Using a mobile app to help men with HIV and stimulant use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of reSET, an FDA-authorized mobile therapeutic, in treating stimulant use disorder among men who have sex with men living with HIV. The approach focuses on optimizing care and supporting treatment adherence to maintain stable HIV viral load suppression. Participants will receive standard care alongside the reSET intervention, which aims to enhance their treatment outcomes. The study targets individuals who are Aids Healthcare Foundation patients in specific metro areas and screens for stimulant use disorder severity.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Jose Szapocznik, PhD — University of Miami
• Study coordinator: Mariya Petrova, PhD
• Email: mpp72@miami.edu
• Phone: 7863386432

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• DynamiCare-based program to support re-entry for stimulant users at risk for HIV

  This study tests whether adding the DynamiCare mobile app plus patient navigation helps people released from justice settings who use stimulants to start HIV care (ART/PrEP) and reduce stimulant use.

  Recruiting at 2 sites University of Texas Southwestern Medical Center · New Haven, Connecticut and 1 other locations · NCT07136363

• Repetitive Transcranial Magnetic Stimulation for Stimulant Use Disorder in Veterans

  A randomized, placebo-controlled test to see if rTMS helps veterans with stimulant use disorder see reduced use and improved outcomes.

  Recruiting VA Office of Research and Development · Palo Alto, California · NCT07112105

• Smartphone support for stimulant use disorder

  This program will test whether two different smartphone app services can help adults with stimulant use disorder (cocaine, crack, or meth) reduce use and need for medical care while using the apps at home.

  Recruiting DynamiCare Health · Boston, Massachusetts · NCT07092059

• Optimizing brain stimulation techniques for stimulant use disorder

  This study is testing different brain stimulation techniques to see if they can help adults with stimulant use disorder who have recently stopped using drugs.

  Recruiting Phase 1 University of Minnesota · Minneapolis, Minnesota · NCT06790576

• Evaluating COVID-19 and influenza vaccine schedules for immunocompromised individuals

  This study is testing different ways to give COVID-19 and flu vaccines to people with weakened immune systems to see which method works best for their protection.

  Recruiting at 2 sites Phase 2 McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec and 2 other locations · NCT06599658

• Integrated care for hospitalized patients with opioid and stimulant use disorders and infections

  This study tests if a new combined care approach for patients with infections from using opioids or stimulants can help them stay healthier and avoid going back to the hospital compared to regular treatment.

  Recruiting at 4 sites University of Maryland, Baltimore · Washington D.C., District of Columbia and 3 other locations · NCT06513156

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.