Routine and rapid point-of-care syphilis testing for pregnant people in the ER and OB triage
Official title: Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department
Run by The University of Texas Health Science Center, Houston · NCT06645106 · Data updated 2026-11-12
This project will offer quick point-of-care and standard lab syphilis tests in the emergency department and obstetric triage to see if that helps pregnant people without prenatal care get diagnosed and start treatment sooner.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 1500 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | February 4, 2025 |
| Main results expected | February 1, 2028 |
| Study ends | February 1, 2028 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT06645106 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant individuals presenting to the University of Texas/ Memorial Hermann/ Lyndon B. Johnson emergency departments or obstetrical triage who have no prenatal care during the index pregnancy or no documented syphilis result during the index pregnancy.
✕Probably not a fit
Pregnant individuals who already have documented prenatal care with recorded syphilis test results for the current pregnancy or those who decline testing are unlikely to benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This program offers both standard laboratory and rapid point-of-care syphilis testing to pregnant patients who present to emergency departments or obstetrical triage and who lack prenatal care or documented syphilis results. Patients with positive rapid tests are linked to a robust care-navigation pathway intended to initiate and complete appropriate treatment and to arrange maternal and newborn follow-up. The study will track treatment completion rates across all syphilis stages and measure adherence to recommended longitudinal follow-up. Social and healthcare navigation factors such as poverty, insurance status, and health literacy will be analyzed to tailor interventions that improve health equity.
Why it matters
Potential benefit: If successful, this approach could increase timely diagnosis and completed treatment for syphilis in pregnancy and reduce the risk of congenital syphilis.
How similar studies have gone: Similar programs using rapid point-of-care syphilis testing have improved screening and treatment initiation in many settings, though their success often depends on effective linkage-to-care and follow-up systems.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant individuals that are 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
Where it's running
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The University of Texas Health Science Center at Houston
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Irene Stafford, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Irene Stafford, MD
- Email: Irene.Stafford@uth.tmc.edu
- Phone: (713) 500-6412
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.