Maintenance Notice

Due to necessary scheduled maintenance, the JMIR Publications website will be unavailable from Wednesday, July 01, 2020 at 8:00 PM to 10:00 PM EST. We apologize in advance for any inconvenience this may cause you.

Who will be affected?

Accepted for/Published in: JMIR Research Protocols

Date Submitted: Aug 29, 2024
Date Accepted: Apr 14, 2025

The final, peer-reviewed published version of this preprint can be found here:

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

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;14:e65921

DOI: 10.2196/65921

PMID: 40540736

PMCID: 12228006

A Pilot Randomized Controlled Trail of an Acceptance Based PrEP Intervention (ACTPrEP) to Engage Young Black MSM in the South: A Protocol Paper

  • Trisha Arnold; 
  • Kayla K Giorlando; 
  • Andrew P Barnett; 
  • Brandon A Gaudiano; 
  • Cara M Antonaccio; 
  • A Rani Elwy; 
  • Precious Patrick Edet; 
  • Lori M Ward; 
  • Laura Whiteley; 
  • Sarah Bailey; 
  • Brooke G Rogers; 
  • Avery Leigland; 
  • Jack C Rusley; 
  • Larry K Brown

ABSTRACT

Background:

Given the high rates of HIV infection among young, Black men who have sex with men (YBMSM) in Jackson, MS, and the underutilization of pre-exposure prophylaxis (PrEP) in this population, there is a critical need for innovative interventions to promote PrEP use. Acceptance and Commitment Therapy (ACT) is a promising intervention for health behavior change.

Objective:

Develop and test an intervention, ACTPrEP, to increase PrEP utilization among YBMSM.

Methods:

We conducted in-depth interviews with 20 YBMSM and 10 PrEP staff to inform the development of ACTPrEP, an intervention that utilizes ACT to improve PrEP utilization. A pilot Randomized Controlled Trail (RCT) will evaluate the feasibility and acceptability of ACTPrEP compared to Enhanced Standard of Care (ESOC) in promoting PrEP use among YBMSM (n=66).

Results:

Specific ACTPrEP adaptations from the qualitative interviews included: service setting (interventionist should be PrEP informed and well-integrated), target audience (provide check-in calls, be caring, and authentically relate), mode of delivery (flexible delivery), and cultural adaptation (normalize PrEP use). Research activities began in September 2023 and are still ongoing. RCT results will be available at a later date.

Conclusions:

This study will inform the development of a larger RCT to evaluate the efficacy of ACTPrEP for increasing PrEP use among YBMSM. Clinical Trial: NCT05087680


 Citation

Please cite as:

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;14:e65921

DOI: 10.2196/65921

PMID: 40540736

PMCID: 12228006

Download PDF


Request queued. Please wait while the file is being generated. It may take some time.

© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.