Rapid Test for Syphilis

(PRESSING Trial)

Overseen By Stacey Clark

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Previous syphilis, Incompetent consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

77 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing for syphilis and HIV, so it's unlikely that your medications would need to change, but you should confirm with the study team.

What data supports the effectiveness of the Rapid Syphilis/HIV point-of-care test treatment?

The Rapid Syphilis/HIV point-of-care test is effective because it provides immediate results, allowing for quick treatment of both syphilis and HIV, which can improve public health outcomes by reducing the spread of these infections. ^{1 2 3 4 5}

Is the rapid test for syphilis safe for humans?

The research articles focus on the performance and feasibility of rapid syphilis tests, but they do not provide specific safety data for humans. These tests are generally used in clinical settings, suggesting they are considered safe for use, but detailed safety information is not available in the provided studies. ^{1 2 3 6 7}

How is the Rapid Syphilis/HIV point-of-care test different from other treatments for syphilis?

The Rapid Syphilis/HIV point-of-care test is unique because it provides immediate results for both syphilis and HIV from a single fingerprick blood sample, allowing for same-day diagnosis and treatment, which is not possible with traditional testing methods. ^{1 2 3 8 9}

What is the purpose of 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).

Research Team

Laura K Erdman, MD PhD FRCPC

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for pregnant individuals at risk of syphilis who attend a low-barrier prenatal clinic. It aims to see if they will agree to and benefit from a rapid finger-prick blood test that checks for syphilis and HIV, providing results in 5 minutes.

Inclusion Criteria

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

Sexual partners of pregnant clients who are newly diagnosed with syphilis, Physically present in the clinic

Exclusion Criteria

Previous syphilis diagnosis

I am unable to understand or agree to the study on my own.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of syphilis/HIV point-of-care testing for prenatal clients and their sexual partners

1 year

Regular visits as part of prenatal care

Follow-up

Participants are monitored for the effectiveness of the point-of-care testing and treatment

4 weeks

Treatment Details

Interventions

• Rapid Syphilis/HIV point-of-care test

Trial Overview The study is testing the feasibility of implementing a rapid point-of-care test for syphilis/HIV in a prenatal setting. It evaluates participant consent rates, healthcare provider execution, and whether the test expedites diagnosis and treatment.

Participant Groups

Group I: Implementation of syphilis/HIV point-of-care testing Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Field evaluation of Standard Diagnostics' Bioline HIV/Syphilis Duo test among female sex workers in Johannesburg, South Africa. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A laboratory-based evaluation of four rapid point-of-care tests for syphilis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Sensitivity and specificity of point-of-care rapid combination syphilis-HIV-HCV tests. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Diagnostic Accuracy of Rapid Point-of-Care Tests for Detecting Active Syphilis: A Systematic Review and Meta-Analysis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Sensitivity and specificity of two investigational Point of care tests for Syphilis and HIV (PoSH Study) for the diagnosis and treatment of infectious syphilis in Canada: a cross-sectional study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Introduction of rapid syphilis testing within prevention of mother-to-child transmission of HIV programs in Uganda and Zambia: a field acceptability and feasibility study. [2022]

7. South Africa pubmed.ncbi.nlm.nih.gov

Laboratory evaluation of the Chembio Dual Path Platform HIV-Syphilis Assay. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Field evaluation of a dual rapid diagnostic test for HIV infection and syphilis in Lima, Peru. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Performance of a Dual Human Immunodeficiency Virus/Syphilis Rapid Test Compared With Conventional Serological Testing for Syphilis and Human Immunodeficiency Virus in a Laboratory Setting: Results From the Zimbabwe STI Etiology Study. [2020]