Screening, Treatment, and Eradication of Hep C

NCT ID: NCT05071261

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 112136 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2030-12-01

Brief Summary

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.

Detailed Description

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.

Conditions

Hepatitis C Virus Infection

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Interventions

Hepatitis C Virus Screening

1-2 Blood Screenings for Hepatitis C Virus

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Subjects must sign the consent to screen and take part in the study.
• Subjects must be at least 15 years of age

• Patients with a current HCV diagnosis
• Patients who underwent a liver transplant

Exclusion Criteria

• Patients will only be enrolled once

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Liver Institute PLLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huma Habib, MBA

Role: STUDY_DIRECTOR

Director

Central Contacts

Kristine Gradisher, MS

Role: CONTACT

kgradisher@liverinstitutepllc.org

520-822-4361

Shahid Habib, MD

Role: CONTACT

shabib@liverinstitutepllc.org

520-382-5972

References

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.

Reference Type: BACKGROUND

PMID: 22213025 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23286849 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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/

Reference Type: BACKGROUND

Homelessness. (n.d.). Retrieved from https://phoenixrescuemission.org/homelessness

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 23675657 (View on PubMed)

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/

Reference Type: BACKGROUND

PMID: 25032367 (View on PubMed)

Mappinghepc. (n.d.). Retrieved from https://mappinghepc.com/maps

Reference Type: BACKGROUND

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/

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 27843598 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14960405 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 19824079 (View on PubMed)

World Health Organization. (2018). Hepatitis C. Retrieved from https://www.who.int/news-room/fact-sheets/detail/hepatitis-c

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 24988388 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

LI-HEPC-AZ

Identifier Type: -

Identifier Source: org_study_id