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

Not Applicable

Not yet recruiting

• Conditions: Syphilis

• Registration Number: NCT06645106
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-14
• Study First Posted: 2024-10-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06
• Study Start: 2025-01-06
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of patients without prenatal care during the index pregnancy who received full treatment for all stages of syphilis	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	within 1 week of presentation until the time of delivery

Secondary Outcome Measures

Name	Time	Method
The percentage of patients who adhere to recommended maternal and newborn longitudinal follow up	at time of postpartum (upto 15 months after delivery)
Percentage of participants that are married on completion of syphilis treatment	at time of postpartum (upto 15 months after delivery)
Percentage of participants that have health insurance on completion of syphilis treatment	at time of postpartum (upto 15 months after delivery)
Percentage of participants that have psychiatric problems on completion of syphilis treatment	at time of postpartum (upto 15 months after delivery)
Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment	at time of postpartum (upto 15 months after delivery)
Percentage of participants that have unstable housing on completion of syphilis treatment	at time of postpartum (upto 15 months after delivery)
Percentage of participants that have transportation on completion of syphilis treatment	at time of postpartum (upto 15 months after delivery)
Percentage of participants that experience intimate partner violence on completion of syphilis treatment	at time of postpartum (upto 15 months after delivery)
number of prenatal care visits on completion of syphilis treatment	at time of postpartum (upto 15 months after delivery)
Number of birth parents that have reinfection	at time of postpartum (upto 15 months after delivery)
Number of neonates that have congenital syphilis	at time of postpartum (upto 15 months after delivery)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States