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

Abstract

Background: Despite health benefits of sanitation, an estimated 12% of the global population practices open defecation, including an estimated 50% of the population of India. Current estimates, however, do not include households that own toilets but do not use them, suggesting that the actual number of people defecating in the open is underestimated. This protocol describes a cluster randomized controlled trial to evaluate an intervention specifically designed to increase latrine use, including the safe disposal of child feces, in rural Odisha, India.

Methods: The trial engages 66 villages in Puri district, 33 randomly allocated to receive the intervention and 33 to serve as controls. The primary outcome is latrine use and is recorded at baseline and endline for all members of all households that own latrines in all trial vilalges. Additional data on determinants of latrine use and safe child feces disposal are also collected to assess change based on the intervetntion. A process evaluation assesses the delivery of the intervention and qualiative research takes place in non-trial villages as well as post-endline in trial villages to help explain trial findings.

Discussion: This is one of four trials taking place simultaneously in rural India with latrine use as the primary outcome. All four studies use the same outcome to gerenate comparable data across sites that can serve the government of India. The trial in Odisha is unique in that it collects latrine use data from all potential users in all households that own latrines, enabling a thorough view of the sanitation situation and factors that influence use at the community level. That latrine use is collected via self-report is a limitation, however any bias in reporting should be the same across villages and not impact the overall assessment of intervention impact.

Trial registration: This trial is registered at clinicaltrials.gov: NCT03274245 .

Keywords: Behavior change; Motivations; Multi-level intervention; Open defecation; Risk perceptions; Sanitation; Social norms; Theory-based intervention; Toilet.

Conflict of interest statement

Ethics approval and consent to participate

Study protocols have been reviewed and approved by the Institutional Review Board at Emory University in Atlanta Georgia (00098293) and the Ethics Review Committee at Xavier Institute of Management in Bhubaneswar, Odisha, India. Relevant changes to the study protocol will be approved by the Institutional Review Board before changes are made in the field. Prior to quantitative and/or qualitative data collection, all participants will be read a consent document by trained research assistants in Odia, the local language, that describes the study and objectives. Research assistants will then ask for the participants’ verbal consent before continuing with data collection. The use of verbal consent (over written) was approved by the Institutional Review Board. Verbal consent was approved as not all adults in the engaged communities are literate and may feel vulnerable signing something they are not able to read. In some cases, women specifically may not be able to sign their name or may not feel they have the agency to sign something. Only members of the research team will have access to particpants names and identifying information.

Consent for publication

Not applicable.

Competing interests

One of the authors (BAC) serves as a member of the editorial board for BMC Public Health.

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Figures

Fig. 1

Flow Diagram for Cluster Randomised Trial to Assess Impact of Sundara Grama Intervention on Latrine Use in Rural Odisha, India