[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561662":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":35,"locations":47,"responsibleParty":216,"collaborators":219,"id":244,"slug":245,"hasResults":246,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":252,"sex":253,"minAge":12,"maxAge":254,"enrollmentInfo":255,"targetDuration":12,"studyType":258,"phases":259,"briefSummary":261,"conditions":262,"keywords":12,"overallStatus":50,"whyStopped":12,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},{"fullName":5,"class":6},"University of Zambia","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","NO_INTERVENTION","The District Hospitals and Primary Health Centres in study districts will implement TB diagnosis for children as per the current Standard of Care (control) in both countries . In Mozambique, the SOC is based on local algorithms which include: TB symptoms screening (TB contact history), HIV testing, Xpert testing on induced sputum (and stool), and a tuberculin skin test. Urine Lipoarabinomannan (LAM) is indicated for Children Living with HIV (CLHIV). No CXR is performed.\n\nIn Zambia, the SOC is based on the Union desk guide algorithm which includes: TB symptom screening (TB contact history), HIV testing and Xpert testing on respiratory or stool samples. Urine LAM is indicated for CLHIV,Severe Acute Malnutrition, sepsis, immune-suppression; chronic kidney diseases and cancer. CXRs are performed depending on the facilities. Other tests and imaging are advised in presumed extrapulmonary TB cases. A confirmed TB diagnosis is made based on a positive Xpert or LAM test.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"The comprehensive TDA based approach","EXPERIMENTAL","Children will benefit from the country SOC as described in the control arm, plus the study intervention",[18],"Other: The comprehensive TDA based approach",[20],{"type":6,"name":14,"description":21,"armGroupLabels":22,"otherNames":12},"The intervention consists of implementing a comprehensive TDA-based approach for TB diagnosis and treatment decision-making, including shorter treatment for non-severe TB in children identified as TB presumptive cases through a CDSS. It will also include the management of high-risk groups. In practice, all sick children will be assessed using the WHO-suggested TDAs A with CXR (DH) and B without CXR (PHC). CLHIV and those hospitalised with SAM at DH will have further assessment and treatment decisions based on the PAANTHER and TB-Speed SAM TDAs, respectively.\n\nClinical and microbiological assessment data will be incorporated into a CDSS to help with the clinical decision to initiate TB treatment. The CDSS will incorporate specific features and test results for high-risk group children based on the PAANTHER TDA and the TB-Speed SAM TDA and will incorporate the results of the severity assessment to guide the choice of TB treatment duration once children are diagnosed with TB.",[14],[24,28,30,32],{"name":25,"affiliation":26,"role":27},"Olivier Marcy","University of Bordeaux","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":5,"role":27},"Chishala Chabala",{"name":31,"affiliation":26,"role":27},"Joanna Orne-Gliemann",{"name":33,"affiliation":34,"role":27},"James Seddon","Imperial College London",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Clementine Roucher","CONTACT","+330557574723","330","clementine.roucher@u-bordeaux.fr",{"name":43,"role":38,"phone":44,"phoneExt":45,"email":46},"Natasha Namuziya","+26021250753","260","natashanamuziya@gmail.com",[48,61,66,71,76,81,86,91,99,104,109,114,119,124,134,139,148,153,158,163,168,173,178,186,191,196,201,206,211],{"facility":49,"status":50,"city":51,"state":52,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":12},"Chawama Urban Health Centre","RECRUITING","Chingola","Copperbelt","Zambia","ZM",{"type":56,"coordinates":57},"Point",[58,59],27.88382,-12.52897,{"lat":59,"lon":58},{"facility":62,"status":50,"city":51,"state":52,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":63,"geoPoint":65,"contacts":12},"Chiwempala Urban Health Centre",{"type":56,"coordinates":64},[58,59],{"lat":59,"lon":58},{"facility":67,"status":50,"city":51,"state":52,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":68,"geoPoint":70,"contacts":12},"Kabundi East Urban Health Clinic",{"type":56,"coordinates":69},[58,59],{"lat":59,"lon":58},{"facility":72,"status":50,"city":51,"state":52,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":73,"geoPoint":75,"contacts":12},"Kasompe Urban Health Centre",{"type":56,"coordinates":74},[58,59],{"lat":59,"lon":58},{"facility":77,"status":50,"city":51,"state":52,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":78,"geoPoint":80,"contacts":12},"Muchinshi Rural Health Centre",{"type":56,"coordinates":79},[58,59],{"lat":59,"lon":58},{"facility":82,"status":50,"city":51,"state":52,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":83,"geoPoint":85,"contacts":12},"Nchanga 1 Urban Health Centre",{"type":56,"coordinates":84},[58,59],{"lat":59,"lon":58},{"facility":87,"status":50,"city":51,"state":52,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":88,"geoPoint":90,"contacts":12},"Nchanga North Referal Hospital",{"type":56,"coordinates":89},[58,59],{"lat":59,"lon":58},{"facility":92,"status":50,"city":93,"state":52,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":94,"geoPoint":98,"contacts":12},"Allessandras Urban Health Centre","Luanshya",{"type":56,"coordinates":95},[96,97],28.41661,-13.13667,{"lat":97,"lon":96},{"facility":100,"status":50,"city":93,"state":52,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":101,"geoPoint":103,"contacts":12},"Chaisa Urban Health Centre",{"type":56,"coordinates":102},[96,97],{"lat":97,"lon":96},{"facility":105,"status":50,"city":93,"state":52,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":106,"geoPoint":108,"contacts":12},"Fisenge Urban Health Centre",{"type":56,"coordinates":107},[96,97],{"lat":97,"lon":96},{"facility":110,"status":50,"city":93,"state":52,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":111,"geoPoint":113,"contacts":12},"Kawama Urban Health Centre",{"type":56,"coordinates":112},[96,97],{"lat":97,"lon":96},{"facility":115,"status":50,"city":93,"state":52,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":116,"geoPoint":118,"contacts":12},"Malaika Urban Health Centre",{"type":56,"coordinates":117},[96,97],{"lat":97,"lon":96},{"facility":120,"status":50,"city":93,"state":52,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":121,"geoPoint":123,"contacts":12},"Mikomfwa Urban Health Centre",{"type":56,"coordinates":122},[96,97],{"lat":97,"lon":96},{"facility":125,"status":50,"city":93,"state":52,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":126,"geoPoint":128,"contacts":129},"Roan Antelope General Hospital",{"type":56,"coordinates":127},[96,97],{"lat":97,"lon":96},[130,132,133],{"name":131,"role":38,"phone":12,"phoneExt":12,"email":12},"Alan Kachuka",{"name":43,"role":38,"phone":12,"phoneExt":12,"email":12},{"name":29,"role":27,"phone":12,"phoneExt":12,"email":12},{"facility":135,"status":50,"city":93,"state":52,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":136,"geoPoint":138,"contacts":12},"Thomson District Hospital",{"type":56,"coordinates":137},[96,97],{"lat":97,"lon":96},{"facility":140,"status":50,"city":141,"state":142,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":143,"geoPoint":147,"contacts":12},"Chipepo Rural Health Centre","Chirundu","Southern Province",{"type":56,"coordinates":144},[145,146],28.84311,-16.03577,{"lat":146,"lon":145},{"facility":149,"status":50,"city":141,"state":142,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":150,"geoPoint":152,"contacts":12},"Hachipilika Rural Health Centre",{"type":56,"coordinates":151},[145,146],{"lat":146,"lon":145},{"facility":154,"status":50,"city":141,"state":142,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":155,"geoPoint":157,"contacts":12},"Jamba Rural Health Centre",{"type":56,"coordinates":156},[145,146],{"lat":146,"lon":145},{"facility":159,"status":50,"city":141,"state":142,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":160,"geoPoint":162,"contacts":12},"Kapululira Rural Health Centre",{"type":56,"coordinates":161},[145,146],{"lat":146,"lon":145},{"facility":164,"status":50,"city":141,"state":142,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":165,"geoPoint":167,"contacts":12},"Lusitu Rural Health Centre",{"type":56,"coordinates":166},[145,146],{"lat":146,"lon":145},{"facility":169,"status":50,"city":141,"state":142,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":170,"geoPoint":172,"contacts":12},"Mtendere Mission Referal hospital",{"type":56,"coordinates":171},[145,146],{"lat":146,"lon":145},{"facility":174,"status":50,"city":141,"state":142,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":175,"geoPoint":177,"contacts":12},"Sikoongo Rural Health Centre",{"type":56,"coordinates":176},[145,146],{"lat":146,"lon":145},{"facility":179,"status":50,"city":180,"state":142,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":181,"geoPoint":185,"contacts":12},"Habulile Rural Health Centre","Kalomo",{"type":56,"coordinates":182},[183,184],26.48369,-17.02581,{"lat":184,"lon":183},{"facility":187,"status":50,"city":180,"state":142,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":188,"geoPoint":190,"contacts":12},"Kalomo District Hospital",{"type":56,"coordinates":189},[183,184],{"lat":184,"lon":183},{"facility":192,"status":50,"city":180,"state":142,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":193,"geoPoint":195,"contacts":12},"Kalomo Urban Health Centre",{"type":56,"coordinates":194},[183,184],{"lat":184,"lon":183},{"facility":197,"status":50,"city":180,"state":142,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":198,"geoPoint":200,"contacts":12},"Mawaya Urban Health Centre",{"type":56,"coordinates":199},[183,184],{"lat":184,"lon":183},{"facility":202,"status":50,"city":180,"state":142,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":203,"geoPoint":205,"contacts":12},"Namwianga Urban Health Centre",{"type":56,"coordinates":204},[183,184],{"lat":184,"lon":183},{"facility":207,"status":50,"city":180,"state":142,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":208,"geoPoint":210,"contacts":12},"Nkandanzovu Rural Health Centre",{"type":56,"coordinates":209},[183,184],{"lat":184,"lon":183},{"facility":212,"status":50,"city":180,"state":142,"zip":12,"country":53,"countryCode":54,"cosmosGeoPoint":213,"geoPoint":215,"contacts":12},"Siachitema Rural Health Centre",{"type":56,"coordinates":214},[183,184],{"lat":184,"lon":183},{"type":217,"investigatorFullName":29,"investigatorTitle":218,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Principal Investigator",[220,221,224,227,229,230,232,234,236,238,240,242],{"name":26,"class":6},{"name":222,"class":223},"Instituto Nacional de Saúde, Mozambique","OTHER_GOV",{"name":225,"class":226},"ADERA","UNKNOWN",{"name":228,"class":6},"University of Stellenbosch",{"name":34,"class":6},{"name":231,"class":226},"Institut de Recherche pour le Développement (IRD)",{"name":233,"class":6},"University of Sheffield",{"name":235,"class":6},"Ludwig-Maximilians - University of Munich",{"name":237,"class":223},"Ministry of Health, Zambia",{"name":239,"class":223},"Ministry of Health, Mozambique",{"name":241,"class":6},"Eduardo Mondlane University",{"name":243,"class":223},"European and Developing Countries Clinical Trials Partnership (EDCTP)","100561662","the-decide-tb-trial-validation-of-treatment-decision-algorithms-for-childhood-tuberculosis-100561662",false,"NCT06593080","The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis","Validation of Treatment Decision Algorithms for Childhood Tuberculosis at District Health Care Levels in Mozambique and Zambia - the Decide-TB Cluster-randomized Pragmatic Trial","DTB","Inclusion Criteria:\n\nThe effectiveness assessment will be conducted using aggregated or individual data from direct beneficiaries of the intervention:\n\n* All sick children aged below 15 years entering the selected health facilities (DH and PHC) at either outpatient (OPD) or inpatient (IPD) departments, including children from high-risk groups, as well as children identified as contact of TB cases through community- or facility-based household contact tracing.\n* Children with presumptive TB.\n\nThe WHO definition of presumptive TB will be used, as defined in the 2022 WHO Operational Handbook, namely: children are classified as having presumptive TB if they have unremitting symptoms lasting more than 2 weeks (any one of cough, fever, not eating well or anorexia, weight loss or failure to thrive, fatigue, reduced playfulness or decreased activity) .\n\nThe definitions of presumptive TB have been adapted locally for the programmatic pilot. All children with presumptive TB as defined locally will be considered in the intervention and in secondary effectiveness and sub-group analyses.\n\nHigh-risk group will be defined using the definition in WHO-suggested TDAs A\\&B as children younger than 2 years, CLHIV or children with SAM. CLHIV will be defined per national testing strategy including positive PCR test for children below the age of 18 months. Children will be considered to have SAM (and thereby be eligible for the TB-Speed SAM algorithm) using WHO criteria. These include being \\\u003C5 years with a weight-for-height Z score (WHZ) \\\u003C -3 SDs or mid-upper arm circumference (MUAC) \\\u003C 115 mm (in children over 6 months) or clinical signs of bilateral pitting oedema, and being aged ≥5 years with a body mass index (BMI) for age Z-score \\\u003C -3SD.\n\nExclusion Criteria:\n\nThere will be no exclusion criteria for the programmatic pilot: all children will be offered the intervention.",true,"ALL","14 Years",{"count":256,"type":257},30240,"ESTIMATED","INTERVENTIONAL",[260],"NA","The Decide-TB project aims to generate evidence for the implementation of a comprehensive Treatment Decision Algorithms (TDA) based approach for TB in children living in high TB burden and resource-limited countries, at District Hospital (DH) and Primary Health Centre (PHC) levels, and to facilitate the integration of this evidence within practices and policies.\n\nThis programmatic pilot led by the National TB Programs (NTP) will test a TDA-based approach integrating TB screening, diagnosis, treatment decision-making, and disease severity assessment for shorter treatment eligibility, for use at a lower level of healthcare. This TDA-based approach will be evaluated in a hybrid effectiveness implementation study based on a pragmatic stepped wedge cluster-randomized trial. The Decide TB project will be implemented at the district level, targeting five districts in each country. Each cluster in a district will be made up of one district hospital and six primary health centers. The study will develop a Clinical Decision Support System (CDSS) to operationalize the use of TDAs, and strengthen District Health Information Systems (DHIS2) to collect individual data, which will contribute to monitoring and evaluation, clinical mentoring, and supervision by the country's NTPs.",[263,264,265,266],"Tuberculosis","Child Health","HIV","Severe Acute Malnutrition","2026-03-19",{"date":269,"type":270},"2026-03-24","ACTUAL",{"date":272,"type":270},"2024-06-01",{"date":274,"type":257},"2027-08-31",{"name":29,"class":6},29]