CompletedNot Applicable

PrEP Affect Regulation Treatment Innovation

United States239 participantsStarted 2022-01-31

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Participants Engaging HIV Acquisition Risk

Timeframe: Up to 12 months

Trial details

NCT IDNCT04899024

SponsorFlorida International University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-01