RecruitingNCT05390567

Project CONTINUITY: Promoting Evidence-Based Cancer Screening Among Underserved Women


Sponsor

University of Florida

Enrollment

800 participants

Start Date

Jun 7, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 25 YearsMax Age: 65 Years

Inclusion Criteria12

  • 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
  • Not currently pregnant (self-report)
  • Not currently menstruating\*
  • Have not used any vaginal products (e.g., oil-based lubricants, antifungal, and douches) in prior 2 days\*. Use of vaginal contraceptives, condoms and water-based lubricants are allowed.
  • Have not given birth in the prior 12 weeks\*
  • Self-report they have not undergone cancer screening in the past 4 years or more OR report being past due according to provider recommended screening schedule.
  • Self-report of using the MOC in the past, no current usual source of care OR usual source of care is a non-UFH provider and/or cervical cancer screening is not accessible through that provider
  • Reside in census tracts where the Mobile Outreach Clinic travels.
  • Have a mobile phone or access to a mobile phone that can be used to receive messages or a valid email address.

Exclusion Criteria1

  • 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.

Interventions

BEHAVIORALParticipant Choice of HPV Self-Test

Opportunity for participants to complete the HPV self-test in a non-clinical setting to be returned via a mailer or courier servie.

BEHAVIORALSurvey: Participant cancer history and cervical cancer prevention/screening knowledge

Asking women to respond to questions about their cancer history and knowledge of cervical cancer prevention and screening.

BEHAVIORALParticipant Choice of Standard of Care in-clinic Pap-test

Participant choice of cervical cancer screening method with either a SOC in-clinic pap test or HPV self-test


Locations(1)

University of Florida

Gainesville, Florida, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05390567


Related Trials