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| Name | Class |
|---|---|
| University of Mississippi Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Control group will include one 30-minute PrEP education session. |
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| ACTPrEP | Experimental | ACTPrEP will include a 60-minute initial session and 30-minute sessions at 2, 6, and 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACTPrEP | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ACTPrEP Feasibility | ACTPrEP feasibility is measured by percentage of participants retained in the study. | 12 week visit |
| ACTPrEP Acceptability | Acceptability is measured with the Client Satisfaction Questionnaire. | 12 week visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trisha Arnold, PhD | Rhode Island Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40540736 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2023 | Oct 31, 2023 | Prot_SAP_000.pdf |
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| Enhanced Standard of Care | Behavioral | Enhanced Standard of Care (ESOC) will include one 30-minute PrEP education session. |
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