Supporting Treatment Adherence for Resilience and Thriving (START)

Florida International University (FIU)

Status: Active, not recruiting

Conditions: HIV-1-infection; Adherence, Medication; Stimulant Use

Treatments: Behavioral: START mHealth Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05140876

20190578

R01DA049843 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 286 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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286 participants in 2 patient groups

START mHealth Intervention

Experimental group

Description:

Participants randomized to receive the START mHealth intervention will have access to the mHealth application for 6 months following randomization.

Treatment:

Behavioral: START mHealth Intervention

Website referrals

No Intervention group

Description:

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.