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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to provide quick and easy syphilis testing in emergency and obstetrical units for pregnant individuals who haven't received prenatal care or syphilis testing. By using rapid point-of-care (POC) tests, the trial seeks to start treatment sooner and ensure both mother and baby receive proper follow-up care. It also examines factors like poverty and health understanding that might impact treatment completion. Pregnant individuals at specific Texas hospitals without prior prenatal care or syphilis testing results are ideal candidates for this trial. As an unphased trial, it offers a unique opportunity to improve healthcare access and outcomes for underserved populations.

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 prior data suggests that this rapid point of care syphilis testing is safe?

Research has shown that the rapid point of care (POC) syphilis test, such as the Syphilis Health Check, has received FDA approval. This approval confirms its safety and effectiveness in diagnosing syphilis. Studies have found these tests easy to use and integral to syphilis testing programs. Designed for speed and simplicity, they provide fast results and treatment, particularly benefiting those who may not regularly visit a doctor. No major reports of negative side effects from the test itself have emerged. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Rapid Point of Care (POC) testing for syphilis because it offers significant advantages over traditional syphilis testing methods. Unlike standard lab tests that can take days to deliver results, POC testing provides quick results, often within minutes, allowing for immediate clinical decisions and timely treatment. This rapid feedback is especially crucial in controlling the spread of syphilis, as it enables healthcare providers to diagnose and treat patients in a single visit. Additionally, POC testing simplifies the testing process, making it more accessible in resource-limited settings where lab facilities may not be available.

What evidence suggests that rapid POC testing is effective for syphilis?

Research has shown that Rapid Point of Care (POC) syphilis testing, which participants in this trial will receive, is highly effective at detecting the infection. One study found that the test correctly identifies people with syphilis 97% of the time. Another study showed it correctly identifies 93.4% of cases and rarely gives a false positive, with 99.5% accuracy in this regard. This reliability makes the test suitable for quick and accurate syphilis detection. Fast results also allow for immediate treatment, crucial for managing the infection, especially in pregnant patients. This can improve the chances of complete treatment and proper follow-up, addressing health factors like access to care and insurance. ^{1 2 3 5 6}

Who Is on the Research Team?

Irene Stafford, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7312211/

Clinical Test Performance of a Rapid Point-of-Care Syphilis ... Using nontreponemal supplemental testing, the sensitivity improved to a pooled sensitivity of 97.0% (94.8–98.6%). The Syphilis Health Check may ...

2. journals.asm.org journals.asm.org/doi/10.1128/jcm.00244-25

a de novo rapid test for treponemal antibody - ASM Journals The FTK test demonstrated excellent overall clinical performance, with 93.4% sensitivity and 99.5% specificity, confirming its reliability for ...

3. cdc.gov cdc.gov/mmwr/volumes/73/rr/rr7301a1.htm

CDC Laboratory Recommendations for Syphilis Testing, ... A 2019 study demonstrated that 11% of 526,540 reactive nontreponemal tests were not associated with syphilis, and in those cases, the tests were ...

4. hhs.gov hhs.gov/sites/default/files/nscss-considerations-for-the-implementation-of-syphilis-poc-tests.pdf

nscss-considerations-for-the-implementation-of-syphilis- ... Counseling, education, and outreach: The rapid results of POC tests for syphilis create new opportunities for testing, treatment, and outreach.

5. bmjopen.bmj.com bmjopen.bmj.com/content/14/12/e089021

Syphilis Point of Care Rapid Test and Immediate Treatment ... This study assesses the real-world implementation and effectiveness of using a recently approved syphilis point-of-care test in conjunction with public health ...

6. globalpointofcare.abbott globalpointofcare.abbott/ww/en/product-details/determine-syphilis.html

Determine™ Syphilis TP Determine™ Syphilis TP is an in vitro, visually read, qualitative immunoassay used to detect antibodies to Treponema pallidum in human serum, plasma, and whole ...