Adherence, Medication, HIV-1-infection, Stimulant Use
Conditions
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.
Interventions
BEHAVIORALSTART mHealth Intervention
The START mHealth intervention is a mobile application that will be downloaded by participants through their mobile phones. The application targets information, motivation, and behavioral skills relevant to ART adherence. Participants will have access to this application for 6 months.
Sponsors
Florida International University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unsuppressed HIV Viral Load | 6 Months | Proportion of participants with a viral load \> 300 copies/mL from dried blood spot samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unsuppressed Viral Load | 12 Months | Proportion of participants with a viral load \> 300 copies/mL from dried blood spot samples |
| Self-Reported Stimulant Use Severity | 12 Months | 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). |
| Self-Reported Anti-Retroviral Therapy (ART) Adherence | 12 Months | 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 |
| Positive Affect | 12 Months | Mean positive affect score as measured by the modified Differential Emotions Scale (Range 0-104) with higher scores being indicative of higher positive affect. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdam W Carrico, PhD
Florida International University
Outcome results
None listed