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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-05848 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (HPV self-collection) | Experimental | 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. |
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| Arm II (usual care) | Active Comparator | Participants receive usual care and standard follow-up care on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
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| Measure | Description | Time Frame |
|---|---|---|
| Cervical cancer screening test | 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. | Up to 6 months from trial enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Follow-up of abnormal results | Assessed by the number of participants who complete follow-up for abnormal results obtained by self-collection or clinician-collection. | Up to 6 months from date of test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathy L. Maclaughlin, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Communication Intervention | Other | Receive portal message |
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| Electronic Health Record Review | Other | EHR reviewed to assess whether recommended follow-up was completed, if follow-up was indicated. |
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| HPV Self-Collection | Procedure | Complete HPV self-collection |
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| Standard Follow-Up Care | Procedure | Receive standard follow-up care |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D057286 | Electronic Health Records |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D016347 | Medical Records Systems, Computerized |
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D009934 | Organization and Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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