Q-Pad menstrual-pad test to detect high-risk HPV and cervical precancer
Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer
This study tests whether a home menstrual-pad kit (Q-Pad) can detect high-risk HPV and cervical precancer in people referred for colposcopy after an abnormal Pap or HPV result.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 25 Years and up |
| Sex | Female |
| Sponsor | Qurasense Industry-sponsored |
| Locations | 4 sites (New Haven, Connecticut and 3 other locations) |
| Trial ID | NCT07281599 on ClinicalTrials.gov |
What this trial studies
The EQUIP study compares hrHPV results from menstrual blood collected at home on a Q-Pad with clinician-collected cervical samples and biopsy results. Menstruating adults referred for colposcopy receive a mailed Q-Pad kit, use it during their period, and mail samples to a central lab for PCR-based hrHPV testing. At the colposcopy visit clinicians collect a standard cervical specimen and perform colposcopy with biopsy as needed, providing a reference standard for disease status. The study also records specimen adequacy, safety events, and participant usability and acceptability of the at-home collection process.
Who should consider this trial
Good fit: Ideal candidates are menstruating adults aged 25 or older with an intact cervix who have been referred for colposcopy after an abnormal Pap or HPV test and can use the app and mail kits.
Not a fit: People who are pregnant, do not have regular menstrual cycles, cannot use or mail the Q-Pad kits, or recently received treatment for cervical precancer are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could make accurate HPV screening easier and more convenient by allowing reliable at-home collection during menstruation.
How similar studies have performed: Self-collected vaginal swabs and mailed kits have previously shown reliable hrHPV detection, while menstrual-blood collection is a newer method with limited but promising early data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New Haven, Connecticut and 3 other locations
- Planned Parenthood of Southern New England — New Haven, Connecticut, United States (Recruiting)
- Planned Parenthood North Central States — Minneapolis, Minnesota, United States (Recruiting)
- Planned Parenthood of Greater Ohio (PPGOH) — Akron, Ohio, United States (Recruiting)
- Planned Parenthood Association of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Brian Weinberg, MS
- Email: care@qvin.com
- Phone: 833-367-7846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.