Actively Recruiting

Phase 4
Age: 18Years +
MALE
Healthy Volunteers
ID07218211

Enhancing PrEP Uptake and Retention Among Latine Transgender Women and Gay, Bisexual, and Other Men Who Have Sex With Men Using Long-Acting Injectable PrEP (lenacapavir)

Led by Duke University · Updated on 2026-02-02

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

G

Gilead Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to test a culturally tailored, community-delivered program using long-acting injectable PrEP (lenacapavir) to improve HIV prevention among Latine gay and bisexual men (GBM) and transgender women (TGW). The study evaluates whether this approach increases persistence on lenacapavir compared to historical data at the Duke PrEP Clinic, focusing on these specific populations in the Southern United States. Participants will receive lenacapavir injections through a community-based program integrated at El Centro Hispano facilities. Peer Navigators will provide culturally appropriate support to help with PrEP uptake, adherence, and persistence. This hybrid implementation study collects data on both the clinical intervention and how well the program is delivered over time. During the study, participants will be monitored for up to one year, including identification of barriers, facilitators, and recommendations related to lenacapavir delivery at the community organization. Researchers will assess acceptability of the intervention through participant responses and measure feasibility from the providers' perspective. The total participation duration may vary, with ongoing assessments to understand program sustainability and participant experiences.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Assigned male sex at birth
  • Report sexual activity with someone assigned male at birth or identify as gay, bisexual men (GBM) or transgender women (TGW)
  • HIV-negative status
  • Identify as Hispanic and/or Latine
  • Able to provide informed consent in English or Spanish
  • At least 18 years old
  • Weigh at least 77 lbs (35 kg) by self-report
  • Interested in PrEP and willing to participate in study procedures
Not Eligible

You will not qualify if you...

  • Living with HIV
  • Assigned female sex at birth
  • Currently taking oral PrEP and unwilling to switch to lenacapavir for the study duration
  • History of severe kidney or liver disease or signs of these diseases on physical exam
  • Taking medication that significantly interacts with lenacapavir

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 1 year

Participants receive culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir) with support from Peer Navigators to enhance uptake, adherence, and persistence.

Trial Site Locations

Total: 1 location

1

El Centro Hispano

Durham, North Carolina, United States, 27701

Actively Recruiting

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Research Team

I

Iris Navarro Clinical Research Coordinator

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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