NCT03274245

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,722

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

September 5, 2017

Last Update Submit

July 16, 2019

Conditions

Keywords

Public Health

Outcome Measures

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.

    Baseline, Post-Intervention (Up to 1 Year)

Secondary Outcomes (1)

  • Change in Number of Toilets

    Baseline, Post-Intervention (Up to 1 Year)

Study Arms (3)

Latrine Use

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Men and women in villages randomized to the control group will not receive an intervention.

Qualitative Research Group

EXPERIMENTAL

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 PackageOther: Qualitative Research

Interventions

* 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.

Latrine UseQualitative Research Group

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.

Qualitative Research Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xavier Institute of Management

Bhubaneswar, Odisha, India

Location

Related Publications (2)

  • 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.

  • 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.

Study Officials

  • Bethany Caruso, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Doctoral Fellow

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 6, 2017

Study Start

January 30, 2018

Primary Completion

February 18, 2019

Study Completion

April 13, 2019

Last Updated

July 18, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations