NCT05390567

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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).

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)

Conditions

• Cervical Cancer Screening Methods

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2024-06-07
• Primary completion: 2027-05-01
• Completion: 2027-12-01
• First posted: 2022-05-25
• Last updated: 2025-07-11

Locations

1 site across 1 country: United States