PrEP Affect Regulation Treatment Innovation

Completed · Not applicable

Conditions studied: Medication Adherence, HIV Prevention, Stimulant Use

In brief

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.

Key facts

Study ID

NCT04899024

Run by

Florida International University

People needed

239

Starts

2022-01-31

Expected to finish

2026-02-01

Last updated by the study team

2026-05-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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