Screening, Treatment, and Eradication of Hep C

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Hepatitis C Virus Screening
  1-2 Blood Screenings for Hepatitis C Virus

Первичные конечные точки

• Number of Subjects Screened [Срок оценки: 5 years]
• Number of Subjects Treated [Срок оценки: 5 years]
• Number of Subjects with a Positive Result for HCV [Срок оценки: 5 years]

Критерии участия

Критерии включения

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

Критерии исключения

• Patients will only be enrolled once
• Patients who do not meet the inclusion criteria
• Patients with a current HCV diagnosis
• Patients who underwent a liver transplant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Экологическое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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
• 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
• 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/
• 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 22213025
• 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 23286849
• Homelessness. (n.d.). Retrieved from https://phoenixrescuemission.org/homelessness

Идентификаторы

NCT: NCT05071261 · LI-HEPC-AZ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗