Project CONTINUITY: Promoting Evidence-Based Cancer Screening Among Underserved Women
Part of paid clinical trials in Gainesville, Florida.
- Sponsor
- University of Florida
- Study ID
- NCT05390567
- Status
- Recruiting
Conditions
- Cervical Cancer Screening Methods
Eligibility Criteria
- Sex
- FEMALE
- Age
- 25 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- 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
Study Details
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).
Key Dates
- Start date
- Jun 7, 2024
- Status verified
- Jul 2025
- Primary completion
- May 1, 2027
- Completion
- Dec 1, 2027
Study Design
- Enrollment
- 800 participants (estimated)
Arms
- Arm: Standard of Care in-clinic Pap-TestParticipant cervical cancer screening method of choice: Standard of Care Pap-Test
- Arm: HPV Self-TestParticipant cervical cancer screening method of choice: HPV Self-Test
Primary Outcome Measure
Adherence to steps in the cervical cancer screening continuum [ Time Frame: 6 months ]
Central Contacts
- Jamie Barrow, MHA, CCRP352-3253703
- Jennifer N Woodard, MPH, CCRP352-294-5974
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 |