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NCT Number: NCT01214785

Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India

The study is a cluster-randomized, controlled trial conducted among 100 villages (including approximately 3500 households and 20,000 people) in Puri district, State of Orissa, India. The study aims to assess the impact of the construction and use of latrines in rural settings on diarrhoeal disease, helminth infections and nutritional status. The study will also report on the cost and cost-effectiveness of the intervention and its impact on lost days at school and work as well as on expenditures on drugs and medical treatment. The study will document how the intervention actually impacts exposure to human excreta along principal transmission pathways by evaluating the impact on (i) faecal contamination of drinking water, (ii) the presence of mechanical vectors (flies) in food preparation areas, and (iii) the presence of faeces in and around participating households and villages. The study will also explore the extent to which different levels of acquisition and use of on-site sanitation among householders impact disease throughout the community.

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Key information

Conditions

Diarrhoea Diarrhea Nutritional Status Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Soil-transmitted Helminth Infection

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xavier Institute of Management

Bhubaneswar, Odisha, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Village level:

  • Little existing sanitation coverage (<10%)
  • WaterAid and implementing partners expects normal scale up
  • Stable and reasonably acceptable water supply
  • No other WASH interventions planned or anticipated in next 30 months
  • Reasonable year-round access by road to permit household visits by surveillance staff

Household level:

  • Presence of a child<4 or a pregnant woman
  • Consent to participate
  • Reside permanently in the village

Treatment and study plan

Provision of household latrines

Behavioral

WaterAid and local NGO partners mobilize householders in target villages to construct and use latrines in accordance with the Government of India's Total Sanitation Campaign.

Primary outcomes

  1. Diarrhoea (<5s)

    Time frame: 21 months

    Longitudinal prevalence of diarrhoea (7-day period prevalence) measured repeatedly every 3 months over a 21-month follow-up period. Diarrhoea is defined according to the WHO definition (three of more stools passed in 24 hrs)

Secondary outcomes

  1. Soil-transmitted helminth infection

    Time frame: baseline and endline

    Prevalence of soil-transmitted helminth infection at the end of the follow-up period

  2. Weight-for-age (<5s)

    Time frame: 21 months

    Weight of children <5 is recorded at each diarrhoea surveillance visit (every 3 months over the 21-month follow-up). Weight-for-age Z (WAZ) scores are calculated using the WHO growth standards. WAZ is used a proxy indicator of recent diarrhoea.

  3. lost days at school and work

    Time frame: 21 months

  4. healthcare expenditure

    Time frame: 21 months

  5. latrine coverage and use

    Time frame: 21 months

  6. bacteriological water quality

    Time frame: 21 months

  7. fly counts

    Time frame: 21 months

  8. Height-for-age

    Time frame: baseline and endline

    Recumbent length measured for children <2 at baseline and endline following standardised procedures for anthropometric assessment.

  9. Diarrhoea (all ages)

    Time frame: 21 months

    Longitudinal prevalence of diarrhoea (7-day period prevalence) measured repeatedly every 3 months over a 21-month follow-up period. Diarrhoea is defined according to the WHO definition (passage of three or more loose stools in 24 hrs).

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Asian Institute of Public Health
  • Bill and Melinda Gates Foundation
  • Department for International Development, United Kingdom
  • Emory University
  • International Initiative for Impact Evaluation
  • Kalinga Institute of Industrial Technology
  • University of California, Davis
  • WaterAid
  • Xavier Institute of Management, Bhubaneswar

Registry information

Official study title

Assessing the Effect of Improved Rural Sanitation on Diarrhoea and Intestinal Nematode Infections: a Cluster Randomised Controlled Trial in Orissa, India

Important dates

Study start
2010
Primary completion
2013
Study completion
2017
First posted
Oct 5, 2010
Registry last updated
Aug 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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