NCT02441699

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,940

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

4.7 years

First QC Date

April 27, 2015

Last Update Submit

August 20, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reported diarrhoea in children <5 years

    7-day recall, assessed 4 times during 3-month follow-up rounds

Secondary Outcomes (7)

  • Reported lower respiratory infection in children <5

    7-day recall, assessed 4 times during 3-month follow-up rounds

  • Diarrhoea among all ages

    7-day recall, assessed 4 times during 3-month follow-up roundsits

  • Lower respiratory infection among all ages

    7-day recall, assessed 4 times during 3-month follow-up roundsts

  • Soil-transmitted helminth infection

    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

    Assessed approximately every 90 days for a total of four measurement over study period

  • +2 more secondary outcomes

Study Arms (2)

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

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.

Interventions

Village-level reticulated water supply with distribution to household taps; pour-flush pit latrines.

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Rural householders living in Ganjam district, Orissa, India.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London School of Hygiene & Tropical Medicine

London, WC1E 7HT, United Kingdom

Location

Related Publications (3)

  • Sinharoy SS, Reese HE, Praharaj I, Chang HH, Clasen T. Effects of a combined water and sanitation intervention on biomarkers of child environmental enteric dysfunction and associations with height-for-age z-score: A matched cohort study in rural Odisha, India. PLoS Negl Trop Dis. 2021 Mar 8;15(3):e0009198. doi: 10.1371/journal.pntd.0009198. eCollection 2021 Mar.

  • Reese H, Routray P, Torondel B, Sinharoy SS, Mishra S, Freeman MC, Chang HH, Clasen T. Assessing longer-term effectiveness of a combined household-level piped water and sanitation intervention on child diarrhoea, acute respiratory infection, soil-transmitted helminth infection and nutritional status: a matched cohort study in rural Odisha, India. Int J Epidemiol. 2019 Dec 1;48(6):1757-1767. doi: 10.1093/ije/dyz157.

  • Reese H, Routray P, Torondel B, Sclar G, Delea MG, Sinharoy SS, Zambrano L, Caruso B, Mishra SR, Chang HH, Clasen T. Design and rationale of a matched cohort study to assess the effectiveness of a combined household-level piped water and sanitation intervention in rural Odisha, India. BMJ Open. 2017 Mar 31;7(3):e012719. doi: 10.1136/bmjopen-2016-012719.

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

MeSH Terms

Conditions

DiarrheaGrowth Disorders

Interventions

Sanitation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Communicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2015

First Posted

May 12, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations