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

NCT05390567 | Recruiting

• 2 other identifiers: IRB202200613OCR41931
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cervical Cancer Screening Methods

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Study Arms (2)

Standard of Care in-clinic Pap-Test

Participant cervical cancer screening method of choice: Standard of Care Pap-Test

Behavioral: Survey: Participant cancer history and cervical cancer prevention/screening knowledge; Behavioral: Participant Choice of Standard of Care in-clinic Pap-test

HPV Self-Test

Participant cervical cancer screening method of choice: HPV Self-Test

Behavioral: Participant Choice of HPV Self-Test; Behavioral: Survey: Participant cancer history and cervical cancer prevention/screening knowledge

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.

HPV Self-Test

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.

HPV Self-Test; Standard of Care in-clinic Pap-Test

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

Standard of Care in-clinic Pap-Test

Eligibility Criteria

• Age: 25 Years - 65 Years
• Gender Eligibility Details: Assigned sex at birth is female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults age 25 to 65 years old whose assigned sex at birth is female.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Study Officials

• Ramzi A Salloum, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie Barrow, MHA, CCRP

CONTACT

352-3253703; jamiehensley@ufl.edu

Jennifer N Woodard, MPH, CCRP

CONTACT

352-294-5974; jenwoodard@ufl.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 25, 2022
• Study Start: June 7, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)