Clinical Research Directory
Browse clinical research sites, groups, and studies.
Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer
Sponsor: Qurasense
Summary
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.
Key Details
Gender
FEMALE
Age Range
25 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2025-12-01
Completion Date
2027-03
Last Updated
2026-02-02
Healthy Volunteers
Yes
Conditions
Interventions
Q-Pad hrHPV Test System
Participants will receive a mailed Q-Pad Kit, which includes two Q-Pads (menstrual pads with removable collection strips called Q-Strips), a Q-Strip Container with desiccant for storing and shipping the strips, and a prepaid return mailer. During the menstrual cycle after their colposcopy visit, participants will follow the Instructions for Use to passively collect menstrual blood with the Q-Pads, then remove the Q-Strips and place them in the Q-Strip Container for mailing to the central laboratory for hrHPV testing. At the colposcopy visit, the clinician will also collect a cervical sample in ThinPrep liquid-based cytology medium for hrHPV testing, which will serve as the comparator specimen.
Locations (4)
Planned Parenthood of Southern New England
New Haven, Connecticut, United States
Planned Parenthood North Central States
Minneapolis, Minnesota, United States
Planned Parenthood of Greater Ohio (PPGOH)
Akron, Ohio, United States
Planned Parenthood Association of Utah
Salt Lake City, Utah, United States