Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT05390567
Status:
RECRUITING
Last Update Posted:
2025-07-11
First Post:
2022-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Project CONTINUITY: Promoting Evidence-Based Cancer Screening Among Underserved Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2022-05-19', 'studyFirstSubmitQcDate': '2022-05-19', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to steps in the cervical cancer screening continuum', 'timeFrame': '6 months', 'description': 'For the HPV self-testing group,\n\n1. HPV test returned (Yes or No)\n2. Results obtained (Yes or No)\n3. Follow-up Pap test completed among those who tested positive for HPV (Yes or No)\n4. Follow-up colposcopy completed among those who had positive Pap test (Yes or No) For the in-clinic testing group,\n\n1\\. 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)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer Screening Methods']}, 'descriptionModule': {'briefSummary': "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).", 'detailedDescription': '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.\n\nThe 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)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults age 25 to 65 years old whose assigned sex at birth is female.', 'genderDescription': 'Assigned sex at birth is female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Using the American Cancer Society (ACS) screening recommendations, adults 25 to 65 will be eligible.\n2. Assigned sex at birth is female\n3. No previous history of cervical cancer\n4. No previous history of a hysterectomy\n5. Not currently pregnant (self-report)\n6. Not currently menstruating\\*\n7. 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.\n8. Have not given birth in the prior 12 weeks\\*\n9. 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.\n10. 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\n11. Reside in census tracts where the Mobile Outreach Clinic travels.\n12. Have a mobile phone or access to a mobile phone that can be used to receive messages or a valid email address.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT05390567', 'briefTitle': 'Project CONTINUITY: Promoting Evidence-Based Cancer Screening Among Underserved Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Project CONTINUITY: Promoting Evidence-Based Cancer Screening Among Underserved Women', 'orgStudyIdInfo': {'id': 'IRB202200613'}, 'secondaryIdInfos': [{'id': 'OCR41931', 'type': 'OTHER', 'domain': 'UF OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard of Care in-clinic Pap-Test', 'description': 'Participant cervical cancer screening method of choice: Standard of Care Pap-Test', 'interventionNames': ['Behavioral: Survey: Participant cancer history and cervical cancer prevention/screening knowledge', 'Behavioral: Participant Choice of Standard of Care in-clinic Pap-test']}, {'label': 'HPV Self-Test', 'description': 'Participant cervical cancer screening method of choice: HPV Self-Test', 'interventionNames': ['Behavioral: Participant Choice of HPV Self-Test', 'Behavioral: Survey: Participant cancer history and cervical cancer prevention/screening knowledge']}], 'interventions': [{'name': 'Participant Choice of HPV Self-Test', 'type': 'BEHAVIORAL', 'description': 'Opportunity for participants to complete the HPV self-test in a non-clinical setting to be returned via a mailer or courier servie.', 'armGroupLabels': ['HPV Self-Test']}, {'name': 'Survey: Participant cancer history and cervical cancer prevention/screening knowledge', 'type': 'BEHAVIORAL', 'description': 'Asking women to respond to questions about their cancer history and knowledge of cervical cancer prevention and screening.', 'armGroupLabels': ['HPV Self-Test', 'Standard of Care in-clinic Pap-Test']}, {'name': 'Participant Choice of Standard of Care in-clinic Pap-test', 'type': 'BEHAVIORAL', 'description': 'Participant choice of cervical cancer screening method with either a SOC in-clinic pap test or HPV self-test', 'armGroupLabels': ['Standard of Care in-clinic Pap-Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Woodard, RN, MPH', 'role': 'CONTACT', 'email': 'jenwoodard@ufl.edu', 'phone': '352-259-5574'}], 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'centralContacts': [{'name': 'Jamie Barrow, MHA, CCRP', 'role': 'CONTACT', 'email': 'jamiehensley@ufl.edu', 'phone': '352-3253703'}, {'name': 'Jennifer N Woodard, MPH, CCRP', 'role': 'CONTACT', 'email': 'jenwoodard@ufl.edu', 'phone': '352-294-5974'}], 'overallOfficials': [{'name': 'Ramzi A Salloum, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division Director, Department of Health Outcomes and Biomedical Informatics, University of Florida; Associate Director, Office of Community Outreach and Engagement, UFHealth Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}