Clinical trial NCT06808750: Performance of Tests for Schistosoma Haematobium Diagnosis
Official title: Schistosoma Haematobium Diagnostic Test Performance in the Elimination Setting Pemba, Tanzania
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Schistosoma Haematobium
Keywords: schistosomiasis
diagnosis
elimination
control
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Public Health Laboratory Ivo de Carneri
name: Enaiblers AB
name: Erasmus Medical Center
name: Leiden University Medical Center
name: Natural History Museum, United Kingdom
First posted: 2025-02-05
Enrollment: 1200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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 criteria will lead to the exclusion of the subject in the diagnostic study:

* 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Sensitivity of each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR).
timeFrame: From enrollment to the end of the study after 6 weeks
Other outcomes:
measure: Specificity of each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR).
timeFrame: From enrollment to the end of the study after 6 weeks.
measure: Correlation of infection markers.
timeFrame: From enrollment to the end of the study after 6 weeks.
measure: Costs of each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR).
timeFrame: 6 month, from start of orders of equipment and material to end of laboratory work.
measure: Time to conduct each diagnostic test (human microscopy, AI microscopy, reagent strips, RPA, UCP-CAA, qPCR).
timeFrame: From enrollment to the end of the study after 6 weeks.
Locations:
city: Chakechake
country: Tanzania
facility: Public Health Laboratory - Ivo de Carneri (PHL-IdC)
state: Pemba
Study officials:
affiliation: Swiss Tropical & Public Health Institute
name: Stefanie Knopp, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Public Health Laboratory Ivo de Carneri
name: Said M Ali, MSc
role: STUDY_DIRECTOR
References: