Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

801

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3 months study duration

First Submitted

Initial submission to the registry

January 8, 2025

Completed

28 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed

5 days until next milestone

Study Start

First participant enrolled

February 10, 2025

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

January 8, 2025

Last Update Submit

September 15, 2025

Conditions

Schistosoma Haematobium

Keywords

schistosomiasisdiagnosiseliminationcontrol

Outcome Measures

Primary Outcomes (1)

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.
From enrollment to the end of the study after 6 weeks

Secondary Outcomes (1)

Sensitivity of each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR).
From enrollment to the end of the study after 6 weeks

Other Outcomes (4)

Specificity of each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR).
From enrollment to the end of the study after 6 weeks.
Correlation of infection markers.
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).
6 month, from start of orders of equipment and material to end of laboratory work.
+1 more other outcomes

Study Arms (2)

Participants of initial screening

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 filtrationDiagnostic Test: Haematuria assessment using reagent strips

Participants of diagnostic study

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 filtrationDiagnostic Test: S. haematobium egg detection by quintuple urine filtrationDiagnostic Test: S. haematobium egg detection by artificial intelligence (AI) microscopyDiagnostic Test: Haematuria assessment using reagent stripsDiagnostic 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

Interventions

S. haematobium egg detection by single urine filtrationDIAGNOSTIC_TEST

The urine samples of children participating in the initial screening will be tested with a single urine filtration by human microscopy.

Participants of diagnostic studyParticipants of initial screening

S. haematobium egg detection by quintuple urine filtrationDIAGNOSTIC_TEST

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.