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Clinical Trials in Canada / NCT06829602
Recruiting Not applicable

The Feasibility of Implementing Syphilis Point-of-care Testing Into a Prenatal Clinic for People Facing Barriers to Care

NCT06829602 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2025-06-25
Last updated
2026-07-07

Condition(s) studied

Syphilis

Investigational drug(s) / intervention(s)

Rapid Syphilis/HIV point-of-care test

Rapid Syphilis/HIV point-of-care test: 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.

Study 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

Sex
ALL
Min age
13 Years
Max age
49 Years
Healthy volunteers
Accepted
1. Pregnant people Inclusion Criteria: * Pregnant clients with at least one risk factor for syphilis infection: 1. Substance use or accessed addiction services in the past 1 year 2. Unstable housing in the past 1 year 3. Multiple sexual partners in the past 1 year 4. History of a sexually transmitted or blood-borne infection (STBBI) 5. Late to prenatal care (initial prenatal visit \>20 weeks) * Eligible for syphilis screening at that clinic visit, as per Public Health guidelines Exclusion Criteria: * Previous syphilis diagnosis * Not competent to consent to study participation 2. Sexual partners Inclusion Criteria: * Sexual partners of pregnant clients who are newly diagnosed with syphilis * Physically present in the clinic Exclusion Criteria: * Previous syphilis diagnosis * Not competent to consent to study participation

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Maternity Centre of Hamilton Hamilton Ontario Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06829602 on ClinicalTrials.gov ↗ ← All trials in Canada