Offering HPV Self-Collection in Novel Healthcare Settings to Improve Uptake of Cervical Cancer Screening
Enrolling by invitation · Not applicable
Conditions studied: Cervical Carcinoma, Human Papillomavirus Infection, Human Papillomavirus-Related Cervical Carcinoma
In brief
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.
Key facts
- Study ID
- NCT07186530
- Run by
- Mayo Clinic
- People needed
- 500
- Starts
- 2025-10-07
- Expected to finish
- 2030-09-30
- Last updated by the study team
- 2026-06-09
Who can join
Age: 30 and older, up to 63. Sex: female. Healthy volunteers: accepted.
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]
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.