NCT05958017

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if reSET, an FDA authorized mobile therapeutic, is effective in treating stimulant use disorder and helping keep HIV viral load suppression stable among men who have sex with men who are living with HIV and have a stimulant use disorder.

Conditions

• Stimulant Use Disorder
• People Living With HIV
• reSET

Interventions

Type	Name	Description
BEHAVIORAL	reSET	Participants in this group will use a mobile application that delivers treatment for substance use disorder. 31 required and 30 optional modules. Among many topics covered in the modules, some are substance use management, communication, emotion management, relationship skills, HIV/Sexually Transmitted Infections and triggers for risky sex. In the reSET app you will get the chance to earn rewards for two activities: (1) completing a module and (2) providing a negative urine drug screen in exchange for a motivational or monetary prize. You will have 12 weeks to complete as many modules as you like, about 4 modules per week. Each module takes approximately 10-15 min. Every 3-4 days you will meet with the same study team member to provide a urine drug screen from a place comfortable for you (e.g. home) which will be observed and read via Zoom.
OTHER	Standard of care	Participants in this group will receive assistance connecting to an in person community-based outpatient treatment program.

Timeline

• Start date: 2025-03-04
• Primary completion: 2028-01-31
• Completion: 2028-01-31
• First posted: 2023-07-24
• Last updated: 2025-08-01

Locations

1 site across 1 country: United States