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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-07

Study Completion Date

2027-12-01

Brief Summary

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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).

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Detailed Description

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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

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Cervical Cancer Screening Methods

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard of Care in-clinic Pap-Test

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

Survey: Participant cancer history and cervical cancer prevention/screening knowledge

Intervention Type BEHAVIORAL

Asking women to respond to questions about their cancer history and knowledge of cervical cancer prevention and screening.

Participant Choice of Standard of Care in-clinic Pap-test

Intervention Type BEHAVIORAL

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

Participant Choice of HPV Self-Test

Intervention Type BEHAVIORAL

Opportunity for participants to complete the HPV self-test in a non-clinical setting to be returned via a mailer or courier servie.

Survey: Participant cancer history and cervical cancer prevention/screening knowledge

Intervention Type BEHAVIORAL

Asking women to respond to questions about their cancer history and knowledge of cervical cancer prevention and screening.

Interventions

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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.

Intervention Type 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.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ramzi A Salloum, PhD

Role: 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