NCT07218211

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
20mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Jan 2026Jan 2028

First Submitted

Initial submission to the registry

October 3, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 20, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

January 13, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2028

Last Updated

February 2, 2026

Status Verified

October 1, 2025

Enrollment Period

12 months

First QC Date

October 3, 2025

Last Update Submit

January 29, 2026

Conditions

HIV PreventionHIV Pre-exposure ProphylaxisHIV Prevention ProgramHIV Prevention and CareHIV Pre-exposure Prophylaxis Use

Keywords

Long-acting Injectable PrEPLenacapavirPrEPPrEP injections

Outcome Measures

Primary Outcomes (3)

  • Number of participants who provided identification of barriers to providing lenacapavir at a Latine community-based organization

    Qualitative identification: "What gets in the way of people in your community starting PrEP? Staying on PrEP?"

    up to 1 year

  • Number of participants who provided recommendations to address barriers to providing lenacapavir at a Latine community-based organization

    Qualitative identification: "Recommendations to address these barriers?"

    up to 1 year

  • Number of participants who provided identification of facilitators to providing lenacapavir at a Latine community-based organization

    Qualitative identification: "What factors support people in your community?"

    up to 1 year

Secondary Outcomes (2)

  • Acceptability as measured by the number of participants who answered "yes" to select modified acceptability questions from Abbreviated Acceptability Rating Profile (AARP)

    up to 1 year

  • Number of providers who found the intervention feasible as measured by the Program Sustainability Assessment Tool (PSAT)

    up to 1 year

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-actingDRUG

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

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsLatine gay and bisexual men (GBM) and transgender women (TGW)
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

919-660-3940inclusion@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)

January 5, 2027

Study Completion (Estimated)

January 5, 2028

Last Updated

February 2, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)