NCT03021434

Brief Summary

The present study is a cluster randomized control trial of low-cost microbiological water test kits in rural and peri-urban communities in the Kanpur region of Uttar Pradesh, India.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
572

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Status
completed

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

January 1, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2017

Completed
Last Updated

June 29, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

January 12, 2017

Last Update Submit

June 28, 2017

Conditions

Keywords

Water Supply/standardsWater microbiologyIndiaHand disinfectionEscherichia coli Infections/prevention & controlHygieneHealth behaviorDrinking waterInformational intervention

Outcome Measures

Primary Outcomes (1)

  • Arithmetic mean E. coli count from sample of stored household drinking water

    A sample of household drinking water will be collected and analyzed in a standard laboratory using membrane filtration.

    1-2 month follow up visit post initial household information session

Secondary Outcomes (2)

  • Water storage, handling, and use behaviors

    1-2 month follow up visit post initial household information session

  • Intervention uptake/use

    1-2 month follow up visit post initial household information session

Study Arms (3)

Standard Testing

EXPERIMENTAL

Households will participate in community and household water safety education sessions, during which they will be given generalized information on water quality and safe water handling. A water sample from these households will be collected for laboratory analysis. Household-specific water quality information will be delivered to households within 72 hours, and households will be informed whether their drinking water was found to be contaminated. A study team member will review the information from the laboratory tests with the household and review information covered in the informational materials on safe water handling, storage, and use behaviours.

Other: Community and household water safety education sessionsOther: Household-specific water quality information

Test Kits

EXPERIMENTAL

Households will participate in community and household water safety education sessions, during which they will be given generalized information on water quality and safe water handling. Data collectors will demonstrate the use of the low-cost microbiological water test kits and test household stored drinking water. A study team member will return to the household within 72 hours and review the household-specific water quality information from the initial test with household members. Households will be given 10 water test kits to use at their discretion over the 1-2 month follow up period. They will be appropriately trained in how to both perform the test and interpret the results. Households will also review information on safe water handling, storage, and use behaviours.

Other: Community and household water safety education sessionsOther: Household-specific water quality informationOther: Low-cost microbiological water test kits

Comparison

ACTIVE COMPARATOR

Households will participate in community and household water safety education sessions, during which they will be given generalized information on water quality and safe water handling. A water sample from these households will be collected for laboratory analysis. Results from this analysis will be returned to the household at project endline. A study team member will return to the household within 72 hours to review the information on safe water handling, storage, and use behaviours.

Other: Community and household water safety education sessions

Interventions

Data collectors will give a short community presentation on water treatment, as well as safe water handling and storage. Then, data collectors will immediately visit households and review this information. Data collectors will return within 72 hours and review this information once more.

ComparisonStandard TestingTest Kits

Household specific water quality data will be provided in two ways. In the Standard Testing Arm, water quality data will be analyzed in a laboratory by standard methods and results will be delivered to households. In the Test Kit arm, water quality data will be analyzed in households using provided water test kits.

Standard TestingTest Kits

Intervention component consists of low-cost, biodegradable that tests for the presence of E. coli in water samples. The test uses Aquatest broth medium with resorufin methyl ester chromogen. Presence of E. coli (positive test) imparts bright red color, making it easy to use/interpret at the household level with minimal training

Test Kits

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Village located within the Kanpur district, within
  • Village population between 100 and 1000 households.
  • No chlorinated water sources available in the village.
  • Consent to participate in the study
  • Contain at least one child who is between 29 days and 60 months of age at the time of enrollment

You may not qualify if:

  • Villages that receive chlorinated water from utility services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (19)

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MeSH Terms

Conditions

DiarrheaEscherichia coli InfectionsHealth Behavior

Interventions

Residence Characteristics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBehavior

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Robert Dreibelbis, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 16, 2017

Study Start

January 1, 2017

Primary Completion

May 25, 2017

Study Completion

May 25, 2017

Last Updated

June 29, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share