<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/NCT03274245</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00098293</org_study_id>
    <nct_id>NCT03274245</nct_id>
  </id_info>
  <brief_title>Evaluating a Latrine Use Intervention in Odisha, India</brief_title>
  <official_title>Implementing and Evaluating a Multi-Level Intervention to Increase Latrine Use and Safe Feces Disposal Among Latrine Owning Households in Rural Puri District, Odisha, India</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this research is to evaluate an intervention focused on increasing latrine&#xD;
      use in rural Odisha India. The present study builds off of previous research, which resulted&#xD;
      in the design of an intervention to increase latrine use. This research evaluates the&#xD;
      intervention designed to determine if significant increases in latrine use are observed among&#xD;
      those who received the intervention compared to those that did not. Qualitative research will&#xD;
      supplement trial data collection to help explain findings and understand perceptions of the&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this research is to evaluate an intervention focused on increasing latrine&#xD;
      use in rural Odisha India. The present study builds off of previous research, which resulted&#xD;
      in the design of an intervention to increase latrine use. This research evaluates the&#xD;
      intervention designed to determine if significant increases in latrine use are observed among&#xD;
      those who received the intervention compared to those that did not. Qualitative research will&#xD;
      supplement trial data collection to help explain findings and understand perceptions of the&#xD;
      intervention.&#xD;
&#xD;
      For trial data collection, household members will be engaged in a survey that asks questions&#xD;
      about the household, the latrine use practices of their family members, and may include&#xD;
      additional questions about social norms attitudes, and other factors influencing latrine use.&#xD;
&#xD;
      Investigators will carry out two discrete qualitative research activities both digitally&#xD;
      recorded: in depth interviews (IDIs) and focus group discussions (FGDs). Topics to be covered&#xD;
      during the qualitative research include: perceptions of the intervention, reasons for&#xD;
      using/not using latrines, motivations for sanitation behaviors.&#xD;
&#xD;
      The primary objective of the study is to evaluate a multi-level, theoretically informed&#xD;
      intervention designed to increase latrine use for defecation among all members of households&#xD;
      that currently own a latrine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2018</start_date>
  <completion_date type="Actual">April 13, 2019</completion_date>
  <primary_completion_date type="Actual">February 18, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Latrine Usage Rate</measure>
    <time_frame>Baseline, Post-Intervention (Up to 1 Year)</time_frame>
    <description>Latrine usage will be assessed via in-depth interviews conducted between the study team and participants. Responses to interview questions will be aggregated and categorized by common themes, and analyzed qualitatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Number of Toilets</measure>
    <time_frame>Baseline, Post-Intervention (Up to 1 Year)</time_frame>
    <description>The number of toilets in the community/village will be collected at baseline and post-intervention.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">11722</enrollment>
  <condition>Latrine Usage</condition>
  <arm_group>
    <arm_group_label>Latrine Use</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Men and women in villages randomized to the latrine use arm will receive the intervention package that includes activities at the community and household levels, with additional activities and hardware for mothers of children under five.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Men and women in villages randomized to the control group will not receive an intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Qualitative Research Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Six villages unassociated with the randomized villages will engage in qualitative research. Three villages will receive the intervention. Three villages will not receive the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention Package</intervention_name>
    <description>Community Level:&#xD;
Palla: songs and skits to increase knowledge of and motivation for latrine use, pit emptying, safe feces disposal;&#xD;
Transect Walk: village walk to identify and mark feces in community;&#xD;
Community meetings: sex-segregated meetings with village members to decide on an action plan to increase community cleanliness/reduce open defecation;&#xD;
Wall painting: village map noting households that use latrines always.&#xD;
Sub-Community level:&#xD;
Mothers meeting: For caregivers with children under age 5, to provide knowledge of and hardware for safe child feces disposal.&#xD;
Household Level:&#xD;
Household visits: to those with latrines to motivate use;&#xD;
Latrine repairs: for households with non-functional latrines to make functional.</description>
    <arm_group_label>Latrine Use</arm_group_label>
    <arm_group_label>Qualitative Research Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Qualitative Research</intervention_name>
    <description>For villages receiving the intervention package, investigators will engage community members through qualitative interviews to gain their perception of the intervention, what they thought of the intervention activities, what information they recall, what aspects they enjoyed or disliked, if they had barriers to attendance or participation.&#xD;
For the three villages not receiving the intervention, investigators will conduct qualitative interviews to determine additional barriers and determinants of latrine use to identify other potential intervention strategies.</description>
    <arm_group_label>Qualitative Research Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Villages located in rural Puri district, Odisha India&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Estimated 60% latrine coverage or higher&#xD;
&#xD;
          -  At least 75 households&#xD;
&#xD;
          -  Have a village leader willing to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Considered open-defecation free (ODF)&#xD;
&#xD;
          -  Participants under the age of 18 will not be targeted for research-related activities,&#xD;
             like interviews and discussions, though we will ask caregivers or other household&#xD;
             members to provide in information about the sanitation-related behaviors of children&#xD;
             under age 18.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bethany Caruso, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xavier Institute of Management</name>
      <address>
        <city>Bhubaneswar</city>
        <state>Odisha</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>July 16, 2019</last_update_submitted>
  <last_update_submitted_qc>July 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Bethany Caruso</investigator_full_name>
    <investigator_title>Post Doctoral Fellow</investigator_title>
  </responsible_party>
  <keyword>Public Health</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </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/NCT03274245
org study id: IRB00098293
nct id: NCT03274245
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this research is to evaluate an intervention focused on increasing latrine
      use in rural Odisha India. The present study builds off of previous research, which resulted
      in the design of an intervention to increase latrine use. This research evaluates the
      intervention designed to determine if significant increases in latrine use are observed among
      those who received the intervention compared to those that did not. Qualitative research will
      supplement trial data collection to help explain findings and understand perceptions of the
      intervention.
The objective of this research is to evaluate an intervention focused on increasing latrine
      use in rural Odisha India. The present study builds off of previous research, which resulted
      in the design of an intervention to increase latrine use. This research evaluates the
      intervention designed to determine if significant increases in latrine use are observed among
      those who received the intervention compared to those that did not. Qualitative research will
      supplement trial data collection to help explain findings and understand perceptions of the
      intervention.

      For trial data collection, household members will be engaged in a survey that asks questions
      about the household, the latrine use practices of their family members, and may include
      additional questions about social norms attitudes, and other factors influencing latrine use.

      Investigators will carry out two discrete qualitative research activities both digitally
      recorded: in depth interviews (IDIs) and focus group discussions (FGDs). Topics to be covered
      during the qualitative research include: perceptions of the intervention, reasons for
      using/not using latrines, motivations for sanitation behaviors.

      The primary objective of the study is to evaluate a multi-level, theoretically informed
      intervention designed to increase latrine use for defecation among all members of households
      that currently own a latrine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Latrine Usage Rate
time frame: Baseline, Post-Intervention (Up to 1 Year)
description: Latrine usage will be assessed via in-depth interviews conducted between the study team and participants. Responses to interview questions will be aggregated and categorized by common themes, and analyzed qualitatively.
measure: Change in Number of Toilets
time frame: Baseline, Post-Intervention (Up to 1 Year)
description: The number of toilets in the community/village will be collected at baseline and post-intervention.
arm group label: Latrine Use
arm group type: Experimental
description: Men and women in villages randomized to the latrine use arm will receive the intervention package that includes activities at the community and household levels, with additional activities and hardware for mothers of children under five.
arm group label: Control Group
arm group type: No Intervention
description: Men and women in villages randomized to the control group will not receive an intervention.
arm group label: Qualitative Research Group
arm group type: Experimental
description: Six villages unassociated with the randomized villages will engage in qualitative research. Three villages will receive the intervention. Three villages will not receive the intervention.
intervention type: Behavioral
intervention name: Intervention Package
description: Community Level:
Palla: songs and skits to increase knowledge of and motivation for latrine use, pit emptying, safe feces disposal;
Transect Walk: village walk to identify and mark feces in community;
Community meetings: sex-segregated meetings with village members to decide on an action plan to increase community cleanliness/reduce open defecation;
Wall painting: village map noting households that use latrines always.
Sub-Community level:
Mothers meeting: For caregivers with children under age 5, to provide knowledge of and hardware for safe child feces disposal.
Household Level:
Household visits: to those with latrines to motivate use;
Latrine repairs: for households with non-functional latrines to make functional.
arm group label: Latrine Use
arm group label: Qualitative Research Group
intervention type: Other
intervention name: Qualitative Research
description: For villages receiving the intervention package, investigators will engage community members through qualitative interviews to gain their perception of the intervention, what they thought of the intervention activities, what information they recall, what aspects they enjoyed or disliked, if they had barriers to attendance or participation.
For the three villages not receiving the intervention, investigators will conduct qualitative interviews to determine additional barriers and determinants of latrine use to identify other potential intervention strategies.
arm group label: Qualitative Research Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bethany Caruso, PhD
role: Principal Investigator
affiliation: Emory University
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Bethany Caruso
investigator title: Post Doctoral Fellow
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)