Actively Recruiting
PREnatal Syphilis Point-of-care Screening in an Urban Low-barrier Clinic: A Prospective Single Arm Feasibility Trial
Led by McMaster University · Updated on 2025-07-06
77
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
McMaster University
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of implementing a rapid finger-prick blood test for syphilis and HIV in a low-barrier prenatal clinic. This test provides results in 5 minutes and aims to improve timely diagnosis and treatment for pregnant people at risk of syphilis and their sexual partners. The study focuses on whether the test is accepted by patients, how well healthcare providers perform it, and if it speeds up treatment initiation. The study will offer the point-of-care syphilis/HIV test to pregnant clients with at least one risk factor for syphilis and to sexual partners of syphilis-positive pregnant clients. The test is part of regular care in an urban clinic and uses a finger-prick blood sample to deliver rapid results. No control group is used; instead, baseline data from previous clinic records will be compared with data collected during the study period. Participants will be asked about their experience with the test and their reasons for accepting or declining it. The study will collect information on health, pregnancy, and syphilis treatment if applicable. Researchers will monitor how many clients accept testing, test performance by clinicians, treatment timeliness, and communication of results. The overall participation period spans from initial testing through pregnancy and treatment follow-up, lasting up to 8 months for some outcomes.
CONDITIONS
Brief Title
The Feasibility of Implementing Syphilis Point-of-care Testing Into a Prenatal Clinic for People Facing Barriers to Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant clients with at least one risk factor for syphilis infection, including substance use or addiction services in the past year
- Pregnant clients with unstable housing in the past year
- Pregnant clients with multiple sexual partners in the past year
- Pregnant clients with history of sexually transmitted or blood-borne infections
- Pregnant clients who started prenatal care after 20 weeks gestation
- Eligible for syphilis screening at clinic visit per Public Health guidelines
- Sexual partners of pregnant clients newly diagnosed with syphilis who are physically present in the clinic
You will not qualify if you...
- Previous diagnosis of syphilis
- Not competent to consent to study participation for both pregnant clients and sexual partners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at the prenatal clinic when the point-of-care test is first offered
Duration - From first prenatal clinic visit until the end of pregnancy, up to 8 months
Participants undergo rapid syphilis/HIV point-of-care testing using a finger-prick blood sample during prenatal visits or when partners are present at the clinic.
Offered at prenatal clinic visits as appropriate; testing occurs at least once during pregnancy; partners tested when present
Duration - Up to 8 months, from positive test until end of pregnancy
Participants with positive syphilis point-of-care test results receive same-day treatment and follow-up care during the clinic visit and through pregnancy as needed.
Same-day treatment during clinic visit; additional visits as needed for treatment and monitoring
Trial Site Locations
Total: 1 location
1
Maternity Centre of Hamilton
Hamilton, Ontario, Canada
Actively Recruiting
Research Team
N
Njideka Sanya
S
Stacey Clark
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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