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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. At a later clinic visit, 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Healthy Volunteers: t
View:

• 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.

Locations
United States
Connecticut
Planned Parenthood of Southern New England
RECRUITING
New Haven
Minnesota
Planned Parenthood North Central States
RECRUITING
Minneapolis
Ohio
Planned Parenthood of Greater Ohio (PPGOH)
RECRUITING
Akron
Utah
Planned Parenthood Association of Utah
NOT_YET_RECRUITING
Salt Lake City
Contact Information
Primary
Brian Weinberg, MS
care@qvin.com
833-367-7846
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2027-03
Participants
Target number of participants: 450
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Qurasense

This content was sourced from clinicaltrials.gov