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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05087680
Other study ID # ACTPrEP
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 14, 2023
Est. completion date December 1, 2025

Study information

Verified date May 2023
Source Rhode Island Hospital
Contact Trisha Arnold, PhD
Phone 4017938701
Email trisha.arnold1@lifespan.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date December 1, 2025
Est. primary completion date December 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 34 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Participating in another PrEP study - Unable to provide consent

Study Design


Related Conditions & MeSH terms


Intervention

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
Enhanced Standard of Care (ESOC) will include one 30-minute PrEP education session.

Locations

Country Name City State
United States Univeristy of Mississippi Medical Center Jackson Mississippi

Sponsors (2)

Lead Sponsor Collaborator
Rhode Island Hospital University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary ACTPrEP Feasibility ACTPrEP feasibility is measured by percentage of participants retained in the study. 12 week visit
Primary ACTPrEP Acceptability Acceptability is measured with the Client Satisfaction Questionnaire. 12 week visit
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