An interventional study of Rapid Point of Care (POC) Syphilis testing in Syphilis, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Diagnostic
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.
126 studies on the registry are indexed under Syphilis; 34 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 354 across 85 interventional studies indexed under Syphilis.
Browse Syphilis studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 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.
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
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)
Percentage of participants that have psychiatric problems on completion of syphilis treatment
Time frame: at time of postpartum (upto 15 months after delivery)
Percentage of participants that show substance abuse including alcohol on completion of syphilis treatment
Time frame: at time of postpartum (upto 15 months after delivery)
Percentage of participants that have unstable housing on completion of syphilis treatment
Time frame: at time of postpartum (upto 15 months after delivery)
Percentage of participants that have transportation on completion of syphilis treatment
Time frame: at time of postpartum (upto 15 months after delivery)
Percentage of participants that experience intimate partner violence on completion of syphilis treatment
Time frame: at time of postpartum (upto 15 months after delivery)
number of prenatal care visits on completion of syphilis treatment
Time frame: at time of postpartum (upto 15 months after delivery)
Number of birth parents that have reinfection
Time frame: from presentation to delivery
Number of birth parents that have reinfection
Time frame: at time of postpartum (upto 15 months after delivery)
Number of neonates that have congenital syphilis
Time frame: from presentation to delivery
Number of neonates that have congenital syphilis
Time frame: at time of postpartum (upto 15 months after delivery)
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Feb 2028, 35 months after the start.
Of 25 interventional studies with no phase under Syphilis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's planned 35 months is above that.
How these figures are worked out, and which studies are left out of them.
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