NCT06645106 Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department
| NCT ID | NCT06645106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Syphilis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2025-02-04 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,500 participants in total. It began in 2025-02-04 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Irene Stafford, MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT06645106 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Syphilis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06645106 currently recruiting?
Yes, NCT06645106 is actively recruiting participants. Contact the research team at Irene.Stafford@uth.tmc.edu for enrollment information.
Where is the NCT06645106 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06645106 clinical trial?
NCT06645106 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Irene Stafford, MD at The University of Texas Health Science Center, Houston. The trial plans to enroll 1,500 participants.