Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India

• ClinicalTrials.gov Identifier: NCT01214785
• Recruitment Status: Completed
• First Posted: October 5, 2010
• Last Update Posted: August 24, 2017
• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: 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
• Information provided by (Responsible Party): Thomas Clasen, London School of Hygiene and Tropical Medicine

Tracking Information

• First Submitted Date: October 4, 2010
• First Posted Date: October 5, 2010
• Last Update Posted Date: August 24, 2017
• Study Start Date: September 2010
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 22, 2013)

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)

Original Primary Outcome Measures (submitted: October 4, 2010)

diarrhoea morbidity [ Time Frame: 21 months ]

The study is powered to assess impact on diarrhoea among children <5. Diarrhoea will also be recorded among participants of all age.

Current Secondary Outcome Measures (submitted: February 22, 2013)

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

Original Secondary Outcome Measures (submitted: October 4, 2010)

• intestinal nematodes [ Time Frame: 21 months ]
• weight-for-age Z-score [ Time Frame: 21 months ]
  among children <5
• lost days at school and work [ Time Frame: 21 months ]
• healthcare expenditure [ Time Frame: 21 months ]
• latrine coverage and use [ Time Frame: 21 months ]
• bacteriological water quality [ Time Frame: 21 months ]
• fly counts [ Time Frame: 21 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India
• Official Title: Assessing the Effect of Improved Rural Sanitation on Diarrhoea and Intestinal Nematode Infections: a Cluster Randomised Controlled Trial in Orissa, India
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Diarrhoea
• Soil-transmitted Helminth Infection
• Nutritional Status

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.

Study Arms

• Active Comparator: Sanitation intervention
  Intervention: Behavioral: Provision of household latrines
• No Intervention: Control

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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: October 4, 2010): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 30, 2017
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT01214785
• Other Study ID Numbers: MR03
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Thomas Clasen, London School of Hygiene and Tropical Medicine
• Original Responsible Party: Thomas Clasen, London School of Hygiene and Tropical Medicine
• Current Study Sponsor: London School of Hygiene and Tropical Medicine
• Original Study Sponsor: Same as current

Collaborators

• 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

• PRS Account: London School of Hygiene and Tropical Medicine
• Verification Date: August 2017