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RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Duke University • ClinicalTrials.gov ID: NCT07218211

Registry updated: 2026-10-19
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Description

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.

Interventions

  • Lenacapavir long-acting (Drug)
    Culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir)

Eligibility 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.

Conditions

HIV Prevention HIV Pre-exposure Prophylaxis HIV Prevention Program HIV Prevention and Care HIV Pre-exposure Prophylaxis Use

Locations

  • El Centro Hispano — Durham, North Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record