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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-07532 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 23-009193 | Other Identifier | Mayo Clinic Institutional Review Board |
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Human Papilloma Virus (HPV) is a cause of cervical cancer in women. This study is being done to identify sites for cervical cancer screening and education regarding HPV vaccination outside of the traditional settings of primary care and gynecologic clinics. Identifying non-traditional cancer screening settings may increase cancer screening completion and HPV vaccination among women with limited health care knowledge and access who are vulnerable to health disparities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational aim 1 & aim 3 | Patients may choose to undergo HPV vaginal swab self-collection on study in the research clinic or at home. Patients may choose to complete an interview on study. In addition, patients have their medical records reviewed on study. |
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| Observational aim 2 | Patients are contacted by the study Clinical Research Coordinator (CRC) by phone on study and informed of HPV vaccination eligibility, asked interest in being vaccinated, and informed of sites for HPV vaccination. Patients are then contacted again by the CRC to determine if HPV vaccination occurred. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-Interventional study |
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| Measure | Description | Time Frame |
|---|---|---|
| Human Papilloma Virus (HPV) sample self-collection following Emergency Department (ED) presentation | Will be assessed by the percentage of women between 25-65 eligible for cervical cancer screening who participate or who opt not to participate in self-collection. | Baseline |
| HPV vaccination following ED presentation | Will be assessed by the percentage of women between 18-26 eligible for HPV vaccination for cervical cancer prevention who participate in HPV vaccination. Participants will be contacted one month after initial contact to determine if the HPV vaccination was administered. | One month |
| Interviews of women who decline self-collection | Phone or video-based interviews will be conducted with eligible participants who decline self-collection to determine reasons for non-participation. | Baseline |
| Interviews of women who consent to self-collection but do not complete the self-collection | Phone or video-based interviews will be conducted with participants who agree to participate but do not complete self-collection after 4 weeks to determine reasons for non-participation. | Up to 6 weeks |
| Interviews of women who complete the self-collection | Phone or video-based interviews will be conducted with participants who completed self-collection for feedback on the process. | Up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Female patients recruited after previous ED visits
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu | |
| Caroline Chang | Contact | 904-953-4637 | Chang.Caroline@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christopher C. DeStephano, MD, MPH | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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