A Stepped Wedge Cluster-Randomized Trial Assessing the Impact of a Riverbank Filtration Intervention to Improve Access to Safe Water on Health in Rural India.

Sustainable and low-cost methods for delivery of safe drinking water in resource-limited settings remain suboptimal, which contributes to global diarrhea morbidity. We aimed to assess whether delivery of riverbank filtration-treated water to newly installed water storage tanks (improved quality and access, intervention condition) reduced reported diarrhea in comparison to delivery of unfiltered river water (improved access alone, control condition) in rural Indian villages. We used a stepped wedge cluster-randomized trial (SW-CRT) design involving four clusters (villages). Selection criteria included village size, proximity to a river, and lack of existing or planned community-level safe water sources. All adults and children were eligible for enrollment. All villages started in the control condition and were sequentially randomized to receive the intervention at 3-month intervals. Our primary outcome was 7-day-period prevalence of self- or caregiver-reported diarrhea, measured at 3-month intervals (five time points). Analysis was by intention to treat. Because blinding was not possible, we incorporated questions about symptoms unrelated to water consumption to check response validity (negative control symptoms). We measured outcomes in 2,222 households (9,836 participants). We did not find a measurable reduction in diarrhea post-intervention (RR: 0.98 [95% CI: 0.24-4.09]); possible explanations include low intervention uptake, availability of other safe water sources, low baseline diarrheal prevalence, and reporting fatigue. Our study highlights both the difficulties in evaluating the impact of real-world interventions and the potential for an optimized SW-CRT design to address budgetary, funding, and logistical constraints inherent in such evaluations.