Status:
NOT_YET_RECRUITING
Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP
Lead Sponsor:
Duke University
Collaborating Sponsors:
Gilead Sciences
Conditions:
HIV Prevention
HIV Pre-exposure Prophylaxis
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this project is to test a culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW). T...
Detailed Description
We propose a mixed methods hybrid type 3 implementation study, which primarily tests an implementation strategy while collecting data on the clinical intervention and related outcomes. Building on exi...
Eligibility Criteria
Inclusion
- Participants must be assigned male sex at birth.
- Report sexual activity with a someone assigned male at birth OR identify as GBM or TGW; be HIV-negative.
- Identify as Hispanic and/or Latine .
- Be able to provide informed consent in English or Spanish .
- Be 18 years or older .
- Weigh at least 77 lbs (35 kg) by self-reported weight.
- Interested in PrEP and willing to undergo the study procedures.
Exclusion
- Individuals living with HIV.
- Individuals assigned female sex at birth will be excluded.
- Individuals who are currently taking oral PrEP from another source and are not willing to switch to lenacapavir for PrEP for the duration of the study will also be excluded.
- Individuals who report a history of severe renal or hepatic disease or with clinical stigmata of either disease on physical exam as assessed by a study clinician will be excluded.
- Individuals taking a medication with a significant interaction with lenacapavir will be excluded from the study.
Key Trial Info
Start Date :
January 5 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 5 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07218211
Start Date
January 5 2026
End Date
January 5 2028
Last Update
October 17 2025
Active Locations (1)
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1
El Centro Hispano
Durham, North Carolina, United States, 27701