[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647882":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":32,"locations":38,"responsibleParty":70,"collaborators":74,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":31,"enrollmentInfo":92,"targetDuration":31,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":112,"whyStopped":31,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"KNCV Tuberculosis Foundation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SIILTIBCY Testing read by CHW and HCW","EXPERIMENTAL","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",[13],"Device: Audiblehealth DX",{"label":15,"type":10,"description":16,"interventionNames":17},"SIILTIBCY Testing read by an AI assited tool and a health practitioner","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",[18,13],"Device: CY-TB Patch",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[15],[26],"CY-TB Software",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"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.",[9,15],null,[33],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Christiaan Mulder, MsC PhD","CONTACT","+31704167234","christiaan.mulder@kncvtbc.org",[39,55],{"facility":40,"status":31,"city":41,"state":31,"zip":31,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"KNCV Tajikistan","Dushanbe","Tajikistan","TJ",{"type":45,"coordinates":46},"Point",[47,48],68.77905,38.53575,{"lat":48,"lon":47},[51],{"name":52,"role":35,"phone":53,"phoneExt":31,"email":54},"Shodmon Khushvakhtov","+(992)900014030","Shodmon.khushvakhtov@kncv.tj",{"facility":56,"status":31,"city":57,"state":58,"zip":31,"country":59,"countryCode":31,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"KNCV Tanzania","Dar es Salaam","Dar es Salaam Region","Tanzania",{"type":45,"coordinates":61},[62,63],39.26951,-6.82349,{"lat":63,"lon":62},[66],{"name":67,"role":35,"phone":68,"phoneExt":31,"email":69},"Lillian Mtei","+255 784 283680","lillian.mtei@kncv.co.tz",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Christiaan Mulder","Principal Investigator",[75,77,78,80],{"name":40,"class":76},"UNKNOWN",{"name":56,"class":76},{"name":79,"class":76},"National Tuberculosis and Leprosy Program Tanzania",{"name":81,"class":76},"National Tuberculosis Program, Tajikistan","100647882","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-100647882",false,"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","SCAF-TB","Inclusion Criteria:\n\n* 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.\n* Age ≥5 years\n* Able to provide written informed consent or assent.\n\nExclusion Criteria:\n\n* • Confirmed TB disease (evidenced by symptoms and\u002For clinical exam findings and\u002For chest radiographic findings suggestive of TB, positive mycobacterial culture or molecular TB testing or currently on TB treatment for TB disease)\n\n  * Likely to move outside the study area during the study period\n  * People already on TPT at time of recruitment\n  * Contra-indication for TPT:\n\n    * Known sensitivity or intolerance to isoniazid or rifamycins\n    * Suspected acute hepatitis or known chronic or unstable liver disease\n    * Alanine aminotransferase (ALT) \\> 3 times the upper limit of normal (ULN)\n    * Total bilirubin \\> 2.5 times the ULN\n    * On contra-indicated medications (as per national guidelines)\n  * Contra-indication for SIILTIBCY:\n\n    * Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 of SIILTIBCY Product Information.\n    * Hypersensitivity to Lactococcus lactis.\n    * Severe local or systemic reaction to other Mycobacterium tuberculosis derived products\n    * Any vaccination within the last 4 weeks\n  * Contra-indication for AudibleHealth:\n\n    * Having any condition making someone cannot cough voluntarily:\n\nHaving aphasia Having a medical history of cribriform plate injury or cribriform plate surgery, diaphragmatic hernia, external beam neck\u002Fthroat \u002F maxillofacial radiation, phrenic nerve injury\u002Fpalsy, radical neck\u002Fthroat \u002F maxillofacial surgery, vocal cord trauma or nodules Having patent tracheostomy stoma\n\nWithin the past year, had:\n\nacute traumatic injury to the head, neck, throat, chest, abdomen, or trunk Chest\u002Fabdomen \u002F trunk trauma or surgery, Intracranial surgery Neurovascular injury Neurovascular surgery",true,"ALL","5 Years",{"count":93,"type":94},880,"ESTIMATED","INTERVENTIONAL",[97],"NA","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.\n\nThe 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).\n\nThe main objectives of the study are:\n\n1. 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.\n2. To determine how feasible and acceptable it is for CHWs to perform home-based SIILTIBCY testing, both with and without AI assistance.\n3. To assess the added value, feasibility, and acceptability of using a mobile cough screening application, administered by CHWs, to help rule out TB disease.\n4. 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.\n\nThe 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.\n\nThe main outcomes of interest are:\n\n1. SIILTIBCY inter-reader agreement CHW (home-based) and HCW (facility-based)\n2. SIILTIBCY inter-reader agreement CHW with AI reading and without AI reading\n3. Proportion tested for TBI out of those eligible for TBI testing\n4. Proportion tested positive for TBI, stratified by demographic characteristics and mode of delivery\n5. Diagnostic agreement between a cough application and symptom screening\n6. Proportion initiated on TPT out of those eligible for TPT, stratified by regimen and mode of testing\n7. Proportion completing TPT out of those initiated on TPT, stratified by regimen and mode of testing.\n8. Interest-holders' perspectives on home-based TBI testing and cough app screening.\n9. Budgetary impact scaling-up home-based TBI testing and cough app screening",[100,101,102],"Tuberculosis Infection, Latent","Tuberculosis Active","TPT",[104,105,106,59,107,108,109,110,111],"AI tools","Contact investigation","Tuberculosis Preventive Treatment","kyrgyzstan","community health care","AI (Artificial Intelligence)","Cough screening App","SIILTIBCY","NOT_YET_RECRUITING","2026-07-14",{"date":115,"type":116},"2026-07-20","ACTUAL",{"date":118,"type":94},"2026-06",{"date":120,"type":94},"2028-03",{"name":5,"class":6},2]