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.
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 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.
Single group
Q-Pad hrHPV Test System
DeviceParticipants 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.
Clinical Performance vs Histology
Clinical sensitivity defined as the proportion of participants with biopsy-confirmed CIN2+ whose menstrual-blood hrHPV result (Q-Pad hrHPV Test System) is positive and Clinical specificity defined as the proportion of participants with \<CIN2 on histology whose menstrual-blood hrHPV result is negative.
Proportion of participants with at least one reportable device-related adverse event (ADE or SADE)
Proportion of participants who experience at least one adverse event or device deficiency that is not on the protocol's non-reportable event list.
Positive, negative, and overall percent agreement between Q-Pad hrHPV testing and clinician-collected cervical hrHPV testing
Positive percent agreement (PPA), negative percent agreement (NPA), and overall percent agreement (concordance) between the Q-Pad hrHPV Test System result on menstrual blood (index test) and the hrHPV result from the paired clinician-collected cervical ThinPrep specimen (comparator test).
Q-Pad hrHPV Test System validity rate and participant usability/acceptability
Proportion of returned Q-Pad menstrual collections that yield a valid hrHPV test result in the central laboratory (i.e., not invalid or quantity-not-sufficient \[QNS\]), together with participant usability and acceptability scores for the Q-Pad kit.
CIN3+ Clinical Sensitivity & Specificity
Using biopsy as reference, calculate clinical sensitivity/specificity of Q-Pad hrHPV for detecting CIN3+ lesions
