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Protocol for a cluster randomised stepped wedge trial assessing the impact of a community-level hygiene intervention and a water intervention using riverbank filtration technology on diarrhoeal prevalence in India
  1. Sarah L McGuinness1,
  2. Joanne E O'Toole1,
  3. Thomas B Boving2,
  4. Andrew B Forbes1,
  5. Martha Sinclair1,
  6. Sumit K Gautam3,
  7. Karin Leder1
  1. 1Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
  2. 2Department of Civil and Environmental Engineering and Geosciences, University of Rhode Island, Kingston, Rhode Island, USA
  3. 3The Energy and Resources Institute (TERI), Bangalore, Karnataka, India
  1. Correspondence to Dr Sarah L McGuinness; sarah.mcguinness{at}monash.com

Abstract

Introduction Diarrhoea is a leading cause of death globally, mostly occurring as a result of insufficient or unsafe water supplies, inadequate sanitation and poor hygiene. Our study aims to investigate the impact of a community-level hygiene education program and a water quality intervention using riverbank filtration (RBF) technology on diarrhoeal prevalence.

Methods and analysis We have designed a stepped wedge cluster randomised trial to estimate the health impacts of our intervention in 4 rural villages in Karnataka, India. At baseline, surveys will be conducted in all villages, and householders will receive hygiene education. New pipelines, water storage tanks and taps will then be installed at accessible locations in each village and untreated piped river water will be supplied. A subsequent survey will evaluate the impact of hygiene education combined with improved access to greater water volumes for hygiene and drinking purposes (improved water quantity). Villages will then be randomly ordered and RBF-treated water (improved water quality) will be sequentially introduced into the 4 villages in a stepwise manner, with administration of surveys at each time point. The primary outcome is a 7-day period prevalence of self-reported diarrhoea. Secondary outcomes include self-reported respiratory and skin infections, and reported changes in hygiene practices, household water usage and water supply preference. River, tank and tap water from each village, and stored water from a subset of households, will be sampled to assess microbial and chemical quality.

Ethics and dissemination Ethics approval was obtained from the Monash University Human Research Ethics Committee in Australia and The Energy and Resources Institute Institutional Ethics Committee in India. The results of the trial will be presented at conferences, published in peer-reviewed journals and disseminated to relevant stakeholders. This study is funded by an Australian National Health and Medical Research Council (NHMRC) project grant.

Trial registration number ACTRN12616001286437; pre-results.

  • PUBLIC HEALTH
  • INFECTIOUS DISEASES
  • EPIDEMIOLOGY

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors SLM revised the study protocol and drafted the manuscript. JEOT codrafted the manuscript. JEOT, MS, TBB, SKG, ABF and KL conceived and designed the study. JEOT designed the data collection tools and developed laboratory protocols. ABF determined the sample size considerations and statistical analysis plan, and will conduct the primary statistical analysis. All authors contributed to refinement of the study protocol and approved the final manuscript.

  • Funding This work was supported by an Australian National Health and Medical Research Council (NHMRC) project grant (APP1083408). KL holds an NHMRC Career Development Fellowship (APP1084351). SLM holds an NHMRC Postgraduate Scholarship (APP1115196).

  • Competing interests None declared.

  • Ethics approval Ethics approval was obtained from the Monash University Human Research Ethics Committee (project number CF15/522-2015000248) in Australia and The Energy and Resources Institute Institutional Ethics Committee in India.

  • Provenance and peer review Not commissioned; externally peer reviewed.