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NCT Number: NCT06645106

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

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.

Recruiting

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

  5. Percentage of participants that have psychiatric problems on completion of syphilis treatment

    Time frame: from presentation to delivery

  6. Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment

    Time frame: from presentation to delivery

  7. Percentage of participants that have unstable housing on completion of syphilis treatment

    Time frame: from presentation to delivery

  8. Percentage of participants that have transportation on completion of syphilis treatment

    Time frame: from presentation to delivery

  9. Percentage of participants that experience intimate partner violence on completion of syphilis treatment

    Time frame: from presentation to delivery

  10. number of prenatal care visits on completion of syphilis treatment

    Time frame: from presentation to delivery

  11. Percentage of participants that are married on completion of syphilis treatment

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

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

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

  13. Percentage of participants that have psychiatric problems on completion of syphilis treatment

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

  14. Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment

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

  15. Percentage of participants that have unstable housing on completion of syphilis treatment

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

  16. Percentage of participants that have transportation on completion of syphilis treatment

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

  17. Percentage of participants that experience intimate partner violence on completion of syphilis treatment

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

  18. number of prenatal care visits on completion of syphilis treatment

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

  19. Number of birth parents that have reinfection

    Time frame: from presentation to delivery

  20. Number of birth parents that have reinfection

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

  21. Number of neonates that have congenital syphilis

    Time frame: from presentation to delivery

  22. Number of neonates that have congenital syphilis

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

Study contacts

Contact information is provided by the study sponsor or research team.

Carrie Bakunas, MD

CONTACT

[email protected]

(713) 500-7878

Irene Stafford, MD

CONTACT

[email protected]

(713) 500-6412

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 16, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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