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