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

Recruiting

• Conditions: Syphilis

• Registration Number: NCT06927843
• Lead Sponsor: University of Manitoba

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 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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-05
• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Primary Completion: 2026-03-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Point of Care Test Performance	From start of enrollment to the end of the enrollment period (12 months)	Sensitivity of POCT: Percentage of participants with laboratory-confirmed active syphilis who are identified as positive by the POCT, Specificity of POCT: Percentage of participants without laboratory-confirmed active syphilis who are identified as negative by the POCT

Secondary Outcome Measures

Name	Time	Method
Secondary POCT Performance Measures	From start of enrollment to the end of the enrollment period (12 months)	False Positive Rate: Percentage of participants without active syphilis who test positive by POCT for active syphilis. False Negative Rate: Percentage of participants with active syphilis who test negative by POCT for active syphilis.
Comparison of Results by POCT Methodology	From start of enrollment to the end of the enrollment period (12 months)	Comparison of visual vs micro-reader assisted results

Trial Locations

Locations (1)

Nine Circles Community Health Centre; 🇨🇦 Winnipeg, Manitoba, Canada