About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Using the American Cancer Society (ACS) screening recommendations, adults 25 to 65 will be eligible.
Assigned sex at birth is female
No previous history of cervical cancer
No previous history of a hysterectomy
Disqualifiers
For patients who are excluded for criterion 6, 7, and 8, the outreach team (community clinical navigator and CHW) will ask the participant if they can be re-contacted for potential future study eligibility assessment. If the participant agrees, the navigator or CHW will collect contact information to re-contact the participant at a later (pre-determined) date up to 20 weeks later for eligibility screening.
Trial population
Adults age 25 to 65 years old whose assigned sex at birth is female.
Trial design
Other
Prospective
Treatments tested in this trial
Participant Choice of HPV Self-Test
BehavioralOpportunity for participants to complete the HPV self-test in a non-clinical setting to be returned via a mailer or courier servie.
Survey: Participant cancer history and cervical cancer prevention/screening knowledge
BehavioralAsking women to respond to questions about their cancer history and knowledge of cervical cancer prevention and screening.
Participant Choice of Standard of Care in-clinic Pap-test
BehavioralParticipant choice of cervical cancer screening method with either a SOC in-clinic pap test or HPV self-test
Treatment groups
Trial outcomes
Primary outcomes
Adherence to steps in the cervical cancer screening continuum
For the HPV self-testing group, 1. HPV test returned (Yes or No) 2. Results obtained (Yes or No) 3. Follow-up Pap test completed among those who tested positive for HPV (Yes or No) 4. Follow-up colposcopy completed among those who had positive Pap test (Yes or No) For the in-clinic 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)
Sponsors and contacts
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