Not Yet RecruitingNot Applicable

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

United States1,400 participantsStarted 2026-04-15

Plain-language summary

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.

Who can participate

Age range14 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of participants that tested for HIV

Timeframe: Baseline

Number of participants that tested for syphilis

Timeframe: Baseline

Number of participants that tested positive for syphilis and who receive same-visit treatment initiation with Benzathine Penicillin G according to the Centers for Disease Control and Prevention (CDC) 2021 Guidelines.

Timeframe: about 15 minutes after baseline

Trial details

NCT IDNCT07525076

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05-31

Contact for this trial

Irene Stafford, M.D., M.S., M.P.H.

(713) 500-6412 Irene.Stafford@uth.tmc.edu

View on ClinicalTrials.gov More HIV Infections trials

Plain-language summary

Who can participate

Age range14 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants that tested for HIV

Timeframe: Baseline

Number of participants that tested for syphilis

Timeframe: Baseline

Timeframe: about 15 minutes after baseline