Clinical trial NCT06645106: Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department
Official title: Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Syphilis
Keywords: syphilis diagnostic testing
pregnancy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Percentage of patients without prenatal care during the index pregnancy who received full treatment for all stages of syphilis
timeFrame: within 1 week of presentation until the time of delivery
measure: Percentage of patients with no documented syphilis test during the index pregnancy who received full treatment for all stages of syphilis
timeFrame: within 1 week of presentation until the time of delivery
Secondary outcomes:
measure: The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up
timeFrame: within 1 week of presentation until the time of delivery
measure: The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up
timeFrame: at time of postpartum (upto 15 months after delivery)
measure: Percentage of participants that are married on completion of syphilis treatment
timeFrame: from presentation to delivery
measure: Percentage of participants that have health insurance on completion of syphilis treatment
timeFrame: from presentation to delivery
measure: Percentage of participants that have psychiatric problems on completion of syphilis treatment
timeFrame: from presentation to delivery
measure: Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment
timeFrame: from presentation to delivery
measure: Percentage of participants that have unstable housing on completion of syphilis treatment
timeFrame: from presentation to delivery
measure: Percentage of participants that have transportation on completion of syphilis treatment
timeFrame: from presentation to delivery
measure: Percentage of participants that experience intimate partner violence on completion of syphilis treatment
timeFrame: from presentation to delivery
measure: number of prenatal care visits on completion of syphilis treatment
timeFrame: from presentation to delivery
measure: Percentage of participants that are married on completion of syphilis treatment
timeFrame: at time of postpartum (upto 15 months after delivery)
measure: Percentage of participants that have health insurance on completion of syphilis treatment
timeFrame: at time of postpartum (upto 15 months after delivery)
measure: Percentage of participants that have psychiatric problems on completion of syphilis treatment
timeFrame: at time of postpartum (upto 15 months after delivery)
measure: Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment
timeFrame: at time of postpartum (upto 15 months after delivery)
measure: Percentage of participants that have unstable housing on completion of syphilis treatment
timeFrame: at time of postpartum (upto 15 months after delivery)
measure: Percentage of participants that have transportation on completion of syphilis treatment
timeFrame: at time of postpartum (upto 15 months after delivery)
measure: Percentage of participants that experience intimate partner violence on completion of syphilis treatment
timeFrame: at time of postpartum (upto 15 months after delivery)
measure: number of prenatal care visits on completion of syphilis treatment
timeFrame: at time of postpartum (upto 15 months after delivery)
measure: Number of birth parents that have reinfection
timeFrame: from presentation to delivery
measure: Number of birth parents that have reinfection
timeFrame: at time of postpartum (upto 15 months after delivery)
measure: Number of neonates that have congenital syphilis
timeFrame: from presentation to delivery
measure: Number of neonates that have congenital syphilis
timeFrame: at time of postpartum (upto 15 months after delivery)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Irene Stafford, MD
role: PRINCIPAL_INVESTIGATOR
References: