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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
HIV Prevention

Intervention / Treatment
-----------------
* Behavioral: ACTPrEP
* Behavioral: Enhanced Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Control group will include one 30-minute PrEP education session. | Behavioral: Enhanced Standard of Care<br>* Enhanced Standard of Care (ESOC) will include one 30-minute PrEP education session.<br>|
| Experimental: ACTPrEP<br>ACTPrEP will include a 60-minute initial session and 30-minute sessions at 2, 6, and 12 weeks. | Behavioral: ACTPrEP<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACTPrEP Feasibility | ACTPrEP feasibility is measured by percentage of participants retained in the study. | 12 week visit | 
| ACTPrEP Acceptability | Acceptability is measured with the Client Satisfaction Questionnaire. | 12 week visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ACT, PrEP