NCT05071261

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112,136

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Sep 2024

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Sep 2024Dec 2030

First Submitted

Initial submission to the registry

September 16, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
2.9 years until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

6.1 years

First QC Date

September 16, 2021

Last Update Submit

August 26, 2024

Conditions

Hepatitis C Virus Infection

Keywords

LiverHepatitis C VirusScreeningDisease Eradication

Outcome Measures

Primary Outcomes (3)

  • Number of Subjects Screened

    Number of subjects screened for HCV

    5 years

  • Number of Subjects Treated

    Number of subjects treated for HCV

    5 years

  • Number of Subjects with a Positive Result for HCV

    Number of subjects who received a positive test result for HCV

    5 years

Interventions

Hepatitis C Virus ScreeningDIAGNOSTIC_TEST

1-2 Blood Screenings for Hepatitis C Virus

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All residents of Arizona

You may qualify if:

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

You may not qualify if:

  • Patients will only be enrolled once
  • Patients with a current HCV diagnosis
  • Patients who underwent a liver transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

  • 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

    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

    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

    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

    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/

    BACKGROUND

  • 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: 22213025BACKGROUND

  • 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.

    PMID: 23286849BACKGROUND

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

    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.

    PMID: 23675657BACKGROUND

  • 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/

    PMID: 25032367BACKGROUND

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

    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/

    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.

    PMID: 27843598BACKGROUND

  • 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.

    PMID: 14960405BACKGROUND

  • 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

    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.

    PMID: 19824079BACKGROUND

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

    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.

    PMID: 24988388BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Huma Habib, MBA

    Director

    STUDY DIRECTOR

Central Study Contacts

Kristine Gradisher, MS

CONTACT

520-822-4361kgradisher@liverinstitutepllc.org

Shahid Habib, MD

CONTACT

520-382-5972shabib@liverinstitutepllc.org

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2021

First Posted

October 8, 2021

Study Start

September 1, 2024

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

IPD will not be shared.