Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department

The purpose of this study is to offer routine lab-based and rapid point of care (POC) syphilis diagnostic testing in the emergency department (ED) and obstetrical (OB) triage , thereby increasing screening and treatment initiation for pregnant patients without prenatal care or with no documented syphilis results during the index pregnancy in other to increase rates of full treatment to determine if the implementation of a robust linkage to care program for pregnant patients with positive rapid POC results will more likely result in complete treatment for all stages of syphilis and adherence to recommended maternal and newborn longitudinal follow up and to assess factors that contribute to treatment completion after implementation of the intervention will also be analyzed to tailor efforts targeting social and healthcare navigation factors that affect health equity; including poverty, insurance, health literacy and others.

Study Overview

• Status: Recruiting
• Conditions: Syphilis
• Intervention / Treatment: Device: Rapid Point of Care (POC) Syphilis testing

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irene Stafford, MD; Phone Number: (713) 500-6412; Email: Irene.Stafford@uth.tmc.edu
• Study Contact Backup: Name: Carrie Bakunas, MD; Phone Number: (713) 500-7878; Email: Carrie.A.Bakunas@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Irene Stafford, MD; Phone Number: 713-500-6412; Email: irene.stafford@uth.tmc.edu
      • Contact: Carrie Bakunas, MD; Phone Number: (713) 500-7878; Email: Carrie.A.Bakunas@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Rapid Point of Care (POC) Syphilis testing

Device: Rapid Point of Care (POC) Syphilis testing; Participants will undergo the point of care (POC) FDA cleared syphilis health check (SHC) POC test by a research staff using 50 microliters or 1-3 drops of whole blood via finger stick. The analyzer is handheld, and all testing equipment is temperature stable and does not need refrigeration. The SHC-Syphilis results will be available within 10 minutes of receipt given the published turnaround time to results of 15 minutes per package insert and will be recorded as a research note in the electronic medical record (EMR) while the provider assigned to the patient and the Houston Health Department will be notified of results and further treatment will be done if results are positive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients without prenatal care during the index pregnancy who received full treatment for all stages of syphilis	within 1 week of presentation until the time of delivery
Percentage of patients with no documented syphilis test during the index pregnancy who received full treatment for all stages of syphilis	within 1 week of presentation until the time of delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up	within 1 week of presentation until the time of delivery
The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up	at time of postpartum (upto 15 months after delivery)
Percentage of participants that are married on completion of syphilis treatment	from presentation to delivery
Percentage of participants that have health insurance on completion of syphilis treatment	from presentation to delivery
Percentage of participants that have psychiatric problems on completion of syphilis treatment	from presentation to delivery
Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment	from presentation to delivery
Percentage of participants that have unstable housing on completion of syphilis treatment	from presentation to delivery
Percentage of participants that have transportation on completion of syphilis treatment	from presentation to delivery
Percentage of participants that experience intimate partner violence on completion of syphilis treatment	from presentation to delivery
number of prenatal care visits on completion of syphilis treatment	from presentation to delivery
Percentage of participants that are married on completion of syphilis treatment	at time of postpartum (upto 15 months after delivery)
Percentage of participants that have health insurance on completion of syphilis treatment	at time of postpartum (upto 15 months after delivery)
Percentage of participants that have psychiatric problems on completion of syphilis treatment	at time of postpartum (upto 15 months after delivery)
Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment	at time of postpartum (upto 15 months after delivery)
Percentage of participants that have unstable housing on completion of syphilis treatment	at time of postpartum (upto 15 months after delivery)
Percentage of participants that have transportation on completion of syphilis treatment	at time of postpartum (upto 15 months after delivery)
Percentage of participants that experience intimate partner violence on completion of syphilis treatment	at time of postpartum (upto 15 months after delivery)
number of prenatal care visits on completion of syphilis treatment	at time of postpartum (upto 15 months after delivery)
Number of birth parents that have reinfection	from presentation to delivery
Number of birth parents that have reinfection	at time of postpartum (upto 15 months after delivery)
Number of neonates that have congenital syphilis	from presentation to delivery
Number of neonates that have congenital syphilis	at time of postpartum (upto 15 months after delivery)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Irene Stafford, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pregnancy; syphilis diagnostic testing
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Spirochaetales Infections; Sexually Transmitted Diseases, Bacterial; Treponemal Infections; Syphilis; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Equipment; Equipment and Supplies; Immunologic Techniques; Immunologic Tests; Serologic Tests; Surgical Instruments; Syphilis Serodiagnosis
• Other Study ID Numbers: HSC-MS-24-0505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No