The impact of improved sanitation on the diarrhoeal reduction of under-five children in Ethiopia

• Register: ISRCTN
• Last refreshed on: 17 April 2023
• Main ID: ISRCTN82492848
• Date of registration: 13/03/2015
• Prospective Registration: Yes
• Primary sponsor: Korea International Cooperation Agency
• Public title: The impact of improved sanitation on the diarrhoeal reduction of under-five children in Ethiopia
• Scientific title: Effect of improved sanitation on diarrhoea incidence of under-five children in Grage zone, SNNPR state, Ethiopia using cluster randomized controlled trial
• Date of first enrolment: 17/10/2015
• Target sample size: 1200
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN82492848
• Study type: Interventional
• Study design: Intervention study using phased-in and factorial design: cluster randomized controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

Ethiopia, Korea, South

Contacts

• Name: Seungman Cha

Key inclusion & exclusion criteria

Inclusion criteria: Households with children aged under 5 years
Exclusion criteria: 1. Households without under-five children
2. Households rejecting registration
3. Households rejecting filling in informed consent form

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Diarrhoea
Infections and Infestations

Intervention(s)

The cluster randomized trial takes Gott as the randomization unit since it is expected to be a cluster in which improved sanitation and hygiene will bring impact on diarrhoea transmission across households. All the interventions will be applied on Gott-wide basis. Since the purpose of the intervention is to reduce diarrhea, Gott would be an appropriate dimension of transmission zone, where humans, vectors, and intermediate hosts are interacting and sharing a common pool of parasites. Of the 240 Gotts, 99 Gotts will be selected for project implementation of clean water supply, and hygiene and sanitation improvement by the selection criteria on the basis of the degree of needs. The 99 Gotts will be stratified by altitude, water and sanitation coverage, accessibility to the main road, and socioeconomic status. 48 Gotts will be selected for trial arms by restricted stratified randomization process. A baseline survey will be conducted in these 48 Gotts, of which 24 Gotts will be randomly assigned to intervention and the other 24 to control in the cluster randomized control trial design. For increasing the comparability of the groups in each arms, we will stratify 48 Gotts into blocks having similar underlying, pre-intervention, risks of diarrhoea and then randomize within each block.

For improved sanitation and hygiene, the project is to roll out only in the intervention arm for the first phase and then the control arm will receive the intervention after the first phase trial is completed. In addition, improved water will be supplied to the intervention arm for the second phase and the control will have access to improved water supply after the second phase trial is completed.

Primary Outcome(s)

Diarrhoeal incidence of under-five children (cases /child*weeks). We will conduct a household-based survey 9 times throughout the sanitation-project period, roughly 10 months, meaning that the household survey will be conducted every month. With regards to measuring the outcmes, diarrhoea will not be diagnosed by a laboratory-based test, instead it will be identified by mothers' or caretakers' self report on the basis of a strict definition developed by the WHO expert group. We will help mothers or caretakers record the incidence of diarrhoea on the spot by using a specially-devised calendar, rather than depending on their recall.

Secondary Outcome(s)

1. Uptake of improved latrine (%)
2. Utilization of improved latrine (%)

Secondary ID(s)

N/A

Source(s) of Monetary Support

Korea International Cooperation Agency

Ethics review

Status:
Approval date:
Contact:

Ethiopian federal government and the ministry of health of SNNPR state – approval pending

Results

• Results available: Yes
• Date Completed: 01/02/2016