Testing a new rapid syphilis antibody test in an STI clinic

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the performance of the Reveal® TP (Syphilis) antibody point-of-care test (POCT) in an urban STI clinic in Vancouver, British Columbia. It compares the results of this rapid test with the conventional gold standard testing method for syphilis. Participants will provide a small blood sample through a finger prick, and a larger sample for routine serology testing. The study aims to assess the acceptability of the POCT among patients while ensuring they receive standard care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients 19 years of age and above attending the BCCDC STI Clinic in Vancouver, British Columbia for routine sexual health care and requiring syphilis testing as part of this care are eligible for this study.

  * Additionally, for each participant category:

    * Group 1: No known (i.e. self-reported or laboratory documented history of syphilis) prior history of syphilis.
    * Group 2: No additional inclusion criteria
    * Group 3: Participants were named as a contact by a confirmed syphilis case within the last year, and have not yet received treatment
    * Group 4: No additional inclusion criteria
  * 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. Once it has been determined that the exclusion criteria does not apply to a patient, the recruitment of the four categories of participants will be offered without other pre-selection criteria unless there may be other unforeseeable circumstances arising, such as shortage of clinic staff or large number of patients showing up.

Exclusion Criteria:

* • Minors, and those who, at the discretion of the health care provider/research co-ordinator, appear intoxicated and/or with extreme distress, or confused, will be excluded from this research because they would not be able to provide informed consent to participate.

  * Additionally, for each participant category:

    * Group 1: Current symptoms that could be consistent with early syphilis.
    * Group 2: No additional exclusion criteria
    * Group 3: Current symptoms that could be consistent with early syphilis.
    * Group 4: Current symptoms that could be consistent with early syphilis.

Where it's running

• BCCDC STI Clinic
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Troy Grennan, Dr — British Columbia Center for Disease Control (BCCDC)
• Study coordinator: Jennifer MacLellan
• Email: jennifer.maclellan@medmira.com
• Phone: 9024501588

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.