Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer
Qurasense
450 participants
Dec 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- You are 25 years old or older and have an intact cervix.
- You were referred for a colposcopy after an abnormal Pap or HPV screen.
- Your periods come regularly-about every 21-35 days.
- You own a smartphone, have an email address, and can read the Qvin app instructions in English.
- You are willing to sign the consent form (electronically).
- You agree to use a condom for any vaginal intercourse or shared penetrative toy use from Q-Pad collection until the colposcopy visit if engaging with a new sexual partner during this period.
Exclusion Criteria4
- You are pregnant or think you might be.
- You are unwilling or unable to use the two Q-Pads and mail them back (mailing costs are covered).
- You had treatment for cervical pre-cancer (CIN2+)-such as LEEP, cone, or ablation-within the last 12 months.
- You have already joined this study or are in another cervical-screening / HPV study right now.
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07281599