1. Community intervention for child tuberculosis active contact investigation and management: study protocol for a parallel cluster randomized controlled trial
- Author
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Martina Casenghi, Sayouba Ouedraogo, Georges Tiendrebeogo, Jennifer Cohn, Patrice Tchendjou, Anca Vasiliu, Elisabete de Carvalho, Michael Kakinda, Stavia Turyahabwe, Daniel Atwine, Peter J. Dodd, Albert Kuate Kuate, Boris Tchounga, Maryline Bonnet, Sabrina Eymard-Duvernay, Stephen M. Graham, Recherches Translationnelles sur le VIH et les maladies infectieuses endémiques et émergentes (TransVIHMI), Institut de Recherche pour le Développement (IRD)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Epicentre Ouganda [Mbarara] [Médecins Sans Frontières], Epicentre [Paris] [Médecins Sans Frontières], University of Sheffield [Sheffield], University of Melbourne, International Union against Tuberculosis and Lung Disease, and Unitaid is funding the CaP TB project through EGPAF. For the CONTACT research study, EGPAF is using the funding through IRD. The funding document available with the submission of this manuscript is the letter between EGPAF and Institut Buisson Bertrand, a management center for the IRD. The funding body has no role in study design, data collection, or writing the manuscript. EGPAF (Dr Appolinaire Tiam, Elizabeth Glaser Pediatric AIDS Foundation, 1140, Connecticut Av. Suite 200, NW, Washington, DC 20036) is the sponsor of the trial.
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Medicine (miscellaneous) ,Community ,Cluster randomized controlled trial ,law.invention ,Study Protocol ,0302 clinical medicine ,Randomized controlled trial ,law ,[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases ,MESH: Child ,Health care ,Clinical endpoint ,Multicenter Studies as Topic ,Uganda ,Pharmacology (medical) ,MESH: Tuberculosis ,030212 general & internal medicine ,Child ,intervention ,Randomized Controlled Trials as Topic ,lcsh:R5-920 ,lcsh:Medicine (General) ,Cluster randomized ,medicine.medical_specialty ,Tuberculosis ,Referral ,030231 tropical medicine ,MESH: Contact Tracing ,03 medical and health sciences ,Contact tracing ,Intervention (counseling) ,medicine ,Humans ,Tuberculosis, Pulmonary ,MESH: Uganda ,Retrospective Studies ,MESH: Tuberculosis, Pulmonary ,[SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics ,MESH: Humans ,business.industry ,Retrospective cohort study ,MESH: Retrospective Studies ,controlled trial ,medicine.disease ,Pediatric tuberculosis ,Community intervention ,MESH: Randomized Controlled Trials as Topic ,Family medicine ,MESH: Multicenter Studies as Topic ,business ,Preventive therapy ,Tuberculosis symptom screening - Abstract
Background There are major gaps in the management of pediatric tuberculosis (TB) contact investigation for rapid identification of active tuberculosis and initiation of preventive therapy. This study aims to evaluate the impact of a community-based intervention as compared to facility-based model for the management of children in contact with bacteriologically confirmed pulmonary TB adults in low-resource high-burden settings. Methods/design This multicenter parallel open-label cluster randomized controlled trial is composed of three phases: I, baseline phase in which retrospective data are collected, quality of data recording in facility registers is checked, and expected acceptability and feasibility of the intervention is assessed; II, intervention phase with enrolment of index cases and contact cases in either facility- or community-based models; and III, explanatory phase including endpoint data analysis, cost-effectiveness analysis, and post-intervention acceptability assessment by healthcare providers and beneficiaries. The study uses both quantitative and qualitative analysis methods. The community-based intervention includes identification and screening of all household contacts, referral of contacts with TB-suggestive symptoms to the facility for investigation, and household initiation of preventive therapy with follow-up of eligible child contacts by community healthcare workers, i.e., all young ( Discussion This study will provide evidence of the impact of a community-based intervention on household child contact screening and management of TB preventive therapy in order to improve care and prevention of childhood TB in low-resource high-burden settings. Trial registration ClinicalTrials.gov NCT03832023. Registered on 6 February 2019
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- 2021