Not Yet RecruitingNot Applicable

SCAF-TB - Saving Children and Their Families From Tuberculosis: Implementation Research to Improve TB Preventive Treatment Initiation and Completion Rates Among Contact Persons in Tajikistan and Tanzania

Tajikistan, Tanzania880 participantsStarted 2026-06

Plain-language summary

The SCAF-TB study aims to evaluate how the WHO-endorsed SIILTIBCY skin test can be best implemented to test close contacts for tuberculosis infection (TBI) in Tajikistan and Tanzania, either facility-based or home-based delivered by community health workers (CHWs) with or without AI-facilitated diagnostic tools. The overall goal of this study is to improve access to innovative tuberculosis (TB) preventive services among children and their families in Tanzania and Tajikistan, both settings with a high burden of TB. Persons in close contact with people diagnosed with bacteriologically confirmed TB disease will be identified through the index patient and home visits. They will decide the preferred location for TBI testing, either at home or at the facility. Community health workers will be trained to implement home-based TB prevention services, including TBI testing and AI-assisted reading, and ruling out TB disease using a cough app (along traditional screening practices). The main objectives of the study are: 1. To assess whether CHWs can reliably measure SIILTIBCY results in TB contact persons at their homes, with or without the support of AI-assisted reading tools. 2. To determine how feasible and acceptable it is for CHWs to perform home-based SIILTIBCY testing, both with and without AI assistance. 3. To assess the added value, feasibility, and acceptability of using a mobile cough screening application, administered by CHWs, to help rule out TB disease. 4. To evaluate the impact of these home-based TBI testing strategies on improving uptake and completion of TB preventive treatment (TPT), as well as their budget implications for both the health care system and affected households. The study will be conducted in primary health care facilities in Tajikistan and Tanzania, which have access to short-course TPT regimens. The study population is composed of persons in close contact with people diagnosed with bacteriologically confirmed TB disease, and eligible for TPT as per national guidelines. The main outcomes of interest are: 1. SIILTIBCY inter-reader agreement CHW (home-based) and HCW (facility-based) 2. SIILTIBCY inter-reader agreement CHW with AI reading and without AI reading 3. Proportion tested for TBI out of those eligible for TBI testing 4. Proportion tested positive for TBI, stratified by demographic characteristics and mode of delivery 5. Diagnostic agreement between a cough application and symptom screening 6. Proportion initiated on TPT out of those eligible for TPT, stratified by regimen and mode of testing 7. Proportion completing TPT out of those initiated on TPT, stratified by regimen and mode of testing. 8. Interest-holders' perspectives on home-based TBI testing and cough app screening. 9. Budgetary impact scaling-up home-based TBI testing and cough app screening

Who can participate

Age range

5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 with…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

SIILTIBCY inter-reader agreement CHW and HCW

Timeframe: From enrollment through 6 months

SIILTIBCY inter-reader agreement CHW with and without TB connect app (Siiltibcy test reading powered AI tool)

Timeframe: Six months after enrollment for an average of 1 year

Trial details

NCT IDNCT07714707

SponsorKNCV Tuberculosis Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Christiaan Mulder, MsC PhD

+31704167234 christiaan.mulder@kncvtbc.org

View on ClinicalTrials.gov More Tuberculosis Infection, Latent trials