Recruiting

Q-Pad System

Sponsor:

Qurasense

Code:

NCT07281599

Conditions

HPV Infection

HPV 16 Infection

High Risk HPV

Cervical Cancer Screening

Cervical Cancer Cin Grade

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Accepted

Interventions

Q-Pad hrHPV Test System

Study Details

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

Study ID

NCT07281599

Start date

Dec 1, 2025

Status verified date

Jul, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Accepted

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 Design

Enrollment

450 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Clinical Performance vs Histology [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Brian Weinberg, MS

833-367-7846care@qvin.com

Locations

Planned Parenthood of Southern New England

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Danielle Salinas, MSCR

203-903-0394danielle.salinas@ppsne.org

Planned Parenthood North Central States

Recruiting

Minneapolis, Minnesota, United States, 55408

Contacts

Bridge McKye, MPH

651-389-0675bmckye@ppncs.org

Planned Parenthood of Greater Ohio (PPGOH)

Recruiting

Akron, Ohio, United States, 44302

Contacts

Penny Paxton

440-279-8109penny.paxton@ppoh.org

More Information

Sponsor

Qurasense

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Qurasense on 2026-07-24.