HIV-1-infection Clinical Trial
— STARTOfficial title:
Supporting Treatment Adherence for Resilience and Thriving
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.
Status | Recruiting |
Enrollment | 350 |
Est. completion date | April 30, 2025 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of MIami Miller School of Medicine | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida International University | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detectable HIV Viral Load | Proportion of participants with a viral load > 300 copies/mL from dried blood spot samples | 6 Months | |
Secondary | Detectable Viral Load | Proportion of participants with a viral load > 300 copies/mL from dried blood spot samples | 12 Months | |
Secondary | Self-Reported Stimulant Use Severity | The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) provides validated composite scores indexing the severity of cocaine and amphetamine use (Mild = 0-3; Moderate = 4-26; Severe = 27 or greater). | 12 Months | |
Secondary | Self-Reported Anti-Retroviral Therapy (ART) Adherence | Participants will rate on a visual analogue scale the percentage (0% meaning no adherence to 100% meaning complete adherence) of ART medications that they took in the past 30 days | 12 Months | |
Secondary | Positive Affect | Mean positive affect score as measured by the modified Differential Emotions Scale (Range 0-104) with higher scores being indicative of higher positive affect. | 12 Months |
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