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The EQUIP Study: At-Home HPV Testing for Cervical Cancer Screening

The EQUIP Study is evaluating a new at-home test called the Q-Pad hrHPV Test System. This test uses a special menstrual pad (Q-Pad) to collect samples for high-risk human papillomavirus (hrHPV) testing, which is the main cause of cervical cancer. You might be able to join if you are a woman aged 25 or older with a regular period, an intact cervix, and have been referred for a colposcopy (a procedure to examine your cervix) after an abnormal Pap or HPV test. The study will compare how well the Q-Pad hrHPV Test System detects precancerous changes compared to standard clinic-based tests. The goal is to see if this at-home method is accurate and safe. The study plans to enroll 450 participants, and its current recruitment status is unclear.

Study design
This study is comparing the Q-Pad hrHPV Test System to standard clinic tests. It plans to enroll 450 participants.
What's involved
You will receive a Q-Pad Kit in the mail and use it during your period to collect samples. You will also have a standard cervical sample collected and undergo a colposcopy as part of your usual care.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for an average of 1 year to measure clinical performance and any device-related side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07281599

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

Recruiting
NAAges 25+InterventionalDiagnostic
Qurasense
~450 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Q-Pad hrHPV Test System

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical Performance vs Histology
Measured over Through study completion, an average of 1 year.
+1 more outcome measured

Conditions

HPV Infection
HPV 16 Infection
High Risk HPV
Cervical Cancer Screening
Cervical Cancer Cin Grade
Cervical Cancer (Early Detection)
HPV
HPV (Human Papillomavirus)-Associated
HPV DNA
HPV Infections
Screening Test

Explore related trials

Cervical CarcinomaHuman Papillomavirus Infection

Where it's being run

3 sites across 3 states
Connecticut1
Minnesota1
Ohio1

Study leadership

  • Paul Blumenthal, MD, MPH · STUDY_DIRECTOR

Who to contact

Brian Weinberg, MS
[email protected]
833-367-7846
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Clinical Performance vs HistologyThrough 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.

  • Proportion of participants with at least one reportable device-related adverse event (ADE or SADE)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.