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

N/AEnrolling By InvitationNCT07186530

Mayo Clinic500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

500

Conditions

Cervical Carcinoma Human Papillomavirus Infection

Interventions

Best PracticeOTHER

Receive usual care

Communication InterventionOTHER

Receive portal message

Electronic Health Record ReviewOTHER

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

HPV Self-CollectionPROCEDURE

Complete HPV self-collection

Standard Follow-Up CarePROCEDURE

Receive standard follow-up care

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 63 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 \[related to outdated Centers for Medicare \& Medicaid Services (CMS) cervical cancer screening coverage rules for Medicare that date back to 2015, 3 years before primary HPV screening was endorsed by USPSTF\]

Outcomes

Primary Outcomes

Cervical cancer screening test

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.

Time frame: Up to 6 months from trial enrollment

Secondary Outcomes

Follow-up of abnormal results

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

Time frame: Up to 6 months from date of test