Supporting Treatment Adherence for Resilience and Thriving
Overview
- Phase
- N/A
- Intervention
- START mHealth Intervention
- Conditions
- Adherence, Medication
- Sponsor
- Florida International University
- Enrollment
- 286
- Locations
- 1
- Primary Endpoint
- Unsuppressed HIV Viral Load
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
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.
Investigators
Adam Carrico, PhD
Professor and Chair
Florida International University
Eligibility Criteria
Inclusion Criteria
- •Assigned male at birth;
- •Identifies as male;
- •Age 18 or older;
- •Reads and speaks English;
- •Continental US residency;
- •Reports ever having had anal sex with a man;
- •Self-reported HIV diagnosis for 3 or more months and currently taking anti-retroviral therapy (ART)
- •Reports a detectable viral load during past year OR no viral load test in the past 10+ months OR reports \< 90% adherence to ART;
- •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);
- •Has an iPhone or Android smartphone;
Exclusion Criteria
- •HIV-negative or never tested for HIV;
- •HIV-positive men without a current ART prescription;
- •Does not return a viable DBS specimen at baseline for viral load testing
- •Not a sexual minority man
Arms & Interventions
START mHealth Intervention
Participants randomized to receive the START mHealth intervention will have access to the mHealth application for 6 months following randomization.
Intervention: START mHealth Intervention
Website referrals
Participants in this condition will receive no intervention and will have access to a website with resources related to substance use disorder treatment and HIV treatment.
Outcomes
Primary Outcomes
Unsuppressed HIV Viral Load
Time Frame: 6 Months
Proportion of participants with a viral load \> 300 copies/mL from dried blood spot samples
Secondary Outcomes
- Unsuppressed Viral Load(12 Months)
- Self-Reported Stimulant Use Severity(12 Months)
- Self-Reported Anti-Retroviral Therapy (ART) Adherence(12 Months)
- Positive Affect(12 Months)