Recruiting

Rapid Syphilis Test

Sponsor:

McMaster University

Code:

NCT06829602

Conditions

Syphilis

Eligibility Criteria

Sex: All

Age: 13 - 49

Healthy Volunteers: Accepted

Interventions

Rapid Syphilis/HIV point-of-care test

Study Details

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).

Conditions

Syphilis

Study ID

NCT06829602

Start date

Jun 25, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 49

Healthy Volunteers: Accepted

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

Study Design

Enrollment

77 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 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

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.

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 ]

Central Contacts and Locations

Central contacts

Njideka Sanya

+1-905-521-2100sanyan@mcmaster.ca

Stacey Clark

+1-905-521-2100clarksta@mcmaster.ca

Locations

Maternity Centre of Hamilton

Recruiting

Hamilton, Ontario, Canada

Contacts

Suzanne Turner

+1-905-547-1110turnes19@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • syphilis
  • pregnancy
  • access to care
  • acceptability
  • point-of-care test

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2026-07-07.