CompletedNot Applicable

Performance of Tests for Schistosoma Haematobium Diagnosis

Tanzania801 participantsStarted 2025-02-10

Plain-language summary

Urogenital schistosomiasis caused by infection with the blood fluke Schistosoma haematobium is a debilitating disease. The World Health Organization (WHO) has set the goal to eliminate schistosomiasis as a public health problem globally by 2030 and to interrupt transmission in selected areas. Many years of control interventions and mass drug administration have reduced substantially the prevalence and infection intensities in several areas. In areas with an infection prevalence \<10%, the WHO suggests to continue population preventive chemotherapy with praziquantel at the same or reduced frequency, or to use a clinical approach of test-and-treat. In areas that have achieved interruption of transmission, elimination needs to be validated and post-elimination surveillance be implemented. For determination of infection prevalence thresholds, for test-and-treat, for validation of elimination and for pre- and post-elimination surveillance, reliable diagnostic tools are needed. In a single-centre study conducted in Pemba, United Republic of Tanzania, the investigators aim to assess the accuracy and performance of standard and new diagnostic tests for S. haematobium diagnosis for use in elimination settings. The primary objective of the study is to assess the sensitivity and specificity of all investigated diagnostic tests, using the S. haematobium egg count results of five urine filtrations conducted on five urine samples collected over five consecutive days as reference test. Secondary objectives are: * To assess the sensitivity and specificity of all investigated diagnostic tests, using latent class analyses. * To assess the sensitivity and specificity of all investigated diagnostic tests, in relation to S. haematobium infection intensity, calculated as mean egg count derived from the egg counts in five urine samples collected over 5 consecutive days. * To assess the sensitivity and specificity of all investigated diagnostic tests, in relation to S. haematobium infection intensity, calculated from the egg counts of the urine sample that was analysed with the respective test and urine filtration. * To assess the sensitivity and specificity of all investigated diagnostic tests, using the results of the up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA) as reference test. * To assess the sensitivity and specificity of all investigated molecular diagnostic tests, using the results of the qPCR as reference test. * To assess the cost and time needed for the implementation of single or multiple-throughput tests. Our study will evaluate the accuracy and performance of diagnostic tests, in a formerly highly endemic setting that is now approaching elimination (Pemba), and will hence provide important information about which tests can be recommended for threshold determination, and test-and-treat and surveillance.

Who can participate

Age range

6 Years – 18 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: Subjects fulfilling all of the following inclusion criteria are eligible for the initial screening: * Attendance of grade 3, 4, 5, or 6 in study school * Randomized to participate in initial screening * Written informed consent signed by the parents * Written assent signed by the participant if aged12-17 years old Subjects fulfilling all of the following inclusion criteria are eligible for the diagnostic study: * Attendance of grade 3, 4, 5, or 6 in study school * Randomized to participate in initial screening * Written informed consent signed by the parents * Written assent signed by the participant if aged12-17 years old * S. haematobium-positive urine filtration result in initial screening OR * S. haematobium-negative urine filtration result in initial screening, but randomized for participation in diagnostic study Exclusion Criteria: The presence of any one of the following exclusion criteria will lead to the exclusion of the subject in the initial screening: * Not attending any study school * Not attending grade 3, 4, 5 or 6 * Not randomized to participate in initial screening * No written informed consent signed by the parents submitted * No written assent signed by the participant if aged12-17 years old submitted * S. haematobium-negative urine filtration result in initial screening, and not randomized for participation in diagnostic performance study * Clinical significant sever disease The presence of any one of the following exclusion cri…

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?

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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.

What they're measuring

Accuracy of tests for S. haematobium diagnosis when compared with a single urine filtration

Timeframe: From enrollment to the end of the study after 6 weeks

Trial details

NCT IDNCT06808750

SponsorStefanie Knopp

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Schistosoma Haematobium trials