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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01214785
Other study ID # MR03
Secondary ID
Status Completed
Phase N/A
First received October 4, 2010
Last updated August 22, 2017
Start date September 2010
Est. completion date June 30, 2017

Study information

Verified date August 2017
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 30, 2017
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
India Xavier Institute of Management Bhubaneswar Orissa

Sponsors (10)

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

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Soil-transmitted helminth infection Prevalence of soil-transmitted helminth infection at the end of the follow-up period baseline and endline
Secondary 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
Secondary lost days at school and work 21 months
Secondary healthcare expenditure 21 months
Secondary latrine coverage and use 21 months
Secondary bacteriological water quality 21 months
Secondary fly counts 21 months
Secondary Height-for-age Recumbent length measured for children <2 at baseline and endline following standardised procedures for anthropometric assessment. baseline and endline
Secondary 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
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