Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention (PROPEL)

May 27, 2026 updated by: Gilead Sciences

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Pacific Oaks Medical Group
      • San Diego, California, United States, 92102
        • Recruiting
        • Family Health Centers of San Diego
      • West Hollywood, California, United States, 90046
        • Recruiting
        • Mills Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80246
        • Recruiting
        • Vivent Health
    • Florida
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Bliss Health
      • Orlando, Florida, United States, 32829
        • Recruiting
        • Pineapple Healthcare Orlando
      • Pensacola, Florida, United States, 32503
        • Recruiting
        • AHF - Pensacola
    • Georgia
      • Atlanta, Georgia, United States, 01111
        • Recruiting
        • Faebris Medical & Community Education
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • The Clinic NOLA
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Chase Brexton Health Care
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Fenway Health
    • Michigan
      • Berkley, Michigan, United States, 48072
        • Recruiting
        • Be Well Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55409
        • Recruiting
        • The Aliveness Project
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • KC Care Health Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Infectious Diseases Clinical Trials Unit
    • Texas
      • Dallas, Texas, United States, 75215
        • Recruiting
        • Abounding Prosperity Inc.
    • West Virginia
      • Charleston, West Virginia, United States, 25302
        • Recruiting
        • West Virginia Health Right, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

People who need or want HIV prevention services identified and engaged through routine clinical practice

Description

Key Inclusion Criteria:

  • 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:

    1. Selects LEN PrEP as their chosen PrEP method; OR,
    2. Selects a different PrEP method or chooses not to start or continue PrEP.

Key Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Drug: Lenacapavir Tablet
Administered orally
Drug: Lenacapavir Injection
Administered via subcutaneous (SC) injection
Other Names:
  • YEZTUGO®
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.
Drug: Emtricitabine/tenofovir disoproxil fumarate (F/TDF)
Tablets administered orally
Other Names:
  • Truvada®
Drug: Emtricitabine/tenofovir alafenamide (F/TAF)
Tablets administered orally
Other Names:
  • Descovy®
Drug: Cabotegravir (CAB)
Administered via intramuscular (IM) injection
Other Names:
  • CAB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants with LEN PrEP Persistence at Week 52
Time Frame: 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 Outcome Measures

Outcome Measure
Time Frame
Uptake of PrEP: Proportion of Participants Who Decided to Use PrEP at Enrollment (Baseline) and Different Types of PrEP
Time Frame: Baselines (Day 1, date of the first LEN/CAB injection or oral PrEP prescription)
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
Time Frame: Up to Week 104
Up to Week 104
PrEP Coverage: Proportion of Days Protected by PrEP at Weeks 26, 52, 78, and 104, Overall and by PrEP Type
Time Frame: Up to Week 104
Up to Week 104
PrEP Persistence: Mean Duration of PrEP Use
Time Frame: Up to Week 104
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
Time Frame: Up to Week 104
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
Time Frame: Up to Week 104
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
Time Frame: Up to Week 104
Up to Week 104
PrEP Interruptions Assessed by Time Between Injections for Participants Initiating LEN PrEP who had to Re-initiate LEN PrEP
Time Frame: Week 26, Week 52, Week 78, and Week 104
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
Time Frame: Week 26, Week 52, Week 78, and Week 104
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
Time Frame: Week 26, Week 52, Week 78, and Week 104
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
Time Frame: Up to Week 104
Up to Week 104
Proportion of Participants with Receipt of First LEN PrEP Injection on the Same Day as Enrollment in the Study
Time Frame: Enrollment up to Week 104
Enrollment up to Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-528-7614

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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