An observational study in Schistosoma Haematobium, sponsored by Stefanie Knopp. Completed at 1 site in Tanzania. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Stefanie Knopp · Observational
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:
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.
21 studies on the registry are indexed under Schistosomiasis haematobia; 2 are open to participants now.
Browse Schistosomiasis haematobia studies →This is the only study on the registry with Stefanie Knopp as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Children from Pemba Island, United Republic of Tanzania, that attend one among the two pre-selected study primary schools in grade 3, 4, 5 or 6.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects fulfilling all of the following inclusion criteria are eligible for the initial screening:
Subjects fulfilling all of the following inclusion criteria are eligible for the 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:
The presence of any one of the following exclusion criteria will lead to the exclusion of the subject in the diagnostic study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Schoolchildren that attend classes in grades 3-6 in each of the two study schools will be invited to submit one urine sample that will be tested with a single urine filtration (Day 1).
Diagnostic Test: S. haematobium egg detection by single urine filtration · Diagnostic Test: Haematuria assessment using reagent strips
All schoolchildren that are tested S. haematobium-positive children in the initial screening plus a sex-adjusted random selection of initially negative-screened children will be included in the diagnostic study. These children will be invited to submit five urine samples in total, over five days (Day 1-5). All samples (Day 1-5) will be tested with a single urine filtration. Samples collected on Day 5 will be tested with all investigated diagnostic tests.
Diagnostic Test: S. haematobium egg detection by single urine filtration · Diagnostic Test: S. haematobium egg detection by quintuple urine filtration · Diagnostic Test: S. haematobium egg detection by artificial intelligence (AI) microscopy · Diagnostic Test: Haematuria assessment using reagent strips · Diagnostic Test: S. haematobium antigen detection by up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA) · Diagnostic Test: S. haematobium DNA detection by recombinase polymerase amplification assay (RPA) · Diagnostic Test: S. haematobium DNA detection by qPCR
The urine samples of children participating in the initial screening will be tested with a single urine filtration by human microscopy.
Five urine samples will be collected from children participating in the diagnostic study over five days. Each of the five urine samples collected per participant will be tested with a single urine filtration by human microscopy.
The urine samples collected on Day 5 of the diagnostic study will be tested with artificial intelligence (AI) microscopy.
The urine samples collected from children participating in the initial screening and in the diagnostic study, respectively, will be tested with reagent strips.
The urine samples collected on Day 5 of the diagnostic study will be tested with the up-converting reporter particle-lateral flow circulating anodic antigen assay (UCP-LF CAA).
The urine samples collected on Day 5 of the diagnostic study will be tested with the recombinase polymerase amplification assay (RPA).
The urine samples collected on Day 5 of the diagnostic study will be tested with qPCR
Accuracy of tests for S. haematobium diagnosis when compared with a single urine filtration
The primary endpoint will be the sensitivity of the investigated diagnostic tests to detect S. haematobium related markers by the examination of a single sample. The primary outcome variable will be the number of S. haematobium infected individuals detected through each test.
Time frame: From enrollment to the end of the study after 6 weeks
Sensitivity of each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR).
Sensitivity is defined as the proportion of positive test results out of all truly positive samples. Reference tests are human microscopy, UCP-CAA, qPCR or a combination thereof, performed with the same urine sample (human microscopy, UCP-CAA, qPCR) or quintuple urine samples (human microscopy).
Time frame: From enrollment to the end of the study after 6 weeks
Specificity of each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR).
Specificity is defined as the proportion of negative test results out of all truly negative samples. Reference tests are human microscopy, UCP-CAA, qPCR or a combination thereof, performed with the same urine sample (human microscopy, UCP-CAA, qPCR) or quintuple urine samples (human microscopy).
Time frame: From enrollment to the end of the study after 6 weeks.
Correlation of infection markers.
Correlation of the amount of infection markers measured by each test (human microscopy: number of S. haematobium eggs, AI microscopy: number of S. haematobium eggs, reagent strips: microhaematuria grading, RPA: fluorescence level, UCP-CAA: amount of CAA antigen, qPCR: cycle-threshold values).
Time frame: From enrollment to the end of the study after 6 weeks.
Costs of each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR).
Costs are defined as the financial costs incurred by each test for equipment, consumables, and staff time to perform the test.
Time frame: 6 month, from start of orders of equipment and material to end of laboratory work.
Time to conduct each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR).
Amount of time spent completing each test.
Time frame: From enrollment to the end of the study after 6 weeks.
Plan to share: Yes — There are data transfer agreements (DTAs) in place between the Public Health Laboratory-Ivo de Carneri (PHL-IdC) in Pemba and the Swiss Tropical and Public Health Institute (Swiss TPH), Switzerland; Leiden University Medical Centre (LUMC), The Netherlands; Natural History Museum (NHM), London, UK; and Enaiblers, Sweden. Anonymized data will be curated and stored for an unlimited period in the data repository "Infectious Diseases Data Observatory" (IDDO; https://www.iddo.org/) and/or Zenodo (https://zenodo.org/). Data may be shared with other researchers upon request.
Ran from Feb 2025 to primary completion in Apr 2025, 2 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.