Home-based tuberculosis infection testing for close contacts of people with TB
Tests home and clinic skin testing for tuberculosis infection in close contacts.
Key facts
- Who runs it
- KNCV Tuberculosis Foundation
- Where
- Dushanbe, TajikistanSee the siteAlso in 1 other country, 1 site
- Trial code
- Registry title
- 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
- Status
- Not yet recruiting
- People taking part
- 880 people, planned
- Started
- Jun 2026
- Expected to end
- Mar 2028
- Type of study
- Interventional, 2 groups
- Treatments tested
- CY-TB Patch
- Audiblehealth DX
- Record updated
- 20 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 5 or older who are close contacts of someone newly diagnosed with lab-confirmed lung tuberculosis (TB).
- Age
- 5 years or older
- Sex
- All sexes can join.
- Disease stage
- Close contacts (household and close contacts) of people newly diagnosed with bacteriologically confirmed pulmonary TB disease. Contacts must not have TB disease themselves.
- Earlier treatment
- People already taking TB preventive treatment (TPT) when recruited cannot join. People currently on treatment for TB disease cannot join.
Main reasons for not taking part
- Confirmed TB disease, or currently on TB treatment
- Already on TB preventive treatment when recruited
- Likely to move outside the study area during the study
- Reasons TB preventive treatment is not safe, such as known sensitivity to isoniazid or rifamycins, or known liver disease
- Any vaccination in the last 4 weeks, or a reaction to the SIILTIBCY skin test ingredients
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- • 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
Where in Tajikistan
Also in 1 other country, 1 site
- KNCV TajikistanDushanbe, TajikistanContact: Shodmon KhushvakhtovNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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
The 2 groups in the trial
- SIILTIBCY Testing read by CHW and HCWTreatment being tested
During the first 6 months of the intervention all eligible participants will be tested for TBI with SIILTIBCY testing and results will be read by a community health care worker and a health care worker
Treatment: Audiblehealth DX
- SIILTIBCY Testing read by an AI assited tool and a health practitionerTreatment being tested
After the first six months, eligible participants will receive the SIILTIBCY testing that will be read by a health pracitioner and by the AI asstited tool for comparison
Treatment: CY-TB Patch and Audiblehealth DX
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Home-based tuberculosis infection testing for close contacts of people with TBGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 20 July 2026