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Enrolling by Invitation

NCT Number: NCT07186530

Offering HPV Self-Collection in Novel Healthcare Settings to Improve Uptake of Cervical Cancer Screening

This clinical trial evaluates whether offering human papillomavirus (HPV) self-collection for cervical cancer screening at Mayo Clinic Express Care clinics improves uptake of cervical cancer screening and receipt of appropriate follow-up care. Cervical cancer is preventable through vaccination, screening, and treatment of pre-cancerous conditions. However, cervical cancer screening rates have declined over the past 25 years, and an estimated 25% of women are unscreened or overdue for screening. Usual care at Mayo Clinic currently includes annual portal or letter communications in the form of scheduled outreach to request scheduling an appointment for cervical cancer screening, as well as reminders from clinicians during clinic appointments. Cervical cancer screening at Mayo Clinic is most often done with a pelvic speculum exam with cervical swabs collected in the office by a clinician. HPV self-collection is Food and Drug Administration-approved and already used in clinical practice, but offering this method of screening in the novel setting of Express Care clinics that have expanded nighttime and weekend hours may improve rates of cervical cancer screening and receipt of appropriate follow-up care.

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Key information

Conditions

Cervical Carcinoma Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Human Papillomavirus Infection Human Papillomavirus-Related Cervical Carcinoma Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

30 year–63 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women ages 30-63 years old receiving primary care with a provider at Mayo Clinic in Rochester and who self-identify as asymptomatic (i.e., no pelvic pain, abnormal vaginal bleeding or abnormal vaginal discharge)
  • Qualify for average risk cervical cancer screening per United States Preventive Services Task Force (USPSTF) guidelines but are overdue by >= 1 year, including those who have never been screened
  • Must have an active Patient Online Services account (patient portal), approval for research contact status in portal/Epic and documentation of Minnesota (MN) research authorization, and health insurance coverage

Exclusion criteria

  • History of hysterectomy
  • Cervical cancer
  • Cervical intraepithelial neoplasia (CIN) 2-3
  • In utero diethylstilbestrol (DES) exposure
  • HIV+
  • Use of chronic immunosuppressant medication
  • Known to be pregnant
  • Medicare-covered women are NOT eligible as Medicare does not cover primary HPV testing by clinician-collection or self-collection [related to outdated Centers for Medicare & Medicaid Services (CMS) cervical cancer screening coverage rules for Medicare that date back to 2015, 3 years before primary HPV screening was endorsed by USPSTF]

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

Communication intervention

Other

Receive portal message

Electronic Health Record Review

Other

EHR reviewed to assess whether recommended follow-up was completed, if follow-up was indicated.

Other names: Electronic Health Record (EHR) Review, EHR Review

HPV Self-Collection

Procedure

Complete HPV self-collection

Other names: HPV Self Collection, Human Papillomavirus Self-Collection, HPV Self-Collection in a healthcare setting

standard follow-up care

Procedure

Receive standard follow-up care

Primary outcomes

  1. Cervical cancer screening test

    Time frame: Up to 6 months from trial enrollment

    Assessed by the number of participants who complete cervical cancer screening collection from invitation to complete a self-collected vaginal swab for HPV testing at Mayo Clinic Express Care clinics compared to the number of participants who complete screening with a clinician-collected cervical swab or self-collected vaginal swab at a primary care office.

Secondary outcomes

  1. Follow-up of abnormal results

    Time frame: Up to 6 months from date of test

    Assessed by the number of participants who complete follow-up for abnormal results obtained by self-collection or clinician-collection.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

HPV Self-Collection in Novel Settings to Increase Cervical Cancer Screening

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Sep 22, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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