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.

INTRODUCTION: 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. METHODS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT02441699.