Status:
ENROLLING_BY_INVITATION
Offering HPV Self-Collection in Novel Healthcare Settings to Improve Uptake of Cervical Cancer Screening
Lead Sponsor:
Mayo Clinic
Conditions:
Cervical Carcinoma
Human Papillomavirus Infection
Eligibility:
FEMALE
30-63 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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are NOT eligible as Medicare does not cover primary HPV testing by clinician-collection or self-collection \[related to outdated Centers for Medicare \& Medicaid Services (CMS) cervical cancer screening coverage rules for Medicare that date back to 2015, 3 years before primary HPV screening was endorsed by USPSTF\]
Key Trial Info
Start Date :
October 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2030
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT07186530
Start Date
October 7 2025
End Date
September 30 2030
Last Update
October 30 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905