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New study aims to close TB prevention gaps for HIV patients

NCT ID NCT05342064

Prevention Sponsor: Baylor College of Medicine 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at better ways to find and prevent tuberculosis (TB) in people living with HIV. Researchers will test a new screening method and offer patients a choice of TB preventive medicines with extra support like text reminders. The goal is to improve TB detection and help more people complete their preventive treatment.

What this could mean

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

Active substance
TB preventive therapy (isoniazid or rifapentine) and adherence support (text reminders, phone calls)
What this could lead to
If successful, this could lead to simpler, more effective TB screening and preventive treatment strategies for people with HIV, reducing TB deaths.
What could go wrong
This is an observational and interventional study, not a treatment trial. Results may not apply to all settings, and adherence support 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 6,500 people

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

Started

Jul 2023

Expected to finish

Sep 2026

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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.

OBJECTIVES 1 and 2: Inclusion Criteria: * HIV positive or HIV exposed and presumptively positive while awaiting confirmatory testing in infants Exclusion Criteria: * do not provide informed consent or assent as appropriate or are currently being treated for TB OBJECTIVE 3: Inclusion Criteria: * negative TB symptom screen OR for whom TB disease has been ruled out in accordance with WHO Guidelines in adults and according to consensus definitions for child TB Exclusion Criteria: * do not provide informed consent or assent as appropriate or are currently being treated for TB

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Conditions

The condition(s) this trial relates to.

coinfection HIV infectious disease latent tuberculosis infection tuberculosis

As listed by the trial registrant

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

HIV coinfection Tuberculosis Tuberculosis infection

Contacts and locations

Locations

  • Baylor College of Medicine Children's Foundation

    Mbabane, Eswatini

  • Baylor College of Medicine Children's Foundation

    Maseru, Lesotho

  • Baylor College of Medicine Children's Foundation

    Lilongwe, Malawi

  • Baylor College of Medicine Children's Foundation

    Mbeya, Tanzania

  • Baylor College of Medicine Children's Foundation

    Kampala, Uganda

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