Patient Self-sampling of HPV to Screen for Cervical Cancer

Validation and Feasibility of Patient Self-sampling of HPV for Cervical Cancer Screening

The purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Researchers will compare the laboratory results of self-collected vaginal swab samples to usual healthcare provider-collected cervical swab samples to determine the laboratory HPV testing accuracy of the self-collection swab.

Study Overview

• Status: Completed
• Conditions: Human Papilloma Virus
• Intervention / Treatment: Diagnostic test: Swab kit (COBAS HPV 4800 Assay -Evalyn brush); Diagnostic test: Clinician-collection of cervical sample for HPV testing

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Appointment at Mayo Clinic Rochester in Gynecology Colposcopy Clinic or ICS (integrated community specialty) Colposcopy Clinic (will always include a speculum exam).
• Appointment at Mayo Clinic Rochester in Gynecology Clinic for indication that will already include a speculum exam (e.g., cervical cancer screening or IUD insertion).

Exclusion Criteria:

• Excluded if self-reported as currently menstruating, pregnant, or within 3 months following pregnancy.
• Excluded if no cervix (history of total hysterectomy).
• Excluded if moderate to heavy vaginal bleeding on the day of the visit.
• Excluded if reason for visit in Gynecology Clinic is abnormal vaginal discharge.
• Exclude patients who are on Gynecology Colposcopy Clinic for LEEP (loop electrosurgical excision procedure).
• Exclude if any use of over-the-counter or prescription vaginal cream for vaginal infection or prescription vaginal estrogen cream for at least two days before using the Evalyn Brush.

(Vaginal contraceptives, condoms and water-based lubricants can be used as normal.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-collected vaginal swab samples; Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab	Diagnostic test: Swab kit (COBAS HPV 4800 Assay -Evalyn brush); Patient self-sampling swab kit to collect a vaginal sample for HPV testing; Diagnostic test: Clinician-collection of cervical sample for HPV testing; Speculum exam and collection of a cervical specimen using standard endocervical brush and spatula placed into ThinPrep medium for HPV testing (Evalyn brush)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection	Patient-collected vaginal swab HPV results compared with gold standard of clinician-collected cervical swab) to accurately detect HPV infection	Baseline (sample was collected up to 21 days form the date of registration)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported Acceptability of Using the Evalyn Brush	Assessed by survey question "Overall, how acceptable was it for you to collect the sample using the Evalyn® brush?," which was answered on a 4-point scale (completely unacceptable, unacceptable, acceptable, or completely acceptable).	Baseline (sample was collected up to 21 days form the date of registration)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Kathy MacLaughlin, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Actual): June 4, 2024
• Study Completion (Actual): June 4, 2024

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Cervical Cancer Screening
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Uterine Diseases; Genital Diseases, Female; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Neoplasms, Squamous Cell; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Papilloma
• Other Study ID Numbers: 22-008247; NCI-2022-10804 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No