Investigational Study to Evaluate the DPP® Syphilis Screen & Confirm Antibody Point-of-care Test (POCT) to Diagnose Infectious Syphilis

Last updated: April 7, 2025
Sponsor: University of Manitoba
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sexually Transmitted Diseases (Stds)

Gynecological Infections

Hiv

Treatment

point of care test

Clinical Study ID

NCT06927843
HS26266
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Individuals attending the Clinic for routine sexual health care and requiringsyphilis testing as part of this care

  • Be able to provide informed consent and are a minimum 18 years of age are eligiblefor this study

  • Those who had other STIs in the past, or being suspected of having other STIs, arenot excluded as long as testing for syphilis is part of the care provided to them

Exclusion

Exclusion Criteria:

  • Those who, at the discretion of the HCP/Research Nurse, appear intoxicated and/orwith 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 areasymptomatic.

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: point of care test
Phase:
Study Start date:
March 05, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Nine Circles Community Health Centre

    Winnipeg, Manitoba R3G 0X2
    Canada

    Active - Recruiting

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