Study Details

PROTOCOL 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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

HIV Infections

Gender

N/A

Date

March 2026 - April 2028

Study Type

OBSERVATIONAL

Study Phase

Product

Lenacapavir Injection, Emtricitabine/tenofovir disoproxil fumarate (F/TDF), Emtricitabine/tenofovir alafenamide (F/TAF), Cabotegravir (CAB), Lenacapavir Tablet

Eligibility Information

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.

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.

Locations

Locations (17)

Pacific Oaks Medical Group

Beverly Hills, California, United States, 90211

Family Health Centers of San Diego

San Diego, California, United States, 92102

Mills Clinical Research

West Hollywood, California, United States, 90046

Vivent Health

Denver, Colorado, United States, 80246

Bliss Health

Orlando, Florida, United States, 32803

Pineapple Healthcare Orlando

Orlando, Florida, United States, 32829

AHF - Pensacola

Pensacola, Florida, United States, 32503

Faebris Medical & Community Education

Atlanta, Georgia, United States, 01111

The Clinic NOLA

New Orleans, Louisiana, United States, 70115

Chase Brexton Health Care

Baltimore, Maryland, United States, 21201

Fenway Health

Boston, Massachusetts, United States, 02215

Be Well Medical Center

Berkley, Michigan, United States, 48072

The Aliveness Project

Minneapolis, Minnesota, United States, 55409

KC Care Health Center

Kansas City, Missouri, United States, 64111

Ohio State University Infectious Diseases Clinical Trials Unit

Columbus, Ohio, United States, 43210

Abounding Prosperity Inc.

Dallas, Texas, United States, 75215

West Virginia Health Right, Inc.

Charleston, West Virginia, United States, 25302

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

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