Condition category
Not Applicable
Date applied
10/02/2020
Date assigned
18/02/2020
Last edited
13/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
While child feces are likely a significant source of fecal exposure, the latest National Family Health Survey (2015-2016) reported only 36% of Indian households safely dispose of their child’s feces into a latrine, with the State of Odisha having the lowest rate at 13%. Emory University conducted an evaluation of a community-based water and sanitation infrastructure program, implemented by the Odisha-based NGO Gram Vikas, and found that while the program led to substantial increases in latrine coverage and use, the practice of safe disposal of child feces continued to be a challenge. Research is needed to better understand what works and what doesn’t when it comes to influencing caregivers to adopt safe child feces management (CFM) practices that can reduce household fecal exposure and ultimately improve health. The primary aim of this study is to evaluate a behavioral intervention aimed at increasing safe CFM practices among caregivers of children aged under 5. The key behaviors of interest are safe disposal of child feces into the household latrine and teaching young children how to use the latrine on their own so they establish the habit of latrine use rather than open defecation. Emory University and Gram Vikas joined together to collaborate on this study with Emory University as the research partner and Gram Vikas as the implementing partner.

Who can participate?
The study will be carried out in 74 rural villages in Ganjam and Gajapati districts that previously participated in Gram Vikas’s community-based water and sanitation infrastructure program (known as MANTRA). Eligible participants will be households that have a latrine and at least one child less than 5 years old. The study will focus on the CFM practices of the primary caregiver of the child but the intervention will target all caregivers of the child such as fathers and grandmothers.

What does the study involve?
The study involves both the design and evaluation of a novel CFM intervention with four key phases: baseline data collection, intervention design, intervention implementation, and endline data collection.
Baseline: a baseline survey will be carried out across the 74 trial villages before implementation of the CFM intervention. The primary respondent for the survey will be the primary caregiver of the child aged under 5. The survey will include questions about household demographics, household water and sanitation, CFM practices, RANAS behavioral factors, perceived stress, and perceived social support. The survey will also include a structured spot check of the household's water and sanitation facilities. A sub-set of households will be approached for hand-rinse and drinking water samples to assess household-level fecal contamination. Once baseline data collection is complete, the villages will be randomly allocated to the intervention or control group.
Intervention design: Emory and Gram Vikas will co-design the novel CFM intervention following the RANAS (Risks, Attitudes, Norms, Abilities, Self-Regulation) approach to behavior change, which utilizes results from the baseline data collection to identify the most important behavioral factors to address in the intervention activities. User-centered design will also be applied to develop hardware that aids caregivers in practicing safe disposal and latrine training.
Implementation: After the behavior change activities of the intervention are fully designed, Gram Vikas will implement across all intervention villages. During implementation, Gram Vikas will also distribute assistive CFM hardware, such as latrine training mats, that was previously developed in a formative research phase using a user-centered design approach. A process evaluation will also be carried out to document whether or not the intervention was implemented with fidelity.
Endline: Finally, endline data collection will take place across the 74 trial villages approximately 1 year after baseline. The endline survey will be similar to the baseline survey but with additional questions about the intervention activities, such as respondent attendance and satisfaction.

What are the possible benefits and risks of participating?
The researchers believe there are no risks to caregivers and households participating in the study. Possible benefits to participation may include a change in CFM practices with a subsequent reduction in household fecal contamination and improved health outcomes for household members. However, the researchers are not measuring health impacts in this study. Findings from this study may also help inform Gram Vikas’s future CFM programming in MANTRA villages.

Where is the study run from?
The study is based out of Gram Vikas’s Mohuda Campus in Berhampur, Odisha as it is located within a few hours’ drive of all enrolled study villages.

When is the study starting and how long is it expected to run for?
April 2019 to March 2021

Who is funding the study?
The Bill and Melinda Gates Foundation (USA)

Who is the main contact?
1. Prof. Thomas Clasen (PI)
tclasen@emory.edu
2. Gloria D. Sclar (Research Manager)
gloria.sclar@emory.edu

Trial website

Contact information

Type

Public

Primary contact

Ms Gloria Sclar

ORCID ID

http://orcid.org/0000-0002-5996-167X

Contact details

1518 Clifton Road
Atlanta
30322
United States of America
+1 (0)703 472 0522
gloria.sclar@emory.edu

Type

Scientific

Additional contact

Prof Thomas F. Clasen

ORCID ID

http://orcid.org/0000-0003-4062-5788

Contact details

Principal Investigator
CNR 2009
1518 Clifton Road
NE Atlanta
30322
United States of America
+1 (0)404 727 3480
TCLASEN@emory.edu

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Implementing and evaluating behavioral interventions on safe child feces management practices among rural villages in Ganjam and Gajapati districts, Odisha, India

Acronym

Study hypothesis

It is hypothesized that the practice of safe disposal of child feces among primary caregivers of children less than 5 years old residing in communities that received the intervention will be higher compared to primary caregivers of children less than 5 years old residing in communities that did not receive the intervention (i.e. control).

Ethics approval

1. Approved 21/10/2019, Emory University Institutional Review Board (Emory University Institutional Review Board, 1599 Clifton Road, 5th floor, Atlanta, GA 30322, USA; Tel: +1 (0)404 712 0720; Email: irb@emory.edu), ref: IRB00115339
2. Approved 22/05/2019, Xavier University Bhubaneswar's Independent Ethics Committee (Xavier Institute of Management, Xavier Square, Bhubaneswar – 751013, India; Tel: +91 (0)6747764880; Email: peppin@xub.edu.in), ref: 220519

Study design

Cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Child feces management behaviors of primary caregivers of children less than 5 years old

Intervention

A baseline survey will be carried out across the 74 trial villages prior to implementation of the CFM intervention. The primary respondent for the survey will be the primary caregiver of the child less than 5. The survey will include questions about household demographics, household water and sanitation, CFM practices, RANAS behavioral factors, perceived stress, and perceived social support. The survey will also include a structured spot check of the household's water and sanitation facilities. A sub-set of households will be approached for hand-rinse and drinking water samples to assess household-level fecal contamination. Once baseline data collection is complete, the villages will be assigned to intervention or control arm using stratified block randomization and no masking.

The treatment arm will receive a novel behavioral intervention designed using the Risks, Attitudes, Norms, Abilities, Self-Regulation (RANAS) approach to behavior change (Mosler, 2012) and will also receive assistive hardware, such as potties or latrine training mats, developed through a user-centered design approach. The behavioral intervention will primarily aim to motivate caregivers to safely dispose of their child's feces into the latrine and/or to teach their child how to use the latrine themselves. The behavioral intervention will be implemented by the NGO Gram Vikas in clusters (i.e. villages) allocated to the intervention arm. During implementation, a process evaluation will be carried out to document whether or not the intervention was implemented with fidelity.

The control arm will not receive the intervention.

*The behavioral intervention is currently being designed using the RANAS behavior change approach and as such, details of the exact intervention activities/components will be updated when complete.

Finally, an endline survey will be carried out across the 74 trial villages approximately 1 year after the baseline survey.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The safe disposal of child feces into the household latrine the last time the child defecated, which includes both the child using the latrine themselves or the caregiver disposing of the child’s feces into the latrine. This is a behavioral outcome that will be self-reported by the primary caregiver of the child less than 5 years old (or by a secondary caregiver if the primary caregiver is not available). The primary outcome will be measured between December 2019 to February 2020, prior to exposure to the intervention, and approximately 1 year later after this baseline measurement.

Secondary outcome measures

Measured between December 2019 to February 2020, prior to exposure to the intervention, and approximately 1 year later after this baseline measurement:
1. Child latrine training measured through self-report by the caregiver using a structured survey
2. Latrine use of children up to age 10 years old measured through self-report by the caregiver using a structured survey
3. RANAS behavioral factors measured through self-report by the caregiver using a structured survey
4. Perceived social support measured through self-report by the caregiver using a structured survey
5. Fecal contamination of the household environment, measured using different environmental sampling techniques such as hand-rinses and drinking water samples analyzed for levels of E. coli

Overall trial start date

01/04/2019

Overall trial end date

31/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Participant-level inclusion criteria:
1. Woman or man of at least 18 years of age
2. Primary caregiver of at least one child less than 5 years old (child age based on age at time of baseline recruitment). If primary caregiver is not available then a secondary caregiver of the child is also eligible for inclusion
2. Household has a latrine
N.B. The study will also engage a sub-set of children ages 0 to 5 years old from eligible households in a hand rinse sample. Participants less than 18 years old will not be engaged in any other research activities, however.

Village-level inclusion criteria:
1. Completed Gram Vikas MANTRA program (a community-based water and sanitation infrastructure program)
2. At least 75% of households in the village have access to a latrine
3. Community water supply system (i.e. water tank) is functional
4. Village size is between 35 to 250 households with at least 5 eligible households (i.e. have a latrine and at least one child less than 5 years old)
5. Village has an Anganwadi Center
6. Village was not engaged during formative research activities
7. Predominant language of village is Oriya
8. Gram Vikas has no significant programming planned for the village in 2020

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

Anticipate around 850 participants across 74 clusters with an average of about 11 participants per cluster. All households that meet the participant inclusion criteria will be approached for recruitment and thus, the exact number of participants enrolled in each cluster is not yet known.

Participant exclusion criteria

Participant exclusion criteria:
1. Less than 18 years old (except for the hand rinse sample which will engage children ages 0 to 5 years old)
2. Not a primary or secondary caregiver of a child less than 5 years old
3. Household does not have a latrine

Recruitment start date

02/12/2019

Recruitment end date

31/03/2021

Locations

Countries of recruitment

India

Trial participating centre

Gram Vikas
Mohuda Village
Brahmapur, Odisha
760002
India

Sponsor information

Organisation

Emory University

Sponsor details

1599 Clifton Road
Atlanta
30322
United States of America
+1 (0)404 727 2503
osp@emory.edu

Sponsor type

University/education

Website

https://www.sph.emory.edu/

Funders

Funder type

Charity

Funder name

Bill and Melinda Gates Foundation

Alternative name(s)

बिल एंड मिलिंडा गेट्स फाउंडेशन, Bill & Melinda Gates Foundation, Gates Foundation, 比尔及梅琳达·盖茨基金会, BMGF, B&MGF

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

United States of America

Results and Publications

Publication and dissemination plan

The researchers aim to submit a study protocol for publication. They anticipate reporting the trial results by August 2021, which will include results from a multivariate analysis showing whether or not intervention status was associated with a change in the primary outcome (safe disposal of child feces). They anticipate publishing the trial results in a peer-reviewed journal by end of 2021 and presenting the trial results at relevant conferences.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/08/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/03/2020: The recruitment end date has been changed from 29/02/2020 to 31/03/2021. 18/02/2020: Trial's existence confirmed by Emory University Institutional Review Board and Xavier University Bhubaneswar's Independent Ethics Committee.