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Recruiting NCT06645106

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

No phase Interventional Syphilis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rapid Point of Care (POC) Syphilis testing.
Who it may be relevant to
Registry conditions: Syphilis. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device 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 electron

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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]
  • 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)]
  • Percentage of participants that are married on completion of syphilis treatment [Time frame: from presentation to delivery]
  • Percentage of participants that have health insurance on completion of syphilis treatment [Time frame: from presentation to delivery]
  • Percentage of participants that have psychiatric problems on completion of syphilis treatment [Time frame: from presentation to delivery]
  • Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment [Time frame: from presentation to delivery]
  • Percentage of participants that have unstable housing on completion of syphilis treatment [Time frame: from presentation to delivery]
  • Percentage of participants that have transportation on completion of syphilis treatment [Time frame: from presentation to delivery]
  • Percentage of participants that experience intimate partner violence on completion of syphilis treatment [Time frame: from presentation to delivery]
  • number of prenatal care visits on completion of syphilis treatment [Time frame: from presentation to delivery]
  • Percentage of participants that are married on completion of syphilis treatment [Time frame: at time of postpartum (upto 15 months after delivery)]
  • Percentage of participants that have health insurance on completion of syphilis treatment [Time frame: at time of postpartum (upto 15 months after delivery)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06645106 · HSC-MS-24-0505

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗