NCT06927843

Investigational Study to Evaluate the DPP® Syphilis Screen & Confirm Antibody Point-of-care Test (POCT) to Diagnose Infectious 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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Syphilis

Interventions

Type	Name	Description
DEVICE	point of care test	DPP Syphilis Screen and Confirm antibody point-of-care-test (POCT)

Timeline

• Start date: 2025-03-05
• Primary completion: 2026-03-31
• Completion: 2026-12-31
• First posted: 2025-04-15
• Last updated: 2026-03-27

Locations

1 site across 1 country: Canada