Status:
ACTIVE_NOT_RECRUITING
PrEP Affect Regulation Treatment Innovation
Lead Sponsor:
Florida International University
Collaborating Sponsors:
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Conditions:
Medication Adherence
HIV Prevention
Eligibility:
MALE
18+ years
Phase:
NA
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 ef...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT04899024
Start Date
January 31 2022
End Date
July 1 2026
Last Update
April 17 2025
Active Locations (2)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136