Community intervention for child tuberculosis active contact investigation and management: study protocol for a parallel cluster randomized controlled trial

Autor:	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
Přispěvatelé:	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, 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.
Jazyk:	angličtina
Rok vydání:	2021
Předmět:	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
Zdroj:	Trials, Vol 22, Iss 1, Pp 1-15 (2021) Trials Trials, 2021, 22 (1), pp.180. ⟨10.1186/s13063-021-05124-9⟩
ISSN:	1745-6215 0383-2023
Popis:	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
Databáze:	OpenAIRE
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