Assessing the Health Impact of a Combined Water and Sanitation Intervention in Rural Odisha, India

Diarrhea Clinical Trial

Official title:

Assessing the Health Impact of a Combined Water and Sanitation Intervention in Rural Odisha, India

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02441699
• Other study ID #: 9071
• Status: Active, not recruiting
• Start date: April 2015
• Est. completion date: December 2019

Study information

• Verified date: August 2019
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a matched-cohort study designed to assess the health impact of a rural demand-driven water and sanitation intervention that provides piped treated water and household level pour-flush latrines and bathing rooms, as implemented by Gram Vikas.

Description:

We will undertake a matched-cohort study among 84 villages in Ganjam district, Orissa, India to assess the health impact of a program that provides improved water supplies and sanitation to rural villages.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2940
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Households in participating villages will be eligible to participate in the study if they have at least one child under 5 years.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Communicable Diseases
• Diarrhea
• Enteric Infection
• Helminthiasis
• Infection
• Soil-transmitted Helminth Infection
• Stunting

Intervention

Behavioral:
• Improved water supply and sanitation
Village-level reticulated water supply with distribution to household taps; pour-flush pit latrines.

Locations

Country	Name	City	State
United Kingdom	London School of Hygiene & Tropical Medicine	London

Sponsors (6)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Bill and Melinda Gates Foundation, Emory University, Gram Vikas, Bhubanesar, Orissa, KIIT University, Bhubaneswar, Orissa, Loyola Hospital, Bhubaneswar, Orissa

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reported diarrhoea in children <5 years		7-day recall, assessed 4 times during 3-month follow-up rounds
Secondary	Reported lower respiratory infection in children <5		7-day recall, assessed 4 times during 3-month follow-up rounds
Secondary	Diarrhoea among all ages		7-day recall, assessed 4 times during 3-month follow-up roundsits
Secondary	Lower respiratory infection among all ages		7-day recall, assessed 4 times during 3-month follow-up roundsts
Secondary	Soil-transmitted helminth infection	Stool samples taken and assayed for ascaris, trichuris, hookworm	Point prevalence assessed in rounds 2 (approximately 90-120 days after study commencement) and 4 (approximately 240 to 360 days after study commencement)
Secondary	Height-for-age among children < 2 years	Children height measured and HAZ scores computed	Assessed approximately every 90 days for a total of four measurement over study period
Secondary	Weight-for-age among children <5	Children weighed and WAZ scores computed	Assessed approximately every 90 days for a total of four measurement over study periodAssessed during all four follow up rounds
Secondary	Biomarkers of environmental enteropathy and enteric infection		Assessed once during round 3 (approximately 180 to 240 days following commencement of study