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

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.

Study Overview

• Status: Recruiting
• Conditions: Stimulant Use Disorder; People Living With HIV; reSET
• Intervention / Treatment: Behavioral: reSET; Other: Standard of care

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose Szapocznik, PhD; Phone Number: (305) 6105723; Email: jszapocz@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Jose Szapocznik, PhD
      • Contact: Paco Castellon, MPH, MBA; Phone Number: 305-205-0072; Email: pcastellon@med.miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: reSET Group; Participants in this group will use the reSET mobile app for 12 weeks.	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 Group; Participants in this group will receive standard of care treatment for 12 weeks.	Other: Standard of care; Participants in this group will receive assistance connecting to an in person community-based outpatient treatment program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with viral suppression	Changes in RNA viral load. Viral suppression (cv<200copies/ml)	3, 9 and 15 months.

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Jose Szapocznik, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Substance use; Adherence to Anti-Retroviral Therapy
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: 20221237; R01DA055563 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No