Evaluation of the diagnostic performance of a mobile digital technology for the detection and quantification of soil-transmitted parasites among school children in Kenya

ISRCTN ISRCTN11195538
DOI https://doi.org/10.1186/ISRCTN11195538
Secondary identifying numbers SERU/4002
Submission date
15/07/2020
Registration date
22/07/2020
Last edited
19/04/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Study website

Contact information

Dr Stella Kepha
Public

29551
Nairobi
00100
Kenya

ORCiD logoORCID ID 0000-0003-4035-6485
Phone +254-20-2731192
Email stellakepha2005@yahoo.com

Study information

Study designObservational cross-sectional study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)School
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluation of the diagnostic performance of a mobile digital technology for the detection and quantification of soil-transmitted helminths among school children in Kenya
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedHelminth infection
InterventionThis 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 typeOther
Primary outcome measurePrevalence 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 measuresThere are no secondary outcome measures
Overall study start date26/05/2020
Completion date30/04/2021

Eligibility

Participant type(s)Healthy volunteer
Age groupChild
Lower age limit5 Years
Upper age limit15 Years
SexBoth
Target number of participants1,354
Total final enrolment1343
Key inclusion criteria1. 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)
Key exclusion criteriaIndividuals unwilling to participate in the study
Date of first enrolment01/09/2020
Date of final enrolment04/04/2021

Locations

Countries of recruitment

  • Kenya

Study participating centre

Kenya Medical Research Institute
Mbagathi Road
P.O. Box 54840
Kwale town
Nairobi
-
Kenya

Sponsor information

Kenya Medical Research Institute
Research organisation

Mbagathi Road
P.O. Box 54840
Nairobi
-
Kenya

Phone +254-20-2722541
Email esacipac@kemri.org
Website http://kemri.org
ROR logo "ROR" https://ror.org/04r1cxt79

Funders

Funder type

Government

European Union’s Horizon 2020 programme

No information available

Results and Publications

Intention to publish date01/08/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThe 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 planThe current data sharing plans for this study are unknown and will be available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 19/04/2022 19/04/2022 No No
Other publications Training of AI system 07/09/2021 19/04/2022 Yes No

Additional files

ISRCTN11195538_BasicResults_19Apr2022.pdf

Editorial Notes

19/04/2022: The following changes have been made:
1. A basic results summary has been uploaded.
2. The final enrolment number has been added from the results summary.
3. Publication reference added.
16/07/2020: Trial’s existence confirmed by Kenya Medical Research Institute