Improving newborn syphilis testing
Official title: Modernizing Perinatal Syphilis Testing
Funded at University of Texas Hlth Sci Ctr Houston · NIH-11241983 · Data updated 2026-11-12
This project will use newer lab tests on mothers and newborns to find syphilis earlier so babies can get treatment sooner.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Texas Hlth Sci Ctr Houston NIH-funded |
| Lab location | 1 site (Houston, United States) |
| Project start | December 21, 2022 |
| Project end | November 30, 2027 |
| Funding year | 2026 |
| Award (this year) | $654,908 |
| NIH project number | 5R01HD108201-04 |
| Project ID | NIH-11241983 on NIH RePORTER |
Who could benefit from this research
✓Could help
Pregnant people with positive or uncertain syphilis test results or other risk factors and their newborns who deliver at participating hospitals are the intended candidates.
✕Less likely to help
People without maternal syphilis exposure or newborns already clearly uninfected are unlikely to receive direct benefit from participation.
What this research studies
If you join, researchers will collect samples from you and your newborn at or soon after birth and run modern molecular tests that look directly for the syphilis bacterium. They will enroll about 924 mother–baby pairs at several hospitals and follow the babies over time to see who develops confirmed congenital syphilis. The new tests include real-time qPCR and the Aptima TMA assay and will be compared to the current diagnostic categories used at birth under 2021 guidelines. Doctors will combine these test results with routine clinical follow-up to determine whether the molecular tests identify infection earlier than existing care.
Why it matters
Potential benefit: If successful, these tests could diagnose congenital syphilis at or soon after birth, reducing delayed or missed treatment and preventing avoidable harm.
How similar studies have gone: Early lab and small clinical studies suggest nucleic acid tests can detect Treponema pallidum, but large multicenter clinical validation is still limited.
Where this research is happening
-
University of Texas Hlth Sci Ctr Houston
Houston, United States Active
Researchers
- Principal investigator: Stafford, Irene a. — University of Texas Hlth Sci Ctr Houston
- Study coordinator: Stafford, Irene a.
Related research
Other NIH-funded projects on the same topics.
-
Syphilis in Pregnancy: Understanding Infection in Moms and Babies
A study following pregnant women with syphilis and their babies to learn how the infection affects pregnancy and newborn health.
-
Syphilis in Pregnancy: Molecular Tests and Immune Responses in Mom and Baby
A study to understand how syphilis affects pregnancy and newborns by using molecular tests and tracking immune responses in 750 pregnant women with syphilis and their babies.
-
Crowdsourced digital messaging to boost syphilis and HIV testing for women in NYC and rural Alabama
A community-driven project tests whether crowdsourced digital messages can encourage women, especially women of color and Native American women, to get syphilis, HIV, and STI tests.
-
Preventing syphilis in pregnant people in Rio de Janeiro
A clinical trial in Brazil tests a pregnancy-safe antibiotic plan to stop syphilis from affecting babies.
-
Cefixime vs Penicillin G for Early Syphilis in HIV and non-HIV patients
This project compares a cefixime-based treatment to standard penicillin for early syphilis in people with and without HIV.
-
Preventing congenital syphilis in pregnant people at risk in Rio de Janeiro
A clinical trial will test a treatment approach during pregnancy to reduce syphilis transmission from mother to baby for pregnant people at risk in Rio de Janeiro.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.