An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2021
CompletedFirst Posted
Study publicly available on registry
October 21, 2021
CompletedStudy Start
First participant enrolled
September 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedNovember 19, 2024
November 1, 2024
2.2 years
September 13, 2021
November 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Control Group
ACTIVE COMPARATORControl group will include one 30-minute PrEP education session.
ACTPrEP
EXPERIMENTALACTPrEP will include a 60-minute initial session and 30-minute sessions at 2, 6, and 12 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- English speaking
- 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
You may not qualify if:
- Participating in another PrEP study
- Unable to provide consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rhode Island Hospitallead
- University of Mississippi Medical Centercollaborator
Study Sites (1)
Univeristy of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Related Publications (1)
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.
PMID: 40540736DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Trisha Arnold, PhD
Rhode Island Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2021
First Posted
October 21, 2021
Study Start
September 14, 2023
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
November 19, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share