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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a quick finger-prick blood test to diagnose syphilis and HIV in pregnant individuals. The focus is to determine if the Rapid Syphilis/HIV point-of-care test can be easily used in clinics for those at risk of syphilis during pregnancy. The trial aims to assess how many pregnant individuals accept the test, how effectively healthcare workers use it, and whether results help expedite treatment. Pregnant individuals who have faced challenges such as substance use, unstable housing, or late prenatal care may be suitable participants. The trial also includes the sexual partners of those newly diagnosed with syphilis. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance prenatal care and treatment access.

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 prior data suggests that this rapid test is safe for prenatal use?

Research has shown that the rapid syphilis/HIV point-of-care test is generally safe. The FDA has approved this test, and it meets specific safety and quality standards for use in healthcare settings.

The primary concern with these tests is accuracy, not safety. Incorrect results can occur. A false negative indicates the test reports no infection when one is present. A false positive indicates the test reports an infection when there is none.

Overall, the test poses no direct safety risks. It is a simple finger-prick test, similar to those used for checking blood sugar levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Rapid Syphilis/HIV point-of-care test is unique because it offers a quick and convenient way to test for both syphilis and HIV at the same time, right at the point of care. Unlike traditional testing methods that require laboratory processing and longer wait times for results, this rapid test can provide results in minutes, making it especially beneficial for pregnant women and the sexual partners of those who test positive for syphilis. This immediate feedback can lead to faster treatment decisions, potentially reducing the spread of these infections and improving health outcomes. Researchers are excited about this approach because it could significantly streamline the testing process and make it more accessible to those at risk.

What evidence suggests that this rapid test is effective for diagnosing syphilis?

Research has shown that using quick tests for both syphilis and HIV can greatly improve health outcomes. These tests prevent more complications during pregnancy than testing for one disease at a time. For instance, one study found that the number of people receiving proper treatment doubled from 30.4% to 61.7% after these quick tests were introduced, leading to a 41% drop in cases of syphilis passed from parent to baby. In this trial, the rapid syphilis/HIV point-of-care test will be offered to all prenatal clients with at least one risk factor for syphilis and to the sexual partners of syphilis-positive participants. These results suggest that the rapid syphilis/HIV test could be a strong tool for quickly identifying and treating syphilis in pregnant individuals. ^{5 6 7 8 9}

Who Is on the Research Team?

Laura K Erdman, MD PhD FRCPC

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK595137/

Point-of-Care HIV and Syphilis Screening - NCBI Bookshelf Most commercially available point-of-care syphilis tests detect treponemal antibodies, and are not designed to distinguish between active and past syphilis ...

2. bmcinfectdis.biomedcentral.com bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-024-09017-5

A clinical utility evaluation of dual HIV/Syphilis point-of-care ... The aim of this study is to determine the feasibility of performing dual HIV-syphilis POCT testing among both users and providers at these non-clinical sites.

3. stacks.cdc.gov stacks.cdc.gov/view/cdc/134181

A systematic review and meta-analysis of studies ... Dual screening for HIV and syphilis was more cost effective than single rapid tests for HIV and syphilis and prevented more adverse pregnancy outcomes.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1201971225002176

Impact of the dual rapid diagnostic test for HIV and syphilis ... Adequate treatment coverage doubled from 30.4% to 61.7% post-RDT introduction. •. Modeled 41% reduction in congenital syphilis and 39% reduction in adverse ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12258646/

Syphilis Point-of-Care Tests (POCTs) - PubMed Central - NIH In this article, we aim to review antibody-detecting syphilis POCTs that are commercially available, their performance in recent Canadian field studies,

6. fda.gov fda.gov/media/142832/download

DPP HIV-Syphilis System Risks associated with point-of-care rapid tests relate primarily to its rate of false negative and false positive results. Performance ...

7. chembio.com chembio.com/products/dpp-hiv-syphilis-usa/

DPP® HIV Syphilis USA An FDA Approved, CLIA Waived* dual rapid test for the detection of antibodies to HIV 1/2 and Treponema pallidum in fingerstick whole blood, venous whole blood, ...

8. who.int who.int/teams/global-hiv-hepatitis-and-stis-programmes/stis/testing-diagnostics/dual-hiv-syphilis-rapid-diagnostic-tests

Dual HIV/syphilis rapid diagnostic tests Multiple dual HIV/syphilis RDTs have received WHO prequalification, providing assurance that these products meet requirements for safety, quality and ...

9. globalpointofcare.abbott globalpointofcare.abbott/id/en/product-details/sd-bioline-hiv-syphilis-duo.html

SD BIOLINE HIV/Syphilis Duo The SD BIOLINE HIV/Syphilis Duo test is a solid phase immunochromatographic assay for the qualitative detection of antibodies to all isotypes(IgG, IgM, and IgA)