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Recruiting NCT05958017

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

No phase Interventional Stimulant Use Disorder People Living With HIV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: reSET, Standard of care.
Who it may be relevant to
Registry conditions: Stimulant Use Disorder, People Living With HIV. Basic parameters: 18 years — 90 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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 exchan
  • Other Standard of care
    Participants in this group will receive assistance connecting to an in person community-based outpatient treatment program.

Primary outcome measures

  • Change in days of stimulant use as measured by Timeline FollowBack [Time frame: 3, 9 and 15 months.]
Secondary outcome measures (1)
  • Proportion of subjects with viral suppression [Time frame: 3, 9 and 15 months.]

Eligibility criteria

Inclusion criteria

  • Assigned male sex at birth and has not undergone any transgender hormonal treatment
  • Reports having had sex with a male in the past 12 months
  • Age 18 or older
  • Is affiliated with a study referral source (e.g., AHF clinic, registry, other healthcare program or clinic) or resides in a city or county where a participating healthcare center or health program is located
  • Screens positive for mild, moderate or severe stimulant use disorder in the last 12 months using the MINI
  • Reports that he is not currently in drug treatment
  • Is living with HIV
  • Reports having an active antiretroviral prescription
  • Have access to a smartphone or tablet with stable internet at least twice a week and can download applications to the smartphone or tablet
  • Able to understand English
  • Consents to participation in the study
  • Provides sufficient locator information
  • Identifies as non-Hispanic White, non-Hispanic Black/African American or Latinx/Hispanic
  • Has been in stable housing for the past 3 months and intends to remain housed for the next 15 months

Exclusion criteria

  • Patient appears to have diminished capacity to consent either because of cognitive impairment or severe psychiatric symptoms (e.g., mania, psychosis).
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT05958017 · 20221237 · R01DA055563

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗