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

Not Applicable

Not yet recruiting

• Conditions: Cervical Carcinoma; Human Papillomavirus Infection; Human Papillomavirus-Related Cervical Carcinoma

• Registration Number: NCT07186530
• Lead Sponsor: Mayo Clinic

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 Despite this, the rates of outdated cervical cancer screening tests are high.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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Study Start: 2025-10-01
• Primary Completion: 2030-09-30
• Study Completion: 2030-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 500

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]

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Mayo Family Clinic Kasson; 🇺🇸 Kasson, Minnesota, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States