NCT07186530

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 30 Years – 63 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-10-07
• Primary completion: 2030-09-30
• Completion: 2030-09-30
• First posted: 2025-09-22
• Last updated: 2025-10-30

Locations

1 site across 1 country: United States