  
 
Upon confirmation of a pregnancy, the pharmacist provider will consult with 
the medical director for referral for comprehensive prenatal care and 
transition of PrEP.  
 

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26 
10 
SUBJECT CONFIDENTIALITY  
10.1 Informed Consent 
 
Written informed consent will be obtained from every study participant prior to any 
study procedures. See Informed Consent document in Appendix (Sections 14.1 
and 14.2). Discussion of risks and possible benefits of participants in this study 
will be provided to study participants. Consent forms describing the study 
procedures and risks are given to the participant and written documentation of 
informed consent is required prior to study enrollment. Consent forms will be IRB 
approved, and the participant will be asked to read and review the document. The 
investigator will then explain the research study to the participant and answer any 
questions. The participant will have the opportunity to think about enrollment in 
the study prior to agreeing to participate. Study participants may withdraw their 
consent at any time during the study for any reason. A copy of the informed 
consent document will be given to participants for their records. The rights and 
welfare of the subjects will be protected by emphasizing to them that the quality of 
their medical care will not be adversely affected if they decline to participate in this 
study. 
10.2 Incentives 
 
Pending IRB approval, participants will be compensated for their time and effort in 
this study. Reimbursement amounts will be specified in the study informed 
consent forms.  
10.3 Confidentiality 
 
The investigator will ensure that subjects’ anonymity will be strictly maintained and 
that their identities are protected from unauthorized parties.  
 
Each study subject will be assigned a unique subject number by the investigator. 
Once a subject number has been assigned to a subject, it will not be reassigned 
to any other subject. A master linking file (linking identifiers to study codes) will be 
stored separately in a locked cabinet or encrypted file accessible only to the study 
personnel. No identifiable data will be transmitted via unsecured email or cloud 
storage. The master linking file will be destroyed as soon as they are no longer 
needed for data verification or study follow-up, but no later than 2 years after data 
collection is complete. The electronic files will be securely deleted using 
institution-approved secure deletion software to ensure they cannot be recovered 
Any printed PHI or paper linking documents will be securely destroyed. After 
destruction, only the de-identified dataset will be retained for analysis and 
publication purposes 
 
Only the subject initials, date of birth or subject number will be recorded on any 
form, survey or study data forms.  

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27 
 
Access to identifiable PHI will be restricted to study personnel listed on the IRB-
approved protocol who have completed HIPAA and human subjects research 
training. PHI will not be shared with any unauthorized individuals. 
 
Paper records: Any PHI printed or abstracted will be stored in a locked file cabinet 
in a secure office accessible only to study personnel. 
 
All study-related information will be stored on a secure and encrypted HIPAA-
compliant Microsoft Teams software channel. Microsoft Teams is a password 
protected and uses multi-factor authentication. Only study staff will have access to 
this secure channel and therefore have access to study-related information. and 
all devices will have automatic screen-lock and secure password policies. 
 
All records that contain names or other personal identifiers, such as locator forms 
and informed consent forms, will be stored separately from study records 
identified by subject number. All local databases will be secured with password-
protected access systems and multifactor authentication. 
 
Study information will not be released without the written permission of the 
participant, except as necessary for monitoring by US FDA, OHRP, other 
government and regulatory authorities, and/or site IRBs. 
 
All data used in presentations, publications, or reports will be de-identified, with 
direct identifiers removed. Only aggregate data or coded study IDs will be 
reported. No individual patient names, dates of birth, medical record numbers, or 
other identifying information will be included. Any tables, figures, or case 
examples will be carefully reviewed by the study team to ensure that individuals 
cannot be indirectly identified. 
 
Study Files and Retention of Records will be maintained until at least 2 years after 
completion or discontinuation of study or according to local laws, whichever is 
longer.  
o Investigator Study File will contain the following: 
 
Protocol/amendments 
 
IRB and governmental approval with correspondence 
 
Informed consent 
 
Staff curriculum vitae and authorization forms 
 
Case report forms 
o Subject Clinical Source Data files will include the following for each subject 
 
Subject identification (name, date of birth, gender) 
 
Documentation that subject meets eligibility criteria 
 
Documentation of the reason a consented individual is not enrolled 
 
Participation in study (including study number) 
 
Study discussed and date of informed consent 
 
Dates of all visits 
 
Documentation that protocol-specific procedures were performed 
 
Record of all adverse events and other safety parameters (start 
and end date, and including causality and severity) 

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28 
 
Concomitant medication 
 
Date of study completion and reason for early discontinuation if it 
occurs 
 
 
10.4 Communicable Disease Reporting Requirements 
 
Study staff will comply with all applicable local requirements to report communicable 
diseases identified among study participants to local health authorities. Participants 
will be made aware of all reporting requirements during the study informed consent 
process. In Washington state, health care professionals are legally required to notify 
public health authorities at their local health jurisdiction of suspected or confirmed 
cases of selected diseases or conditions. These are referred to as notifiable 
conditions.  
10.5 Study Discontinuation 
 
The study also may be discontinued at any time by the investigators, other 
government, or regulatory authorities (OHRP), or site IRBs. 
 
Discontinuation procedures will be arranged, and the appropriate regulatory 
authorities will be notified.  
 
 
 

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29 
11 
TIMELINES 
Milestone 
Target Date 
IRB approval, Survey creation, protocol on clinicaltrials.gov  
09/01/2025 
Marketing plan initiated 
09/15/2025 
Pharmacist Training 
09/15/2025 
Study start 
09/30/2025 
50% participant enrollment 
11/15/2025 
100% participant enrollment 
01/31/2025 
Study End 
09/30/2026 
Data collection and analysis 
10/30/2026 
Submission of 48-week abstract/post/oral presentation 
12/31/2026 
Manuscript Submitted 
03/01/2027 

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30 
12 
PRESENTATION AND PUBLICATION PLANS 
The results of this study may be published or presented at scientific meetings. If this is foreseen, 
the investigator agrees to submit all manuscripts or abstracts to Gilead Sciences before 
submission. This allows Gilead Sciences to protect proprietary information and provide 
comments.  

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31 
13 
LITERATURE REFERENCES 
Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of 
Confounding in Observational Studies. Multivariate Behav Res. 2011;46(3):399-424. 
doi:10.1080/00273171.2011.568786 
 
Bell-Mandla N, Wilson E, Sharma D, et al. Predictors of participant retention in a community-
based HIV prevention cohort: perspectives from the HPTN 071 (PopART) study. Trials. 
2023;24(1):434. Published 2023 Jun 27. doi:10.1186/s13063-023-07404-y 
 
Centers for Disease Control and Prevention. Advancing team based care through collaborative 
practice agreements: a resource and implementation guide for adding pharmacists to the care 
team. Atlanta, GA, USA: Centers for Disease Control and Prevention, U.S. Department of 
Health and Human Services; 2017. Available online at: 
https://www.cdc.gov/cardiovascular-resources/media/cpa-team-based-care.pdf [verified 28 July 
2025]. 
 
Centers for Disease Control and Prevention. PREEXPOSURE PROPHYLAXIS FOR THE 
PREVENTION OF HIV INFECTION IN THE UNITED STATES – 2021 UPDATE. Atlanta, GA, 
USA: Centers for Disease Control and Prevention, U.S. Department of Health and Human 
Services; 2021. Available online at https://stacks.cdc.gov/view/cdc/112360 [verified 28 July 
2025]. 
 
Garcia MR, Leslie SW, Wray AA. Sexually Transmitted Infections. [Updated 2024 Apr 20]. In: 
StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: 
https://www.ncbi.nlm.nih.gov/books/NBK560808/http://cdc.gov/sti/prevention/index.html 
 
Gilead Sciences, Inc. (n.d.). Yetztugo™ (lenacapavir) tablets for oral use: Prescribing 
information. https://www.gilead.com/-/media/files/pdfs/medicines/hiv/yeztugo/yeztugo_pi.pdf 
 
Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion 
interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322-1327. 
doi:10.2105/ajph.89.9.1322 
 
Groot Bruinderink ML, Boyd A, Coyer L, et al. Online-Mediated HIV Pre-exposure Prophylaxis 
Care and Reduced Monitoring Frequency for Men Who Have Sex With Men: Protocol for a 
Randomized Controlled Noninferiority Trial (EZI-PrEP Study). JMIR Res Protoc. 
2023;12:e51023. Published 2023 Nov 8. doi:10.2196/51023 
 
Iwagami M, Shinozaki T. Introduction to Matching in Case-Control and Cohort Studies. Ann Clin 
Epidemiol. 2022;4(2):33-40. Published 2022 Apr 4. doi:10.37737/ace.22005 
Lopez MI, Cocohoba J, Cohen SE, et al. Implementation of pre-exposure prophylaxis at a 
community pharmacy through a collaborative practice agreement with San Francisco 
Department of Public Health. JAPhA, 2020:60:138-144. 
 
Jourdain H, de Gage SB, Desplas D, Dray-Spira R. Real-world effectiveness of pre-exposure 
prophylaxis in men at high risk of HIV infection in France: a nested case-control study. Lancet 
Public Health. 2022;7(6):e529-e536. doi:10.1016/S2468-2667(22)00106-2 
 
Lopez MI, Grant RM, Dong BJ. Community pharmacy delivered PrEP to STOP HIV 

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32 
transmission: An opportunity NOT to miss! JAPhA, 2020: 60; e18-e24. 
 
Montaño MA, Dombrowski JC, Dasgupta S, et al. Differences in sexually transmitted infection 
risk comparing preexposure prophylaxis users and propensity score matched historical controls 
in a clinic setting. AIDS. 2019;33(11):1773-1780. doi:10.1097/QAD.0000000000002281 
 
Nair AS, Diwan S. Propensity Score Matching with Retrospective and Observational Data in 
Palliative Care. Indian J Palliat Care. 2020;26(1):149-150. doi:10.4103/IJPC.IJPC_100_19 
 
Qato DM, Zenk S, Wilder J, Harrington R, Gaskin D, Alexander GC. The availability of 
pharmacies in the United States: 2007e2015. PLoS One. 2017;12(8). e0183172. 
 
Rogers BG, Sosnowy C, Zanowick-Marr A, et al. Facilitators for retaining men who have sex 
with men in pre-exposure prophylaxis care in real world clinic settings within the United States. 
BMC Infect Dis. 2022;22(1):673. Published 2022 Aug 5. doi:10.1186/s12879-022-07658-y 
 
Tung E, Thomas A, Eichner A, et al. Implementation of a community pharmacy-based 
preexposure prophylaxis services: a novel model for pre-exposure prophylaxis care. Sexual 
Health. 2018;15:556-561. 
 
Wagner GA, Wu KS, Anderson C, Burgi A, Little SJ. Predictors of Human Immunodeficiency 
Virus Pre-Exposure Prophylaxis (PrEP) Uptake in a Sexual Health Clinic With Rapid PrEP 
Initiation. Open Forum Infect Dis. 2023;10(3):ofad060. Published 2023 Feb 8. 
doi:10.1093/ofid/ofad060 
 
Zucker J, Carnevale C, Richards P, et al. Predictors of Disengagement in Care for Individuals 
Receiving Pre-exposure Prophylaxis (PrEP). J Acquir Immune Defic Syndr. 2019;81(4):e104-
e108. doi:10.1097/QAI.0000000000002054 

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33 
14 
APPENDICES 
14.1 Study Subject Informed Consent 
14.2 Pharmacist Provider Informed Consent 
14.3 Study Participant Surveys 
14.3.1 Baseline Survey 
 
Please enter your study ID number [free text box] 
 
These questions ask about your background 
1. How old are you today in years? (Mark one answer) 
a. 18 to 24 
b. 25 to 29 
c. 30 to 39 
d. 40 to 49 
e. 50 to 59 
f. 60 or over 
g. Prefer not to answer 
2. What is your race? (Mark one answer) 
a. American Indian or Alaska Native 
b. Asian 
c. Black or African American 
d. Native Hawaiian or Pacific Islander 
e. White 
f. Different race not listed (please specify) 
g. Prefer not to answer 
3. What is your Ethnicity? (Mark one answer) 
a. Hispanic or La 
tinx 
b. Not Hispanic or Latinx 
c. Prefer not to answer 
4. How do you describe yourself? (Mark one answer) 
a. Male 
b. Female 
c. Trans Male/Trans Man 
d. Trans Female/Trans Woman 
e. Genderqueer/Gender nonconforming 
f. Different identity (please specify) 
g. Prefer not to answer 
5. What sex were you assigned at birth, such as on the original birth 
certificate? (Mark one answer) 
a. Male 
b. Female 
c. Prefer not to answer 

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34 
6. What do you consider your sexual orientation to be? 
a. Heterosexual or straight 
b. Gay 
c. Lesbian 
d. Bisexual 
e. Pansexual 
f. Different sexual orientation not listed 
g. Prefer not to answer 
7. What is your marital status? (Mark one answer) 
a. Married (civil union or legal partnership) 
b. Not married, but living with primary or main partner 
c. Have a primary or main partner, not living together 
d. Single 
e. Divorced 
f. Widowed 
g. Prefer not to answer 
8. What is your level of education? (Mark one answer) 
a. Less than high school 
b. High school graduate 
c. Some college 
d. Bachelor’s degree or higher 
e. Prefer not to answer 
9. What is your current employment status? (Mark one answer) 
a. Employed, Full time working 
b. Employed, Part time working 
c. Unemployed, Seeking opportunities currently 
d. Unemployed, not seeking opportunities (on leave, disability, 
etc.) 
e. Retired 
f. Prefer not to answer 
10. What is your annual income? (Mark one answer) 
a. Less than $18,000 
b. $18,000 to $50,000 
c. $51,000 to $74,999 
d. Over $75,000 
e. Prefer not to answer 
11. What is your living situation today? (Mark one answer) 
a. I have a steady place to live 
b. I have a place to live today, but I am worried about losing it in 
the future 
c. I do not have a steady place to live (I am temporarily staying 
with others, in a shelter, hotel, living outside or in a car) 
d. Prefer not to answer 
 
These questions ask about your sexual activity 
12. What do you think the chances are that you will ever get HIV? (Mark 
one answer) 
a. Very high 
b. Somewhat high 
c. Neutral 

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35 
d. Low 
e. Very low 
13. Which kind of sex do you engage in? (Select all that apply) 
a. Solo masturbation 
b. Mutual masturbation (two people stimulating each other at the 
same time, hand job) 
c. Receiving oral sex 
d. Giving oral sex 
e. Receiving vaginal (front hole) sex 
f. Insertive vaginal (front hole) sex 
g. Receiving anal (back hole) sex 
h. Insertive anal (back hole) sex 
i. Different type of sex not listed (please specify) 
14. Are you in an ongoing sexual relationship with a partner who is living 
with HIV? 
a. Yes 
b. I am unsure of my partner(s) HIV status 
c. No 
15. Have you had anal sex without a condom in the last 6 months? 
a. Yes 
b. No 
16. Have you been diagnosed with an STI (Example: chlamydia, 
gonorrhea, or syphilis) in the last 6 months? 
a. Yes 
b. No 
17. Have you injected drugs that were not prescribed for you in the last 6 
months? 
a. Yes 
b. No 
18. Have you used HIV post-exposure prophylaxis, also known as PEP 
(used in emergencies by someone without HIV within 72 hours of HIV 
exposure), in the last 12 months? 
a. Yes 
b. No 
19. What are you doing to prevent pregnancy? 
a. Rhythm or calendar method 
b. Birth control pills 
c. Birth control patches 
d. Vaginal ring (Nuvaring®) 
e. Injection (Depo-Provera®) 
f. Diaphragm 
g. IUD 
h. Condoms 
i. Vasectomy (surgery to cut the tube that supplies sperm to your 
semen near the testicles) 
j. Hysterectomy (removal of uterus) 
k. Oophorectomy (removal of ovaries) 
l. I do not have sex with people with reproductive organs that are 
different than mine 
m. Different method not listed (Please specify:_____________) 

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36 
n. I am not actively trying to prevent pregnancy 
 
These questions ask about PrEP 
20. Have you ever used PrEP before? (Mark one answer) 
a. Never (skip to question 24) 
b. I am currently on PrEP 
c. I have previously been on PrEP, but stopped within the last 90 
days (3 months) 
d. I have previously been on PrEP, but stopped over 90 days (3 
months) ago 
21. What PrEP options have you used in the past? (Select all that apply) 
a. Truvada® (emtricitabine/tenofovir disoproxil fumarate) one pill 
daily 
b. Truvada® (emtricitabine/tenofovir disoproxil fumarate) On 
Demand, or 2-1-1 
c. Descovy® (emtricitabine/tenofovir alafenamide) one pill daily 
d. Apretude® (cabotegravir) one injection every month for 2 
months followed by 1 injection every 2 months 
22. If you have stopped PrEP in the past for more than 2 weeks, why? 
(Select all that apply) 
a. Insurance or financial problems 
b. Clinic or pharmacy problems (long wait times, limited hours, 
delays in refills, miscommunication with pharmacy providers, 
difficulty getting patient assistance programs) 
c. Scheduling barriers (getting to clinic for appointments) 
d. Moved and needed to find a new provider 
e. PrEP medication side effects 
f. Drug interactions with PrEP medicine 
g. Disease or problems with organs (example: kidney or liver) with 
PrEP 
h. Trouble with remembering to take the medication 
i. Medication beliefs (do not want to take medicine every day, act 
of taking a pill makes you feel old or sick) 
j. Decreased risk (changes in relationship status, becoming 
monogamous, or decreasing sexual activity) 
l. I cannot remember a time where I stopped PrEP in the past for 
more than 2 weeks 
k. Different reasons not listed (Please specify: ______________) 

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37 
14.3.2 HIVPrev-TSQs 
 

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38 
 

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39 
14.3.3 HIVPrev-TSQc 
 

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40 
 

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41 
14.3.4 HIVPrev-TSQ (early discontinuation) 
 

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42 
 
 
 
 

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43 
14.4 Pharmacist Provider Survey  
Acceptability of Intervention Measure (AIM) 
 
 
Completely 
disagree 
Disagree
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. Lenacapavir for PrEP in a Community 
Pharmacy Setting meets my approval. 
 
 
 
 
 
2. Lenacapavir for PrEP in a Community 
Pharmacy Setting is appealing to me. 
 
 
 
 
 
3. I like Lenacapavir for PrEP in a 
Community Pharmacy Setting. 
 
 
 
 
 
4. I welcome Lenacapavir for PrEP in a 
Community Pharmacy Setting. 
 
 
 
 
 
 
Intervention Appropriateness Measure (IAM) 
 
 
Completely 
disagree 
Disagree
Neither 
agree 
nor 
disagree
Agree 
Completely 
agree 
1. Lenacapavir for PrEP in a Community 
Pharmacy Setting seems fitting. 
 
 
 
 
 
2. Lenacapavir for PrEP in a Community 
Pharmacy Setting seems suitable. 
 
 
 
 
 
3. Lenacapavir for PrEP in a Community 
Pharmacy Setting seems applicable. 
 
 
 
 
 
4. Lenacapavir for PrEP in a Community 
Pharmacy Setting seems like a good match. 
 
 
 
 
 
 
Feasibility of Intervention Measure (FIM) 
 
 
Completely 
disagree 
Disagree
Neither 
agree 
nor 
disagree
Agree 
Completely 
agree 
1. Lenacapavir for PrEP in a Community 
Pharmacy Setting seems implementable. 
 
 
 
 
 
2. Lenacapavir for PrEP in a Community 
Pharmacy Setting seems possible. 
 
 
 
 
 
3. Lenacapavir for PrEP in a Community 
Pharmacy Setting seems doable. 
 
 
 
 
 
4. Lenacapavir for PrEP in a Community 
Pharmacy Setting seems easy to use. 
 
 
 
 
 
 

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44 
14.5 Forms for Safety Data Reporting 
14.5.1 FDA Form 3500A 
 

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45 
 

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46 
 

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47 
 

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48 
 

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49 
 

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50 
 
 

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51