Recruiting

Syphilis Testing

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06645106

Conditions

Syphilis

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Rapid Point of Care (POC) Syphilis testing

Study Details

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

Study ID

NCT06645106

Start date

Feb 4, 2025

Status verified date

May, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

1500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Rapid Point of Care (POC) Syphilis testing

Interventions

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.

Primary outcome measure

  • Percentage of patients without prenatal care during the index pregnancy who received full treatment for all stages of syphilis [ Time Frame: 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 [ Time Frame: within 1 week of presentation until the time of delivery ]

Central Contacts and Locations

Central contacts

Irene Stafford, MD

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

Carrie Bakunas, MD

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Irene Stafford, MD

713-500-6412Irene.Stafford@uth.tmc.edu

Carrie Bakunas, MD

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • syphilis diagnostic testing
  • pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-05-06.