Actively Recruiting
Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
Led by Gilead Sciences · Updated on 2026-05-04
3000
Participants Needed
10
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide signed written informed consent before screening
- Willing and able to follow all study requirements
- Attending a study site needing or wanting PrEP for HIV prevention according to local guidelines
- Includes new PrEP users and current or former users of oral or injectable PrEP interested in discussing available PrEP methods
- Eligible for LEN PrEP by standard care, including confirmed HIV-1 negative status at screening with FDA-approved test
- After counseling about PrEP methods, chooses LEN PrEP or selects a different method or opts not to start or continue PrEP
You will not qualify if you...
- Any condition or indication that makes participant ineligible for LEN PrEP according to local guidelines, protocols, US Prescribing Information, or CDC guidance
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211
Actively Recruiting
2
Mills Clinical Research
West Hollywood, California, United States, 90046
Actively Recruiting
3
Bliss Health
Orlando, Florida, United States, 32803
Actively Recruiting
4
Pineapple Healthcare Orlando
Orlando, Florida, United States, 32829
Actively Recruiting
5
AHF - Pensacola
Pensacola, Florida, United States, 32503
Actively Recruiting
6
Faebris Medical & Community Education
Atlanta, Georgia, United States, 01111
Actively Recruiting
7
Chase Brexton Health Care
Baltimore, Maryland, United States, 21201
Actively Recruiting
8
Be Well Medical Center
Berkley, Michigan, United States, 48072
Actively Recruiting
9
The Aliveness Project
Minneapolis, Minnesota, United States, 55409
Actively Recruiting
10
KC Care Health Center
Kansas City, Missouri, United States, 64111
Actively Recruiting
Research Team
G
Gilead Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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