Actively Recruiting
Offering Routine and Rapid Point of Care Syphilis Testing in Pregnant Patients Presenting to the Emergency Department
Led by The University of Texas Health Science Center, Houston · Updated on 2026-05-06
1500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to improve syphilis screening and treatment in pregnant patients who come to the emergency department or obstetrical triage without prenatal care or documented syphilis test results during their current pregnancy. It evaluates whether offering routine lab-based and rapid point of care (POC) syphilis testing along with a strong follow-up care program can increase the rates of full treatment for all stages of syphilis. The study also looks at social and healthcare factors like poverty, insurance, and health literacy that might affect treatment completion and health equity. Participants will receive a rapid POC syphilis test using a handheld device that analyzes a small blood sample from a finger stick, providing results within about 10 minutes. Positive results will be recorded in the medical record, and the care team and health department will be notified for timely treatment. This study focuses on pregnant patients without prenatal care or syphilis test documentation during pregnancy, aiming to link them to care effectively. Participants will be followed from the time of testing until delivery and up to 15 months postpartum to assess treatment completion and adherence to recommended maternal and newborn follow-up care. Researchers will collect data on social factors, prenatal visits, reinfection rates, and cases of congenital syphilis. The main outcomes include the percentage of patients who receive full treatment within one week of presentation and maintain follow-up through delivery and postpartum. The study runs until February 2028 and is sponsored by The University of Texas Health Science Center, Houston.
CONDITIONS
Brief Title
Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant individuals seeking care at University of Texas, Memorial Herman, and Lyndon B Johnson emergency departments or obstetrical triage units
- No prenatal care during the current pregnancy
- No documented syphilis test results during the current pregnancy
You will not qualify if you...
- Pregnant individuals with documented prenatal care and syphilis test results during the current pregnancy for the specific trimester as required by Texas law
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo rapid point of care syphilis testing using a handheld device that provides results within 10 minutes. Testing is performed by research staff using a finger stick blood sample.
1 visit (in-person)
Duration - Up to 15 months postpartum
Participants are monitored for adherence to recommended maternal and newborn follow-up care, syphilis treatment completion, and health and social factors from presentation until delivery and up to 15 months postpartum.
Follow-up visits as part of routine care up to delivery and postpartum
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
I
Irene Stafford, MD
C
Carrie Bakunas, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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