Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP
Recruiting now · Phase 4
Conditions studied: HIV Prevention, HIV Pre-exposure Prophylaxis, HIV Prevention Program, HIV Prevention and Care, HIV Pre-exposure Prophylaxis Use
In brief
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). The objective is to evaluate whether this intervention demonstrates greater persistence on lenacapavir for Latine GBM and TGW compared with what has been observed historically at the Duke PrEP Clinic.
Key facts
- Study ID
- NCT07218211
- Run by
- Duke University
- People needed
- 100
- Starts
- 2026-01-13
- Expected to finish
- 2028-01-05
- Last updated by the study team
- 2026-02-02
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- El Centro Hispano — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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