An interventional study of Rapid Syphilis/HIV point-of-care test in Syphilis, sponsored by McMaster University. Recruiting at 1 site in Canada. Open to participants aged 13 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by McMaster University · Not applicable, Interventional, and Other
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:
Participants will:
Early testing and treatment for syphilis during pregnancy, along with treating sexual partners, can prevent infection of the baby (known as congenital syphilis). However, many pregnant people at risk of syphilis also face barriers to prenatal care due to social determinants of health such as substance use and unstable housing. These barriers may lead to delays in management of syphilis in pregnancy, which may result in poor maternal and infant health outcomes.
A major issue is the standard syphilis blood test. This test takes about a week to return results. This delay makes it difficult to communicate positive results to people with limited phone or internet access, and it can be hard for people to return for treatment. Additionally, it may be challenging to take blood for the syphilis test from people whose veins are damaged from intravenous drug use. As a result, syphilis diagnosis and/or treatment in pregnancy may be delayed or missed altogether.
Health Canada has approved a point-of-care test for syphilis and HIV that uses a finger-prick blood sample and gives results in 5 minutes. This rapid test enables same-day syphilis treatment initiation with intramuscular penicillin antibiotic, and could overcome some of the barriers described above. However, point-of-care syphilis testing has not been studied in pregnant people facing barriers to prenatal care.
An urban low-barrier prenatal clinic (Maternity Centre of Hamilton) will implement the point-of-care syphilis/HIV test as part of regular care. The test will be offered to pregnant clients at risk of syphilis, and to the sexual partners of syphilis-positive pregnant clients, given the critical importance of treating partners to prevent re-infection during pregnancy. Over 1 year, the study will evaluate the feasibility of test implementation, in terms of acceptability by clients and test performance by clinicians. The study will also preliminarily assess whether the point-of-care test improves timeliness and adequacy of treatment of syphilis-positive pregnant clients and their sexual partners. The investigators did not feel it was ethical to have a control group with delayed access to point-of-care testing given the potential harms of delayed diagnosis of syphilis in pregnancy; rather, baseline data regarding management of syphilis in pregnancy at the clinic will be established using retrospective chart review, and compared to syphilis management over the study period.
Importantly, if pregnant clients or sexual partners decline study participation, they are still eligible for point-of-care testing to learn their syphilis and HIV status.
126 studies on the registry are indexed under Syphilis; 34 are open to participants now.
This study's planned enrollment of 77 is below the median of 354 across 85 interventional studies indexed under Syphilis.
Browse Syphilis studies →McMaster University is the lead sponsor of 741 studies on the registry; 127 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pregnant people
Inclusion Criteria:
Pregnant clients with at least one risk factor for syphilis infection:
Exclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
The syphilis/HIV point-of-care test will be offered to all prenatal clients with at least 1 risk factor for syphilis, and to the sexual partners of syphilis-positive participants
Diagnostic 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.
Proportion of pregnant clients with syphilis risk factors who undergo syphilis/HIV point-of-care testing the first time it is offered
Time frame: Single time-point - At time of first offer of point-of-care test - approximately 5 minutes
Proportion of pregnant participants with syphilis risk factors who undergo syphilis/HIV point-of-care testing at least once during pregnancy
Time frame: From the first prenatal clinic visit until the end of pregnancy - up to 8 months
Proportion of pregnant participants who undergo syphilis/HIV point-of-care testing, and are willing to undergo the test in future based on post-test survey
Time frame: Single time-point - at time of post-test survey - approximately 5 minutes
Proportion of partner participants who undergo syphilis/HIV point-of-care testing, and are willing to undergo the test in future based on post-test survey
Time frame: Single time-point - at time of post-test survey - approximately 5 minutes
Proportion of syphilis/HIV point-of-care tests with valid results on clinician's first attempt, as defined by the manufacturer's instructions
Time frame: From initiation to completion of point-of-care test - approximately 5 minutes
Proportion of syphilis/HIV point-of-care tests that are correctly interpreted by the clinician, as per consensus of 2 blinded independent study staff reviewing digital photographs of the results
Time frame: From initiation to completion of point-of-care test - approximately 5 minutes
Proportion of pregnant participants with a positive syphilis point-of-care test, who receive same-day treatment initiation with penicillin
Time frame: From positive syphilis point-of-care test result until end of clinic visit - up to 3 hours
Time to communicate test results to syphilis serology-positive pregnant participants, from date of first positive syphilis test (days)
Time frame: From the day of syphilis testing to notification of client - range 5 minutes to 8 months
Time to first penicillin treatment for syphilis serology-positive pregnant participants, from date of first positive syphilis test (days)
Time frame: From the day of syphilis testing to treatment of client - range 5 minutes to 8 months
Proportion of syphilis serology-positive pregnant participants who receive any syphilis treatment in pregnancy
Time frame: From the day of syphilis testing to end of pregnancy - up to 8 months
Proportion of syphilis serology-positive pregnant participants who receive the recommended treatment in pregnancy, based on syphilis staging
Time frame: From the day of syphilis testing to treatment of client - up to 8 months
Time to first penicillin treatment of partner participants, from date of pregnant person's date of first positive syphilis test (days)
Time frame: From the day of pregnant person's syphilis testing to treatment of partner - range 1 hour to 8 months
Proportion of partner participants who receive any syphilis treatment during pregnancy
Time frame: From the day of pregnant person's syphilis testing to treatment of partner - up to 8 months
Proportion of partner participants who receive the recommended syphilis treatment during pregnancy, based on their syphilis staging
Time frame: From the day of pregnant person's syphilis testing to treatment of partner - up to 8 months
Plan to share: No
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