Clinical trial Recruiting at 1 site Interventional Ages 13 to 49

Rapid finger‑prick syphilis and HIV testing at a low‑barrier prenatal clinic

Official title: PREnatal Syphilis Point-of-care ScreenING in an Urban Low-barrier Clinic: A Prospective Single Arm Feasibility Trial

Run by McMaster University · NCT06829602 · Data updated 2026-11-12

We will test if a five-minute finger‑prick syphilis/HIV test works for pregnant people who face barriers to prenatal care to speed diagnosis and treatment.

More Syphilis trials

Quick facts

Study typeInterventional
Ages13 Years to 49 Years
SexAll
Enrollment77 (estimated)
SponsorMcMaster University
Academic / other
Locations1 site (Hamilton, Ontario)
StatusRecruiting
StartedJune 25, 2025
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedJuly 7, 2026
Trial IDNCT06829602 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Pregnant people receiving care at the Maternity Centre of Hamilton who have at least one syphilis risk factor (for example, substance use, unstable housing, multiple partners, prior STBBI, or late prenatal care), and sexual partners who are physically present, are eligible.

Probably not a fit

People with a prior syphilis diagnosis, those not competent to consent, or individuals who cannot attend the clinic in person are not eligible and are unlikely to benefit from this testing approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project will introduce a Health Canada–approved rapid syphilis/HIV finger‑prick test at the Maternity Centre of Hamilton and measure how it is used in routine prenatal visits. The team will record how often eligible pregnant clients accept the test, how well clinic staff perform the test, and whether results lead to faster diagnosis and same-day treatment for clients and their partners. Participants will give feedback about their testing experience and share basic health and pregnancy information, while researchers will compare time-to-diagnosis and treatment against usual laboratory-based testing. The intervention focuses on people with barriers to care such as substance use, unstable housing, multiple partners, prior STBBIs, or late entry to prenatal care.

Why it matters

Potential benefit: If successful, same-day finger‑prick testing could enable immediate treatment and reduce missed or delayed syphilis diagnoses in pregnancy, lowering the risk of congenital syphilis.

How similar studies have gone: Rapid point-of-care syphilis tests have been used in other settings and can speed treatment, but their implementation has not been studied specifically in pregnant people facing barriers to prenatal care.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Maternity Centre of Hamilton
    Hamilton, Ontario, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.