Abstract
We conducted a cluster-randomized trial in 48 rural villages of Ethiopia to assess the effect of community-led total sanitation (CLTS) on the diarrhea incidence of children. Twenty-four villages were randomly assigned to the intervention group and the other 24 were assigned to the control group. A CLTS intervention was implemented from January 2016 through January 2017. Baseline data collection was conducted during October and November 2015. At baseline, 906 children were recruited and followed-up until January 2017. These 906 children were randomly selected among all children in the 48 villages. To determine the 7-day period prevalence of diarrhea, four household-based surveys were conducted by independent data collectors at 3, 5, 9, and 10 months after the CLTS was initiated. To determine the incidence and longitudinal prevalence, the presence of daily diarrhea presence was recorded for 140 days using diary methods. The loss to follow-up rates were 95% for period prevalence and 93% for incidence and longitudinal prevalence. The incidence ratio and longitudinal prevalence ratio were 0.66 (95% confidence interval [CI], 0.45-0.97; P = 0.03) and 0.70 (95% CI, 0.52-0.95; P = 0.02) after adjusting for clustering and stratification. The relative risk of period prevalence was 0.66 (95% CI, 0.45-0.98; P = 0.04) at 3 months after initiation. Improved toilet coverage increased from 0.0% at baseline to 35.0% at 10 months in the intervention villages, whereas it increased from 0.7% to 2.8% in the control villages. Adherence to the intervention was comparable with that of previous studies; therefore, we suggest that the findings of this study are replicable.