Condition category
Digestive System
Date applied
21/02/2015
Date assigned
13/03/2015
Last edited
07/09/2016
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 under five, accounting for 11% of child death in 2013. Human waste and poor sanitation is also associated with worm infections, trachoma (a bacterial eye infection ), lymphatic filariasis (a parasitic infection that leads to elephantiasis) and schistosomiasis. However, without a significant acceleration in progress, the Millennium Development Goals (MDG) target on sanitation coverage is unlikely to be met. Current trends show that the total number of people without access to improved sanitation will still be around 2.4 billion. In this study, we want to find evidence for the impact of improved sanitation on diarrhoea for children under the age of five. This study will play a central role in speeding up a reduction in diarrhoea-specific disease and death amongst children across the globe by demonstrating clear evidence of effectiveness of improved sanitation with rigorous methodology.

Who can participate?
Households with at least one child under five and living in a study area.

What does the study involve?
Villages recruited to this study are divided into a number of “quartiers”, or divisions. Each quartier is randomly allocated into one of two groups, the intervention group or the control group. A sanitation campaign is delivered to the people living in one of the intervention groups. The aim of this campaign is to increase the availability of latrines (a deep hole that is used as a toilet) using Community-led total sanitation (CLTS) principles, where communities are encouraged to take steps to stop open defecation. Boreholes are drilled in all communities in either group. During this study, people in the intervention group are activity encouraged to use the improved latrine facilities voluntarily. As the principle of CLTS are being applied to this project, details latrine design and materials are developed by the community people themselves. Assessments include the incidence of diarrhoea in the under fives, improvements in latrine facilities and improvements in the number of people using the latrines.

What are the possible benefits and risks of participating?
No financial subsidies will be provided since the principle of Community Led Total Sanitation should be strictly complied with. We, however, expect the participants will less likely to contract diarrhoea and it will eventually benefit their neighbours also. After the trial is over, water facilities will be connected for all in the community both for intervention group and control group.

Where is the study run from?
Idiofa health office, Bandundu province (Democratic Republic of Congo)

When is the study starting and how long is it expected to run for?
December 2014 to December 2015

Who is funding the study?
Korea International Cooperation Agency

Who is the main contact?
Dr Seungman Cha
jesusdongja@hanmail.net

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
82-10-3959-3286
jesusdongja@hanmail.net

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 Idiofa territory, Bandundu province, DR Congo using cluster randomized controlled trial

Acronym

Study hypothesis

Improved sanitation will reduce the diarrhoeal incidence of under-five children in Idiofa territory, Bandundu province, DR Congo by 50%.

Ethics approval

Not provided at time of registration

Study design

Intervention study using phased-in and factorial design: cluster randomized control trial.

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

The coverage of improved sanitation is exceedingly low in many rural area of DR Congo although diarrhoea is the main killer of children under five.

Intervention

For intervention arms, sanitation compaign will be conducted for increasing latrine coverage using CLTS principle and boreholdes will be drilled in the communities of both arms. Drilling boreholes will be undertaken in the second phase of the project.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Diarrhoeal incidence of under-five children (cases /child*weeks)

Secondary outcome measures

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

Overall trial start date

15/12/2014

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Household with children under five years

Participant type

All

Age group

Child

Gender

Both

Target number of participants

720 households; all the children in the 720 households

Participant exclusion criteria

1. Households rejecting registration
2. Households rejecting filling in informed consent form

Recruitment start date

15/12/2014

Recruitment end date

15/12/2015

Locations

Countries of recruitment

Congo, Democratic Republic

Trial participating centre

Idiofa health office
Bandundu province
-
Congo, Democratic Republic

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

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes