Actively Recruiting

Phase Not Applicable
Age: 13Years - 49Years
All Genders
Healthy Volunteers
ID06829602

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

Age: 13Years - 49Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

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

Implementation

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

Follow-up

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

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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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