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

August 24, 2026 updated by: Duke University

INCLUSION - Enhancing PrEP Uptake and Retention Among Latine Transgender Women and Gay, Bisexual, and Other Men Who Have Sex With Men in the South Using Long-Acting Injectable PrEP

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

We propose a mixed methods hybrid type 3 implementation study, which primarily tests an implementation strategy while collecting data on the clinical intervention and related outcomes. Building on existing partnerships between Duke University and El Centro Hispano, we will integrate lenacapavir delivery on-site at El Centro Hispano facilities, leveraging El Centro Hispano Peer Navigators to provide culturally congruent support for PrEP uptake, adherence, and persistence among Latine GBM and TGW.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Iris Navarro Clinical Research Coordinator
  • Phone Number: 919-660-3940
  • Email: inclusion@duke.edu

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Recruiting
        • El Centro Hispano
        • Sub-Investigator:
          • Emilia Ismael-Simental
        • Sub-Investigator:
          • Alma Ortega
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Long-acting Injectable PrEP (lenacapavir) program
Community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW)
Drug: Lenacapavir long-acting
Culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir)
Other Names:
  • PrEP
  • Yeztugo
  • Lenacapavir injection
  • Injectable PrEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the intervention measured by questionnaire
Time Frame: 6 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.
6 and 12 months
Feasibility of the intervention measured by programmatic indicators
Time Frame: 6 months and 12 months
Evaluated using programmatic indicators including recruitment rate, adherence and retention.
6 months and 12 months
Sustainability of the intervention
Time Frame: 6 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.
6 months and 12 months
The persistence on lenacapavir among participants receiving care at El Centro Hispano at 12 months.
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence at 6 months
Time Frame: 6 months
Persistence will be measured by the proportion of participants remaining on continuous, appropriately dosed lenacapavir at 6 months.
6 months
Adherence
Time Frame: 6 months and 12 months
Adherence measured by participants receiving each lenacapavir injection within 28 weeks after the last injectionParticipants requiring oral bridging due to delayed injections will be considered persistent but not fully adherent to the scheduled injection protocol. This is measured at 6 months and at 12 months.
6 months and 12 months
Retention
Time Frame: 6 months and 12 months
Retention, defined as continued receipt of appropriately dosed lenacapavir at El Centro Hispano, rather than transfer to care to another clinical site.
6 months and 12 months
Continuation
Time Frame: 12 months
Continuation, defined as continued receipt of lenacapavir at El Centro Hispano, regardless of whether gaps in coverage occurred. This is measured at 12 months.
12 months
Patient Satisfaction measured by questionnaire
Time Frame: 6 months and 12 months
Measured with the following 4 questions: 1. Overall, how satisfied are you with lenacapavir (Likert scale)? 2. Would you recommend lenacapavir to others (yes/no)? 3. Overall, how satisfied are you with getting PrEP at El Centro (Likert scale)? 4. Would you recommend getting PrEP at El Centro to others (yes/no)? Items #1 and #3 are rated on a 5-point Likert scale from 1 (Very satisfied) to 5 (Very dissatisfied); lower scores indicate greater patient satisfaction.
6 months and 12 months
Quality of Life measured by questionnaire
Time Frame: 6 months and 12 months
How would you describe your health in general? (Excellent, Very good, Good, Fair, Poor)
6 months and 12 months
Safety measured by Adverse events
Time Frame: 6 months and 12 months
Prevalence of adverse events, such as injection site reactions.
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Tonia Poteat, PhD, Duke University Medical Center - Professor in the School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

October 3, 2025

First Submitted That Met QC Criteria

October 15, 2025

First Posted (Actual)

October 20, 2025

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00118575

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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