Health TrialsbyHealthPanel

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

ConditionSyphilis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-49
SponsorMcMaster University

About this 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:

* 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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant people

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

Disqualifiers

Previous syphilis diagnosis

Not competent to consent to study participation

Sexual partners

Sexual partners of pregnant clients who are newly diagnosed with syphilis

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

77 Participants
are divided into 1 treatment group
Group A: Implementation of syphilis/HIV point-of-care testingExperimental treatment 1 intervention

Trial outcomes

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

Time frame
Single time-point - At time of first offer of point-of-care test - approximately 5 minutes

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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