Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Diarrhoea; Soil-transmitted Helminth Infection; Nutritional Status	Behavioral: Provision of household latrines	Not Applicable

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	September 2010
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	June 30, 2017

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. Soil-transmitted helminth infection [ Time Frame: baseline and endline ]
   Prevalence of soil-transmitted helminth infection at the end of the follow-up period
2. 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.
3. lost days at school and work [ Time Frame: 21 months ]
4. healthcare expenditure [ Time Frame: 21 months ]
5. latrine coverage and use [ Time Frame: 21 months ]
6. bacteriological water quality [ Time Frame: 21 months ]
7. fly counts [ Time Frame: 21 months ]
8. Height-for-age [ Time Frame: baseline and endline ]
   Recumbent length measured for children <2 at baseline and endline following standardised procedures for anthropometric assessment.
9. 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).

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Thomas Clasen, Dr, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:	NCT01214785 History of Changes
Other Study ID Numbers:	MR03
First Posted:	October 5, 2010
Last Update Posted:	August 24, 2017
Last Verified:	August 2017

Additional relevant MeSH terms:

Infection; Diarrhea; Helminthiasis	Signs and Symptoms, Digestive; Signs and Symptoms; Parasitic Diseases