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

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.