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PrEP Affect Regulation Treatment Innovation

CompletedNA

Sponsor: Florida International University

Conditions: Medication Adherence, HIV Prevention, Stimulant Use

Interventions: PARTI, Attention-Control, Contingency Management for PrEP Adherence

Countries: United States

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.

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (2)

San Francisco, California, United States
Miami, Florida, United States