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

NCT07281599 | Recruiting FDA Device

• 1 other identifier: ALM_QT2/DOC-392
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 4

Brief Summary

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

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

Keywords

Q-Pad; Self-sampling; Self-collection; self-collect; cervical cancer screening; menstural blood; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Genital Diseases; Papillomavirus Infections; HPV; high risk HPV; pap smear; at-home collection

Outcome Measures

Primary Outcomes (2)

• Clinical Performance vs Histology

  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)

  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 Outcomes (2)

• Positive, negative, and overall percent agreement between Q-Pad hrHPV testing and clinician-collected cervical hrHPV testing

  Through study completion, an average of 1 year.

• Q-Pad hrHPV Test System validity rate and participant usability/acceptability

  Through study completion, an average of 1 year.

Other Outcomes (1)

• CIN3+ Clinical Sensitivity & Specificity

  Through study completion, an average of 1 year.

Study Arms (1)

Non-invasive, passive self-collection / Clinician collection

OTHER

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

Interventions

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.

Also known as: Q-Pad Kit, Colposcopy, Clinician collection

Non-invasive, passive self-collection / Clinician collection

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qurasense: lead

Study Sites (4)

Planned Parenthood of Southern New England

New Haven, Connecticut, 06511, United States

RECRUITING

Planned Parenthood North Central States

Minneapolis, Minnesota, 55408, United States

RECRUITING

Planned Parenthood of Greater Ohio (PPGOH)

Akron, Ohio, 44302, United States

RECRUITING

Planned Parenthood Association of Utah

Salt Lake City, Utah, 84102, United States

RECRUITING

Related Publications (3)

• Arbyn M, Peeters E, Benoy I, Vanden Broeck D, Bogers J, De Sutter P, Donders G, Tjalma W, Weyers S, Cuschieri K, Poljak M, Bonde J, Cocuzza C, Zhao FH, Van Keer S, Vorsters A. VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples. J Clin Virol. 2018 Oct;107:52-56. doi: 10.1016/j.jcv.2018.08.006. Epub 2018 Aug 22.

  PMID: 30195193 BACKGROUND

• Naseri S, Young S, Cruz G, Blumenthal PD. Screening for High-Risk Human Papillomavirus Using Passive, Self-Collected Menstrual Blood. Obstet Gynecol. 2022 Sep 1;140(3):470-476. doi: 10.1097/AOG.0000000000004904. Epub 2022 Aug 3.

  PMID: 35926207 BACKGROUND

• U.S. Food and Drug Administration, "510(k) Substantial Equivalence Determination Decision Summary: Q-Pad A1c Test System (K231465)," 2023, accessed June 11, 2025, https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231465.pdf.

  BACKGROUND

Related Links

• Qurasense, Inc. DBA Qvin public facing website

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Genital Diseases

Interventions

Colposcopy

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Paul Blumenthal, MD, MPH

  STUDY DIRECTOR

Central Study Contacts

Brian Weinberg, MS

CONTACT

833-367-7846; care@qvin.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, single-cohort, paired-sample diagnostic accuracy study.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 15, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)