Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
MALE
NCT05958017

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

Led by University of Miami · Updated on 2025-08-01

500

Participants Needed

1

Research Sites

151 weeks

Total Duration

On this page

Sponsors

U

University of Miami

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 90Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  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
Not Eligible

You will not qualify if you...

  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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

J

Jose Szapocznik, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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