Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India
This study is ongoing, but not recruiting participants.
Sponsor:
London School of Hygiene and Tropical Medicine
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: February 22, 2013
Last verified: February 2013
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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:
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 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| Genders Eligible for Study: | Both |
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
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
No publications provided
| 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: | February 22, 2013 |
| Health Authority: | United Kingdom: Research Ethics Committee India: Institutional Review Board |
Additional relevant MeSH terms:
|
Diarrhea Helminthiasis Signs and Symptoms, Digestive Signs and Symptoms Parasitic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013