HPV InfectionEQUIPNCT07281599
Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer
A study testing Q-Pad hrHPV Test System in people with HPV Infection and HPV 16 Infection, run by Qurasense at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, HPV 16 Infection, High Risk HPV
- What is being tested?
- Q-Pad hrHPV Test System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Dec 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Planned Parenthood of Greater Ohio (PPGOH)
Akron, Ohio, 44302
Penny Paxton, 440-279-8109, penny.paxton@ppoh.org
- Recruiting
Planned Parenthood North Central States
Minneapolis, Minnesota, 55408
Bridge McKye, MPH, 651-389-0675, bmckye@ppncs.org
- Recruiting
Planned Parenthood of Southern New England
New Haven, Connecticut, 06511
Danielle Salinas, MSCR, 203-903-0394, danielle.salinas@ppsne.org
About this study
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.
Read the detailed description
The EQUIP Study is a prospective, multicenter method-comparison study designed to evaluate the diagnostic performance of the Q-Pad hrHPV Test System for cervical cancer screening. Menstruating adults referred for colposcopy after an abnormal cervical screening result receive a mailed Q-Pad Kit and use it during the menstrual cycle immediately after their clinic visit to collect a menstrual samples at home, guided by written instructions and an optional accompanying smartphone application. These samples are returned by mail to a central laboratory, where hrHPV testing is performed using a PCR assay.
At the colposcopy visit, clinicians obtain a standard cervical specimen for routine cytology and hrHPV testing on the same assay platform and perform colposcopy with biopsy as clinically indicated. Each participant therefore provides both an at-home menstrual sample (index test) and a clinician-collected cervical sample (comparator) within the same episode of care, with biopsy and histopathology providing disease status. The study focuses on comparing hrHPV results between the two specimen types and on evaluating safety, specimen adequacy, and participant usability and acceptability of the Q-Pad at-home menstrual collection approach.
- Conditions
- HPV Infection, HPV 16 Infection, High Risk HPV, Cervical Cancer Screening, Cervical Cancer Cin Grade, Cervical Cancer (Early Detection)
- Being tested
- Q-Pad hrHPV Test System
- Keywords
- Q-Pad, Self-sampling, Self-collection, self-collect, cervical cancer screening, menstural blood, Sexually Transmitted Diseases, Viral, Sexually Transmitted Diseases, Genital Diseases, Papillomavirus Infections, HPV, high risk HPV, pap smear, at-home collection
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms, Sexually Transmitted Diseases, Viral, Sexually Transmitted Diseases, Genital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-Pad hrHPV Test SystemDevice
Also called Q-Pad Kit, Colposcopy, Clinician collection
Participants will receive a mailed Q-Pad Kit, which includes two Q-Pads (menstrual pads with removable collection strips called Q-Strips), a Q-Strip Container with desiccant for storing and shipping the strips, and a prepaid return mailer. During the menstrual cycle after their colposcopy visit, participants will follow the Instructions for Use to passively collect menstrual blood with the Q-Pads, then remove the Q-Strips and place them in the Q-Strip Container for mailing to the central laboratory for hrHPV testing. At the colposcopy visit, the clinician will also collect a cervical sample in ThinPrep liquid-based cytology medium for hrHPV testing, which will serve as the comparator specimen.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive, passive self-collection / Clinician collection | Other | 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. Receives: Device: Q-Pad hrHPV Test System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance vs Histology
Clinical sensitivity defined as the proportion of participants with biopsy-confirmed CIN2+ whose menstrual-blood hrHPV result (Q-Pad hrHPV Test System) is positive and Clinical specificity defined as the proportion of participants with <CIN2 on histology whose menstrual-blood hrHPV result is negative.
Measured: Through study completion, an average of 1 year.
Proportion of participants with at least one reportable device-related adverse event (ADE or SADE)
Proportion of participants who experience at least one adverse event or device deficiency that is not on the protocol's non-reportable event list.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (2)
Positive, negative, and overall percent agreement between Q-Pad hrHPV testing and clinician-collected cervical hrHPV testing
Positive percent agreement (PPA), negative percent agreement (NPA), and overall percent agreement (concordance) between the Q-Pad hrHPV Test System result on menstrual blood (index test) and the hrHPV result from the paired clinician-collected cervical ThinPrep specimen (comparator test).
Measured: Through study completion, an average of 1 year.
Q-Pad hrHPV Test System validity rate and participant usability/acceptability
Proportion of returned Q-Pad menstrual collections that yield a valid hrHPV test result in the central laboratory (i.e., not invalid or quantity-not-sufficient [QNS]), together with participant usability and acceptability scores for the Q-Pad kit.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multicenter, single-cohort, paired-sample diagnostic accuracy study.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qurasense
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Blumenthal, MD, MPH, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281599
- Sponsor's protocol ID
- ALM_QT2/DOC-392
- Acronym
- EQUIP
- Status last verified
- Jul 2026
- First submitted
- 3 Dec 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Arbyn M, Peeters E, Benoy I, Vanden Broeck D, Bogers J, De Sutter P, Donders G, Tjalma W, Weyers S, Cuschieri K, Poljak M, Bonde J, Cocuzza C, Zhao FH, Van Keer S, Vorsters A. VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples. J Clin Virol. 2018 Oct;107:52-56. doi: 10.1016/j.jcv.2018.08.006. Epub 2018 Aug 22.
PubMed 30195193Naseri S, Young S, Cruz G, Blumenthal PD. Screening for High-Risk Human Papillomavirus Using Passive, Self-Collected Menstrual Blood. Obstet Gynecol. 2022 Sep 1;140(3):470-476. doi: 10.1097/AOG.0000000000004904. Epub 2022 Aug 3.
PubMed 35926207U.S. Food and Drug Administration, "510(k) Substantial Equivalence Determination Decision Summary: Q-Pad A1c Test System (K231465)," 2023, accessed June 11, 2025, https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231465.pdf.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer
- ClinicalTrials.gov ID
- NCT07281599
- Acronym / sponsor ID
- EQUIP / ALM_QT2/DOC-392
- Conditions
- HPV Infection, HPV 16 Infection, High Risk HPV, Cervical Cancer Screening, Cervical Cancer Cin Grade, Cervical Cancer (Early Detection)
- Keywords
- Q-Pad, Self-sampling, Self-collection, self-collect, cervical cancer screening, menstural blood, Sexually Transmitted Diseases, Viral, Sexually Transmitted Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- QurasenseIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The EQUIP Study is a prospective, multicenter method-comparison study designed to evaluate the diagnostic performance of the Q-Pad hrHPV Test System for cervical cancer screening. Menstruating adults referred for colposcopy after an abnormal cervical screening result receive a mailed Q-Pad Kit and use it during the menstrual cycle immediately after their clinic visit to collect a menstrual samples at home, guided by written instructions and an optional accompanying smartphone application. These samples are returned by mail to a central laboratory, where hrHPV testing is performed using a PCR assay.
At the colposcopy visit, clinicians obtain a standard cervical specimen for routine cytology and hrHPV testing on the same assay platform and perform colposcopy with biopsy as clinically indicated. Each participant therefore provides both an at-home menstrual sample (index test) and a clinician-collected cervical sample (comparator) within the same episode of care, with biopsy and histopathology providing disease status. The study focuses on comparing hrHPV results between the two specimen types and on evaluating safety, specimen adequacy, and participant usability and acceptability of the Q-Pad at-home menstrual collection approach.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicenter, single-cohort, paired-sample diagnostic accuracy study.
| Arm | Type | Receives |
|---|---|---|
| Non-invasive, passive self-collection / Clinician collection | Other | Device: Q-Pad hrHPV Test SystemParticipants 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q-Pad hrHPV Test SystemAlso: Q-Pad Kit, Colposcopy, Clinician collectionParticipants will receive a mailed Q-Pad Kit, which includes two Q-Pads (menstrual pads with removable collection strips called Q-Strips), a Q-Strip Container with desiccant for storing and shipping the strips, and a prepaid return mailer. During the menstrual cycle after their colposcopy visit, participants will follow the Instructions for Use to passively collect menstrual blood with the Q-Pads, then remove the Q-Strips and place them in the Q-Strip Container for mailing to the central laboratory for hrHPV testing. At the colposcopy visit, the clinician will also collect a cervical sample in ThinPrep liquid-based cytology medium for hrHPV testing, which will serve as the comparator specimen. | Device | Non-invasive, passive self-collection / Clinician collection |
Primary outcome
Clinical Performance vs Histology
Time frame: Through study completion, an average of 1 year.
Clinical sensitivity defined as the proportion of participants with biopsy-confirmed CIN2+ whose menstrual-blood hrHPV result (Q-Pad hrHPV Test System) is positive and Clinical specificity defined as the proportion of participants with <CIN2 on histology whose menstrual-blood hrHPV result is negative.
Proportion of participants with at least one reportable device-related adverse event (ADE or SADE)
Time frame: Through study completion, an average of 1 year.
Proportion of participants who experience at least one adverse event or device deficiency that is not on the protocol's non-reportable event list.
2 secondary outcomes
Positive, negative, and overall percent agreement between Q-Pad hrHPV testing and clinician-collected cervical hrHPV testing
Time frame: Through study completion, an average of 1 year.
Q-Pad hrHPV Test System validity rate and participant usability/acceptability
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Background: PubMed 30195193Arbyn M, Peeters E, Benoy I, Vanden Broeck D, Bogers J, De Sutter P, Donders G, Tjalma W, Weyers S, Cuschieri K, Poljak M, Bonde J, Cocuzza C, Zhao FH, Van Keer S, Vorsters A. VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples. J Clin Virol. 2018 Oct;107:52-56. doi: 10.1016/j.jcv.2018.08.006. Epub 2018 Aug 22.
- Background: PubMed 35926207Naseri S, Young S, Cruz G, Blumenthal PD. Screening for High-Risk Human Papillomavirus Using Passive, Self-Collected Menstrual Blood. Obstet Gynecol. 2022 Sep 1;140(3):470-476. doi: 10.1097/AOG.0000000000004904. Epub 2022 Aug 3.
- BackgroundU.S. Food and Drug Administration, "510(k) Substantial Equivalence Determination Decision Summary: Q-Pad A1c Test System (K231465)," 2023, accessed June 11, 2025, https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231465.pdf.
- Qurasense, Inc. DBA Qvin public facing websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Blumenthal, MD, MPH study director
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Q-Pad hrHPV Test System in people with HPV Infection and HPV 16 Infection, run by Qurasense at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Weinberg, MS (833-367-7846, care@qvin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Performance vs Histology (time frame: Through study completion, an average of 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07281599, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.