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Simple change could save thousands from TB: study tests 'Opt-Out' approach

NCT ID NCT04466488

Knowledge-focused Sponsor: Johns Hopkins 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a simple way to get more HIV patients in South Africa the medicine that prevents tuberculosis (TB). Instead of doctors having to choose to prescribe it, the new approach made TB prevention the standard option, requiring doctors to actively opt out if they didn't want to give it. Over 50,000 adults from public clinics took part to see if this 'choice architecture' could boost the number of people getting life-saving TB prevention.

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

50,798 people

The number who actually took part.

Started

Sep 2021

Finished

Nov 2024

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

Accepted

You do not need to have the condition being studied to take part.

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: * Adult (≥18 years old) patients initiating ART * Adult (≥18 years old) patients already on ART and coming for ART re-prescribing Exclusion Criteria: * None

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Conditions

The condition(s) this trial relates to.

AIDS tuberculosis prevention target

As listed by the trial registrant

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

HIV/AIDS Tuberculosis

Contacts and locations

Locations

  • Perinatal HIV Research Unit

    Soweto, Gauteng, 1864, South Africa

More trials for these conditions

Other studies related to the condition(s) this trial covers.