RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-06-07
Study Completion:2025-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05390567

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Using the American Cancer Society (ACS) screening recommendations, adults 25 to 65 will be eligible.
  2. 2. Assigned sex at birth is female
  3. 3. No previous history of cervical cancer
  4. 4. No previous history of a hysterectomy
  5. 5. Not currently pregnant (self-report)
  6. 6. Not currently menstruating\*
  7. 7. 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.
  8. 8. Have not given birth in the prior 12 weeks\*
  9. 9. 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.
  10. 10. 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
  11. 11. Reside in census tracts where the Mobile Outreach Clinic travels.
  12. 12. Have a mobile phone or access to a mobile phone that can be used to receive messages or a valid email address.
  1. * 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.

Contacts and Locations

Study Contact

Jamie Barrow, MHA, CCRP
CONTACT
352-3253703
jamiehensley@ufl.edu
Jennifer N Woodard, MPH, CCRP
CONTACT
352-294-5974
jenwoodard@ufl.edu

Principal Investigator

Ramzi A Salloum, PhD
PRINCIPAL_INVESTIGATOR
Division Director, Department of Health Outcomes and Biomedical Informatics, University of Florida; Associate Director, Office of Community Outreach and Engagement, UFHealth Cancer Center

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32610
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Ramzi A Salloum, PhD, PRINCIPAL_INVESTIGATOR, Division Director, Department of Health Outcomes and Biomedical Informatics, University of Florida; Associate Director, Office of Community Outreach and Engagement, UFHealth Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-07
Study Completion Date2025-05-01

Study Record Updates

Study Start Date2024-06-07
Study Completion Date2025-05-01

Terms related to this study

Additional Relevant MeSH Terms

  • Cervical Cancer Screening Methods