Q-Pad menstrual-pad test to detect high-risk HPV and cervical precancer
Official title: Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer
Run by Qurasense · NCT07281599 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 25 Years and up |
| Sex | Women only |
| Enrollment | 450 (estimated) |
| Sponsor | Qurasense Industry-sponsored |
| Locations | 3 sites (New Haven, Connecticut and 2 other locations) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | March 2027 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT07281599 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Study contacts
- Study coordinator: Brian Weinberg, MS
- Email: care@qvin.com
- Phone: 833-367-7846
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Self-sampling HPV screening offered in the emergency department
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CHW4CervixHealth: HPV self-collection kits with community health workers
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Patient-centered cervical cancer screening and treatment linkage program in Nairobi
This project will try a multi-part care approach (DADA LINK) using care coordinators and an mHealth app to help women ages 25–49 in Nairobi get screened for cervical cancer and linked to treatment when needed.
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Routine shallow-coverage Whole Genome Sequencing of Cervical Smears to See if Ovarian Cancer is Found Earlier
Researchers test whether analyzing DNA from cervical smears with shallow whole-genome sequencing can help detect high-grade serous ovarian cancer early in patients undergoing treatment for this cancer.
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Can people collect their own vaginal sample for HPV testing as well as clinician collection for comparison?
This study tests whether individuals can correctly use a self-collection device to gather a vaginal sample for high-risk HPV screening and whether the self-collected sample agrees with clinician-collected samples.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.