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CompletedNCT03274245Updated Jul 18, 2019

Evaluating a Latrine Use Intervention in Odisha, India

An interventional study of Intervention Package and Qualitative Research in Latrine Usage, sponsored by Emory University. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-18.

Sponsored by Emory University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
11,722
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Latrine Usage

Keywords

  • Public Health
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Villages located in rural Puri district, Odisha India

Inclusion criteria

Inclusion Criteria:

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
11,722 participants (actual)

Study arms

  • 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

  • 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 · Other: Qualitative Research

Interventions

  • BehavioralIntervention 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.

  • OtherQualitative 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.

05

What researchers measure

Primary outcomes

  1. Change in Latrine Usage Rate

    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.

    Time frame: Baseline, Post-Intervention (Up to 1 Year)

Secondary outcomes

  1. Change in Number of Toilets

    The number of toilets in the community/village will be collected at baseline and post-intervention.

    Time frame: Baseline, Post-Intervention (Up to 1 Year)

06

Study locations

1 site
  • Xavier Institute of Management
    Bhubaneswar, Odisha, India
07

References and documents

Publications

  • Caruso BA, Sclar GD, Routray P, Nagel CL, Majorin F, Sola S, Koehne WJ 3rd, Clasen T. Effect of a low-cost, behaviour-change intervention on latrine use and safe disposal of child faeces in rural Odisha, India: a cluster-randomised controlled trial. Lancet Planet Health. 2022 Feb;6(2):e110-e121. doi: 10.1016/S2542-5196(21)00324-7. PubMed 35150621 ↗
  • Caruso BA, Sclar GD, Routray P, Majorin F, Nagel C, Clasen T. A cluster-randomized multi-level intervention to increase latrine use and safe disposal of child feces in rural Odisha, India: the Sundara Grama research protocol. BMC Public Health. 2019 Mar 18;19(1):322. doi: 10.1186/s12889-019-6601-z. PubMed 30885158 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf

08

Registry details

Key details

Study ID
NCT03274245
Lead sponsor
Emory University
Responsible party
Bethany Caruso (Post Doctoral Fellow, Emory University) — Principal investigator
First posted
Sep 6, 2017
Start date
Jan 30, 2018
Primary completion
Feb 18, 2019
Completion
Apr 13, 2019
Last update
Jul 18, 2019

Study contacts

Bethany Caruso, PhD
principal investigator · Emory University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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