HPV Self-Collection in Novel Settings to Increase Cervical Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Cervical cancer screening test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 63 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •History of hysterectomy
- •Cervical cancer
- •Cervical intraepithelial neoplasia (CIN) 2-3
- •In utero diethylstilbestrol (DES) exposure
- •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]
研究组 & 干预措施
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.
干预措施: Communication Intervention (Other)
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.
干预措施: Best Practice (Other)
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.
干预措施: Electronic Health Record Review (Other)
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.
干预措施: HPV Self-Collection (Procedure)
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.
干预措施: Standard Follow-Up Care (Procedure)
Arm II (usual care)
Participants receive usual care and standard follow-up care on study.
干预措施: Best Practice (Other)
Arm II (usual care)
Participants receive usual care and standard follow-up care on study.
干预措施: Electronic Health Record Review (Other)
Arm II (usual care)
Participants receive usual care and standard follow-up care on study.
干预措施: Standard Follow-Up Care (Procedure)
结局指标
主要结局
Cervical cancer screening test
时间窗: Up to 6 months from trial enrollment
Assessed by the number of participants who complete cervical cancer screening collection from invitation to complete a self-collected vaginal swab for HPV testing at Mayo Clinic Express Care clinics compared to the number of participants who complete screening with a clinician-collected cervical swab or self-collected vaginal swab at a primary care office.
次要结局
- Follow-up of abnormal results(Up to 6 months from date of test)