RecruitingNot ApplicableNCT05958017

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


Sponsor

University of Miami

Enrollment

500 participants

Start Date

Mar 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a smartphone-based app called reSET as a tool to help gay and bisexual men living with HIV who are struggling with stimulant drug use (such as cocaine or methamphetamine). The app delivers a digital therapeutic program to reduce drug use and improve HIV medication adherence. **You may be eligible if...** - You identify as male and have had anal intercourse with a male partner in the past year - You are 18 or older and living with HIV as a patient at an AIDS Healthcare Foundation clinic in Atlanta, Dallas/Fort Worth, Fort Lauderdale, or Los Angeles - You have moderate or severe stimulant use disorder in the last 3 months and are not currently in drug treatment - You are on antiretroviral (HIV) therapy but taking it less than 90% of the time - You can access stable internet at least twice a week and understand English **You may NOT be eligible if...** - You appear to have diminished capacity to consent (e.g., cognitive impairment or severe psychiatric symptoms) - You are currently incarcerated - You have moderate to severe opioid use disorder (you will be referred to specialized treatment) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALreSET

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.

OTHERStandard of care

Participants in this group will receive assistance connecting to an in person community-based outpatient treatment program.


Locations(1)

University of Miami

Miami, Florida, United States

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NCT05958017


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