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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | SERU/4002 |
| Sponsor | Kenya Medical Research Institute |
| Funder | European Union’s Horizon 2020 programme |
- 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
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
Contact information
Public
29551
Nairobi
00100
Kenya
 ORCID ID |
0000-0003-4035-6485 |
|---|---|
| Phone | +254-20-2731192 |
| stellakepha2005@yahoo.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross-sectional study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 30/04/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 15 Years |
| Sex | All |
| Target sample size at registration | 1354 |
| Total final enrolment | 1343 |
| Key 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) |
| Key exclusion criteria | Individuals unwilling to participate in the study |
| Date of first enrolment | 01/09/2020 |
| Date of final enrolment | 04/04/2021 |
Locations
Countries of recruitment
- Kenya
Study participating centre
P.O. Box 54840
Kwale town
Nairobi
-
Kenya
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN11195538_BasicResults_19Apr2022.pdf
- Basic results
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
