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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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 in participants attending the Nine Circles Community Health Centre in Winnipeg, Manitoba. The main questions are: Does the POCT provide accurate results compared to conventional syphilis serology methods? and Can the use of POCT improve the timeline for diagnosis and treatment of syphilis? Researchers will compare the POCT results with conventional laboratory testing to assess if the rapid test can reliably diagnose syphilis during the initial clinic visit. Participants will: Provide a blood sample via fingerstick for POCT testing and complete a feedback survey to evaluate the POCT experience. Key details: This study will involve approximately 600 participants aged 18 and older over the course of 12 months which includes both new and repeat visits

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Canada
Nine Circles Community Health Centre
RECRUITING
Winnipeg
Contact Information
Primary
Project Coordinator
kathleen.whyte@phac-aspc.gc.ca
+1204-789-2130
Time Frame
Start Date: 2025-03-05
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 600
Related Therapeutic Areas
Sponsors
Collaborators: Public Health Agency of Canada (PHAC), Chembio Diagnostic Systems, Inc.
Leads: University of Manitoba

This content was sourced from clinicaltrials.gov

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