Routine and rapid point-of-care syphilis testing for pregnant people in the ER and OB triage
Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06645106 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.