Offering HPV Self-Collection in Novel Healthcare Settings to Improve Uptake of Cervical Cancer Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Best Practice, Communication Intervention, Electronic Health Record Review, HPV Self-Collection.
- Who it may be relevant to
- Registry conditions: Cervical Carcinoma, Human Papillomavirus Infection, Human Papillomavirus-Related Cervical Carcinoma. Basic parameters: 30 years — 63 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
HPV Self-Collection in Novel Settings to Increase Cervical Cancer Screening
Overview
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.
Interventions
- Other Best Practice
Receive usual care - Other Communication Intervention
Receive portal message - Other Electronic Health Record Review
EHR reviewed to assess whether recommended follow-up was completed, if follow-up was indicated. - Procedure HPV Self-Collection
Complete HPV self-collection - Procedure Standard Follow-Up Care
Receive standard follow-up care
Primary outcome measures
- Cervical cancer screening test [Time frame: Up to 6 months from trial enrollment]
Secondary outcome measures (1)
- Follow-up of abnormal results [Time frame: Up to 6 months from date of test]
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 \[related to outdated Centers for Medicare \& Medicaid Services (CMS) cervical cancer screening coverage rules for Medicare that date back to 2015, 3 years before primary HPV screening was endorsed by USPSTF\]
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07186530 · 25-000735 · NCI-2025-05848