About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Q-Pad hrHPV Test System

Treatment groups

450 Participants
are divided into 1 treatment group

Locations

4
Planned Parenthood of Southern New England06511, New HavenConnecticut, United States
Planned Parenthood North Central States55408, MinneapolisMinnesota, United States
Planned Parenthood of Greater Ohio (PPGOH)44302, AkronOhio, United States
Planned Parenthood Association of Utah84102, Salt Lake CityUtah, United States

Sponsors and collaborators

Qurasense

Lead sponsor