xml: <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/NCT06003816</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00009931</org_study_id>
      <nct_id>NCT06003816</nct_id>
    </id_info>
    <brief_title>Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)</brief_title>
    <official_title>Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Johns Hopkins Bloomberg School of Public Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Research Training and Management International (RTMI)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Johns Hopkins Bloomberg School of Public Health</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Objective: The investigators objective is to develop and evaluate the effectiveness of a case&#xD;
        area targeted water, sanitation, and hygiene (WASH) intervention in reducing cholera&#xD;
        infections and increasing sustained WASH behaviors in transmission hotspots in a ring around&#xD;
        cholera cases.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Worldwide there are estimated to be 2.9 million cholera cases annually. Effective&#xD;
        targeted water, sanitation, and hygiene (WASH) interventions are urgently needed to reduce&#xD;
        cholera globally. The investigators study in Bangladesh found that individuals living within&#xD;
        50 meters of a cholera patient were at 30 times higher risk of developing cholera than the&#xD;
        general population during the first week after the index patient sought care at a health&#xD;
        facility. However, there has been little work done to develop and evaluate interventions for&#xD;
        this high risk population.&#xD;
  &#xD;
        Objective: The investigators objective is to develop and evaluate the effectiveness of a case&#xD;
        area targeted WASH intervention in reducing cholera infections and increasing sustained WASH&#xD;
        behaviors in transmission hotspots in a ring around cholera cases.&#xD;
  &#xD;
        Previous studies: The investigators research group developed the&#xD;
        Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7), a WASH intervention delivered to&#xD;
        cholera patients and the participants household members in a health facility. the&#xD;
        investigators randomized controlled trial (RCT) in Bangladesh of CHoBI7 demonstrated this&#xD;
        intervention was effective in significantly reducing cholera, and led to sustained increases&#xD;
        in handwashing with soap and improved drinking water quality 12 months post-intervention in&#xD;
        cholera patient households. This intervention, however, solely focused on cholera patients&#xD;
        households. There are no studies to date that have evaluated the impact on reducing cholera&#xD;
        of delivering a ring WASH intervention to households living near cholera patients.&#xD;
  &#xD;
        Design and Setting: The Director of Disease Control at the Bangladesh Ministry of Health and&#xD;
        Family Welfare would like to take CHoBI7 to scale across Bangladesh, and has requested the&#xD;
        investigators build evidence on scalable approaches for delivering CHoBI7 as a CATI in a ring&#xD;
        around cholera patient households. This study will have 3 phases. During the formative&#xD;
        research and planning phase the investigators will develop a scalable, theory and evidence&#xD;
        based ring WASH intervention through in-depth interviews, focus group discussions, workshops,&#xD;
        and a pilot. During the intervention implementation and evaluation phase the investigators&#xD;
        will conduct a RCT to prospectively follow 3120 participants from 1040 households living in&#xD;
        40 rings around cholera cases to evaluate the effectiveness of the intervention in: (1)&#xD;
        reducing cholera infections during the first week after the index patient in the ring seeks&#xD;
        care at a health facility; and (2) increasing handwashing with soap and stored water quality&#xD;
        over a 12 month period. The first arm will receive the standard recommendation given in&#xD;
        Bangladesh during diarrhea outbreaks on oral rehydration solution use and a leaflet on WASH&#xD;
        practices during a single visit. The second arm will receive this message and the ring WASH&#xD;
        intervention which includes group sessions and home visits and mobile health messages. Whole&#xD;
        genome sequencing will be performed on water and clinical Vibrio cholerae strains collected&#xD;
        to investigate spatiotemporal transmission dynamics of V. cholerae in hotspots. During the&#xD;
        dissemination and policy planning phase, the investigators will partner with the Director of&#xD;
        Disease Control to disseminate study findings and inform cholera control policies.&#xD;
  &#xD;
        Significance: This will be the first RCT of a CATI WASH program to evaluate whether this&#xD;
        intervention approach can reduce cholera.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2025</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>Number of non-baseline cholera infections among individuals residing in a ring around cholera patients</measure>
      <time_frame>1 month</time_frame>
      <description>cholera infection assessed by bacterial culture and/or vibriocidal antibody titer</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Diarrhea among individuals residing in a ring around cholera patients</measure>
      <time_frame>12 months</time_frame>
      <description>Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Child development for children under 5 years of age as assessed by the Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)</measure>
      <time_frame>12 Months</time_frame>
      <description>Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of Handwashing with soap at stool and food related events</measure>
      <time_frame>12 Months</time_frame>
      <description>Rate of patient household members handwashing with soap at stool and food related events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Free chlorine concentration (mg/L) in stored drinking water</measure>
      <time_frame>12 months</time_frame>
      <description>Free chlorine concentration (mg/L) in stored drinking water</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Presence of Vibrio cholerae and E. coli in stored drinking water</measure>
      <time_frame>12 months</time_frame>
      <description>E.coli and Vibrio cholerae measured by bacterial culture</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hand washing psychosocial risk factors as assessed by Water, Sanitation, and Hygiene (WASH) questionnaire</measure>
      <time_frame>12 months</time_frame>
      <description>Water, Sanitation, and Hygiene (WASH) psychosocial risk factor questionnaire which involves both multiple choice questions and spot checks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Height-for-age measurements among children under 2 years of age</measure>
      <time_frame>12 months</time_frame>
      <description>Height and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate height-for-age z-scores according to the World Health Organization child growth standards</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Height-for-age measurements among children under 5 years of age</measure>
      <time_frame>12 months</time_frame>
      <description>Height and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate height-for-age z-scores according to the World Health Organization child growth standards</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight-for-age measurements among children under 2 years of age</measure>
      <time_frame>12 months</time_frame>
      <description>Weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate weight-for-age z-scores according to the World Health Organization child growth standards</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight-for-age measurements among children under 5 years of age</measure>
      <time_frame>12 months</time_frame>
      <description>Weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate weight-for-age z-scores according to the World Health Organization child growth standards</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight-for-height measurements among children under 2 years of age</measure>
      <time_frame>12 months</time_frame>
      <description>Height, weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate weight-for-height z-scores according to the World Health Organization child growth standards</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight-for-height measurements among children under 5 years of age</measure>
      <time_frame>12 months</time_frame>
      <description>Height, weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate weight-for-height z-scores according to the World Health Organization child growth standards</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">3140</enrollment>
    <condition>Cholera</condition>
    <condition>Diarrhea</condition>
    <arm_group>
      <arm_group_label>Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The CHoBI7 program is first delivered during group sessions by a health promoter to those residing in a ring around a cholera patient. The health promoter delivers a pictorial WASH module on how diarrhea can spread, and instructions on handwashing with soap, water treatment, and safe water storage. A cholera prevention package is provided containing: a one-month supply of chlorine tablets for water treatment, a soapy water bottle for handwashing, a handwashing station, and a water vessel with a lid and tap to ensure safe water storage. After the group session, households receive weekly voice and text messages from the CHoBI7 mHealth program over 12 months on the recommended WASH behaviors.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Message Arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard message given in the Bangladesh to diarrhea patients at health facility discharge on use of oral rehydration solution</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI</intervention_name>
      <description>The CHoBI7 program is during group sessions by a health promoter to those residing in a ring around a cholera patient reinforced through weekly voice and text messages from the CHoBI7 mHealth program over 12 months on the recommended water, sanitation, and hygiene behaviors.</description>
      <arm_group_label>Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standard message</intervention_name>
      <description>Standard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution</description>
      <arm_group_label>Standard Message Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Index cholera patient have no running water inside of their home&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No one will be excluded because of age, sex, religion, or sexual preference&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Christine Marie George, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Christine Marie George, PhD</last_name>
      <phone>(202) 657-5798</phone>
      <email>cmgeorge@jhu.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>International Centre for Diarrhoeal Disease Research, Bangladesh</name>
        <address>
          <city>Dhaka</city>
          <country>Bangladesh</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Training and Management International</name>
        <address>
          <city>Dhaka</city>
          <country>Bangladesh</country>
        </address>
      </facility>
      <contact>
        <last_name>Tahmina Parvin</last_name>
        <email>tahminaph14@yahoo.com</email>
      </contact>
      <investigator>
        <last_name>Tahmina Parvin</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Bangladesh</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>randomized controlled trial</keyword>
    <keyword>water</keyword>
    <keyword>sanitation</keyword>
    <keyword>hygiene</keyword>
    <keyword>case area targeted intervention</keyword>
    <keyword>Bangladesh</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cholera</mesh_term>
      <mesh_term>Diarrhea</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>All data will be de-identified and available to our collaborators</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06003816
  org study id: IRB00009931
  nct id: NCT06003816
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Objective: The investigators objective is to develop and evaluate the effectiveness of a case
        area targeted water, sanitation, and hygiene (WASH) intervention in reducing cholera
        infections and increasing sustained WASH behaviors in transmission hotspots in a ring around
        cholera cases.
  Background: Worldwide there are estimated to be 2.9 million cholera cases annually. Effective
        targeted water, sanitation, and hygiene (WASH) interventions are urgently needed to reduce
        cholera globally. The investigators study in Bangladesh found that individuals living within
        50 meters of a cholera patient were at 30 times higher risk of developing cholera than the
        general population during the first week after the index patient sought care at a health
        facility. However, there has been little work done to develop and evaluate interventions for
        this high risk population.
  
        Objective: The investigators objective is to develop and evaluate the effectiveness of a case
        area targeted WASH intervention in reducing cholera infections and increasing sustained WASH
        behaviors in transmission hotspots in a ring around cholera cases.
  
        Previous studies: The investigators research group developed the
        Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7), a WASH intervention delivered to
        cholera patients and the participants household members in a health facility. the
        investigators randomized controlled trial (RCT) in Bangladesh of CHoBI7 demonstrated this
        intervention was effective in significantly reducing cholera, and led to sustained increases
        in handwashing with soap and improved drinking water quality 12 months post-intervention in
        cholera patient households. This intervention, however, solely focused on cholera patients
        households. There are no studies to date that have evaluated the impact on reducing cholera
        of delivering a ring WASH intervention to households living near cholera patients.
  
        Design and Setting: The Director of Disease Control at the Bangladesh Ministry of Health and
        Family Welfare would like to take CHoBI7 to scale across Bangladesh, and has requested the
        investigators build evidence on scalable approaches for delivering CHoBI7 as a CATI in a ring
        around cholera patient households. This study will have 3 phases. During the formative
        research and planning phase the investigators will develop a scalable, theory and evidence
        based ring WASH intervention through in-depth interviews, focus group discussions, workshops,
        and a pilot. During the intervention implementation and evaluation phase the investigators
        will conduct a RCT to prospectively follow 3120 participants from 1040 households living in
        40 rings around cholera cases to evaluate the effectiveness of the intervention in: (1)
        reducing cholera infections during the first week after the index patient in the ring seeks
        care at a health facility; and (2) increasing handwashing with soap and stored water quality
        over a 12 month period. The first arm will receive the standard recommendation given in
        Bangladesh during diarrhea outbreaks on oral rehydration solution use and a leaflet on WASH
        practices during a single visit. The second arm will receive this message and the ring WASH
        intervention which includes group sessions and home visits and mobile health messages. Whole
        genome sequencing will be performed on water and clinical Vibrio cholerae strains collected
        to investigate spatiotemporal transmission dynamics of V. cholerae in hotspots. During the
        dissemination and policy planning phase, the investigators will partner with the Director of
        Disease Control to disseminate study findings and inform cholera control policies.
  
        Significance: This will be the first RCT of a CATI WASH program to evaluate whether this
        intervention approach can reduce cholera.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Number of non-baseline cholera infections among individuals residing in a ring around cholera patients
  time frame: 1 month
  description: cholera infection assessed by bacterial culture and/or vibriocidal antibody titer
  measure: Diarrhea among individuals residing in a ring around cholera patients
  time frame: 12 months
  description: Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)
  measure: Child development for children under 5 years of age as assessed by the Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)
  time frame: 12 Months
  description: Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)
  measure: Rate of Handwashing with soap at stool and food related events
  time frame: 12 Months
  description: Rate of patient household members handwashing with soap at stool and food related events
  measure: Free chlorine concentration (mg/L) in stored drinking water
  time frame: 12 months
  description: Free chlorine concentration (mg/L) in stored drinking water
  measure: Presence of Vibrio cholerae and E. coli in stored drinking water
  time frame: 12 months
  description: E.coli and Vibrio cholerae measured by bacterial culture
  measure: Hand washing psychosocial risk factors as assessed by Water, Sanitation, and Hygiene (WASH) questionnaire
  time frame: 12 months
  description: Water, Sanitation, and Hygiene (WASH) psychosocial risk factor questionnaire which involves both multiple choice questions and spot checks
  measure: Height-for-age measurements among children under 2 years of age
  time frame: 12 months
  description: Height and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate height-for-age z-scores according to the World Health Organization child growth standards
  measure: Height-for-age measurements among children under 5 years of age
  time frame: 12 months
  description: Height and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate height-for-age z-scores according to the World Health Organization child growth standards
  measure: Weight-for-age measurements among children under 2 years of age
  time frame: 12 months
  description: Weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate weight-for-age z-scores according to the World Health Organization child growth standards
  measure: Weight-for-age measurements among children under 5 years of age
  time frame: 12 months
  description: Weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate weight-for-age z-scores according to the World Health Organization child growth standards
  measure: Weight-for-height measurements among children under 2 years of age
  time frame: 12 months
  description: Height, weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate weight-for-height z-scores according to the World Health Organization child growth standards
  measure: Weight-for-height measurements among children under 5 years of age
  time frame: 12 months
  description: Height, weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate weight-for-height z-scores according to the World Health Organization child growth standards
  arm group label: Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI
  arm group type: Experimental
  description: The CHoBI7 program is first delivered during group sessions by a health promoter to those residing in a ring around a cholera patient. The health promoter delivers a pictorial WASH module on how diarrhea can spread, and instructions on handwashing with soap, water treatment, and safe water storage. A cholera prevention package is provided containing: a one-month supply of chlorine tablets for water treatment, a soapy water bottle for handwashing, a handwashing station, and a water vessel with a lid and tap to ensure safe water storage. After the group session, households receive weekly voice and text messages from the CHoBI7 mHealth program over 12 months on the recommended WASH behaviors.
  arm group label: Standard Message Arm
  arm group type: Active Comparator
  description: Standard message given in the Bangladesh to diarrhea patients at health facility discharge on use of oral rehydration solution
  intervention type: Behavioral
  intervention name: Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI
  description: The CHoBI7 program is during group sessions by a health promoter to those residing in a ring around a cholera patient reinforced through weekly voice and text messages from the CHoBI7 mHealth program over 12 months on the recommended water, sanitation, and hygiene behaviors.
  arm group label: Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI
  intervention type: Behavioral
  intervention name: Standard message
  description: Standard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution
  arm group label: Standard Message Arm
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Christine Marie George, PhD
  role: Principal Investigator
  affiliation: Johns Hopkins Bloomberg School of Public Health
  last name: Christine Marie George, PhD
  phone: (202) 657-5798
  email: cmgeorge@jhu.edu
  facility: 
  facility: 
  contact: 
  investigator: 
  country: Bangladesh
  responsible party type: Sponsor
  mesh term: Cholera
  mesh term: Diarrhea
  sharing ipd: No
  ipd description: All data will be de-identified and available to our collaborators