title: Design and rationale of a matched cohort study to assess the effectiveness of a combined household-level piped water and sanitation intervention in rural Odisha, India.
abstract: Government efforts to address massive shortfalls in rural water and sanitation in India have centred on construction of community water sources and toilets for selected households. However, deficiencies with water quality and quantity at the household level and community coverage and actual use of toilets have led Gram Vikas, a local non-governmental organization in Odisha, India, to develop an approach that provides household-level piped water connections contingent on full community-level toilet coverage.
  
  
  
  This matched cohort study was designed to assess the effectiveness of a combined piped water and sanitation intervention. Households with children <5 years in 45 randomly selected intervention villages and 45 matched control villages will be followed over 17 months. The primary outcome is prevalence of diarrhoeal diseases; secondary health outcomes include soil-transmitted helminth infection, nutritional status, seroconversion to enteric pathogens, urogenital infections and environmental enteric dysfunction. In addition, intervention effects on sanitation and water coverage, access and use, environmental fecal contamination, women's empowerment, as well as collective efficacy, and intervention cost and cost-effectiveness will be assessed.
  
  
  
  The study protocol has been reviewed and approved by the ethics boards of the London School of Hygiene and Tropical Medicine, UK and KIIT University, Bhubaneswar, India. Findings will be disseminated via peer-reviewed literature and presentation to stakeholders, government officials, implementers and researchers.
  
  
  
  NCT02441699.
authors.affiliation: Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.
authors.forename: Heather
authors.initials: H
authors.lastname: Reese
authors.affiliation: London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Parimita
authors.initials: P
authors.lastname: Routray
authors.affiliation: London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Belen
authors.initials: B
authors.lastname: Torondel
authors.affiliation: Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.
authors.forename: Gloria
authors.initials: G
authors.lastname: Sclar
authors.affiliation: Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.|London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Maryann G
authors.initials: MG
authors.lastname: Delea
authors.affiliation: Nutrition and Health Sciences Program, Laney Graduate School, Emory University, Atlanta, Georgia, USA.
authors.forename: Sheela S
authors.initials: SS
authors.lastname: Sinharoy
authors.affiliation: Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Zambrano
authors.affiliation: Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.
authors.forename: Bethany
authors.initials: B
authors.lastname: Caruso
authors.affiliation: School of Biotechnology, KIIT University, Bhubaneswar, Odisha, India.
authors.forename: Samir R
authors.initials: SR
authors.lastname: Mishra
authors.affiliation: Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.
authors.forename: Howard H
authors.initials: HH
authors.lastname: Chang
authors.affiliation: Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.|London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Thomas
authors.initials: T
authors.lastname: Clasen
mesh_terms: D000072296:Bathroom Equipment; D002675:Child, Preschool; D015331:Cohort Studies; D003362:Cost-Benefit Analysis; D003967:Diarrhea / Q000453:epidemiology*; D004323:Drainage, Sanitary; D004751:Enteritis / Q000453:epidemiology*; D004777:Environment; D005191:Family Characteristics; D005243:Feces; D006801:Humans; D007194:India / Q000453:epidemiology; D007223:Infant; D007231:Infant, Newborn; D007411:Intestinal Diseases, Parasitic / Q000453:epidemiology*; D009752:Nutritional Status; D009938:Organizations; D012141:Respiratory Tract Infections / Q000453:epidemiology; D012499:Sanitation; D000069078:Seroconversion; D014038:Toilet Facilities; D014881:Water Supply
keywords: diarrheal diseases; piped water supply; sanitation