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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06645106
Status
Recruiting
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Conditions

  • Syphilis

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Feb 4, 2025
Status verified
May 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2028

Study Design

Enrollment
1,500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Rapid Point of Care (POC) Syphilis testing

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Irene Stafford, MD
[email protected]
713-500-6412
Carrie Bakunas, MD
[email protected]
(713) 500-7878

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