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

Lifespan

Status: Enrolling

Conditions: HIV Prevention

Treatments: Behavioral: Enhanced Standard of Care; Behavioral: ACTPrEP

Study type: Interventional

Funder types: Other

Identifiers

NCT05087680

ACTPrEP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: Male

Ages: 18 to 34 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Control group will include one 30-minute PrEP education session.

Treatment:

Behavioral: Enhanced Standard of Care

ACTPrEP

Experimental group

Description:

ACTPrEP will include a 60-minute initial session and 30-minute sessions at 2, 6, and 12 weeks.

Treatment:

Behavioral: ACTPrEP