Rapid finger‑prick syphilis and HIV testing at a low‑barrier prenatal clinic
PREnatal Syphilis Point-of-care ScreenING in an Urban Low-barrier Clinic: A Prospective Single Arm Feasibility Trial
NA · McMaster University · NCT06829602
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.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 77 (estimated) |
| Ages | 13 Years to 49 Years |
| Sex | All |
| Sponsor | McMaster University (other) |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT06829602 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hamilton, Ontario
- Maternity Centre of Hamilton — Hamilton, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Laura K Erdman, MD PhD FRCPC — McMaster University
- Study coordinator: Njideka Sanya
- Email: sanyan@mcmaster.ca
- Phone: +1-905-521-2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Syphilis, syphilis, pregnancy, access to care, acceptability, point-of-care test