The Feasibility of Implementing Syphilis Point-of-care Testing Into a Prenatal Clinic for People Facing Barriers to Care
PREnatal Syphilis Point-of-care ScreenING in an Urban Low-barrier Clinic: A Prospective Single Arm Feasibility Trial
McMaster University
77 participants
Jun 25, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if a finger-prick blood test for rapid diagnosis of syphilis infection can be implemented in a low-barrier prenatal clinic for people at risk of syphilis in pregnancy. The test gives results in 5 minutes and also tests for HIV. The main questions the study aims to answer are: * How often do pregnant people at risk of syphilis agree to the rapid test? * How well do healthcare providers perform the rapid test? * Does the rapid test speed up diagnosis and treatment of syphilis in pregnant people and their sexual partners? Participants will: * Give feedback about why they did or did not want to take the rapid test, and what their experience was taking the test; and * Share information about their health, pregnancy, and syphilis treatment (if applicable).
Eligibility
Inclusion Criteria10
- Pregnant people
- Pregnant clients with at least one risk factor for syphilis infection:
- Substance use or accessed addiction services in the past 1 year
- Unstable housing in the past 1 year
- Multiple sexual partners in the past 1 year
- History of a sexually transmitted or blood-borne infection (STBBI)
- Late to prenatal care (initial prenatal visit \>20 weeks)
- Eligible for syphilis screening at that clinic visit, as per Public Health guidelines
- Sexual partners of pregnant clients who are newly diagnosed with syphilis
- Physically present in the clinic
Exclusion Criteria5
- Previous syphilis diagnosis
- Not competent to consent to study participation
- Sexual partners
- Previous syphilis diagnosis
- Not competent to consent to study participation
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The INSTI Multiplex HIV/Syphilis Duo Antibody Test is a rapid immunoassay that can detect HIV and syphilis antibodies in the blood using finger-prick blood samples. The test is Health Canada-approved.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06829602