[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615503":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":57,"collaborators":59,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":18,"enrollmentInfo":80,"targetDuration":18,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":94,"whyStopped":18,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Universitas Padjadjaran","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Near Point-of-Care (nPOC) Testing","ACTIVE_COMPARATOR","The intervention arm will comprise HCFs operating in the selected CHC catchment areas, including CHCs, public hospitals, private hospitals, private clinics, and private laboratories. A multi-component public health intervention package, which will incorporate nPOC testing for TB diagnosis, will be provided for these HCFs, including patients visiting the HCFs and the community residents in the selected CHC catchment areas.",[13],"Diagnostic Test: nPOC Testing Intervention Package",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","NO_INTERVENTION","HCFs in the control arm will continue standard of care with no intervention, except for refresher training on reporting and notifying TB cases to the National TB Information System before the intervention package is rolled out.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIAGNOSTIC_TEST","nPOC Testing Intervention Package","The intervention package will comprise:\n\n1. Introduction of a new-generation diagnostic test (nPOC test) into the HCFs;\n2. Optimisation of clinical algorithms with the incorporation of the new test;\n3. Promotional package to encourage patient attendance and utilisation of tests at HCFs by practitioners in the intervention areas;\n4. TB household contact investigation using the new test according to an algorithm with community health volunteers (cadres) involvement in the intervention areas.",[9],[26],{"name":27,"affiliation":28,"role":29},"Bachti Alisjahbana, Professor, MD, PhD","Research Center for Care and Control of Infectious Diseases Universitas Padjadjaran","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"EVIDENT Study Contact Centre","CONTACT","+6281324285417","evident.pokja3@gmail.com",{"name":37,"role":33,"phone":18,"phoneExt":18,"email":38},"Nur Afifah, MD, MSc","nurafifah3393@gmail.com",[40],{"facility":41,"status":18,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Bandung District Health Office","Bandung","West Java","40911","Indonesia","ID",{"type":48,"coordinates":49},"Point",[50,51],107.60694,-6.92222,{"lat":51,"lon":50},[54],{"name":41,"role":33,"phone":55,"phoneExt":18,"email":56},"+62225897520","dinkes@bandungkab.go.id",{"type":58,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[60,62,64,66,68],{"name":61,"class":6},"Bill and Melinda Gates Foundation",{"name":63,"class":6},"University of Otago",{"name":65,"class":6},"University of Melbourne",{"name":67,"class":6},"Radboud University Medical Center",{"name":69,"class":6},"Universitas Sebelas Maret","100615503","evaluation-and-demonstration-of-new-tuberculosis-diagnostics-for-indonesia-100615503",false,"NCT07293455","Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia","Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia; Work Package 3: Cluster Randomised Controlled Trial of A Diagnostic Package to Increase the Number of Tuberculosis Cases Notified","EVIDENT","Inclusion Criteria:\n\n1. Aged between \\>28 days and 14 years old with the following symptoms:\n\n   * Cough ≥2 weeks\n   * Acute malnutrition\n   * Weight loss or weight faltering during the past 3 months among those who had contact history with patients with TB in the past 12 months.\n2. Aged ≥15 years old who had a cough for ≥2 weeks or bloody cough, with or without the following symptoms:\n\n   * Cough with\u002Fwithout sputum\n   * Fever\n   * Weight loss\n   * Night sweat\n   * Fatigue\n   * Chest pain\u002Fdiscomfort\n   * Breathlessness\n   * Loss of appetite\n   * Shivering\n\nExclusion Criteria:\n\n* Have started TB treatment or TB prophylaxis therapy.","ALL","29 Days",{"count":81,"type":82},40000,"ESTIMATED","INTERVENTIONAL",[85],"NA","The goal of this cluster-randomised controlled trial (CRCT) is to learn whether the use of new non-sputum-based diagnostic tests and other intervention components for tuberculosis (TB) diagnosis in healthcare facilities (HCF) can increase TB notifications. The main questions it aims to answer are: (1) Does the diagnostic intervention package raise TB notifications by HCF?; (2) Does the diagnostic intervention package raise the proportion of patients with TB who are diagnosed with microbiological tests, lower the time needed for TB diagnosis, lower the number of visits to HCF before TB diagnosis, raise the use of TB tests by healthcare providers, and lower the costs for TB diagnosis?\n\nResearchers will compare the diagnostic intervention package provided to HCFs and the community in the intervention arm with the standard of care in the control arm to assess the intervention's effect. Healthcare providers will be trained to provide diagnostic interventions to patients visiting their HCFs and to community residents in the areas surrounding HCFs.",[88],"Tuberculosis",[88,90,91,92,93],"Diagnosis","Tongue swab","Near point-of-care test","Cluster randomised controlled trial","NOT_YET_RECRUITING","2026-02-06",{"date":97,"type":98},"2026-02-10","ACTUAL",{"date":100,"type":82},"2026-03",{"date":102,"type":82},"2027-10",{"name":5,"class":6},1]