Clinical trial NCT05071261: Screening, Treatment, and Eradication of Hep C
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatitis C Virus Infection
Keywords: Liver
Hepatitis C Virus
Screening
Disease Eradication
Lead sponsor: Liver Institute PLLC
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 112136
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All residents of Arizona

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.

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Subjects Screened
timeFrame: 5 years
measure: Number of Subjects Treated
timeFrame: 5 years
measure: Number of Subjects with a Positive Result for HCV
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Director
name: Huma Habib, MBA
role: STUDY_DIRECTOR
References:
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
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