Hand Washing and WASH Educational Intervention in Reducing Incidence of Diarrhea Among Under-five Children in Eastern Ethiopia: A Community-based Cluster Randomized Controlled Trial

METHODS Ethics statement The study protocols have been reviewed and approved by the Jigjiga University ethical review committee. Study consent was obtained from district administration, district health office and community leaders. Control group received books and pens to support the children's education during the study period and health education after the completion of the study. Written consent was taken from the mothers of the children. During the study no one was harmed nor died of the disease.

Study Setting The current study was conducted in the rural areas of Jigjiga district of Ethiopian-Somali Regional State (ESRS) in the Eastern Ethiopia from February 1 to July 30, 2015. The ESRS is one of the nine regional states that constitute the Federal Democratic Republic of Ethiopia. Pastoralism is a way of life whereby the livelihood of the people depends on raising livestock and living on its milk and meat (23). Nearly 90% of the population in ESRS resides in rural areas, leading either a pastoralist or agro-pastoralist lifestyle. The majority of these pastoralists are nomadic and have a pattern of seasonal movement from place to place for cattle grazing. Jigjiga district is one of the 68 districts of the region, part of Fafan zone, with a total population of 277,560 according to 2007 census conducted by the central statiscal agency of Ethiopia of whom 149,292 are men and 128,268 women. A total of 34 Kebele is found in the district of which 4 are urban and 30 are rural Kebele in the district. Finally Jigjiga district was selected for the study because of its notable of high incidence of diarrhea disease and acute watery diarrhea epidemics as reported by the Regional Health Bureau.

Sample size determination The sample was calculated by using methods published by Hayes and Bennett (24) to determine the number of communities required to detect a between-group difference in diarrhea incidence density for the under five years old. Given recent studies conducted in Eastern Ethiopia indicated disease rates for incidence of child diarrhea among home based chlorine treatment intervention and non intervention group of 4.5 episodes/100 person week observations and 10.4 episodes/100 person week observations respectively (13), 80% power, 95% confidence interval, considering a coefficient of between-cluster variation (k) of 0.62, adjusting for loss of follow up of individual households, incomplete longitudinal data and 10% drop out and design effect of three from clustering. The final sample 24 communities was calculated (12 intervention and 12 controls) with 50 children of under-five in each cluster.

Study design and procedures The study subjects was divided into 2 study groups according to clusters of community that received hygiene education and hand washing with soap interventions and those control clusters that did not receive any interventions. Only rural community of the district were selected for the study. A household was considered eligible for the study if the following criteria are met: a) at least one child aged 0-59 months living in the home and b) non model health extension household. A household was excluded if the household graduated model health extension households. The 24 communities were allocated to the intervention and control arms by having a meeting with community leaders, Kebele heads and representative from the district health office.

Intervention