SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening (NCT06120205)
SELF-CERV Pivotal Study: Method Comparison of Self-collection Using the Teal Wand Self-Collection Device and HCP (Health Care Provider) Cervical Collection for Detection of High-risk HPV (hrHPV) for Cervical Cancer Screening
🩺 Plain-English Summary (8th-Grade Level)
The goal of this method comparison study is to compare the detection of hrHPV collected using the Teal Wand Self-Collection device to hrHPV detected from HCP (health care provider) cervical collection using primary HPV testing assays. Participants will be asked to use the Teal Wand to provide a self-collected sample prior to a healthcare provider collected sample to be tested for hrHPV. Secondary measure will include usability and preferences.
Who can join: Review the eligibility criteria below.
Location: Birmingham OBGYN / Alabama Clinical Therapeutics — Birmingham, Alabama
Age range: 25 Years to 65 Years
🧪 Interventions in This Study
📋 "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 (15 Sites)
- Birmingham OBGYN / Alabama Clinical Therapeutics — Birmingham, Alabama
- Planned Parenthood Northern California — San Francisco, California
- University of Colorado Anschutz Medical Campus — Aurora, Colorado
- Planned Parenthood Southern New England — New Haven, Connecticut
- Yale University — New Haven, Connecticut
- Woman's Hospital — Baton Rouge, Louisiana
- Johns Hopkins University — Baltimore, Maryland
- Planned Parenthood League of Massachusetts — Boston, Massachusetts
- Planned Parenthood St. Louis Region — St Louis, Missouri
- Washington University — St Louis, Missouri
- New York University Langone Hospital — Mineola, New York
- Unified Women's Clinical Research Raleigh — Raleigh, North Carolina
- Unified Women's Clinical Research - Lyndhurst — Winston-Salem, North Carolina
- Planned Parenthood Gulf Coast — Houston, Texas
- University of Wisconsin - Madison — Madison, Wisconsin
💰 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.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.