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

Phase 4RecruitingNCT07218211

Duke University100 enrolled

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.

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

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Conditions

HIV Prevention HIV Pre-exposure Prophylaxis HIV Prevention Program

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Acceptability of the intervention measured by questionnaire

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.

Time frame: 6 and 12 months

Feasibility of the intervention measured by programmatic indicators

Evaluated using programmatic indicators including recruitment rate, adherence and retention.

Time frame: 6 months and 12 months

Sustainability of the intervention

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.

Time frame: 6 months and 12 months

The persistence on lenacapavir among participants receiving care at El Centro Hispano at 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.

Time frame: 12 months

Secondary Outcomes

Persistence at 6 months

Persistence will be measured by the proportion of participants remaining on continuous, appropriately dosed lenacapavir at 6 months.

Time frame: 6 months

Adherence

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.

Time frame: 6 months and 12 months

Retention

Retention, defined as continued receipt of appropriately dosed lenacapavir at El Centro Hispano, rather than transfer to care to another clinical site.

Time frame: 6 months and 12 months

Continuation

Continuation, defined as continued receipt of lenacapavir at El Centro Hispano, regardless of whether gaps in coverage occurred. This is measured at 12 months.

Time frame: 12 months

Patient Satisfaction measured by questionnaire

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.

Time frame: 6 months and 12 months

Quality of Life measured by questionnaire

How would you describe your health in general? (Excellent, Very good, Good, Fair, Poor)

Time frame: 6 months and 12 months

Safety measured by Adverse events

Prevalence of adverse events, such as injection site reactions.

Time frame: 6 months and 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts