Smartphone therapy: could an app help men with HIV kick stimulants?
NCT ID NCT05958017
First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times
Summary
This study investigates whether a mobile app called reSET can help men who have sex with men, are living with HIV, and have a stimulant use disorder reduce their drug use and keep their HIV under control. Participants use the app for 12 weeks, completing modules on topics like managing emotions and relationships, and can earn rewards for progress. The goal is to see if this digital therapy improves both substance use and HIV viral suppression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- reSET mobile app (behavioral therapy)
- What this could lead to
- If effective, this app could offer a convenient, scalable way to help people with HIV reduce stimulant use and stay healthy.
- What could go wrong
- This is a relatively small study testing a behavioral intervention, which may not work for everyone or in broader populations. Results depend on participants' engagement with the app.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 260 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2025
- Expected to finish
-
Jan 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 90 years
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for People living with HIV are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
University of Miami
RECRUITINGMiami, Florida, 33136, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a vaccine boost HIV immunity in people already on treatment?
- Could an antidepressant help curb meth use in people treated for opioid addiction?
- Feel-Good web tool helps HIV patients beat depression
- Jail-Based PTSD therapy could curb overdose deaths after release
- Brain zaps to beat addiction? VA tests rTMS for stimulant relapse
- Should you get your COVID and flu shots together? new study aims to find out for immunocompromised patients