AI-Powered skin patch could bring TB prevention to People's doorsteps

NCT ID NCT07714707

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study explores whether community health workers can use a new skin test, with or without AI help, to test close contacts of TB patients at home instead of at a clinic. The goal is to make it easier for people, especially children and families in Tajikistan and Tanzania, to get tested and start preventive treatment. Researchers will compare home-based testing to clinic-based testing to see which approach leads to more people completing their full course of TB prevention.

What this could mean

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

Active substance
CY-TB Patch (a skin test patch) and TB Connect app (AI-assisted reading tool)
What this could lead to
If successful, this approach could make TB preventive care more accessible and increase treatment completion rates, reducing TB spread in high-burden communities.
What could go wrong
This is an implementation study, not a drug trial, so it tests logistics and feasibility rather than a new cure. Results may vary between countries and settings.

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

Jun 2026

An estimate. Start dates often move.

Expected to finish

Mar 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

5 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: * Contact persons (household and close contacts as defined by country guidelines) of people newly diagnosed with bacteriologically confirmed pulmonary TB disease (or as defined per national guidelines). National guidelines will determine whether we could include both contacts of index patients with drug-susceptible TB and drug-resistant TB. * Age ≥5 years * Able to provide written informed consent or assent. Exclusion Criteria: * • Confirmed TB disease (evidenced by symptoms and/or clinical exam findings and/or chest radiographic findings suggestive of TB, positive mycobacterial culture or molecular TB testing or currently on TB treatment for TB disease) * Likely to move outside the study area during the study period * People already on TPT at time of recruitment * Contra-indication for TPT: * Known sensitivity or intolerance to isoniazid or rifamycins * Suspected acute hepatitis or known chronic or unstable liver disease * Alanine aminotransferase (ALT) \> 3 times the upper limit of normal (ULN) * Total bilirubin \> 2.5 times the ULN * On contra-indicated medications (as per national guidelines) * Contra-indication for SIILTIBCY: * Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 of SIILTIBCY Product Information. * Hypersensitivity to Lactococcus lactis. * Severe local or systemic reaction to other Mycobacterium tuberculosis derived products * Any vaccination within the last 4 weeks * Contra-indication for AudibleHealth: * Having any condition making someone cannot cough voluntarily: Having aphasia Having a medical history of cribriform plate injury or cribriform plate surgery, diaphragmatic hernia, external beam neck/throat / maxillofacial radiation, phrenic nerve injury/palsy, radical neck/throat / maxillofacial surgery, vocal cord trauma or nodules Having patent tracheostomy stoma Within the past year, had: acute traumatic injury to the head, neck, throat, chest, abdomen, or trunk Chest/abdomen / trunk trauma or surgery, Intracranial surgery Neurovascular injury Neurovascular surgery

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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

    2 sites in 2 countries. 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

  • KNCV Tajikistan

    Dushanbe, Tajikistan

  • KNCV Tanzania

    Dar es Salaam, Dar es Salaam Region, Tanzania

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