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

NCT07525076

Not Yet RecruitingNA

Sponsor: The University of Texas Health Science Center, Houston

Conditions: HIV Infections, Syphilis Infection

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

Countries: United States

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 overview

Sex: FEMALE

Age: 14 Years to 45 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Locations (1)

Houston, Texas, United States