NCT05390567 · University of Florida
Project CONTINUITY: Promoting Evidence-Based Cancer Screening Among Underserved Women
What this study is about
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.
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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).
Interventions
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
Primary outcome measures
Adherence to steps in the cervical cancer screening continuum
Time frame: 6 months
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
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
- Gainesville, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 11, 2025 · Source of record for eligibility and locations