Plain English Summary
Background and study aims
Soil-transmitted helminths (STH), including hookworm, roundworm and whipworms, are common intestinal infections in Kenya. Global estimates indicate that more than 1.4 billion people are infected with at least one STH species. They cause anaemia, gastro-intestinal problems, tiredness amongst other symptoms. The most affected and at-risk populations are school children and these infections impede their physical growth and cognitive development, contributing significantly to school absenteeism. The current control strategy recommended by the World Health Organization (WHO) is yearly treatment of children with a single-dose treatment of albendazole. However, after treatment, reinfection can occur if the environment remains contaminated with infective eggs/larvae. In this research, we want to learn more about new ways to detect eggs/larvae in stool.
Who can participate?
Children attending classes 1-6 who are aged 5-15 years will be randomly selected to participate. In total we will recruit 1,354 school children.
What does the study involve?
We will take a small stool sample from the study participants to find out whether they are infected with worms or not. We will also provide a questionnaire to learn about the households of the participants, deworming medication used and the availability and use of safe water and sanitation. We will also map participant’s houses in order to help locate the household during follow-up visits.
What are the possible benefits and risks of participating?
All infected individuals will receive deworming treatment recommended by the ministry of Health. Participants may be uncomfortable providing stool samples for worm screening.
Where is the study run from?
Kenya Medical Research Institute
When is the study starting and how long is it expected to run for?
May 2020 to April 2021
Who is funding the study?
European Union Horizon 2020
Who is the main contact?
Dr. Stella Kepha, stellakepha2005@yahoo.com
Trial website
Contact information
Type
Public
Primary contact
Dr Stella Kepha
ORCID ID
http://orcid.org/0000-0003-4035-6485
Contact details
29551
Nairobi
00100
Kenya
+254-20-2731192
stellakepha2005@yahoo.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
SERU/4002
Study information
Scientific title
Evaluation of the diagnostic performance of a mobile digital technology for the detection and quantification of soil-transmitted helminths among school children in Kenya
Acronym
Study hypothesis
The diagnostic performance of a modified version of KK technique which entails; visualization of the sample through (1) a mobile phone coupled to the ocular of the microscope and (2) a web-based telemicroscopy platform is as sensitive as conventional visual analysis using only optical microscopy, as it is done in conventional KK technique
Ethics approval
Approved 26/05/2020, Kenya Medical Research Institute, Scientific and Ethics Committee (P.O. Box 54840-00200, Nairobi, Kenya; +254 2722541; erc@kemri.org), ref: KEMRI/RESR/7/3/1
Study design
Observational cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Schools
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Helminth infection
Intervention
This study will be a school-based cross-sectional survey among school children (5-15 y) conducted to determine the prevalence of STH among this age group. This study will be conducted over 1 y.
In each school eligible children with signed informed consent [class/grade 1-6, age (5-15 y)] will be randomly selected and tested for the presence of STH.
To determine the performance of the SpotLab technology in assessing the treatment efficacy of albendazole, 250 STH positive children will provide 2 consecutive days stool sample before and 21 days after treatment.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Prevalence of soil transmitted infection based on the detection of STH eggs on a slide by using the Kato-Katz thick smear method at baseline and 21 days
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
26/05/2020
Overall trial end date
30/04/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Permanent resident of community (≥ 6 months)
2. School children aged 5-15 years
3. Provision of informed consent or informed consent from parent or legal guardian
4. Provision of assent by individuals (12-15)
Participant type
Healthy volunteer
Age group
Child
Gender
Both
Target number of participants
1,354
Participant exclusion criteria
Individuals unwilling to participate in the study
Recruitment start date
01/09/2020
Recruitment end date
04/04/2021
Locations
Countries of recruitment
Kenya
Trial participating centre
Kenya Medical Research Institute
Mbagathi Road
P.O. Box 54840
Kwale town
Nairobi
-
Kenya
Sponsor information
Organisation
Kenya Medical Research Institute
Sponsor details
Mbagathi Road
P.O. Box 54840
Nairobi
-
Kenya
+254-20-2722541
esacipac@kemri.org
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
European Union’s Horizon 2020 programme
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results will be presented at appropriate national and international scientific meetings and papers will be written and submitted to peer-reviewed scientific journals for publication.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.
Intention to publish date
01/08/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list