PrEP Affect Regulation Treatment Innovation (PARTI)

Optimizing PrEP Adherence in Sexual Minority Men Who Use Stimulants

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.

Study Overview

• Status: Completed
• Conditions: Medication Adherence; HIV Prevention; Stimulant Use
• Intervention / Treatment: Behavioral: PARTI; Behavioral: Contingency Management for PrEP Adherence; Behavioral: Attention-Control

• Study Type: Interventional
• Enrollment (Actual): 239
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Assigned male at birth
• Identifies as male
• Age 18 or older
• Reads and speaks English
• Reports condomless anal sex (CAS) with men in the past 6 months
• self-reported HIV negative
• Active prescription for daily oral PrEP for at least 2 months and reports any non-adherence in the past month OR initiated daily oral PrEP in the past 2 months, regardless of self-reported adherence
• Has an iPhone or Android smartphone
• Screens positive for a moderate or severe stimulant use disorder with an abbreviated version of the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST; total score of 4 or more) OR reports using stimulants at least weekly in the past 3 months.
• Lives in California or Florida with no plans to move out of state in the next 6 months

Exclusion Criteria:

• Unable or unwilling to provide informed consent
• Unwilling to upload upload 3 video recordings of directly observed PrEP doses using a smartphone application
• Identifies as transfeminine (e.g., transgender woman)
• Unable or Unwilling to provide dried blood spot (DBS) specimen at baseline
• Switched from daily oral PrEP with disoproxil fumarate (TDF) to daily oral PrEP with tenofovir alafenamide (TAF) in the past 5 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PARTI and CM (Contingency Management); The PARTI intervention will be delivered in five individual sessions during a 12-week contingency management protocol for PrEP adherence	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: 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.
Active Comparator: Attention-Control and CM (Contingency Management); The attention-control condition will consist of five individual sessions where participants complete self-report measures and neutral writing exercises during a 12-week contingency management protocol for PrEP adherence	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Engaging HIV Acquisition Risk	Percentage of participants engaging in HIV acquisition risk (i.e., defined as tenofovir - diphosphate levels from dried blood spots that are indicative of less than four oral PrEP doses per week AND any self-reported recent condomless anal sex)	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Persistence	Percentage of participants who continue taking PrEP medication	Up to 12 months
Retention in PrEP Care	Percentage of participants who report attending a medical visit with the PrEP provider in the past three months	Up to 12 months
Self-Reported Stimulant Use Severity	The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) provides validated composite scores indexing the severity of cocaine and amphetamine use (Mild = 0-3; Moderate = 4-26; Severe = 27 or greater).	Up to 12 months
Positive Affect	Mean positive affect score as measured by the modified Differential Emotions Scale (Range 0-104) with higher scores being indicative of higher positive affect.	Up to 12 months
PrEP Self-Efficacy	A 10-item self-reported measure where higher scores (Range = 9-90) reflect greater perceived self-efficacy for managing PrEP.	Up to 12 months

Collaborators and Investigators

• Sponsor: Florida International University
• Collaborators: National Institute on Drug Abuse (NIDA); University of California, San Francisco
• Investigators: Principal Investigator: Adam W Carrico, PhD, Florida International University

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): February 1, 2026
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: HIV; Contingency Management; Sexual Minority Men; PrEP Adherence
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Medication Adherence
• Other Study ID Numbers: 20200231; R01DA051848 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No