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OpenTrials
Completed

NCT Number: NCT05087680

An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South

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.

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Key information

Conditions

Age range

18 year–34 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Enhanced Standard of Care

Behavioral

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

Primary outcomes

  1. ACTPrEP Feasibility

    Time frame: 12 week visit

    ACTPrEP feasibility is measured by percentage of participants retained in the study.

  2. ACTPrEP Acceptability

    Time frame: 12 week visit

    Acceptability is measured with the Client Satisfaction Questionnaire.

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • University of Mississippi Medical Center

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 21, 2021
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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