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Can a phone app help end HIV stigma? south africa trial tests U=U education

NCT ID NCT07199634

Knowledge-focused Sponsor: Boston University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Updated 2 times

Summary

This study tests whether a video app that explains 'Undetectable = Untransmittable' (U=U) can help people with HIV stay on treatment and keep the virus under control. About 880 people from clinics in South Africa will use the app during counseling. The goal is to see if better understanding of U=U improves viral suppression and retention in care.

What this could mean

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

Active substance
Undetectable & You HIV treatment literacy app
What this could lead to
If successful, this could show that a simple video app can improve HIV treatment adherence and reduce transmission in a real-world setting.
What could go wrong
This is a cluster-randomized trial, but results may not apply to other regions or populations. The app's impact depends on consistent use and access to smartphones.

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 880 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

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 years and older

Sex

Anyone

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- Clinic inclusion criteria: * Public sector facility * Primary care, outpatient clinic * Follows national guidelines for HIV counseling * Has dedicated HIV counselors * At least 10 patients receiving HIV counseling per week (based on pre-study data) * Follows national guidelines for lab monitoring (CD4 at diagnosis; VLs at 3 and 10 months on ART) * Is interested in participating, as indicated by "sign-off" from the head nurse / facility director Individual participant inclusion criteria: * Adult (at least 18 years) * Received HIV post-test counselling or adherence counseling * Able to consent * Provides informed consent * Speaks one of the primary study languages: English, Zulu, Sotho, Tsonga * Receives care at the facility as evidence by having a clinical record there Individual participant exclusion Criteria: * Require acute medical care that would be hindered by participation in the study * Determined by clinical staff not to be physically or emotionally able to initiate ART * Children (under 18 years). * Prisoners or other institutionalized persons. * Do not speak one of the primary study languages: English, Zulu, Sotho * Are not able to consent (e.g. intoxicated or of limited mental capacity) * Do not consent to participate in the study, including linkage to clinical records for follow-up

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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.

HIV

How to take part

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  1. The official record

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