Trial of Low-cost Microbiological Water Test Kits

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cluster Randomized Trial of Low-cost Microbiological Water Test Kits

Conditions
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Diarrhea, E.Coli Infections

Intervention / Treatment
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* Other: Community and household water safety education sessions
* Other: Household-specific water quality information
* Other: Low-cost microbiological water test kits


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Testing<br>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 sessions<br>* 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.<br>Other: Household-specific water quality information<br>* 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.<br>|
| Experimental: Test Kits<br>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 sessions<br>* 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.<br>Other: Household-specific water quality information<br>* 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.<br>Other: Low-cost microbiological water test kits<br>* 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<br>|
| Active Comparator: Comparison<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Water storage, handling, and use behaviors | Self-reported water treatment practices, verifiable water treatment practices, water handling and water storage practices in the home, and changes in primary water source. This outcome is measured using baseline and follow up survey questionnaires, as well as direct observation of handwashing station and water storage containers | 1-2 month follow up visit post initial household information session | 
| Intervention uptake/use | For households participating in the Test Kit Arm, intervention update will be assessed visual inspection of the number of test kits remaining in the household at end line (to determine utilization) as well as targeted survey question on the ease of use and perceived utility of the test kits. | 1-2 month follow up visit post initial household information session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Water Supply/standards, Water microbiology, India, Hand disinfection, Escherichia coli Infections/prevention & control, Hygiene, Health behavior, Drinking water, Informational intervention