Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer

The EQUIP Study is testing whether high-risk human papillomavirus (hrHPV), the virus that causes most cervical cancers, can be accurately detected from menstrual blood collected at home. People who have been referred for colposcopy after an abnormal Pap or hrHPV test will use the Q-Pad Kit during their period to collect menstrual samples on a special menstrual pad and mail them to a central laboratory for hrHPV testing. The same participants will have a standard cervical sample collected for routine hrHPV testing and will undergo colposcopy as part of their usual care. By comparing hrHPV results from menstrual samples with results from cervical samples and biopsy findings, the study will evaluate how well the Q-Pad hrHPV Test System detects cervical precancer and will also assess how easy and acceptable it is for participants to use this at-home collection method.

NCT Number	NCT07281599
Lead Sponsor	Qurasense
Conditions	HPV Infection, HPV 16 Infection, High Risk HPV, Cervical Cancer Screening, Cervical Cancer Cin Grade, Cervical Cancer (Early Detection), HPV, HPV (Human Papillomavirus)-Associated +3 more
Enrollment	450 participants
Start Date	2025-12-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2026-07-24