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

HIV Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05087680
• Other study ID #: ACTPrEP
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2023
• Source: Rhode Island Hospital
• Contact: Trisha Arnold, PhD
• Phone: 4017938701
• Email: trisha.arnold1[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Prevention

Intervention

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

Locations

Country	Name	City	State
United States	Univeristy of Mississippi Medical Center	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACTPrEP Feasibility	ACTPrEP feasibility is measured by percentage of participants retained in the study.	12 week visit
Primary	ACTPrEP Acceptability	Acceptability is measured with the Client Satisfaction Questionnaire.	12 week visit