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RecruitingAccepts healthy volunteersPhase 4

Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP

Duke University · with Gilead Sciences · NCT07218211

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Men only
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
100
US sites recruiting
1
Study start
January 13, 2026
Record last updated
October 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Lenacapavir long-acting

Conditions: HIV Prevention; HIV Pre-exposure Prophylaxis; HIV Prevention Program; HIV Prevention and Care; HIV Pre-exposure Prophylaxis Use

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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.

Recruiting US locations

  • El Centro Hispano

    Durham, NC 27701

    Site contact: Orlando Martinez J Peer Navigator · 1(919) 687-4635 · jomartinez@elcentronc.org

Study contacts (from the official record)

  • Iris Navarro Clinical Research Coordinator · 919-660-3940 · inclusion@duke.edu
All healthy volunteers studies in North Carolina →
Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in… (NCT07218211) | Bored Studies