NCT04899024

PrEP Affect Regulation Treatment Innovation

Optimizing PrEP Adherence in Sexual Minority Men Who Use Stimulants

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Florida International University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This multi-site randomized controlled trial enrolling sexual minority men who use stimulants and are currently taking pre-exposure prophylaxis (PrEP). This randomized controlled trial will test the efficacy of a PrEP Affect Regulation Treatment Innovation (PARTI) condition comprised of a 5-session positive affect intervention delivered during smartphone-based Contingency Management (CM) for directly observed PrEP doses (PARTI+CM) compared to an attention-control condition delivered during CM. The primary outcome is HIV acquisition risk measured using a combination of tenofovir-diphosphate levels in dried blood spots that are indicative of sub-optimal adherence to PrEP and recent condomless anal sex.

Conditions

• Medication Adherence
• HIV Prevention
• Stimulant Use

Interventions

Type	Name	Description
BEHAVIORAL	PARTI	PARTI will provide positive affect skills. Each 1-hour session delivered via Zoom consists of a didactic portion with in vivo skills practice and participants are asked to complete home practice of the skills between sessions. Many sessions include formal exercises that have been utilized in Mindfulness-Based Relapse Prevention to cultivate mindfulness and meta-cognitive awareness.
BEHAVIORAL	Attention-Control	Attention-Control will provide a core set of coping and affect measures as well as neutral writing exercises. Each 1-hour attention-control session will be administered via Zoom.
BEHAVIORAL	Contingency Management for PrEP Adherence	Participants will complete a 12-week contingency management protocol via their smartphone that consists of uploading brief videos taking PrEP medications up to four times per week. Total possible contingency management incentive for completing 48 observed PrEP doses is $360.

Timeline

• Start date: 2022-01-31
• Primary completion: 2026-02-01
• Completion: 2026-12-01
• First posted: 2021-05-24
• Last updated: 2026-02-06

Locations

2 sites across 1 country: United States