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Evaluation of an AI-DP for STH Deworming Programs: a Study Protocol

NCT06055530 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1100

Last updated 2023-10-02

No results posted yet for this study

Summary

The goal of this observational study is to test a new AI diagnostic tool for detection, specification and quantification of parasitic infections (Ascaris, Trichuris, hookworm and S. Mansoni) in School aged children in Ethiopia and Uganda. The main questions it aims to answer are:

* Diagnostic Performance of the AI tool and compare to traditional manual microscopy
* Repeatability and reproducibility of the AI tool and compare to traditional manual microscopy
* Time-to-result for the AI tool
* Cost efficiency for the AI tool and traditional manual microscopy to inform programmatic decisions.
* Usability of the AI tool

Participants will be asked to provide a stool sample for examination by the AI tool and traditional manual microscopy. Participants with a positive test result will receive the proper treatment (Deworming drug).

Conditions

  • Soil Transmitted Helminths
  • Schistosomiasis Mansoni

Interventions

DIAGNOSTIC_TEST

Artificial Intelligence Digital Pathology

School aged children will be asked to leave a stool sample. The samples will be prepared with the Kato-Katz method and scanned and processed by an artificial intelligence digital pathology system to determine the infection level of soil transmitted helminths and schistosomiasis. The samples will also be analyzed by a human microscopist for comparison.

Sponsors & Collaborators

  • Jimma University

    collaborator OTHER

  • Ministry of Health, Uganda

    collaborator OTHER_GOV

  • University Ghent

    collaborator OTHER

  • Enaiblers AB

    lead INDUSTRY

Principal Investigators

  • Bruno Levecke, PhD · University Ghent

  • Zeleke Mekonnen, PhD · Jimma University

  • Narcis Kabatereine, PhD · Ministry of Health, Uganda

Eligibility

Min Age
5 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2023-12-31
Completion
2024-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06055530 on ClinicalTrials.gov