Fact CheckerSign in

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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Miami
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.