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Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT01214785
First received: October 4, 2010
Last updated: September 9, 2016
Last verified: September 2016
History of Changes
  Purpose
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 Intervention
Diarrhoea
Soil-transmitted Helminth Infection
Nutritional Status
 Behavioral: Provision of household latrines

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Diarrhoea (<5s) [ Time Frame: 21 months ] [ Designated as safety issue: No ]
    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:
  • Soil-transmitted helminth infection [ Time Frame: baseline and endline ] [ Designated as safety issue: No ]
    Prevalence of soil-transmitted helminth infection at the end of the follow-up period

  • Weight-for-age (<5s) [ Time Frame: 21 months ] [ Designated as safety issue: No ]
    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.

  • lost days at school and work [ Time Frame: 21 months ] [ Designated as safety issue: No ]
  • healthcare expenditure [ Time Frame: 21 months ] [ Designated as safety issue: No ]
  • latrine coverage and use [ Time Frame: 21 months ] [ Designated as safety issue: No ]
  • bacteriological water quality [ Time Frame: 21 months ] [ Designated as safety issue: No ]
  • fly counts [ Time Frame: 21 months ] [ Designated as safety issue: No ]
  • Height-for-age [ Time Frame: baseline and endline ] [ Designated as safety issue: No ]
    Recumbent length measured for children <2 at baseline and endline following standardised procedures for anthropometric assessment.

  • Diarrhoea (all ages) [ Time Frame: 21 months ] [ Designated as safety issue: No ]
    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).
Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: June 2017
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214785

Locations
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
Principal Investigator: Thomas Clasen, PhD London School of Hygiene and Tropical Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Thomas Clasen, Dr, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01214785     History of Changes
Other Study ID Numbers: MR03 
Study First Received: October 4, 2010
Last Updated: September 9, 2016
Health Authority: United Kingdom: Research Ethics Committee
India: Institutional Review Board

Additional relevant MeSH terms:
Infection
Diarrhea
Helminthiasis
 Signs and Symptoms, Digestive
Signs and Symptoms
Parasitic Diseases

ClinicalTrials.gov processed this record on September 26, 2016