Plain English Summary
Background and study aims
Diarrhoeal disease and lack of access to safe water remain significant public health issues in developing countries. There is also growing concern about the potential for disease, including diarrhoeal infections, to be transmitted from livestock to humans. This project addresses the potential drinking-water contamination risks to human health in rural sub-Saharan Africa, where people and livestock often live in close proximity. Preliminary fieldwork will be carried out in rural Kenya, building on an ongoing study that is simultaneously recording human and livestock disease in ten villages. The fieldwork will test different techniques to identify contamination hazards from livestock, alongside water quality testing and recording of diarrhoea in children. These techniques will include checklists for recording signs of livestock hazards at water sources and around water stored in the home. The aim of this study is to look at how feasible it is to record hazards using these techniques and statistically assess whether we find greater water contamination and greater diarrhoea in children where there are more recorded hazards.
Who can participate?
Children aged 6-59 months old and their households.
What does the study involve?
Participants who agree to take part in the study are asked about how they store, treat and handle water in the home, as well as livestock-keeping, handwashing and sanitation arrangements. The study team makes observations of potential contamination hazards, both concerning water stored in the home and at water sources. The study team also takes samples of source water and of water stored in the home, testing these for microbial contamination. The team returns 12 weeks later, asking the same questions, taking the same water samples, and making the same observations. Participants are also asked about diarrhea in children 1 week and 13 weeks later as part of the ongoing study of human and livestock disease.
What are the possible benefits and risks of participating?
Where practical to do so, participants are provided with advice on steps that could be taken to reduce contamination risks affecting water sources such as wells or rainwater systems. There is potential for the study team to inadvertently contaminate stored water during sampling.
Where is the study run from?
Kenya Medical Research Institute (Kenya)
When is the study starting and how long is it expected to run for?
October 2016 to December 2018
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Dr James Wright
Trial website
Contact information
Type
Public
Primary contact
Dr James Wright
ORCID ID
http://orcid.org/0000-0002-8842-2181
Contact details
University of Southampton
Geography and Environment
Highfield
Southampton
SO17 1BJ
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MR/P024920/1
Study information
Scientific title
A longitudinal study of child diarrhoea and stored water contamination in rural Kenyan households in relation to livestock management and ownership
Acronym
OneHealthWater
Study hypothesis
Livestock management and ownership affects faecal contamination of household stored water and thereby diarrhoea in children.
Ethics approval
1. Kenya Medical Research Institute Scientific and Ethics Review Unit, 17/10/2017, ref: KEMRI/SERU/CGHR/091/3493
2. Ethics Committe of the Faculty of Social, Human and Mathematical Sciences, University of Southampton, 20/07/2017, ref: 25247
Study design
Prospective observational longitudinal study at a single centre, Siaya County, Kenya, with two sets of observations taking place in wet and dry seasons in a six month period
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Community
Trial type
Prevention
Patient information sheet
See additional files
Condition
Self-reported diarrhoeal disease
Intervention
Participants who give their informed consent to participate in the study are asked via questionnaire interview about how they store, treat and handle water in the home, as well as livestock-keeping, handwashing and sanitation arrangements. Recording observations and questionnaire responses via cell phone data entry, the study team makes observations of potential contamination hazards, both concerning water stored in the home and at water sources. The study team also takes samples of source water and of water stored in the home, testing these for two faecal indicator bacteria groups, E. coli and intestinal enterococci. The team then returns 12 weeks after baseline to administer the same questionnaire, taking the same water samples and testing these for faecal indicator bacteria, and making the same observations. Participants are also asked via questionnaire interview about diarrhea in children 1 week and 13 weeks after baseline, via their participation in the ongoing linked human and animal disease syndromic (PBASS) study. The total duration of observation is thus 13 weeks with 12 weeks of follow-up, thereby observing conditions in both wet and dry season.
Intervention type
Other
Phase
Drug names
Primary outcome measure
E. coli and intestinal enterococci in household stored water are measured respectively through membrane filtration (0.45μm pore size) and culture with chromogenic coliform agar medium (incubation period: 24 hours) and m-Enterococcus agar medium (incubation period: 48 hours), followed by enumeration of both target organisms at baseline and 12 weeks thereafter.
Secondary outcome measures
Self-reported diarrhea (defined as ≥3 loose stools within a 24-hour period) is measured using questionnaire interview to household members at 1 week and 13 weeks.
Overall trial start date
01/10/2016
Overall trial end date
14/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children aged 6-59 months (as the cohort at greatest risk of diarrhoeal disease) in households
2. Participating in an ongoing population-based animal syndromic surveillance (PBASS) study
Participant type
Healthy volunteer
Age group
Child
Gender
Both
Target number of participants
200
Participant exclusion criteria
Child's carer/parent unavailable or unable to provide informed consent
Recruitment start date
13/02/2018
Recruitment end date
29/03/2018
Locations
Countries of recruitment
Kenya
Trial participating centre
Kenya Medical Research Institute
Kisumu
PO Box 1578-40100
Kenya
Sponsor information
Organisation
University of Southampton
Sponsor details
Research Governance Office
Building 37
Highfield
Southampton
SO17 1BJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Medical Research Council
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Funder name
Department for International Development
Alternative name(s)
Department for International Development, UK, DFID
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal with an approximate planned publication date of 01/10/2019. We do not plan to make our study protocol available.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository at http://doi.org/10.5255/UKDA-SN-854302.
Intention to publish date
14/12/2019
Participant level data
Stored in repository
Basic results (scientific)
See additional file ISRCTN69058168_BasicResults_07Jun2020 (added 11/06/2020)
Publication list
Publication citations
Additional files
- ISRCTN69058168_ParticipantInformationSheet_v1.5_14Dec17.pdf Uploaded 09/08/2018
- ISRCTN69058168_ConsentForm_v1.5_14Dec17.pdf Uploaded 09/08/2018
- ISRCTN69058168_BasicResults_07Jun2020.pdf Uploaded (11/06/2020)