HIV InfectionsPROPELNCT07473778
Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
An observational study of HIV Infections, run by Gilead Sciences at 44 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Lenacapavir Injection, Emtricitabine/tenofovir disoproxil fumarate (F/TDF) and Emtricitabine/tenofovir alafenamide (F/TAF)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 3,000 participants
- Where
- 44 sitesUnited States
- Study dates
- 17 Mar 2026to Apr 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: People who need or want HIV prevention services identified and engaged through routine clinical practice
Who may be able to join
- 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.
Who cannot join
- 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.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
44 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
44 sites in 1 country
United States44 sites, 44 recruiting
- Recruiting
Faebris Medical & Community Education
Atlanta, Georgia, 01111
- Recruiting
Grady Memorial Hospital
Atlanta, Georgia, 30303
- Recruiting
Chase Brexton Health Care
Baltimore, Maryland, 21201
- Recruiting
Be Well Medical Center
Berkley, Michigan, 48072
- Recruiting
Pacific Oaks Medical Group
Beverly Hills, California, 90211
- Recruiting
UAB 1917 Research Clinic
Birmingham, Alabama, 35222
- Recruiting
Fenway Health
Boston, Massachusetts, 02215
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
West Virginia Health Right, Inc.
Charleston, West Virginia, 25302
- Recruiting
Northwestern Medicine
Chicago, Illinois, 60611
- Recruiting
DOM/Project WISH Research Clinic
Chicago, Illinois, 60612
- Recruiting
Rush University Medical Center/Division of Infectious Diseases
Chicago, Illinois, 60612
- Recruiting
Ruth M. Rothstein CORE Center
Chicago, Illinois, 60612
- Recruiting
Howard Brown Health
Chicago, Illinois, 60613
- Recruiting
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
- Recruiting
Ohio State University Infectious Diseases Clinical Trials Unit
Columbus, Ohio, 43210
- Recruiting
Abounding Prosperity Inc.
Dallas, Texas, 75215
- Recruiting
Prism Health
Dallas, Texas, 75246
- Recruiting
Vivent Health
Denver, Colorado, 80246
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
- Recruiting
UT Health
Houston, Texas, 77009
- Recruiting
Thomas Street at Quentin Mease Health Center
Houston, Texas, 77030
- Recruiting
KC Care Health Center
Kansas City, Missouri, 64111
- Recruiting
Ruane Clinical Research Group Inc.
Los Angeles, California, 90036
- Recruiting
CAN Community Health
Miami, Florida, 33055
- Recruiting
The Aliveness Project
Minneapolis, Minnesota, 55409
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37204
- Recruiting
The Clinic NOLA
New Orleans, Louisiana, 70115
- Recruiting
Ochsner Baptist Medical Center
New Orleans, Louisiana, 70121
- Recruiting
NYC Health + Hospitals / Bellevue
New York, New York, 10016
- Recruiting
Colombia University Irving Medical Center
New York, New York, 10032
- Recruiting
Sutter Health- East Bay Advanced Care
Oakland, California, 94609
- Recruiting
University of Nebraska Medical Center/Nebraska Medicine Specialty Care Center
Omaha, Nebraska, 68198
- Recruiting
Bliss Health
Orlando, Florida, 32803
- Recruiting
Pineapple Healthcare Orlando
Orlando, Florida, 32829
- Recruiting
AHF - Pensacola
Pensacola, Florida, 32503
- Recruiting
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19107
- Recruiting
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
- Recruiting
Family Health Centers of San Diego
San Diego, California, 92102
- Recruiting
UC San Diego (UCSD) AntiViral Research Center (AVRC)
San Diego, California, 92103
- Recruiting
Kelley-Ross Pharmacy
Seattle, Washington, 98122
- Recruiting
Washington University School of Medicine Infectious Disease Clinical Research Unit
St Louis, Missouri, 63110
- Recruiting
BronxCare Health System
The Bronx, New York, 10457
- Recruiting
Mills Clinical Research
West Hollywood, California, 90046
About this study
Official title: Pioneering Research to Optimize Pre-exposure Prophylaxis (PrEP) Expansion With Lenacapavir (LEN)
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.
- Conditions
- HIV Infections
- Being tested
- Lenacapavir Injection, Emtricitabine/tenofovir disoproxil fumarate (F/TDF), Emtricitabine/tenofovir alafenamide (F/TAF), Cabotegravir (CAB), Lenacapavir Tablet
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenacapavir InjectionDrug
Also called YEZTUGO®
Administered via subcutaneous (SC) injection
Emtricitabine/tenofovir disoproxil fumarate (F/TDF)Drug
Also called Truvada®
Tablets administered orally
Emtricitabine/tenofovir alafenamide (F/TAF)Drug
Also called Descovy®
Tablets administered orally
Cabotegravir (CAB)Drug
Also called CAB
Administered via intramuscular (IM) injection
Lenacapavir TabletDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Lenacapavir Injection; Drug: Lenacapavir Tablet | |
| 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. Receives: Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF); Drug: Emtricitabine/tenofovir alafenamide (F/TAF); Drug: Cabotegravir (CAB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 52
Secondary outcomes (12)
Uptake of PrEP: Proportion of Participants Who Decided to Use PrEP at Enrollment (Baseline) and Different Types of PrEP
Measured: 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
Measured: Up to Week 104
PrEP Coverage: Proportion of Days Protected by PrEP at Weeks 26, 52, 78, and 104, Overall and by PrEP Type
Measured: Up to Week 104
PrEP Persistence: Mean Duration of PrEP Use
Measured: 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
Measured: Up to Week 104
PrEP Interruptions Assessed by Proportion of Participants who Adopted/Continued PrEP at Enrollment and Experienced Interruptions at Different Time Points at Week 26, 52, 78, and 104
Measured: Up to Week 104
PrEP Interruptions Assessed by Proportion of Participants who Needed one or More LEN PrEP Re-initiations who Adopted/Continued LEN PrEP at Enrollment, at Week 26, 52, 78, and 104
Measured: Up to Week 104
PrEP Interruptions Assessed by Time Between Injections for Participants Initiating LEN PrEP who had to Re-initiate LEN PrEP
Measured: Week 26, Week 52, Week 78, and Week 104
Switching (Any Switch): Proportion of Participants Who Use any PrEP Method Different from the PrEP Method Adopted/Continued at Enrollment, at Weeks 26, 52, 78, and 104
Measured: Week 26, Week 52, Week 78, and Week 104
Switch (Switch to LEN PreP): Proportion of Participants Switching to LEN PrEP among Participants who did not Initiate LEN PrEP at Enrollment, at Weeks 26, 52, 78, and 104
Measured: Week 26, Week 52, Week 78, and Week 104
Time to First LEN Injection: Days From Enrollment and Choice of LEN PrEP to First Dose of LEN Injection as PrEP
Measured: Up to Week 104
Proportion of Participants with Receipt of First LEN PrEP Injection on the Same Day as Enrollment in the Study
Measured: Enrollment up to Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start17 Mar 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473778
- Sponsor's protocol ID
- GS-US-528-7614
- Acronym
- PROPEL
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No