The effects of improved sanitation on diarrheal prevalence, incidence, and duration in children under five in the SNNPR State, Ethiopia: study protocol for a randomized controlled trial

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Abstract
Diarrhea is one of the leading causes of death, killing 1.3 million in 2013 across the globe, of whom, 0.59 million were children under 5 years of age. Globally, about 1 billion people practice open defecation, and an estimated 2.4 billion people were living without improved sanitation facilities in 2015. Much of the previous research investigating the effect of improved sanitation has been based on observational studies. Recent studies have executed a cluster-randomized controlled trial to investigate the effect of improved sanitation. However, none of these recent studies achieved a sufficient level of latrine coverage. Without universal or at least a sufficient level of latrine coverage, a determination of the effect of improved latrines on the prevention of diarrheal disease is difficult. This cluster-randomized trial aims to explore the net effect of improved latrines on diarrheal prevalence and incidence in children under five and to investigate the effect on the diarrheal duration. A phase-in and factorial design will be used for the study. The intervention for improving latrines will be implemented in an intervention arm during the first phase, and the comparable intervention will be performed in the control arm during the second phase. During the second phase, a water pipe will be connected to the gotts (villages) in the intervention arm. After the second phase is completed, the control group will undergo the intervention of receiving a water pipe connection. For diarrheal prevalence, five rounds of surveying will be conducted at the household level. The first four rounds will be carried out in the first phase to explore the effect of improved latrines, and the last one, in the second phase to examine the combined effects of improved water and sanitation. For documentation of diarrheal incidence and duration, the mother or caregiver will record the diarrheal episodes of her youngest child on the “Sanitation Calendar” every day. Of 212 gotts in the project area, 48 gotts were selected for the trial, and 1200 households with a child under 5 will be registered for the intervention or control arm. Informed consent from 1200 households will be obtained from the mother or caregiver in written form. To our knowledge, this is the second study to assess the effects of improved latrines on child diarrheal reduction through the application of Community-Led Total Sanitation. Current Controlled Trials, ISRCTN82492848

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