NCT07525076

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,400 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: Female
• Age: 14 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Syphilis Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Chembio HIV/Syphilis rapid Point of Care (POC) test	Participants will undergo dual rapid HIV/syphilis testing by fingerstick using the Chembio DPP® HIV-Syphilis System.
DIAGNOSTIC_TEST	Laboratory-based HIV and syphilis testing	Laboratory-based HIV and syphilis testing

Timeline

• Start date: 2026-04-15
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study