SyphilisPRESSINGNCT06829602
The Feasibility of Implementing Syphilis Point-of-care Testing Into a Prenatal Clinic for People Facing Barriers to Care
A study testing Rapid Syphilis/HIV point-of-care test in people with Syphilis, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Syphilis
- What is being tested?
- Rapid Syphilis/HIV point-of-care test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant clients with at least one risk factor for syphilis infection:
- Substance use or accessed addiction services in the past 1 year
- Unstable housing in the past 1 year
- Multiple sexual partners in the past 1 year
- History of a sexually transmitted or blood-borne infection (STBBI)
- Late to prenatal care (initial prenatal visit >20 weeks)
Show all 9Show fewer
- Eligible for syphilis screening at that clinic visit, as per Public Health guidelines
- Sexual partners of pregnant clients who are newly diagnosed with syphilis
- Physically present in the clinic
Who cannot join
- Previous syphilis diagnosis
- Not competent to consent to study participation
- Sexual partners
- Previous syphilis diagnosis
- Not competent to consent to study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Maternity Centre of Hamilton
Hamilton, Ontario
Suzanne Turner, +1-905-547-1110, turnes19@mcmaster.ca
About this study
Official title: PREnatal Syphilis Point-of-care ScreenING in an Urban Low-barrier Clinic: A Prospective Single Arm Feasibility Trial
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:
Read more
- 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).
Read the detailed description
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.
- Conditions
- Syphilis
- Being tested
- Rapid Syphilis/HIV point-of-care test
- Keywords
- syphilis, pregnancy, access to care, acceptability, point-of-care test
- Medical subject headings
- Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Syphilis/HIV point-of-care testDiagnostic 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 group | Role | What they receive |
|---|---|---|
| Implementation of syphilis/HIV point-of-care testing | Experimental | 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 Receives: Diagnostic Test: Rapid Syphilis/HIV point-of-care test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of pregnant clients with syphilis risk factors who undergo syphilis/HIV point-of-care testing the first time it is offered
Measured: Single time-point - At time of first offer of point-of-care test - approximately 5 minutes
Secondary outcomes (13)
Proportion of pregnant participants with syphilis risk factors who undergo syphilis/HIV point-of-care testing at least once during pregnancy
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: From the day of pregnant person's syphilis testing to treatment of partner - up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start25 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SyphilisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Laura K Erdman, MD PhD FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829602
- Sponsor's protocol ID
- AS1-192615
- Acronym
- PRESSING
- Status last verified
- Jul 2026
- First submitted
- 5 Jan 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanya N, Vaccaro ME, Uppal M, Glen S, Kirkby C, Zafar T, Gasparelli J, MacNeil K, Milliken S, Pernica J, Wong J, Duncan DB, Smieja M, Ramdyal A, Lennox R, O'Shea T, Cvetkovic A, Mbuagbaw L, Turner S, Erdman L. PREnatal Syphilis point-of-care ScreenING in an urban low-barrier clinic (PRESSING) study: Protocol for a prospective single arm feasibility trial. PLoS One. 2026 Oct 22;21(10):e0360150. doi: 10.1371/journal.pone.0360150. eCollection 2026.
PubMed 42911975
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREnatal Syphilis Point-of-care ScreenING in an Urban Low-barrier Clinic: A Prospective Single Arm Feasibility Trial
- ClinicalTrials.gov ID
- NCT06829602
- Acronym / sponsor ID
- PRESSING / AS1-192615
- Conditions
- Syphilis
- Keywords
- syphilis, pregnancy, access to care, acceptability, point-of-care test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implementation of syphilis/HIV point-of-care testing | Experimental | Diagnostic Test: Rapid Syphilis/HIV point-of-care testThe 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 |
Who may qualify
- Ages
- 13 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Sexual partners of pregnant clients who are newly diagnosed with syphilis
- Physically present in the clinic
Key exclusion criteria (5 listed)
- Sexual partners
- Previous syphilis diagnosis
- Not competent to consent to study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Syphilis/HIV point-of-care testThe 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. | Diagnostic test | Implementation of syphilis/HIV point-of-care testing |
Primary outcome
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
13 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Derived from this study: PubMed 42911975Sanya N, Vaccaro ME, Uppal M, Glen S, Kirkby C, Zafar T, Gasparelli J, MacNeil K, Milliken S, Pernica J, Wong J, Duncan DB, Smieja M, Ramdyal A, Lennox R, O'Shea T, Cvetkovic A, Mbuagbaw L, Turner S, Erdman L. PREnatal Syphilis point-of-care ScreenING in an urban low-barrier clinic (PRESSING) study: Protocol for a prospective single arm feasibility trial. PLoS One. 2026 Oct 22;21(10):e0360150. doi: 10.1371/journal.pone.0360150. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura K Erdman, MD PhD FRCPC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Syphilis/HIV point-of-care test in people with Syphilis, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Njideka Sanya (+1-905-521-2100 ext. 77577, sanyan@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06829602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.