Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
PROPEL
Pioneering Research to Optimize Pre-exposure Prophylaxis (PrEP) Expansion With Lenacapavir (LEN)
1 other identifier
observational
3,000
1 country
17
Brief Summary
The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP. The primary objective of this study is to evaluate real-life persistence on LEN PrEP at Week 52 in diverse clinical settings in the United States.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2026
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2026
CompletedFirst Posted
Study publicly available on registry
March 16, 2026
CompletedStudy Start
First participant enrolled
March 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
May 29, 2026
May 1, 2026
2 years
March 11, 2026
May 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Participants with LEN PrEP Persistence at Week 52
LEN PrEP persistence at Week 52 is defined as the proportion of participants receiving a LEN injection at enrollment who had an on-time injection at Week 26 and an on-time Week 52 visit ('on time' is defined as ≤ 28 weeks from the last injection).
Week 52
Secondary Outcomes (12)
Uptake of PrEP: Proportion of Participants Who Decided to Use PrEP at Enrollment (Baseline) and Different Types of PrEP
Baselines (Day 1, date of the first LEN/CAB injection or oral PrEP prescription)
PrEP Persistence: Proportion of Participants who Persistently Used PrEP at Weeks 26, 78 and 104, Overall and by PrEP Type
Up to Week 104
PrEP Coverage: Proportion of Days Protected by PrEP at Weeks 26, 52, 78, and 104, Overall and by PrEP Type
Up to Week 104
PrEP Persistence: Mean Duration of PrEP Use
Up to Week 104
PrEP Continuation: Proportion of Participants who Continued to Use PrEP at Week 26, 52, 78, and 104, Overall and Specific Types of PrEP
Up to Week 104
- +7 more secondary outcomes
Study Arms (2)
LEN PrEP
Participants in diverse clinical settings in the United States (US) who choose subcutaneous (SC) Lenacapavir (LEN) Pre-Exposure Prophylaxis for HIV Prevention (PrEP) at enrollment in the study or anytime during the follow-up period
Other PrEP
Participants in diverse clinical settings in the United States (US) who choose other PrEP options ( F/TDF, F/TAF, CAB) or No PrEP.
Interventions
Administered via subcutaneous (SC) injection
Tablets administered orally
Tablets administered orally
Eligibility Criteria
People who need or want HIV prevention services identified and engaged through routine clinical practice
You may qualify if:
- Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of screening study procedures;
- Willing and able to comply with all study requirements;
- Presents at a study site needing or wanting PrEP for HIV prevention as determined by local clinical practice guidelines and institutional protocols, including new PrEP users (PrEP naïve) and current or former users of oral (emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®; F/TDF) or emtricitabine/tenofovir alafenamide (coformulated; Descovy®; F/TAF)) or injectable (LEN or cabotegravir (CAB)) PrEP who indicate interest in discussing PrEP methods that they are clinically eligible to receive;
- Eligible for LEN PrEP per standard of care procedures, for example, being HIV-1 negative at screening using a Food and Drug Administration (FDA) approved/cleared test for diagnosis of acute or primary HIV-1 infection;
- After PrEP counseling to learn about the advantages and disadvantages of various PrEP methods:
- Selects LEN PrEP as their chosen PrEP method; OR,
- Selects a different PrEP method or chooses not to start or continue PrEP.
You may not qualify if:
- Any other indication not already listed above that would make the participant ineligible for LEN PrEP at enrollment according to local guidelines, organizational protocols, US Prescribing Information (USPI) for the PrEP product, and/or Center for Disease and Control (CDC) guidance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (17)
Pacific Oaks Medical Group
Beverly Hills, California, 90211, United States
Family Health Centers of San Diego
San Diego, California, 92102, United States
Mills Clinical Research
West Hollywood, California, 90046, United States
Vivent Health
Denver, Colorado, 80246, United States
Bliss Health
Orlando, Florida, 32803, United States
Pineapple Healthcare Orlando
Orlando, Florida, 32829, United States
AHF - Pensacola
Pensacola, Florida, 32503, United States
Faebris Medical & Community Education
Atlanta, Georgia, 01111, United States
The Clinic NOLA
New Orleans, Louisiana, 70115, United States
Chase Brexton Health Care
Baltimore, Maryland, 21201, United States
Fenway Health
Boston, Massachusetts, 02215, United States
Be Well Medical Center
Berkley, Michigan, 48072, United States
The Aliveness Project
Minneapolis, Minnesota, 55409, United States
KC Care Health Center
Kansas City, Missouri, 64111, United States
Ohio State University Infectious Diseases Clinical Trials Unit
Columbus, Ohio, 43210, United States
Abounding Prosperity Inc.
Dallas, Texas, 75215, United States
West Virginia Health Right, Inc.
Charleston, West Virginia, 25302, United States
Related Links
Biospecimen
Blood Samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Central Study Contacts
Gilead Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2026
First Posted
March 16, 2026
Study Start
March 17, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2029
Last Updated
May 29, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share