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

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: HIV Prevention; HIV Pre-exposure Prophylaxis; HIV Prevention Program; HIV Prevention and Care; HIV Pre-exposure Prophylaxis Use
• Intervention / Treatment: Drug: Lenacapavir long-acting

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

• 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: Orlando Martinez J Peer Navigator; Phone Number: 919-687-4635; Email: jomartinez@elcentronc.org

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability as measured by the number of participants who answered "yes" to select modified acceptability questions from Abbreviated Acceptability Rating Profile (AARP)	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"	up to 1 year
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.	up to 1 year

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): January 5, 2027
• Study Completion (Estimated): January 5, 2028

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): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: PrEP; Lenacapavir; Long-acting Injectable PrEP; PrEP injections
• Additional Relevant MeSH Terms: lenacapavir
• 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