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
Conditions: Hepatitis C Virus Infection
Sponsor: Liver Institute PLLC

Screening, Treatment, and Eradication of Hep C 
 
Pending IRB Approval 
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Approval Pending 
 
 
 
 
 
 
Protocol Number:   
 
 
LI-HEPC-AZ 
Protocol Version: 
 
 
 
Version 1.0 
Date of IRB Submission: 
 
 
Pending 
Date of IRB Acceptance:  
 
 
Pending 
IRB Protocol Number: 
 
 
Pending 
Study Sponsor & Investigator: 
 
Shahid Habib, MD 
 
 
 
 
 
 
Liver Institute PLLC 
 
 
 
 
 
 
5295 E Knight Dr.  
 
 
 
 
 
 
Tucson, AZ 85712 
 
 
 
 
 
 
United States of America 
 
Study Related Phone Numbers: 
 
Office – 520-382-5972 
 
 
 
 
 
 
Research & 24hr – 520-822-4361 
 
 
Clinical Study Protocol 
 
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  
Confidential: This document contains confidential information that is the property of Liver 
Institute PLLC and must not be disclosed to anyone other than the designees of Liver Institute 
for the conduct of the study, the recipient clinical Investigator(s) and their designees and 
members of the Institutional Review Board. This information must not be used for any purpose 
other than the evaluation or conduct of the clinical investigation without the prior written 
consent of Liver Institute PLLC.  

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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation:  
 
 
 
Definition: 
AA 
 
 
 
 
 
Alcoholics Anonymous 
AE 
 
 
 
 
 
Adverse Event 
ADHS  
 
 
 
 
Arizona Department of Health Services 
CDC  
 
 
 
 
Center for Disease Control 
ELISA  
 
 
 
 
Enzyme-linked Immunosorbent Assay 
FAQ  
 
 
 
 
Frequently Asked Questions 
GCP  
 
 
 
 
Good Clinical Practices 
HCC  
 
 
 
 
Hepatocellular Carcinoma (liver cancer) 
HCV  
 
 
 
 
Hepatitis C Virus 
IBM 
 
 
 
 
 
International Business Machines Corporation 
ICH 
 
 
 
 
 
International Conference on Harmonization 
IEC 
 
 
 
 
 
Independent Ethics Committee  
IRB 
 
 
 
 
 
Institutional Review Board 
NA 
 
 
 
 
 
Narcotics Anonymous  
NHANES 
 
 
 
 
National Health and Nutrition Examination Survey  
PCR 
 
 
 
 
 
Polymerase Chain Reaction 
PHI 
 
 
 
 
 
Protected Health Information 
Hep C Antibody Screening 
 
 
A test used to screen for hepatitis C by identifying 
antibodies the body makes in response to HCV 
infection. 

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Hep C RNA Test 
 
 
 
A more accurate test used for diagnosing hepatitis C 
by measuring the number of HCV genetic material 
(viral RNA). 
Cirrhosis 
 
 
 
 
Degenerative liver disease characterized by fibrosis 
and scarring of the liver tissue and is caused by 
various chronic conditions affecting the liver. 
HIV 
 
 
 
 
 
Human Immunodeficiency Virus: HIV is also 
transmitted through blood contact and carry the 
same risk factors as HCV, therefore the two may 
happen simultaneously. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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LIST OF FIGURES 
Figure 
Number 
Figure Title 
Page 
Number 
1 
Age based HCV Related Distribution of Deaths in Arizona 2011-
20149. 
9 
2 
NHANES Hepatitis C Follow‐Up Questionnaire results (n = 133)16. 
10 
3 
Study Protocol 
14 
4 
Average Annual Rate of Hepatitis C by County, 2002 – 2008. 
Retrieved from ADHS1. 
19 
5 
Risk Factors for all clients who had positive HCV results compared to 
all clients tested2. 
20 
6 
Hepatitis C Outreach Program Methodology 
22 
7 
HCV Expected and current screening and treatment rates. Treatment 
cascade created by Yahia BR, et al. Graph was modified to display 
2015 cumulative number of reported new cases of Hepatitis C in 
Arizona1, 18. 
25 
 
 
 
 

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Table of Contents 
 
 
Section 
Number 
Content 
Page Number 
0.1 
0.2 
0.3 
0.4 
List of Abbreviations and Definitions of Terms 
List of Figures 
Table of Contents 
Protocol Synopsis 
2-3 
4 
5 
6-8 
1.0  
      1.1  
      1.2  
      1.3  
      1.4 
Introduction 
Disease Background 
Scientific Rationale 
Current Standards: Outreach, Screening, and Treatment 
Research Hypotheses 
9 
9 
9-10 
10-11 
11 
2.0 
      2.1 
      2.2 
Objectives and Endpoints 
Objectives 
Endpoints 
12 
12 
12 
3.0 
      3.1 
      3.2 
      3.3   
      3.4 
      3.5 
Investigational Plan 
Study Design  
Subjects  
Educational Outreach Methods  
Population Screening  
Links to Care: Treatment of HCV Infection 
13 
13-19 
19-21 
21 
21-22 
22 
4.0 
      4.1 
      4.2 
      4.3 
HCV screening Methods 
Inclusion Criteria  
Exclusion Criteria  
Withdrawal of Patients 
23 
23 
23 
23 
5.0 
      5.1 
      5.2 
      5.3 
Data Management and Analysis  
Data Entry and Management  
Data Analysis  
Results 
24 
24 
24 
24-25 
6.0 
      6.1 
      6.2 
      6.3 
      6.4   
      6.5  
      6.6 
Legal and Ethical Considerations 
IRB/IEC Approval  
Subject Information and Informed Consents  
Confidentiality  
Record Retention  
Publication Policy  
Financial Support 
26 
26 
26-27 
27 
27 
27 
27 
7.0 
Discussion and Challenges 
28 
8.0 
      8.1 
      8.2 
      8.3 
      8.4 
      8.5 
      8.6 
      8.7 
Appendix 
Email Message Template 
Text Message Template 
Frequently Asked Questions (FAQ) 
Abbvie Infographic 
Resources Needed and Time Allocations 
Investigator’s Agreement and Signature 
Signature of Sub-Investigators  
29 
29 
29 
29-30 
30 
30 
31 
32 
9.0 
References 
33-35 

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Clinical Study Protocol Synopsis 
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 
 
Site Location:  
Liver Institute PLLC 
 
 
 
5295 E Knight Dr 
 
 
 
Tucson, AZ 85712 
 
 
 
United States of America 
 
Objective:   
To eradicate the prevalence of hepatitis C in Arizona through improving 
awareness, increasing population screening rates, and providing linkage to 
care. 
 
Introduction:  
The World Health Organization has set a goal of Hepatitis C (HCV) 
eradication by 2030 and this study’s focus is to assist in accomplishing 
this goal. The utility of modern technology such as texting, emails, and 
phone calls in eradication of a communicable disease has not been studied 
and validated. 
Hypothesis:   
The utilization of modern technology such as texting, emails, and phone 
calls will expedite population-based HCV screening. Digital coding of 
these screened subjects will help to connect individuals with care. 
Moreover, the utility of digital technology such as telemedicine would 
increase the rate of HCV treatment. Taken together, modern technology 
will expedite the process of HCV eradication. 
Research Aim:  
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. 
Research Gaps: 
Currently, patients are screened by a primary care physician based upon 
presentation including liver function tests, abnormal liver imaging, or 
disclosed high risk behavior. Although the Center for Disease Control 
(CDC) has recommended universal screening of “baby boomers”, 
adherence to this recommendation is poor in the primary care setting. With 
the current rate of screening for HCV infection, eradication of HCV 

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infection by 2030 as per WHO recommendations is not an achievable 
timeline in the United States. 
Methods:  
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. 
Results: 
The study will allow us to obtain diagnostic rates for each communication 
method as well as the number of HCV positive individuals that are linked 
to care for treatment. By comparing diagnostic rates between 
communication methods, we can identify the most successful method to 
utilize for a bigger subject outreach. Additionally, by determining the rates 
of HCV positive individuals linked to care, we can identify deficits in the 
treatment of screened individuals. These components taken together will 
allow us to evaluate the overall success of our study. 
Conclusion: 
The United States is well behind the overall goal of HCV eradication by 
2030. To successfully facilitate completion of this goal, a new process of 
HCV screening and linkage to treatment is necessary. We propose a study 

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focused on evaluating various methods of modern communication to 
increase the HCV screening rate in Arizona and link these individuals to 
treatment centers based on their insurance status. With the design of this 
study, we can evaluate the most successful method of communication and 
address the gaps in linking positive HCV individuals to treatment. Overall, 
the aggressive nature of our study is a step in the process to accomplish 
the goal of HCV eradication. 
Principal Investigator:  
Shahid Habib, MD & PI 
Sub-Investigators: 
Kristine Gradisher, MS (Physiology), Clinical Research 
Coordinator, & Sub-I 
 
 
 
 
Julie Piittmann, FNPC & Sub-I 
 
IRB Number: 
 
Pending 
 
Protocol Date: 
 
Pending 
 
 
 

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1.0 Introduction 
1.1 Disease Background 
CDC statistics from 2013 indicate that deaths due to hepatitis C (HCV) surpassed the 
number of deaths due to 60 other infectious diseases combined, including HIV and tuberculosis3. 
HCV is an ever-growing public health issue that continues to be the cause of mortality in 
millions. Additionally, prevalence of the disease is constantly increasing due to the initial 
asymptomatic phase and infectious nature of the disease3. Approximately 60-80% of people with 
the virus will develop chronic HCV infection, characterized by a lifelong illness with serious 
life-threatening complications such as cirrhosis, and hepatocellular carcinoma15. The risk of 
disease progression increases with concurrent heavy alcohol consumption, ingestion of hepatoxic 
medications or supplements, and presence of poorly managed insulin resistance, iron overload, 
or other comorbid conditions such as end stage renal disease4.  
With current effective and well-tolerated antiviral oral therapies, 95% of patients can be 
effectively treated15. However, their benefit will be unremarkable if efforts to improve rates of 
diagnosis and treatment remain the same2. Many barriers continue to prevent control and 
eradication of the disease. These include identifying HCV carriers, connecting to treatment and 
prevention. Most people infected with the virus are asymptomatic and therefore are unaware of 
their infection while still being able to transmit it to others. The only way to diagnose the disease 
in this case is to get tested. Therefore, nationwide screening is required if the future public health 
burden of hepatitis C is to be ameliorated16. 
1.2 Scientific Rational: Eradication of HCV in Arizona 
 
HCV related malignancies are among the leading causes of mortality in comparison to 
death from all other causes in Arizona, especially in the middle-age population (Figure 1). The 
World Health Organization (WHO) set several recommendations with the goal of eradicating 
HCV by 2030 and several developed countries have taken the initiative to meet these goals17. 
The United States on the other hand is significantly lagging to achieve this target. With the 
current rate of screening, diagnosis, and treatment, it will take several decades to meet the goals 
of eradication. There is an urgent need to take aggressive action. 
 
 
 
 
Figure 1: Age based HCV Related Distribution of Deaths in Arizona 2011-20142. 

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According to the Institute of Medicine (IOM), 75-90% of HCV positive individuals in the 
United are unaware of their infection10. Current HCV standards encourage screening to only 
those who are thought to be at risk including injection-drug users, baby boomers, persons with 
known HCV exposure, HIV infection and patients with signs/symptoms of liver disease7, 2. 
However, these standards leave millions undiagnosed, hence the increasing trends of HCV1, 6. 
According to the results of the NHANES questionnaire (Figure 2), the primary reason for lack of 
treatment is lack of diagnosis16. 
 
 
 
 
 
 
 
 
 
 
 
 
For each new acute HCV case that is reported in the United States, the CDC estimates 
there are approximately 13.9 actual new HCV cases (reported and unreported)15. This high ratio 
(total estimated cases to actual reported cases) is primarily a result of the large proportion of 
individuals with acute HCV who have asymptomatic or minimally symptomatic infection. 
Therefore, many may continue to transmit the disease to others but find it unnecessary to seek 
medical care. 
1.3 Current Standards: Outreach, Screening, and Therapies 
➢ Currently, there is no standard model of public hepatitis C education and 
screening promotion. Although approaches like newspaper or media 
advertisement were used in the past, their benefit remains unknown. On the 
contrary, there are published reports evaluating the benefit of media campaigns on 
awareness of breast and cervical cancer screenings. Evaluating the benefit of this 
project is quite challenging, a meta-analysis revealed short term response of 4% to 
mass education on improving awareness for mammogram and pelvic examination 
for breast and cervical cancers, respectively14. There are no prior studies to 
estimate the response to HCV screening education in the mass population. 
➢ Current standards encourage HCV screening for individuals considered to be at 
risk. This includes baby boomers, individuals exposed to infected blood or illicit 
 
Figure 2: NHANES Hepatitis C Follow-Up Questionnaire Results (n=133)16. 

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drug users. However, these standards do not take into consideration the 
transmission of disease and other possible causes, leaving millions undiagnosed. 
➢ There are a variety of tests that can detect the presence of Hepatitis C Virus, one 
of which utilizes anti-HCV ELISA test and is confirmed by HCV PCR. 
Additional methods include imaging studies and liver biopsies. 
➢ Current standards of treatment include several antiviral medicines that effectively 
cure the disease in most cases. The course of treatment typically takes 12-24 
weeks based on the genotype of disease, extent of liver damage and whether the 
patient was treated for hepatitis C in the past. In addition to antiviral therapy, 
complications like cirrhosis and subsequent complications can also be treated 
using different medical procedures or medicines to prevent risk of liver failure, 
portal hypertension and liver cancer13. 
➢ The Arizona Department of Public Health lags three year on their data 
compilation and reporting. Most recent data available for review is from 2016. 
1.4 Research Hypotheses 
1. We hypothesize that aggressive approach to increased awareness of the entire population 
while providing effective links to care will promote higher screening rates and therefore 
increase diagnosis rates. 
2. We hypothesize that providing screening with no charges would ultimately be a cost-
effective and time-efficient approach towards eradication of the disease. It will facilitate 
the process and invite more of the population to get screened with resultant increase in 
the rates of diagnosis and therefore higher treatment rates. 
3. We hypothesize that creating a central system to link the identified HCV patients to a 
facility that could provide effective treatment with their insurance plans would help 
eradicate HCV in a timely and cost-efficient manner. 
4. We hypothesize that an aggressive educational and treatment approach would minimize 
onset of new HCV infection in the future. 
 
 
 
 
 
 
 
 
 
 

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2.0 Objectives and Endpoints 
2.1 Objectives 
➢ To evaluate the net benefit of an aggressive approach utilizing modern day tools to reach 
the total population of Arizona at both an individual and population level. 
➢ To evaluate the magnitude of increase in diagnosis rates of Hepatitis C with aggressive 
outreach to eradicate the disease in the state. 
➢ To evaluate the benefit of utilizing a central system that links identified individuals to a 
treatment center based upon insurance status. 
 
2.2 Endpoints 
 
Primary Endpoints: 
➢ Patients screened 
➢ Patients treated 
Secondary Endpoints: 
➢ Rate of diagnosed HCV+ individuals 
➢ Rate of patients undergoing treatment 
➢ Increased awareness 
➢ Identify challenges in terms of identification 
 
 
 

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3.0 Investigational Plan 
3.1 Study Design 
➢ This is a prospective study performed over a 45-month period. The principal design plan 
will follow Figure 3 below. 
 
➢ The study design is based on HCV prevalence order, which was determined based on 
statistical data from the Arizona Department of Health Services and rate of Hepatitis C 
per 100,000 (Figure 4). High prevalence counties (123+ cases per 100,000) including La 
Paz, Mohave, and Yavapai with a total targeted population of 391,999 individuals. 
Medium-prevalence Counties (101-123 cases per 100,000) are Coconino, Gila, Greenlee, 
Maricopa, Pima and Pinal with total targeted population of 4,724,421. Low-prevalence 
counties (<101 per 100,000) including Apache, Cochise, Graham, Navajo, Santa Cruz, 
and Yuma with a population of 490,388.  
 
 
➢ For the initial 9 months the study will utilize direct communication methods (email and 
text messages) to reach high prevalence areas (Month 1-6), medium prevalence areas 
(Months 7- 12), and low prevalence areas (Month 13-18). 
 
➢ The second phase of the study will utilize indirect communication methods (Newspapers 
and Radio advertisements) and similarly target areas of high prevalence (Month 12-24), 
medium prevalence (Month 25-30) and low prevalence (Month 31-36). 
 
 
➢ The third and last phase is detected for shelter visits and homeless education in high 
prevalence areas (Month 37-39), mid-prevalence areas (Month 40-42) and low 
prevalence areas (Month 43- 45). 
 
➢ This program will follow a streamline cascade of care with three complementary, 
consecutive portions: Patient education during intervention periods, connection to 
appropriate care and treatment during gap periods (Figure 3). 
 
 
➢ The person responsible for conducting and implementing the project will be the program 
coordinator. The coordinator will be responsible for responding to calls or emails 
regarding the study in reference to the FAQ in Appendix 8.3. One hour daily, 5 days per 
week will be dedicated to answering emails and responding to voice messages or calls. 
The number of hours will be adjusted according to project performance and needs. 
 
 
 

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Phase 1: Direct Communication 
1. Direct Customized Email Messages 
 
Email messages are customizable and tailored to individual people. The expected 
response rate as compared to similar healthcare content is about 2%, 112,136 of our targeted 
group.  
a. Generating Email List 
 
Email listings of Arizona residents will be obtained from National Data Group and mass 
emails will be sent through sendgrid.com. 
b. Frequency and Resources 
 
Emails will be sent out daily during intervention periods of 2 months followed by a 1-
month gap for two rounds for each of the different prevalence groups. A project coordinator at 
the Liver Institute PLLC will assure expectations and targeted numbers are met. 
c. Email Content 
 
The email content will follow the template in Appendix 8.1, including an introduction of 
the program coordinator, introduction to the project as well as brief background information on 
 
Figure 3: Study Protocol 

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the disease and its risk factors (Appendix 8.6). It will also include the steps that need to be taken 
and contact information to answer any questions. 
d. Progress Monitoring 
 
Updates will be obtained from the carrier company as documented proof of the number of 
emails sent. Information will also be collected on how many emails were rejected and how many 
were opened. This information will then be used to guide adjustments of upcoming steps if 
expected response rates are not reached. 
2. Direct Text Messages 
Response rates to text messages are similar to that of emails at about 2% or 112,136 of the 
targeted population. 
a. Generating Phone List 
 
A list of Arizona residents phone numbers will be generated by National Data Group and 
messages will be sent to the targeted population through Verizon wireless. 
b. Frequency and Resources 
Text messaging will similarly follow the protocol described in Figure 3. Messages will be 
sent daily during the intervention period for 2-month followed by a 1-month gap for two rounds 
for each of the different prevalence groups. 
c. Text Content 
 
The text content will follow the template in Appendix 8.2. The message will be brief in 
comparison to the email content. It will include an introduction of the program coordinator, 
introduction to the project, the steps that need to be taken to get screened and a link to more 
information and background on the disease. It will additionally include contact information to 
answer any questions or connect to screening and treatment resources. 
d. Progress Monitoring 
Updates will be obtained from the carrier companies as to how many messages were sent 
daily and how many were rejected. This information will then be used to guide further changes 
or alterations if expected response rates are not reached. 
 
Phase 2: Indirect Communication 
1. Newspapers, Advertisement Content, and Duration 
 
Newspaper advertisements are assumed to generate a response rate of 2% or 112,136 of 
the targeted population. However, according to the local newspaper statistics, the response rate is 
expected to be higher. 
a. Newspapers 

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The most common local newspaper in Arizona is The Arizona Republic. Both 
newspapers are well-rounded, published daily or weekly and readily available to 
the public. This newspaper serves all counties in Arizona, making it efficient and 
more accessible to all members of the population. 
➢ The Arizona Republic – Best Life 
According to republicmedia.com, “Best Life” is the section inside 
the Arizona Republic dedicated for active, healthy adults and 
include preventative health tips and postings. This section is 
published weekly on Mondays and typically generates 46% 
response rate from the reader population. 
➢ The Arizona Republic – Overview 
Since the previous section focuses on health-conscious individuals, 
another post will be published in the overview section, which is 
distributed daily. According to republicmedia.com, this section 
reaches 1.1. million adults weekly in the Phoenix area, 32% of 
local residents. Advertising through the Arizona Republic is 
therefore likely to generate the expected response rate and reach 
the majority of our targeted population. 
b. Duration and Monitoring 
➢ The hepatitis C newspaper advertisement will run similarly to 
other communication methods during the intervention periods; in 
2-month intervals followed by 1-month gap for two rounds for 
each of the different prevalence groups. 
➢ Data collection and monitoring will be based on screening 
numbers during the gap periods. The project coordinator will be 
responsible for communicating with the magazine to make 
adjustments as needed. 
c. Advertisement Content 
➢ The content of the newspaper advertisement will be an infographic 
designed to present background information on the disease, a brief 
explanation of the program and its rationale and next steps that 
need to be taken. 
➢ The infographic will be designed by the program coordinator to 
display the information in a simple and clear format to comply 
with the newspaper’s requirements. 
2. Social Media 
The third approach aimed to target the remaining 33%; 835,414 is social media: including 
radio and YouTube advertisements. This method is expected to generate a response rate of about 
2%. 
 
 

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a. YouTube 
➢ Type of Advertisement 
Bumper advertisements are only six seconds and play before videos. Since our target 
population consists of the entire population of Arizona, the ad will be constricted by location to 
only appear to viewers from the State of Arizona. 
➢ Resources and Content 
Since TrueView video has longer duration than bumper ads, it will be more detailed and 
include a combination of project introduction and rationale along with contact information and 
links to more information. The bumper ad on the other hand is limited to 6 seconds and will 
therefore be more concise. Both videos will provide links for more information and connections 
to screening locations and communication methods to answer any questions in relation to the 
study. 
➢ Frequency and Implementation 
The YouTube advertisement will similarly run for 2-month intervals followed by a 1-
month gap for two rounds for each of the different prevalence groups. The frequency will be 
determined in accordance with agent feedback and adjusted according to performance thereafter. 
➢ Monitoring 
By utilizing a Google AdWords account, we will monitor our TrueView ad performance 
and views. This information can be used to optimize and to adjust throughout the duration of the 
study if needed. 
b. Radio 
➢ Resources 
 
Radio advertising is one of the powerful means of communication that can reach a large 
audience from all age groups. The project will therefore employ widely known radio stations in 
the State of Arizona, one of which is iHeartRadio. 
➢ Content 
 
The content will be like that used in other methods of outreach and will include a brief 
introduction to the project and its rationale as well as contact information to the project 
coordinator to answer any questions or inquiries. 
➢ Duration and Frequency 
 
The radio advertisement will run in accordance with the other forms of advertising, 
during intervention periods for 2 months followed by a 1-month gap for two rounds for each of 
the different prevalence groups. The ads will run 5-7 time per week. The timing will be 
determined based on feedback from an advertising specialist from iHeartRadio and will be 
during programs dedicated to the older Arizona population of 40+ years of age. 
➢ Monitoring 

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The radio advertisements will be monitored through regular performance updates of the 
frequency the advertisements were played over the duration of the study, what time they were 
played and how many were the expected number of listeners. These updates will guide any mid-
study adjustments to the design if needed. 
Phase 3: Conferences and Shelter Visits 
 
The final method is educational conferences and visits to homeless shelters and NA/AA 
meetings. With approximately 0.64% of the population being homeless and 67% of HCV cases 
with a history of intravenous drug use1, conference visits are expected to reach the remaining 
population. 
a. Approaches 
 
The first method of reaching this group is through educational visits to homeless shelters 
and NA/AA meetings in Arizona. There are 22 homeless shelters in the Phoenix area and 14 in 
Tucson. 
b. Conference Visits Frequency 
 
The shelter and NA/AA visits will be conducted during the intervention periods of the 
study with an anticipated average of three visits per shelter. 
c. Monitoring 
 
To monitor the progress of this step the number of attendees to each conference meeting 
will be recorded. The impact on the other hand will be measured through the screening and test 
results during the gab period. 
 

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3.2 Subjects 
The targeted study population consists of the entire Arizona population 15+ years of age. 
According to the ADHS 2017 vital statistics, this age range makes up 80% of the population and 
a total of 5,606,808 people. The targeted population is divided and ordered as below based on 
two parameters: known hepatitis C prevalence rates and risk, and the optimal method of 
communication. 
1. Adults (45+) 
Baby boomers are 5 times more likely to have hepatitis C than adults from any other age 
group4. According to AZ DHS population statistics, this group makes up 51% of the 
targeted population; 2,864,689 people. We hypothesize that older people are not exposed 
to social media as adolescents and young adults are. Therefore, it is important to utilize 
Email, direct text messages and newspaper outreach to reach this population. 
 
 
 
 
Figure 4: Average Annual Rate of Hepatitis C by County, 2002-2008. Retrieved from ADHS1. 

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2. Nasal and Injection Drug Users 
Another extremely high-risk subgroup is nasal and injection drug users. Figure 5 below 
shows the rate of HCV positive antibody tests compared to the percentage tested 
categorized by risk factors. The results indicate 88% of the HCV positive clients had 
history of nasal drug use compared to 69% amongst all clients1. We believe reaching out 
to this community would be an essential step in diminishing hepatitis C. To reach out to 
this group we plan on distributing pamphlets to treatment and rehabilitation entities. 
 
 
 
 
 
 
 
 
 
 
 
 
 
3. Homeless 
Another high-risk subgroup likely to develop infectious diseases is the homeless. 
According to Phoenix Rescue Mission, there are over 36,000 homeless people in 
Arizona, 71% of which are in Maricopa county8. In addition to their lack of awareness, 
this group likely do not have access to healthcare or healthy living environments, making 
them even more prone to fatal viruses and diseases. The most appropriate method to 
reach this subgroup would be through homeless shelter visits. 
4. Adults (20-44) 
This age groups makes up about 40% of the targeted population; 2,273,230 people. This 
group is likely exposed to social media as well as newspapers and direct communication 
methods such as email and text messages. 
 
 
Figure 5: Risk factors for all clients who had a positive HCV result compared to all clients tested9. 

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5. Millennials / Adolescents (<19 years of age) 
We believe this age group, consisting of 8% of the targeted population; 468,889 people, 
would be equally responsive to social media and directed Emails and text messages. With 
the growing impact social media has on this category, it has more potential of engaging 
them than any other means of communication would. 
 
3.3 Educational Outreach 
The systemized approach that will be taken in this study will target all patients repeatedly 
through a series of methods starting with individuals of higher risk, priority and expected 
response rate. Outreach program will follow AZ HCV prevalence map (Figure 4), starting from 
high prevalence counties with 123 or more Hepatitis C cases per 100,000, medium prevalence 
areas with 101-123 cases per 100,000 and finally low prevalence counties with less than 101 
cases per 100,0001. 
 
3.4 Population Screening 
➢ Screening Promotion 
A time limited screening test promotion code, specific to educational outreach methods, 
will be obtained from Sonora Quest Laboratories and advertised in both direct and indirect 
communication methods of the educational program. Interested individuals would be required to 
present a specific promotional code and sign the Informed Consent Form. 
➢ Screening Locations 
Screening will take place in all branches of Sonora Quest Laboratories over the state of 
Arizona. Patients will have the opportunity to present at any of the locations and get free 
screening regardless of their insurance coverage or whether they are considered at risk or not. 
➢ Informed Consents 
The study, expectations and rights will be explained to patients. Informed consents will 
be obtained electronically by the screening team to perform anti- HCV test, to share personal 
information and test result with Liver Institute study investigator team, and to agree to discuss 
treatment options if HCV test become positive. Consents will be sent to the Liver Institute PLLC 
where they will be stored in an encrypted electronic data capture system as per Western 
Institutional Review Board (WIRB) guidelines. 
➢ Clinical Parameters 
Demographics data and contact information will be recorded for each patient in Sonora 
Quest Laboratories data system as per their guidelines. Clinical and relevant history pertaining to 
hepatitis C including diabetes and existing conditions will be collected by study team from HCV 
positive individuals. 

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➢ Screening 
Screening will be conducted by members of the Sonora Quest Laboratories with ELISA 
IV antibody test with reflex to HCV PCR test to confirm the diagnosis. Patients will be contacted 
with their test results by a member of the research team, as well as by Sonora Quest.  
 
3.5 Links to Care: Treatment of HCV Infection 
➢ In case of a positive test results, the project coordinator will communicate with 
the patients for treatment options. 
➢ Patients with HCV+ screening results will be contacted during the gap periods by 
the program coordinator, who will link these patients to treatment and care. 
➢ Project coordinator will identify HCV care provider for each HCV positive 
patient depending upon patient’s insurance status. 
➢ Project coordinator will help and facilitate assistance program applications to 
patients without insurance. 
➢ The screening process is shown in Figure 6. 
 
 
 
 
Figure 6: Hepatitis C Outreach Program Methodology. 

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4.0 Selection and Withdrawal of Subjects 
4.1 Inclusion Criteria 
➢ Subjects must sign the consent to screen and take part in the study. 
➢ Subjects must be at least 15 years of age.  
 
4.2 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 
 
4.3 Withdrawal of Patients  
➢ Patients who do not wish to participate in the study can withdraw at any time.  
 
 
 
 

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5.0 Data Management and Analysis 
5.1 Data Entry and Management 
➢ Data will be entered into the electronic data capture system utilized by the Liver 
Institute PLLC. 
➢ Data and results will be entered within a week after they are collected during the 
mid-study and end-of-study data collection phases. 
➢ Data will be de-identified prior to analysis 
 
5.2 Data Analysis  
➢ A statistician will overlook and conduct final data analysis 
➢ Data will be analyzed for trends at the end of the study 
➢ Analysis will be completed using IBM SPSS statistics version 24 
 
5.3 Results  
➢ Assuming similar response as obtained for breast cancer or cervical cancer 
projects, we expect 4% of the targeted population to respond. 
➢ Based on the prior data, we computed the trend of increase in number of new HCV 
patients added per year to the pool of diagnosed cohort. 
➢ According to mapping hep C11, the total number of Antibody screening tests 
performed in 2016 is 53,580, or 4,465 per month, which is expected to be like 
current rates of 2019. 
➢ We estimate that similar number of subjects will come for self-screening 
➢ We expected to, at minimum, double the number of screenings to 8,930 tests per 
month, which will be evaluated after each intervention period as defined in Figure 
3. This increase will correlate with the increase in diagnosis rates per 100,000 from 
776 to at least 1,552. These numbers will be used as measures of success for the 
project. 
➢ Assuming the current rate of 5.2% positive HCV tests holds, we expect at least 464 
people to be HCV+ per month from the 8,930 people screened. 
➢ From the total number of HCV positive individuals, only 26.1% in Arizona get 
treatment, which correlates with 120 people per month from the screened 
population or total of 1440 by the end of the study. Considering there are multiple 
challenges to treatment and complete eradication, the goal of the study is to 
promote treatment for those with access to healthcare; expecting to increase 
treatment rate to about 30%. 
➢ Statistical data and trends of HCV prevalence over previous years, obtained from 
the Arizona Department of Public Health, will be compared with the study 
outcomes to assess the success rate of the study. we expect the number of screened 
individuals to double and the diagnosis rate to remain at 5.2%. A measure of 
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➢ The proposed intervention aims to increase the rate of diagnosed individuals to 
identify more of the HCV infected population as predicted by Yahia BR, et al 
(Figure 7)18. By increasing the number of screened individuals, we predict a 4.0% 
increase in addition to the current 50% diagnosed and aware. 
 
 
 
 
 
Figure 7: HCV Expected and current screening and treatment rates. Treatment cascade created by Yahia BR, et al. Graph was modified 
to display 2015, cumulative number of reported cases of Hepatitis C in Arizona1, 18. 

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6.0 Legal and Ethical Considerations 
The Principal Investigator and the study staff are responsible for conducting this study in 
accordance with the applicable principles which have their origins in the Declaration of Helsinki, 
ICH, GCPs, and all other applicable laws and regulations. 
 
6.1 Institutional Review Board / Independent Ethics Committee (IRB/IEC) Approval  
➢ This protocol, the Informed Consent, relevant supporting information, and all types of 
subject recruitment or advertisement information must be approved by the appropriate 
IRB/IEC before the study is initiated. Any amendments to the protocol must also be 
approved, where necessary, by the IRB/IEC prior to implementing changes in the study. 
The IRB/IEC used must comply with current regulations and GCP. 
➢ The investigator’s responsibilities regarding the IRB/IEC are as follows: 
o Obtaining IRB/IEC approval of the protocol, informed consent, and any 
advertisements to recruit subjects prior to their use. 
o Obtaining IRB/IEC approval for any protocol amendments and Informed Consent 
revisions before implementing the changes. 
o Providing the IRB/IEC with any required information before and during the study. 
o Submitting progress reports to the IRB/IEC as required. 
o Notifying the IRB/IEC within 10 days (unless required sooner by IRB/IEC) of all 
serious and unexpected AEs related to the study medications that are reported to 
you by the Sponsor. The investigator is responsible for updating the IRB/IEC on 
the progress of the study and of any changes made to the protocol at least once a 
year or at regular intervals as required by the IRB/IEC. The investigator must also 
keep the IRB/IEC informed of any AEs, according to the IRB/IEC policy. 
 
6.2 Subject Information and Informed Consents  
➢ Informed consent (per 21 CFR, Part50) and Health Insurance Portability and 
Accountability Act of 1996 authorization (per 45 CFR, Part 164) will be obtained from 
each subject and their caregiver prior to conducting/ obtaining any study-related 
assessments including the discontinuation of any study prohibited medications. An 
informed consent document that includes both information about the study and the 
consent from will be prepared and given to the subject. The document must be in a 
language understandable to the subject and must specify who informed the subject. 
➢ The investigator’s draft Informed Consent must be reviewed by the Liver Institute, prior 
to IRB/IEC submission for approval. 
➢ If, during the study, the subject’s protected health information (PHI) is to be used or 
disclosed in a manner that is inconsistent with the Informed Consent, the investigator 
must obtain a new authorization from the subject or a waiver of authorization from the 
IRB/IEC or privacy board, as applicable. If the Informed Consent is amended during the 
study, the investigator must follow all applicable regulatory requirements pertaining to 

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approval of the amended Informed Consent by the IRB/IEC and use of the amended form 
(including for ongoing subjects). 
➢ The Informed Consent documents the study-specific information the investigator 
provides to the subject and the subject’s agreement to participate. 
 
 
6.3 Confidentiality  
➢ Anonymity of subjects participating in this study will be maintained. Every effort will be 
made to maintain the confidentiality of documents that identify the subjects by name 
(e.g., signed informed consent document and patient data). 
➢ The investigator and other study site personnel will keep confidential any information 
related to this study and all data and records generated in the course of conducting the 
study, and will not use the information, data, or records for any purpose other than 
conducting the study. These restrictions do not apply to:  
1. Information which becomes publicly available through no fault of the 
investigator or study site personnel  
2. Information which it is necessary to disclose in confidence to an IRB/EC 
solely for the evaluation of the study 
or 
3. Study results which may be published. If a written contract for the conduct 
of the study which includes confidentiality provisions inconsistent with 
this statement is executed, that contract’s confidentiality provisions shall 
apply rather than this statement. 
 
6.4 Record Retention  
➢ Essential documents as described above should be retained for one of the following time 
periods: At least 2 years after conclusion of the study. 
 
6.5 Publication Policy  
➢ Institution and the investigator shall have the right, consistent with academic standards, to 
publish or present the results of the study, provided such publication or presentation does 
not disclose confidential information. 
 
6.6 Financial Support  
➢ This study is funded by the Liver Institute PLLC.  
 
 

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7.0 Discussion and Expected Challenges 
➢ Several challenges stand in the way towards complete Hepatitis C eradication. In addition 
to lack of public awareness leading to low screening percentage, only about 26.1% of the 
HCV+ population receive treatment. 
➢ During the gap periods of the study the project coordinator will communicate with 
patients and providers to facilitate the process of treatment. However, several challenges 
like insurance and access to healthcare might not be inevitable, making it unlikely to 
increase the treatment rate significantly. On the other hand, the total number is expected 
to proportionally increase with the number of screened individuals. 
➢ Increasing the public awareness will likely result in a sustained increase in screening 
rates and gradual improvement in treatment availability and access. Therefore, and 
through utilizing more efforts the treatment rates can be expected to increase over the 
upcoming years, moving closer towards our goal of HCV eradication. 
 
 
 
 

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8.0 Appendix 
8.1 Email Message Template  
“Dear Patient Name,  
My name is coordinator name, and I am the coordinator of a Hepatitis C Outreach 
program designed to increase awareness and promote screening of all the Arizona population for 
a goal of improved total community health.  
Hepatitis C is a widespread, possibly asymptomatic disease affecting millions of the 
population and could result in severe liver damage and even mortality if left untreated. While 
historically people with risk factors are screened, these standards left millions undiagnosed and 
therefore contributed to making it an epidemic. We encourage you to go over the attached 
infographic for more information on hepatitis C.  
To avoid complications of this treatable condition, we have collaborated with Sonora 
Quest Laboratories in the state of Arizona to provide screening services, free of charge, to all 
individuals in the state. If needed, our research team will contact you for further links to care and 
treatment. We ask you to please use the promotional code at any Sonora Quest to get your 
Hepatitis C screening. click on the link below to select your preferred Sonora Quest and schedule 
an appointment.  
‘Link’  
Best regards,  
‘Attached infographic’  
Contact Information” 
 
8.2 Text Message Template 
“We are reaching out to you regarding our Hepatitis C eradication program. Hepatitis C is 
widespread, possibly asymptomatic disease and, if left untreated, could result in serious liver 
damage. Our goal is to increase awareness and promote screening of all individuals residing in 
Arizona. If interested, use the code below to get free screening at any Sonora Quest labs.” 
 
8.3 FAQ Section 
1. Is hepatitis C curable?  
a. Yes. With current and evolving antiviral treatments and liver transplants, 95% 
of hepatitis C cases are treated.  
2. Does it cause any complications?  
a. Hepatitis C is a progressive infection and can lead to cirrhosis (scarring of the 
liver tissue), liver cancer and liver failure.  
3. Is hepatitis C fatal?  

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a. Hepatitis C can be fatal if left untreated as it can lead to cirrhosis, HCC (liver 
cancer), and several other complications.  
4. Am I at risk?  
a. You are considered at risk if you:  
i. Were born between 1945 and 1965.  
ii. Had a blood transfusion or organ transplant before the year of 1992  
iii. Received clotting factors prior to 1987  
iv. Received hemodialysis for a long period of time  
v. Were born to a mother with hepatitis C  
vi. Have piercings or tattoos  
vii. Have a risky sex life  
viii. Have injected or inhaled illicit drugs  
ix. Have HIV (Human Immunodeficiency Virus)  
x. Work in healthcare and have been exposed to infected blood  
5. Where can I get screened?  
a. Screening will be provided at any of our collaborating pharmacies in the State 
of Arizona.  
6. What will be the next step if I test positive?  
a. In case the antibody test is positive, further testing will be done and you will 
be linked to specialists for treatment.  
7. Can I get screened if I do not have insurance?  
a. Yes. Screening will be provided free of charge at any of our collaborating 
pharmacies.  
8. Are there any lifestyle changes I need to follow in case of Hepatitis C diagnosis?  
a. Some lifestyle changes that could slow the progression of Hepatitis C are to 
stop drinking alcohol, avoid medications that can cause liver damage 
including some herbal supplements and over-the-counter drugs. 
 
 
8.4 Abbvie Infographic  
➢ Available at the following link: AbbVie Breaking Barriers Infographic_Global 031918  
 
 
8.5 Resources Needed and Time Allocations 
 
 
 
 

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8.6 Investigator’s Agreement and Signature 
I have read the attached protocol: 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 and agree to abide by all provisions set 
forth therein.  
I agree to comply with the International Council for Harmonization Guidelines for 
Good Clinical Practices, and the laws, rules, regulations, and guidelines of the 
community, country, state, or locality relating to the conduct of the clinical study.  
I also agree that persons debarred from conducting or working on clinical studies 
by any court or regulatory agency will not be allowed to conduct or work on studies for 
the sponsor or a partnership in which the sponsor is involved. I will immediately disclose 
it in writing to the sponsor if any person who is involved in the study is debarred, or if 
any proceeding for debarment is pending, or, to the best of my knowledge, threatened.  
This document contains confidential information of the sponsor, which must not 
be disclosed to anyone other than the recipient study staffs and members of the IRB. I 
agree to ensure this information will not be used for any purpose other than the 
evaluation or conduct of clinical investigation without prior written consent of the 
sponsor (Liver Institute PLLC.) 
 
 
 
 
 
 
Recoverable Signature
X Shahid Habib
Shahid Habib
MD, Principal Investigator
Signed by: 514635c7-6bc0-499a-a3c3-2f50de45918d  
 
 
 
 
 
 
 
 
 
 
 
 

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8.7 Signature of Sub-Investigators 
 
To the best of my knowledge, this report accurately describes the planned conduct of the 
study. 
 
Study 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 
 
Protocol Number: LI-HEPC-AZ 
 
Protocol Version: Version 1.0 
 
 
 
 
Kristine Gradisher, MS (Physiology), Clinical Research Coordinator, Sub-Investigator 
Recoverable Signature
X Kristine Gradisher
Kristine Gradisher
MS (Physiology), Clinical Research Coordinato...
Signed by: 514635c7-6bc0-499a-a3c3-2f50de45918d  
 
 
 
 
Julie Piittmann, FNPC, Sub-Investigator 
Recoverable Signature
X Julie Piittmann
Julie Piittmann
FNPC, Sub-I
Signed by: 514635c7-6bc0-499a-a3c3-2f50de45918d  
 

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9.0 References 
1. 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   
2. 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    
3. 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   
4. 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    
5. 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/    
6. Denniston M., Klevens R., McQuillan G., Jiles R. (2012). 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. 55(6):1652-
1661. doi: 10.1002/hep.25556  
7. Hagan, L.M., Schinazi, R.F. (2014). Best strategies for global HCV eradication. Liver Int. 
33(0_1): 68-79. doi: 10.1111/liv.12063.  
8. Homelessness. (n.d.). Retrieved from https://phoenixrescuemission.org/homelessness   
 

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9. Holmberg, S. D., Spradling, P. R., Moorman, A. C., & Denniston, M. M. (2013). Hepatitis C 
in the United States. The New England journal of medicine, 368(20), 1859–1861. 
doi:10.1056/NEJMp1302973  
10. Institute of Medicine. (2010). Hepatitis and liver cancer: a national strategy for prevention 
and control of hepatitis B and C. Washington, D.C: The National Academies Press. 
retrieved from https://www.ncbi.nlm.nih.gov/pubmed/25032367 
11. Mappinghepc. (n.d.). Retrieved from https://mappinghepc.com/maps  
12. 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/  
13. Pinter, M., Trauner, M., Peck-Radosavljevic, M., & Sieghart, W. (2016). Cancer and liver 
cirrhosis: implications on prognosis and management. ESMO open, 1(2), e000042. 
doi:10.1136/esmoopen-2016-000042  
14. Snyder, L., Hamilton, M., Mitchell, E., Kiwanuja-Tondo, J., Fleming-Milici, F., Proctor, D. 
(2004). A meta-analysis of the effect of mediated health communication campaigns on 
behavior change in the United States. Journal of Health Communications. 1:71-96. doi: 
10.1080/10810730490271548  
15. 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/PressAnnounce
ment s/2010/ucm217318.htm   
16. Volk M., Tocco R, Saini S., Lok A. (2009). Public health impact of antiviral therapy for 
hepatitis C in the United States. Hepatology. 50(6):1750-5. doi:10.1002/hep.23220  

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17. World Health Organization. (2018). Hepatitis C. Retrieved from https://www.who.int/news-
room/fact-sheets/detail/hepatitis-c  
18. Yehia, B., Schranz, A., Umscheid, C., Lo Re, V. (2014). The Treatment Cascade for Chronic 
Hepatitis C Virus Infection in the United States: A Systematic Review and Meta-
Analysis. PLoS ONE. 9(7): e101554. doi: 10.1371/journal.pone.0101554