Skip to main content
Clinical Trials/NCT05087680
NCT05087680
Recruiting
Not Applicable

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

Rhode Island Hospital1 site in 1 country66 target enrollmentSeptember 14, 2023
ConditionsHIV Prevention

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Prevention
Sponsor
Rhode Island Hospital
Enrollment
66
Locations
1
Primary Endpoint
ACTPrEP Feasibility
Status
Recruiting
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
September 14, 2023
End Date
December 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

ACTPrEP Feasibility

Time Frame: 12 week visit

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

ACTPrEP Acceptability

Time Frame: 12 week visit

Acceptability is measured with the Client Satisfaction Questionnaire.

Study Sites (1)

Loading locations...

Similar Trials