NCT07186530Enrolling by invitation
Offering HPV Self-Collection in Novel Healthcare Settings to Improve Uptake of Cervical Cancer Screening
HPV Self-Collection in Novel Settings to Increase Cervical Cancer Screening
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 15 Sept 2025
- Start date
- 7 Oct 2025
- Primary completion date
- 30 Sept 2030
- Lead sponsor
- Mayo Clinic
- Diseases
- Cervical cancer
- NCT number
- NCT07186530
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 7 Oct 2025 to the primary completion date, 30 Sept 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of chronic immunosuppressant medication
Other illness
- History of hysterectomy
- Cervical cancer
- HIV+
- Medicare-covered women are NOT eligible as Medicare does not cover primary HPV testing by clinician-collection or self-collection \[related to outdated Centers for Medicare \& Medicaid Services (CMS) cervical cancer screening coverage rules for Medicare that date back to 2015, 3 years before primary HPV screening was endorsed by USPSTF\]
Other
- Cervical intraepithelial neoplasia (CIN) 2-3
- In utero diethylstilbestrol (DES) exposure
- Known to be pregnant
Who the study is looking for
- 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
Age in the registry: 30 years to 63 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.