Evaluation of an AI-DP for STH Deworming Programs: a Study Protocol (NCT06055530) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of an AI-DP for STH Deworming Programs: a Study Protocol
1,100 participantsStarted 2023-10
Plain-language 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).
Who can participate
Age range
5 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject, male or female, is 5-14 years of age
* Parent(s)/guardian(s) of subject signed an informed consent document indicating that they understand the purpose and procedures required for the study and that they are willing to have their child participate in the study
* Subject of ≥6 (Ethiopia) /8 (Uganda) years old has assented to participate in the study\*
* Subject of ≥12 years old has signed an informed consent document indicating that they understand the purpose of the study and procedures required for the study, and are willing to participate in the study (Ethiopia only)\*
* Subject has provided a stool sample of minimum 5 grams
Exclusion Criteria:
* Subject has active diarrhoea (defined as the passage of 3 or more loose or liquid stools per day) at baseline or follow-up.
* Subject is experiencing a severe concurrent medical condition or has an acute medical condition
* Subject has received anthelmintic treatment within 90 days prior to the start of the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.