Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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