{
  "abstract": "Introduction Of 1.2 million children and young adolescents (<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.Methods and analysis 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.Ethics and dissemination Ethics approval was obtained from national ethics committees in Mozambique (Instituto Nacional de Saúde 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’s 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.Trial registration number NCT06593080; PACTR202407866544155.",
  "authors": [
    {
      "affiliations": [
        "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"
      ],
      "name": "Joanna Orne-Gliemann"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Clémentine Roucher"
    },
    {
      "affiliations": [
        "Instituto Nacional de Saúde, Marracuene, Mozambique",
        "Department of Physiological Science, Clinical Pharmacology, Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique",
        "Departments of International Public Health and Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK"
      ],
      "name": "Celso Khosa"
    },
    {
      "affiliations": [
        "School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia",
        "Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa",
        "Department of Human, Biological & Translational Medical Science, School of Medicine, University of Namibia, Windhoek, Namibia",
        "The University of Sydney Infectious Diseases Institute (Sydney ID), Sydney, New South Wales, Australia"
      ],
      "name": "Graeme Hoddinott"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Marc d’Elbée"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Minh Huyen Ton Nu Nguyet"
    },
    {
      "affiliations": [
        "Instituto Nacional de Saúde, Marracuene, Mozambique",
        "Centre for International Health, University Hospital, LMU Munich, Munich, Germany"
      ],
      "name": "Denise Banze"
    },
    {
      "affiliations": [
        "TransVIHMI, University of Montpellier, National Institute for Health and Medical Research (Inserm), IRD, Montpellier, Provence-Alpes-Côte d’Azur, France"
      ],
      "name": "Maryline Bonnet"
    },
    {
      "affiliations": [
        "Instituto Nacional de Saúde, Marracuene, Mozambique"
      ],
      "name": "Katia Cossa"
    },
    {
      "affiliations": [
        "TransVIHMI, University of Montpellier, National Institute for Health and Medical Research (Inserm), IRD, Montpellier, Provence-Alpes-Côte d’Azur, France"
      ],
      "name": "Emilie Desselas"
    },
    {
      "affiliations": [
        "Sheffield Centre for Health Related Research, School of Medicine & Population Health, The University of Sheffield, Sheffield, England, UK"
      ],
      "name": "Peter J Dodd"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Cleia Etoa"
    },
    {
      "affiliations": [
        "National TB and Leprosy Program, Zambia Ministry of Health, Lusaka, Zambia"
      ],
      "name": "Alan Kachuka"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Natacha Lebrun"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, University of Zambia School of Medicine, Lusaka, Zambia",
        "Adult’s Hospital, University of Zambia University Teaching Hospital, Lusaka, Zambia"
      ],
      "name": "Patrick Lungu"
    },
    {
      "affiliations": [
        "National TB Program Ministry of Health, Maputo, Mozambique"
      ],
      "name": "Benedita José"
    },
    {
      "affiliations": [
        "Instituto Nacional de Saúde, Marracuene, Mozambique"
      ],
      "name": "Sylvia Manguele"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Carla Monin"
    },
    {
      "affiliations": [
        "National TB and Leprosy Program, Zambia Ministry of Health, Lusaka, Zambia"
      ],
      "name": "Angel Mubanga"
    },
    {
      "affiliations": [
        "National TB Program Ministry of Health, Maputo, Mozambique"
      ],
      "name": "Crimenia Mutemba"
    },
    {
      "affiliations": [
        "Children’s Hospital, University of Zambia University Teaching Hospital, Lusaka, Zambia"
      ],
      "name": "Natasha Namuziya"
    },
    {
      "affiliations": [
        "Institute of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich, Munich, Germany",
        "German Centre for Infection Research (DZIF), Partner Site Munich, Munich, Germany",
        "Fraunhofer Institute ITMP, Immunology, Infection and Pandemic Research, Munich, Germany"
      ],
      "name": "Laura Olbrich"
    },
    {
      "affiliations": [
        "Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa"
      ],
      "name": "Megan Palmer"
    },
    {
      "affiliations": [
        "Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa"
      ],
      "name": "Marieke M van der Zalm"
    },
    {
      "affiliations": [
        "Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa",
        "Department of Infectious Diseases, Imperial College London, London, UK"
      ],
      "name": "James A Seddon"
    },
    {
      "affiliations": [
        "Children’s Hospital, University of Zambia University Teaching Hospital, Lusaka, Zambia",
        "University of Zambia, School of Medicine, Department of Paediatrics, Lusaka, Zambia"
      ],
      "name": "Chishala Chabala"
    },
    {
      "affiliations": [
        "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"
      ],
      "name": "Olivier Marcy"
    },
    {
      "affiliations": [],
      "name": "on behalf of Decide TB study group"
    }
  ],
  "title": "Validation of treatment decision algorithms for childhood tuberculosis at district healthcare levels in Mozambique and Zambia: the Decide TB cluster-randomised pragmatic trial – a study protocol",
  "uid": "a5001be4-16ee-5186-836d-9178bea9379c"
}