Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India

NCT01214785 | Completed

• 1 other identifier: MR03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhoea; Soil-transmitted Helminth Infection; Nutritional Status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Soil-transmitted helminth infection

  baseline and endline

• Weight-for-age (<5s)

  21 months

• lost days at school and work

  21 months

• healthcare expenditure

  21 months

• latrine coverage and use

  21 months

Study Arms (2)

Sanitation intervention

ACTIVE COMPARATOR

Behavioral: Provision of household latrines

Control

NO INTERVENTION

Interventions

Provision of household latrines BEHAVIORAL

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.

Sanitation intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Xavier Institute of Management

Bhubaneswar, Odisha, India

Location

Related Publications (4)

• 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.

  PMID: 28511653 DERIVED

• 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.

  PMID: 27496512 DERIVED

• 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.

  PMID: 25442689 DERIVED

• 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.

  PMID: 25084699 DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Clasen, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 5, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: June 30, 2017
• Last Updated: August 24, 2017

Record last verified: 2017-08

Locations

IN (1)