The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Location status: Recruiting
Location contact
Carrie Bakunas, MD
CONTACT
Irene Stafford, MD
CONTACT
NCT Number: NCT06645106
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.
Interested in participating?
Request Info18 year–50 year
Female
Interventional
Not applicable
Houston, Texas, 77030, United States
Location status: Recruiting
Carrie Bakunas, MD
CONTACT
Irene Stafford, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: within 1 week of presentation until the time of delivery
Time frame: within 1 week of presentation until the time of delivery
Time frame: within 1 week of presentation until the time of delivery
Time frame: at time of postpartum (upto 15 months after delivery)
Time frame: from presentation to delivery
Time frame: from presentation to delivery
Time frame: from presentation to delivery
Time frame: from presentation to delivery
Time frame: from presentation to delivery
Time frame: from presentation to delivery
Time frame: from presentation to delivery
Time frame: from presentation to delivery
Time frame: at time of postpartum (upto 15 months after delivery)
Time frame: at time of postpartum (upto 15 months after delivery)
Time frame: at time of postpartum (upto 15 months after delivery)
Time frame: at time of postpartum (upto 15 months after delivery)
Time frame: at time of postpartum (upto 15 months after delivery)
Time frame: at time of postpartum (upto 15 months after delivery)
Time frame: at time of postpartum (upto 15 months after delivery)
Time frame: at time of postpartum (upto 15 months after delivery)
Time frame: from presentation to delivery
Time frame: at time of postpartum (upto 15 months after delivery)
Time frame: from presentation to delivery
Time frame: at time of postpartum (upto 15 months after delivery)
Contact information is provided by the study sponsor or research team.
Carrie Bakunas, MD
CONTACT
Irene Stafford, MD
CONTACT
The University of Texas Health Science Center, Houston
Other
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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