Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India

Study Overview
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Brief Summary
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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.

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

Conditions
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Diarrhoea, Soil-transmitted Helminth Infection, Nutritional Status

Intervention / Treatment
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* Behavioral: Provision of household latrines


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sanitation intervention<br> | Behavioral: Provision of household latrines<br>* 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.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diarrhoea (<5s) | 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) | 21 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soil-transmitted helminth infection | Prevalence of soil-transmitted helminth infection at the end of the follow-up period | baseline and endline | 
| Weight-for-age (<5s) | 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. | 21 months | 
| lost days at school and work |  | 21 months | 
| healthcare expenditure |  | 21 months | 
| latrine coverage and use |  | 21 months | 
| bacteriological water quality |  | 21 months | 
| fly counts |  | 21 months | 
| Height-for-age | Recumbent length measured for children <2 at baseline and endline following standardised procedures for anthropometric assessment. | baseline and endline | 
| Diarrhoea (all ages) | 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). | 21 months |