A Novel Model of Hepatitis C Treatment as Anchor to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior
Conditions: HCV, Buprenorphine, PreP
Sponsor: University of Maryland, Baltimore

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Clinical Study Protocol 
 
A Novel model of Hepatitis C Treatment as Anchor to Prevent HIV, Initiate Opioid 
Substitution Therapy, and Reduce Risky Behavior 
 (ANCHOR) 
 
 
Principal Investigator:  Elana Rosenthal, MD 
 
Study No: HP-00071577 
 
Version Number: 14 
 
October 11, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
The information contained herein is the property of IHV and may not be reproduced, published 
or disclosed to others without written authorization. 

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Study Staff Roster 
Principal Investigator:   
 
Elana Rosenthal, MD, 
 
 
 
 
 
Institute of Human Virology (IHV) 
 
 
 
 
 
725 West Lombard Street 
 
 
 
 
 
Baltimore, MD 21201 
 
 
 
 
 
Tel: 410-706-1720 
 
 
 
 
 
Fax: 410-706-2499 
Sub-Investigators: 
 
Shyamasundaran Kottilil, MD, PhD, IHV 
Sarah Kattakuzhy, MD, IHV  
 
 
 
 
 
Rahwa Eyasu, NP, IHV 
Rachel Silk, RN, BSN, MPH, IHV 
Jenny Hoffman, MSN, IHV 
 
Ameer Abutaleb, MD, SOM 
Shivakumar Narayanan, MD, SOM 
Poonam Mathur, MD, IHV 
Ashley Davis, NP, IHV 
Amelia Cover, NP 
Britt Gayle, MD, IHV 
Onyinyechi Ogbumbadiugha, IHV 
Emade Ebah, IHV 
Kenzie Preston, PhD, NIDA 
Karran Phillips, MD, NIDA 
Research Assistants:  
 
David Sternberg, HIPS 
Krisit Hill, CCMD/NIH 
Miriam Jones, HIPS 
Dana McCullough, HIPS 
Phyllis Bijole, HIPS  
Laura Nussdorf, NIH 
Aaron DAmore, CCMD/NIH 

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Christopher Brokus, CCMD/NIH 
Jasmine Stevens, CCMD/NIH 
Julia Mount, CCMD/NIH 
 
Epidemiologist/Statistician:  
Kristen Stafford, PhD, MPH, IHV/UMB 
 
 
Laboratory:   
 
 
Bhawna Poonia, PhD   
 
Study Sites/Site Collaborators: 
The University of Maryland Drug Treatment 
Center (UMDTC) 
 
1001 West Pratt Street 
 
Baltimore, MD 21223 
 
Site Collaborator: Eric Weintraub, MD 
 
Eweintra@psych.umaryland.edu> 
 
 
 
 
 
 
 
HIPS, Inc. 
906 H Street, NE 
Washington, DC 20002 
Site Collaborator: Cyndee Clay 
cyndeeclay@hips.org 
 
 
 

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Table of Contents 
LIST OF ABBREVIATIONS .................................................................................................................................. 7 
PROTOCOL SUMMARY ........................................................................................................................................ 8 
PRÉCIS ................................................................................................................................................................... 10 
1 
BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE .................................................... 11 
1.1 
BACKGROUND INFORMATION .............................................................................................................................. 11 
1.2 
INSTITUTIONAL OVERVIEW .................................................................................................................................. 12 
1.3 
TREATMENT ............................................................................................................................................................ 13 
1.4 
RATIONALE .............................................................................................................................................................. 13 
2 
STUDY OBJECTIVES .................................................................................................................................. 13 
2.1 
PRIMARY OBJECTIVE .............................................................................................................................................. 13 
2.2 
SECONDARY OBJECTIVE ........................................................................................................................................ 13 
2.3 
EXPLORATORY OBJECTIVE .................................................................................................................................... 14 
3 
STUDY DESIGN ........................................................................................................................................... 14 
3.1 
DESCRIPTION OF THE STUDY DESIGN ................................................................................................................. 14 
3.2 
STUDY DRUGS .......................................................................................................................................................... 14 
3.2.1 
HCV: ......................................................................................................................................................................... 14 
3.2.2 
PrEP: ........................................................................................................................................................................ 14 
3.2.3 
Opioid substitution therapy: ......................................................................................................................... 14 
3.3 
RESEARCH STRATEGY ............................................................................................................................................ 15 
3.4 
PRIMARY HYPOTHESIS .......................................................................................................................................... 15 
4 
STUDY POPULATION ............................................................................................................................... 15 
4.1 
RATIONALE FOR SUBJECT SELECTION ................................................................................................................ 15 
4.2 
SUBJECT INCLUSION CRITERIA ............................................................................................................................. 15 
4.3 
SUBJECT EXCLUSION CRITERIA ............................................................................................................................ 16 
4.3.1 
Justification for Exclusion .............................................................................................................................. 16 
4.4 
VULNERABLE/INCARCERATED PARTICIPANTS ................................................................................................ 16 
5 
INTERVENTIONS ....................................................................................................................................... 17 
5.1 
ASSESSMENT OF SUBJECT ADHERENCE .............................................................................................................. 17 
5.2 
CONCOMITANT MEDICATIONS AND PROCEDURES ........................................................................................... 17 
5.3 
PROHIBITED MEDICATIONS .................................................................................................................................. 17 
6 
STUDY SCHEDULE ..................................................................................................................................... 17 
6.1 
SCREENING /ENROLLMENT .................................................................................................................................. 18 
6.2 
STANDARD OF CARE HCV TREATMENT .............................................................................................................. 18 
6.3 
STUDY PROCEDURES – HCV TREATMENT ......................................................................................................... 18 
6.3.1 
ADHERENCE MONITORING .................................................................................................................................... 18 
6.3.2 
RISK ASSESSMENTS ................................................................................................................................................ 18 
6.3.3 
URINE DRUG SCREEN ............................................................................................................................................. 18 
6.3.4 
STORED SAMPLE COLLECTION .............................................................................................................................. 19 
6.3.5 
FIBROSCAN .............................................................................................................................................................. 19 
6.3.6 
HIV AND HCV MONITORING ................................................................................................................................ 19 

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6.3.7 
VIRAL SEQUENCING ................................................................................................................................................ 19 
6.4 
OPTIONAL STANDARD OF CARE PREP WITH TDF/FTC ................................................................................ 19 
6.4.1 
STUDY LABWORK ................................................................................................................................................... 19 
6.4.2 
ADHERENCE MONITORING ................................................................................................................................... 20 
6.4.3 
LINKAGE TO CARE ................................................................................................................................................... 20 
6.5 
OPTIONAL STANDARD OF CARE OPIOID SUBSTITUTION THERAPY WITH BUPRENORPHINE ................... 20 
6.5.1 
Retention Monitoring ...................................................................................................................................... 20 
6.5.2 
LINKAGE TO CARE ................................................................................................................................................... 20 
6.6 
OPTIONAL GEOGRAPHIC MOMENTARY ASSESSMENT ..................................................................................... 20 
6.7 
EARLY TERMINATION VISIT ................................................................................................................................. 22 
7 
POTENTIAL RISKS AND BENEFITS ...................................................................................................... 22 
7.1 
POTENTIAL RISKS .................................................................................................................................................. 22 
7.2 
POTENTIAL BENEFITS ........................................................................................................................................... 23 
8 
STORED SAMPLES AND FUTURE RESEARCH ................................................................................... 23 
8.1 
INTENDED USE: ...................................................................................................................................................... 24 
8.2 
STORAGE: ................................................................................................................................................................. 24 
8.3 
TRACKING: ............................................................................................................................................................... 24 
8.4 
DISPOSITION AT THE COMPLETION OF THE PROTOCOL: ................................................................................. 24 
8.5 
REPORTING THE LOSS OR DESTRUCTION OF SAMPLES/SPECIMENS/DATA TO THE IRB: ....................... 24 
9 
ASSESSMENT OF SAFETY ........................................................................................................................ 25 
9.1 
RECORDING/DOCUMENTATION .......................................................................................................................... 25 
9.2 
DEFINITIONS ........................................................................................................................................................... 25 
9.3 
REPORTING PROTOCOL DEVIATIONS, AES AND DEATHS ................................................................................ 25 
9.3.1 
Expedited Reporting to the IRB ................................................................................................................... 26 
9.3.2 
Waiver of Reporting Anticipated Protocol Deviations, Expected non-UP AEs and Deaths 26 
9.4 
ANNUAL REPORTING TO THE IRB ....................................................................................................................... 26 
9.4.1 
Type and Duration of the Follow-up of Subject after Adverse Events ........................................ 26 
10 WITHDRAWAL OF A SUBJECT .............................................................................................................. 27 
10.1 
RETURN OF WITHDRAWN/REMOVED SUBJECTS ............................................................................................. 27 
11 REMUNERATION PLAN FOR SUBJECTS .............................................................................................. 27 
12 MONITORING ............................................................................................................................................. 28 
13 STATISTICAL CONSIDERATIONS ......................................................................................................... 28 
13.1 
DESCRIPTION OF THE ANALYSES ......................................................................................................................... 28 
13.2 
SAMPLE SIZE JUSTIFICATION ................................................................................................................................ 28 
14 ETHICS/PROTECTION OF HUMAN SUBJECTS .................................................................................. 29 
14.1 
INFORMED CONSENT PROCESS ............................................................................................................................ 29 
14.2 
ILLITERACY AND CONSENTING ............................................................................................................................ 29 
14.3 
SUBJECT CONFIDENTIALITY ................................................................................................................................. 29 
APPENDIX A: SCIENTIFIC REFERENCES ...................................................................................................... 30 
APPENDIX B: STUDY SCHEDULE ................................................................................................................... 35 
APPENDIX C:  EPIDEMIOLOGIAL SUVREY (IDU IN LAST 3 MONTHS) ................................................ 37 
APPENDIX D:  HIV RISK ASSESSMENT ......................................................................................................... 38 
APPENDIX E:  AUDIT-C ..................................................................................................................................... 39 

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APPENDIX F: HCV PATIENT REPORTED OUTCOMES SURVEY ............................................................. 40 
APPENDIX G: GEOGRAPHIC MOMENTARY ASSESSMENT (GMA) DAILY PHONE SURVEYS ......... 41 
APPENDIX H: ADVERSE CHILDHOOD EXPERIENCES (ACE) QUESTIONAIRRE ................................ 42 
APPENDIX I: GMA ADHERENCE PACKET 5 ................................................................................................. 43 
APPENDIX J: EPIDEMIOLOGY SURVEY (NON-IDU WITH LAST 3 MONTHS) ..................................... 44 
APPENDIX K: PREP RETROSPECTIVE QUESTIONNAIRE ........................................................................ 45 
 

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List of Abbreviations 
 
 
ACE  
 
Adverse Childhood Experiences 
AE 
 
 
Adverse Event/Adverse Experience 
CCMD 
 
Critical Care Medicine Department 
Co-Infection  
Identifier for those with both HIV and hepatitis B or C  
DAA  
 
Directly Acting Antiviral 
DC PFAP 
 
DC Partnership for AIDS Progress 
EMA  
 
Ecological Momentary Assessment 
GMA  
 
Geographical Momentary Assessment 
HCV  
 
Hepatitis C Infection 
HIPS  
 
HIPS, Inc (partner site) 
HIPAA 
 
Health Insurance Portability and Accountability Act 
GWU  
 
George Washington University 
ANCHOR 
 
Study short name 
HRPP  
 
Human Research Protection Program 
MSM  
 
Men who have sex with men 
NIH 
 
 
National Institutes of Health 
PWID  
 
People who inject drugs 
IHV 
 
 
Institute of Human Virology 
IRB 
 
 
Institutional Review Board 
MTA  
 
Materials Transfer Agreement 
N 
 
 
Number (typically refers to number of subjects/sample size) 
OST 
 
 
Opiod Substittion Therapy 
OUD  
 
Opiod Use Disorder 
PI 
 
 
Principal Investigator 
PrEP  
 
Pre Exposure Prophylaxis 
PRO 
 
 
Patient Reported Outcomes 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SEP 
 
 
Syrigne Exhange Program 
SOM  
 
School of Medicine 
SUD  
 
Substance Use Disorder 
SVR 
 
 
Sustained Viral Reponse 
TDF/FTC 
 
tenofovir/emtricitabine 
UP 
 
 
Unanticipated Problem 
UPnonAE 
 
Unanticipated Problem that is not an Adverse Event 
RNI 
 
 
Reportable New Information 
UMDTC 
University of Maryland Drug Treatment Center (partner site) 
 
 
 
 
 
 

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Protocol Summary 
Full Title: 
A Novel model of Hepatitis C Treatment to Prevent HIV, Initiate 
Opioid Substitution Therapy, and Reduce Risky Behavior 
Short Title: 
ANCHOR 
Conducted by: 
Institute of Human Virology, University of Maryland 
Principal Investigator: 
Elana Rosenthal, MD 
Sample Size: 
N= 200 for on-treatment (phase 1, n = 100;  phase 2, n = 100);  
will enroll up to 400 for screening 
Study Population: 
Adults infected with HCV 
Accrual Period: 
48 months (24 months for phase 1 ; 24 months for phase 2) 
Study Design: 
 
This is an open label, non-randomized, observational pilot study to 
evaluate a model of care for treatment of hepatitis C in people with 
ongoing injection drug use. Participants will be treated with 
direct-acting antivirals (DAA) as per standard of care and will 
concomittantly be offered pre-exposure prophylaxis for HIV 
prevention and buprenorphine for treatment of opioid use disorder 
when clinically indicated.   
Study Duration: 
 
Start Date: September 2016  
 
 
End Date: January 2022 
Primary Objective:  
To evaluate the efficacy of DAAs for treatment of hepatitis C in 
people with ongoing injection drug use.   
Secondary Objectives: 
1) Evaluate uptake of PrEP  
 
 
2) Evaluate adherence to PrEP  
 
 
3) Evaluate uptake of buprenorphine when clinically indicated 
(objective restricted to HIPS) 
 
 
4) Evaluate retention in buprenorphine program (objective 
restricted to HIPS) 
 
 
5) Assess change in risk behaviors at baseline, during, and after 
HCV treatment 
 
 
6) Evaluate the impact of active IDU vs non-injecting opioid 
misuse on efficacy of DAAs for the treatment of HCV 
 
 
7) Evaluate the impact of OST on HCV treatment outcomes  
 
Exploratory Objectives: 
1) Rates of HCV reinfection after treatment with DAAs 
 
 
2) Rates of new HIV infection  
 
 
3) Immunologic and virologic correlates of protective immunity 
against reinfection  
 
 
4) Evaluate adherence to HCV medication 
 
 
5) Evaluate psychological, social, and behavioral factors related to 
drug use 

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6) Evaluate the impact of collocation of OST on HCV treatment 
outcomes 
 
 
 

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Précis 
 
Hepatitis C (HCV) is a chronic infection with significant morbidity and mortality. The 
development of directly acting antivirals (DAA) has dramatically improved the cure rate of HCV 
treatment. However, despite the availability of effective therapy, the global epidemic of HCV 
infection continues to be driven by people with ongoing injection drug use (PWID), who are 
largely excluded from HCV therapy. Several critical barriers exist preventing high-risk patients’ 
entry to care, including (1) lack of engagement in the traditional healthcare system by 
marginalized patient populations, and (2) insurance restrictions due to concerns regarding 
treatment adherence and HCV reinfection. Furthermore, ongoing injection drug use places these 
individuals at high risk of HIV acquisition. However, studies have repeatedly demonstrated that 
pre-exposure prophylaxis (PrEP) reduces HIV acquisition and opioid substitution therapy with 
buprenorphine reduces HIV and HCV acquisition in PWID.  
 
As such, we propose a comprehensive model of care to engage individuals with ongoing 
injection drug use in treatment of HCV, in conjunction with collocated services to prevent HIV 
acquisition and HCV reinfection, including pre-exposure prophylaxis and opioid substitution 
therapy. This pilot trial will demonstrate whether a comprehensive model of care can 
simultaneously treat HCV, and prevent HCV reinfection, HIV acquisition and effectively treat 
opioid use disorder. 
 
 
 
 
 
 
 
 

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1 Background Information and Scientific Rationale 
 
1.1 Background Information 
 
Hepatitis C virus (HCV) is a serious infection that chronically infects approximately 135 
million people worldwide.(1) There is ongoing acute transmission of HCV, especially in young 
people who inject drugs,(2) and human immunodeficiency virus (HIV) infected men who have 
sex with men.(3) Chronic infection with HCV can lead to cirrhosis, liver cancer, and death, and 
is the leading cause of liver transplantation in the United States.(4) HCV is treatable, and the 
goal of treatment is to achieve a sustained virologic response (SVR), considered to be a 
functional cure (absence of plasma HCV RNA 12 weeks after completing therapy). Historically, 
treatment of HCV using interferon-alfa involved significant toxicities and poor rates of SVR, 
particularly in patients with HIV and/or black race.  
The advent of direct-acting antivirals (DAA) has been revolutionary in the advancement 
of HCV treatment. DAAs have few side effects, short durations of treatment, and high SVR. In 
addition, they are effective regardless of race, gender, or HIV status, leaving few barriers to 
treatment. (5, 6) Therefore, in HCV infected individuals, DAAs have the potential to lower 
mortality, improve quality of life, reduce long-term costs of complications and interrupt the 
current global HCV epidemic.(7)   
 
Although DAAs have been extremely effective in curing existing HCV infections, there 
continues to be transmission of HCV. In 2013, there were an estimated 29,718 cases of acute 
HCV in the U.S. (8). This acute epidemic of HCV is being driven by individuals with high risk 
practices, including people who inject drugs (PWID) and men who have sex with men (MSM) 
(9, 10). Many of these individuals lack access to providers and treatment for HCV (11). 
Therefore, the current barrier to eradicating HCV is implementing accessible treatment programs 
in high-risk populations in order to effectively cure those who are chronically infected, in order 
to prevent transmission of disease. 
 
Further, individuals with HCV and high-risk behaviors are often at risk for HIV 
acquisition. However, multiple evidence based strategies have been demonstrated to decrease 
acquisition of HIV in PWID.(12) Specifically, pre-exposure prophylaxis (PrEP) with 
tenofovir/emtricitabine (TDF/FTC) in PWID has been shown to reduce the risk of HIV by 49% 
in those with regular use of TDF/FTC, and 74% in those with consistent use.(13) Further, 
utilizing OST with methadone or buprenorphine significantly reduces incidence of HIV and 
HCV in PWID with opioid use disorder (OUD).(14)  
 
Despite available therapies to treat HCV and prevent HIV, there are multiple barriers to 
successfully implementing HCV treatment and HIV prevention strategies in these individuals. 
PWID are a challenging patient population, often with chaotic lifestyles, distrust of the medical 
system, and poor healthcare literacy.(15) In addition, many system level barriers prevent these 
patients from receiving healthcare.(16) However, many of these barriers can be ameliorated by 
embedding comprehensive, patient-centered services at culturally competent sites, and engaging 
patients on issues which they consider to be a priority. In comparison to specialized OST centers 
where addiction treatment exists in a separate silo from other medical care, models of 
comprehensive care where medication-assisted treatment for addiction is integrated and 

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collocated with chronic medical care have demonstrated improved uptake of and retention in 
OST, as well as decreased concomitant drug use.(17, 18)  These models have demonstrated 
greater efficacy in treatment of chronic diseases in PWID, such as HIV.(19-22)  
 
In addition, PWID have demonstrated significant desire to obtain HCV treatment. In the 
era of complicated, toxic, interferon-based therapy, multiple studies demonstrated over 70-80% 
interest in initiating treatment for HCV.(23-26) When given scenarios of few side effects or 
greater than 70% SVR, the interest in uptake of HCV treatment was even higher (89% and 93% 
respectively).(24) Further, a study of HCV treatment with DAA in people with OUD on OST 
demonstrated equivalent efficacy of and adherence to treatment as compared to people who do 
not use drugs. Notably, over 50% of these patients had positive urine drug screens at baseline 
and during the course of treatment.(27) This indicates that in the era of DAAs, which have 
minimal side effects and greater than 90% efficacy, we may be able to use HCV treatment as an 
anchor to engage PWID in HIV prevention. 
Therefore, we propose a model of comprehensive care, which uses HCV treatment in 
embedded clinics as an anchor to engage high-risk populations in medical care. As part of this 
care, we will offer collocated services to prevent HIV (PrEP), as well as reduce the incidence of 
HIV and HCV reinfection (buprenorphine in people with OUD).  
1.2 Institutional Overview 
 
Overview of the DC PFAP Hepatitis Program  
 
In 2008, the National Institutes of Health and the DC Department of Health collaborated to 
establish the DC Partnership for AIDS Progress (DC PFAP), a partnership for community-based 
clinical care and research whose aim is to reduce the incidence and prevalence of HIV/AIDS in 
the District of Columbia. A plan was developed to create a research program to build a sustainable 
model for urban areas working to reduce the HIV/AIDS crisis. A needs assessment within the 
area’s medical community demonstrated a significant deficit in hepatitis C virus care and 
treatment. This led to the development of a Hepatitis branch within DC PFAP, rooted in direct 
subspecialty medical services and clinical research addressing the limitations of standard of care 
therapy.  
 
The Hepatitis program is currently based at the Institute of Human Virology and operates out of 
three campuses: (1) clinical partners within Washington DC, (2) National Institutes of Health, 
Bethesda, MD and (3) University of Maryland Institute of Human Virology, Baltimore, MD. The 
overarching goals of the programs are to: 
 
• 
establish improved access to subspecialty care for underinsured patients with HIV  
• 
develop access to HIV and hepatitis related research for residents of DC 
• 
expand integrated care for hepatitis C in the community HIV clinics  
• 
provide national leadership in the development and delivery of effective, safe, convenient 
therapies, initially focusing on HCV  
 
The clinical aspects of the program are set within partner centers in Washington DC and Baltimore 
City in addition to the IHV. At HIPS, there is an embedded hepatitis clinic at this previously non-
clinical organization providing services for trans people, people who inject drugs, and sex workers. 

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In Baltimore City, there is an embedded hepatitis clinic at the University of Maryland Drug 
Treatment Center (UMDTC). Patients are managed by state of the art standard of care as well as 
offered opportunities to participate in clinical research as appropriate. To date, over 1240 HIV and 
HCV infected patients have been linked to care and over 900 patients cured of hepatitis C through 
treatment with novel directly acting therapy within these subspecialty clinics. Through direct 
linkage to care, effective treatment, and continual outcome measurement, the Hepatitis program 
has developed an effective model for management of hepatitis C in an urban setting. 
1.3 Treatment 
Until recently, a major limiting factor in expansion of treatment for HCV has been standard of care 
therapy with pegylated interferon, ribavirin, and more recently for genotype 1 disease, boceprevir 
and telaprevir. These medications have significant side effect profiles, response-based dosing 
regimens of over 6 months, and decreased efficacy in key groups including: those with genotype 
1 disease, HIV coinfection, and cirrhosis. However, there has been dramatic improvement using 
all oral DAA regimens with sustained virologic response (SVR) rates over 90%, short-duration 
therapies and well-tolerated, simple regimens including among those with HIV coinfection. 
However, most data on the use of DAAs is from clinical trials, which often enroll a patient 
population not representative of the HCV epidemic. Therefore, few studies have been published 
addressing the efficacy of interferon-free, DAA-based HCV treatment among PWID. However, a 
study of patients on opioid substitution therapy who were treated with DAAs demonstrated 
equivalent efficacy and adherence, even amongst those with persistently positive urine drug 
screens(28), indicating that effective treatment of PWID with ongoing drug use may be feasible.  
1.4 Rationale 
HIV and HCV are diseases of concern in the Baltimore and DC metropolitan areas. New DAA 
treatments allow for effective treatment of chronic HCV, however, individuals with high-risk 
practices are largely excluded from care due to insurance restrictions, and as such, ongoing 
transmission of HCV persists. This study will demonstrate feasibility and efficacy of treating 
people with chronic HCV infection and ongoing injection drug use at clinics embedded in non-
traditional healthcare settings. Further, we aim to demonstrate a model of care which 
combines HCV treatment with HIV prevention strategies, in an attempt to cure HCV and 
prevent incident HIV infection.   
2  Study Objectives 
2.1 Primary Objective 
Efficacy of DAA for treatment of HCV in people with ongoing injection drug use. 
2.2 Secondary Objective  
1. Evaluate uptake of PrEP  
2. Evaluate adherence to PrEP 
3. Evaluate uptake of buprenorphine when clinically indicated (HIPS site only) 
4. Evaluate retention in buprenorphine programs (HIPS site only) 
5. Assess change in risk behaviors at baseline, during, and after HCV treatment 

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6. Evaluate the impact of active IDU vs non-injecting opioid misuse on efficacy of DAAs 
for the treatment of HCV 
7. Evaluate the impact of OST on HCV treatment outcomes 
2.3 Exploratory Objective 
1. Rate of HCV reinfection after treatment with DAAs 
2. Rates of new HIV infection 
3. Immunologic and virologic studies  
4. Evaluate adherence to HCV medications 
5. Evaluate the psychological, social, and behavioral factors related to drug use 
6. Evaluate the impact of collocation of OST on HCV treatment outcomes 
 
  
3 Study Design 
3.1 Description of the Study Design  
This is an open label, observational pilot study to evaluate a model of care for treatment of HCV 
in people with ongoing injection drug use through embedded clinics at HIPS in Washington, DC 
(Phase 1 and 2) and the UMDTC in Baltimore (Phase 2), and the IHV while offering collocated 
HIV preventive interventions when clinically indicated.  
3.2 Study drugs 
3.2.1 HCV:  
For the treatment of chronic HCV, patients will be treated with FDA 
approved direct-acting antivirals with or without ribavirin as per standard 
of care per the AASLD/IDSA HCV Treatment Guidelines and per the 
discretion of the investigator.  
3.2.2 PrEP: 
For the purposes of pre-exposure prophylaxis for HIV prevention, 
participants will be offered treatment with tenofovir-emtricitabine 
(TDF/FTC), as per standard of care per the CDC guidelines and per the 
discretion of the investigator.  
3.2.3 Opioid substitution therapy:  
For the treatment of opioid use disorder, eligible participants will be 
offered treatment with buprenorphine or buprenorphine/naloxone as per 
standard of care. Buprenorphine will be prescribed by a physician who 
has completed the buprenorphine waiver training and has DEA approval 
for prescription of buprenorphine for this indication.  

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3.3 Research Strategy 
Study participants will be selected based on inclusion criteria, and will be treated at the IHV or 
the HCV clinics embedded at either of 2 sites: 
1) The University of Maryland Drug Treatment Center (UMDTC), Baltimore, MD:  
a. A clinic for treatment of individuals with substance use disorder. Participants 
have access to treatment with methadone, buprenorphine, naltrexone, as well as 
counseling and primary medical home services.  
2) HIPS, Washington, DC 
a. An organization providing services to people who inject drugs, trans persons, and 
sex workers. Participants have access to HIV and HCV testing, syringe exchange, 
naloxone distribution, counseling services, case management, community health 
worker services, as well as drop-in center with on-site laundry, shower, internet 
and community lunch.  
 
All participants will be treated for chronic HCV with DAAs as per standard of care (see 3.2.1). 
All eligible participants will be offered PrEP with TDF/FTC per CDC guidelines (see 3.2.2) and 
treated in conjunction with HCV care. Eligible individuals at the HIPS site with opioid use 
disorder will be offered buprenorphine (see 3.2.3) in conjunction with HCV care.  
 
3.4 
Primary Hypothesis 
The primary hypothesis is that a comprehensive model of care for individuals with high-risk 
sexual and drug use practices that incorporates standard of care HCV treatment with collocated 
PrEP and buprenorphine (when indicated) will result in high rates of HCV cure, as well as 
decreased incidence of HIV and HCV reinfection.   
4 Study Population 
Participants are individuals with chronic HCV infection and in the first phase (first 100 enrolled 
participants) ongoing injection drug use, defined as self-report of injection of a non-prescription 
drug within three months of screening visit, or in the second phase (enrolled participants 101-
200) patients with self-report of opioid misuse within one year.  
4.1 Rationale for Subject Selection 
Subjects of any gender will be considered for inclusion in this study. There will be no racial, 
ethnic, or gender discrimination. Persons in jail or prison are not eligible for this study (see 
4.3.2). Pregnant and breastfeeding women will not be eligible (see section 4.3.1). 
4.2 Subject Inclusion Criteria 
To be eligible for participation on this protocol, a participant must satisfy all of the following 
conditions: 
 

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1. Age ³18 years old 
2. Able and willing to sign informed consent 
3. Chronically infected with HCV, defined as any individual with documentation of 
positive HCV antibody and positive HCV RNA test  (HCV RNA of 2,000 IU/mL or 
greater). 
4. Willing to have samples stored for future use 
5. Ongoing opioid misuse: defined as self-report of either: 
a. Phase 1 (first 100 enrolled participants) Injection of non-prescription opioids 
within three months of screening visit;  
or 
b. Phase 2 (enrolled participants 101-200) Use of non-prescription opioids within 
twelve months of screening visit  
4.3 Subject Exclusion Criteria 
A participant will be ineligible to participate in this study if any of the following criteria are met: 
1. Decompensated liver disease (Childs Pugh B or C) 
2. Unable to comply with research study visits 
3. Poor venous access not allowing screening laboratory collection 
4. Have any condition that the investigator considers a contraindication to study 
participation  
5. Pregnant or breastfeeding woman 
4.3.1 Justification for Exclusion 
 
Pregnancy: Pregnant women are excluded from this study per FDA guidance, as there are no 
studies of DAAs in pregnant women, and no DAA is currently FDA approved for use in 
pregnant women.  
 
Breastfeeding: Breastfeeding women are excluded from this study per FDA guidance as there 
are no studies of DAAs in lactating women, and no DAA is currently FDA approved for use in 
lactating women.  
 
Exclusion of Children: Safety and effectiveness of DAAs have not been established in pediatric 
patients, and as such subjects 18 years of age or younger will be excluded from the study. 
Because insufficient data regarding dosing or adverse events (AEs) are available in adults to 
judge the potential risk in children, this study poses greater than minimal risk and does not meet 
the Department of Health and Human Services guideline 45 Code of Federal Regulations (CFR) 
46, subpart D, governing the participation of children in research. 
4.4 Vulnerable/Incarcerated Participants 
 
Because of the high rates of incarceration amongst people who use drugs, it is possible that 
participants will become incarcerated during the course of the study. While we will not enroll 
participants during a time of incarceration, participants will not be removed from the study if the 

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study team becomes aware of their incarceration during the study period. This will enable the 
study team to continue to provide direct acting antiviral medication to the participants, which 
would not be possible if the participant is removed from the study. In this way, ongoing inclusion 
in the study will benefit the participant, even during this vulnerable time. Participants will have 
the right to refuse treatment during incarceration.  
Participants who become incarcerated during the course of the study will not have study data 
collected during their incarceration.  In the cases where the study team is made aware of a 
participant’s incarceration while they are on active HCV treatment (taking direct acting antiviral 
therapy at the time of incarceration), the study team will make a reasonable effort to deliver the 
remaining course of HCV treatment to the jail/prison so the participant can have the best chance 
of being cured for hepatitis C and does not develop resistance to hepatitis C medication.     
 
5 INTERVENTIONS  
5.1 
Assessment of Subject Adherence   
Adherence will be assessed by subject interview and pill count as per study schedule.      
5.2 
Concomitant Medications and Procedures  
All concomitant prescription and over the counter medications taken during study participation 
will be recorded.  For this protocol, a prescription medication is defined as a medication that can 
be prescribed only by a properly authorized/licensed clinician.   
5.3 
Prohibited Medications  
Contraindicated medications will be determined per the package inserts of prescribed 
medications as per standard of care.  
 
6 Study Schedule  
Study visits, including screening, will occur at the IHV and clinics in UMDTC and HIPS based 
upon scheduling availability to accommodate each treatment group. The research coordinators 
will also oversee research operations in the clinics. See Appendix B. 
 
All phlebotomy related to the study will be done by a phlebotomist working in the clinic or clinic 
staff. All laboratory studies related to standard of care will be performed as per the standard 
practice at the site. All blood samples for storage for research will be couriered to the IHV lab. 
 
Participants will be given a calendar of scheduled study visits and will be informed that any 
clinic visits outside of scheduled study visits may be either unscheduled visits or non-study 
visits. Subjects will receive this information when given the visit calendar. 
 
Participants who are no-show for visits will be contacted as per the standard procedure for 
missed visits at each clinic site. 

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6.1 
Screening /Enrollment 
Screening will occur at the collocated HCV clinics at the following sites: 
o UMDTC (Phase 2) 
o HIPS (Phase 1 & 2)  
Subjects who meet inclusion criteria and who consent to the study will be enrolled. Outside labs 
performed within the last 6 months may be used to determine eligibility.  
6.2 
Standard of care HCV treatment  
All participants will be started on HCV treatment after confirming eligibility on Day 0. Patients 
will complete visits and laboratory monitoring as per standard of care guidelines. 
6.3 
Study procedures – HCV treatment  
During HCV treatment and in the follow-up period, patients will undergo monitoring for 
treatment adherence, and complete interval surveys for risk assessement, urine drug screens, HIV 
antibody/antigen testings, and HCV RNA levels. Blood samples for storage and research may be 
obtained (PBMC, plasma, serum and Paxgene RNA). Patients may undergo serial evaluation of 
liver fibrosis with fibroscan.  See Appendix A Study Schedule. 
6.3.1 Adherence monitoring 
On weeks 4, 8, 12 participants will meet with study staff to complete counts of remaining pills, 
as well as answering questions regarding HCV treatment adherence. 
6.3.2 Risk assessments 
At screening patients will complete a baseline epidemiologic survey (Appendix C). Patients will 
also complete interval risk assessments with the HIV Risk-taking Behavior Scale (Appendix D) 
at weeks 4, 12, 24, 48, 72 and 96. Assessments will be administed by study staff at the time of 
study visit.  As part of standard practice at the HIPS site, patients will be asked about their use of 
the syringe exchange program (SEP) at those visits. AUDIT-C brief alcohol screen will be 
administered at the time of fibroscan at weeks 24, 48 and 96 (Appendix E).  Additionallly at 
screening, week 12, and week 24 the validated 16-item HCV-PRO questionnaire will be 
administed (Appendix F). This version of the HCV-PRO questionnaire was developed to be self-
administered for persons with a diagnosis of chronic hepatitis viral infection, including treatment 
naïve, currently treated, and previously treated but who have remained infected in an attempt to 
assess change in patient reported outcomes prior to treatment, during treatment, and after 
treatment completion. At week 24 or next possible time point, participants will be administered 
the validated Adverse Childhood Experience (ACE) Questionnaire (Appendix H) which has 
shown to be a significant risk factor for substance use disorders and will better inform our 
understanding of the study population. 
6.3.3 Urine drug screen 
Urine will be collected for drug screen at screening, weeks 4, 12, 24, 48, 72, and 96.  

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6.3.4 Stored sample collection 
Blood samples for storage and research will be obtained at screening, total of 11 tsp, and a total 
of 9 tsp at weeks 4, 12, 24, 48 and 96. Samples collected will include:  
• Serum storage (10 mL) SST/tiger top (2 teaspoons) 
• Plasma storage (6ml) EDTA (1 teaspoon) 
• DNA paxgene will be collected (8.5ml) one time at baseline (1 ½ teaspoon) 
• RNA paxgene will be collected (2.5ml) (1/2 teaspoon) 
• Peripheral blood mononuclear cells (30 ml) Green top/heparin (6 teaspoons) 
6.3.5 Fibroscan  
Patients may have assessment of liver fibrosis by transient elastography with fibroscan at 
screening, 24, 48 weeks, and 96 weeks.   
6.3.6 HIV and HCV monitoring 
HIV antibody/antigen will be checked at weeks 4, 24, 36, 48, 72, and 96 with a one month 
window. HCV RNA will be checked per standard of care, and subsequently at weeks 36, 48, 72, 
and 96 with a one month window.  
6.3.7 Viral sequencing  
Individuals with new seroconversion to HIV will have sample sent for viral sequencing and 
phylogenetic analysis. Individuals with detectable HCV RNA after completion of HCV treatment 
or new infection during the follow up period will have current sample, and baseline stored 
sample sent for viral sequencing and phylogenetic analysis. Phylogenetic analysis will enable us 
to demonstrate mode of transmission of new infections and resistance associated variants that 
may impact ART and DAA therapy in the future.  
6.4 
Optional Standard of Care PrEP with TDF/FTC 
All eligible subjects will be offered initiation of standard of care treatment with TDF/FTC for 
HIV prevention from Day 0 through week 24 of HCV treatment. Patients will be seen and 
monitored as per standard of care. Patients who uptake PrEP will be treated for a 12 month time 
period, and then transitioned to a community provider. The first day of PrEP treatment will be 
considered day P0.   See Appendix A Study Schedule.   
 
On or after week 48, all participants enrolled in ANCHOR study will be administered a brief  
PrEP Retrospective questionnaire (Appendix K) to clarify why they did or did not uptake PrEP. 
 
6.4.1 Study Labwork  
Any participant who seroconverts to HIV while on PrEP treatment will have serum sample 
collected for sequencing and phylogenetic analysis.  

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6.4.2 Adherence Monitoring 
On weeks P4, P12, P24, P36, and P48 participants will meet with study staff to complete counts 
of remaining pills, answer questions regarding PrEP treatment adherence, and provide blood 
samples to evaluate tenofovir levels.  Tenofovir levels will be done on the first 50 participants at 
Month 1, Month 6 and Month 9 treatment.   
6.4.3 Linkage to care  
Participants will be treated for up to 12 months from the time of initiation of PrEP. As this is a 
chronic medication, at the end of treatment, patients interested in continuing on PrEP will be 
linked to care with a community provider.  
Any participant who seroconverts to HIV will be immediately linked to care, in DC through the 
Red Carpet Entry Program, and in Baltimore through the JACQUES program.  
6.5 
Optional Standard of Care Opioid Substitution Therapy with 
Buprenorphine 
All subjects who meet criteria for opioid use disorder per the DSM-V will be offered initiation of 
standard of care treatment with buprenorphine for treatment of opioid use disorder. Patients will 
be seen and monitored as per standard of care. Patients will be offered uptake from day 0 until 
week 24 of HCV treatment , and will be treated for a 12 month time period, and then transitioned 
to a community provider. The first day of buprenorphine treatment will be considered day B0.   
See Appendix A Study Schedule. 
6.5.1 Retention Monitoring 
Patients will be monitored for ongoing retention in buprenorphine program by observation of 
buprenorphine prescription. Documentation of buprenorphine prescription will be done at day B0 
and weeks B2, B4, B8, B12, B24, B36.  
6.5.2 Linkage to care  
Participants will be treated for up to 12 months from the time of initiation of buprenorphine. As 
this is a chronic medication, at the end of treatment, patients interested in continuing on 
buprenorphine will be linked to care with a community provider.  
6.6 
Optional Geographic Momentary Assessment  
All enrolled subjects in Phase 2 (participants 101-200) will be offered participation in the 
Geographic Momentary Assesment (GMA),  an optional, exploratory outcome through a 
research collaboration with the National Institute of Drug Abuse (NIDA) to further explore drug 
use, overdose, risky behaviors, and barriers to hepatitis C treatment and PrEP.     
 
While many patients inducted and stabilized on buprenorphine or methadone reduce or eliminate 
opioid use, there remains a group of individuals who continue to use opioids despite opioid 
agonist therapy.  Additionally, there are patients in treatment who continue to use drugs other 
than opioids including alcohol, marijuana, stimulants among others.  These individuals remain at 

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risk for harm including overdose, acquiring or transmitting HIV, HCV, and other diseases, and 
poor adherence to medical treatment.   
 
This NIDA-developed technology, GMA, combines Ecological Momentary Assessment (EMA), 
the collection of real-time in the field data via smartphones, with GPS of self-reported data on 
craving, drug use, and stressors collected daily in real time via a cell-phone based application 
(APPENDIX G).   Using the smartphone’s GPS log, we will collect data on participants’ 
locations throughout the day to assess how changes in environment affect mood and activities.  
GMA overcomes the limitations of retrospective assessments, which may not adequately 
measure the dynamics of craving or accurately depict the relationships between craving and use 
(Tiffany & Wray, 2012; Kavanagh et al., 2013; Serre et al., 2015).   The GPS receiver chipsets 
have become ubiquitous in smartphones and, by combining GPS information with information 
on the strength of signals obtained from cellular data networks and wireless internet data 
connections (i.e., assisted GPS), smartphones can provide accurate location information more 
quickly than standalone GPS units and in cases where GPS signals are attenuated (e.g., indoors, 
in urban areas with many tall buildings) (Zandbergen, 2009; Zandbergen & Barbeau, 2011).  
 
These assessments will be evaluated on an ongoing basis by Drs. Preston and Phillips (sub-
investigators on the protocol), who are nationally recognized experts in the field of GMA as it 
relates to substance use-disorder and drug craving.   NIDA has been conducting GMA studies 
since 2005 and has collected data on over 850 study participants.  The results of their work have 
been published in high-quality journals; the first paper was published in 2009 in Archives of 
General Psychiatry (30-57). Recently NIDA used GMA to study the effects of clonidine on relapse 
to opioid use in patients receiving buprenorphine maintenance which was published in the 
American Journal of Psychiatry(42). 
 
This exploratory outcome will parallel hepatitis C treatment and PrEP and 
buprenorphine/methadone treatment as indicated, without impacting the above listed research 
assessments or study visit schedule. Using cell phones with active data plans provided free to 
enrolled subjects for one year, subjects will be queried by an GMA-specific application four 
times per day from Day 0 – Week 24 and one-time daily from Week 25-48 to complete an 
assessment of drug use, craving, stress, and other social and behavioral factors as an in-depth risk 
assessment (see Appendix G). Subjects will have training on use of the GMA application on Day 
0, and phones will be distributed. Subjects will then complete surveys on a daily basis and will 
return their cell phones at Week 48.  These prompts will take between 5 and 8 minutes on 
average to complete, and will be associated with weekly remuneration if completed regularly 
(see section 11).   Participants can briefly turn off the alerts if they are driving, showering, etc.  
Participants are otherwise instructed to respond, even if at work.  
 
For participants enrolled in GMA, at their ANCHOR visits they will complete an Adherence 
Packet-4 at baseline.  The Adherence packet-4 (APPENDIX I) consists of 4 questionnaires (total 
about 15 minutes) including: 
1. The Perceived Stress scale (PSS) (Cohen et al., 1983) is a 14-item measure of self-rated 
stress levels and coping ability over the past month.  Takes about 5 minutes (Appendix 
37).  

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2. HIV Knowledge Questionnaire (Carey & Schroder, 2002). The HIV Knowledge 
Questionnaire is an 18-item questionnaire used to assess knowledge of HIV transmission 
and protective behaviors. The HIV Knowledge Questionnaire shows good internal 
consistencies (Cronbach’s α=.75-.89) and reliability (r=.76-.94). It takes about 3 minutes 
to complete. 
3. HIV Attitudes Scale. The HIV Attitudes Scale is an 11-item questionnaire assessing 
attitudes and concerns about transmitting/contracting HIV. The questionnaire takes about 
3 minutes to complete.  
4. Food, Housing, and Health Security Questionnaire (FHHSQ). This is a condensed 8-
item questionnaire including 3 questions from the NHANES Food-Security 
Questionnaire (NHANES FSQ), 4 questions from the Housing-Security 
Questionnaire, and 1 question from the NHANES HIQ/HUQ. It takes about 2 minutes 
to complete.  
 
An Adherence Packet-2 (comprised of questionnaires 1-PSS, and 2-FHHSQ listed above) will be 
completed at weeks 4, 12, 24, and 48. 
 
6.7 
Early Termination Visit 
Participants who discontinue HCV treatment prior to treatment completion for medical or 
personal reasons will be given the option of being followed as per study schedule for risk 
assessments, lab monitoring, and ongoing optional PrEP and buprenorphine (if already initiated). 
Participants who discontinue PrEP or buprenorphine will continue to be monitored per the HCV 
study schedule, however will no longer have monitoring specific to PrEP or buprenorphine. The 
participant should have an end of treatment visit scheduled as soon as possible after all therapy is 
discontinued. The reason for any early termination will be documented.   
 
7 Potential Risks and Benefits 
7.1 
Potential Risks  
Given this investigation is centered on implementation of a novel model of care, the main risks are 
related to any blood draw outside of standard of care, and loss of confidential data.  
 
The potential risks include risks of phlebotomy that include: pain, bruising, fainting and very 
rarely, infection. These risks will be minimized by having trained staff perform the procedure.  
 
There is potential for loss of confidentiality, which will be minimized by providing privacy during 
study visits. In addition, all laboratory specimens, and research records will be coded by a number 
to maintain subject confidentiality. All paper records will be kept locked with limited access. 
Electronic data will be password protected and will not include participant names or contact 
details. 
 
Risks from smartphones and GMA. Carrying and using the smartphone could be annoying or 
embarrassing to the study participant.  The smartphone will be collecting personal 

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information and location, but this information will not be displayed on the phone and not 
linked to any of personal information/identifiers.  A PIN code is needed to access the 
smartphone and the specific application that is used to provide data.  Responses will 
regularly be transferred from the smartphone to secure password-protected computers 
located at the National Institute on Drug Abuse (NIDA), limiting the amount of information 
that is contained on the phone.  The data does not contain information that could be used to 
identify participants.  The data is transferred from phone to NIDA secure server.   
 
7.2 
  Potential Benefits 
Subjects may be cured of hepatitis C during the course of this study. Further, they may have 
decreased risk of HIV acquisition and may decrease or abstain from opioid misuse. They will 
contribute to the body of scientific research on treatment of hepatitis C and prevention of HIV in 
high-risk populations and therefore may confer long term benefits on other patients within their 
community. It is possible that subjects will receive no benefit from the study participation. 
 
8 Stored Samples and Future Research 
We will study the viral and host immunity to HCV and HIV in all patients. The results will be 
used to characterize each individual with regards to immune status and chronicity of disease. 
Studies on research samples may include the following: 
A] HCV genome sequencing may be performed on plasma using the protocol as described and 
compared for variability and relatedness of sequences. 
 
B] We will screen sera from all patients for differential expression of protein  using multiplex 
cytokine arrays, which has the capability of detecting several different cytokines and other 
biologically relevant proteins. 
 
C] We will perform detailed phenotypic and functional evaluation of immune cell types in the 
periphery. This will help us in determining the nature of antiviral immune responses in patients 
who are chronically infected, achieve SVR and acquire new HCV and HIV infections. 
Determination of specific immune defects in these individuals are important milestones in 
deciding future therapeutics and protective immunity to reinfection. Exhaustion and activation 
markers on T, B and NK cells will be quantified. Specific immune responses against pooled 
HCV peptides will be performed using an ELISPOT assay and/or  flow cytometry. 
 
Future use of the specimens will be based on the scientific merit of the investigation and would 
be decided by the Principal Investigator. They would be related to the study of HCV and/or HIV. 
Other investigators may wish to study these samples and/or data.  In that case, IRB approval 
must be sought prior to any sharing of samples and/or data.  Any clinical information shared 
about the sample would similarly require prior IRB approval. If approved, and once a Material 
Transfer Agreement (MTA) has been established, the study team may send de-identified samples 
to the collaborators. Investigators will use stored samples only for research.  
 
 

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8.1 
Intended Use:  
Some blood samples may be stored for future analysis in this research study. These samples will 
be stored by the IHV researchers and may be used in future research to learn more about HCV 
and HIV, the immune system and/or other related medical conditions. The blood will be used 
over time to gain a better understanding of the pathogenesis of HCV and HIV.  Genetic testing 
will be performed. Different analytical and laboratory methods will be employed including but 
not limited to: PCR, ELISA, ELISPOT and immunohistochemistry; RNA/DNA, cytokine and 
antibody quantitation; viral particle detection and identification of genetic markers. The consent 
will include language for specimen storage. 
8.2 
Storage:   
Samples will be kept in secure facilities with limited access. Samples and data will be stored 
using a unique identifier.  Only investigators and study staff will have access to the samples and 
data.  
 
GMA Data  - Electronic data will be stored on secure password-protected computers.   
UMB has an executed Collaboration Agreement dated 5/1/18 with the National Institute on Drug 
Abuse (NIDA), National Institutes of Health (NIH) and will share some data as specified in the 
agreement with our scientific research partners at NIH. There will be no particiant identifiers in 
the shared data.   
 
8.3 
Tracking:   
Extra blood samples will be stored using a unique identifier that only the study team can trace 
back to the participants. These stored samples as well as a linkage file will be maintained in a 
database that will be managed by the Investigators and/or Study Coordinators and will be 
maintained on the IHV server. This database will also be stored on the password-protected 
computer of the Lead-Investigator/Study Coordinator in an encrypted and/or password-coded 
file. 
8.4 
Disposition at the Completion of the Protocol:  
At the completion of the protocol (termination), samples and data will either be destroyed, or 
after IRB approval, transferred to another existing protocol. Final disposition of any samples 
cannot be done without written permission from the PI. 
8.5 
Reporting the Loss or Destruction of Samples/Specimens/Data to 
the IRB: 
 
o Any loss or unanticipated destruction of samples or data resulting in a violation that 
compromises the scientific integrity of the data collected for the study will be 
reported to the IRB.  
o Participants may request at any point not to have their samples stored. In this case, the 
Principal Investigator will destroy all known remaining samples and report what was done to 

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both the participant and to the IRB. This decision will not affect the subject’s participation in 
any other protocols.  
 
Generally, the results from the research stored samples will not be given to the participant's 
primary care provider or appear in the medical record. This is because the test results, unlike 
routine medical testing, may be experimental or preliminary. The relevance of these tests to 
direct patient care may be unknown. At the participant's request, the results of any research tests 
will be discussed with the primary care physician by the Investigators. 
 
9 Assessment of Safety  
As this is an observational study involving standard of card treatment, with interventions limited 
to non-standard fo care blooddraws and epidemiologic information collection, safety issues are 
not expected.  Only those reportable Adverse Events (AEs) related to the research procedures 
will be reported. The PI will review the safety data and report any unexpected events to the IRB 
along with annual continuing review  
 
9.1 
Recording/Documentation 
At each contact with the patient, information regarding adverse or unexpected events related to 
research procedures will be elicited by appropriate questioning and examinations and will be 
immediately recorded on a source document.  Source documents will include: progress notes, 
laboratory reports and data collection tools. Source documents will be reviewed in a timely 
manner by the research team. 
9.2 
Definitions 
Adverse Event: Any untoward medical occurrence in a human subject, including any abnormal 
sign, symptom, or disease, temporally associated with the subject’s participation in research, 
whether or not considered related to the subject’s participation in the research.   
 
Protocol Deviation: Any change, divergence, or departure from the IRB approved study 
procedures in a research protocol. Protocol deviations are designated as serious or non-
serious and further characterized as: 
• Those that occur because a member of the research team deviates from the protocol. 
• Those that are identified before they occur, but cannot be prevented. 
• Those that are discovered after they occur 
9.3 
Reporting Protocol deviations, AEs and Deaths 
Anticipated deviations in the conduct of the protocol will not be reported to the IRB unless they 
occur at a rate greater than anticipated by the study team. Expected adverse events will not be 
reported to the IRB unless they occur at a rate greater than that known to occur in those having 
phlebotomy procedures normally. If the rate of these events exceeds the rate expected by the 
study team, the events will be classified and reported. Deaths related to the natural history of 
hepatitis will be reported at the time of continuing review (see annual reporting to the IRB).  

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9.3.1 Expedited Reporting to the IRB 
Any reportable new information (RNI) will be reported to the IRB within 5 business days. 
This includes: 
1) Information that indicates a new or increased risk, or a safety issue. 
2) Any harm experienced by a subject or other individual, which in the opinion of 
the investigator are unexpected and probably related to the research 
procedures. 
3) Non-compliance with the federal regulations governing human research or 
with the requirements or determinations of the IRB, or an allegation of such 
non-compliance.  
4) Failure to follow the procedure due to the action or inaction of the investigator 
or research staff.  
5) Breach of confidentiality. 
6) Change to the protocol taken without prior IRB review to eliminate an 
apparently immediate hazard to a subject.  
7) Incarceration of a subject in a study not approved by the IRB to involve 
prisoners.  
8) Complaint of a subject that cannot be resolved by the research team.  
9) Premature suspension or termination of the research by the sponsor or the 
investigator.   
10) Audit, inspection, or inquiry by a federal agency.  
11) Written reports of study monitors.  
 
9.3.2 Waiver of Reporting Anticipated Protocol Deviations, Expected non-
UP AEs and Deaths   
Deviations in the protocol that do not rise to the level of serious or continuing non-compliance, 
and unanticipated or adverse events that are NOT serious, unexpected AND related to research 
protocols need not be reported in an expedited manner to the IRB.  Rather, such RNI should be 
reported as a group at the time of annual renewal (see below). 
 
9.4 
Annual Reporting to the IRB 
The following items will be reported to the University of Maryland IRB in summary at the time 
of Continuing Review: 
• Serious adverse events or deaths that are not related to the research 
• All adverse events associated with research including expected AEs Protocol 
deviations.  This includes AEs related to phlebotomy within 48 hours of procedure. 
• Serious, continuing, and minor non-compliance 
• Any trends or events which in the opinion of the investigator should be reported 
• Any study particpants incarcerated while on active HCV treatment that were 
provided their remaining HCV medications in the jail/prison 
9.4.1 Type and Duration of the Follow-up of Subject after Adverse Events 

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All SAEs and non-serious AEs identified in this study will be followed until resolution or until 
the PI judges the AE/SAE has stabilized and no more follow-up is required.  This requirement 
indicates that the follow-up may be required for some events after the participant discontinues 
participation from the study.  These events will be reported to the IRB annually. 
10  
Withdrawal of a Subject 
A participant may withdraw from the study at any time.  As part of their duties to ensure that 
research participants are protected, the IRB, IHV, or other government agencies may discontinue 
the study at any time. Voluntary withdrawal from the protocol may occur at any time at the request 
of either the participant or the PI.  If a request is made to withdraw from the protocol, all further 
planned study procedures will be immediately cancelled and further follow-up will be terminated. 
Samples and data collected already collected may be used. 
 
If a patient becomes pregnant during the course of the study, the patient will be discontinued 
from the study.  
10.1 Return of Withdrawn/Removed Subjects 
A participant who has withdrawn may not return to the study. 
11 Remuneration Plan for Subjects  
Participants will not be renumerated for receiving HCV treatment.  
 
Participants will not be renumerated for standard of care PrEP or buprenorphine.  
 
Participants will receive $25 remuneration as gift cards at those visits where HIV risk assessment 
and stored sample blood draws are completed.   Those 7 visits are Screening, Week 4, Week 12, 
Week 24, Week 48, Week 72 and  Week 96 only.  For adherence visits for PrEP which DO NOT 
coincide with HIV risk assessment or stored sample visits, participants will receive $25 
reumeration as gift cards for those visits.  This would be a maximum of 6 additional visits at 
$25/visit.  We will encourage combined visits. 
 
Participants who choose to enroll in the GMA will be renumerated as follows: 
 
Compensation for 
GMA data 
collection  
A)  Weeks 1-24 
Participants can receive a total of $480 between 
weeks 1-24 for answering random daily prompts 
based on how many prompts they answer in each 
week:  
Answering 1-7 prompts/week = $5 
Answering 8-14 prompts/week = $10 
Answering 15-21 prompts/week = $15 
Answering 22-28 prompts/week = $20 
 
B) Weeks 25-48 
Up to $920.00 

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Participants can receive a total of $240 between 
weeks 25-48 for answering random daily prompts 
based on how many prompts they answer each week:   
Answering 1-3 prompts/week = $5 
Answering 4-7 prompts/week = $10 
 
C) End of Study Week 48 
Participants can receive up to $200 for returning the 
smartphone in working condition at Week 48, to be 
pro-rated by week for those participants who do not 
complete 48 weeks of the study, 
 
 
 
 
12 Monitoring 
As this is an observational study with intervention limited to blood and epidemiologic data 
collection, safety issues are not expected.  PI and the study team will conduct regular 
monitoring of safety on a weekly basis and report to the IRB as specified in section 9.  
 
13 Statistical Considerations 
13.1 Description of the Analyses 
The primary outcome is achievement of SVR12 in phase 1 (first 100 enrolled participants). The 
primary analysis of efficacy for phase 1 is intention-to-treat for the proportion of patients who 
achieve SVR along with exact two-sided 95% confidence intervals, overall and by sub-
categories. All patients who receive at least one dose of direct acting antiviral are included in the 
intention-to-treat analysis and patients without follow-up data are considered to have treatment 
failure. Chi-squared or Fisher’s exact text will be used to assess the association of SVR12 with 
baseline characteritics such as HIV-status, as well as on treatment factors such as medication 
adherence and OST status. Percentage and standard error will be calculated for each of the 
secondary outcome of PrEP and buprenorphine including uptake, adherence, and retention. In 
phase 2, participants without recent IDU (opioid misuse within 1 year but not within 3 months) 
will be compared to patients with recent IDU, and the impact of collocated OST vs non-
collocated OST will be assessed.  
13.2 Sample Size Justification 
Based on the available DAA drugs, we expect to be able to treat up to 200 patients for HCV, 
with primary efficacy analysis after the first 100 enrolled participants  (phase 1). The SVR of the 
general US population for HCV-infected and non-injection drug users is estimated at >90%. We 
target in our population of injection-drug users no greater than a ± 10% SVR difference from the 
standard 90% SVR. For the primary objective, we will have 85% power to reject the null 
hypothesis if the actual proportion of patients with SVR is 80% or higher at a 2-sided, a=0.05 
significance level.  

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14 Ethics/Protection of Human Subjects 
14.1 Informed Consent Process 
Informed consent is a process where information is presented to enable persons to 
voluntarily decide whether or not to participate as a research subject. It is an on-going 
conversation between the human research subject and the researchers, which begins 
before consent is given and continues until the end of the subject's involvement in the 
research. Discussions about the research will provide essential information about the 
study and include: purpose, duration, procedures, alternatives, risks and benefits.  
Subjects will be given the opportunity to ask questions and have them answered.  
The subjects will personally sign and date the informed consent document prior to 
undergoing any research procedures. The subjects may withdraw consent at any time 
throughout the course of the trial.  A copy of the informed consent document will be 
given to the subjects for their records. Consenting process will be documented in the 
record. The rights and welfare of the subjects will be protected by emphasizing to them 
that the quality of their medical care will not be adversely affected if they decline to 
participate in this study.  
14.2 Illiteracy and Consenting 
As the majority of the patient populations from which the study participants are drawn are 
literate, written consent will be obtained. Per UMB IRB policy, for participants unable to 
read, the written informed consent and any other written information will be read and 
explained to the participant by the person obtaining consent. An impartial third party will 
be present for the entire consent process.  Once the subject has orally consented, the 
participant and witness will sign the consent form.  
14.3 Subject Confidentiality 
All records will be kept confidential to the extent provided by federal, state and local law. 
The study monitors and other authorized representatives of the Sponsor may inspect all 
documents and records required to be maintained by the Investigator, including but not 
limited to, medical records. Records will be kept locked and all computer entry and 
networking programs will be done with coded numbers only.  Clinical information will 
not be released without written permission of the subject, except as necessary for 
monitoring by IRB, FDA, the Joint Commission or the HHRP. 
 

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APPENDIX A: Scientific References 
 
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Patients Infected With Hepatitis C Virus: A Systematic Review and Meta-analysis of the 
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5. Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, et al. Ledipasvir and 
sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 
2014;370(16):1483-93. 
6. Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, et al. Ledipasvir and 
sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370(20):1889-
98. 
7. Cousien A, Tran VC, Deuffic-Burban S, Jauffret-Roustide M, Dhersin JS, Yazdanpanah 
Y. Hepatitis c treatment as prevention of viral transmission and liver-related morbidity in 
persons who inject drugs. Hepatology. 2015. 
8. 2013;Pageshttp://www.cdc.gov/hepatitis/statistics/index.htm on 8/27 2015. 
9. Control CfD, Prevention. Notes from the field: risk factors for hepatitis C virus infections 
among young adults--Massachusetts, 2010. MMWR. Morbidity and mortality weekly 
report. 2011;60(42):1457. 
10. Control CfD, Prevention. Sexual transmission of hepatitis C virus among HIV-infected 
men who have sex with men--New York City, 2005-2010. MMWR. Morbidity and 
mortality weekly report. 2011;60(28):945. 
11. Denniston MM, Klevens RM, McQuillan GM, Jiles RB. Awareness of infection, 
knowledge of hepatitis C, and medical follow-up among individuals testing positive for 
hepatitis C: National Health and Nutrition Examination Survey 2001-2008. Hepatology. 
2012;55(6):1652-61. 
12. Degenhardt L, Mathers B, Vickerman P, Rhodes T, Latkin C, Hickman M. Prevention of 
HIV infection for people who inject drugs: why individual, structural, and combination 
approaches are needed. Lancet. 2010;376(9737):285-301. 
13. Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, et 
al. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, 
Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled 
phase 3 trial. Lancet. 2013;381(9883):2083-90. 
14. Sullivan LE, Fiellin DA. Buprenorphine: its role in preventing HIV transmission and 
improving the care of HIV-infected patients with opioid dependence. Clin Infect Dis. 
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15. Edlin BR, Seal KH, Lorvick J, Kral AH, Ciccarone DH, Moore LD, et al. Is it justifiable 
to withhold treatment for hepatitis C from illicit-drug users? N Engl J Med. 
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16. Salvalaggio G ea. Patient-Provider Rapport in the Health Care of People Who Inject 
Drugs. SAGE Open 2013:1-13. 
17. 1Carrieri PM, Michel L, Lions C, Cohen J, Vray M, Mora M, et al. Methadone induction 
in primary care for opioid dependence: a pragmatic randomized trial (ANRS Methaville). 
PLoS One. 2014;9(11):e112328. 
18. Wittchen HU, Apelt SM, Soyka M, Gastpar M, Backmund M, Golz J, et al. Feasibility 
and outcome of substitution treatment of heroin-dependent patients in specialized 
substitution centers and primary care facilities in Germany: a naturalistic study in 2694 
patients. Drug Alcohol Depend. 2008;95(3):245-57. 
19. Wall TL ea. Adherence to zidovudine (AZT) among HIV-infected methadone patients: a 
pilot study of supervised therapy and dispensing compared to usual care. . Drug Alcohol 
Depend. 1995;37:261-9. 
20. Selwyn PA ea. Utilization of onsite primary care services by HIV-seropositive and 
seronegative drug users in a methadone maintenance program. Public Health Rep 
1993;108:492-500. 
21. McCance-Katz EF, Gourevitch MN, Arnsten J, Sarlo J, Rainey P, Jatlow P. Modified 
directly observed therapy (MDOT) for injection drug users with HIV disease. Am J 
Addict. 2002;11(4):271-8. 
22. Moatti JP, Carrieri MP, Spire B, Gastaut JA, Cassuto JP, Moreau J. Adherence to 
HAART in French HIV-infected injecting drug users: the contribution of buprenorphine 
drug maintenance treatment. The Manif 2000 study group. AIDS. 2000;14(2):151-5. 
23. Grebely J, Genoway KA, Raffa JD, Dhadwal G, Rajan T, Showler G, et al. Barriers 
associated with the treatment of hepatitis C virus infection among illicit drug users. Drug 
Alcohol Depend. 2008;93(1-2):141-7. 
24. Doab A, Treloar C, Dore GJ. Knowledge and attitudes about treatment for hepatitis C 
virus infection and barriers to treatment among current injection drug users in Australia. 
Clin Infect Dis. 2005;40 Suppl 5:S313-20. 
25. Stein MD, Maksad J, Clarke J. Hepatitis C disease among injection drug users: 
knowledge, perceived risk and willingness to receive treatment. Drug Alcohol Depend. 
2001;61(3):211-5. 
26. Strathdee SA, Latka M, Campbell J, O'Driscoll PT, Golub ET, Kapadia F, et al. Factors 
associated with interest in initiating treatment for hepatitis C Virus (HCV) infection 
among young HCV-infected injection drug users. Clin Infect Dis. 2005;40 Suppl 5:S304-
12. 
27. Dore GJ ea. Elbasvir–Grazoprevir to Treat Hepatitis C Virus Infection in Persons 
Receiving Opioid Agonist Therapy. Ann Intern Med. 2016;Epub ahead of print  
28. Dore G GJ, Altice F, et al. C-EDGE CO-STAR: Adherence and Drug Use in HCV-
Infected Persons who Inject Drugs (PWID) on Opioid Agonist Therapy (OAT) Receiving 
Grazoprevir + Elbasvir (GZR/EBR) Fixed Dose Combination (FDC) for 12 Weeks. 4th 
International Symposium on Hepatitis Care in Substance Users, 2015. Sydney, Australia. 
29. Darke S, Hall W, Heather N, Ward J, Wodak A. The reliability and validity of a scale to 
measure HIV risk-taking behaviour among intravenous drug users. AIDS. 1991;5(2):181-
5. 

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30. Moran, L., Epstein, D.H., Preston, K.L. Sex differences in daily life stress and craving in 
drug-dependent patients. American Journal of Drug and Alcohol Abuse, 2018 Apr 11:1-
12. doi: 10.1080/00952990.2018.1454934. [Epub ahead of print] 
31. Kowalczyk, W.J., Moran, L.M., Bertz, J.W., Phillips, K.A., Ghitza, U.E., Epstein, D.H., 
Preston, K.L. Using ecological momentary assessment to examine the relationship 
between craving and affect with opioid use in a clinical trial of clonidine as an adjunct 
medication to buprenorphine treatment. American Journal of Drug and Alcohol Abuse, 
2018 Apr 10:1-10. doi: 10.1080/00952990.2018.1454933. [Epub ahead of print] 
32. Bertz, J.W., Epstein, D.H., Preston, K.L. Combining ecological momentary assessment 
with objective, ambulatory measures of behavior and physiology in substance-use 
research. Addictive Behaviors, 2017 Nov 16. pii: S0306-4603(17)30409-4. doi: 
10.1016/j.addbeh.2017.11.027. [Epub ahead of print] 
33. Preston, K.L., Kowalczyk, W.J., Phillips, K.A., Vahabzadeh, M., Lin, J.-L., Mezghanni, 
M., Epstein, D.H. Exacerbated craving in the presence of stress and drug cues in drug-
dependent patients. Neuropsychopharmacology, 43(4): 859-867, 2018.  
34. Kowalczyk, W., Bertz, J.W., Moran, L.M., Phillips, K.A., Ghitza, U., Epstein, D.H., 
Preston, K.L. Reducing the cost of free time: Clonidine increases the likelihood that 
abstinence can withstand unstructured time in buprenorphine-maintained outpatients. 
Journal of Addiction Medicine, 11(6):454-460. 
35. Preston, K.L., Kowalczyk, W.J., Phillips, K.A., Jobes, M.L., Vahabzadeh, M., Lin, J.-L., 
Mezghanni, M., Epstein, D.H. Context and craving during stressful events in the daily 
lives of drug-dependent patients. Psychopharmacology (Berl), 234:2631-2642. 2017 Jun 
8. doi: 10.1007/s00213-017-4663-0. 
36. Moran, L., Phillips, K.A., Kowalczyk, W.J., Ghitza, U.E., Agage, D.A., Epstein, D.H., 
Preston, K.L.  Aripiprazole for cocaine abstinence: a randomized controlled trial with 
ecological momentary assessment. Behavioural Pharmacology, 28:63-73, 2017 [Epub 
ahead of print]. 
37. Preston, K.L., Jobes, M.L., Phillips, K.A., Epstein E.H. Real-time assessment of alcohol 
drinking and drug use in opioid-dependent polydrug users. Behavioural Pharmacology, 
27: 579-584, 2016. 
38. Sarker, H., Tyburski, M., Rahman, M.M., Hovsepian K., Sharmin, M., Epstein, D., 
Preston, K.L., Furr-Holden C.D., Milam, A., Nahum-Shani, I., al'Absi, M., Kumar, S. 
Finding significant stress episodes in a discontinuous time-series of rapidly varying 
mobile sensor data. Proceedings of the 2016 CHI Conference on Human Factors in 
Computing Systems, 4489-4501, 2016, ACM, New York. 
39. Willner-Reid, J., Whitaker, D., Epstein, D.H., Phillips, K.A., Pulaski, A., Preston, K.L., 
Willner, P. Cognitive-behavioral therapy for heroin and cocaine use: ecological 
momentary assessment of homework simplification and compliance. Psychology and 
Psychotherapy: Theory, Research and Practice, 2015 Nov 4. doi: 10.1111/papt.12080. 
40. Sharmin, M., Raij, A., Epstein, D.H., Nahum-Shani, I., Beck, G., Vhaduri, S., Preston, K.L., 
Kumar, S. Visualization of time-series sensor data to inform the design of just-in-time adaptive 
stress interventions. 2015 ACM International Joint Conference on Pervasive and Ubiquitous 
Computing (UbiComp 2015), Osaka, Japan, 2015. 
41. Furnari, M., Epstein, D.H., Phillips, K.A., Jobes, M.L., Kowalczyk, W., Vahabzadeh, M., Lin, J.-
L., Preston, K.L. Some of the people, some of the time: Field evidence for associations and 
dissociations between stress and drug use. Psychopharmacology, 232, 3529-3537, 2015, DOI: 
10.1007/s00213-015-3998-7. 

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42. Kowalczyk, W., Phillips, K.A., Jobes, M.L., Kennedy, A.P., Ghitza, U., Agage, D., Schmittner, 
J.P., Epstein, D.H., Preston, K.L. Clonidine increases the length of opiate abstinence and time to 
lapse during buprenorphine maintenance: a randomized controlled trial. American Journal of 
Psychiatry, 2015, 172(8):760-7. doi: 10.1176/appi.ajp.2014.14081014. 
43. Kennedy, A., Epstein, D.H., Jobes, M.L., Agage, D., Tyburski, M., Phillips, K.A., Ertin, E., Ali, 
A.A., Bari, R., Hossain, S.M., Hovsepian, K., Rahman, M.M., Kumar, S., Preston, K.L.  
Continuous in-the-field measurement of physiological correlates of drug use, craving, stress, and 
mood in opioid/cocaine users. Drug and Alcohol Dependence, 151:159-66, 2015. doi: 
10.1016/j.drugalcdep.2015.03.024.  
44. Rahman, M.M., Bari, R., Ali, A.A., Sharmin, M., Raij, A., Hovsepian, K., Hossain, S.M, Ertin, 
E., Kennedy, A., Epstein, D., Preston, K., Jobes, M., Kedia, S., Ward, W., al’Absi, M., Kumar, S. 
Are we there yet? Feasibility of continuous stress assessment via physiological sensors in field. 
Proc. ACM Conference on Bioinformatics, Computational Biology and Health Informatics, 
Newport Beach, CA, pp. 479-488, 2014. 
45. Phillips, K.A., Epstein, D.H., Vahabzadeh, M., Mezghanni, M., Lin, J.-L., Preston, K.L.  
Substance use and hepatitis C – an Ecological Momentary Assessment study. Health Psychology, 
2014 Jul;33(7):710-9. doi: 10.1037/hea0000087. 
46. Hossain, S.M., Ali, A.A., Rahman, M.M., Ertin, E., Epstein, D., Kennedy, A., Preston, K., 
Umbricht, A., Chen, Y., Kumar, S. Identifying drug (cocaine) intake events from acute 
physiological response in the presence of free-living physical activity. Proc. ACM/IEEE 
International Conference on Information Processing in Sensor Networks (IPSN), Berlin, 
Germany, 2014, pp. 71-82. 
47. Epstein, D.H., Tyburski, M., Craig, I.M., Phillips, K.A., Jobes, M.L., Vahabzadeh, M., 
Mezghanni, M., Lin, J.-L., Fur-Holden, C.D.M., Preston, K.L. Real-time tracking of 
neighborhood surroundings and mood in urban drug misusers: application of a new method to 
study behavior in its geographical context. Drug and Alcohol Dependence, 134; 22–29, 2014. 
48. Kennedy, A., Epstein, D.H., Phillips, K.A., Preston, K.L.  Sex differences in cocaine/heroin 
users: drug-use triggers and craving in daily life. Drug and Alcohol Dependence, 132(1-2): 29-37, 
2013.  
49. Phillips, K.A., Epstein, D.H., Preston, K.L. Daily temporal patterns of heroin and cocaine use and 
craving: relationship with business hours regardless of actual employment status addictive 
behaviors. Addictive Behaviors, 38(10):2485-2491, 2013.  
50. Phillips, K.A., Epstein, D.H., Mezghanni, M., Vahabzadeh, M., Reamer, D., Agage, D., Preston, 
K.L. Smartphone-delivery of Mobile HIV Risk Reduction Education. AIDS Research and 
Treatment, 2013; Article ID 231956; 9 pages. doi: 10.1155/2013/231956. Epub 2013 Sep 17. 
51. Epstein, D.H., Preston, K.L. TGI Monday?: drug-dependent outpatients report lower stress and 
more happiness at work than elsewhere. American Journal on Addictions, 21(3):189-98, 2012. 
52. Preston, K.L., Epstein, D.H. Stress in the daily lives of cocaine and heroin users: Relationship to 
mood, craving, relapse triggers, and cocaine use. Psychopharmacology, 218(1):29-37, 2011 [Feb 
12, 2011 Epub ahead of print].  
53. Vahabzadeh, M., Mezghanni, M., Lin, J.-L., Epstein, D.H., Preston, K.L.  PGIS: Electronic diary 
data integration with GPS data— initial application in substance-abuse patients. Computer-Based 
Medical Systems (CBMS), 2010 IEEE 23rd International Symposium on, vol., no., pp.474-479, 
12-15 Oct. 2010 doi: 10.1109/CBMS.2010.6042691 
URL: http://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=6042691&isnumber=6042608.  
54. Epstein, D.H., Marrone, G.F., Heishman, S.J., Schmittner, J.P., Preston, K.L. Cocaine and 
tobacco: Craving and use during daily life. Addictive Behaviors, 35, 318-324, 2010 [2009 Nov 12 
Epub ahead of print]. 
55. Epstein, D.H., Preston K.L.  Daily life hour by hour, with and without cocaine: an ecological 
momentary assessment study. Psychopharmacology, 211, 223-232, 2010.  Epub 2010 June 9. 

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56. Vahabzadeh, M., Lin, J.-L., Mezghanni, M., Epstein, D.H., Preston, K.L. Automation in an 
addiction treatment research clinic:  Computerized contingency management, ecological 
momentary assessment, and a protocol workflow system.  Drug and Alcohol Review, 28(1), 3-11, 
2009. 
57. Epstein, D.H., Willner-Reid, J., Vahabzadeh, M., Mezghanni, M., Lin, J.-L., Preston, K.L.  Real-
time electronic-diary reports of cue exposure and mood in the hours before drug craving and use.  
Archives of General Psychiatry, 66, 88-94, 2009. 
 

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APPENDIX B: Study Schedule 
 
 
 
 
 
M1 
M2 
M3 
M6 
M9 
M12 
M18 
M24 
HCV Treatment 
Screening 
Day 0 
Week 2 
Week 3 
Week 4 
Week 8 
Week 12 
Week 24 
Week 36 
Week 48 
Week 72 
Week 96 
MD Visit 
X 
X* 
 
 
X* 
X* 
X* 
X* 
 
 
 
 
HCV SOC Labwork 
X 
 
 
 
X 
 
X 
X 
 
 
 
 
HCV RNA 
X 
 
 
 
X 
 
X 
X 
 
X 
X 
X 
HCV Adherence 
 
 
X 
 
X 
X 
X 
 
 
 
 
 
Stored Samples 
X 
 
 
 
X 
 
X 
X 
 
X 
 
X 
Fibroscan  
X 
 
 
 
 
 
 
X 
 
X 
 
X 
PrEP Retrospective 
Questionnaire 
 
 
 
 
 
 
 
 
 
X 
X 
X 
PrEP** 
 
Day P0 
 
 
Week P4 
 
Week P12 
Week P24 
Week P36 
Week P48 
 
 
MD Visit 
 
X 
 
 
X 
 
X 
X 
X 
X 
 
 
Adherence 
 
 
 
 
X 
 
X 
X 
X 
X 
 
 
Labwork 
 
X 
 
 
X 
 
X 
X 
X 
X 
 
 
Buprenorphine*** 
 
Day B0 
Week B2 
 
Week B4 
Week B8 
Week B12 
Week B24 
Week B36 
Week B48 
 
 
MD Visit 
 
X 
X 
 
X 
X 
X 
X 
X 
X 
 
 
Urine Buprenorphine 
 
 
X 
 
X 
X 
X 
X 
X 
X 
 
 
Assess Retention  
 
 
X 
 
X 
X 
X 
X 
X 
X 
 
 
Risk Monitoring 
Screening 
Day 0 
Week 2 
Week 3 
Week 4 
Week 8 
Week 12 
Week 24 
Week 36 
Week 48 
Week 72 
Week 96 
Epidemiologic Survey 
X 
 
 
 
 
 
 
 
 
 
 
 
HCV PRO  
X 
 
 
 
 
 
X 
X 
 
 
 
 
HIV Risk/SEP 
Assessment  
 
X 
 
 
X 
 
X 
X 
 
X 
X 
X 

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Urine Drug Screen 
X 
 
 
 
X 
 
X 
X 
 
X 
X 
X 
HIV 4th gen 
X 
 
 
 
X 
 
X 
X 
 
X 
X 
X 
AUDIT-C 
X 
 
 
 
 
 
 
X 
 
X 
 
X 
ACE 
 
 
 
 
 
 
 
X 
 
 
 
 
GMA 
Assessment**** 
 
 
 
 
 
 
 
 
 
 
 
 
GMA Training and 
Cell Distribution 
 
X 
 
 
 
 
 
 
 
 
 
 
Adheence Packet -4 
 
X 
 
 
 
 
 
 
 
 
 
 
Adherence Packet-2 
 
 
 
 
X 
 
X 
X 
 
X 
 
 
Return Cell Phone 
 
 
 
 
 
 
 
 
 
X 
 
 
 
*Study participants will be offered PrEP and buprenorphine at every MD visit if have not currently uptaking 
**PrEP uptake is optional. Day P0 can be on any day from Day 0 to Week 24 of HCV treatment.  
***Buprenorphine uptake is optional. Day B0 can be on any day from Day 0 to Week 24 of HCV treatment.  
****GMA participation is optional.  
 
 
 
 

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Appendix C:  Epidemiologial Suvrey (IDU in last 3 months) 
 
 
 

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Appendix D:  HIV Risk Assessment 
 
 
 
 

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Appendix E:  AUDIT-C  
 
 

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Appendix F: HCV Patient Reported Outcomes Survey 
 
 

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Appendix G: Geographic Momentary Assessment (GMA) Daily Phone Surveys  
 
 
 
 

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Appendix H: Adverse Childhood Experiences (ACE) Questionairre 
 
 

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Appendix I: GMA Adherence Packet 5  
 
 

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Appendix J: Epidemiology Survey (Non-IDU with last 3 months)  
 
 
 

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Appendix K: PrEP Retrospective Questionnaire