An interventional study of ACTPrEP and Enhanced Standard of Care in HIV Prevention, sponsored by Rhode Island Hospital. Completed at 1 site in United States. Open to male participants aged 18 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Prevention
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.
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.
Rhode Island Hospital is the lead sponsor of 187 studies on the registry; 37 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Control group will include one 30-minute PrEP education session.
Behavioral: Enhanced Standard of Care
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.
Enhanced Standard of Care (ESOC) will include one 30-minute PrEP education session.
ACTPrEP Feasibility
ACTPrEP feasibility is measured by percentage of participants retained in the study.
Time frame: 12 week visit
ACTPrEP Acceptability
Acceptability is measured with the Client Satisfaction Questionnaire.
Time frame: 12 week visit
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Rhode Island Hospital