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

Duke University

Status and phase

Enrolling

Phase 4

Conditions

HIV Prevention

HIV Prevention Program

HIV Pre-exposure Prophylaxis Use

HIV Pre-exposure Prophylaxis

HIV Prevention and Care

Treatments

Drug: Lenacapavir long-acting

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07218211

PRO00118575

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.