Offering HPV Self-Collection In Novel Healthcare Settings To Improve Uptake Of Cervical Cancer Screening

Overview

About this study

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 Despite this, the rates of outdated cervical cancer screening tests are high.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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

* Women ages 30-63 years old receiving primary care with a provider at Mayo Clinic in Rochester or Mayo Family Clinic Kasson 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 \[related to outdated Centers for Medicare \& Medicaid Services (CMS) cervical cancer screening coverage rules for Medicare that date back to 2015, 3 years before primary HPV screening was endorsed by USPSTF\]

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kathy MacLaughlin

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available