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Open Access 01-12-2015 | Study protocol

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

Authors: Lena Shah, Marlene Rojas, Oscar Mori, Carlos Zamudio, Jay S. Kaufman, Larissa Otero, Eduardo Gotuzzo, Carlos Seas, Timothy F. Brewer

Published in: BMC Public Health | Issue 1/2015

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.

Trial registration

ClinicalTrials.gov NCT02174380. Registered 24 Jun 2014

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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
Authors: Lena Shah
Marlene Rojas
Oscar Mori
Carlos Zamudio
Jay S. Kaufman
Larissa Otero
Eduardo Gotuzzo
Carlos Seas
Timothy F. Brewer
Publication date: 01-12-2015
Publisher: BioMed Central
Published in: BMC Public Health / Issue 1/2015
Electronic ISSN: 1471-2458
DOI: https://doi.org/10.1186/s12889-015-1883-2

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

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

Abstract

Background

Methods/Design

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial registration

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