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HIV Prevention Study for Latine TGW and GBM Using Lenacapavir

This study is testing a new way to deliver a long-acting injectable medication called lenacapavir for HIV prevention. It's designed for Latine gay and bisexual men (GBM) and transgender women (TGW) in the South. The study wants to see if offering lenacapavir through a community-based organization, with support from peer navigators, helps more people use and stick with this HIV prevention method. We're looking for 100 participants who are 18 or older, identify as Hispanic and/or Latine, are HIV-negative, and meet specific criteria related to their sex assigned at birth or identity. The main goal is to understand what helps or hinders providing lenacapavir in a community setting, and to gather recommendations to improve this process.

Study design
This is an interventional study planning to enroll 100 participants. It's a mixed-methods study that tests a new way to deliver HIV prevention while also looking at the effects of the intervention.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes related to barriers, recommendations, and facilitators for up to 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07218211

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

Recruiting
PHASE4Ages 18+InterventionalPrevention
Duke University
~100 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Lenacapavir long-acting

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acceptability of the intervention measured by questionnaire
Measured over 6 and 12 months
+3 more outcomes measured

Conditions

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

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Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Tonia Poteat, PhD · PRINCIPAL_INVESTIGATOR · Duke University Medical Center - Professor in the School of Nursing

Who to contact

Iris Navarro Clinical Research Coordinator
[email protected]
919-660-3940
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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.

What this trial measures

  • Acceptability of the intervention measured by questionnaire6 and 12 months

    Measured using an adapted Abbreviated Acceptability Rating Profile. Items are rated on a 5-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree); higher scores indicate greater acceptability of the intervention.

  • Feasibility of the intervention measured by programmatic indicators6 months and 12 months

    Evaluated using programmatic indicators including recruitment rate, adherence and retention.

  • Sustainability of the intervention6 months and 12 months

    Number of providers who found the intervention feasible as measured by the Program Sustainability Assessment Tool (PSAT). The PSAT will provide a structured way to assess organizational capacity and sustainability for scale up. It has a score range of 0 to 40, where a higher score indicates greater feasibility.

  • The persistence on lenacapavir among participants receiving care at El Centro Hispano at 12 months.12 months

    Persistence will be defined as the proportion of participants remaining on continuous, appropriately dosed lenacapavir at each follow-up visit. Appropriately dosed lenacapavir is defined as either on-time injection (within 28 weeks after the last injection) or with oral tablets taken as a bridge according to Package Insert instructions.