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

January 29, 2026 updated by: Qurasense

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Brian Weinberg, MS
  • Phone Number: 833-367-7846
  • Email: care@qvin.com

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Planned Parenthood of Southern New England
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55408
        • Recruiting
        • Planned Parenthood North Central States
        • Contact:
    • Ohio
      • Akron, Ohio, United States, 44302
        • Recruiting
        • Planned Parenthood of Greater Ohio (PPGOH)
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Recruiting
        • Planned Parenthood Association of Utah
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Non-invasive, passive self-collection / Clinician collection
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.
Device: Q-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.
Other Names:
  • Colposcopy
  • Q-Pad Kit
  • Clinician collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Performance vs Histology
Time Frame: Through study completion, an average of 1 year.
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.
Through study completion, an average of 1 year.
Proportion of participants with at least one reportable device-related adverse event (ADE or SADE)
Time Frame: Through study completion, an average of 1 year.
Proportion of participants who experience at least one adverse event or device deficiency that is not on the protocol's non-reportable event list.
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive, negative, and overall percent agreement between Q-Pad hrHPV testing and clinician-collected cervical hrHPV testing
Time Frame: Through study completion, an average of 1 year.
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).
Through study completion, an average of 1 year.
Q-Pad hrHPV Test System validity rate and participant usability/acceptability
Time Frame: Through study completion, an average of 1 year.
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.
Through study completion, an average of 1 year.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
CIN3+ Clinical Sensitivity & Specificity
Time Frame: Through study completion, an average of 1 year.
Using biopsy as reference, calculate clinical sensitivity/specificity of Q-Pad hrHPV for detecting CIN3+ lesions
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qurasense

Investigators

  • Study Director: Paul Blumenthal, MD, MPH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALM_QT2/DOC-392

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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