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NOT YET RECRUITING

NCT07714707

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

Sponsor: KNCV Tuberculosis Foundation

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

5 Years - Any

Study Type

INTERVENTIONAL

Enrollment

880

Start Date

2026-06

Completion Date

2028-03

Last Updated

2026-07-20

Healthy Volunteers

Yes

Conditions

Tuberculosis Infection, Latent Tuberculosis Active TPT

Interventions

DEVICE

CY-TB Patch

The TB Smart Patch (CY-TB Patch) is an adhesive patch that is to be placed on the forearm of the test subject by health practitioner. A QR code which is unique to each patch can be seen printed on the patch. Also, a circular flap which is demarcated by dotted line can be seen on the patch. This circular portion is removable and acts as the site for administration of test. The TB Connect app (CY-TB Software) is used to register and monitor the subjects. The app has an integrated system for recording data and tracking each individual. It is to be used by the health practitioners providing SIILTIBCY.

DEVICE

Audiblehealth DX

The AudibleHealth AI screening platform (RAIsonance Inc) uses advanced AI models to identify individuals who are likely to have active infections with respiratory diseases including TB. These cough sounds, sometimes referred to as Forced Cough Vocalizations (FCVs), provide the basis for respiratory screening assessments using the AI models. All participants will be screened for active TB with this app, and symptom screening rule out prior to being screened for TBI.

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

Locations (2)

KNCV Tajikistan

Dushanbe, Tajikistan

KNCV Tanzania

Dar es Salaam, Dar es Salaam Region, Tanzania