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Recruiting NCT07218211

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

Phase IV Interventional HIV Prevention HIV Pre-exposure Prophylaxis HIV Prevention Program HIV Prevention and Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lenacapavir long-acting.
Who it may be relevant to
Registry conditions: HIV Prevention, HIV Pre-exposure Prophylaxis, HIV Prevention Program, HIV Prevention and Care. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Number of participants who provided identification of barriers to providing lenacapavir at a Latine community-based organization [Time frame: up to 1 year]
  • Number of participants who provided recommendations to address barriers to providing lenacapavir at a Latine community-based organization [Time frame: up to 1 year]
  • Number of participants who provided identification of facilitators to providing lenacapavir at a Latine community-based organization [Time frame: up to 1 year]
Secondary outcome measures (2)
  • 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]
  • Number of providers who found the intervention feasible as measured by the Program Sustainability Assessment Tool (PSAT) [Time frame: up to 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • El Centro Hispano — Durham

Identifiers

NCT: NCT07218211 · PRO00118575

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗