Clinical trial NCT05831098: Evaluation of the Sensitivity, Specificity, and Utility of the Reveal® TP (Syphilis) Antibody POCT
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Syphilis Infection
Syphilis
Early Syphilis, Symptomatic
Keywords: Rapid Vertical Flow (RVF)
Reveal TP
Syphilis
POCT
MedMira
Lead sponsor: MedMira Laboratories Inc.
Sponsor class: INDUSTRY
Collaborators: name: Public Health Agency of Canada (PHAC)
First posted: 2023-04-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is to test the Reveal® TP (Syphilis) antibody POCT (MedMira, Inc., Halifax, Nova Scotia) for its performance in an urban STI clinic in Vancouver, British Columbia and compare its performance in parallel with the usual testing method (the gold standard).

Detailed description: This study is to test the Reveal® TP (Syphilis) antibody POCT (MedMira, Inc., Halifax, Nova Scotia) for its performance in an urban STI clinic in Vancouver, British Columbia and compare its performance in parallel with the usual testing method (the gold standard).

The healthcare professional will advise patients about the study, and with their permission refer them to research staff for recruitment. Should patients choose to participate in the study they will be asked to provide consent to have a few drops of blood sample obtained through a finger prick to be used in the POCT. POCT results will not be provided to participants and this will be explained in both the recruitment script and informed consent form. A sample of 5 to 10 ml venous whole blood will also be obtained for the conventional syphilis serology testing which is part of the routine for care of the four categories of patients (regardless of this research). This research will take approximately 15 to 30 minutes and will be on top of the regular care that patients will receive in the clinic. Upon completing the tests, participants will be asked to complete a brief feedback survey to assess patients' acceptability of syphilis POCT.

Eligibility 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.

Primary outcomes:
measure: To determine the accuracy of Reveal TP (Syphilis) Antibody Test
timeFrame: 1 patient visit of approximately 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BCCDC STI Clinic
state: British Columbia
Study officials:
affiliation: British Columbia Center for Disease Control (BCCDC)
name: Troy Grennan, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: National Microbiology Laboratory Branch, Public Health Agency of Canada
name: Raymond Tsang, Dr
role: PRINCIPAL_INVESTIGATOR
References: