๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-01-22

Single Visit Clinical Validation of ScreenFire, a Low-cost HPV Test (NCT05431699)

SCALE: Single Visit Clinical Validation of ScreenFire, a Low-cost HPV Test: Efficacy and Cost Effectiveness

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic ๐Ÿฉบ Clinical Procedure Protocol Sponsor: The Cleveland Clinic

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The purpose of this study is to validate a new low-cost, self-collected HPV screening test (ScreenFire) and compare it to the standard provider collected careHPV, for the detection of high grade cervical cancer.

Who can join: Review the eligibility criteria below.

Location: Ministerio de Salud โ€” San Salvador

Age range: 30 Years to 59 Years

๐Ÿงช Interventions in This Study

  • ScreenFire HPV test (DIAGNOSTIC_TEST)
  • careHPV test (DIAGNOSTIC_TEST)
  • Colposcopy and biopsy (PROCEDURE)
  • Gas-based cryotherapy (PROCEDURE)
  • Thermal ablation (PROCEDURE)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Ministerio de Salud โ€” San Salvador,

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—