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

NCT06829602 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2025-07-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • McMaster University

    lead OTHER

Principal Investigators

  • Laura K Erdman, MD PhD FRCPC · McMaster University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-25
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06829602 on ClinicalTrials.gov