NCT04899024Completed
PrEP Affect Regulation Treatment Innovation
Optimizing PrEP Adherence in Sexual Minority Men Who Use Stimulants
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 239 (actual)
- First submitted
- 7 May 2021
- Start date
- 31 Jan 2022
- Primary completion date
- 1 Feb 2026
- Lead sponsor
- Florida International University
- Diseases
- HIV
- NCT number
- NCT04899024
What you commit to
- Study type: Interventional
- Participants enrolled: 239
- From 31 Jan 2022 to the primary completion date, 1 Feb 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Miller School of Medicine Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.