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

Mayo Clinic

Status: Invitation-only

Conditions: Human Papillomavirus Infection; Cervical Carcinoma; Human Papillomavirus-Related Cervical Carcinoma

Treatments: Other: Electronic Health Record Review; Procedure: Standard Follow-Up Care; Other: Communication Intervention; Other: Best Practice; Procedure: HPV Self-Collection

Study type: Interventional

Funder types: Other

Identifiers

NCT07186530

NCI-2025-05848 (Registry Identifier)

25-000735 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 30 to 63 years old

Volunteers: Accepts Healthy Volunteers

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]

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Arm I (HPV self-collection)

Experimental group

Description:

Participants receive a portal message inviting them to schedule and complete cervical cancer screening via HPV self-collection at an Express Care clinic. Participants are also informed they can choose the usual care of a cervical cancer screening test with their primary care team in clinic instead. Participants who complete screening receive standard follow-up care.

Treatment:

Procedure: HPV Self-Collection

Other: Best Practice

Other: Communication Intervention

Procedure: Standard Follow-Up Care

Other: Electronic Health Record Review

Arm II (usual care)

Active Comparator group

Description:

Participants receive usual care and standard follow-up care on study.

Treatment:

Other: Best Practice

Procedure: Standard Follow-Up Care

Other: Electronic Health Record Review