Cervical Carcinoma, Human Papillomavirus Infection, Human Papillomavirus-Related Cervical Carcinoma
Conditions
Brief summary
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.
Interventions
OTHERBest Practice
Receive usual care
OTHERCommunication Intervention
Receive portal message
OTHERElectronic Health Record Review
EHR reviewed to assess whether recommended follow-up was completed, if follow-up was indicated.
PROCEDUREHPV Self-Collection
Complete HPV self-collection
PROCEDUREStandard Follow-Up Care
Receive standard follow-up care
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 63 Years
Healthy volunteers
Yes
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 \[related to outdated Centers for Medicare & Medicaid Services (CMS) cervical cancer screening coverage rules for Medicare that date back to 2015, 3 years before primary HPV screening was endorsed by USPSTF\]
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical cancer screening test | 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
| Measure | Time frame | Description |
|---|---|---|
| Follow-up of abnormal results | 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. |
Countries
United States
Outcome results
None listed