Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India

Not Applicable

Completed

• Conditions: Soil-transmitted Helminth Infection; Diarrhoea; Nutritional Status
• Interventions: Behavioral: Provision of household latrines

• Registration Number: NCT01214785
• Lead Sponsor: London School of Hygiene and Tropical Medicine

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 available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-04
• Study First Posted: 2010-10-05
• Primary Completion: 2013-12
• Study Completion: 2017-06-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sanitation intervention	Provision of household latrines	-

Primary Outcome Measures

Name	Time	Method
Diarrhoea (<5s)	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

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

Trial Locations

Locations (1)

Xavier Institute of Management; 🇮🇳 Bhubaneswar, Orissa, India