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

ConditionSyphilis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: Rapid Point of Care (POC) Syphilis testingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up

Time frame
within 1 week of presentation until the time of delivery
2

The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up

Time frame
at time of postpartum (upto 15 months after delivery)
3

Percentage of participants that are married on completion of syphilis treatment

Time frame
from presentation to delivery
4

Percentage of participants that have health insurance on completion of syphilis treatment

Time frame
from presentation to delivery

Other outcomes

Sponsors and contacts

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