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

NCT06645106 | Recruiting FDA Device

• 1 other identifier: HSC-MS-24-0505
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Syphilis

Keywords

syphilis diagnostic testing; pregnancy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (22)

• 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

Study Arms (1)

Rapid Point of Care (POC) Syphilis testing

EXPERIMENTAL

Device: Rapid Point of Care (POC) Syphilis testing

Interventions

Rapid Point of Care (POC) Syphilis testing DEVICE

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.

Rapid Point of Care (POC) Syphilis testing

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnant individuals with documented care and syphilis results in the index pregnancy for specific trimester as mandated by Texas law

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Syphilis

Interventions

Surgical Instruments; Syphilis Serodiagnosis

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies; Serologic Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Irene Stafford, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Stafford, MD

CONTACT

(713) 500-6412; Irene.Stafford@uth.tmc.edu

Carrie Bakunas, MD

CONTACT

(713) 500-7878; Carrie.A.Bakunas@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 16, 2024
• Study Start: February 4, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)