Rapid POC Testing for Syphilis

Overseen By Carrie Bakunas, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Documented care, Syphilis results, others

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

Compensation: Varies

Number of Visits: 2

Duration: Immediate

1500 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to offer routine lab-based and rapid point of care (POC) syphilis diagnostic testing in the emergency department (ED) and obstetrical (OB) triage , thereby increasing screening and treatment initiation for pregnant patients without prenatal care or with no documented syphilis results during the index pregnancy in other to increase rates of full treatment to determine if the implementation of a robust linkage to care program for pregnant patients with positive rapid POC results will more likely result in complete treatment for all stages of syphilis and adherence to recommended maternal and newborn longitudinal follow up and to assess factors that contribute to treatment completion after implementation of the intervention will also be analyzed to tailor efforts targeting social and healthcare navigation factors that affect health equity; including poverty, insurance, health literacy and others.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of Rapid Point of Care (POC) Syphilis testing as a treatment?

Rapid Point of Care (POC) tests for syphilis have shown good performance in detecting syphilis by identifying specific antibodies, which helps in diagnosing the condition quickly and starting treatment immediately. Studies indicate these tests have a high accuracy, with sensitivity (ability to correctly identify those with the disease) of 86% and specificity (ability to correctly identify those without the disease) of 99%, making them effective for increasing syphilis screening and treatment. ^{1 2 3 4 5}

Is rapid point-of-care testing for syphilis safe for humans?

The research does not specifically address safety concerns for rapid point-of-care syphilis tests, but these tests are widely used for early diagnosis and treatment in various settings, suggesting they are generally considered safe for human use. ^{1 2 3 4 6}

Research Team

Irene Stafford, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for pregnant patients who come to the emergency department or obstetrical triage without prenatal care or documented syphilis tests during their current pregnancy. It aims to help those who might face barriers like poverty, lack of insurance, and low health literacy.

Inclusion Criteria

Pregnant individuals seeking care at University of Texas, Memorial Herman, and Lyndon B Johnson sites ED or obstetrical triage units

No prenatal care during index pregnancy

No documented syphilis result during the index pregnancy

Exclusion Criteria

Pregnant individuals with documented care and syphilis results in the index pregnancy for specific trimester as mandated by Texas law

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Routine lab-based and rapid point of care (POC) syphilis diagnostic testing is offered in the emergency department and obstetrical triage

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for treatment completion and adherence to recommended maternal and newborn longitudinal follow-up

6 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Rapid Point of Care (POC) Syphilis testing

Trial Overview The study is testing whether offering routine lab-based and rapid point-of-care syphilis tests can increase screening and treatment initiation in pregnant women. It also examines if a strong support program leads to complete treatment adherence.

Participant Groups

Group I: Rapid Point of Care (POC) Syphilis testing Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Findings from Research

The dual point-of-care syphilis test demonstrated high sensitivity (96.7% for whole blood, 96.4% for fingerprick blood, and 94.6% for blood plasma) and specificity (99.3% for whole blood, 99.1% for fingerprick blood, and 99.6% for blood plasma) when compared to the Treponema pallidum particle agglutination (TPPA) assay, indicating its effectiveness in accurately diagnosing syphilis.

This test is particularly promising for use in resource-limited settings, as it can utilize various specimen types and still maintain high diagnostic performance, making syphilis screening and treatment more accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A dual point-of-care test shows good performance in simultaneously detecting nontreponemal and treponemal antibodies in patients with syphilis: a multisite evaluation study in China. Yin, YP., Chen, XS., Wei, WH., et al.[2021]

References

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

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

2. 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]

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

A dual point-of-care test shows good performance in simultaneously detecting nontreponemal and treponemal antibodies in patients with syphilis: a multisite evaluation study in China. [2021]

4. Egypt pubmed.ncbi.nlm.nih.gov

Canadian Public Health Laboratory Network laboratory guidelines for the use of point-of-care tests for the diagnosis of syphilis in Canada. [2020]

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

An evaluation of a novel dual treponemal/nontreponemal point-of-care test for syphilis as a tool to distinguish active from past treated infection. [2019]

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

Feasibility and Field Performance of a Simultaneous Syphilis and HIV Point-of-Care Test Based Screening Strategy in at Risk Populations in Edmonton, Canada. [2021]