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 — BEHAVIORAL
    Opportunity 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 — BEHAVIORAL
    Asking 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 — BEHAVIORAL
    Participant 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-Test
    Participant cervical cancer screening method of choice: Standard of Care Pap-Test
  • Arm: HPV Self-Test
    Participant 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Jennifer Woodard, RN, MPH
352-259-5574

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