<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03021434</url>
  </required_header>
  <id_info>
    <org_study_id>11920/RR/5743</org_study_id>
    <nct_id>NCT03021434</nct_id>
  </id_info>
  <brief_title>Trial of Low-cost Microbiological Water Test Kits</brief_title>
  <official_title>Cluster Randomized Trial of Low-cost Microbiological Water Test Kits</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Indian Institute of Technology Kanpur</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>London School of Hygiene and Tropical Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study is a cluster randomized control trial of low-cost microbiological water&#xD;
      test kits in rural and peri-urban communities in the Kanpur region of Uttar Pradesh, India.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed trial utilizes a cluster randomized controlled methodology, with clustering&#xD;
      occurring at the village level. The intervention that will be tested in this cluster&#xD;
      randomized controlled trial is informed by the development of a simple, low-cost water&#xD;
      quality test kit developed and piloted by J. Brown and colleagues in Nagpur, Maharashtra.&#xD;
&#xD;
      There will be two intervention arms and one control/comparison arm. In all selected villages,&#xD;
      the study team will work with local government to conduct a village-level information session&#xD;
      on water quality and key water safety behaviours. Informational material on water safety&#xD;
      behaviours will be distrubted to all houseohlds following this information session. In the&#xD;
      control group, households will be visited to provide water safety informational cards and&#xD;
      collect a drinking water sample to be analyzed in the lab. They will not receive the results&#xD;
      of the analysis until the conclusion of the study. Households in Intervention Arm 1 (Standard&#xD;
      Testing) will have their water sampled and analyzed in the lab, and results of the analysis&#xD;
      will be delivered to the households. They will receive informational cards describing water&#xD;
      purification strategies. Households in Intervention Arm 2 (Test Kits) will be provided with&#xD;
      the materials and training needed to perform water quality testing in their own household&#xD;
      using the newly developed testing kits. They will also receive informational cards describing&#xD;
      water purification strategies.&#xD;
&#xD;
      Following the initial village-level information session, the study team will randomly sample&#xD;
      households for participation in the trial. Participating households will complete a short&#xD;
      survey on household demographics and water handling, storage, and use behaviours and a water&#xD;
      sample will be taken and tested in the lab for fecal indicator bacteria. At an unannounced&#xD;
      follow-up visit, roughly 1 - 2 months after enrollment, households will complete a short&#xD;
      survey about changes in water handling, storage, and use behaviours and a second sample of&#xD;
      household stored drinking water will be collected for laboratory analysis. The effect of the&#xD;
      cluster randomized controlled trial on water quality will be determined by comparing&#xD;
      arithmetic mean E. coli count from samples of household water and changes in water safety&#xD;
      behaviours between baseline and endline.&#xD;
&#xD;
      Microbiological drinking water quality will be assessed at two time points: baseline and&#xD;
      endline. At each visit, a 330 ml sample of household water will be collected for analysis; we&#xD;
      will ask participants to fill the sample container as if it were a drinking cup for a child&#xD;
      living in the household. Samples will be kept cold (on ice in a cooler) until delivery to the&#xD;
      laboratory and thereafter stored at 4oC until processing, to begin within 8 hours of the&#xD;
      sampling event.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">May 25, 2017</completion_date>
  <primary_completion_date type="Actual">May 25, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Arithmetic mean E. coli count from sample of stored household drinking water</measure>
    <time_frame>1-2 month follow up visit post initial household information session</time_frame>
    <description>A sample of household drinking water will be collected and analyzed in a standard laboratory using membrane filtration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Water storage, handling, and use behaviors</measure>
    <time_frame>1-2 month follow up visit post initial household information session</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention uptake/use</measure>
    <time_frame>1-2 month follow up visit post initial household information session</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">572</enrollment>
  <condition>Diarrhea</condition>
  <condition>E.Coli Infections</condition>
  <arm_group>
    <arm_group_label>Standard Testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Kits</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Community and household water safety education sessions</intervention_name>
    <description>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.</description>
    <arm_group_label>Comparison</arm_group_label>
    <arm_group_label>Standard Testing</arm_group_label>
    <arm_group_label>Test Kits</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Household-specific water quality information</intervention_name>
    <description>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.</description>
    <arm_group_label>Standard Testing</arm_group_label>
    <arm_group_label>Test Kits</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low-cost microbiological water test kits</intervention_name>
    <description>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</description>
    <arm_group_label>Test Kits</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (for villages) :&#xD;
&#xD;
          -  Village located within the Kanpur district, within&#xD;
&#xD;
          -  Village population between 100 and 1000 households.&#xD;
&#xD;
          -  No chlorinated water sources available in the village.&#xD;
&#xD;
        Inclusion Criteria (for households) :&#xD;
&#xD;
          -  Consent to participate in the study&#xD;
&#xD;
          -  Contain at least one child who is between 29 days and 60 months of age at the time of&#xD;
             enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Villages that receive chlorinated water from utility services&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Dreibelbis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>London School of Hygiene and Tropical Medicine</affiliation>
  </overall_official>
  <reference>
    <citation>Kotloff KL, Nataro JP, Blackwelder WC, Nasrin D, Farag TH, Panchalingam S, Wu Y, Sow SO, Sur D, Breiman RF, Faruque AS, Zaidi AK, Saha D, Alonso PL, Tamboura B, Sanogo D, Onwuchekwa U, Manna B, Ramamurthy T, Kanungo S, Ochieng JB, Omore R, Oundo JO, Hossain A, Das SK, Ahmed S, Qureshi S, Quadri F, Adegbola RA, Antonio M, Hossain MJ, Akinsola A, Mandomando I, Nhampossa T, Acacio S, Biswas K, O'Reilly CE, Mintz ED, Berkeley LY, Muhsen K, Sommerfelt H, Robins-Browne RM, Levine MM. Burden and aetiology of diarrhoeal disease in infants and young children in developing countries (the Global Enteric Multicenter Study, GEMS): a prospective, case-control study. Lancet. 2013 Jul 20;382(9888):209-22. doi: 10.1016/S0140-6736(13)60844-2. Epub 2013 May 14.</citation>
    <PMID>23680352</PMID>
  </reference>
  <reference>
    <citation>Million Death Study Collaborators; Bassani DG, Kumar R, Awasthi S, Morris SK, Paul VK, Shet A, Ram U, Gaffey MF, Black RE, Jha P. Causes of neonatal and child mortality in India: a nationally representative mortality survey. Lancet. 2010 Nov 27;376(9755):1853-60. doi: 10.1016/S0140-6736(10)61461-4. Epub 2010 Nov 12.</citation>
    <PMID>21075444</PMID>
  </reference>
  <reference>
    <citation>Lakshminarayanan S, Jayalakshmy R. Diarrheal diseases among children in India: Current scenario and future perspectives. J Nat Sci Biol Med. 2015 Jan-Jun;6(1):24-8. doi: 10.4103/0976-9668.149073.</citation>
    <PMID>25810630</PMID>
  </reference>
  <reference>
    <citation>Hamoudi A, Jeuland M, Lombardo S, Patil S, Pattanayak SK, Rai S. The effect of water quality testing on household behavior: evidence from an experiment in rural India. Am J Trop Med Hyg. 2012 Jul;87(1):18-22. doi: 10.4269/ajtmh.2012.12-0051.</citation>
    <PMID>22764286</PMID>
  </reference>
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    <citation>Davis J, Pickering AJ, Rogers K, Mamuya S, Boehm AB. The effects of informational interventions on household water management, hygiene behaviors, stored drinking water quality, and hand contamination in peri-urban Tanzania. Am J Trop Med Hyg. 2011 Feb;84(2):184-91. doi: 10.4269/ajtmh.2011.10-0126.</citation>
    <PMID>21292883</PMID>
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    <citation>Magro G, Bain RE, Woodall CA, Matthews RL, Gundry SW, Davis AP. Synthesis and application of resorufin beta-D-glucuronide, a low-cost chromogenic substrate for detecting Escherichia coli in drinking water. Environ Sci Technol. 2014 Aug 19;48(16):9624-31. doi: 10.1021/es502319n. Epub 2014 Jul 29.</citation>
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    <citation>Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. doi: 10.1093/ije/28.2.319.</citation>
    <PMID>10342698</PMID>
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    <citation>Duflo, E., R. Glennerster, and M. Kremer, Using Randomization in Development Economics Research: A Toolkit, in T. Schultz and John Strauss, eds., Handbook of Development Economics. 2008, North Holland: Amsterdam and New York.</citation>
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    <citation>Zhou H, Taber C, Arcona S, Li Y. Difference-in-Differences Method in Comparative Effectiveness Research: Utility with Unbalanced Groups. Appl Health Econ Health Policy. 2016 Aug;14(4):419-429. doi: 10.1007/s40258-016-0249-y.</citation>
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  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>June 28, 2017</last_update_submitted>
  <last_update_submitted_qc>June 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Water Supply/standards</keyword>
  <keyword>Water microbiology</keyword>
  <keyword>India</keyword>
  <keyword>Hand disinfection</keyword>
  <keyword>Escherichia coli Infections/prevention &amp; control</keyword>
  <keyword>Hygiene</keyword>
  <keyword>Health behavior</keyword>
  <keyword>Drinking water</keyword>
  <keyword>Informational intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Escherichia coli Infections</mesh_term>
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03021434
org study id: 11920/RR/5743
nct id: NCT03021434
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: 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
description: A sample of household drinking water will be collected and analyzed in a standard laboratory using membrane filtration.
measure: Water storage, handling, and use behaviors
time frame: 1-2 month follow up visit post initial household information session
description: 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
measure: Intervention uptake/use
time frame: 1-2 month follow up visit post initial household information session
description: 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.
arm group label: Standard Testing
arm group type: Experimental
description: 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.
arm group label: Test Kits
arm group type: Experimental
description: 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.
arm group label: Comparison
arm group type: Active Comparator
description: 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 type: Other
intervention name: Community and household water safety education sessions
description: 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.
arm group label: Comparison
arm group label: Standard Testing
arm group label: Test Kits
intervention type: Other
intervention name: Household-specific water quality information
description: 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.
arm group label: Standard Testing
arm group label: Test Kits
intervention type: Other
intervention name: Low-cost microbiological water test kits
description: 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
arm group label: Test Kits
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Dreibelbis, PhD
role: Principal Investigator
affiliation: London School of Hygiene and Tropical Medicine
citation: Kotloff KL, Nataro JP, Blackwelder WC, Nasrin D, Farag TH, Panchalingam S, Wu Y, Sow SO, Sur D, Breiman RF, Faruque AS, Zaidi AK, Saha D, Alonso PL, Tamboura B, Sanogo D, Onwuchekwa U, Manna B, Ramamurthy T, Kanungo S, Ochieng JB, Omore R, Oundo JO, Hossain A, Das SK, Ahmed S, Qureshi S, Quadri F, Adegbola RA, Antonio M, Hossain MJ, Akinsola A, Mandomando I, Nhampossa T, Acacio S, Biswas K, O'Reilly CE, Mintz ED, Berkeley LY, Muhsen K, Sommerfelt H, Robins-Browne RM, Levine MM. Burden and aetiology of diarrhoeal disease in infants and young children in developing countries (the Global Enteric Multicenter Study, GEMS): a prospective, case-control study. Lancet. 2013 Jul 20;382(9888):209-22. doi: 10.1016/S0140-6736(13)60844-2. Epub 2013 May 14.
PMID: 23680352
citation: Million Death Study Collaborators; Bassani DG, Kumar R, Awasthi S, Morris SK, Paul VK, Shet A, Ram U, Gaffey MF, Black RE, Jha P. Causes of neonatal and child mortality in India: a nationally representative mortality survey. Lancet. 2010 Nov 27;376(9755):1853-60. doi: 10.1016/S0140-6736(10)61461-4. Epub 2010 Nov 12.
PMID: 21075444
citation: Lakshminarayanan S, Jayalakshmy R. Diarrheal diseases among children in India: Current scenario and future perspectives. J Nat Sci Biol Med. 2015 Jan-Jun;6(1):24-8. doi: 10.4103/0976-9668.149073.
PMID: 25810630
citation: Hamoudi A, Jeuland M, Lombardo S, Patil S, Pattanayak SK, Rai S. The effect of water quality testing on household behavior: evidence from an experiment in rural India. Am J Trop Med Hyg. 2012 Jul;87(1):18-22. doi: 10.4269/ajtmh.2012.12-0051.
PMID: 22764286
citation: Davis J, Pickering AJ, Rogers K, Mamuya S, Boehm AB. The effects of informational interventions on household water management, hygiene behaviors, stored drinking water quality, and hand contamination in peri-urban Tanzania. Am J Trop Med Hyg. 2011 Feb;84(2):184-91. doi: 10.4269/ajtmh.2011.10-0126.
PMID: 21292883
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responsible party type: Sponsor
mesh term: Escherichia coli Infections
mesh term: Diarrhea
sharing ipd: No