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

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).

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer Screening Methods
• Intervention / Treatment: Behavioral: Survey: Participant cancer history and cervical cancer prevention/screening knowledge; Behavioral: Participant Choice of Standard of Care in-clinic Pap-test; Behavioral: Participant Choice of HPV Self-Test

Detailed Description

The purpose of this pilot project is to gather information about the extent to which women residing in high SEV neighborhoods who choose HPV self-sampling relative to in-clinic Pap/HPV testing adhere to the cancer screening continuum steps, for which they are eligible. The women will self-select into HPV self-sampling versus in-clinic Pap/HPV testing combined with follow-up telephone calls and text messages from community clinical navigators and CHWs.

The research components of this study involve: 1) offering women the opportunity to complete the HPV self-test in a non-clinical setting to be returned via a mailer or handed to the community clinical navigator or CHW and 2) asking women to respond to questions about their cancer history and knowledge of cervical cancer prevention and screening. All other components of this study are part of clinical care. All other planned activities align with clinically based recommendations and guidelines (e.g., follow-up for colposcopy for + Paps)

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Jennifer N Woodard, MPH, CCRP; Phone Number: 352-294-5974; Email: jenwoodard@ufl.edu
• Study Contact Backup: Name: Jamie Barrow, MHA, CCRP; Phone Number: 352-3253703; Email: jamiehensley@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
      • Contact: Jennifer Woodard, RN, MPH; Phone Number: 352-259-5574; Email: jenwoodard@ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Using the American Cancer Society (ACS) screening recommendations, adults 25 to 65 will be eligible.
2. Assigned sex at birth is female
3. No previous history of cervical cancer
4. No previous history of a hysterectomy
5. Not currently pregnant (self-report)
6. Not currently menstruating*
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. Have not given birth in the prior 12 weeks*
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. 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. Reside in census tracts where the Mobile Outreach Clinic travels.
12. Have a mobile phone or access to a mobile phone that can be used to receive messages or a valid email address.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Asking women to respond to questions about their cancer history and knowledge of cervical cancer prevention and screening.; Behavioral: Participant 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
HPV Self-Test; Participant cervical cancer screening method of choice: HPV Self-Test	Behavioral: Survey: 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.; Behavioral: Participant 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to steps in the cervical cancer screening continuum	For the HPV self-testing group,; HPV test returned (Yes or No); Results obtained (Yes or No); Follow-up Pap test completed among those who tested positive for HPV (Yes or No); 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

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: IRB202200613; OCR41931 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No