Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer

Recruiting now · Not applicable

Conditions studied: HPV Infection, HPV 16 Infection, High Risk HPV, Cervical Cancer Screening, Cervical Cancer Cin Grade, Cervical Cancer (Early Detection), HPV, HPV (Human Papillomavirus)-Associated, HPV DNA, HPV Infections, Screening Test

In brief

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.

Key facts

Study ID

NCT07281599

Run by

Qurasense

People needed

450

Starts

2025-12-01

Expected to finish

2027-03-01

Last updated by the study team

2026-07-24

Who can join

Age: 25 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Planned Parenthood of Southern New England — New Haven, Connecticut, United States (enrolling)
• Planned Parenthood North Central States — Minneapolis, Minnesota, United States (enrolling)
• Planned Parenthood of Greater Ohio (PPGOH) — Akron, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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