VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples.
M Arbyn, E Peeters, I Benoy...
https://pubmed.ncbi.nlm.nih.gov/30195193Actively Recruiting
Phase Not Applicable
Age: 25Years +
FEMALE
Healthy Volunteers
ID07281599
Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer
Led by Qurasense · Updated on 2026-02-02
450
Participants Needed
4
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Q-Pad hrHPV Test System to detect high-risk human papillomavirus (hrHPV), the virus that causes most cervical cancers, using menstrual blood collected at home. The study focuses on people who have been referred for colposcopy after an abnormal Pap smear or hrHPV test to compare the accuracy of hrHPV detection from menstrual samples versus standard cervical samples. This prospective, multicenter study aims to assess how well the Q-Pad system identifies cervical precancer and its ease of use and acceptability among participants. Participants will receive a mailed Q-Pad Kit containing special menstrual pads with removable collection strips (Q-Strips) and instructions, including an optional smartphone app. During their menstrual cycle following the colposcopy referral, they will collect menstrual blood at home using the Q-Pads and mail the Q-Strips to a central lab for hrHPV testing. At the colposcopy visit, clinicians will collect a cervical sample for routine hrHPV testing and perform colposcopy with biopsy as needed. This allows direct comparison between the home-collected menstrual samples and clinician-collected cervical samples. During the study, participants provide both sample types within the same care episode, with biopsy confirming disease status. Researchers will evaluate the clinical performance of the Q-Pad system compared to histology results, monitor any device-related adverse events, and assess participant usability and satisfaction with the home collection method. The study includes safety monitoring and will continue through an average of one year, with all samples tested using PCR assays at a central laboratory.
CONDITIONS
Brief Title
Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer
Who Can Participate
Age: 25Years +
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 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 to 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 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.
You will not qualify if you...
- You are pregnant or think you might be pregnant.
- 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 or HPV study right now.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for colposcopy and clinician-collected cervical specimen
Implementation
Duration - 1 menstrual cycle after colposcopy visit
Participants use the Q-Pad hrHPV Test System to collect menstrual blood at home during the menstrual cycle immediately after their colposcopy visit. They then mail the collected sample to a central laboratory for testing.
1 home collection and mailing of sample
Diagnostic Evaluation
Duration - Same episode of care as colposcopy visit
Clinicians perform colposcopy with biopsy as clinically indicated and test both clinician-collected cervical samples and participant-collected menstrual samples to evaluate hrHPV status and precancer detection.
1 visit (in-person) for colposcopy and biopsy
Long-term Monitoring
Duration - Up to 1 year
Participants are followed for up to 1 year to monitor clinical performance, safety, and usability of the Q-Pad hrHPV Test System.
Follow-up contacts as needed; no specific visit schedule
Trial Site Locations
Total: 4 locations
1
Planned Parenthood of Southern New England
New Haven, Connecticut, United States, 06511
Actively Recruiting
2
Planned Parenthood North Central States
Minneapolis, Minnesota, United States, 55408
Actively Recruiting
3
Planned Parenthood of Greater Ohio (PPGOH)
Akron, Ohio, United States, 44302
Actively Recruiting
4
Planned Parenthood Association of Utah
Salt Lake City, Utah, United States, 84102
Actively Recruiting
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Research Team
B
Brian Weinberg, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Published Research Related To This Trial
Screening for High-Risk Human Papillomavirus Using Passive, Self-Collected Menstrual Blood.
Sara Naseri, Stephen Young, Giovanna Cruz...
https://pubmed.ncbi.nlm.nih.gov/35926207