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 Despite this, the rates of outdated cervical cancer screening tests are high.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.
Additional locations may be listed on ClinicalTrials.gov for NCT07186530.
Locations matching your search criteria
United States
Minnesota
Rochester
Mayo Clinic in RochesterStatus: Active
Contact: Kathy Lynn Maclaughlin
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.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorKathy Lynn Maclaughlin
