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Implementation of a stepped-wedge cluster randomized design in routine public health practice: design and application for a tuberculosis (TB) household contact study in a high burden area of Lima, Peru

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dc.contributor.author Shah, Lena
dc.contributor.author Rojas, Marlene
dc.contributor.author Mori, Oscar
dc.contributor.author Zamudio, Carlos
dc.contributor.author Kaufman, Jay S.
dc.contributor.author Otero, Larissa
dc.contributor.author Gotuzzo, Eduardo
dc.contributor.author Seas, Carlos
dc.contributor.author Brewer, Timothy F.
dc.date.accessioned 2019-02-06T14:59:05Z
dc.date.available 2019-02-06T14:59:05Z
dc.date.issued 2015
dc.identifier.uri https://hdl.handle.net/20.500.12866/5516
dc.description.abstract BACKGROUND: We designed a pragmatic stepped-wedge cluster randomized controlled trial in order to evaluate provider-initiated evaluation of household contacts (HCs) of smear positive tuberculosis (TB) cases within a routine TB program in Lima, Peru. METHODS/DESIGN: National TB program (NTP) officers of San Juan de Lurigancho District (Lima, Peru) and university-based researchers jointly designed a pragmatic stepped-wedge cluster randomized trial design in order to evaluate a planned active case finding (ACF) program for all HCs of smear-positive TB cases in 34 district healthcare centres. Randomization of time to intervention initiation was stratified by health centre TB case rate. The ACF intervention included provider-initiated home visits of all new sputum smear positive TB patients in order to evaluate household contacts for active TB. Active TB was diagnosed using symptom screening, sputum screening, chest x-ray and clinical evaluation. Once initiated, ACF was provided by NTP staff and integrated into the routine DOTS TB program activities. DISCUSSION: This study protocol describes the pragmatic stepped-wedge cluster randomized trial of active household contact evaluations within an NTP. The stepped-wedge design met overlapping needs of local TB programmers and researchers to adequately evaluate the large-scale roll out of a new control program in a TB endemic setting. Multiple planning meetings were required to develop the necessary networks and in order to understand the operations, needs and goals of the NTP staff and researchers collaborating on this project. The advantages and challenges of using this study design in practice and within existing routine TB programs in a middle-income country context are discussed. en_US
dc.language.iso eng
dc.publisher BioMed Central
dc.relation.ispartof urn:issn:1471-2458
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Humans en_US
dc.subject Peru/epidemiology en_US
dc.subject Research Design en_US
dc.subject Sputum/microbiology en_US
dc.subject Family en_US
dc.subject Public Health Practice en_US
dc.subject Contact Tracing/methods en_US
dc.subject Tuberculosis/diagnosis/epidemiology/transmission en_US
dc.title Implementation of a stepped-wedge cluster randomized design in routine public health practice: design and application for a tuberculosis (TB) household contact study in a high burden area of Lima, Peru en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1186/s12889-015-1883-2
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.00 es_PE


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