Testing a new rapid syphilis antibody test in an STI clinic
Evaluation of the Sensitivity, Specificity, and Utility of the Reveal® TP (Syphilis) Antibody POCT to Diagnose Infectious Syphilis in Participants Attending the BCCDC's STI Clinic in Vancouver, BC
This study is testing a quick syphilis blood test in an STI clinic to see how well it works compared to the usual testing method and to find out if patients like it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | MedMira Laboratories Inc. Industry-sponsored |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT05831098 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and above attending the BCCDC STI Clinic for routine sexual health care requiring syphilis testing.
Not a fit: Patients who do not require syphilis testing as part of their care will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to quicker and more accessible syphilis testing for patients.
How similar studies have performed: Other studies have shown promise in using rapid tests for syphilis, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Vancouver, British Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.