Cluster Randomized Trial of Low-cost Microbiological Water Test Kits
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 572
- Primary Endpoint
- Arithmetic mean E. coli count from sample of stored household drinking water
Study Overview
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.
Detailed Description
The proposed trial utilizes a cluster randomized controlled methodology, with clustering occurring at the village level. The intervention that will be tested in this cluster randomized controlled trial is informed by the development of a simple, low-cost water quality test kit developed and piloted by J. Brown and colleagues in Nagpur, Maharashtra.
There will be two intervention arms and one control/comparison arm. In all selected villages, the study team will work with local government to conduct a village-level information session on water quality and key water safety behaviours. Informational material on water safety behaviours will be distrubted to all houseohlds following this information session. In the control group, households will be visited to provide water safety informational cards and collect a drinking water sample to be analyzed in the lab. They will not receive the results of the analysis until the conclusion of the study. Households in Intervention Arm 1 (Standard Testing) will have their water sampled and analyzed in the lab, and results of the analysis will be delivered to the households. They will receive informational cards describing water purification strategies. Households in Intervention Arm 2 (Test Kits) will be provided with the materials and training needed to perform water quality testing in their own household using the newly developed testing kits. They will also receive informational cards describing water purification strategies.
Following the initial village-level information session, the study team will randomly sample households for participation in the trial. Participating households will complete a short survey on household demographics and water handling, storage, and use behaviours and a water sample will be taken and tested in the lab for fecal indicator bacteria. At an unannounced follow-up visit, roughly 1 - 2 months after enrollment, households will complete a short survey about changes in water handling, storage, and use behaviours and a second sample of household stored drinking water will be collected for laboratory analysis. The effect of the cluster randomized controlled trial on water quality will be determined by comparing arithmetic mean E. coli count from samples of household water and changes in water safety behaviours between baseline and endline.
Microbiological drinking water quality will be assessed at two time points: baseline and endline. At each visit, a 330 ml sample of household water will be collected for analysis; we will ask participants to fill the sample container as if it were a drinking cup for a child living in the household. Samples will be kept cold (on ice in a cooler) until delivery to the laboratory and thereafter stored at 4oC until processing, to begin within 8 hours of the sampling event.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •(for villages) :
- •Village located within the Kanpur district, within
- •Village population between 100 and 1000 households.
- •No chlorinated water sources available in the village.
- •Inclusion Criteria (for households) :
- •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
Exclusion Criteria
- •Villages that receive chlorinated water from utility services
Arms & Interventions
Standard Testing
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.
Intervention: Community and household water safety education sessions (Other)
Standard Testing
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.
Intervention: Household-specific water quality information (Other)
Test Kits
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.
Intervention: Community and household water safety education sessions (Other)
Test Kits
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.
Intervention: Household-specific water quality information (Other)
Test Kits
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.
Intervention: Low-cost microbiological water test kits (Other)
Comparison
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.
Intervention: Community and household water safety education sessions (Other)
Outcomes
Primary Outcomes
Arithmetic mean E. coli count from sample of stored household drinking water
Time Frame: 1-2 month follow up visit post initial household information session
A sample of household drinking water will be collected and analyzed in a standard laboratory using membrane filtration.
Secondary Outcomes
- Intervention uptake/use(1-2 month follow up visit post initial household information session)
- Water storage, handling, and use behaviors(1-2 month follow up visit post initial household information session)