Evaluating a Latrine Use Intervention in Odisha, India

July 16, 2019 updated by: Bethany Caruso, Emory University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11722

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Odisha
      • Bhubaneswar, Odisha, India
        • Xavier Institute of Management

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Post-Intervention (Up to 1 Year)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Post-Intervention (Up to 1 Year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bethany Caruso, PhD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 18, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00098293

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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