Improving cervical cancer screening for underserved women

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

This study is testing if personalized cervical cancer screening options and support can help underserved women get the screenings they need.

Quick facts

• Study type: Observational
• Enrollment: 800 (estimated)
• Ages: 25 Years to 65 Years
• Sex: Female
• Sponsor: University of Florida (other)
• Locations: 1 site (Gainesville, Florida)
• Trial ID: NCT05390567 on ClinicalTrials.gov

What this trial studies

Project CONTINUITY aims to enhance adherence to cervical cancer screening among underserved women by offering personalized screening options, including HPV self-sampling and in-clinic Pap/HPV testing. The study utilizes community clinical navigators and health workers to provide support and follow-up, addressing social determinants of health that may hinder access to care. Participants will choose their preferred screening method and receive tailored messages and assistance to ensure they complete necessary follow-up care. The project focuses on women living in high socioeconomic vulnerability neighborhoods to improve their screening outcomes.

Who should consider this trial

Good fit: Ideal candidates are women aged 25 to 65 who have not undergone cervical cancer screening in the past four years and reside in areas served by the Mobile Outreach Clinic.

Not a fit: Patients with a history of cervical cancer or those who have had a hysterectomy will not benefit from this study.

Why it matters

Potential benefit: If successful, this project could significantly increase cervical cancer screening rates among underserved women, leading to earlier detection and better health outcomes.

How similar studies have performed: Other studies have shown success in using community health workers and personalized approaches to improve cancer screening adherence, indicating that this approach is promising.

Eligibility criteria

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.

Where this trial is running

Gainesville, Florida

• University of Florida — Gainesville, Florida, United States (RECRUITING)

Study contacts

• 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 coordinator: Jamie Barrow, MHA, CCRP

Conditions: Cervical Cancer Screening Methods