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

NCT ID: NCT06829602

Last Updated: 2025-07-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-25
• Study Completion Date: 2026-05-31

Brief 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).

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Implementation of syphilis/HIV point-of-care testing

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

Group Type: EXPERIMENTAL

Rapid Syphilis/HIV point-of-care test

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• 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

2. Sexual partners

• Previous syphilis diagnosis
• Not competent to consent to study participation

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura K Erdman, MD PhD FRCPC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Maternity Centre of Hamilton

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Njideka Sanya

Role: CONTACT

sanyan@mcmaster.ca

+1-905-521-2100 ext. 77577

Stacey Clark

Role: CONTACT

clarksta@mcmaster.ca

+1-905-521-2100 ext. 77577

Facility Contacts

Suzanne Turner

Role: primary

turnes19@mcmaster.ca

+1-905-547-1110

Other Identifiers

AS1-192615

Identifier Type: -

Identifier Source: org_study_id