RECRUITING
I'm interested ...!!
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 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.
Conditions:
🦠 Medication Adherence 🦠 HIV Prevention 🦠 Stimulant Use
🗓️ Study Start (Actual) 31 January 2022
🗓️ Primary Completion (Estimated) 1 July 2025
✅ Study Completion (Estimated) 1 July 2026
👥 Enrollment (Estimated) 240
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 San Francisco, California, United States
📍 Miami, Florida, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Assigned male at birth
    • * Identifies as male or gender non-conforming
    • * Age 18 or older
    • * Reads and speaks English
    • * Past 6 months, reports condomless anal sex (CAS) with men
    • * HIV negative
    • * Currently has an active prescription for daily oral PrEP for at least 2 months and reports any non-adherence in the past month OR was initiated on PrEP in the past 2 months, regardless of 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 weekly use of either methamphetamine or cocaine.
    • * Lives in California or Florida

    Exclusion Criteria:

    • * Unable to provide informed consent
    • * Unwilling to participate in smartphone-based CM for directly observed PrEP doses
    • * Identifies as transfeminine (e.g., transgender woman)
    • * Assigned female at birth
    • * Unwilling to provide dried blood spot (DBS) specimen - either in-person or remotely
    • * Plans to move out of the state in the next 6 months
    • * Not taking PrEP daily (e.g., if taking intermittent 2-1-1 dosing)
    • * Switched from Truvada to Descovy in the last 5 months
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 May 2021
  • First Submitted that Met QC Criteria 19 May 2021
  • First Posted 24 May 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 November 2023
  • Last Update Posted 2 November 2023
  • Last Verified November 2023
I'm interested ...!!