PrEP Affect Regulation Treatment Innovation

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

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.

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Florida International University

  lead OTHER

Principal Investigators

• Adam W Carrico, PhD · Florida International University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-01-31

Primary Completion

2026-02-01

Completion

2026-02-01

Countries

• United States

Study Locations