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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Not yet enrolling

Conditions

Syphilis

Treatments

Device: Rapid Point of Care (POC) Syphilis testing

Study type

Interventional

Funder types

Other

Identifiers

NCT06645106
HSC-MS-24-0505

Details and patient eligibility

About

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.

Enrollment

1,500 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,500 participants in 1 patient group

Rapid Point of Care (POC) Syphilis testing
Experimental group
Treatment:
Device: Rapid Point of Care (POC) Syphilis testing

Trial contacts and locations

1

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Central trial contact

Carrie Bakunas, MD; Irene Stafford, MD

Data sourced from clinicaltrials.gov

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