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

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

25 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Q-Pad hrHPV Test System — DEVICE
  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 Details

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 Dates

Start date

Dec 1, 2025

Status verified

Jan 2026

Primary completion

Dec 31, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

450 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Other: Non-invasive, passive self-collection / Clinician collection
  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.

Primary Outcome Measure

Clinical Performance vs Histology [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts

• Brian Weinberg, MS
  833-367-7846
  [email protected]

Locations (4)

Find similar trials in New Haven, CT

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