~1000 spots leftby Dec 2030

Rapid POC Testing for Syphilis

Recruiting in Palo Alto (17 mi)
Overseen byIrene Stafford, MD
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: The University of Texas Health Science Center, Houston
No Placebo Group

Trial Summary

What is the purpose of this trial?

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

This trial is for pregnant patients who come to the emergency department or obstetrical triage without prenatal care or documented syphilis tests during their current pregnancy. It aims to help those who might face barriers like poverty, lack of insurance, and low health literacy.

Inclusion Criteria

Pregnant individuals 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

Treatment Details

Interventions

  • Rapid Point of Care (POC) Syphilis testing (Diagnostic Test)
Trial OverviewThe study is testing whether offering routine lab-based and rapid point-of-care syphilis tests can increase screening and treatment initiation in pregnant women. It also examines if a strong support program leads to complete treatment adherence.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Rapid Point of Care (POC) Syphilis testingExperimental Treatment1 Intervention

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
The University of Texas Health Science Center at HoustonHouston, TX
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Who Is Running the Clinical Trial?

The University of Texas Health Science Center, HoustonLead Sponsor

References