An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| 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.
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| 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.
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Outcome Measures
Primary Outcome Measures
- ACTPrEP Feasibility [12 week visit]
ACTPrEP feasibility is measured by percentage of participants retained in the study.
- ACTPrEP Acceptability [12 week visit]
Acceptability is measured with the Client Satisfaction Questionnaire.
Eligibility Criteria
Criteria
Inclusion Criteria:
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English speaking
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Between 18-34 years old
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Male sex assigned at birth
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Identify as African American/Black
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Not enrolled in another PrEP related study
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Able to give consent
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Not taken PrEP in past 3 months
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Report having sex with a man in the past 3 months
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PrEP-eligible according to CDC guidelines
Exclusion Criteria:
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Participating in another PrEP study
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Unable to provide consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Univeristy of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
Sponsors and Collaborators
- Rhode Island Hospital
- University of Mississippi Medical Center
Investigators
- Principal Investigator: Trisha Arnold, PhD, Rhode Island Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACTPrEP