PrEP Affect Regulation Treatment Innovation

NCT04899024 | Active Not Recruiting

• 2 other identifiers: 20200231R01DA051848
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Sexual Minority Men; HIV; PrEP Adherence; Contingency Management

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Engaging HIV Acquisition Risk

  Percentage of participants engaging in HIV acquisition risk (i.e., defined as tenofovir - diphosphate levels \< 700 fmol per punch from dried blood spots and any self-reported recent condomless anal sex)

  Up to 12 months

Secondary Outcomes (4)

• PrEP Persistence

  Up to 12 months

• Retention in PrEP Care

  Up to 12 months

• Self-Reported Stimulant Use Severity

  Up to 12 months

• Positive Affect

  Up to 12 months

Study Arms (2)

PARTI and CM (Contingency Management)

EXPERIMENTAL

The PARTI intervention will be delivered in five individual sessions during a 12-week contingency management protocol for PrEP adherence

Behavioral: PARTI; Behavioral: Contingency Management for PrEP Adherence

Attention-Control and CM (Contingency Management)

ACTIVE COMPARATOR

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: Attention-Control; Behavioral: Contingency Management for PrEP Adherence

Interventions

PARTI BEHAVIORAL

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.

PARTI and CM (Contingency Management)

Attention-Control BEHAVIORAL

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.

Attention-Control and CM (Contingency Management)

Contingency Management for PrEP Adherence BEHAVIORAL

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.

Attention-Control and CM (Contingency Management); PARTI and CM (Contingency Management)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Assigned male at birth and identifies as male.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Florida International University: lead

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Adam W Carrico, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 24, 2021
• Study Start: January 31, 2022
• Primary Completion: February 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)