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

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.

Detailed description

The EQUIP Study is a prospective, multicenter method-comparison study designed to evaluate the diagnostic performance of the Q-Pad hrHPV Test System for cervical cancer screening. Menstruating adults referred for colposcopy after an abnormal cervical screening result receive a mailed Q-Pad Kit and use it during the menstrual cycle immediately after their clinic visit to collect a menstrual samples at home, guided by written instructions and an optional accompanying smartphone application. These samples are returned by mail to a central laboratory, where hrHPV testing is performed using a PCR assay. At the colposcopy visit, clinicians obtain a standard cervical specimen for routine cytology and hrHPV testing on the same assay platform and perform colposcopy with biopsy as clinically indicated. Each participant therefore provides both an at-home menstrual sample (index test) and a clinician-collected cervical sample (comparator) within the same episode of care, with biopsy and histopathology providing disease status. The study focuses on comparing hrHPV results between the two specimen types and on evaluating safety, specimen adequacy, and participant usability and acceptability of the Q-Pad at-home menstrual collection approach.

Arms & interventions

• DeviceQ-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.

Outcome measures

Eligibility criteria