Pilot Study of a Community-Pharmacy Model to Expand Access to Medications to Treat and Prevent Hepatitis C, Opioid Use Disorders, Overdose and HIV Among Persons Who Inject Drugs
Conditions: Hepatitis C
Sponsor: University of Washington

 
 
HepPSI Phase 2 Protocol –  v2.7 10 May 2022 
 
 
Hepatitis C Pharmacy-based Strategy for Injectors: 
Phase 2 Pilot Study (HepPSI Study Phase 2) 
 
 
IRB Protocol Number: STUDY00010476 
National Clinical Trial (NCT) Identified Number:  NCT04698629 
Principal Investigator: Judith Tsui, MD, MPH 
 
 
 
Funded by: NIDA 1R34DA047660 
Version Number:  v2.7 
10 May 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
HepPSI Phase 2 Protocol –  v2.7 10 May 2022 
 
 
 

This is the Protocol for “A Prospective Study to Pilot a Community-pharmacy 
Program for Medications to Treat HCV, and Prevent Overdose and HIV, Among 
PWID With HCV,” also known as Hepatitis C Pharmacy-based Strategy for 
Injectors: Phase 2 (HepPSI Study Phase 2)

  
HepPSI Phase 2 Protocol –  v2.7 10 May 2022 
 
 
Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
STUDY TEAM MEMBERS AND OTHER CONTACTS ......................................................................................... 2 
1 
INTRODUCTION ............................................................................................................................................ 2 
1.1 
Overview ............................................................................................................................................... 2 
1.2 
Background........................................................................................................................................... 2 
2 
STUDY OBJECTIVE ...................................................................................................................................... 3 
3 
STUDY DESIGN ............................................................................................................................................. 3 
3.1 
Overall Design ...................................................................................................................................... 3 
3.1.1 
Compensation................................................................................................................... 3 
3.1.2 
Study Schema .................................................................................................................. 4 
3.2 
Eligibility ................................................................................................................................................ 4 
3.2.1 
Inclusion Criteria............................................................................................................... 4 
3.2.2 
Exclusion Criteria ............................................................................................................. 5 
3.3 
Recruitment and Retention Strategies.............................................................................................. 5 
3.3.1 
Recruitment Strategy ....................................................................................................... 5 
3.3.2 
Retention Strategy ........................................................................................................... 5 
3.3.3 
Patient Navigator Responsibilities ................................................................................. 6 
3.4 
Study Sites ............................................................................................................................................ 6 
3.4.1 
Hepatitis Education Project ............................................................................................ 6 
3.4.2 
Evergreen Treatment Services/ Downtown Emergency Service Center ................. 7 
4 
STUDY ASSESSMENTS AND PROCEDURES ....................................................................................... 7 
4.1 
Screening .............................................................................................................................................. 7 
4.1.1 
Determining Eligibility ...................................................................................................... 7 
4.1.2 
Data Collected During Screening .................................................................................. 8 
4.2 
Enrollment Procedures ....................................................................................................................... 8 
4.2.1 
Informed Consent ............................................................................................................. 8 
4.3 
Study Visits ........................................................................................................................................... 9 
4.3.1 
Assessments Overview ................................................................................................... 9 
4.3.2 
Data collection Tools ..................................................................................................... 12 
4.4 
Payment Tracking .............................................................................................................................. 12 
5 
PARTICIPANT SAFETY .............................................................................................................................. 12 
5.1 
Potential Risks ................................................................................................................................... 13 
5.1.1 
Psychological Stress ..................................................................................................... 13 
5.1.2 
Loss of Confidentiality ................................................................................................... 13 
5.2 
Privacy and Confidentiality ............................................................................................................... 13 
5.2.1 
RedCAP 14 
5.3 
Adverse Events and Serious Adverse Events ............................................................................... 14 
5.3.1 
Definition of Adverse Events (AE) ............................................................................... 14 
5.3.2 
Definition of Serious Adverse Events (SAE) .............................................................. 14 
5.3.3 
Classification of an Adverse Event .............................................................................. 14 
5.3.4 
Adverse Event (And SAE) Reporting .......................................................................... 16 
5.4 
Data Safety Monitoring Plan ............................................................................................................ 16 
5.4.1 
Safety Oversight ............................................................................................................. 16 
5.5 
COVID-19 Regulations ..................................................................................................................... 17 

  
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STATISTICAL ANALYSES ......................................................................................................................... 17 
7 
REFERENCES ............................................................................................................................................. 18 
8 
APPENDICES ............................................................................................................................................... 21 
8.1 
Participant Locator Form .................................................................................................................. 21 
8.2 
IRB-approved Screening Script ....................................................................................................... 23 
8.2.1 
Eligibility Script ............................................................................................................... 23 
8.3 
Adverse Event Form.......................................................................................................................... 25 
8.4 
Medical Case Manager “Step by Step” Document: (Integration of HepPSI PN roles) ............ 30 

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STATEMENT OF COMPLIANCE 
 
The HepPSI Study will be carried out in accordance with International Conference on 
Harmonisation Good Clinical Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR 
Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812)  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
 
A protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the Institutional Review Board (IRB) for review and approval.  Approval of both the 
protocol and the consent form must be obtained before any participant is enrolled.  Any major 
amendments to the protocol will require review and approval by the IRB before the changes are 
implemented to the study.  In addition, all changes to the consent form will be IRB-approved; a 
determination will be made regarding whether a new consent needs to be obtained from 
participants who provided consent, using a previously approved consent form. 
 
 
 
 

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STUDY TEAM MEMBERS AND OTHER CONTACTS 
 
UW Research Group 
Judith Tsui, PI 
Email: tsuij@uw.edu 
Office number: 206-744-1835 
 
Alex Gojic, Research Coordinator 
Email: agojic@uw.edu  
Office number: 206-744-1801 
 
Ellie Pickering, Research Assistant 
Email: eipicke@uw.edu 
Office number: 206-744-1838 
 
Sarah Glick, PhD 
Email: snglick@uw.edu 
 
Emily Williams 
Email: emily.williams3@va.gov 
 
Elizabeth Austin, MPH 
Email: austie@uw.edu  
 
Michael Ninburg 
Email: mhninburg@hepeducation.org  
 
John Scott 
Email: jdscott@uw.edu 
 
Joanne D. Stekler 
Email: jstekler@uw.edu 
 
Other Contacts 
Elyse Tung 
Email: etung@kelley-ross.com 
 
Kathleen Pierce 
Email: kpierce@kelley-ross.com 
 
Madison McPadden 
Email: madison@hepeducation.org 
 
Sarah Deutsch 
Email:sarah@hepeducation.org 
 
Angelica Bedrosian 
Email:angelica@hepeducation.org 
 
Sarah Villafuerte 
Email:srv@hepeducation.org 
 
 
 
 
 
 
 

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INTRODUCTION 
 
1.1 
OVERVIEW 
 
This is the protocol for a single-arm, prospective observational study concerned with the feasibility and 
acceptability of a newly implemented community pharmacy model to treat HCV for persons who inject 
drugs who historically have faced many barriers to care within conventional healthcare systems. 
 
1.2 
BACKGROUND  
 
Opioid use disorder (OUD) and related health problems have emerged as a national health crisis. In 
2017, an estimated 1.7 million American adults had a pharmaceutical opioid use disorder (OUD), and 0.7 
million had a heroin-involved OUD.(1) The increase in opioid abuse and injection drug use (IDU) has led 
to a rise in overdose deaths(2) and new cases of HIV and hepatitis C virus infection (HCV).(3, 4) Injection 
drug use is the primary mode of transmission for HCV infection in the U.S.(5-7) After more than a decade 
of decline, the incidence of HCV is again on the rise, particularly among young adults, (8, 9) and in rural 
areas.(10) The recent outbreak in rural Indiana is also a stark reminder of the ever-present risk for HIV 
associated with IDU. (4) 
 
We are at a unique historical moment, as we possess effective medications that can improve and 
sustain the lives of people who inject drugs (PWID). Currently there are medications that can be 
prescribed to 1) cure HCV (directly-acting antivirals), 2) prevent HIV infection (Pre-exposure Prophylaxis 
[PrEP]) and treat/prevent overdose (naloxone and medications to treat OUD). Furthermore, there is an 
unprecedented opportunity to eliminate HCV, a disease that affects the majority of PWID and causes 
substantial morbidity and mortality.(11)  With the introduction of new directly-acting antiviral (DAA) 
medications, nearly all patients with HCV can be cured with 2–3 months of oral medications with 
minimal side effects. Expanding HCV treatment to populations at risk can reduce incidence and 
prevalence over time(12) (a concept known as “treatment as prevention”) and as such, the World Health 
Organization has proposed an ambitious goal to eliminate HCV by 2030.(13) Unfortunately, there is a 
translational gap in the delivery of these medications to PWID. Prior studies, including our own, show 
that <10% of PWID have been successfully treated.(14-16) While models of HCV care integrated in 
addiction treatment have been successful,(17, 18) many PWID lack access. Moreover, there are still 
major gaps in access to naloxone and PrEP among PWID.(19-22) 
 
A community-pharmacy model has the potential to expand health services delivery and provide 
comprehensive, patient-centered care to PWID. For decades, pharmacists have been utilized in clinic 
and hospital settings to assist with management of acute and chronic diseases.(23, 24) Many successful 
specialty clinics that treat HCV currently depend heavily on the services of pharmacists. Pharmacists 
have extensive clinical training and highly developed expertise in pharmacotherapy, which makes them 
ideally suited for the management of HCV. Through the mechanism of Collaborative Drug Therapy 
Agreements (CDTAs), pharmacists are granted the authority to autonomously perform tasks related to 
medication management in collaboration with the practitioner through detailed protocols.(25) 
Restrictions on these designated services vary from state to state but can include all aspects of 

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medication management from testing and counseling to prescribing and dispensing medication.(26) 
Kelley-Ross, our community-pharmacy partner, in 2012 successfully implemented a take-home naloxone 
program for persons at risk for opioid overdose(68) and more recently started a program for providing 
PrEP (“One-Step PrEP”),(27) which enables persons to receive all services (screening, counseling, 
prescribing, dispensing, and follow-up) at their pharmacy site.   
 
The HepPSI Study builds upon the existing Kelley-Ross PrEP clinic platform to offer a comprehensive 
package for HCV treatment that would also include access to naloxone and PrEP on-site, as well as 
linkages to low-threshold opioid treatment programs that provide buprenorphine or methadone. During 
Phase 1 of this research, we conducted qualitative interviews with people who inject drugs living with 
hepatitis C regarding motivators, barriers, and preferences for HCV treatment. Phase 1 findings have 
since been used to inform the development of the community-pharmacy program (One-Step Hep C 
Free) that will be piloted in this Phase 2 research. 
 
2 
STUDY OBJECTIVE 
 
Single-arm, prospective observational study of 40 adult persons who inject drugs (PWID) who screen 
positive for hepatitis C virus (HCV) with a reactive antibody test at community sites who are offered 
facilitated linkage to community-pharmacy program through patient navigators. Individuals who are 
eligible and enroll will complete a baseline survey to assess sociodemographics, substance use, HIV risk 
behaviors, and awareness of and interest in HCV treatment. After the survey, the participants will be 
linked to the community-pharmacy program, via the patient navigator, where treatment for HCV and 
opioid use disorder (OUD), as well as pre-exposure prophylaxis (PrEP), Naloxone and vaccinations, will 
be offered to participants. 
 
After 6 months, participants will complete a follow-up survey, which will include questions on: whether 
an evaluation for HCV occurred at the community pharmacy or elsewhere, whether HCV treatment was 
initiated since baseline visit and whether cure was achieved,  substance use, HIV risk behaviors, receipt of 
medications for opioid use disorder, Naloxone and PrEP receipt, medication adherence, and information 
on injecting networks. 
 
3 
STUDY DESIGN  
 
3.1 
OVERALL DESIGN 
 
Forty participants will complete two study visits during this time. After screening and enrollment at a 
community site, participants will complete a Baseline Survey.  Upon completion of the Baseline Visit, 
participants will either be connected to a patient navigator responsible for linking the participants to the 
community-pharmacist OR referred directly to the community-pharmacist if on site. Six months after the 
initial Baseline Visit, participants will be contacted to complete a final Follow-up Survey. 
 
3.1.1 COMPENSATION 

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Participants will be compensated for their time and may receive up to $80. Payment for visits will differ as follows: 
 
$30 reimbursement for the completion of Baseline Survey 
 
$50 reimbursement for the completion of Follow-up Survey 
3.1.2 STUDY SCHEMA 
 
 
 
3.2 
ELIGIBILITY 
3.2.1 INCLUSION CRITERIA 
 
1. >18 years old 
2. Reports injecting drugs with 90 days of screening 
3. Positive HCV test documented (screening antibody test or viral load test) 
4. Not currently taking medications to treat HCV, and never previously treated with direct-acting 
antivirals (DAAs) for HCV 
5. Willing to undergo evaluation for HCV through a community pharmacy program and work with 
Patient Navigators 
6. Provides release of information (“ROI”) to access community pharmacy program records and/or 
other HCV treatment providers 

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3.2.2 EXCLUSION CRITERIA 
 
1. People who plan to leave the Seattle area within 6 months 
2. Who do not wish to be treated for their HCV infection 
3. Who are known to be pregnant 
4. Who report impending incarceration that would disrupt clinical care 
5. Who are not comfortable reading and speaking English 
At researcher’s discretion, participants may be excluded if their behavior poses safety concerns for 
research staff or other participants. 
3.3 
RECRUITMENT AND RETENTION STRATEGIES 
 
3.3.1 RECRUITMENT STRATEGY 
 
Subjects will be recruited though (1) syringe services programs (including the Downtown Needle 
Exchange at Robert Clewis Center) (2) opioid treatment and behavioral health programs (including 
Evergreen Treatment Services) (3) community-based agencies that serve persons who inject drugs living 
with HCV (including the Hepatitis Education Project), and (4) low-income housing sites/homeless 
shelters. We will also recruit participants from the Phase 1 qualitative study who gave permission to be 
contacted in the future to participate in this new study. 
 
The uncertainty of the COVID-19 response’s impact has led us to develop multiple recruitment plans: 
1. 
Research staff may receive referrals to the study from personnel who interact with 
potential subjects at these sites.  
2. 
Potential participants may self-refer to the study by contacting Research staff directly 
using information on public recruitment materials. 
3. 
If research staff are able to go to sites listed above for recruitment, they will approach 
potential subjects directly.  
 
We will primarily rely on staff at the community sites listed above to make referrals to study staff 
members and will keep signage and flyers on-site at these locations with our recruitment times at a 
given site. When appropriate, we may directly approach potential participants at these sites. Prior to 
conducting eligibility screening visits in person at these agencies, staff will identify a physical space at a 
given agency that will allow staff to maintain confidentiality. 
 
3.3.2 RETENTION STRATEGY 
During the consent process, study staff will collect the participant’s contact information (HepPSI 
Participant Locator Form, Appendix 8.1). Participants consent to providing additional contacts in case a 

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study staff person is unable to reach the study participant. Forms have space for up to four additional 
contacts. The study staff person collecting this information will inform the participant, again, that these 
individuals will only be contacted if they themselves cannot be reached. This form will be stored in a 
locked filing cabinet with the research team and should never be stored with participant study data. This 
information will be entered into the HepPSI Phase 2 Participant Tracking Database project on REDCap 
under the form “Participant Contact Information”.  
Research staff will contact participants every 2 months to ensure contact information is up to date and 
to check-in. Staff will utilize Patient Navigator to stay connected with participants when possible. Each 
time contact with a participant is made, that instance will be documented in the HepPSI Phase 2 
Participant Tracking Database project on REDCap under the form “Contact Log”. 
For further information regarding HepPSI Phase 2 Participant Tracking via REDCap, refer to the HepPSI 
Phase 2 REDCap Manual of Procedures. 
3.3.3 PATIENT NAVIGATOR RESPONSIBILITIES 
Primary  
1. Facilitated linkage to community-pharmacy program 
2. Outreach at syringe exchange programs, addiction treatment programs, homeless shelters, and 
advocacy groups for individuals who may be eligible for the community-pharmacy program  
Secondary  
1. Maintain contact with participants throughout treatment; facilitated by medical case 
management intake (see section 8.4) 
2. Refer interested participants to other resources (including linkages to existing “low-threshold” 
programs that offer OUD medications in close proximity) 
3.4 
STUDY SITES 
3.4.1 HEPATITIS EDUCATION PROJECT 
 
The Hepatitis Education Project (HEP) is an advocacy group that provides numerous services for persons 
with HCV, including medical case management, Hepatitis B and C screening, a syringe access program, 
and more. Participants will be recruited from the various community sites where the Hepatitis Education 
Project currently offers HCV screening. This includes local syringe exchange programs, opioid treatment 
programs, homeless and urban drop-in shelters, low income housing units, and the main HEP office near 
downtown Seattle*. 
 

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Community Pharmacists will be onsite at the main HEP office during their syringe service program hours 
(Thursdays 1-5pm, as of 11/05/2020).  
*11/05/2020 – as a result of the COVID-19 Pandemic, HEP has limited their outreach services and 
general operations. Their syringe service program will be located outdoors in a lot adjacent to the main 
HEP office. 
3.4.2 EVERGREEN TREATMENT SERVICES/ DOWNTOWN EMERGENCY SERVICE CENTER 
Evergreen Treatment Services (ETS) is an opioid treatment program organization with three locations in 
the Puget Sound region. Study recruitment will be focused at the Seattle Clinic site where ETS patient 
attend medical provider appointments, counseling services, and receive their medications for opioid use 
disorder (MOUD). ETS medical providers and counselors can refer their patients for HCV treatment to 
the Community Pharmacists and Patient Navigator when both are located at the ETS Seattle Clinic one 
morning a week, or directly to the Kelley-Ross pharmacy/HEP locations. Community Pharmacists and 
Patient Navigator will be onsite at the Seattle Clinic on Thursdays mornings 9am-12pm, as of 
03/04/2021. 
Downtown Emergency Service Center (DESC) provides supportive housing, case management, substance 
use disorder treatment, and medical services at 12 locations throughout Seattle and several other 
adjacent cities. DESC providers at several locations are able to refer clients interested to HCV care to the 
Community Pharmacists for treatment. However, given the limited space available at DESC locations, 
DESC clients who are interested in participating in the study would need to travel to HEP so that 
research staff could screen for eligibility and complete consent procedures. 
4 
STUDY ASSESSMENTS AND PROCEDURES 
 
4.1 
SCREENING 
 
Staff at community sites will be educated about the study and asked to refer interested individuals who 
may be eligible. If research staff are onsite, community site staff will “hand off” potential participants to 
speak with research staff directly. Otherwise, interested individuals will be referred or self-refer to 
research staff via phone or email.  Once connected to interested individuals, the trained research staff 
will explain the study and screen them in a private space on site or over the phone (See IRB-approved 
Screening Script, Appendix 8.2). Each screened subject will receive a unique screening ID (YXXX) that will 
be documented in a protected spreadsheet, along with the results of the screening encounter. 
4.1.1 DETERMINING ELIGIBILITY 
A REDCap Screener assessment has been designed to notify the assessor when a subject meets all 
inclusion criteria and is considered eligible. If an eligible subject is uninterested in participating, the 

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assessor should document the reason on REDCap. Please refer to the HepPSI Phase 2 REDCap Manual 
of Procedures for further information and procedures when eligibility has been determined.  
If time allows, consenting, enrollment, and the baseline visit will follow the screening visit on the same 
day. 
4.1.2 DATA COLLECTED DURING SCREENING 
Data collected during screening will be captured in REDCap. This data includes the subject’s date of 
birth, basic demographic information, any major comorbidities that would preclude treatment through 
the community-pharmacy program, and other items related to determining whether the subject meets 
inclusion criteria. The screener form is coded in REDCap to automatically notify the assessor on whether 
the subject is eligible or ineligible to participate in the study.  
No personal identifying information will be entered into the REDCap Phase 2 Screener Project. 
4.2 
ENROLLMENT PROCEDURES 
Once deemed eligible to participate in the study, study staff will facilitate enrollment procedures, beginning with 
informed consent after which subjects will confirm their intent to continue the enrollment process. During the 
enrollment process, participants will also consent to provide contact and alternate contact information for tracking 
purposes (See Retention Strategies). At the end of the enrollment process, participants will be assigned a unique 
Study ID (40XX). 
4.2.1 INFORMED CONSENT 
   
Consent will be obtained by trained research staff from patients who meet all inclusion criteria. The PI 
will not consent patients. The process of consenting participants will occur in a private space. The study 
will be described and the potential subject will be asked if they have any questions about the study 
procedures. If the individual agrees to participate after consideration of all options, they will provide 
written consent. 
  
The research staff will give the subjects adequate time to look at and read the informed consent form, 
summarize each section and ask the subjects if they understand and if they have any questions about 
the study procedure. As part of the informed consent, the research staff may assess the subjects’ 
understanding of the information presented during the consent process. This may include having the 
subject articulate their understanding of the study purpose, procedures, risks, etc. 
 
After reading through informed the consent form, subjects who agree to participate will sign two copies. 
One copy will be sent home with the participant and the other will be stored in a locked cabinet with the 
research study team. This form should never be stored with participant study data. 

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4.2.1.1 HIPAA AUTHORIZATION AND RELEASE OF INFORMATION FORMS 
4.2.1.1.1 HIPAA AUTHORIZATION FORM 
The University of Washington IRB office has been contacted to obtain an organization specific HIPAA 
Authorization template, and study staff made necessary changes to the template to meet study needs. 
Study staff must have the study participant complete and sign two HIPAA Authorization Forms. One 
form will be given to the participant and the other will be stored in a locked filing cabinet with the 
research team. This form should never be stored with participant study data. 
4.2.1.1.2 RELEASE OF INFORMATION FORMS 
Participants will be asked to sign Release of Information (ROI) forms that allow study staff to disclose 
medical information relevant to the study. Medical information may include sexually transmitted 
disease, acquired immunodeficiency syndrome (AIDS), or human immunodeficiency virus (HIV). 
Participant’s health records may also include sensitive information about behavioral or mental health 
services and treatment for alcohol and drug abuse 
Upon enrolling in the study, participants will sign two ROI forms permitting disclosure of medical information: one 
for Hepatitis Education Project, and one for Kelley-Ross Pharmacy. 
4.3 
STUDY VISITS 
Participants will be enrolled and complete the baseline assessment at study start. Over the course of the 
study, two total assessments will be conducted: one at baseline visit (study start) and one at final visit 
(six months post-study start date). Study visits will take place in-person at Hepatitis Education Project or 
other community sites hosting HEP services. Due to the COVID-19 pandemic, study staff are prepared to 
transition to remote visits if need be. After the baseline study visit, participants will receive a $30 
reimbursement, and then they will be linked to a HEP Patient Navigator who will facilitate their 
connection to the community pharmacy program. After the final study visit, participants will receive a 
$50 reimbursement. 
Assessment data will be collected primarily on REDCap, but research staff completing research visits 
should have, at all times, IRB approved paper assessment copies in case of any technical difficulties with 
study laptop.  
Besides having paper copies of all assessments, research staff will carry a small binder of Assessment 
Cards. These Assessment cards are response options to all assessment items in large printed font to 
assist participants during the assessments.   
4.3.1 ASSESSMENTS OVERVIEW 

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The baseline survey will assess socio-demographics, substance use*, HIV risk behaviors*, and awareness 
of and interest in HCV treatment. After 6 months, participants will complete a follow-up (final) survey 
which will include information on: 
a) Whether an evaluation for HCV occurred at the community pharmacy or another site since the 
baseline visit 
b) Whether HCV treatment was initiated since baseline visit— assessed by self-report and 
pharmacy/medical records for confirmation.  
c) For patients who report that they have not been treated for HCV, reasons why (co-morbid conditions 
interfering, competing priorities, lack of interest, spontaneous clearance, etc.). 
d) Substance use*—measured by the modified Addiction Severity Index (ASI)(28)  
e)  HIV Risk Behaviors*—measured by the modified HIV Risk Behaviors Survey (RBS)(29, 30) 
f) Receipt of naloxone, PrEP, and medications for OUD: self-report, confirmed with review of pharmacy 
record of dispensation/refills. 
g) Medication satisfaction, tailored to direct-acting antiviral treatment 
h) Medication adherence— assessed by record of medication pick-ups and also through self-report 
i) Injecting network (number of partners they have shared injected drugs with and, of those, how many 
they would be willing to refer to the site where they were treated) 
j) Completion of HCV Treatment – self-report and medical record chart review to assess if HCV treatment 
was fully completed. 
k) Sustain Virologic Response (SVR12) – Medical record review to assess obtainment of SVR12 results 
among participants who complete HCV treatment. For patients missing SVR12 results at the time of 6 
month follow-up (either due to not yet having reached 12 post-treatment date or simply missing data), 
chart reviews will be conducted again up to 3 months after the 6 month follow-up.   
 
4.3.1.1 DATA VARIABLE TABLE 
 

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Baseline Visit 
Final Visit 
Medical 
Record 
Review 
Social History (age, sex, gender, housing/employment 
status, healthcare insurance coverage) 
X 
X 
 
Treatment history (methadone, buprenorphine, direct-
acting antivirals, interferon, pre-exposure prophylaxis) 
X 
X 
 
Lifetime (ASI- drug of concern + injection drug  use) 
30 days (ASI) 
X 
X 
 
X 
 
HIV Risk Behaviors (RBS) 
X 
X 
 
Depression (PHQ-9) 
X 
X 
 
Anxiety (GAD-7) 
X 
X 
 
Value of Health (EQ-5D-5L) 
X 
X 
 
HCV Treatment experience/satisfaction 
 
X 
 
Pharmacist care satisfaction 
 
X 
 
Patient Navigator satisfaction 
 
X 
 
Injection Network/Community Pharmacy 
Recommendation 
 
X 
 
HCV Treatment Completion  
 
X 
X 

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Sustain Virologic Response (SVR12) 
 
 
X 
 
4.3.2 DATA COLLECTION TOOLS 
The primary method of collecting data will be completed electronically through REDCap. REDCap is a 
web-based HIPAA compliant platform that will be used to collect and export participant data. Each 
participant will have a unique Study ID (40XX) that will be used to distinguish their REDCap records. 
Identifiable participant information will be kept separately from participant data. In instances where 
paper assessments are used, those documents will be stored in a locked cabinet at Harborview Medical 
Center, separated from any identifiable patient information as well. Study ID assignments and 
participant names will be tracked through a password-protected Excel spreadsheet that will be stored 
on a secure drive accessible to only study staff. This Excel spreadsheet will also document information 
regarding study visits, including start date, the projected final visit date, and actual final visit date, as 
well as any study withdrawal details. 
Further information about REDCap can be found in the HepPSI REDCap Manual of Procedures. 
4.4 
PAYMENT TRACKING 
After completing a research visit, research staff administering assessments will provide the participant 
their monetary reimbursement for the information they provided and their time. The reimbursements 
should be kept in an envelope when given to the participant. It is important that research staff track 
participant payments and document that the participant did in fact receive their payment. Research 
staff should carry paper copies of the Participant Payment Tracking Form and have the participant sign 
and date that they received their incentive. These forms should then be kept and locked in designated 
study file folders, away from any participant data. Additionally, at the bottom of the verification form is 
a HepPSI Payment Reference number. This number will be entered into the REDCap HepPSI Participant 
Tracking Database project in the “Participant Visit and Payment Log” form within each participant’s 
record. 
Study staff should work with their office’s designated finance officer to determine the set-up and 
maintenance of field advances. Money and ATM card will be kept in a secure lock-box. Along with the 
money and ATM, the study staff should have a log of when the lock-box is accessed for proper tracking 
purposes. Research staff should also keep every ATM receipt as their office’s finance officer will need 
this to reconcile the budget and field advances later at the end of the budget year and end of project. 
5 
PARTICIPANT SAFETY 

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5.1 
POTENTIAL RISKS 
5.1.1 PSYCHOLOGICAL STRESS 
There are no anticipated risks to participants’ physical health during this study. However, there are 
other risks to be considered. Talking about sensitive topics may cause participants to feel uncomfortable 
or distressed. This will be minimized by training the research staff to look for signs of distress and 
provide reassurance. Participants will be reminded that they have the option to refuse answering 
assessment questions that cause undue distress. They will also be offered regular breaks during the 
assessment session. 
5.1.2 LOSS OF CONFIDENTIALITY 
Breach of security of data collected is a potential risk for study participants. To reduce this risk, all data 
analysis will be conducted on data identified by study ID only and will not include any direct identifiers. 
Only a unique ID will be used to identify individual data collection forms; no subject names will be 
recorded on data collection forms. A crosswalk file linking subject identifiers and unique ID will be stored 
in a separate location from the data. All data will be stored on secure server and access to the data will 
be restricted by means of unique login names and passwords. All study files with identifiable 
information will be kept in locked file cabinets in a private office space, and only research staff will have 
access. 
5.2 
PRIVACY AND CONFIDENTIALITY 
Study staff will safeguard the confidentiality of personal data collected from study participants through 
the use of Study ID codes instead of names on all research materials. The link referencing code number 
to name will be kept in a password-protected file accessible by computers that are password protected, 
as will all files related to the study. 
Any printed study materials will be marked with participant’s code and kept in a locked file cabinet in a 
private office. No one other than study staff will have access to these materials. The list relating names 
to number codes will be destroyed at the end of the investigation.  
Only trained and approved study staff (research assistants, coordinators or PI) will interview subjects. 
We will work to arrange assessments with participants at a time and location so they can have privacy.  
Participants will be covered by the Certificate of Confidentiality. This will help protect participant privacy 
by allowing study team members to refuse to provide identifying information about participants even if 
asked to by a court of law. We will use the Certificate to resist any demands for identifying information. 

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This does not prevent participants from sharing information about themselves or a part of the research 
if they choose to do so. 
 
 
5.2.1 REDCAP 
Study staff will enter data captured in visits from all participants into REDCap. The system is password 
protected and restricted to study staff. Participant assessment data, screening data, and 
tracking/payment information are each stored in separate REDCap projects with different record IDs. 
Research staff will have paper copies of all assessments in case REDCap is not accessible to collect 
participant’s information.  
5.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
 
5.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
 
Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease 
temporally associated with the use of a medical treatment or procedure, regardless of whether it is 
considered related to the medical treatment or procedure.   
 
5.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
 
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of either the 
investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse 
event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant 
incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital 
anomaly/birth defect.  
 
5.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
Adequate review, assessment, and monitoring of adverse events require that they be classified as to 
severity, expectedness, and potential relatedness to the study intervention. Study protocols will include 
a description of how adverse events will be classified in these terms and the appropriate course of 
action. 
5.3.3.1 SEVERITY OF EVENT 
 
Classifications include the following:  

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Mild: Awareness of signs or symptoms, but easily tolerated and are of minor irritant type causing no loss 
of time from normal activities. Symptoms do not require therapy or a medical evaluation; signs and 
symptoms are transient. 
 
Moderate: Events introduce a low level of inconvenience or concern to the participant and may 
interfere with daily activities, but are usually improved by simple therapeutic measures; moderate 
experiences may cause some interference with functioning 
 
Severe:  Events interrupt the participant’s normal daily activities and generally require systemic drug 
therapy or other treatment; they are usually incapacitating 
 
Severity is not synonymous with seriousness. A severe rash is not likely to be an SAE.  
Likewise, a severe headache is not necessarily an SAE.  However, mild chest pain may result in a day’s 
hospitalization and thus is an SAE. 
 
5.3.3.2 RELATIONSHIP TO STUDY INTERVENTION 
 
The site investigator assesses the potential event relationship to the study intervention and/or 
participation. A comprehensive scale in common use to categorize an event is: 
 
• 
Definitely Related:  The adverse event is clearly related to the investigational agent/procedure – 
i.e. an event that follows a reasonable temporal sequence from administration of the study 
intervention, follows a known or expected response pattern to the suspected intervention, that is 
confirmed by improvement on stopping and reappearance of the event on repeated exposure and 
that could not be reasonably explained by the known characteristics of the subject’s clinical state. 
• 
Possibly Related:  An adverse event that follows a reasonable temporal sequence from 
administration of the study intervention follows a known or expected response pattern to the 
suspected intervention, but that could readily have been produced by a number of other factors. 
• 
Not Related:  The adverse event is clearly not related to the investigational agent/procedure. –  
i.e. another cause of the event is most plausible; and/or a clinically plausible temporal sequence is 
inconsistent with the onset of the event and the study intervention and/or a causal relationship is 
considered biologically implausible. 
 
5.3.3.3 EXPECTEDNESS  
 
AEs must be assessed as to whether they were expected to occur or unexpected, meaning not 
anticipated based on current knowledge found in the protocol, investigator brochure, product insert, or 
label. Categories are: 
 
Unexpected - nature or severity of the event is not consistent with information about the condition 
under study or intervention in the protocol, consent form, product brochure, or investigator brochure. 
 
Expected - event is known to be associated with the intervention or condition under study.   

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5.3.4 ADVERSE EVENT (AND SAE) REPORTING  
 
Adverse Events (AEs) and Serious Adverse Events (SAEs) have specific reporting procedures. AEs will be 
collected via REDCap. If REDCap is down, research staff should use the paper form Adverse Event 
Reporting Form (See Appendix 8.3).  
All AEs are collected on an Adverse Event Form that includes the date of the event, what occurred, 
actions taken by project staff, planned follow up (if any) , whether the event appears to be related to 
the intervention, the seriousness of the event, and whether participant will continue in the study (see 
appendix). All AEs experienced by the participant during the time frame specified in the protocol (e.g., 
from the time of study drug administration through the end of the study intervention period) are to be 
reported.  
 
Please note that the AE form contains a column to indicate whether the event is serious. Thus, SAEs are 
a subset of the reported AEs. 
 
All SAEs, unless otherwise specified in the protocol and approved by the IRB or DSMP (as applicable), 
require expedited reporting by the Principal Investigator to the study's safety monitoring bodies. Serious 
adverse events will be reported to the site PI within 24 hours of research staff becoming aware of the 
event. SAEs that are unanticipated problems will be reported to the NIDA PO within 24 hours by email 
and a written follow up will be submitted within 2 days of the event.  
 
Any IRB action response will be reported to NIDA PO within 3 days of the receipt of notice of the action. 
5.4 
DATA SAFETY MONITORING PLAN 
 
5.4.1 SAFETY OVERSIGHT 
 
Principal Investigator (PI) will be responsible for ensuring participants’ safety on a daily basis. The 
Independent Safety Monitor will act in an advisory capacity to monitor participant safety, to evaluate 
the progress of the study, and  to review procedures for maintaining the data confidentiality, collection 
quality, management, and analyses. 
5.4.1.1 INDEPENDENT SAFETY MONITOR 
Jeanette Tetrault, MD – Professor at Yale University School of Medicine 
The Independent Safety Monitor will oversee the safety of the participants and the validity and integrity 
of the data. Responsibilities will include: 

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• Evaluating the research protocols and plans for safety and data monitoring 
• Evaluating the progress of the study, including periodic assessments of data quality and timeliness, 
participant recruitment, accrual and retention, performance of the trial sites, and other factors that can 
affect study outcome 
• Considering factors external to the study when relevant information becomes available, such as 
scientific or therapeutic developments that may have an impact on the safety of the participants or the 
ethics or practicality of the trial 
• Reviewing study site performance, making recommendations and assisting in the resolution of 
problems reported by study team 
• Ensuring the confidentiality of the trial data and the results of monitoring 
5.4.1.2 INDEPENDENT SAFETY MONITOR MEETINGS 
The PI will meet annually with the ISM by teleconference. At each meeting the ISM will review individual 
SAEs and cumulative AE reports. Following each meeting, the monitor will make recommendations on 
continuation, modification, or termination of the study. 
5.5 
COVID-19 REGULATIONS 
Study staff will follow UW Human Subjects Division protocols regarding COVID-19 safety. Staff members will wear 
recommended face coverings in accordance with UW guidelines to prevent possible SARS-CoV-2 transmission, and 
will ask participants to do the same. When possible to do so while maintaining confidentiality, visits will be 
conducted in well-ventilated spaces, rooms with open windows, contained spaces outdoors, etc. As is expected at 
the time of writing, staff members will complete the COVID-19 Symptoms Self-Attestation for On-Site Personnel 
and Visitors on Workday prior to conducting in-person visits. As recommendations and protocols for COVID-19 
safety are subject to change, we will adjust our procedures to match the most up-to-date recommendations and 
protocols available. 
Kelley-Ross Pharmacy Program and HEP staff will operate under the COVID-19 safety protocols of their respective 
home agencies.  
6 
STATISTICAL ANALYSES 
This study will provide estimates of what proportion of HCV-infected PWID successfully link to and utilize the 
community-pharmacy model.  
The primary feasibility/acceptability outcome will be the proportion (and 95% confidence intervals) of participants 
who are evaluated for HCV treatment in the community-pharmacy program. Secondarily, we will evaluate HCV 
treatment outcomes (initiation, completion, and SVR12/cure), medication adherence, substance use, HIV risk 

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behaviors, and receipt of other medications (naloxone, PrEP, and medications for OUD). Finally, we will assess 
treatment satisfaction and willingness to refer an injecting partner to the community pharmacy for treatment. 
Given our estimated sample size of 40 we can provide a range of estimates and 95% confidence intervals (CIs) for 
the following hypothetical scenarios: Using binomial “exact” calculation to estimate CIs, if we assume 0.5 of the 
sample (i.e., 20/40 participants) achieves the outcome, the estimated 95% CI is 0.34 to 0.66. If 10/40 achieves the 
outcome (0.25), the estimated 95% CI is 0.13-0.41; if 30/40 achieves the outcome (0.75) the estimated 95% CI is 
0.59-0.87. 
 
7 
REFERENCES  
 
1. 
Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental 
Health Indicators in the United States: Results from the 2017 National Survey on Drug Use and Health. 
Rockville, MD2018 [Available from: https://www.samhsa.gov/data/report/2017-nsduh-annual-national-
report. 
2. 
Prevention CfDCa. Drug Overdose Death Data 2017 [updated December 19, 2017. Available 
from: https://www.cdc.gov/drugoverdose/data/statedeaths.html. 
3. 
Zibbell JE, Asher AK, Patel RC, Kupronis B, Iqbal K, Ward JW, et al. Increases in Acute Hepatitis C 
Virus Infection Related to a Growing Opioid Epidemic and Associated Injection Drug Use, United States, 
2004 to 2014. Am J Public Health. 2018;108(2):175-81. 
4. 
Peters PJ, Pontones P, Hoover KW, Patel MR, Galang RR, Shields J, et al. HIV Infection Linked to 
Injection Use of Oxymorphone in Indiana, 2014-2015. N Engl J Med. 2016;375(3):229-39. 
5. 
Klevens RM, Hu DJ, Jiles R, Holmberg SD. Evolving epidemiology of hepatitis C virus in the United 
States. Clin Infect Dis. 2012;55 Suppl 1:S3-9. 
6. 
Edlin BR, Carden MR. Injection drug users: the overlooked core of the hepatitis C epidemic. Clin 
Infect Dis. 2006;42(5):673-6. 
7. 
Williams IT, Bell BP, Kuhnert W, Alter MJ. Incidence and transmission patterns of acute hepatitis 
C in the United States, 1982-2006. Arch Intern Med. 2011;171(3):242-8. 
8. 
Centers for Disease Control and Prevention. Notes from the field: risk factors for hepatitis C 
virus infections among young adults--Massachusetts, 2010. MMWR Morb Mortal Wkly Rep. 
2011;60(42):1457-8. 
9. 
Suryaprasad AG, White JZ, Xu F, Eichler BA, Hamilton J, Patel A, et al. Emerging epidemic of 
hepatitis C virus infections among young nonurban persons who inject drugs in the United States, 2006-
2012. Clin Infect Dis. 2014;59(10):1411-9. 

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10. 
Zibbell JE, Iqbal K, Patel RC, Suryaprasad A, Sanders KJ, Moore-Moravian L, et al. Increases in 
hepatitis C virus infection related to injection drug use among persons aged </=30 years - Kentucky, 
Tennessee, Virginia, and West Virginia, 2006-2012. MMWR Morb Mortal Wkly Rep. 2015;64(17):453-8. 
11. 
Ly KN, Hughes EM, Jiles RB, Holmberg SD. Rising Mortality Associated With Hepatitis C Virus in 
the United States, 2003-2013. Clin Infect Dis. 2016;62(10):1287-8. 
12. 
Martin NK, Vickerman P, Grebely J, Hellard M, Hutchinson SJ, Lima VD, et al. Hepatitis C virus 
treatment for prevention among people who inject drugs: Modeling treatment scale-up in the age of 
direct-acting antivirals. Hepatology. 2013;58(5):1598-609. 
13. 
World Health Organization. Combating hepatitis B and C to reach elimination by 2030. 
Switzerland2016. 
14. 
Carey KJ, Huang W, Linas BP, Tsui JI. Hepatitis C Virus Testing and Treatment Among Persons 
Receiving Buprenorphine in an Office-Based Program for Opioid Use Disorders. J Subst Abuse Treat. 
2016;66:54-9. 
15. 
Mehta SH, Genberg BL, Astemborski J, Kavasery R, Kirk GD, Vlahov D, et al. Limited uptake of 
hepatitis C treatment among injection drug users. J Community Health. 2008;33(3):126-33. 
16. 
Tsui JI, Miller CM, Scott JD, Corcorran MA, Dombrowski JC, Glick SN. Hepatitis C Continuum of 
Care and Utilization of Healthcare and Harm Reduction Services among Persons who Inject Drugs in 
Seattle. Drug Alcohol Depend. 2018. 
17. 
Litwin AH, Soloway IJ, Cockerham-Colas L, Reynoso S, Heo M, Tenore C, et al. Successful 
treatment of chronic hepatitis C with triple therapy in an opioid agonist treatment program. The 
International journal on drug policy. 2015;26(10):1014-9. 
18. 
Litwin AH, Harris KA, Jr., Nahvi S, Zamor PJ, Soloway IJ, Tenore PL, et al. Successful treatment of 
chronic hepatitis C with pegylated interferon in combination with ribavirin in a methadone maintenance 
treatment program. J Subst Abuse Treat. 2009;37(1):32-40. 
19. 
Glick SN, Tsui J, Hanrahan M, Banta-Green CJ, Thiede H. Naloxone uptake and use among people 
who inject drugs in the Seattle area, 2009–2015. Drug Alcohol Depend. 2017;171. 
20. 
Freeman PR, Hankosky ER, Lofwall MR, Talbert JC. The changing landscape of naloxone 
availability in the United States, 2011 - 2017. Drug Alcohol Depend. 2018;191:361-4. 
21. 
Edelman EJ, Moore BA, Calabrese SK, Berkenblit G, Cunningham C, Patel V, et al. Primary Care 
Physicians' Willingness to Prescribe HIV Pre-exposure Prophylaxis for People who Inject Drugs. AIDS 
Behav. 2017;21(4):1025-33. 
22. 
Adams LM, Balderson BH. HIV providers' likelihood to prescribe pre-exposure prophylaxis (PrEP) 
for HIV prevention differs by patient type: a short report. AIDS Care. 2016;28(9):1154-8. 

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23. 
Santschi V, Chiolero A, Burnand B, Colosimo AL, Paradis G. Impact of pharmacist care in the 
management of cardiovascular disease risk factors: a systematic review and meta-analysis of 
randomized trials. Arch Intern Med. 2011;171(16):1441-53. 
24. 
Bond CA, Raehl CL. Pharmacist-provided anticoagulation management in United States 
hospitals: death rates, length of stay, Medicare charges, bleeding complications, and transfusions. 
Pharmacotherapy. 2004;24(8):953-63. 
25. 
Snyder ME, Earl TR, Gilchrist S, Greenberg M, Heisler H, Revels M, et al. Collaborative drug 
therapy management: case studies of three community-based models of care. Prev Chronic Dis. 
2015;12:E39. 
26. 
Association; AP. Consortium recommendations for advancing pharmacists' patient care services 
and collaborative practice agreements. J Am Pharm Assoc. 2013;53(2):e132-41. 
27. 
Tung E, Thomas A, Eichner A, Shalit P, editors. Feasibility of a pharmacist-run HIV PrEP clinic in a 
community pharmacy setting. Conference on Retroviruses and Opportunistic Infections; 2017. 
28. 
McLellan AT, Luborsky L, Woody GE, O'Brien CP. An improved diagnostic evaluation instrument 
for substance abuse patients. The Addiction Severity Index. J Nerv Ment Dis. 1980;168(1):26-33. 
29. 
Weatherby NL, Needle R, Cesari H, Booth R, McCoy CB, Watters JK, et al. Validity of self-reported 
drug use among injection drug users and crack cocaine users recruited through street outreach. Eval 
Prog Plann. 1994;17(4):347-55. 
30. 
Needle R, Fisher DG, Weatherby N, Chitwood D, Brown B, Cesari H, et al. Reliability of self-
reported HIV risk behaviors of drug users. Psychol Addict Behav. 1995;9(4):9. 
 
 
 

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8 
APPENDICES 
8.1 
PARTICIPANT LOCATOR FORM 
HepPSI Phase II Participant Contact Document 
Do not list the participant’s Study ID Number on this document. 
 
Participant’s personal contact information 
Name on medical records - legal (Last, First) 
 
Name you go by, if different 
 
 
Pronouns you use  
 She/her         They/them       He/him 
Something else: ________________________
DOB (MM/DD/YYYY) 
 
SSN (if none, use 999-99-9999) 
Mailing address 1: 
 
 
 
 
Do you receive mail at this 
address? 
 Yes         No 
Mailing address 2: 
 
 
 
 
Do you receive mail at this 
address? 
 Yes         No 
Best way(s) to contact you: 
 Cell phone 
 Landline phone 
 Text 
 Email 
 Facebook message 
 Other social media: _____________________ 
 Through someone else – who?* 
[Still collect even if not the preferred method of 
contact] 
 
Primary phone #: __________________________ 
 Cell   Landline  Work  Shared phone 
Alternate phone #: _________________________ 
 Cell   Landline  Work  Shared phone 
Alternate phone #: _________________________ 
 Cell   Landline  Work  Shared phone 
 
Primary Email address: ______________________ 
 
Email address: ____________________________ 
 
Social media handle/link: ____________________ 
 
Social media handle/link: ____________________ 
*Should be alternate contact 1 

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If we attempt to contact you through one of the alternate contacts you provide, we will not disclose your 
involvement in this research study or any health information about you. We will announce our name, that we work 
with the University of Washington, and that we are trying to reach you. We will ask whomever we contact to put 
you in touch with us if possible. If you would like us to take care regarding any other information, please let us 
know. 
Please provide us with as many alternative contacts as you can (up to 4). This could include family members or 
friends who know how to get ahold of you. This can also include case managers, social workers, or organizations 
you go to frequently (such as Bailey-Boushay House or the Seattle Indian Health Board).  
Alternate contact 1 
Name 
 
Relation to you 
 Friend     Family member (specify): __________      
 Case manager 
Other:
Best way(s) to contact them: 
 Cell phone 
 Landline phone 
 Text 
 Email 
 Facebook message 
 Other social media: ______________________ 
 
Cell phone#: _________________________ 
 
Landline#: _________________________ 
 
Email address: ____________________________ 
 
Social media handle/link: ____________________ 
 
Alternate contact 2 
Name 
 
Relation to you 
 Friend     Family member (specify): __________      
 Case manager 
Other:
Best way(s) to contact them: 
 Cell phone 
 Landline phone 
 Text 
 Email 
 Facebook message 
 Other social media: ______________________ 
 
Cell phone#: _________________________ 
 
Landline#: _________________________ 
 
Email address: ____________________________ 
 
Social media handle/link: ____________________ 
 
 
 

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8.2 
IRB-APPROVED SCREENING SCRIPT 
My name is ____________, and I am part of a UW research team. I am talking with individuals 
to see if they qualify for a study we are doing, and if they are interested in participating. 
Participants in this study will receive HEP patient navigation services and will be linked to a 
community pharmacy program, where they may be offered several medications, including 
those that treat HCV. I am interested in asking you some questions to see if you may be eligible 
for this study. Would you like to be screened?  
 
 Yes  Continue with screening. 
 No  Thank individual for their time, end screening. 
 
Before we start, I want to provide you with more information about this eligibility survey. You 
will not be compensated for the answers you provide for this eligibility survey. Participation in 
the study is not required; it is entirely your choice to participate and saying yes right now does 
not mean you have to be in the study. This survey will take just a few minutes. The answers you 
provide will be assigned a unique ID and stored in our password protected computer. If you are 
eligible to participate in the study, I can explain more about the study. Is this okay with you?  
 
 Yes  Continue with screening. 
 No  Thank individual for their time, end screening. 
8.2.1 ELIGIBILITY SCRIPT 
Eligible – Thank you for your time. I’d like to briefly explain more about the study you are 
eligible for. Participants in this study will be linked to a community pharmacy program where 
they will be offered medications that (1) treat hepatitis C, (2) treat opioid use disorder, (3) 
prevent overdose, and (4) prevent HIV infection. You may get other medications that you need 
through the pharmacy program, too. We are interested in whether this new method of offering 
hepatitis C medications through a community pharmacy program that is convenient and 
accessible for people who inject drugs, who are living with hepatitis C, in Seattle. We will have 
two study visits over six months. Upon completing the first visit, you will receive a $30 cash or 
gift card honorarium, and for the second you will receive a $50 cash or gift card honorarium. 

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We will also review your medical records related to receiving medications that treat hepatitis C, 
treat opioid use disorder, prevent overdose, and prevent HIV. We will complete a release of 
information together that gives the study staff access to this information. Your enrollment in the 
study is contingent upon completing this paperwork. If you are interested in learning more and 
participating, we can review the consent process and discuss more details of the study. 
Are you interested in participating?  
 Yes  
 No  Why are you uninterested in participating? (Select all that apply) 
 Too busy  
 No interest in participating in research  
 Transportation difficulties  
 Other – Please specify: ____________________ 
Ineligible – It looks like you are not eligible for this research study.  We are looking for people 
with a different combination of characteristics. Thank you for your time today.  
 
 

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8.3 
ADVERSE EVENT FORM 
HepPSI Phase II Adverse Event Report Form 
Adverse event- Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or 
disease temporally associated with the use of a medical treatment or procedure, regardless of whether it is 
considered related to the medical treatment or procedure. 
This form is to be completed by HepPSI Phase II Research staff upon notice of an adverse event and updated until 
event is resolved and all necessary parties are notified of the specific singular event.  
Adverse Event Record ID: 
__ __ __ 
Date of Report: 
Date report was written. 
Name of staff completing report: 
First and Last Name of Research Staff Person 
Research Role of staff completing initial report 
☐Research Assistant  
☐Research Coordinator 
☐Co-Investigator  
☐Primary Investigator 
Date Research Staff became aware of event:  
Date Staff became aware of event 
How did Research Staff become aware of event:  
☐Electronic Medical Record  
☐Informant: Who was the informant?  
☐Other: How did you become privy to the event? 
 
Date of Event: 
When did the event occur? 
Participant’s Study ID: 
__ __ __ __ 
Description of Event: 
Describe the event – what happened, how did it happen, how upset does the participant 
seem, etc. 
 
 
 

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1. Was the event serious?  
☐  YES (please indicate reason)  
☐  NO 
☐ Death  
 
 
☐ Life-Threatening  
 
☐ Hospitalization  
☐ Persistent or significant disability/incapacity  
☐ Result in birth defect  
☐ Breach of Confidentiality  
☐ Other – Specify the other serious outcome 
2. Was the event related to study participation?  
☐  YES (please indicate degree of relatedness)  
☐  NO 
☐Possibly Related 
☐Definitely Related 
Justification for degree of Relatedness 
Refer to DSMP to explain reasoning for 
selected degree of relatedness. 
 
3. Was the event expected?   
☐  YES                                           ☐  NO 
4. Which organ system(s) were affected? 
☐Blood and Lymphatic 
System Disorders ☐
Cardiac Disorders ☐
Congenital, Familial and 
Genetic Disorders 
☐
Ear and Labyrinth 
Disorders 
☐Endocrine Disorders ☐
Eye Disorders 
☐
Gastrointestinal 
Disorders 
☐Hepatobiliary Disorders☐Immune System Disorders
☐
Infections and 
Infestations 
☐
Injury, Poisoning and 
Procedural 
Complications 
☐
Investigations 
☐
Metabolism and 
Nutrition Disorders ☐
Musculoskeletal and 
Connective Tissue 
Disorders 
☐
Neoplasms Benign, 
Malignant and Unspecified 
(Including Cysts and Polyps)
☐
Nervous System 
Disorders 
☐
Pregnancy, Puerperium 
and Perinatal 
Conditions 
☐
Product Issues 
☐Psychiatric Disorders ☐
Renal and Urinary 
Disorders 
☐Reproductive System and 
Breast Disorders 
☐
Respiratory, Thoracic 
and Mediastinal 
Disorders 
☐Skin and Subcutaneous 
Tissue Disorders ☐
Social Circumstances 
☐Surgical and Medical 
Procedures
☐
Vascular Disorders 
 
 
 

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What is the severity of the event?  
☐  Mild  
☐  Moderate  
☐  Severe 
Justification for degree of Severity 
Refer to DSMP to explain reasoning for selected degree of severity  
 
If the answer to Q1 and Q2 above are “YES” and Q3 is “NO”, then: 
- 
Research staff should notify and report  to Site PI within 24 hours of becoming aware of the event 
- 
Research Team should then notify the NIDA PO within 24 hours of the event by email and then submit a written 
follow-up plan to the PO within 2 days of the event. 
- 
Research Team should also plan to report the event to their Site IRB 
 
 
Action taken by research staff following notice of 
event: 
Describe action taken 
Describe any actions staff took once they became aware of the event.   
 
 
 
 
Is a planned follow-up need?  
☐ YES (please indicate follow-up plan) 
☐ NO  
 
Description of Follow-up Plan: 
What is the Follow-up plan to resolve any issues? 
 
 
 
Date of Follow-up plan implemented 
What date was the follow-up plan implemented? 
 
 
To be completed by PI upon notice of an event  
Has the Site PI been notified of the event?  
☐ YES (Please provide dates of notification and reviewed)  
☐ NO (notify Site PI immediately) 
Notified: Click here to enter a date. 
Reviewed: Click here to enter a date.  
(Completed by Site PI) 

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Additional Notes  
 
Actions to be taken by HepPSI Phase II Research Staff for Events 
Unanticipated Problems 
Does the Site PI believe that the event put greater than 
minimal risk than was previously known or recognized?  
☐Yes                         ☐No 
 
 
If the event is determined to be a Serious Adverse Event that is an unanticipated problem, then the NIDA PO needs to be 
notified.  
NIDA PO Notified?  
☐  YES (please note dates of contact)  
☐  NO   
Initial Email Date: Click here to enter a date. 
Follow-up plan Email: Click here to enter a date. 
 
 
Has the site IRB been notified of the event? 
☐Yes                                                  ☐No 
Date of Site IRB notified:  
Click here to enter a date. 
Action Requested by IRB:  
☐ YES (please describe IRB action) 
☐ NO  
IRB Requested Action  
Describe the requested IRB action. 
 
 
Date of IRB Action Request:  
Click here to enter a date. 
Date of NIDA PO notified of IRB Action Request 
Click here to enter a date. 
 
 
Outcome of Event:  
☐Unresolved – yet to be reviewed by PI 
☐Ongoing – PI reviewed, waiting for responses from necessary 
parties  
☐Unknown (lost to f/u) 
☐Resolved – No more further action required 
(Resolved Date: Click here to enter a date.) 
☐Death (Date: Click here to enter a date.) 
Will the participant continue study involvement?  
☐  YES                                           ☐  NO 

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If the event is 1) serious, resulting in at least one of the 5 listed outcomes and/or causes greater risk of harm than 
was previously known or recognized (i.e. “Other”); 2) either possibly or definitely related to the participant’s study 
involvement; and 3) unexpected, then research staff must do the following for this unanticipated problem: 
- 
Report to Site PI, Dr. Judith Tsui within 24 hours of becoming aware of the event (tsuij@uw.edu)  
- 
Report to NIDA PO within 24 hours by email and submit a written follow-up within 2 days of the event 
[NIDA PO – Minnjuan Flournoy (minnjuan.flournoyfloyd@nih.gov)] 
- 
Report to IRB  
o 
UW – (link to UW HSD IRB Reporting Guidelines)  
 
If the event is a breach (risk or loss) of confidentiality – report event to IRB within 24 
hours.  
 
If the event did not result in breach of confidentiality but still an unanticipated event 
UW Research Team must report to IRB within 10 business days of the event 
Events that are not unanticipated problems  
If the event is not considered to be an unanticipated problem, then the event is considered an AE/SAE and will 
need to be reviewed by research team at the following weekly meeting. In addition, research staff then must do 
the following: 
- 
Report to Site IRB  
o 
UW – Report recommendations made by the ISM at yearly meetings as Reportable New 
Information.  
- 
Report all AE/SAEs to NIDA PO at annual continuing review/progress reports (i.e. RPPR and 6-month 
review)  
- 
Report all AE/SAEs to ISM during annual Data Safety Monitoring Meeting  
 
ISM Reviews and Reports 
All individual SAEs and cumulative AEs are to be reviewed by the project’s designated Independent Safety Monitor, 
Dr. Jeanette Tetrault , annually. Research staff will be notified a month prior to the meeting to begin preparing all 
reports for review. Following the annual ISM AE/SAE Review, reports and, if needed, plans of action to modify 
study design to improve participant safety will be submitted to the IRBs. Reports are to be shared with the NIDA 
PO within a month of being written.  
 
UW – must send in Data Safety Monitoring reports and audit reports, regardless if changes are requested or not, 
within 10 days following the review 
 
 

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8.4 Medical Case Manager “Step by Step” Document: (Integration of HepPSI PN 
roles) 
1. Meeting Client (referral, community, phone call) 
a. Introduce self, discuss MCM program and inquire if client is interested in enrolling into MCM 
program 
b. Take down client’s name, DOB, and contact information 
 
i. *ask if it is okay to leave a voicemail/text message in order to provide a reminder for the 
scheduled appointment  
c. 
Schedule an appointment to conduct MCM intake  
d. Schedule a “future appointment” on the database to remind client of intake appointment  
e. Input client intake information on work calendar  
i. *invite Conference Room calendar to event to reserve the space  
2. Intake Appointment  
a. Introduce self, offer refreshments, build rapport, discuss Hepatitis Education Project as a non-
profit agency, and discuss different programs (ex. MCM, DOC, POP, SSP, Advocacy) 
b. Ask how client heard about HEP 
c. 
Explain what Medical Case Management is/expectations of being in the program 
d. State that today’s appointment will be to fill out paperwork to be enrolled in MCM program 
e. Inquire if the client has insurance and a PCP in order to see an overview of what the rest of the 
intake appointment will look like  
f. 
Provide hepatitis C education  
i. Inquire what the client already knows about hepatitis C  
ii. Discuss hepatitis C basics (ex. what is hep C, transmission, treatment)  
g. 
Go over MCM Intake documents 
i. Client’s Rights and Responsibilities 
ii. Client Consent for Services 
iii. Demographic Form 
1. After client has completed filling out demographic form, scan the form for 
answers that may prompt more discussion (ex. hep A/B vaccines, alcohol use, 
SSP needs, etc.)  
3. Insurance  
a. If client does not have insurance, help client sign up for insurance on Washington Health Plan 
Finder or refer client to a clinic that has Insurance Navigators on staff 
i. Seattle Indian Health Board  
ii. NeighborCare 45th St. Clinic  
iii. *when scheduling an appointment at any of these clinics, ask to schedule an 
appointment on day where the insurance navigator will be there 
4. Linkage to Care 
a. Discuss whether the client would be interested in receiving treatment at a community pharmacy 
i. If no, discuss where client would like to be seen 
1. Offer suggestions/referral to PCP’s that are treating for hepatitis C 
2. Fill out HEP’s Release of Information with chosen Clinic’s information 
3. Fill out chosen Clinic’s Release of Information with HEP’s information 
4. Call clinic to schedule an appointment  

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a. When calling to schedule an appointment at a PCP, request an 
appointment as a new patient and report that you have hepatitis C.  
5. Provide client with HEP’s fold over business card with appointment information 
in order to request appropriate lab work. 
ii. If yes, please ask the client the following questions to assess if their medical care would 
be appropriate for treatment from a pharmacist. 
1. Do you have HIV? 
2. Do you have active hepatitis B? 
3. Have you ever been diagnosed with liver cirrhosis, had a liver transplant, or had 
liver cancer? 
4. Have you ever been diagnosed with kidney disease or had a kidney transplant? 
5. Are you currently pregnant? 
6. Have you ever been treated for Hep C before? 
iii. If the client reports yes to any of the above conditions, please refer to section 4i above. 
If the client reports no to all of the above conditions, please move to next section (4iv) 
iv. fill out HEP’s Release of Information with Kelley-Ross’ information 
1. Fill out Kelley-Ross’ Release of Information with HEP’s information 
2. Inform client they can seen by the pharmacist on [days/hours TBD] at HEP for 
HCV treatment if they’d like 
3. Provide client with HEP’s fold over business card with appointment information 
in order to request appropriate lab work. 
b. *** If client might be a candidate for HepPSI study and HCV treatment at Kelley-Ross***   
(HCV+, potential interest in receiving HCV treatment, likely recent IVDU) 
i. Ask if client would be interested in participating in a paid research study. Remind client 
that their answer will not affect whether they can be treated or where they would like 
to seek treatment. 
1. If yes, refer client to Ellie and Alex for study screening  
a. Study cell number: (206) 659-6181 
b. Onsite at HEP: Days/hours TBD 
c. 
Onsite at ETS: Mondays 8am-1pm 
5. Database 
a. Input all demographic information into MCM/Testing database  
b. Write case note of intake with important information that was discussed 
c. 
Schedule a future appointment to remind client about appointment 
d. Schedule a follow-up appointment on when to check-in with client about doctor or pharmacy 
visit  
6. Follow-up on Initial Appointment  
a. Follow-up with client after initial doctor or pharmacy visit and inquire how the visit went  
b. Ask when upcoming appointment will be either for further hepatitis C testing or discussion of 
results  
c. 
Input client appointment date in the MCM database as a reminder that the client will be having 
an appointment to prompt a reminder call/text and follow-up 
7. Reminders & Follow-ups on Appointments  
a. When a client has an any type appointment, ask if the client would like a reminder call/text 
message about the appointment  

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i. Appointments include: further hepatitis C related testing, liver ultrasound, liver biopsy, 
and pharmacy appointment  
b. Always follow-up with a client after their appointment to gather more information about their 
hepatitis C (ex. genotype, viral load, fibrosis score, etc.) 
8. Client started treatment! 
a. Once the client has started treatment inquire on treatment information (ex. Medication 
prescription, start date, and # of weeks on treatment) 
b. Inquire when/what time the client will be taking the medication.  
c. 
Discuss the importance of taking medication the same time everyday  
9. Check-ins on treatment 
a. Discuss adherence support with client  
b. Check-in with clients to see if they are experiencing any side effects.  
c. 
Inquire if there are any other upcoming appointments they may have  
10. 4 week/8 week/End of Treatment Blood Draws   
a. Provide appointment reminders and post appointment follow-up to inquire on lab results  
b. Input lab result information on MCM database  
11. After Treatment   
a. Congratulate client for finishing up treatment! 
b. SVR-12 
i. Discuss with client if they can get hepatitis C again, after they have been cured. 
ii. State that an “undetectable” hepatitis C viral load does not mean that the client is 
cured. Discuss the importance of getting SVR-12 (sustained virological response) is what 
determines if a client is cured. If the client’s results come back “undetectable” it means 
the client is cured 
c. 
Discuss Re-infection 
i. Tell clients that there is no hepatitis C vaccine = no immunity to hepatitis C  
ii. Inform clients that they can get re-infected from their own old blood before they cured. 
Advise clients to throw away any hygiene equipment (ex. Razors, clippers, toothbrushes, 
ect.) or anything that may have their old blood on it.  
iii. Provide information on syringe exchange programs in order to pick up new clean sterile 
supplies.  
iv. Avoid other people’s blood AT ALL COST! Discuss the importance of not sharing any 
injection supplies or personal care items that may be an exposure risk.  
v. Encourage client to stay engaged with doctor to keep track of overall health. 
d. State that you will continue to follow-up with client until their SVR-12 appointment and results. 
Report that you will check-in on a monthly basis instead of normal check-in occurrences while 
client was on treatment  
12. Monthly post treatment check-ins 
a. Schedule (3) future appointments for “monthly check-ins” with clients to ensure that you do not 
lose client contact while they are waiting for SVR-12 
b. Check-in with client about how they are feeling post treatment, if they need any additional 
services, extend invite to MMU and SSP, and discuss re-infection as often as possible  
c. 
Inquire when client’s SVR-12 appointment is  
13. SVR-12  
a. When client has reached SVR-12, inquire on date and results.  
b. If client’s test results come back “undetectable” that means the client is cured!  

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c. 
If client does not need any other support post SVR-12, close client case.