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Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 4, 2010
First Posted Date  ICMJE October 5, 2010
Last Update Posted Date August 24, 2017
Study Start Date  ICMJE September 2010
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2013)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2010)
diarrhoea morbidity [ Time Frame: 21 months ]
The study is powered to assess impact on diarrhoea among children <5. Diarrhoea will also be recorded among participants of all age.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2013)
  • Soil-transmitted helminth infection [ Time Frame: baseline and endline ]
    Prevalence of soil-transmitted helminth infection at the end of the follow-up period
  • 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.
  • lost days at school and work [ Time Frame: 21 months ]
  • healthcare expenditure [ Time Frame: 21 months ]
  • latrine coverage and use [ Time Frame: 21 months ]
  • bacteriological water quality [ Time Frame: 21 months ]
  • fly counts [ Time Frame: 21 months ]
  • Height-for-age [ Time Frame: baseline and endline ]
    Recumbent length measured for children <2 at baseline and endline following standardised procedures for anthropometric assessment.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2010)
  • intestinal nematodes [ Time Frame: 21 months ]
  • weight-for-age Z-score [ Time Frame: 21 months ]
    among children <5
  • lost days at school and work [ Time Frame: 21 months ]
  • healthcare expenditure [ Time Frame: 21 months ]
  • latrine coverage and use [ Time Frame: 21 months ]
  • bacteriological water quality [ Time Frame: 21 months ]
  • fly counts [ Time Frame: 21 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India
Official Title  ICMJE Assessing the Effect of Improved Rural Sanitation on Diarrhoea and Intestinal Nematode Infections: a Cluster Randomised Controlled Trial in Orissa, India
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diarrhoea
  • Soil-transmitted Helminth Infection
  • Nutritional Status
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: Sanitation intervention
    Intervention: Behavioral: Provision of household latrines
  • No Intervention: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 4, 2010)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2017
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01214785
Other Study ID Numbers  ICMJE MR03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Thomas Clasen, London School of Hygiene and Tropical Medicine
Original Responsible Party Thomas Clasen, London School of Hygiene and Tropical Medicine
Current Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Thomas Clasen, PhD London School of Hygiene and Tropical Medicine
PRS Account London School of Hygiene and Tropical Medicine
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP