Investigational Study to Evaluate the DPP® Syphilis Screen & Confirm Antibody Point-of-care Test (POCT) to Diagnose Infectious Syphilis
NCT ID: NCT06927843
Last Updated: 2025-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2025-03-05
2026-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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point of care test
DPP Syphilis Screen and Confirm antibody point-of-care-test (POCT)
Eligibility Criteria
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Inclusion Criteria
* 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 below the age of 18 years
* if it has been less than 90 days since their last POCT study visit and they are asymptomatic.
18 Years
ALL
Yes
Sponsors
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Public Health Agency of Canada (PHAC)
OTHER_GOV
Chembio Diagnostic Systems, Inc.
INDUSTRY
University of Manitoba
OTHER
Responsible Party
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Principal Investigators
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Principal Investigator
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Locations
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Nine Circles Community Health Centre
Winnipeg, Manitoba, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HS26266
Identifier Type: -
Identifier Source: org_study_id
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