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

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

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

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Kathy L. Maclaughlin, MD · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

63 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-10-07

Primary Completion

2030-09-30

Completion

2030-09-30

Countries

• United States

Study Locations