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

NCT06829602 | Recruiting

• 1 other identifier: AS1-192615
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of pregnant clients with syphilis risk factors who undergo syphilis/HIV point-of-care testing the first time it is offered

  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

  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

  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

  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

  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

  From initiation to completion of point-of-care test - approximately 5 minutes

Study Arms (1)

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

Diagnostic Test: Rapid Syphilis/HIV point-of-care test

Interventions

Rapid Syphilis/HIV point-of-care test 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.

Implementation of syphilis/HIV point-of-care testing

Eligibility Criteria

• Age: 13 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• Eligible for syphilis screening at that clinic visit, as per Public Health guidelines

You may not qualify if:

• Previous syphilis diagnosis
• Not competent to consent to study participation
• Sexual partners
• Sexual partners of pregnant clients who are newly diagnosed with syphilis
• Physically present in the clinic
• Previous syphilis diagnosis
• Not competent to consent to study participation

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Maternity Centre of Hamilton

Hamilton, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Syphilis

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Laura K Erdman, MD PhD FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Njideka Sanya

CONTACT

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

Stacey Clark

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: February 17, 2025
• Study Start: June 25, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)