An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South

Rhode Island Hospital66 enrolled

Overview

Investigators will use a generalized framework for the adaptation of EBIs to inform the development of a brief Acceptance and Commitment Therapy (ACT)-based culturally appropriate pre-exposure prophylaxis (PrEP) intervention tailored to young Black men who have sex with men (YBMSM), named ACTPrEP. Specific Aim 1) Gather data from YBMSM (n = 20) and clinic staff (n = 10) through in-depth interviews to assess quantitative measures, intervention design, and experiences most relevant to PrEP engagement. Specific Aim 2) Develop ACTPrEP utilizing Aim 1 data, working iteratively with experts, and an intervention "run through" with a sample of participants. CLINICAL TRIAL IS AIM 3 ONLY Specific Aim 3) Evaluate ACTPrEP. Enroll 66 participants. Primary outcomes will be feasibility (measured by percentage eligible, consented, randomized, and retained) and acceptability (measured by the Client Satisfaction Questionnaire). Secondary outcomes will compare ACTPrEP vs. enhanced standard of care condition (ESOC) on behavior outcomes (uptake, adherence, and PrEP persistence) and possible mediators over the course of 24 weeks. Barriers and facilitators to implementing ACTPrEP will be assessed with post-RCT qualitative interviews using the i-PARIHS framework.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

HIV Prevention

Interventions

ACTPrEPBEHAVIORAL

ACTPrEP will include a 60-minute initial session and a series of 30-minute follow-up sessions. Sessions will focus on the Thoughts, Emotions, Associations, Memories, and Sensations (TEAMS) relevant to PrEP uptake and adherence.

Enhanced Standard of CareBEHAVIORAL

Enhanced Standard of Care (ESOC) will include one 30-minute PrEP education session.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 34 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * English speaking * Between 18-34 years old * Male sex assigned at birth * Identify as African American/Black * Not enrolled in another PrEP related study * Able to give consent * Not taken PrEP in past 3 months * Report having sex with a man in the past 3 months * PrEP-eligible according to CDC guidelines Exclusion Criteria: * Participating in another PrEP study * Unable to provide consent

Locations (1)

Univeristy of Mississippi Medical Center

Jackson, Mississippi, United States

Outcomes

Primary Outcomes

ACTPrEP Feasibility

ACTPrEP feasibility is measured by percentage of participants retained in the study.

Time frame: 12 week visit

ACTPrEP Acceptability

Acceptability is measured with the Client Satisfaction Questionnaire.

Time frame: 12 week visit

Data from ClinicalTrials.gov

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