Overview

This trial is active, not recruiting.

Conditions diarrhea, enteric infection, soil-transmitted helminth infection, stunting
Treatment improved water supply and sanitation
Sponsor London School of Hygiene and Tropical Medicine
Collaborator Emory University
Start date April 2015
End date November 2016
Trial size 2940 participants
Trial identifier NCT02441699, 9071

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Rural villages in which Gram Vikas has fully implemented its water supply and sanitation (Mantra) intervention. Intervention villages must: 1) be within 3 hours travel to the study office in Brahmapur, 2) have started the intervention by January 2003, and 3) have completed the intervention by January 2013.
improved water supply and sanitation
Village-level reticulated water supply with distribution to household taps; pour-flush pit latrines.
Rural villages that have been matched with intervention villages on demographics and other criteria. The sampling frame for control villages is limited to those: 1) within 3 hours travel to the study office in Brahmapur, and 2) within Gram Panchayats which do not include an intervention village and are not adjacent to an intervention village, to minimize spillover effects. In addition, both intervention and control villages must appear in the Government of India Census in 2001.

Primary Outcomes

Measure
Reported diarrhoea in children <5 years
time frame: 7-day recall, assessed 4 times during 3-month follow-up rounds

Secondary Outcomes

Measure
Reported lower respiratory infection in children <5
time frame: 7-day recall, assessed 4 times during 3-month follow-up rounds
Diarrhoea among all ages
time frame: 7-day recall, assessed 4 times during 3-month follow-up roundsits
Lower respiratory infection among all ages
time frame: 7-day recall, assessed 4 times during 3-month follow-up roundsts
Soil-transmitted helminth infection
time frame: Point prevalence assessed in rounds 2 (approximately 90-120 days after study commencement) and 4 (approximately 240 to 360 days after study commencement)
Height-for-age among children < 2 years
time frame: Assessed approximately every 90 days for a total of four measurement over study period
Weight-for-age among children <5
time frame: Assessed approximately every 90 days for a total of four measurement over study periodAssessed during all four follow up rounds
Biomarkers of environmental enteropathy and enteric infection
time frame: Assessed once during round 3 (approximately 180 to 240 days following commencement of study

Eligibility Criteria

Male or female participants of any age.

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:

Additional Information

Official title Assessing the Health Impact of a Combined Water and Sanitation Intervention in Rural Odisha, India
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by London School of Hygiene and Tropical Medicine.