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Smartphone therapy: could an app help men with HIV kick stimulants?

NCT ID NCT05958017

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Miami, Florida, 33136, United States

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