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
Date Issued
12 December 2015
Access level
open access
Resource Type
journal article
Publisher(s)
BioMed Central
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
Volume
15
Issue
1
Language
English
OCDE Knowledge area
Sistema respiratorio
Scopus EID
2-s2.0-84933514650
PubMed ID
Source
BMC Public Health
Resource of which it is part
BMC Public Health
ISSN of the container
14712458
Sponsor(s)
Funding for the described study protocol is provided by the Canadian Institutes of Health Research (CIHR) Operating Grant (MOP 123370). Additional travel for the primary author was provided by the CIHR Michael Smith Travel Supplement and the International Development Research Centre (IDRC) Doctoral Research Award.
Sources of information: Directorio de Producción Científica Scopus