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NCT Number: NCT07281599

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

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.

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Key information

Conditions

HPV Infection Cervical Cancer (Early Detection) Cervical Cancer Cin Grade Cervical Cancer Screening Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HPV HPV (Human Papillomavirus)-Associated HPV 16 Infection HPV DNA HPV Infections High Risk HPV Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Screening Test Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood of Southern New England, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Q-Pad hrHPV Test System

Device

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: Q-Pad Kit, Colposcopy, Clinician collection

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

  2. 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.

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Brian Weinberg, MS

CONTACT

[email protected]

833-367-7846

Sponsors and collaborators

Lead sponsor

Qurasense

Industry

Registry information

Acronym: EQUIP

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 15, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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