Offering HPV Self-Collection in Novel Healthcare Settings to Improve Uptake of Cervical Cancer Screening

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07186530
Status
Enrolling By Invitation

Conditions

  • Cervical Carcinoma
  • Human Papillomavirus Infection
  • Human Papillomavirus-Related Cervical Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
30 Years - 63 Years
Healthy Volunteers
Accepted

Interventions

  • Best Practice — OTHER
    Receive usual care
  • Communication Intervention — OTHER
    Receive portal message
  • Electronic Health Record Review — OTHER
    EHR reviewed to assess whether recommended follow-up was completed, if follow-up was indicated.
  • HPV Self-Collection — PROCEDURE
    Complete HPV self-collection
  • Standard Follow-Up Care — PROCEDURE
    Receive standard follow-up care

Study Details

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 Dates

Start date
Oct 7, 2025
Status verified
Jun 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Arm I (HPV self-collection)
    Participants receive a portal message inviting them to schedule and complete cervical cancer screening via HPV self-collection at an Express Care clinic. Participants are also informed they can choose the usual care of a cervical cancer screening test with their primary care team in clinic instead. Participants who complete screening receive standard follow-up care.
  • Active Comparator: Arm II (usual care)
    Participants receive usual care and standard follow-up care on study.

Primary Outcome Measure

Cervical cancer screening test [ Time Frame: Up to 6 months from trial enrollment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Rochester, MN

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Mayo Clinic in Rochester· Rochester, MN

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