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| ID | Type | Description | Link |
|---|---|---|---|
| OCR41931 | Other Identifier | UF OnCore |
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Project CONTINUITY (Connecting You to Care in the Community) was developed to increase adherence to cervical cancer screening regimens from initial screening to needed follow-up care by (1) providing personalized approaches to improve adherence through the combined use of patient choice for the initial screening method (Pap/HPV co-testing vs. HPV self-test collection), community clinical navigators and community health workers (CHWs), customized messages and support for patient portal access for test results and (2) implementing strategies to address social determinants of health (SDoH) that may influence an individual's ability to adhere to the screening regimen, with an initial focus on removing transportation barriers through the use of a mobile outreach clinics (MOC).
The purpose of this pilot project is to gather information about the extent to which women residing in high SEV neighborhoods who choose HPV self-sampling relative to in-clinic Pap/HPV testing adhere to the cancer screening continuum steps, for which they are eligible. The women will self-select into HPV self-sampling versus in-clinic Pap/HPV testing combined with follow-up telephone calls and text messages from community clinical navigators and CHWs.
The research components of this study involve: 1) offering women the opportunity to complete the HPV self-test in a non-clinical setting to be returned via a mailer or handed to the community clinical navigator or CHW and 2) asking women to respond to questions about their cancer history and knowledge of cervical cancer prevention and screening. All other components of this study are part of clinical care. All other planned activities align with clinically based recommendations and guidelines (e.g., follow-up for colposcopy for + Paps)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care in-clinic Pap-Test | Participant cervical cancer screening method of choice: Standard of Care Pap-Test |
| |
| HPV Self-Test | Participant cervical cancer screening method of choice: HPV Self-Test |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Participant Choice of HPV Self-Test | Behavioral | Opportunity for participants to complete the HPV self-test in a non-clinical setting to be returned via a mailer or courier servie. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to steps in the cervical cancer screening continuum | For the HPV self-testing group,
1. In-clinic Pap test completed (Yes or No) 2. Results Obtained (Yes or No) 3. Follow-up colposcopy completed among those who had positive Pap test (Yes or No) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Assigned sex at birth is female
Adults age 25 to 65 years old whose assigned sex at birth is female.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamie Barrow, MHA, CCRP | Contact | 352-3253703 | jamiehensley@ufl.edu | |
| Jennifer N Woodard, MPH, CCRP | Contact | 352-294-5974 | jenwoodard@ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ramzi A Salloum, PhD | Division Director, Department of Health Outcomes and Biomedical Informatics, University of Florida; Associate Director, Office of Community Outreach and Engagement, UFHealth Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Gainesville | Florida | 32610 | United States |
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| Survey: Participant cancer history and cervical cancer prevention/screening knowledge | Behavioral | Asking women to respond to questions about their cancer history and knowledge of cervical cancer prevention and screening. |
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| Participant Choice of Standard of Care in-clinic Pap-test | Behavioral | Participant choice of cervical cancer screening method with either a SOC in-clinic pap test or HPV self-test |
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