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

NCT ID: NCT07186530

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-07
• Study Completion Date: 2030-09-30

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.

Conditions

Cervical Carcinoma; Human Papillomavirus Infection; Human Papillomavirus-Related Cervical Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Arm I (HPV self-collection)

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.

Group Type: EXPERIMENTAL

Best Practice

Intervention Type: OTHER

Receive usual care

Communication Intervention

Intervention Type: OTHER

Receive portal message

Electronic Health Record Review

Intervention Type: OTHER

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

HPV Self-Collection

Intervention Type: PROCEDURE

Complete HPV self-collection

Standard Follow-Up Care

Intervention Type: PROCEDURE

Receive standard follow-up care

Arm II (usual care)

Participants receive usual care and standard follow-up care on study.

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Receive usual care

Electronic Health Record Review

Intervention Type: OTHER

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

Standard Follow-Up Care

Intervention Type: PROCEDURE

Receive standard follow-up care

Interventions

Best Practice

Receive usual care

Intervention Type: OTHER

Communication Intervention

Receive portal message

Intervention Type: OTHER

Electronic Health Record Review

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

Intervention Type: OTHER

HPV Self-Collection

Complete HPV self-collection

Intervention Type: PROCEDURE

Standard Follow-Up Care

Receive standard follow-up care

Intervention Type: PROCEDURE

Other Intervention Names

standard of care; standard therapy; Electronic Health Record (EHR) Review; EHR Review; HPV Self Collection; Human Papillomavirus Self-Collection; HPV Self-Collection in a healthcare setting

Eligibility Criteria

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]

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 63 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathy L. Maclaughlin, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2025-05848

Identifier Type: REGISTRY

Identifier Source: secondary_id

25-000735

Identifier Type: -

Identifier Source: org_study_id