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

NCT05958017 | Recruiting DMC

• 2 other identifiers: 20221237R01DA055563
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Substance use; Adherence to Anti-Retroviral Therapy

Outcome Measures

Primary Outcomes (1)

• Change in days of stimulant use as measured by Timeline FollowBack

  Number of days of stimulant use as measured by the Timeline FollowBack using the formula: Daily opioid use- the proportion of days of use

  3, 9 and 15 months.

Secondary Outcomes (1)

• Proportion of subjects with viral suppression

  3, 9 and 15 months.

Study Arms (2)

reSET Group

EXPERIMENTAL

Participants in this group will use the reSET mobile app for 12 weeks.

Behavioral: reSET

Standard of Care Group

OTHER

Participants in this group will receive standard of care treatment for 12 weeks.

Other: Standard of care

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.

reSET Group

Standard of care OTHER

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

Standard of Care Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identifies as male
• Reports past year anal intercourse with a male
• Age 18 or older (reSET is only approved for use with adults)
• 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
• Screens positive for a moderate or severe stimulant use disorder in the last 3-months using the MINI
• Reports that he is not currently in drug treatment
• Currently has an active antiretroviral therapy prescription and reports \< 90% HIV Tx adherence on the 3-item Wilson measure in the past 30 days
• Can obtain access to stable internet with privacy acceptable to the participant at least twice a week
• Indicates being able to understand English (reSET is only available in English; can be read or heard)
• Consents to participation in the study
• Provides sufficient locator information

You may not qualify if:

• 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.
• Persons that meet criteria for prisoner status will be excluded at baseline.
• 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.
• Participants will be excluded prior to randomization, if they do not complete at baseline the Time-Line Follow-Back or the laboratory visit.

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jose Szapocznik, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Szapocznik, PhD

CONTACT

(305) 6105723; jszapocz@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: March 4, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)