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

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ClinicalTrials.gov Identifier: NCT02441699
Recruitment Status : Active, not recruiting
First Posted : May 12, 2015
Last Update Posted : August 9, 2018
Sponsor:
Collaborators:
Emory University
KIIT University, Bhubaneswar, Orissa
Gram Vikas, Bhubanesar, Orissa
Loyola Hospital, Bhubaneswar, Orissa
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief 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.

Condition or disease Intervention/treatment
Diarrhea Enteric Infection Soil-transmitted Helminth Infection Stunting Behavioral: Improved water supply and sanitation

Detailed 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.

Study Type : Observational
Estimated Enrollment : 2940 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing the Health Impact of a Combined Water and Sanitation Intervention in Rural Odisha, India
Actual Study Start Date : April 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Group/Cohort Intervention/treatment
Intervention group
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.
Behavioral: Improved water supply and sanitation
Village-level reticulated water supply with distribution to household taps; pour-flush pit latrines.

Control group
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 Outcome Measures :
  1. Reported diarrhoea in children <5 years [ Time Frame: 7-day recall, assessed 4 times during 3-month follow-up rounds ]

Secondary Outcome Measures :
  1. Reported lower respiratory infection in children <5 [ Time Frame: 7-day recall, assessed 4 times during 3-month follow-up rounds ]
  2. Diarrhoea among all ages [ Time Frame: 7-day recall, assessed 4 times during 3-month follow-up roundsits ]
  3. Lower respiratory infection among all ages [ Time Frame: 7-day recall, assessed 4 times during 3-month follow-up roundsts ]
  4. 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) ]
    Stool samples taken and assayed for ascaris, trichuris, hookworm

  5. Height-for-age among children < 2 years [ Time Frame: Assessed approximately every 90 days for a total of four measurement over study period ]
    Children height measured and HAZ scores computed

  6. 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 ]
    Children weighed and WAZ scores computed

  7. Biomarkers of environmental enteropathy and enteric infection [ Time Frame: Assessed once during round 3 (approximately 180 to 240 days following commencement of study ]

Biospecimen Retention:   Samples With DNA
Stool samples will be collected and divided into two aliquots. One aliquot will be fixed and used for assessing the rate and intensity of soil-transmitted helminth (STH) infection and the second aliquot will be frozen and used to assess biomarkers of environmental enteropathy and enteric infection


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Rural householders living in Ganjam district, Orissa, India.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02441699


Locations
United Kingdom
London School of Hygiene & Tropical Medicine
London, United Kingdom, WC1E 7HT
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Emory University
KIIT University, Bhubaneswar, Orissa
Gram Vikas, Bhubanesar, Orissa
Loyola Hospital, Bhubaneswar, Orissa
Bill and Melinda Gates Foundation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02441699     History of Changes
Other Study ID Numbers: 9071
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Infection
Communicable Diseases
Diarrhea
Helminthiasis
Signs and Symptoms, Digestive
Signs and Symptoms
Parasitic Diseases