Condition category
Infections and Infestations
Date applied
22/01/2015
Date assigned
13/03/2015
Last edited
04/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Korea International Cooperation Agency

Sponsor details

825 Daewangpangyo-ro
Sejeong-gu
Seongman-si
Gyeonggi-do
461-833
Korea
South

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27089872

Publication citations

Additional files

Editorial Notes

04/05/2016: Publication reference added.