Modernizing Perinatal Syphilis Testing (NCT06082453)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to determine the testing performance of real-time quantitative polymerase chain reaction and transcription mediated amplification by comparing test performance of these novel molecular tests to current 2021 CDC CS guidelines for maternal/neonatal dyads at risk for syphilis infection and to determine whether CS is associated with adverse neurodevelopmental outcomes.
Who can join: Review the eligibility criteria below.
Location: University of Southern California — Los Angeles, California
Age range: Not specified to 45 Years
🧪 Interventions in This Study
- Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum (DIAGNOSTIC_TEST)
- Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum (DIAGNOSTIC_TEST)
- Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- University of Southern California — Los Angeles, California
- University of California, Los Angeles — Los Angeles, California
- Johns Hopkins University — Baltimore, Maryland
- Kennedy Krieger Institute — Baltimore, Maryland
- Nationwide Children's Hospital — Columbus, Ohio
- Baylor College of Medicine — Houston, Texas
- Texas Children's Hospital — Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas
- Christus Health — 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.
More studies in Syphilis
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- Linezolid for Syphilis Pilot Study — Chicago, Illinois
- Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department — Houston, Texas
- Daily Doxycycline for Early Syphillis — Seattle, Washington
- Cefixime Clinical Trial — Los Angeles, California
- A Cross-sectional Investigational Study to Evaluate the Sensitivity, Specificity, and Utility of the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) to Diagnose Infectious Syphilis in Participants Attending the Sexual Health Clinic in Ottawa, Ontario. — Ottawa, Ontario
Explore by condition: All Syphilis clinical trials
💡 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.