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
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.
• 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
Known sensitivity or intolerance to isoniazid or rifamycins
Sequential
CY-TB Patch
DeviceThe 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.
Audiblehealth DX
DeviceThe 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.
SIILTIBCY inter-reader agreement CHW and HCW
Inter-reader agreement defined as the proportion of SIILTIBCY assessments with concordant binary interpretations (TBI positive or TBI negative) between a community health worker (home-based interpretation) and a healthcare worker (facility-based interpretation). The numerator is the number of SIILTIBCY assessments with concordant interpretations between CHW and HCW. The denominator is the total number of SIILTIBCY assessments independently interpreted by both a CHW and an HCW.
SIILTIBCY inter-reader agreement CHW with and without TB connect app (Siiltibcy test reading powered AI tool)
Inter-reader agreement defined as the proportion of SIILTIBCY assessments with concordant binary interpretations (TBI positive or TBI negative) between a community health worker (CHW) interpreting the test with the Smartpatch and TB Connect app and a CHW interpreting the test without the Smartpatch and TB Connect app. The numerator is the number of SIILTIBCY assessments for which the two CHW interpretations are concordant. The denominator is the total number of SIILTIBCY assessments independently interpreted by both a CHW using the TB Connect app and a CHW not using the app.
Proportion of participants initiating TPT
Proportion of participants initiated on TPT out of those eligible for TPT, stratified by regimen and mode of testing
Proportion of participants with concordant screening results using cough screening application, symptom screening, and chest X-ray (if available)
To assess the diagnostic agreement between the cough application, symptom screening, and chest X-ray screening
Proportion of participants completing TPT
Proportion completing TPT out of those initiated on TPT, stratified by regimen and mode of testing.
Proportion testing TBI positive
Proportion tested positive for TBI, stratified by demographic characteristics and mode of delivery
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KNCV Tuberculosis Foundation
Lead sponsor
KNCV Tajikistan
Collaborator
KNCV Tanzania
Collaborator
National Tuberculosis and Leprosy Program Tanzania
Collaborator
National Tuberculosis Program, Tajikistan
Collaborator
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