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

Официальное название

HPV Self-Collection in Novel Settings to Increase Cervical Cancer Screening

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Cervical cancer screening test [Срок оценки: Up to 6 months from trial enrollment]

Вторичные конечные точки (1)

• Follow-up of abnormal results [Срок оценки: Up to 6 months from date of test]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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 \[related to outdated Centers for Medicare \& Medicaid Services (CMS) cervical cancer screening coverage rules for Medicare that date back to 2015, 3 years before primary HPV screening was endorsed by USPSTF\]

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT07186530 · 25-000735 · NCI-2025-05848

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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