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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02174380. Registered 24 Jun 2014.
authors.affiliation: Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Purvis Hall, 1020 Pine Ave. West, Montreal, QC, Canada. lena.shah@mail.mcgill.ca.
authors.forename: Lena
authors.initials: L
authors.lastname: Shah
authors.affiliation: Red de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Peru. eumarle@hotmail.com.
authors.forename: Marlene
authors.initials: M
authors.lastname: Rojas
authors.affiliation: Red de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Peru. omori77@gmail.com.
authors.forename: Oscar
authors.initials: O
authors.lastname: Mori
authors.affiliation: Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru. carlos.zamudio@upch.pe.
authors.forename: Carlos
authors.initials: C
authors.lastname: Zamudio
authors.affiliation: Department of Epidemiology, Biostatistics & Occupational Health, McGill University, Purvis Hall, 1020 Pine Ave. West, Montreal, QC, Canada. jay.kaufman@mcgill.ca.
authors.forename: Jay S
authors.initials: JS
authors.lastname: Kaufman
authors.affiliation: Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru. larissa.otero@upch.pe.
authors.forename: Larissa
authors.initials: L
authors.lastname: Otero
authors.affiliation: Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru. eduardo.gotuzzo@upch.pe.|Departamento de Enfermedades Infecciosas, Tropicales y Dermatológicas, Hospital Nacional Cayetano Heredia, Lima, Peru. eduardo.gotuzzo@upch.pe.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Gotuzzo
authors.affiliation: Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru. carlos.seas@upch.pe.|Departamento de Enfermedades Infecciosas, Tropicales y Dermatológicas, Hospital Nacional Cayetano Heredia, Lima, Peru. carlos.seas@upch.pe.
authors.forename: Carlos
authors.initials: C
authors.lastname: Seas
authors.affiliation: Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA. tbrewer@conet.ucla.edu.
authors.forename: Timothy F
authors.initials: TF
authors.lastname: Brewer
mesh_terms: D016358:Contact Tracing / Q000379:methods*; D005190:Family; D006801:Humans; D010568:Peru / Q000453:epidemiology; D015980:Public Health Practice; D012107:Research Design; D013183:Sputum / Q000382:microbiology; D014376:Tuberculosis / Q000175:diagnosis / Q000453:epidemiology* / Q000635:transmission*