Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07218211

Enhancing PrEP Uptake and Retention Among Latine TGW and GBM 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

El Centro Hispano

Durham, North Carolina, 27701, United States

Location status: Recruiting

Location contact

Alma Ortega

SUB_INVESTIGATOR

Emilia Ismael-Simental

SUB_INVESTIGATOR

Orlando Martinez J Peer Navigator

CONTACT

[email protected]

919-687-4635

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lenacapavir long-acting

Drug

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

Other names: Yeztugo, Lenacapavir injection, PrEP, Injectable PrEP

Primary outcomes

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

    Time frame: up to 1 year

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

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

    Time frame: up to 1 year

    Qualitative identification: "Recommendations to address these barriers?"

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

    Time frame: up to 1 year

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

Secondary outcomes

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

    Time frame: up to 1 year

    AARP items will help quantify acceptability and will help validate community perceptions: "I believe lenacapavir injections are an effective way to prevent HIV", "I would be willing to receive lenacapavir injections in the future when this study is complete", "Receiving lenacapavir in a community setting fits my lifestyle and preferences", "I feel comfortable receiving lenacapavir injections from professionals working with El Centro", "I would recommend lenacapavir to a friend who is at risk for HIV", "I found lenacapavir preferable to oral PrEP", "Compared to a daily pill, I feel that injectable PrEP gives me more privacy", "I am concerned about possible side effects from lenacapavir injections", "Compared to a daily pill, I feel that injectable PrEP reduces concerns about being judged by others"

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

    Time frame: up to 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Iris Navarro Clinical Research Coordinator

CONTACT

[email protected]

919-660-3940

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Acronym: INCLUSION

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Oct 20, 2025
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.