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Completed

NCT Number: NCT04899024

PrEP Affect Regulation Treatment Innovation

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.

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Key information

Conditions

Medication Adherence Behavior HIV Prevention Health Behavior Patient Acceptance of Health Care Patient Compliance Stimulant Use Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Percentage of Participants Engaging HIV Acquisition Risk

    Time frame: Up to 12 months

    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)

Secondary outcomes

  1. PrEP Persistence

    Time frame: Up to 12 months

    Percentage of participants who continue taking PrEP medication

  2. Retention in PrEP Care

    Time frame: Up to 12 months

    Percentage of participants who report attending a medical visit with the PrEP provider in the past three months

  3. Self-Reported Stimulant Use Severity

    Time frame: Up to 12 months

    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).

  4. Positive Affect

    Time frame: Up to 12 months

    Mean positive affect score as measured by the modified Differential Emotions Scale (Range 0-104) with higher scores being indicative of higher positive affect.

  5. PrEP Self-Efficacy

    Time frame: Up to 12 months

    A 10-item self-reported measure where higher scores (Range = 9-90) reflect greater perceived self-efficacy for managing PrEP.

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of California, San Francisco

Registry information

Official study title

Optimizing PrEP Adherence in Sexual Minority Men Who Use Stimulants

Acronym: PARTI

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 24, 2021
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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