Using a mobile app to help men with HIV and stimulant use disorder

reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)

This study is testing a mobile app to see if it can help men living with HIV who also struggle with stimulant use disorder improve their treatment and stay healthy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 90 Years
• Sex: Male
• Sponsor: University of Miami (Academic / other)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT05958017 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of reSET, an FDA-authorized mobile therapeutic, in treating stimulant use disorder among men who have sex with men living with HIV. The approach focuses on optimizing care and supporting treatment adherence to maintain stable HIV viral load suppression. Participants will receive standard care alongside the reSET intervention, which aims to enhance their treatment outcomes. The study targets individuals who are Aids Healthcare Foundation patients in specific metro areas and screens for stimulant use disorder severity.

Who should consider this trial

Good fit: Ideal candidates are men living with HIV who have a moderate to severe stimulant use disorder and are AHF patients in designated metro areas.

Not a fit: Patients currently undergoing drug treatment or those without access to a smartphone or stable internet may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment adherence and health outcomes for men living with HIV who also struggle with stimulant use disorder.

How similar studies have performed: Other studies have shown promise in using mobile therapeutics for substance use disorders, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Identifies as male
2. Reports past year anal intercourse with a male
3. Age 18 or older (reSET is only approved for use with adults)
4. Person living with HIV who is an AIDS Healthcare Foundation (AHF) patient at one of the four metro areas: Atlanta, Dallas/Fort Worth, Fort Lauderdale, Los Angeles
5. Screens positive for a moderate or severe stimulant use disorder in the last 3-months using the MINI
6. Reports that he is not currently in drug treatment
7. Currently has an active antiretroviral therapy prescription and reports \< 90% HIV Tx adherence on the 3-item Wilson measure in the past 30 days
8. Can obtain access to stable internet with privacy acceptable to the participant at least twice a week
9. Indicates being able to understand English (reSET is only available in English; can be read or heard)
10. Consents to participation in the study
11. Provides sufficient locator information

Exclusion Criteria:

1. Otherwise eligible participants will be excluded if they appear to display diminished capacity to consent either because of: (a) an apparent inability to provide consent (e.g., cognitive impairment) or (b) apparent severe psychiatric symptoms (e.g., mania, psychosis) that may impair capacity to consent.
2. Persons that meet criteria for prisoner status will be excluded at baseline.
3. Patients who screen positive for moderate to severe opioid use disorder will be excluded from the study because effective pharmacological agents exist for the treatment of this disorder. These patients will be referred to community-based programs that provide specialized treatment for this disorder.
4. Participants will be excluded prior to randomization, if they do not complete at baseline the Time-Line Follow-Back or the laboratory visit.

Where this trial is running

Miami, Florida

• University of Miami — Miami, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Jose Szapocznik, PhD — University of Miami
• Study coordinator: Jose Szapocznik, PhD

Conditions Stimulant Use Disorder; People Living With HIV; reSET; Substance use; Adherence to Anti-Retroviral Therapy