Condition category
Infections and Infestations
Date applied
24/01/2020
Date assigned
27/02/2020
Last edited
29/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diarrhoea is a major killer of children aged under five, remaining the fourth-leading cause of disability-adjusted life-years (DALYs) among children in 2017. Sanitation coverage is still exceedingly below target and lack of sanitation causes a large disease burden in many developing countries. Community-led total sanitation (CLTS) approaches started in 2000. CLTS interventions have been implemented in more than 60 countries and adopted as sanitation policy in more than 30 countries. However, as few studies have investigated the effect of CLTS on reducing diarrhoea in children under five, we do not know how much benefit CLTS would bring, especially for reducing child morbidity and mortality. 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 CLTS on diarrhoea in children under five.

Who can participate?
Caregivers with a child(ren) aged under 5 years

What does the study involve?
Community-led total sanitation (CLTS) would take place in the intervention community. Participating caregivers would be required to keep a diary record of diarrhea in their child(ren) aged under 5 years over the 6 month study period.

What are the possible benefits and risks of participating?
No material or financial subsidies will be provided to participants. However, we expect that the participants will gain health and economic benefits such as a reduction in diarrhea, saving on health care expenses and etc. To our understanding, there is no risk of participating in CLTS activities.

Where is the study run from?
The UNICEF Kenya Country office, the UNICEF Turkana office and the KOICA Kenya office (Kenya)

When is the study starting and how long is it expected to run for?
August 2019 to December 2021

Who is funding the study?
Korea International Cooperation Agency, KOICA (South Korea)

Who is the main contact?
Prof Seungman Cha
seungman.cha@handong.edu

Trial website

Contact information

Type

Scientific

Primary contact

Prof Seungman Cha

ORCID ID

http://orcid.org/0000-0003-1264-3313

Contact details

Department of Global Development and Entrepreneurship
Graduate School of Global Development and Entrepreneurship
Handong Global University
Pohang
37554
Korea
South
+82 1039593286
seungman.cha@handong.edu

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

N/A

Study information

Scientific title

Effects of community-led total sanitation on the diarrhoeal incidence and prevalence in children under five in rural areas of Kenya

Acronym

Study hypothesis

Community-led total sanitation will reduce the diarrhoeal incidence of under-five children in Turkana county of Kenya by 29%

Ethics approval

Approved 18/05/2020, KEMRI Scientific and Ethics Review Unit (SERU) (Kenya Medical Research Institute, PO Box 54840-00200, Nairobi, Kenya; +254 2722541; info@kemri.org), ref: KEMRI/RES/7/3/1

Study design

Cluster-randomized controlled 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 the contact details below to request a participant information sheet

Condition

Diarrhoea

Intervention

The cluster-randomized trial takes the community as the randomization unit since it is expected to be a cluster in which improved sanitation will bring impact on diarrhea transmission across households. All the interventions will be applied on a community-wide basis. Since the purpose of the intervention is to reduce diarrhea, the community 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 1950 communities, 720 communities 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 720 communities will be stratified by water and sanitation coverage, accessibility to the main road, and socioeconomic status.

Of the 720 communities, 60 will be selected for trial arms. These 60 communities will be stratified into blocks having similar underlying, pre-intervention, risks of diarrhea. Then they will be randomized within each block by a restricted, stratified randomization process such that 30 comparable communities will each be randomly assigned to either the intervention arm or the control arm.

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.

A baseline survey will be conducted in the 60 participating communities at enrolment and at the end of the first phase to assess child diarrhoeal incidence and longitudinal prevalence and latrine coverage.

The participating households will be required to take up household latrines using locally available and affordable materials in intervention arms. The households in control arms will not be involved in any activities for the first phase; however, they will be required to take up household latrines during the second phase of the trial.

Participating caregivers would be required to keep a daily diary record of diarrhea incidence in their child(ren) aged under 5 years over the study period.

The total duration of the study and follow-up for all study arms is 12 months

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Child diarrheal incidence and longitudinal prevalence measured by diary methods on the daily diarrheal incidence of the youngest under-five child in intervention and control villages at baseline and at every single day of 6 months of follow-up

Secondary outcome measures

Latrine coverage measured by direct observation on latrine presence at the household level in intervention and control villages at baseline and at 1, 2, 3, 4, 5, and 6 months of follow-up

Overall trial start date

25/08/2019

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Households with a child(ren) aged under 5 years

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

Caregivers of 900 households with at least one under-five child in 60 communities

Participant exclusion criteria

1. Households who reject the registration
2. Households who do not provide informed consent

Recruitment start date

01/03/2020

Recruitment end date

15/03/2020

Locations

Countries of recruitment

Kenya

Trial participating centre

UNICEF Turkana office
Lodwar Turkana County
Lodwar
N/A
Kenya

Sponsor information

Organisation

Korea International Cooperation Agency

Sponsor details

825 Daewangpangyo-ro
Sujeong-gu
Seongnam-si
13449
Korea
South
+82 31-7400-114
yjanne1020@koica.go.kr

Sponsor type

Government

Website

http://www.koica.go.kr/english/main.html

Funders

Funder type

Government

Funder name

Korea International Cooperation Agency

Alternative name(s)

KOICA

Funding Body Type

unknown

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD Sharing statement:
The data-sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/07/2020: The ethics approval was added. 07/02/2020: Trial’s existence confirmed by the Korea International Cooperation Agency.