Testing methods for diagnosing Schistosoma haematobium infections
Schistosoma Haematobium Diagnostic Test Performance in the Elimination Setting Pemba, Tanzania
This study is testing different ways to diagnose infections caused by the Schistosoma haematobium parasite to help improve detection and treatment for people affected by urogenital schistosomiasis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Swiss Tropical & Public Health Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chakechake, Pemba) |
| Trial ID | NCT06808750 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate various diagnostic tests for urogenital schistosomiasis caused by Schistosoma haematobium. It focuses on assessing the effectiveness of different methods, including urine filtration techniques and artificial intelligence microscopy, to detect the presence of the parasite. The study is aligned with the World Health Organization's goal to eliminate schistosomiasis as a public health issue by 2030, particularly in areas with low infection prevalence. By validating reliable diagnostic tools, the study seeks to enhance surveillance and treatment strategies in affected populations.
Who should consider this trial
Good fit: Ideal candidates for this study are school-aged children in grades 3 to 6 who are attending participating schools and have provided informed consent.
Not a fit: Patients who do not attend the specified grades in participating schools or do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods that facilitate the elimination of schistosomiasis and better health outcomes for affected populations.
How similar studies have performed: Other studies have shown success with similar diagnostic approaches, but the specific combination of methods in this study may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chakechake, Pemba
- Public Health Laboratory - Ivo de Carneri (PHL-IdC) — Chakechake, Pemba, Tanzania (Recruiting)
Study contacts
- Principal investigator: Stefanie Knopp, PhD — Swiss Tropical & Public Health Institute
- Study coordinator: Stefanie Knopp, PhD
- Email: s.knopp@swisstph.ch
- Phone: +41612848727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.