Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer (NCT07281599) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer
United States450 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range
25 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Performance vs Histology
Timeframe: Through study completion, an average of 1 year.
2
Proportion of participants with at least one reportable device-related adverse event (ADE or SADE)
Timeframe: Through study completion, an average of 1 year.