Plain English Summary
Background and study aims
Diarrhoea is a major killer of children aged under five, accounting for 11% of child deaths in 2013. Sanitation coverage is still exceedingly below target and lack of sanitation causes a large disease burden in many developing countries. However, as few studies have investigated the effect of improved sanitation on reducing diarrhoea in children under five, we do not know how much benefit improved sanitation would bring, especially for reducing child deaths. More evidence is required for appropriate resource allocation and also for formulating evidence-based health policy. We aim to find evidence of the impact of improved sanitation on diarrhoea in children under five.
Who can participate?
Households with children aged under five in Gurage zone, SNNPR satte of Ethiopia.
What does the study involve?
A survey will be conducted in 48 Gotts (groups of households), of which 24 Gotts will be randomly allocated to the intervention group and the other 24 to the control group. During the first phase of the study the intervention group will receive improved sanitation and hygiene, and the control group will receive the improvements after the first phase is completed. For the second phase of the study the intervention group will have access to an improved water supply, and the control group will have access to the improved water supply after the second phase is completed.
What are the possible benefits and risks of participating?
No financial subsidies will be provided but we expect the participants will less likely to contract diarrhoea and it will eventually also benefit their neighbours. After the study is over, the water supply will be connected to all the Gotts, both for the intervention group and the control group.
Where is the study run from?
Enemor Ena district and Cheha district, Gurage zone, Ethiopia
When is the study starting and how long is it expected to run for?
February 2015 to February 2016
Who is funding the study?
Korea International Cooperation Agency
Who is the main contact?
Dr Seungman Cha
webmaster@koica.go.kr
Trial website
Contact information
Type
Scientific
Primary contact
Dr Seungman Cha
ORCID ID
Contact details
Siheungsi Siheungdaero 73-gil 11
Seoul
153-762
Korea
South
+82 (0)10 3959 3286
webmaster@koica.go.kr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of improved sanitation on diarrhoea incidence of under-five children in Grage zone, SNNPR state, Ethiopia using cluster randomized controlled trial
Acronym
Study hypothesis
Improved sanitation will reduce the diarrhoeal incidence of under-five children in Gurage zone, SNNPR satte of Ethiopia by 50%.
Ethics approval
Ethiopian federal government and the ministry of health of SNNPR state – approval pending
Study design
Intervention study using phased-in and factorial design: cluster randomized controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
Condition
Diarrhoea
Intervention
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.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
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 measures
1. Uptake of improved latrine (%)
2. Utilization of improved latrine (%)
Overall trial start date
01/02/2015
Overall trial end date
01/02/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Households with children aged under 5 years
Participant type
Other
Age group
Child
Gender
Both
Target number of participants
1200 households; all the children in the 1200 households
Participant exclusion criteria
1. Households without under-five children
2. Households rejecting registration
3. Households rejecting filling in informed consent form
Recruitment start date
15/01/2015
Recruitment end date
31/12/2015
Locations
Countries of recruitment
Ethiopia
Trial participating centre
Enemor Ena district and Cheha district, Gurage zone, Ethiopia
-
Ethiopia
Trial participating centre
KOICA
825 Daewangpangyo-ro
Sujeong-gu
Seongnam-si Gyoungi-do
Seoungnam si
461-833
Korea, South
Funders
Funder type
Government
Funder name
Korea International Cooperation Agency
Alternative name(s)
KOICA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Korea, South
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27089872