Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India

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

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.

Study Overview

• Status: Completed
• Conditions: Nutritional Status; Diarrhoea; Soil-transmitted Helminth Infection
• Intervention / Treatment: Behavioral: Provision of household latrines

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Orissa
    • Bhubaneswar, Orissa, India
      • Xavier Institute of Management

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Emory University; University of California, Davis; Bill and Melinda Gates Foundation; Department for International Development, United Kingdom; Asian Institute of Public Health; International Initiative for Impact Evaluation; WaterAid; Xavier Institute of Management, Bhubaneswar; Kalinga Institute of Industrial Technology

Publications and helpful links

General Publications

• Routray P, Torondel B, Jenkins MW, Clasen T, Schmidt WP. Processes and challenges of community mobilisation for latrine promotion under Nirmal Bharat Abhiyan in rural Odisha, India. BMC Public Health. 2017 May 16;17(1):453. doi: 10.1186/s12889-017-4382-9.
• Freeman MC, Majorin F, Boisson S, Routray P, Torondel B, Clasen T. The impact of a rural sanitation programme on safe disposal of child faeces: a cluster randomised trial in Odisha, India. Trans R Soc Trop Med Hyg. 2016 Jul;110(7):386-92. doi: 10.1093/trstmh/trw043.
• Clasen T, Boisson S, Routray P, Torondel B, Bell M, Cumming O, Ensink J, Freeman M, Jenkins M, Odagiri M, Ray S, Sinha A, Suar M, Schmidt WP. Effectiveness of a rural sanitation programme on diarrhoea, soil-transmitted helminth infection, and child malnutrition in Odisha, India: a cluster-randomised trial. Lancet Glob Health. 2014 Nov;2(11):e645-53. doi: 10.1016/S2214-109X(14)70307-9. Epub 2014 Oct 9.
• Boisson S, Sosai P, Ray S, Routray P, Torondel B, Schmidt WP, Bhanja B, Clasen T. Promoting latrine construction and use in rural villages practicing open defecation: process evaluation in connection with a randomised controlled trial in Orissa, India. BMC Res Notes. 2014 Aug 1;7:486. doi: 10.1186/1756-0500-7-486.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: October 4, 2010
• First Submitted That Met QC Criteria: October 4, 2010
• First Posted (ESTIMATE): October 5, 2010

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Parasitic Diseases; Infections; Diarrhea; Helminthiasis
• Other Study ID Numbers: MR03