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New app and urine test aim to boost HIV med adherence in men who use stimulants

NCT ID NCT07125235

Disease control Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a program called reSTART for men living with HIV who also use stimulants. It combines a smartphone app, a urine test to check medication levels, and motivational messages to help them remember to take their HIV drugs. The goal is to see if this approach can lower their viral load and reduce stimulant use. About 270 men are being recruited for this trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mobile health app and urine tenofovir self-test
What this could lead to
If successful, this could provide a practical tool to help men with HIV and stimulant use stay on their medication and achieve viral suppression.
What could go wrong
This is a relatively small, early-stage trial (270 participants) focused on a specific group, so results may not apply broadly. The intervention relies on self-monitoring, which may not work for everyone.

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 270 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Jul 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 70 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: * Prescribed antiretroviral therapy (ART) with a tenofovir-based regimen. * Documented virologic non-suppression, urine tenofovir testing without tenofovir detected, or self-reported adherence \<100%. * Reports stimulant use. * Has a mailing address within the U.S. * Currently has a smartphone with photo capabilities. Exclusion Criteria: * Have any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions. * Not prescribed ART. * Unwilling to perform urine self-testing or to attend a local Quest site for viral load monitoring. * Unable to provide a hair sample of \~50-100 strands of hair that are non-gray, not bleached, and at least 1cm in length

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Art adherence Behavioral intervention Viral suppression of HIV infection

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 California, San Francisco

    RECRUITING

    San Francisco, California, 94110, United States

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