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Evaluating a Latrine Use Intervention in Odisha, India

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ClinicalTrials.gov Identifier: NCT03274245
Recruitment Status : Completed
First Posted : September 6, 2017
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Bethany Caruso, Emory University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Latrine Usage Behavioral: Intervention Package Other: Qualitative Research Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11722 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : February 18, 2019
Actual Study Completion Date : April 13, 2019

Arm Intervention/treatment
Experimental: Latrine Use
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.
Behavioral: Intervention Package
  • 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.

No Intervention: Control Group
Men and women in villages randomized to the control group will not receive an intervention.
Experimental: Qualitative Research Group
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.
Behavioral: Intervention Package
  • 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.

Other: Qualitative Research

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.





Primary Outcome Measures :
  1. Change in Latrine Usage Rate [ Time Frame: Baseline, Post-Intervention (Up to 1 Year) ]
    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.


Secondary Outcome Measures :
  1. Change in Number of Toilets [ Time Frame: Baseline, Post-Intervention (Up to 1 Year) ]
    The number of toilets in the community/village will be collected at baseline and post-intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Villages located in rural Puri district, Odisha India

Inclusion Criteria:

  • Estimated 60% latrine coverage or higher
  • At least 75 households
  • Have a village leader willing to participate

Exclusion Criteria:

  • Considered open-defecation free (ODF)
  • Participants under the age of 18 will not be targeted for research-related activities, like interviews and discussions, though we will ask caregivers or other household members to provide in information about the sanitation-related behaviors of children under age 18.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274245


Locations
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India
Xavier Institute of Management
Bhubaneswar, Odisha, India
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Bethany Caruso, PhD Emory University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bethany Caruso, Post Doctoral Fellow, Emory University
ClinicalTrials.gov Identifier: NCT03274245     History of Changes
Other Study ID Numbers: IRB00098293
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bethany Caruso, Emory University:
Public Health