Actively Recruiting

Phase Not Applicable
Age: 25Years +
FEMALE
Healthy Volunteers
NCT07281599

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

Led by Qurasense · Updated on 2026-02-02

450

Participants Needed

4

Research Sites

65 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 25Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Planned Parenthood of Southern New England

New Haven, Connecticut, United States, 06511

Actively Recruiting

2

Planned Parenthood North Central States

Minneapolis, Minnesota, United States, 55408

Actively Recruiting

3

Planned Parenthood of Greater Ohio (PPGOH)

Akron, Ohio, United States, 44302

Actively Recruiting

4

Planned Parenthood Association of Utah

Salt Lake City, Utah, United States, 84102

Actively Recruiting

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Research Team

B

Brian Weinberg, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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