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

RecruitingNA

Sponsor: University of Miami

Conditions: Stimulant Use Disorder, People Living With HIV

Interventions: reSET, Standard of care

Countries: United States

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.

Eligibility overview

Sex: MALE

Age: 18 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Assigned male sex at birth and has not undergone any transgender hormonal treatment
2. Reports having had sex with a male in the past 12 months
3. Age 18 or older
4. 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
5. Screens positive for mild, moderate or severe stimulant use disorder in the last 12 months using the MINI
6. Reports that he is not currently in drug treatment
7. Is living with HIV
8. Reports having an active antiretroviral prescription
9. Have access to a smartphone or tablet with stable internet at least twice a week and can download applications to the smartphone or tablet
10. Able to understand English
11. Consents to participation in the study
12. Provides sufficient locator information
13. Identifies as non-Hispanic White, non-Hispanic Black/African American or Latinx/Hispanic
14. Has been in stable housing for the past 3 months and intends to remain housed for the next 15 months

Exclusion Criteria:

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

Locations (1)

Miami, Florida, United States