An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South
NCT ID: NCT05087680
Last Updated: 2024-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2023-09-14
2025-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control Group
Control group will include one 30-minute PrEP education session.
Enhanced Standard of Care
Enhanced Standard of Care (ESOC) will include one 30-minute PrEP education session.
ACTPrEP
ACTPrEP will include a 60-minute initial session and 30-minute sessions at 2, 6, and 12 weeks.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Unable to provide consent
18 Years
34 Years
MALE
Yes
Sponsors
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University of Mississippi Medical Center
OTHER
Rhode Island Hospital
OTHER
Responsible Party
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Principal Investigators
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Trisha Arnold, PhD
Role: PRINCIPAL_INVESTIGATOR
Rhode Island Hospital
Locations
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Univeristy of Mississippi Medical Center
Jackson, Mississippi, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Arnold T, Giorlando KK, Barnett AP, Gaudiano BA, Antonaccio CM, Elwy AR, Patrick Edet P, Ward LM, Whiteley L, Bailey S, Rogers BG, Leigland A, Rusley JC, Brown LK. Acceptance-Based Pre-Exposure Prophylaxis Intervention (ACTPrEP) to Engage Young Black Men Who Have Sex With Men in the Southern United States: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Jun 20;14:e65921. doi: 10.2196/65921.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ACTPrEP
Identifier Type: -
Identifier Source: org_study_id
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