Actively Recruiting
Led by Rhode Island Hospital · Updated on 2024-11-19
66
Participants Needed
1
Research Sites
N/A
Total Duration
R
Rhode Island Hospital
Lead Sponsor
U
University of Mississippi Medical Center
Collaborating Sponsor
Researchers are evaluating a brief Acceptance and Commitment Therapy (ACT)-based intervention called ACTPrEP, designed to be culturally appropriate for young Black men who have sex with men (YBMSM). The study aims to improve engagement with pre-exposure prophylaxis (PrEP) for HIV prevention among this specific group. The trial involves developing and testing this tailored intervention through a randomized controlled process to assess its feasibility and acceptability. The study compares two groups: one receiving the ACTPrEP intervention, which includes a 60-minute initial session followed by three 30-minute follow-up sessions focusing on thoughts, emotions, and sensations related to PrEP use; and a control group receiving a single 30-minute PrEP education session as enhanced standard of care (ESOC). The intervention sessions occur at weeks 0, 2, 6, and 12. Participants will be involved for 24 weeks, during which researchers will measure how feasible and acceptable the ACTPrEP intervention is, using tools like the Client Satisfaction Questionnaire at 12 weeks. They will also track behaviors such as PrEP uptake, adherence, and persistence over time. Additional qualitative interviews will explore barriers and facilitators to implementing ACTPrEP. The study is sponsored by Rhode Island Hospital and focuses on young Black men aged 18 to 34 years who are eligible for PrEP according to CDC guidelines.
CONDITIONS
An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive the assigned intervention: either a 60-minute initial ACTPrEP session followed by 30-minute follow-up sessions at 2, 6, and 12 weeks, or a one-time 30-minute PrEP education session as enhanced standard of care.
1 initial session and up to 3 follow-up sessions depending on the intervention group
Duration - 12 weeks
Participants are observed over a total of 24 weeks to evaluate PrEP uptake, adherence, persistence, and other behavioral outcomes after the intervention period.
Visits as scheduled for outcome assessments up to 24 weeks
Total: 1 location
1
Univeristy of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
T
Trisha Arnold, PhD
L
Larry Brown, MD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Trisha Arnold, Kayla K Giorlando, Andrew P Barnett...
https://pubmed.ncbi.nlm.nih.gov/40540736