Implementation of an Opt-Out Testing and Rapid Diagnostic Strategy for Syphilis and HIV in Pregnant Patients Presenting to the Emergency Department

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age14-45
SponsorThe University of Texas Health Science Center, Houston

About this trial

The purpose of this study is to evaluate infection detection and treatment initiation rates for syphilis and HIV before and after integration of the Chembio DPP® HIV-Syphilis rapid POC test into an ongoing Emergency Department (ED) testing program and to determine whether dual rapid testing improves early initiation of HIV therapy in pregnant patients with newly identified HIV infection.

Eligibility criteria

Qualifiers

Pregnancy

Presentation to the ED or obstetrical triage during the index pregnancy.

No established prenatal care (≤1 visit) and/or no documented HIV or syphilis testing during the current pregnancy.

Disqualifiers

Medically unstable or critically ill at the time of ED presentation.

Incarcerated at the time of ED presentation.

Decline participation in testing (opt-out) or refuse survey participation.

Trial design

Treatments tested in this trial

  • Chembio HIV/Syphilis rapid Point of Care (POC) test
  • Laboratory-based HIV and syphilis testing

Treatment groups

1,400 Participants
are divided into 1 treatment group

Sponsors and collaborators

The University of Texas Health Science Center, Houston

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator