OVERVIEW
Pioneering Research to Optimize Pre-exposure Prophylaxis (PrEP) Expansion With Lenacapavir (LEN) (PROPEL)
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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
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 (28)
UAB 1917 Research Clinic
Birmingham, Alabama, United States, 35222
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211
Ruane Clinical Research Group Inc.
Los Angeles, California, United States, 90036
Family Health Centers of San Diego
San Diego, California, United States, 92102
Mills Clinical Research
West Hollywood, California, United States, 90046
Pineapple Healthcare Orlando
Orlando, Florida, United States, 32829
Faebris Medical & Community Education
Atlanta, Georgia, United States, 01111
Chase Brexton Health Care
Baltimore, Maryland, United States, 21201
The Aliveness Project
Minneapolis, Minnesota, United States, 55409
KC Care Health Center
Kansas City, Missouri, United States, 64111
Washington University School of Medicine Infectious Disease Clinical Research Unit
St Louis, Missouri, United States, 63110
University of Nebraska Medical Center/Nebraska Medicine Specialty Care Center
Omaha, Nebraska, United States, 68198
NYC Health + Hospitals / Bellevue
New York, New York, United States, 10016
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267
Ohio State University Infectious Diseases Clinical Trials Unit
Columbus, Ohio, United States, 43210
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19107
West Virginia Health Right, Inc.
Charleston, West Virginia, United States, 25302
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