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Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India

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ClinicalTrials.gov Identifier: NCT01214785
Recruitment Status : Completed
First Posted : October 5, 2010
Last Update Posted : August 24, 2017
Sponsor:
Collaborators:
WaterAid
Xavier Institute of Management, Bhubaneswar
Bill and Melinda Gates Foundation
International Initiative for Impact Evaluation
Department for International Development, United Kingdom
University of California, Davis
Emory University
Asian Institute of Public Health
Kalinga Institute of Industrial Technology
Information provided by (Responsible Party):
Thomas Clasen, London School of Hygiene and Tropical Medicine

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diarrhoea Soil-transmitted Helminth Infection Nutritional Status Behavioral: Provision of household latrines Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessing the Effect of Improved Rural Sanitation on Diarrhoea and Intestinal Nematode Infections: a Cluster Randomised Controlled Trial in Orissa, India
Study Start Date : September 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sanitation intervention Behavioral: Provision of household latrines
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.
No Intervention: Control


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214785


Locations
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India
Xavier Institute of Management
Bhubaneswar, Orissa, India
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
WaterAid
Xavier Institute of Management, Bhubaneswar
Bill and Melinda Gates Foundation
International Initiative for Impact Evaluation
Department for International Development, United Kingdom
University of California, Davis
Emory University
Asian Institute of Public Health
Kalinga Institute of Industrial Technology
Investigators
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Principal Investigator: Thomas Clasen, PhD London School of Hygiene and Tropical Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thomas Clasen, Dr, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01214785    
Other Study ID Numbers: MR03
First Posted: October 5, 2010    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Infections
Helminthiasis
Diarrhea
Signs and Symptoms, Digestive
Parasitic Diseases