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

NCT07186530 | Enrolling By Invitation

• 2 other identifiers: 25-000735NCI-2025-05848
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cervical cancer screening test

  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.

  Up to 6 months from trial enrollment

Secondary Outcomes (1)

• Follow-up of abnormal results

  Up to 6 months from date of test

Study Arms (2)

Arm I (HPV self-collection)

EXPERIMENTAL

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.

Other: Best Practice; Other: Communication Intervention; Other: Electronic Health Record Review; Procedure: HPV Self-Collection; Procedure: Standard Follow-Up Care

Arm II (usual care)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Electronic Health Record Review; Procedure: Standard Follow-Up Care

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm I (HPV self-collection); Arm II (usual care)

Communication Intervention OTHER

Receive portal message

Arm I (HPV self-collection)

Electronic Health Record Review OTHER

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

Also known as: Electronic Health Record (EHR) Review, EHR Review

Arm I (HPV self-collection); Arm II (usual care)

HPV Self-Collection PROCEDURE

Complete HPV self-collection

Also known as: HPV Self Collection, Human Papillomavirus Self-Collection, HPV Self-Collection in a healthcare setting

Arm I (HPV self-collection)

Standard Follow-Up Care PROCEDURE

Receive standard follow-up care

Arm I (HPV self-collection); Arm II (usual care)

Eligibility Criteria

• Age: 30 Years - 63 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 \[related to outdated Centers for Medicare \& Medicaid Services (CMS) cervical cancer screening coverage rules for Medicare that date back to 2015, 3 years before primary HPV screening was endorsed by USPSTF\]

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections

Interventions

Practice Guidelines as Topic; Standard of Care; Electronic Health Records

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Kathy L. Maclaughlin, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)