The impact of improved sanitation on the diarrhoeal reduction of under-five children in Democratic Republic of Congo

ISRCTN ISRCTN10419317
DOI https://doi.org/10.1186/ISRCTN10419317
Secondary identifying numbers N/A
Submission date
21/02/2015
Registration date
13/03/2015
Last edited
20/09/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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. The aim of this study is 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. It is expected that the participants will be less likely to contract diarrhoea and it will eventually benefit their neighbours also. After the study is over, water facilities will be connected for all in the community both for the intervention group and the 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

Contact information

Dr Seungman Cha
Scientific

Siheungsi Siheungdaero 73-gil 11
Seoul
153-762
Korea, South

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

Study information

Study designIntervention study using phased-in and factorial design: cluster randomized control trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Community
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleEffect of improved sanitation on diarrhoea incidence of under-five children in Idiofa territory, Bandundu province, DR Congo using cluster randomized controlled trial
Study hypothesisImproved sanitation will reduce the diarrhoeal incidence of under-five children in Idiofa territory, Bandundu province, DR Congo by 50%.
Ethics approval(s)Not provided at time of registration
ConditionThe coverage of improved sanitation is exceedingly low in many rural area of DR Congo although diarrhoea is the main killer of children under five.
InterventionFor 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 typeBehavioural
Primary outcome measureDiarrhoeal incidence of under-five children (cases /child*weeks)
Secondary outcome measures1. Uptake of improved latrine (%)
2. Utilization of improved latrine (%)
Overall study start date15/12/2014
Overall study end date31/12/2015

Eligibility

Participant type(s)All
Age groupChild
Upper age limit5 Years
SexBoth
Target number of participants720 households; all the children in the 720 households
Participant inclusion criteriaHousehold with children under five years
Participant exclusion criteria1. Households rejecting registration
2. Households rejecting filling in informed consent form
Recruitment start date15/12/2014
Recruitment end date15/12/2015

Locations

Countries of recruitment

  • Congo, Democratic Republic

Study participating centre

Idiofa health office
Bandundu province
-
Congo, Democratic Republic

Sponsor information

Korea International Cooperation Agency
Government

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

ROR logo "ROR" https://ror.org/0106d7657

Funders

Funder type

Government

Korea International Cooperation Agency
Government organisation / National government
Alternative name(s)
KOICA
Location
Korea, South

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination plan
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 19/09/2017 Yes No

Editorial Notes

20/09/2017: Publication reference added.