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PrEP Affect Regulation Treatment Innovation | Clinical Trials | Clareo Health

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Active Not RecruitingNANCT04899024

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 ef...

Lead sponsor: Florida International University•2 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Florida International University

Collaborators

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

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Yes

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 6, 2026Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

PhaseNA

Enrollment239

Start dateJan 2022

Last updatedFeb 6, 2026

Condition

Medication Adherence HIV Prevention Stimulant Use

Locations shown

University of California, San Francisco

San Francisco, California

University of Miami Miller School of Medicine

Miami, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2026Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions