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

NCT ID: NCT05958017

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-04
• Study Completion Date: 2028-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

reSET Group

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

Group Type: EXPERIMENTAL

reSET

Intervention Type: 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 Group

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

Group Type: OTHER

Standard of care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

Standard of care

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Jose Szapocznik

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose Szapocznik, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jose Szapocznik, PhD

Role: CONTACT

jszapocz@miami.edu

(305) 6105723

Facility Contacts

Paco Castellon, MPH, MBA

Role: primary

pcastellon@med.miami.edu

305-205-0072

Other Identifiers

R01DA055563

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20221237

Identifier Type: -

Identifier Source: org_study_id