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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT05958017
Status
Recruiting
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Conditions

  • People Living With HIV
  • Stimulant Use Disorder
  • reSET

Eligibility Criteria

Sex
MALE
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • reSET — BEHAVIORAL
    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.
  • Standard of care — OTHER
    Participants in this group will receive assistance connecting to an in person community-based outpatient treatment program.

Study Details

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.

Key Dates

Start date
Mar 4, 2025
Status verified
Jun 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: reSET Group
    Participants in this group will use the reSET mobile app for 12 weeks.
  • Other: Standard of Care Group
    Participants in this group will receive standard of care treatment for 12 weeks.

Primary Outcome Measure

Change in days of stimulant use as measured by Timeline FollowBack [ Time Frame: 3, 9 and 15 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Paco Castellon, MPH, MBA
[email protected]
305-205-0072
Jose Szapocznik, PhD (PRINCIPAL_INVESTIGATOR)

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