NCT05958017Recruiting
reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- First submitted
- 14 Jul 2023
- Start date
- 4 Mar 2025
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- University of Miami
- Diseases
- HIV
- NCT number
- NCT05958017
What you commit to
- Study type: Interventional
- Planned participants: 260
- From 4 Mar 2025 to the primary completion date, 31 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient appears to have diminished capacity to consent either because of cognitive impairment or severe psychiatric symptoms (e.g., mania, psychosis).
- 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.
Lab values
- Participants will be excluded prior to randomization, if they do not complete at baseline the Time-Line Follow-Back or the laboratory visit.
Other
- Persons that meet criteria for prisoner status will be excluded at baseline.
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.