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Isoniazid preventive therapy completion in children under 5years old who are contacts of tuberculosis cases in Lima, Peru: study protocol for an open-label, cluster-randomized superiority trial.

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dc.contributor.author Otero Vegas, Larissa
dc.contributor.author Zetola, N.
dc.contributor.author Campos, M.
dc.contributor.author Zunt, J.
dc.contributor.author Bayer, Angela Marie
dc.contributor.author Curisinche, M.
dc.contributor.author Ochoa Woodell, Theresa Jean
dc.contributor.author Reyes, M.
dc.contributor.author Vega, V.
dc.contributor.author Van der Stuyft, P.
dc.contributor.author Sterling, T.R.
dc.coverage.spatial Villa Maria del Triunfo, Lima, Perú
dc.coverage.spatial San Juan de Miraflores, Lima, Perú
dc.date.accessioned 2023-02-20T13:28:11Z
dc.date.available 2023-02-20T13:28:11Z
dc.date.issued 2023
dc.identifier.uri https://hdl.handle.net/20.500.12866/13164
dc.description.abstract BACKGROUND: Children<5years old in contact with TB cases are at high risk for developing severe and fatal forms of TB. Contact investigation, BCG vaccination, and isoniazid preventive therapy (IPT) are the most effective strategies to prevent TB among children. However, the implementation of IPT faces challenges at several stages of the cascade of care of TB infection among children, particularly those less than 5years old. In Peru, a large proportion of children do not complete IPT, which highlights the need to design effective interventions that enhance preventive therapy adherence and completion. Although the body of evidence for such interventions has grown, interventions in medium TB incidence settings are lacking. This study aims to test the effectiveness, acceptability, and feasibility of an intervention package to increase information and motivation to complete IPT among children<5 who have been prescribed IPT.METHODS: An open-label, cluster-randomized superiority trial will be conducted in two districts in South Lima, Peru. Thirty health facilities will be randomized as clusters, 10 to the intervention and 20 to control (standard of care). We aim to recruit 10 children from different households in each cluster. Participants will be caretakers of children aged<5years old who initiated IPT. The intervention consists of educational material, and short message services (SMS) reminders and motivators. The primary outcomes will be the proportion of children who picked up>90% of the 24weeks of IPT (22 pick-ups) and the proportion of children who picked up the 24weeks of IPT. The standard of care is a weekly pick-up with monthly check-ups in a health facility. Feasibility and acceptability of the intervention will be assessed through an interview with the caretaker.DISCUSSION: Unfavorable outcomes of TB in young children, high effectiveness of IPT, and low rates of IPT completion highlight the need to enhance adherence and completion of IPT among children<5years old. Testing of a context-adapted intervention is needed to improve IPT completion rates and therefore TB prevention in young children. en_US
dc.language.iso eng
dc.publisher BioMed Central
dc.relation.ispartofseries Trials
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Tuberculosis en_US
dc.subject Child en_US
dc.subject Preschool en_US
dc.subject Latent M. tuberculosis/prevention and control en_US
dc.subject Peru en_US
dc.subject Randomized controlled trial en_US
dc.subject.mesh Tuberculosis
dc.subject.mesh Child, Preschool
dc.subject.mesh Peru
dc.subject.mesh Randomized Controlled Trial
dc.title Isoniazid preventive therapy completion in children under 5years old who are contacts of tuberculosis cases in Lima, Peru: study protocol for an open-label, cluster-randomized superiority trial. en_US
dc.title.alternative Finalización de la terapia preventiva con isoniazida en niños menores de 5 años que son contactos de casos de tuberculosis en Lima, Perú: protocolo de estudio para un ensayo de superioridad abierto, aleatorizado por conglomerados. en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1186/s13063-022-07062-6
dc.relation.issn 1745-6215

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