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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Prevention
• Intervention / Treatment: Behavioral: Enhanced Standard of Care; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trisha Arnold, PhD; Phone Number: 4017938701; Email: trisha.arnold1@lifespan.org
• Study Contact Backup: Name: Larry Brown, MD; Email: larry_brown@brown.edu

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Recruiting
      • Univeristy of Mississippi Medical Center
      • Contact: Trisha Arnold, PhD; Phone Number: 401-793-8701; Email: trisha.arnold1@lifespan.org
      • Contact: Lori Ward, PhD; Email: lward@umc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: University of Mississippi Medical Center
• Investigators: Principal Investigator: Trisha Arnold, PhD, Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: PrEP; ACT
• Other Study ID Numbers: ACTPrEP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No