Clinical trial NCT06927843: Investigational Study to Evaluate the DPP® Syphilis Screen & Confirm Antibody Point-of-care Test (POCT) to Diagnose Infectious Syphilis
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Syphilis
Keywords: syphilis
Point of Care Test
Serology
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Canada (PHAC)
name: Chembio Diagnostic Systems, Inc.
First posted: 2025-04-15
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population for this research comprises individuals seeking care at the Nine Circles Community Health Centre in Winnipeg, Manitoba, Canada. Participants are adults (aged 18 years or older) attending the clinic for routine sexual health care, which includes syphilis testing as part of their standard care. The clinic caters to a diverse urban population which is comprised of newcomers to Canada, indigenous, and LGBTQ2S+ community and receives a significant number of syphilis serology specimens annually, reflecting a broad spectrum of individuals who may present with varying sexual health needs. This setting provides a unique opportunity to evaluate the performance of the DPP® Syphilis Screen \& Confirm antibody point-of-care test in a real-world clinical environment

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


Eligibility criteria: 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.

Primary outcomes:
measure: Point of Care Test Performance
timeFrame: From start of enrollment to the end of the enrollment period (12 months)
Secondary outcomes:
measure: Secondary POCT Performance Measures
timeFrame: From start of enrollment to the end of the enrollment period (12 months)
measure: Comparison of Results by POCT Methodology
timeFrame: From start of enrollment to the end of the enrollment period (12 months)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Nine Circles Community Health Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References: