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

Status: approved

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. Despite this, the rates of outdated cervical cancer screening tests are high. 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.

Inclusion Criteria

Women ages 30-63 years old empaneled to a primary care provider in primary care in Rochester (RST) and Kasson who self-identify as asymptomatic (i.e., no pelvic pain, abnormal vaginal bleeding or vaginal abnormal discharge)
Qualify for average risk cervical cancer screening per United States Preventive Services Task Force (USPSTF) guidelines but are overdue by >= 1 years, including those who have never been screened
Must have an active Patient Online Services account, 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are NOT eligible as Medicare does not cover primary HPV testing by clinician-collection or self-collection (related to outdated Centers for Medicare & Medicaid Services [CMS] cervical cancer screening coverage rules for Medicare that date back to 2015, 3 years before primary HPV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)

PRIMARY OBJECTIVES:

I. Assess the impact upon the rate of screening uptake of a portal invitation to women empaneled in primary care in Rochester and Kasson to update their cervical cancer screening with a self-collected vaginal swab for HPV testing at Mayo Clinic Express Care clinics (intervention group) compared to cervical cancer screening uptake with a clinician-collected cervical swab or self-collected vaginal swab at a primary care office encounter among women empaneled in primary care in Rochester and Kasson (control group) over the study period.

II. Assess follow-up of abnormal results obtained by self-collection and clinician-collection.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: 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.

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

After completion of study intervention, participants are followed up for 6 months.

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

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