Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 9:54 PM
Study NCT ID:
NCT05071261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-27
First Post:
2021-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening, Treatment, and Eradication of Hep C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-08', 'size': 812685, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-16T13:58', 'hasProtocol': True}, {'date': '2021-09-08', 'size': 292691, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-09-16T13:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112136}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2030-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2021-09-16', 'studyFirstSubmitQcDate': '2021-09-27', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Screened', 'timeFrame': '5 years', 'description': 'Number of subjects screened for HCV'}, {'measure': 'Number of Subjects Treated', 'timeFrame': '5 years', 'description': 'Number of subjects treated for HCV'}, {'measure': 'Number of Subjects with a Positive Result for HCV', 'timeFrame': '5 years', 'description': 'Number of subjects who received a positive test result for HCV'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver', 'Hepatitis C Virus', 'Screening', 'Disease Eradication'], 'conditions': ['Hepatitis C Virus Infection']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '2016 Viral Hepatitis Epidemiologic Profile for Arizona (2016). Retrieved form https://www.azdhs.gov/documents/preparedness/epidemiology-disease-control/hepatitis/arizona-2016-viral-hepatitis-profile.pdf'}, {'type': 'BACKGROUND', 'citation': 'American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA). (n.d.). Recommendations for testing, management, and treating hepatitis C. HCV testing and linkage to care. Retrieved from http://www.hcvguidelines.org'}, {'type': 'BACKGROUND', 'citation': 'Center for Disease Control and Prevention (CDC), (2016). Hepatitis C kills more Americans than any other infectious disease. Retrieved from https://www.cdc.gov/media/releases/2016/p0504- hepc-mortality.html'}, {'type': 'BACKGROUND', 'citation': 'Center for Disease Control and Prevention (CDC), (2018). Hepatitis C questions and answers for the public. Retrieved from https://www.cdc.gov/hepatitis/hcv/cfaq.htm#A1'}, {'type': 'BACKGROUND', 'citation': 'Chaffey, D. (2019) How do we compare? 2019 Email marketing statistics compilation. Retrieved from https://www.smartinsights.com/email-marketing/email-communications-strategy/statistics-sources-for-email-marketing/'}, {'pmid': '22213025', 'type': 'BACKGROUND', 'citation': 'Denniston MM, Klevens RM, McQuillan GM, Jiles RB. Awareness of infection, knowledge of hepatitis C, and medical follow-up among individuals testing positive for hepatitis C: National Health and Nutrition Examination Survey 2001-2008. Hepatology. 2012 Jun;55(6):1652-61. doi: 10.1002/hep.25556. Epub 2012 Apr 10.'}, {'pmid': '23286849', 'type': 'BACKGROUND', 'citation': 'Hagan LM, Schinazi RF. Best strategies for global HCV eradication. Liver Int. 2013 Feb;33 Suppl 1(0 1):68-79. doi: 10.1111/liv.12063.'}, {'type': 'BACKGROUND', 'citation': 'Homelessness. (n.d.). Retrieved from https://phoenixrescuemission.org/homelessness'}, {'pmid': '23675657', 'type': 'BACKGROUND', 'citation': 'Holmberg SD, Spradling PR, Moorman AC, Denniston MM. Hepatitis C in the United States. N Engl J Med. 2013 May 16;368(20):1859-61. doi: 10.1056/NEJMp1302973. No abstract available.'}, {'pmid': '25032367', 'type': 'BACKGROUND', 'citation': 'Institute of Medicine (US) Committee on the Prevention and Control of Viral Hepatitis Infection; Colvin HM, Mitchell AE, editors. Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. Washington (DC): National Academies Press (US); 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK220039/'}, {'type': 'BACKGROUND', 'citation': 'Mappinghepc. (n.d.). Retrieved from https://mappinghepc.com/maps'}, {'type': 'BACKGROUND', 'citation': 'Palgrave-Jones, J. (2017). 5 Stats that prove 2017 is the year for SMS marketing. Retrieved from https://www.textlocal.com/blog/2017/06/16/5-stats-that-prove-2017-is-the-year-for-sms-marketing/'}, {'pmid': '27843598', 'type': 'BACKGROUND', 'citation': 'Pinter M, Trauner M, Peck-Radosavljevic M, Sieghart W. Cancer and liver cirrhosis: implications on prognosis and management. ESMO Open. 2016 Mar 17;1(2):e000042. doi: 10.1136/esmoopen-2016-000042. eCollection 2016.'}, {'pmid': '14960405', 'type': 'BACKGROUND', 'citation': 'Snyder LB, Hamilton MA, Mitchell EW, Kiwanuka-Tondo J, Fleming-Milici F, Proctor D. A meta-analysis of the effect of mediated health communication campaigns on behavior change in the United States. J Health Commun. 2004;9 Suppl 1:71-96. doi: 10.1080/10810730490271548.'}, {'type': 'BACKGROUND', 'citation': 'US Food and Drug Administration. (n.d.). FDA approves rapid test for antibodies to hepatitis C virus. News and Events. Retrieved from https://wayback.archive-it.org/7993/20170112215729/http:/www.fda.gov/NewsEvents/Newsroom/PressAnnouncement s/2010/ucm217318.htm'}, {'pmid': '19824079', 'type': 'BACKGROUND', 'citation': 'Volk ML, Tocco R, Saini S, Lok AS. Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology. 2009 Dec;50(6):1750-5. doi: 10.1002/hep.23220.'}, {'type': 'BACKGROUND', 'citation': 'World Health Organization. (2018). Hepatitis C. Retrieved from https://www.who.int/news-room/fact-sheets/detail/hepatitis-c'}, {'pmid': '24988388', 'type': 'BACKGROUND', 'citation': 'Yehia BR, Schranz AJ, Umscheid CA, Lo Re V 3rd. The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PLoS One. 2014 Jul 2;9(7):e101554. doi: 10.1371/journal.pone.0101554. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the HCV screening rate in Arizona by identification of potential HCV patients/subjects through different methods of communication - text message, email, social media, radio, newspaper ads, and flyers.', 'detailedDescription': "The study will focus on various methods of communication to reach the population of Arizona from the most prevalent counties to lowest prevalence. The study is organized into phases focusing on the various communication methods beginning with direct communication through mass text messages and mass emails followed by indirect communication through social media (YouTube, Facebook), newspaper, radio, Alcoholics Anonymous meetings, Narcotics Anonymous meetings, and homeless shelters. Each phase will consist of four cycles of a monthly intervention period in which communication will be active and a two-month gap that will be used to assess effectiveness of the communication method. Subjects will receive information on HCV, contact information for the study coordinator at the Liver Institute PLLC to address questions or concerns, and a code that will allow them to receive a free HCV screening test at their local Sonora Quest Lab. This code can be used at the time of receipt or a few months later, whenever the subject is ready for testing. This timeline allows to enhance subject compliance. The results from Sonora Quest Lab will be transmitted to the study coordinator at the Liver Institute PLLC and depending on the subject's insurance status will link the subject to a treatment center. Ideally it will be their primary care physician but if the subject does not have one then it will be the closest treatment center. Alternatively, the Liver Institute PLLC is also equipped to provide telemedicine appointments to evaluate the subject and provide treatment depending on insurance status. Those that are uninsured will be provided with available options for treatment. All subjects will receive information on the disease to reduce transmission and encourage friends/family to get tested. This study will function on a version of the test-and-treat approach to help reduce the spread of HCV in the Arizona population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All residents of Arizona', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must sign the consent to screen and take part in the study.\n* Subjects must be at least 15 years of age\n\nExclusion Criteria:\n\n* Patients will only be enrolled once\n* Patients who do not meet the inclusion criteria\n* Patients with a current HCV diagnosis\n* Patients who underwent a liver transplant'}, 'identificationModule': {'nctId': 'NCT05071261', 'briefTitle': 'Screening, Treatment, and Eradication of Hep C', 'organization': {'class': 'OTHER', 'fullName': 'Liver Institute PLLC'}, 'officialTitle': 'A Communication-Based Study Focused on Assessing and Improving Hepatitis C Screening Rates, As Well As Treatment Rates in Arizona as a Step Towards Disease Eradication', 'orgStudyIdInfo': {'id': 'LI-HEPC-AZ'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hepatitis C Virus Screening', 'type': 'DIAGNOSTIC_TEST', 'description': '1-2 Blood Screenings for Hepatitis C Virus'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kristine Gradisher, MS', 'role': 'CONTACT', 'email': 'kgradisher@liverinstitutepllc.org', 'phone': '520-822-4361'}, {'name': 'Shahid Habib, MD', 'role': 'CONTACT', 'email': 'shabib@liverinstitutepllc.org', 'phone': '520-382-5972'}], 'overallOfficials': [{'name': 'Huma Habib, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liver Institute PLLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}