Status:
RECRUITING
Investigational Study to Evaluate the DPP® Syphilis Screen & Confirm Antibody Point-of-care Test (POCT) to Diagnose Infectious Syphilis
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Public Health Agency of Canada (PHAC)
Chembio Diagnostic Systems, Inc.
Conditions:
Syphilis
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this observational study is to evaluate the sensitivity, specificity, and utility of the DPP® Syphilis Screen \& Confirm antibody point-of-care test (POCT) to diagnose infectious syphilis ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 5 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06927843
Start Date
March 5 2025
End Date
December 31 2026
Last Update
April 15 2025
Active Locations (1)
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1
Nine Circles Community Health Centre
Winnipeg, Manitoba, Canada, R3G 0X2