{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T05:25:05Z","timestamp":1784093105229,"version":"3.55.0"},"reference-count":43,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T00:00:00Z","timestamp":1778803200000},"content-version":"unspecified","delay-in-days":14,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"the Fogarty International Center of the National Institutes of Health","award":["K43 TW011028"],"award-info":[{"award-number":["K43 TW011028"]}]},{"name":"EDCTP2 program","award":["TMA2019SFP-2836 TB lung-FACT2"],"award-info":[{"award-number":["TMA2019SFP-2836 TB lung-FACT2"]}]},{"name":"Global Health EDCTP3 Joint Undertaking","award":["101103283 decide-tb\u2013horizon-ju-gh-edctp3-2022-01"],"award-info":[{"award-number":["101103283 decide-tb\u2013horizon-ju-gh-edctp3-2022-01"]}]},{"name":"African Research Initiative for Scientific Excellence, European Union","award":["DCI-PANAF\/2020\/420-028"],"award-info":[{"award-number":["DCI-PANAF\/2020\/420-028"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,4,23]]},"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Of 1.2\u2009million children and young adolescents (&lt;15 years) developing tuberculosis (TB) yearly, more than 50% are undiagnosed and unreported to national TB programmes (NTPs) and the World Health Organization (WHO). This is mainly due to poor performance of microbiological tests, limited clinical skills and structural barriers for childhood TB diagnosis at decentralised levels of care. Treatment decision algorithms (TDAs) could improve child TB outcomes but require external validation. We aim to evaluate a comprehensive TDA-based approach for childhood TB screening, diagnosis and treatment decision-making at district hospital (DH) and primary health centre (PHC) levels in Mozambique and Zambia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>Decide TB is a pragmatic, hybrid effectiveness-implementation type 2 cluster-randomised trial with a stepped wedge design. The comprehensive TDA-based approach (intervention) will be implemented under programmatic conditions in four districts in each country (each comprising one DH and six PHCs), randomly selected to switch sequentially from the standard of care to the intervention. Evaluations will assess epidemiological, clinical, economic, social sciences, implementation and health policy endpoints. Aggregated and individual data from children with presumptive TB will be extracted from facility registers and individual data will be collected using an electronic medical record (EMR), both data sources will be entered in national Demographic Health Information System 2 databases. Questionnaires and individual\/group interviews (among healthcare workers (HCWs), parents\/caregivers and key informants), supervision and mentoring reports and quantitative cost tools will be used.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethics approval was obtained from national ethics committees in Mozambique (Instituto Nacional de Sa\u00fade review board and National Committee for Bioethics in Health) and Zambia (University of Zambia ethical review board and National Health Research Authority); this includes a waiver for analysing data collected by NTPs (no identifiable information reported, intervention with minimal risk) without individual consent from children\u2019s parents\/caregivers. Informed consent will be obtained from HCWs, parents\/caregivers and key informants. Results will be openly shared with the scientific community, WHO and national and international stakeholders for translation into policy and practice. Procedures for requesting further use of Decide TB data will be publicly available.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06593080\">NCT06593080<\/jats:ext-link>\n                      ; PACTR202407866544155.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-114005","type":"journal-article","created":{"date-parts":[[2026,5,17]],"date-time":"2026-05-17T12:03:24Z","timestamp":1779019404000},"page":"e114005","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Validation of treatment decision algorithms for childhood tuberculosis at district healthcare levels in Mozambique and Zambia: the Decide TB cluster-randomised pragmatic trial \u2013 a study protocol"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct06593080","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06593080","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0359-4089","authenticated-orcid":false,"given":"Joanna","family":"Orne-Gliemann","sequence":"first","affiliation":[{"name":"National Institute for Health and Medical Research (Inserm) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, University of Bordeaux, Bordeaux, Nouvelle-Aquitaine, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8544-5193","authenticated-orcid":false,"given":"Cl\u00e9mentine","family":"Roucher","sequence":"additional","affiliation":[{"name":"National Institute for Health and Medical Research (Inserm) UMR 1219, Research Institute for Sustainable Development 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Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa"},{"name":"Department of Human, Biological & Translational Medical Science, School of Medicine, University of Namibia, Windhoek, Namibia"},{"name":"The University of Sydney Infectious Diseases Institute (Sydney ID), Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8827-019X","authenticated-orcid":false,"given":"Marc","family":"d\u2019Elb\u00e9e","sequence":"additional","affiliation":[{"name":"National Institute for Health and Medical Research (Inserm) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, University of Bordeaux, Bordeaux, Nouvelle-Aquitaine, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-9471-4488","authenticated-orcid":false,"given":"Minh","family":"Huyen Ton Nu 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