Q-Pad hrHPV Test for Cervical Cancer Screening

(EQUIP Trial)

Recruiting at 3 trial locations

Overseen By Brian Weinberg, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Qurasense

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

At a later clinic visit, 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.

Who Is on the Research Team?

Paul Blumenthal, MD, MPH

Principal Investigator

Are You a Good Fit for This Trial?

The trial is for individuals referred for colposcopy after an abnormal Pap or hrHPV test. Participants will collect menstrual blood at home using the Q-Pad Kit and send it to a lab for testing. They must be comfortable with self-collection and mailing samples, as well as attending clinic visits.

Inclusion Criteria

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

Exclusion Criteria

I had treatment for early-stage cervical cancer within the last year.

You have already joined this study or are in another cervical-screening / HPV study right now

You are pregnant or think you might be

What Are the Treatments Tested in This Trial?

Interventions

• Q-Pad hrHPV Test System

Trial Overview

The EQUIP Study is evaluating the effectiveness of the Q-Pad hrHPV Test System in detecting high-risk human papillomavirus from menstrual blood compared to standard cervical samples during routine care.

How Is the Trial Designed?

Group I: Non-invasive, passive self-collection / Clinician collection Experimental Treatment 1 Intervention

Participants referred for colposcopy after abnormal cervical screening will collect menstrual blood at home using the Q-Pad kit and mail the sample for hrHPV testing. At the colposcopy visit, they will have a clinician-collected cervical specimen obtained for hrHPV testing and undergo colposcopy with biopsy as part of standard care.

Who Is Running the Clinical Trial?

Qurasense

Lead Sponsor