AI-Powered skin patch could bring TB prevention to People's doorsteps
NCT ID NCT07714707
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
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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
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About 880 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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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
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5 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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KNCV Tajikistan
Dushanbe, Tajikistan
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KNCV Tanzania
Dar es Salaam, Dar es Salaam Region, Tanzania
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A mobile x-ray van with AI could spot TB before it spreads
- Community-Driven TB screening aims to reach vulnerable immigrants
- Shorter TB regimens could simplify treatment
- AI could revolutionize TB care by predicting who needs shorter treatment
- New study tracks TB drugs in breastmilk to protect infants