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

NCT07218211 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: PRO00118575
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Long-acting Injectable PrEP; Lenacapavir; PrEP; PrEP injections

Outcome Measures

Primary Outcomes (4)

• Acceptability of the intervention measured by questionnaire

  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.

  6 and 12 months

• Feasibility of the intervention measured by programmatic indicators

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

  6 months and 12 months

• Sustainability of the intervention

  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.

  6 months and 12 months

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

  12 months

Secondary Outcomes (7)

• Persistence at 6 months

  6 months

• Adherence

  6 months and 12 months

• Retention

  6 months and 12 months

• Continuation

  12 months

• Patient Satisfaction measured by questionnaire

  6 months and 12 months

Study Arms (1)

Long-acting Injectable PrEP (lenacapavir) program

OTHER

Community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW)

Drug: Lenacapavir long-acting

Interventions

Lenacapavir long-acting DRUG

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

Also known as: Yeztugo, Lenacapavir injection, PrEP, Injectable PrEP

Long-acting Injectable PrEP (lenacapavir) program

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Latine gay and bisexual men (GBM) and transgender women (TGW)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Gilead Sciences: collaborator

Study Sites (1)

El Centro Hispano

Durham, North Carolina, 27701, United States

RECRUITING

MeSH Terms

Interventions

lenacapavir

Study Officials

• Tonia Poteat, PhD

  Duke University Medical Center - Professor in the School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Navarro Clinical Research Coordinator

CONTACT

919-660-3940; inclusion@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2025
• First Posted: October 20, 2025
• Study Start: January 13, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 26, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)