Evaluating a new point-of-care test for diagnosing syphilis
A Cross-sectional Investigational Study to Evaluate the Sensitivity, Specificity, and Utility of the DPP® Syphilis Screen & Confirm Antibody Point-of-care Test (POCT) to Diagnose Infectious Syphilis in Participants Attending the Nine Circles Community Health Centre in Winnipeg, Manitoba
This study is testing a quick blood test for syphilis to see if it can accurately diagnose the infection right in the clinic, helping people get treated faster.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Manitoba Academic / other |
| Locations | 1 site (Winnipeg, Manitoba) |
| Trial ID | NCT06927843 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the sensitivity, specificity, and overall utility of the DPP® Syphilis Screen & Confirm antibody point-of-care test (POCT) for diagnosing infectious syphilis. Participants will provide a blood sample via fingerstick for the POCT and complete a feedback survey regarding their experience. The results from the POCT will be compared to conventional laboratory testing to determine if the rapid test can reliably diagnose syphilis during the initial clinic visit, potentially improving the timeline for diagnosis and treatment. Approximately 600 participants aged 18 and older will be involved over a 12-month period.
Who should consider this trial
Good fit: Ideal candidates are individuals attending the clinic for routine sexual health care who require syphilis testing.
Not a fit: Patients who are intoxicated, in extreme distress, or confused may not benefit from this study.
Why it matters
Potential benefit: If successful, this test could lead to faster and more accurate diagnoses of syphilis, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using point-of-care tests for diagnosing STIs, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals attending the Clinic for routine sexual health care and requiring syphilis testing as part of this care * Be able to provide informed consent and are a minimum 18 years of age are eligible for this study * Those who had other STIs in the past, or being suspected of having other STIs, are not excluded as long as testing for syphilis is part of the care provided to them Exclusion Criteria: * Those who, at the discretion of the HCP/Research Nurse, appear intoxicated and/or with extreme distress, or confused, will be excluded * Those below the age of 18 years * if it has been less than 90 days since their last POCT study visit and they are asymptomatic.
Where this trial is running
Winnipeg, Manitoba
- Nine Circles Community Health Centre — Winnipeg, Manitoba, Canada (Recruiting)
Study contacts
- Principal investigator: Principal Investigator — University of Manitoba
- Study coordinator: Project Coordinator
- Email: kathleen.whyte@phac-aspc.gc.ca
- Phone: +1204-789-2130
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.