Supporting Treatment Adherence for Resilience and Thriving (START)
This Phase II randomized controlled trial is testing the efficacy of a cell phone application called START for helping men who use stimulants like methamphetamine to get the most out of their HIV treatment.
Conditions:
🦠 Adherence, Medication 🦠 HIV-1-infection 🦠 Stimulant Use
🗓️ Study Start (Actual) 15 June 2022
🗓️ Primary Completion (Estimated) 31 October 2024
✅ Study Completion (Estimated) 30 April 2025
👥 Enrollment (Estimated) 350
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Miami, Florida, United States

📋 Eligibility Criteria

Description

  • 1. Assigned male at birth;
  • 2. Identifies as male;
  • 3. Age 18 or older;
  • 4. Reads and speaks English;
  • 5. Continental US residency;
  • 6. Reports ever having had anal sex with a man;
  • 7. Self-reported HIV diagnosis for 3 or more months and currently taking anti-retroviral therapy (ART)
  • 8. Reports a detectable viral load during past year OR no viral load test in the past 10+ months OR reports \< 90% adherence to ART;
  • 9. Screens positive for a moderate or severe stimulant use disorder in the past 3 months with an abbreviated version of the National Institute on Drug Abuse (NIDA)-modified Alcohol, Smoking and Substance. Involvement Screening Test (ASSIST);
  • 10. Has an iPhone or Android smartphone;
  • 11. Is willing to participate in an mHealth intervention

Exclusion Criteria:

  • 1. HIV-negative or never tested for HIV;
  • 2. HIV-positive men without a current ART prescription;
  • 3. Does not return a viable DBS specimen at baseline for viral load testing
  • 4. Not a sexual minority man
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No

🗓️ 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 15 November 2021
  • First Submitted that Met QC Criteria 15 November 2021
  • First Posted 2 December 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 November 2023
  • Last Update Posted 2 November 2023
  • Last Verified November 2023