Implementation of an Opt-Out Testing and Rapid Diagnostic Strategy for Syphilis and HIV in Pregnant Patients Presenting to the Emergency Department (NCT07525076)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (4 items).
Location: The University of Texas Health Science Center at Houston — Houston, Texas
Age range: 14 Years to 45 Years
🧪 Interventions in This Study
- Chembio HIV/Syphilis rapid Point of Care (POC) test (DIAGNOSTIC_TEST)
- Laboratory-based HIV and syphilis testing (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- The University of Texas Health Science Center at Houston — Houston, Texas
📞 Contact the Study Coordinator
Phone: (713) 500-6412
Email: Irene.Stafford@uth.tmc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.