Accessible Care Intervention for Engaging People Who Inject Illicit Drugs in HCV Care
Phase: NA
Conditions: Hepatitis C, People Who Inject Drugs, PWID, HCV Coinfection
Sponsor: City University of New York, School of Public Health

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Tool!Revision!History:!
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Version!Number!
Version!Date!
Summary!of!Revisions!Made!
FINAL!
16!April!2021!
FINAL!version!
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ACCESSIBLE!CARE!INTERVENTION!FOR!ENGAGING!PEOPLE!WHO!
INJECT!DRUGS!(PWID)!IN!HEPATITIS!C!CARE!
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Principal!Investigator:!
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Benjamin!Eckhardt!
Department!of!Medicine!–!Division!of!Infectious!Diseases!
462!1st!Ave.,!NBV16SJ5,!New!York,!NY!10016!
Benjamin.eckhardt@nyumc.org!
347J237J6490!
Additional!Investigators:!
!
Kristen!Marks!(CoJPI)!
Weill!Medical!College!of!Cornell!University!–!Department!of!
Medicine!
1300!York!Avenue,!4th!Floor,!New!York,!NY!10021!
markskr@med.cornell.edu!
212J746J7602!
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Pedro!MateuJGelabert!(CoJPI)!
CUNY!School!of!Public!Health!
Pedro.MateuJGelabert@sph.cuny.edu!
NYULMC!Study!Number:!
i17J00811!!
Funding!Sponsor:!!
CUNY!School!of!Public!Health!
IND/IDE!Number:!!
N/A!
Regulatory!Sponsor:!!
N/A!
Study!Product:!
N/A!
Study!Product!Provider:!!
N/A!
ClinicalTrials.gov!
Number!!!!!!!!!!!!!!!!!
NCT03214679!
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Initial!version:! 4.26.17!
Amended:!
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Amended:!
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Study!number:!17J00811!
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Statement!of!Compliance!
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This!study!will!be!conducted!in!accordance!with!the!Code!of!Federal!Regulations!on!the!Protection!of!
Human!Subjects!(45!CFR!Part!46),!21!CFR!Parts!50,!56,!312,!and!812!as!applicable,!any!other!applicable!
US!government!research!regulations,!and!institutional!research!policies!and!procedures.!The!International!
Conference!on!Harmonisation!(“ICH”)!Guideline!for!Good!Clinical!Practice!(“GCP”)!(sometimes!referred!to!
as!“ICHJGCP”!or!“E6”)!will!be!applied!only!to!the!extent!that!it!is!compatible!with!FDA!and!DHHS!regulations.!
The!Principal!Investigator!will!assure!that!no!deviation!from,!or!changes!to!the!protocol!will!take!place!
without!prior!agreement!from!the!sponsor!and!documented!approval!from!the!Institutional!Review!Board!
(IRB),!except!where!necessary!to!eliminate!an!immediate!hazard(s)!to!the!trial!participants.!All!personnel!
involved!in!the!conduct!of!this!study!have!completed!Human!Subjects!Protection!Training.!
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Table!of!Contents!
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STATEMENT!OF!COMPLIANCE!...............................................................................................................!III!
LIST!OF!ABBREVIATIONS!......................................................................................................................!VII!
PROTOCOL!SUMMARY!..............................................................................................................................!1!
SCHEMATIC!OF!STUDY!DESIGN!..............................................................................................................!3!
1!
KEY!ROLES!........................................................................................................................................!4!
2!
INTRODUCTION,!BACKGROUND!INFORMATION!AND!SCIENTIFIC!RATIONALE!.......................!5!
2.1!
BACKGROUND!INFORMATION!AND!RELEVANT!LITERATURE!...............................................................!5!
2.2!
NAME!AND!DESCRIPTION!OF!THE!INVESTIGATIONAL!AGENT!..............................................................!5!
2.2.1!
Preclinical!Data!.......................................................................................................................!5!
2.2.2!
Clinical!Data!to!Date!...............................................................................................................!5!
2.2.3!
Dose!Rationale!(if!applicable)!.................................................................................................!5!
2.3!
RATIONALE!...................................................................................................................................!6!
2.4!
POTENTIAL!RISKS!&!BENEFITS!.......................................................................................................!6!
2.4.1!
Known!Potential!Risks!............................................................................................................!6!
2.4.2!
Known!Potential!Benefits!........................................................................................................!6!
3!
OBJECTIVES!AND!PURPOSE!...........................................................................................................!6!
3.1!
PRIMARY!OBJECTIVE!.....................................................................................................................!6!
4!
STUDY!DESIGN!AND!ENDPOINTS!.......................................!ERROR!!BOOKMARK!NOT!DEFINED.!
4.1!
DESCRIPTION!OF!STUDY!DESIGN!....................................................................................................!7!
4.2!
STUDY!ENDPOINTS!........................................................................................................................!8!
4.2.1!
Primary!Study!Endpoints!........................................................................................................!8!
4.2.2!
Secondary!Study!Endpoints!...................................................................................................!9!
4.2.3!
Exploratory!Endpoints!.............................................................................................................!9!
5!
STUDY!ENROLLMENT!AND!WITHDRAWAL!....................................................................................!9!
5.1!
INCLUSION!CRITERIA!......................................................................................................................!9!
5.2!
EXCLUSION!CRITERIA!....................................................................................................................!9!
5.3!
VULNERABLE!POPULATIONS!...........................................................................................................!9!
5.4!
STRATEGIES!FOR!RECRUITMENT!AND!RETENTION!............................................................................!9!
5.5!
DURATION!OF!STUDY!PARTICIPATION!...........................................................................................!10!
5.6!
TOTAL!NUMBER!OF!PARTICIPANTS!AND!SITES!...............................................................................!10!
5.7!
PARTICIPANT!WITHDRAWAL!OR!TERMINATION!...............................................................................!10!
5.7.1!
Reasons!for!Withdrawal!or!Termination!...............................................................................!10!
5.7.2!
Handling!of!Participant!Withdrawals!or!Termination!.............................................................!10!
5.8!
PREMATURE!TERMINATION!OR!SUSPENSION!OF!STUDY!.................................................................!10!
6!
STUDY!AGENT!(STUDY!DRUG,!DEVICE,!BIOLOGIC,!VACCINE!ETC.)!AND/OR!PROCEDURAL!
INTERVENTION!.........................................................................................................................................!11!
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7!
STUDY!PROCEDURES!AND!SCHEDULE!.......................................................................................!11!
7.1!
STUDY!PROCEDURES/EVALUATIONS!.............................................................................................!11!
7.4!
CONCOMITANT!MEDICATIONS,!TREATMENTS,!AND!PROCEDURES!....................................................!13!
7.5!
JUSTIFICATION!FOR!SENSITIVE!PROCEDURES!................................................................................!13!
7.6!
PROHIBITED!MEDICATIONS,!TREATMENTS,!AND!PROCEDURES!........................................................!13!
7.7!
PROPHYLACTIC!MEDICATIONS,!TREATMENTS,!AND!PROCEDURES!...................................................!13!
7.8!
RESCUE!MEDICATIONS,!TREATMENTS,!AND!PROCEDURES!.............................................................!14!
7.9!
PARTICIPANT!ACCESS!TO!STUDY!AGENT!AT!STUDY!CLOSURE!........................................................!14!

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ASSESSMENT!OF!SAFETY!.............................................................................................................!14!
8.1!
SPECIFICATION!OF!SAFETY!PARAMETERS!.....................................................................................!14!
8.1.1!
Definition!of!Adverse!Events!(AE)!........................................................................................!14!
8.1.2!
Definition!of!Serious!Adverse!Events!(SAE)!.........................................................................!14!
8.1.3!
Definition!of!Unanticipated!Problems!(UP)!...........................................................................!14!
8.2!
CLASSIFICATION!OF!AN!ADVERSE!EVENT!.......................................................................................!15!
8.2.1!
Severity!of!Event!...................................................................................................................!15!
8.2.2!
Relationship!to!Study!Agent!.................................................................................................!15!
8.2.3!
Expectedness!.......................................................................................................................!16!
8.3!
TIME!PERIOD!AND!FREQUENCY!FOR!EVENT!ASSESSMENT!AND!FOLLOWJUP!....................................!16!
8.4!
REPORTING!PROCEDURES!–!NOTIFYING!THE!IRB!..........................................................................!17!
8.4.1!
Adverse!Event!Reporting!......................................................................................................!17!
8.9!
SAFETY!OVERSIGHT!....................................................................................................................!17!
9!
STATISTICAL!CONSIDERATIONS!..................................................................................................!19!
9.1!
STATISTICAL!AND!ANALYTICAL!PLANS!(SAP)!.................................................................................!19!
9.2!
STATISTICAL!HYPOTHESES!...........................................................................................................!19!
9.3!
ANALYSIS!DATASETS!...................................................................................................................!21!
9.5!
SAMPLE!SIZE!..............................................................................................................................!21!
9.6!
MEASURES!TO!MINIMIZE!BIAS!......................................................................................................!21!
9.6.1!
Enrollment/Randomization/Masking!Procedures!..............................................................!21!
9.6.2!
Evaluation!of!Success!of!Blinding!....................................................................................!21!
9.6.3!
Breaking!the!Study!Blind/Participant!Code!.......................................................................!21!
10!
SOURCE!DOCUMENTS!AND!ACCESS!TO!SOURCE!DATA/DOCUMENTS!.................................!21!
11!
ETHICS/PROTECTION!OF!HUMAN!SUBJECTS!............................................................................!21!
11.1!
ETHICAL!STANDARD!....................................................................................................................!22!
11.2!
INSTITUTIONAL!REVIEW!BOARD!....................................................................................................!22!
11.3!
INFORMED!CONSENT!PROCESS!....................................................................................................!22!
11.3.1!
Consent/Assent!and!Other!Informational!Documents!Provided!to!Participants!...............!22!
11.3.2!
Consent!Procedures!and!Documentation!.........................................................................!22!
11.4!
PARTICIPANT!AND!DATA!CONFIDENTIALITY!....................................................................................!23!
11.4.1!
Research!Use!of!Stored!Human!Samples,!Specimens,!or!Data!......................................!23!
11.5!
FUTURE!USE!OF!STORED!SPECIMENS!...........................................................................................!24!
12!
DATA!HANDLING!AND!RECORD!KEEPING!..................................................................................!24!
12.1!
DATA!COLLECTION!AND!MANAGEMENT!RESPONSIBILITIES!..............................................................!24!
12.2!
STUDY!RECORDS!RETENTION!......................................................................................................!25!
12.3!
PROTOCOL!DEVIATIONS!...............................................................................................................!25!
12.4!
PUBLICATION!AND!DATA!SHARING!POLICY!....................................................................................!25!
13!
STUDY!FINANCES!...........................................................................................................................!26!
13.1!
FUNDING!SOURCE!.......................................................................................................................!26!
13.2!
COSTS!TO!THE!PARTICIPANT!........................................................................................................!26!
13.3!
PARTICIPANT!REIMBURSEMENTS!OR!PAYMENTS!............................................................................!26!
14!
CONFLICT!OF!INTEREST!POLICY!.................................................................................................!26!
19!
ATTACHMENTS!...............................................................................................................................!28!
 
 
 
 
 
 
 

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Study!number:!17J00811!
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List!of!Abbreviations!
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AE!
Adverse!Event/Adverse!Experience!
CFR!
Code!of!Federal!Regulations!
CRF!
Case!Report!Form!
CSOC!
Clinical!Study!Oversight!Committee!
DCC!
Data!Coordinating!Center!
DHHS!
Department!of!Health!and!Human!Services!
DSMB!
Data!and!Safety!Monitoring!Board!
FFR!
Federal!Financial!Report!
FWA!
Federalwide!Assurance!
GCP!
Good!Clinical!Practice!
HIPAA!
Health!Insurance!Portability!and!Accountability!Act!
ICF!
Informed!Consent!Form!
ICH!
International!Conference!on!Harmonisation!
IRB!
Institutional!Review!Board!
ISM!
Independent!Safety!Monitor!
MOP!
Manual!of!Procedures!
N!
Number!(typically!refers!to!participants)!
NIH!
National!Institutes!of!Health!
OHRP!
Office!for!Human!Research!Protections!
OHSR!
Office!of!Human!Subjects!Research!
PI!
Principal!Investigator!
QA!
Quality!Assurance!
QC!
Quality!Control!
SAE!
Serious!Adverse!Event/Serious!Adverse!Experience!
SOP!
Standard!Operating!Procedure!
US!
United!States!
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Study!number:!!
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Page!1!
Version:!
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Protocol!Summary!
Title!
Accessible!Care!Intervention!for!Engaging!People!who!Inject!Illicit!
Drugs!(PWID)!in!Hepatitis!C!Care!
Short!Title!
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Brief!Summary!
The!proposed!study!will!examine!the!feasibility,!acceptability,!safety,!
effectiveness,!and!cost!of!an!Accessible!Care!intervention!for!engaging!
people!who!inject!illicit!drugs!(PWID)!in!hepatitis!C!care.!Accessible!Care!for!
PWID!is!lowJthreshold!care!provided!in!programs!designed!specifically!for!
PWID!where!they!can!comfortably!access!care!without!fear!of!shame!or!
stigma.!Accessible!Care!will!be!provided!by!coJlocating!a!hepatitis!treatment!
provider,!together!with!a!Hepatitis!C!Care!Coordinator!(HCCC),!onJsite!at!our!
collaborating!needle!exchange!program.!The!proposed!study!will!compare!
the!effectiveness!of!Accessible!Care!with!Usual!Care!(referrals!to!existing!
services)!in!facilitating!linkage,!engagement,!and!retention!of!PWID!in!care!
for!hepatitis!C,!addiction,!and!HIV!prevention.!Our!primary!outcome!is!
sustained!virologic!response,!which!constitutes!virologic!cure.!Substance!use!
and!HIV!and!HCV!risk!behaviors!are!secondary!outcomes.!The!Specific!Aims!
of!this!study!are!to!compare!active!PWID!receiving!Accessible!Care!or!Usual!
Care!on!the!following!outcomes:!1.!Hepatitis!C!Outcomes:!(1a)!Linkage!and!
engagement!in!hepatitis!C!care,!(1b)!Successful!hepatitis!C!treatment,!(1c)!
Safety!of!hepatitis!C!treatment,!and!(1d)!Rates!of!reinfection.!2.!Substance!
use!outcomes!3.!Reductions!in!selfJreported!HIV!and!HCV!risk!behaviors.!As!
allJoral!regimens!become!available!to!patients!who!do!not!inject!drugs,!the!
substantial!health!disparities!in!hepatitis!C!already!evident!will!become!
worse,!as!the!haves!are!cured!and!the!haveJnots!are!not.!Data!are!needed!
on!effective!methods!to!provide!successful!antiviral!therapy!to!the!core!
population!affected!by!the!epidemic,!persons!who!are!currently!using!illicit!
drugs,!so!that!they,!too,!may!benefit.!Treatment!can!also!help!end!the!HCV!
epidemic!by!preventing!onward!transmission,!but!only!if!we!have!effective!
models!for!delivering!treatment!to!people!actively!injecting!drugs.!
Phase!
Clinical!study!phase!4!
Objectives!
The!proposed!study!will!compare!the!effectiveness!of!Accessible!Care!with!
Usual!Care!in!facilitating!linkage,!engagement,!and!retention!of!PWID!in!care!
for!hepatitis!C,!addiction,!and!HIV!prevention.!!
Methodology!
Open!labell!Randomized!control!
Endpoint!
Our!primary!outcome!is!sustained!virologic!response!(SVR),!which!
constitutes!virologic!cure.!!Substance!use!and!HIV!and!HCV!risk!
behaviors!are!secondary!outcomes.!
Study!Duration!
4!years!
Participant!Duration!
52!to!144!weeks!
Duration!of!IP!
administration!
N/A!
Population!
500!men!and!women,!age!>/=!18!who!have!injected!drugs!in!the!last!90!days.!
Study!Sites!
Lower!East!Side!Harm!Reduction!Center!
Number!of!participants!
500!participants!all!enrolled!at!the!Lower!East!Side!Harm!Reduction!Center!

Study!number:!17J00811!
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Description!of!Study!
Agent/Procedure!
The!research!will!be!investigating!a!new!model!of!Hepatitis!C!care!delivery,!
‘Accessible!Care’.!!Accessible!Care!is!lowJthreshold!care!provided!in!
programs!designed!specifically!for!PWID,!in!communityJbased!
locations!where!they!can!comfortably!access!care!without!fear!of!
shame!or!stigma.!!!!
Reference!Therapy!
Accessible!Care!intervention!will!be!compared!to!referral!of!hepatitis!C!
infected!patient!to!existing!hepatitis!C!treatment!sites!(clinics!and!hospitals).!
Key!Procedures!
Blood!draws!that!are!considered!standard!of!care!for!hepatitis!C!treatment!
will!take!place!as!part!of!the!study.!
Statistical!Analysis!
We!will!compare!the!frequency!of!four!hepatitis!C!treatment!endpoints!
in!the!two!arms!in!an!intentJtoJtreat!fashion,!in!order!to!evaluate!the!
hypotheses!that!PWID!in!the!intervention!arm!will!be!more!likely!than!those!in!
the!control!arm!to!begin,!adhere!to,!complete,!and!achieve!virologic!
responses!to!antiviral!treatment!for!hepatitis!C.!The!four!endpoints!will!be!
defined!as!follows.!Antiviral!treatment!initiation!will!be!defined!as!taking!the!
first!dose!of!antiviral!medication!within!3!months!of!randomization.!Adherence!
to!antiviral!treatment!will!be!assessed!by!selfJreport!and!calculated!as!a!
percentage!of!prescribed!doses.!Treatment!completion!will!be!defined!as!
taking!the!prescribed!medications!for!the!entire!prescribed!treatment!
duration.!Sustained!virologic!response!(SVR)!will!be!defined!as!testing!HCV!
RNA!negative!12!weeks!after!treatment!completion,!the!standard!definition.!
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Schematic!of!Study!Design!
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Total!N:!300,!Obtain!informed!consent.!Screen!potential!subjects!by!inclusion!and!
exclusion!criterial!obtain!history,!document. 
Randomize 
Control!!!!!!!!!!
150!Subjects 
Accessible!Care!!!!!!!!
150!Subjects 
Baseline research survey assessing demographics, prior HCV engagement, 
experience with medical providers, prior and current drug use. 
On-site treatment of HCV 
FollowJup!assessments!of!study!participants!for!HCV!reJinfection! 
Rates!of!HCV!Cure 
Visit!1 
baseline 
Prior!to! 
Enrollment 
HCV!
Treatment 
3,!6,!9!
month!
follow;up 
Post;
treatment!
follow;up 
12!
month 
Repeat research interview assessing changes in drug use and health practices 
Referral for HCV treatment 

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1! Key!Roles!
NYU:!
Benjamin!Eckhardt!will!be!involved!in!the!development!of!survey!instrument!and!will!be!the!lead!clinician!
providing!HCV!care!onJsite!at!Lower!East!Side!Harm!Reduction!Center.!Participants!randomized!to!the!
‘Accessible!Care’!arm!of!the!research!study!will!be!offered!onJsite!Hepatitis!C!treatment,!with!Dr.!Benjamin!
Eckhardt!being!the!primary!medical!provider.!!His!studyJrelated!tasks!will!include:!
1.! obtaining!a!detailed!medical!history!
2.! performing!a!thorough!physical!examination!
3.! performing!venopuncture!to!obtain!laboratory!specimen!!
4.! discussing!hepatitis!C!treatment!options!
5.! prescribing!standard!of!care!hepatitis!C!medication!in!accordance!with!national!guidelines!
6.! providing!routine!followJup!care!to!participants!started!on!hepatitis!C!treatment!
•! Lab!testing!will!be!conducted!at!the!community!based!research!site!(Lower!East!Side!
Harm!Reduction!Center)!with!all!labs!being!sent!either!to!New!York!PresbyterianJ
Cornell’s!Central!Lab!or!Weill!Cornell!Medicine’s!Clinical!and!Translational!Science!
Center.!!No!specimens!of!any!form!will!be!obtained,!processed,!or!analyzed!at!New!
York!School!of!Medicine.!
NonJNYU!
Kristen!Marks!(CoJPI)!
Weill!Medical!College!of!Cornell!University!–!Department!of!Medicine!
1300!York!Avenue,!4th!Floor,!New!York,!NY!10021!
markskr@med.cornell.edu!
212J746J7602!
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Pedro!MateuJGelabert!(CoJPI)!
CUNY!School!of!Public!Health!
Pedro.MateuJGelabert@sph.cuny.edu!
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Shashi!Kapadia!(coJinvestigator)!
Weill!Medical!College!of!Cornell!University!–!Department!of!Medicine!
Shk9078@med.cornell.edu!
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Yesenia!AponteJMelendez!(Research!Coordinator)!
CUNY!School!of!Public!Health!
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Chunki!Fong!(Biostatistician)!
CUNY!School!of!Public!Health!
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Melinda!Pai!(Research!Assistant)!
Weill!Cornell!Medicine!
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2! Introduction,!Background!Information!and!Scientific!Rationale!
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2.1! Background!Information!and!Relevant!Literature!
The!proposed!study!will!examine!the!feasibility,!acceptability,!safety,!effectiveness,!and!cost!of!an!
Accessible!Care!intervention!for!engaging!people!who!inject!illicit!drugs!(PWID)!in!hepatitis!C!care.!Four!
times!as!prevalent!in!the!US!as!HIV!infection,!hepatitis!C!is!already!the!leading!cause!of!liver!failure!and!
liver!transplantation,!and!the!disease!burden!and!health!care!costs!will!continue!to!rise!in!the!coming!
decades.!The!1.5J2.0!million!PWID!constitute!the!core!of!the!hepatitis!C!epidemic!in!the!United!States,!
with!prevalence!rates!>70%!in!most!studies.!New,!allJoral!antiviral!treatment!regimens!can!eradicate!HCV!
in!nearly!100%!of!previously!untreated!patients.!Nonetheless,!few!studies!have!reported!successful!
treatment!of!this!infection!in!active!PWID!—!none!with!the!new!allJoral!regimens!—!and!they!are!rarely!
offered!antiviral!treatment.!As!more!advantaged!populations!gain!access!to!the!treatments!and!are!cured,!
health!disparities!in!hepatitis!C!outcomes!will!sharpen.!
!
Obstacles!to!engaging!active!PWID!in!care!include!their!competing!priorities!(e.g.,!legal,!financial,!
interpersonal,!drugJrelated,!housing),!more!pressing!medical!or!social!problems,!comorbid!psychiatric!
illness,!addiction,!fear!of!stigma,!and!historically!poor!relations!with!health!care!providers.!Other!barriers!
exist!at!the!provider,!healthcare!system,!and!structural!levels.!>!
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2.2! Name!and!Description!of!the!Investigational!Agent!!
Accessible!Care!for!PWID!is!lowJthreshold!care!provided!in!programs!designed!specifically!for!PWID,!in!
communityJbased!locations!where!they!can!comfortably!access!care!without!fear!of!shame!or!stigma.!In!
collaboration!with!communityJbased!organizations!providing!services!to!PWID!in!the!South!Bronx,!East!
Harlem,!and!the!Lower!East!Side!of!Manhattan,!we!developed!an!Accessible!Care!program!and!found!
that!we!could!effectively!treat!both!hepatitis!C!and!addiction!in!a!sample!of!PWID!recruited!from!
communityJbased!settings!who!were!actively!using!illicit!drugs.!By!reducing!illicit!drug!use!and!providing!
effective!HIV!and!HCV!prevention,!the!intervention!reduced!HIV!risk!behavior!as!well!—!a!finding!
supported!by!a!low!HCV!reinfection!rate!in!followJup.!
!
The!proposed!study!will!compare!the!effectiveness!of!Accessible!Care!with!Usual!Care!in!facilitating!
linkage,!engagement,!and!retention!of!PWID!in!care!for!hepatitis!C,!addiction,!and!HIV!prevention.!
!
2.2.1! Preclinical!Data!
N/A!
!
2.2.2! Clinical!Data!to!Date!
In!a!single!arm!pilot!study!conducted!by!our!team!we!treated!53!participants!at!a!community!based!
syringe!service!program!in!Washington!Heights!and!found!high!rates!of!sustained!virologic!response!
of!91%.!!
!
2.2.3! Dose!Rationale!(if!applicable)!!
N/A!
!

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2.3! Rationale!
PWID!are!less!likely!to!engage!in!HCV!care!through!existing!models!of!care!delivery.!!Obstacles!to!
engaging!active!PWID!in!care!include!their!competing!priorities!(e.g.,!legal,!financial,!interpersonal,!drugJ
related,!housing),!more!pressing!medical!or!social!problems,!comorbid!psychiatric!illness,!addiction,!fear!
of!stigma,!and!historically!poor!relations!with!health!care!providers.!Other!barriers!exist!at!the!provider,!
healthcare!system,!and!structural!levels.!
!
2.4! Potential!Risks!&!Benefits!
2.4.1! Known!Potential!Risks!
Risk!of!social!harm:!
Participants!may!feel!uncomfortable!responding!to!questions!about!your!medical!conditions,!their!
feelings,!their!drug!use,!or!their!sexual!behaviors.!Some!of!the!questions!are!about!topics!that!may!make!
them!feel!guilty,!anxious,!or!embarrassed.!!
!
Risk!of!drawing!blood:!
Drawing!participant!blood!could!cause!pain,!swelling,!bruising,!lightJheadedness,!or,!rarely,!infection!at!
the!place!where!your!blood!was!drawn.!!
!
Each!of!these!potential!risk!are!low!risk,!and!in!our!the!potential!gain!outweighs!the!risk.!
!
2.4.2! Known!Potential!Benefits!
!People!who!inject!drugs!are!the!risk!group!most!likely!to!be!infected!with!HCV,!and!the!least!likely!to!be!
offered!treatment.!This!study!will!offer!important!insights!into!the!feasibility,!safety!and!efficacy!of!treating!
active!drug!users!using!a!coJlocated!model!of!care!designed!with!their!needs!in!mind.!Identifying!effective!
ways!to!approach!HCV!treatment!in!this!marginalized!population!will!improve!overall!health!and!quality!of!
life!and!reduce!the!spread!of!this!disease.!Participation!in!the!study!may!benefit!participants!by!
eliminating!the!hepatitis!C!virus!or!halting!the!progression!of!this!disease.!Subjects!may!also!benefit!from!
the!discontinuation!of!illicit!drug!use!through!our!treatment!model!and!improved!health!status!and!quality!
of!life.!Serious!adverse!events!related!to!HCV!antiviral!treatment!are!uncommon.!Should!they!occur!the!
close!monitoring!structure!allows!early!detection!and!intervention!and!the!timely!provision!of!expert!
medical!care.!Given!the!low!risk!presented!by!participation!in!this!study,!the!risk/benefit!ratio!is!very!
favorable.!
!
3! Objectives!and!Purpose!
3.1! Primary!Objective!
!
The!proposed!study!will!compare!the!effectiveness!of!Accessible!Care!with!Usual!Care!in!
facilitating! linkage,! engagement,! and! retention! of! PWID! in! care! for! hepatitis! C,! addiction,! and! HIV!
prevention.!
!
Hepatitis!C!Outcomes!
Linkage!and!engagement!in!hepatitis!C!care,!assessed!as!(a)!stated!interest!in!hepatitis!C!treatment!
evaluation,!(b)!attendance!at!an!initial!visit!with!a!hepatitis!provider,!(c)!completion!of!a!medical!evaluation!
for!antiviral!treatment,!and!(d)!attendance!at!two!visits!with!a!hepatitis!treatment!provider!within!3!months.!
Successful!hepatitis!C!treatment,!defined!as!(e)!beginning!antiviral!treatment,!(f)!adherence!to!antiviral!
treatment,!(g)!completion!of!antiviral!treatment,!and!(h)!sustained!virologic!response,!the!primary!

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outcome.!We!will!also!describe!(i)!the!reasons!for!any!participants!not!reaching!treatment!endpoints!(a)–
(h)!according!to!staff!and!participant!report,!and!(i)!the!costs!of!the!intervention!in!each!arm.!
Safety!of!hepatitis!C!treatment!measured!by!the!frequency!of!side!effects,!adverse!events,!and!
doselimiting!toxicity,!since!these!rates!haven’t!been!reported!in!PWID!receiving!allJoral!regimens.!
Rates!of!reinfection!in!active!PWID!who!have!achieved!SVRs!with!antiviral!therapy!for!hepatitis!C.!
Reinfection!is!one!of!the!primary!reasons!cited!for!withholding!antiviral!treatment!from!PWID.!
!
Substance!use!outcomes!
Substance!abuse!treatment!entry!and!retention!in!each!arm!3,!6,!and!9!months!after!randomization.!
Reductions!in!substance!use!during!followJup!assessed!as!(a)!selfJreported!frequency!of!drug!injection,!
and!(b)!selfJreported!percentage!of!days!of!drug!or!alcohol!use,!and!(c)!urine!toxicology.!
!
4! Study!Design!and!Endpoints!
4.1! Description!of!Study!Design!
The!proposed!study!will!evaluate!the!effectiveness!of!Accessible!Care!(AC)!for!engaging!and!
retaining!PWID!in!care!for!hepatitis!C,!as!compared!with!Usual!Care!(UC).!A!sample!of!300!PWID!with!
chronic!hepatitis!C!will!be!recruited!from!the!Lower!East!Side!Harm!Reduction!Center,!our!communityJ
based!partner,!and!offered!enrollment!in!a!longitudinal!study!in!which!they!will!be!randomized!1:1!to!
receive!AC!or!UC.!Participants!will!be!given!an!appointment!with!a!Hepatitis!C!Care!Coordinator!(AC)!or!
referrals!to!existing!community!resources!(UC),!according!to!their!study!arm.!To!assure!that!any!observed!
effects!can!be!attributed!to!the!intervention!and!not!to!differences!in!insurance,!transportation,!or!
physician!characteristics,!study!participants!in!both!arms!will!receive!assistance!signing!up!for!health!
insurance!(Medicaid)l!transit!fare!(MetroCards)!as!needed!for!appointmentsl!and!access!to!the!same!
study!physicians!at!the!Weill!Cornell!Medical!Center!(WCMC)!Center!for!the!Study!of!Hepatitis!C.!!
!
All!patients!who!choose!to!receive!antiviral!treatment!and!have!no!contraindications!will!undergo!stateJofJ
theJart!antiviral!therapy!according!to!standard!clinical!protocols.!Study!physicians!are!committed!to!caring!
for!people!who!use!drugs!without!shaming,!blaming,!or!stigmatizing!them!or!withholding!care!on!the!basis!
of!arbitrary!requirements!for!abstinence!from!substance!use.!!
!
Participants!in!both!arms!will!be!interviewed!at!baseline!and!3,!6,!and!9!months!after!randomization.!To!
assure!retention!in!followJup!and!reduce!differential!attrition,!all!patients!will!be!seen!monthly!for!a!checkJ
in!to!update!contact!information,!as!we!have!done!in!previous!research.!Outreach!workers!will!help!retain!
participants!in!the!study!by!reminding!them!of!upcoming!appointments!and!searching!for!those!lost!to!
followJup.!Participants!in!both!arms!will!be!asked!monthly!if!they’ve!started!antiviral!therapy!and!those!
receiving!antiviral!therapy!will!be!interviewed!monthly!while!on!therapy!to!assess!adherence!and!side!
effects.!Patients!will!receive!cash!stipend!for!each!study!interview!or!monthly!checkJin.!!
!
Clinical!data,!including!medication!start!and!stop!dates!and!doses,!viral!RNA!levels,!other!laboratory!test!
results,!and!adverse!events,!will!be!abstracted!electronically!from!the!WCMC!electronic!medical!record!or!
by!requesting!records!from!other!facilities.!The!effectiveness!of!AC!will!be!assessed!and!compared!with!
Usual!Care!through!formal!intentJtoJtreat!analyses!comparing!study!endpoints.!SemiJstructured!
qualitative!interviews!will!also!be!conducted!with!a!theoretically!sampled!group!of!60!participants!6!
months!after!randomization,!including!some!who!dropped!out!or!did!not!pursue!treatment,!to!provide!
contextualized!data!on!how!the!intervention!worked,!or!didn’t,!and!its!strengths!and!weaknesses.!All!
patients!achieving!SVR!will!be!followed!up!with!quarterly!HCV!RNA!testing!for!the!duration!of!the!study!to!
detect!reinfections.!The!cost!of!the!intervention!in!each!arm!will!be!estimated!as!a!key!component!of!
assessing!the!feasibility!of!the!interventions.!While!our!program!requires!intensive!effort!by!intervention!
staff,!we!anticipate!that!that!the!incremental!cost!of!this!effort!will!be!well!within!the!range!of!the!current!
cost!of!hepatitis!C!treatment.!

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4.2! Study!Endpoints!
4.2.1! Primary!Study!Endpoints!
We!have!chosen!a!series!of!5!hepatitis!C!outcomes!that!represent!the!continuum!of!care!—!3!
assessing!linkage!and!engagement,!and!2!assessing!successful!treatment.!!Outcomes!will!be!
compared!using!intentJtoJtreat!analyses,!which!classify!participants!lost!to!followJup!as!not!having!
reached!any!unmeasured!endpoint.!SVR,!the!fifth!and!last!of!these!outcomes,!is!the!
primary!endpointl!SVR!indicates!the!elimination!of!HCV!infection!and!the!cessation!of!the!hepatitis!
disease!process,!and!is!universally!considered!the!ultimate!goal!of!treatment.!!Four!
proximal!hepatitis!C!endpoints!have!been!chosen,!however,!so!that!if!the!intervention!is!not!ultimately!
successful!in!achieving!SVRs!we!can!examine!at!what!stage!the!failures!occurred.!For!each!comparison,!
the!null!hypothesis!of!no!difference!between!the!arms!will!be!assessed!using!the!chiJsquare!test!and!
rejected!if!p<0.05.!!
!
Aim!1a.!Hepatitis!C!treatment!engagement.!We!will!assess!the!proportion!of!patients!in!each!arm!who!(a)!
referral!to!hepatitis!C!treatment!provider,!(b)!attend!an!initial!visit!with!a!hepatitis!treatment!provider,!and!
(c)!complete!a!medical!evaluation!for!antiviral!treatment,!including!a!history,!physical!examination,!and!
laboratory!evaluation.!!Proportions!with!95%!confidence!intervals!(CIs)!calculated!using!the!exact!
binomial!method!will!be!reported.!!Persons!who!are!lost!to!followJup!will!be!considered!in!each!analysis!
as!not!having!reached!the!outcome,!according!to!intentJtoJtreat!principles.!
!
Aim!1b.!Hepatitis!C!treatment!success.!We!will!compare!the!frequency!of!four!hepatitis!C!treatment!
endpoints!in!the!two!arms!in!an!intentJtoJtreat!fashion,!in!order!to!evaluate!the!hypotheses!that!PWID!in!
the!intervention!arm!will!be!more!likely!than!those!in!the!control!arm!to!begin!treatment,!and!achieve!
virologic!responses!to!antiviral!treatment!for!hepatitis!C.!The!two!endpoints!will!be!defined!as!follows.!
Antiviral!treatment!initiation!will!be!defined!as!physically!receiving!the!first!dose!of!antiviral!medication!
(without!necessarily!having!confirmed!ingestion).!Sustained!virologic!response!(SVR)!will!be!defined!as!
testing!HCV!RNA!negative!12!weeks!after!treatment!completion,!the!standard!definition!
!
Aim!1c.!Cost!of!intervention:!The!HCCC!and!the!Clinician!will!log!time!spent!providing!services,!excluding!
research!activities.!Costs!will!be!assigned!to!staff!time!based!on!prevailing!national!wage!rates.!Patient!
time!costs!will!also!be!estimated!based!on!time!spent!with!staff!members!and!will!be!valued!based!on!the!
minimum!wage!because!most!patients!are!likely!to!be!unemployed.!We!will!describe!patientJreported!
health!care!visits,!employment,!and!incarceration!that!will!be!used!as!inputs!to!future!cost!or!costJ
effectiveness!studies.!
!
Aim!1d.!Safety:!Because!concern!about!side!effects!has!been!cited!as!a!reason!not!to!treat!PWID!for!
hepatitis!C,and!because!experience!with!these!drugs!in!PWID!has!not!been!reported,!we!will!report!
prospectively!collected!data!on!safety!outcomes!on!all!participants!who!receive!antiviral!therapy.!All!
treatmentJemergent!side!effects!(e.g.,!fatigue,!headache,!nausea,!insomnia,!irritability,!anorexia,!diarrhea,!
constipation,!etc.)!will!be!tabulated,!as!will!adverse!events,!including!abnormalities!in!serum!bilirubin,!liver!
enzymes,!infections,!hospitalizations,!and!deaths),!and!any!adverse!effects!requiring!treatment!
discontinuation,!according!to!OHRP152!and!NIH153!guidelines.!We!will!describe!the!frequency!of!side!
effects,!adverse!events,!and!treatmentJlimiting!outcomes,!among!all!study!participants!who!received!at!
least!one!dose!of!antiviral!medication.!If!numbers!permit,!we!will!compare!the!rates!in!the!two!arms!to!see!
whether!AC!influences!perceived!side!effects.!
!
Aim!1e.!Reinfection:!We!will!report!reinfection!rates!in!all!patients!in!both!arms!who!achieve!SVR!using!
timeJtoevent!methods.!If!150!participants!initiate!antiviral!therapy!(50%!overall)!and!120!(80%)!of!those!
achieve!SVR,!with!2%/month!attrition!(21.5%/yr),!we!will!have!198.3!personJyears!of!followJup!when!data!
collection!is!concluded,!enough!for!a!reasonably!robust!estimate.!
!
4.2.2! Secondary!Study!Endpoints!
Aim!2:!Substance!use.!We!will!report!rates!of!addiction!treatment!entry!and!retentionl!

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changes!in!levels!of!selfJreported!alcohol!and!illicit!drug!consumptionl!and!urine!toxicology!results.!
Outcomes!will!be!examined!at!3,!6,!and!9!months!after!randomization,!to!assess!the!magnitude!and!
durability!of!intervention!effects.!Effect!sizes!and!95%!CIs!will!be!reported.!
!
Aim!3:!HIV!and!HCV!risk!behaviors.!We!will!report!changes!in!frequency!of!three!injection!related!and!
three!sexual!HIV!risk!behaviors:!(a)!injection!drug!use,!(b)!use!of!a!syringe!previously!used!by!another!
person,!and!(c)!use!of!any!injection!equipment!(cooker,!cotton,!mixing!water,!mixing!syringe,!rinse!water)!
previously!or!simultaneously!used!by!another!person,!(d)!condomless!vaginal!or!anal!sex,!(e)!sex!with!
multiple!partners!(≥!2!in!past!6!months),!and!(f)!sex!in!exchange!for!money!or!drugs.!Outcomes!will!be!
reported!at!3,!6,!and!9!months!after!randomization,!to!assess!the!possibility!of!transient!intervention!
effects.!
!
4.2.3! Exploratory!Endpoints!
Although!not!a!study!aim,!we!will!also!report!quality!of!life!as!an!additional!outcome.!Quality!of!life!will!be!
measured!using!the!HQLQ139!at!baseline!and!3,!6,!and!9!months.!Scores!at!3,!6,!and!9!months!will!be!
regressed!on!baseline!scores!to!examine!the!effect!of!the!intervention!as!compared!with!Usual!Care.!
Effect!sizes!and!95%!CIs!will!be!reported!for!the!effect!of!each!intervention.!
5! Study!Enrollment!and!Withdrawal!
5.1! Inclusion!Criteria!
In!order!to!be!eligible!to!participate!in!this!study,!an!individual!must!meet!all!of!the!following!criteria:!!
!
Persons!will!be!eligible!for!HCV!and!HIV!screening!if!they:!!
(1)!are!18!years!or!older,!!!
(2)!injected!!!heroin,!cocaine,!or!other!drugs!in!the!past!30!days.!
5.2! Exclusion!Criteria!
An!individual!who!meets!any!of!the!following!criteria!will!be!excluded!from!participation!in!this!study:!
(1)! Persons!already!in!care!for!hepatitis!C,!defined!as!having!had!at!least!2!visits!with!a!hepatitis!
treatment!provider!within!the!past!6!months,!will!be!excluded.!
!
5.3! Vulnerable!Subjects!
N/A!
5.4! Strategies!for!Recruitment!and!Retention!
The!Lower!East!Side!Harm!Reduction!Center!is!a!community!based!syringe!exchange!programs!in!New!
York!City.!Through!funding!from!the!New!York!City!Department!of!Health!'Check!Hep!C'!program!these!
facilities!have!been!screening!syringe!exchange!participants!for!hepatitis!C.!Subjects!who!have!active!
hepatitis!C!infection!through!screening!done!by!the!partnering!facilities!will!be!referred!to!the!study!team!
for!potential!enrollment.!Study!staff!will!work!with!syringe!program!staff!to!recruit!participants.!Syringe!
program!staff!will!refer!participants!from!their!program!in!person!to!onsite!study!staff.!Recruitment!will!
occur!through!word!of!mouth!with!planned!information!sessions!scheduled!at!the!syringe!program's!
weekly!hepatitis!C!support!groups.!We!will!also!seek!referrals!from!other!organizations!serving!people!
who!use!drugs!(methadone!maintenance!treatment!programs,!homeless!services,!harm!reduction!
organizations).!In!partnership!with!those!organizations,!we!will!engage!in!active!and!passive!recruitment!
strategies.!Staff!at!the!collaborating!organization!will!engage!in!active!recruitment!by!identifying!potential!
participants!and!providing!a!direct!referral!to!study!staff!(either!by!phone!or!using!a!referral!form).!A!
passive!recruitment!strategy!will!be!the!display!of!informational!flyers!at!the!collaborating!sites!(see!
attached!flyer).!The!study!flyer!will!include!a!brief!description!of!the!study,!some!inclusion!criteria!and!
contact!information.!Additional!passive!recruitment!strategies!will!include!posting!and!distributing!study!

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flyers!in!areas!where!people!who!use!drugs!are!known!to!congregate!(e.g.,!parks,!near!street!drug!
markets).!
!
5.5! Duration!of!Study!Participation!
52!to!144!weeks!
5.6! Total!Number!of!Participants!and!Sites!!
500!participants!approached,!300!participants!randomized.!!No!participants!will!be!enrolled!at!NYUMC.!
!
!
5.7! Participant!Withdrawal!or!Termination!
5.7.1! Reasons!for!Withdrawal!or!Termination!
!
Participants!are!free!to!withdraw!from!participation!in!the!study!at!any!time!upon!request.!An!investigator!
may!terminate!participation!in!the!study!if:!
•!
Any!clinical!adverse!event!(AE),!laboratory!abnormality,!or!other!medical!condition!or!situation!
occurs!such!that!continued!participation!in!the!study!would!not!be!in!the!best!interest!of!the!
participant!
•!
The!participant!meets!an!exclusion!criterion!(either!newly!developed!or!not!previously!
recognized)!that!precludes!further!study!participation!
!
5.7.2! Handling!of!Participant!Withdrawals!or!Termination!
!
We!will!make!every!effort!must!be!made!to!undertake!protocolJspecified!safety!followJup!procedures!to!
capture!AEs,!serious!adverse!events!(SAEs),!and!unanticipated!problems!(UPs).!!
!
There!will!be!no!replacement!of!participants!who!withdraw!or!discontinue!early.!Data!will!be!analyzed!as!
intentionJtoJtreat.!
5.8! Premature!Termination!or!Suspension!of!Study!
!
This!study!may!be!temporarily!suspended!or!prematurely!terminated!if!there!is!sufficient!reasonable!
cause.!Written!notification,!documenting!the!reason!for!study!suspension!or!termination,!will!be!provided!
by!the!suspending!or!terminating!party!to!<investigator,!funding!agency,!the!IND/IDE!sponsor!and!
regulatory!authorities>.!If!the!study!is!prematurely!terminated!or!suspended,!the!PI!will!promptly!inform!
the!IRB!and!will!provide!the!reason(s)!for!the!termination!or!suspension.!
Circumstances!that!may!warrant!termination!or!suspension!include,!but!are!not!limited!to:!
•!
Determination!of!unexpected,!significant,!or!unacceptable!risk!to!participants!
•!
Demonstration!of!efficacy!that!would!warrant!stopping!
•!
Insufficient!compliance!to!protocol!requirements!
•!
Data!that!are!not!sufficiently!complete!and/or!evaluable!
•!
Determination!of!futility!
!
Study!may!resume!once!concerns!about!safety,!protocol!compliance,!data!quality!are!addressed!and!
satisfy!the!sponsor,!IRB!and/or!FDA.!
!

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6! Study!Agent!(Study!drug,!device,!biologic,!vaccine!etc.)!and/or!
Procedural!Intervention!!
N/A!
7! Study!Procedures!and!Schedule!
7.1! Study!Procedures/Evaluations!
Initial!Research!Visit!(all!participants):!
1.! !After!signing!the!consent!form,!participants!will!be!asked!to!provide!contact!information,!including!
your!personal!telephone!number.!!Also,!we!will!ask!participants!whether!there!are!friends!or!
family!members!that!we!can!contact!if!we!have!lost!contact!with!you!for!any!reason.!!No!personal!
health!information!will!be!shared!with!these!family!or!friends.!These!persons!will!simply!be!asked!
to!convey!the!message!that!the!study!team!is!interested!in!seeing!you.!!Every!month!participants!
will!be!asked!to!briefly!check!in!with!the!study!staff,!and!participants!be!asked!if!there!are!any!
changes!in!your!contact!information.!
2.! A!member!of!the!study!team!will!administer!a!detailed!questionnaire!at!the!time!of!enrollment!into!
the!study.!!This!questionnaire!will!ask!questions!about!participants’!demographics!(e.g.,!age,!
gender,!race),!alcohol!and!drug!use!history!and!practices,!sexual!behavior,!and!experience!with!
health!care.!!!!
3.! Human!Immunodeficiency!Virus!(HIV)!Testing.!Participants!will!have!a!10Jto!15Jminute!HIV!
prevention!counseling!session!with!a!trained!staff!member.!The!session!will!cover!the!meaning!of!
results!from!the!HIV!test.!Participants!will!also!learn!about!how!to!reduce!your!chances!of!being!
infected!with!HIV!and!other!infectious!diseases.!Participants!will!get!counseling!about!what!the!
test!result!means.!Participants!can!get!the!result!of!your!HIV!test!within!about!20!minutes.!
Participants!will!get!also!get!postJtest!counseling!from!a!trained!staff!member!and!referrals!to!
services!you!may!need.!If!participants!already!know!they!have!infection!with!the!HIV!virus,!they!
may!provide!results!of!their!HIV!test!from!their!medical!records!instead!of!doing!this!test.!
!
At!the!initial!research!visit,!participants!will!be!randomly!assigned!to!one!of!these!two!groups:!
!
Group!A:!Accessible!Care!
!
OR!
!
Group!B:!Usual!Care!!
!
!
If!you!take!part!in!this!study!and!are!assigned!to!Group!A,!you!will!have!the!following!tests!and!
procedures:!
!
Group!AaAccessible!Care!(Hepatitis!C!Care!at!Lower!East!Side!Harm!Reduction!Center)The!study!
will!follow!participants!while!receiving,!or!being!offered,!treatment!for!their!hepatitis!C!infection!at!the!
Lower!East!Side!Harm!Reduction!Center.!The!hepatitis!C!treatment,!and!the!medications!participants!
may!receive!for!it,!are!not!being!tested!as!part!of!the!study.!!However,!their!response!to!treatment,!and!
the!laboratory!tests!taken!as!routine!usual!care!during!treatment!will!be!used!for!study!purposes.!!
!
Research!only!visits!(every!3!mos):!Information!that!will!be!collected!for!the!study!will!consist!of!(1)!
detailed!questionnaires,!and!(2)!one!or!more!extra!blood!tests.!!The!details!of!the!study!are!as!follows:!
1.! Questionnaires!will!be!administered!every!three!months!for!up!to!12!months,!independent!of!
whether!participants!receive!treatment!for!your!hepatitis!C,!with!questions!about!their!substance!
use!history!and!practices,!sexual!practices,!and!experience!with!health!care.!!These!interviews!
can!be!conducted!at!the!research!site,!inJperson!at!a!different!location,!or!over!the!telephone.!
2.! Human!Immunodeficiency!Virus!(HIV)!Testing!as!described!above!will!be!offered!at!a!research!
visit!every!6!months!to!those!participants!who!previously!tested!negative!for!HIV.!

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3.! If!participants’!Hepatitis!C!is!cured!they!will!continue!to!be!followed!for!up!to!144!weeks!after!
treatment!completion!for!the!duration!of!the!study.!!!!
!
Hepatitis!Care!and!Treatment:!
4.! Participants!will!be!scheduled!to!see!a!hepatitis!C!medical!doctor!at!your!harm!reduction!facility!
(Lower!East!Side!Harm!Reduction).!!If!a!participant!decides!to!attend!the!hepatitis!C!medical!
evaluation,!a!study!doctors!will!evaluate!them!to!find!out!whether!you!would!benefit!from!
treatment!for!hepatitis!C.!!The!doctor!will!ask!participants!questions,!examine!them,!give!them!
information,!and!answer!their!questions!about!hepatitis!C,!about!treatment!for!hepatitis!C,!and!
about!the!risks!and!benefits!of!being!treated.!!The!purpose!of!the!medical!evaluation!is!to!decide!
whether!participants!need!treatment!for!your!hepatitis!C!and!what!the!best!treatment!would!be.!!
Participants!will!receive!a!standard!medical!evaluation!to!assess!your!Hepatitis!C!treatment!
needs.!
5.! At!the!medical!evaluation,!about!20mL!(4teaspoons)!of!blood!will!also!be!drawn!by!one!of!the!
other!research!staff!members,!and!sent!to!New!York!Presbyterian!Hospital.!The!blood!will!be!
tested!to!assess!participants’!health!and!liver.!A!small!percentage!of!the!blood!drawn!will!be!
stored!at!the!Weill!Cornell!Medical!College!Clinical!and!Translational!Science!Center!for!future!
testing!of!characteristics!of!your!hepatitis!C!virus.!!!
6.! We!will!schedule!participants!to!come!back!in!2!weeks!to!find!out!the!results!of!your!blood!tests.!!
Participants!and!their!hepatitis!C!doctor!will!work!together!to!make!an!informed!decision!about!
whether!participants!will!take!medication!used!to!treat!hepatitis!C.!The!doctor!will!explain!the!risks!
and!benefits!of!taking!any!medicines!before!you!take!them.!!The!medications!the!doctor!will!
prescribe!are!the!current!best!standard!of!HCV!treatment!available.!!If!the!doctor!recommends!
that!the!participant!take!these!medications,!participants!will!be!free!to!decide!whether!or!not!to!
take!them.!
7.! If!participants!take!the!medication!for!hepatitis!C,!they!will!get!appointments!to!come!back!to!pick!
up!their!medication.!Hepatitis!C!medications!prescriptions!will!be!sent!to!specialty!pharmacies,!
and!when!obtained,!delivery!of!medication!will!be!to!the!harm!reduction!facility!or!patients!
residence!if!novel!coronavirus!is!an!issue.!
8.! If!participants!begin!treatment!for!hepatitis!C,!standard!blood!tests!for!monitoring!the!treatment!
will!be!performed!by!a!members!of!the!research!staff!(or!commercial!lab!testing!centres!if!novel!
coronavirus!is!an!issue),!at!weeks!2,!4!and!12!of!treatment,!and!4!and!12!weeks!after!the!end!of!
treatment.!In!addition,!an!extra!two!teaspoons!of!blood!may!be!drawn!at!each!of!these!visits!for!
research!purposes!and!sent!for!storage!at!Cornell’s!Clinical!and!Translational!Science!Center.!!
These!samples!may!be!tested!to!look!for!signs!of!multiple!concurrent!hepatitis!C!infections,!and!
help!to!decipher!treatment!failure!from!reJinfection!in!participants!who!do!not!achieve!cure!of!their!
hepatitis!C.!
9.! If!participants!start!the!medications!used!to!treat!hepatitis!C!and!want!to!stop!them!before!their!
treatment!is!finished,!they!are!free!to!do!so!and!will!not!be!penalized!in!any!way,!although!this!
could!limit!the!success!of!hepatitis!C!treatment.!!Participants!will!be!encouraged!to!continue!with!
the!study!questionnaires!every!three!months.!
10.!Within!6!months!of!enrolling!in!the!study,!participants!will!have!a!oneJonJone!meeting!with!a!
hepatitis!C!study!coordinator!to!review!harm!reduction!practices.!!This!discussion!will!include!
discussions!on!prevention!of!hepatitis!C!transmission!and!reJinfection,!ways!to!engage!in!safe!
injection!practices!and!avoid!crossJcontamination!of!injection!equipment!while!injecting!with!
others.!!!
11.!Data!from!participants’!clinical!medical!records!will!be!entered!into!our!research!database!during!
the!course!of!your!treatment!by!a!members!of!the!research!staff.!!These!data!include,!but!are!not!
limited!to,!hepatitis!C!genotype,!hepatitis!C!viral!load,!fibrosure!results(looking!for!signs!of!
cirrhosis),!HIV!antibody,!sustained!virologic!response!(defined!as!no!detectable!hepatitis!C!virus!
12!weeks!after!completing!therapy),!and!any!side!effects!or!adverse!effects!you!experience!
during!therapy!
!
If!participants!agree!to!take!part!in!this!study!and!are!assigned!to!Group!B,!participants!will!have!the!
following!tests!and!procedures:!
!

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Group!B!–Usual!Care!Group!(Hepatitis!Care!at!usual!locations!in!the!community):!If!assigned!to!this!
group,!participants!will!participate!in!research!visits!but!not!receive!hepatitis!care!or!treatment!at!the!
Lower!East!Side!Harm!Reduction!Center!as!part!of!the!study.!!Participants!can!obtain!care!and!treatment!
for!hepatitis!C!at!the!usual!locations!in!the!community.!
!
Research!Visits!(every!3!mos):!Information!that!will!be!collected!for!the!study!will!consist!of!(1)!detailed!
questionnaires,!and!(2)!one!or!more!extra!blood!tests.!!The!details!of!the!study!are!as!follows:!
1.! Questionnaires!will!be!administered!every!three!months!for!up!to!12!months,!independent!of!
whether!participants!receive!treatment!for!your!hepatitis!C,!with!questions!about!their!
demographics!(e.g.,!age,!gender,!race),!their!alcohol!and!drug!use!history!and!practices,!sexual!
practices!and!experience!with!health!care.!
2.! One!teaspoon!of!your!blood!will!be!drawn!and!sent!to!New!York!Presbyterian!Hospital!–Weill!
Cornell!Translation!Science!Center!where!it!will!be!processed!and!stored!for!potential!future!
testing!of!characteristics!of!your!Hepatitis!C!virus.!!!
3.! Human!Immunodeficiency!Virus!(HIV)!testing!as!described!above!will!be!offered!at!a!research!
visit!every!6!months!to!those!participants!who!previously!tested!negative!for!HIV.!
!
Hepatitis!Care!and!Treatment:!
4.! Participants!will!be!referred!to!a!hepatitis!C!case!manager!(funded!through!the!New!York!City!
Department!of!Health!Check!Hep!C!Program),!on!site!at!their!harm!reduction!facility!(Lower!East!
Side!Harm!Reduction!Center),!who!will!assist!participants!with!referral!for!hepatitis!C!care!within!
the!community.!!!
5.! If!participants!start!treatment!for!hepatitis!C!during!their!time!in!the!study,!we!will!ask!participants!
to!give!us!permission!to!talk!with!their!hepatitis!C!doctor!so!we!can!have!access!to!their!medical!
records!and!monitor!how!they!are!responding!to!treatment.!!!
6.! If!participants!achieve!a!sustained!virologic!response!after!completing!hepatitis!C!treatment,!
which!means!that!the!treatment!was!successful,!participants!will!be!given!an!appointment!to!
come!back!every!three!months!to!complete!a!study!interview!and!be!tested!for!hepatitis!C,!for!up!
to!144!weeks!after!treatment!completion,!to!find!out!whether!they!are!still!negative,!or!to!see!
whether!they!get!reJinfected.!
!
QUALITATIVE!INTERVIEWS!During!the!study,!we!may!ask!participants!to!take!part!in!an!interview!about!
their!experiences!related!to!hepatitis!C!treatment.!!This!will!last!about!60J90Jminutes.!If!participants!
choose!to!participate,!the!interview!will!be!digitally!audioJrecorded.!If!participants!are!selected!for!this!
interview!we!will!ask!participants!about:!health!care!and!hepatitis!CJrelated!healthcare!experiences,!
alcohol!and!drug!use,!injection!risk!behaviors!and!sexual!practices.!We!will!ask!participants!how!these!
changed,!if!they!did,!during!their!taking!part!in!the!study.!
!
!
7.2! Concomitant!Medications,!Treatments,!and!Procedures!
N/A!
7.3! Justification!for!Sensitive!Procedures!
N/A!
7.4! Prohibited!Medications,!Treatments,!and!Procedures!
N/A!
7.5! Prophylactic!Medications,!Treatments,!and!Procedures!
N/A!

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7.6! Rescue!Medications,!Treatments,!and!Procedures!
N/A!
7.7! Participant!Access!to!Study!Agent!at!Study!Closure!
N/A!–!finite!course!of!treatment.!
!
8! Assessment!of!Safety!
8.1! Specification!of!Safety!Parameters!!
We!anticipate!that!providing!HCV!care!and!treatment!on!site!at!a!community!syringe!exchange!center!will!
allow!access!to!treatment!for!greater!numbers!of!people!who!inject!drugs!(PWID).!Treatment!on!this!study!
will!include!FDAJapproved!standard!of!care!regimens!with!excellent!safety!profilel!however!limited!data!
exists!on!the!use!of!these!agents!in!PWID.!While!experts!have!little!concern!for!drugJdrug!interactions!
between!most!DAAs!and!illicit!drugs,!we!have!chosen!to!monitor!HCV!TreatmentJrelated!SAEs,!
Hospitalizations!and!Deaths!related!to!Overdose,!and!Overall!Deaths!as!safety!endpoints!that!
would!trigger!review!of!the!study.!Other!on!treatment!side!effects!will!also!be!captured!and!described,!but!
will!not!impact!conduct!of!the!study!and!thus!will!not!be!reported!to!DSMB.!Currently,!HCV!cure!rates!
exceed!90%!with!currently!available!all!oral!DAA!regimens!in!clinical!trials!and!recent!clinical!cohorts!
regardless!of!HCV!genotypel!however!little!is!known!about!treatment!efficacy!and!safety!in!active!drug!
users!as!these!patients!are!typically!excluded!from!clinical!trials.!One!clinical!trial!of!a!modern!era!DAA!
regimen!was!conducted!in!301!persons!receiving!opioid!agonist!therapy!(OAT)!(Merck!CJEDGE!
CoJSTAR)!and!provides!some!safety!and!efficacy!data!relevant!to!our!study.!It!did!not!exclude!patients!
who!were!actively!using!drugs!of!potential!abuse,!and!more!than!50%!of!patients!had!at!least!one!urine!
drug!screen!positive!for!potential!drugs!of!abuse.!The!study!randomized!patients!to!the!fixed!dose!
combination!of!elbasvir/grazoprevir!or!placebo,!so!that!safety!could!be!carefully!ascertained!in!this!patient!
population!perceived!as!being!high!risk!for!unrelated!adverse!events.!Those!that!received!placebo!were!
subsequently!treated!open!label.!The!primary!efficacy!outcome!showed!an!SVR!12!of!91.5%!in!the!
immediate!treatment!group!and!89.5%!in!the!delayed!treatment!group.!Positive!urine!drug!screens!did!not!
affect!adherence!or!efficacy.!18!patients!had!recurrent!viremia!and!5!were!due!to!probable!reinfection.!
The!safety!profile!was!similar!between!treatment!and!placebo!with!rare!SAEs!(3.5%!in!treated,!4%!in!
placebo)l!however,!only!1!SAE!in!each!group!was!considered!treatmentJrelated.!The!high!efficacy!and!
relative!safety!of!this!study!of!patients!on!OAT,!many!of!who!also!used!drugs!of!potential!abuse,!is!
reassuring!that!HCV!treatment!may!be!safely!delivered!to!our!study!population.!!
!
8.1.1! Definition!of!Adverse!Events!(AE)!
!
An!adverse!event!(AE)!is!any!symptom,!sign,!illness!or!experience!that!develops!or!worsens!in!severity!
during!the!course!of!the!study.!!Intercurrent!illnesses!or!injuries!should!be!regarded!as!adverse!events.!!
Abnormal!results!of!diagnostic!procedures!are!considered!to!be!adverse!events!if!the!abnormality:!
•! results!in!study!withdrawal!
•! is!associated!with!a!serious!adverse!event!
•! is!associated!with!clinical!signs!or!symptoms!
•! leads!to!additional!treatment!or!to!further!diagnostic!tests!
•! is!considered!by!the!investigator!to!be!of!clinical!significance!
!
8.1.2! Definition!of!Serious!Adverse!Events!(SAE)!
!
Serious!Adverse!Event!
Adverse!events!are!classified!as!serious!or!nonJserious.!!A!serious!adverse!event!is!any!AE!that!is:!!
•! fatal!

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•! lifeJthreatening!
•! requires!or!prolongs!hospital!stay!
•! results!in!persistent!or!significant!disability!or!incapacity!
•! a!congenital!anomaly!or!birth!defect!
•! an!important!medical!event!
!
Important!medical!events!are!those!that!may!not!be!immediately!life!threatening,!but!are!clearly!of!major!
clinical!significance.!They!may!jeopardize!the!subject,!and!may!require!intervention!to!prevent!one!of!the!
other!serious!outcomes!noted!above.!For!example,!drug!overdose!or!abuse,!a!seizure!that!did!not!result!
in!inJpatient!hospitalization,!or!intensive!treatment!of!bronchospasm!in!an!emergency!department!would!
typically!be!considered!serious.!!
!
All!adverse!events!that!do!not!meet!any!of!the!criteria!for!serious!should!be!regarded!as!nonWserious!
adverse!events.!!
!
8.1.3! Definition!of!Unanticipated!Problems!(UP)!
!
!
Unanticipated!Problems!Involving!Risk!to!Subjects!or!Others!
Any!incident,!experience,!or!outcome!that!meets!all!of!the!following!criteria:!!
•! Unexpected!in!nature,!severity,!or!frequency!!(i.e.!not!described!in!studyJrelated!documents!such!
as!the!IRBJapproved!protocol!or!consent!form,!the!investigators!brochure,!etc)!
•! Related!or!possibly!related!to!participation!in!the!research!(i.e.!possibly!related!means!there!is!a!
reasonable!possibility!that!the!incident!experience,!or!outcome!may!have!been!caused!by!the!
procedures!involved!in!the!research)!
•! Suggests!that!the!research!places!subjects!or!others!at!greater!risk!of!harm!(including!physical,!
psychological,!economic,!or!social!harm).!
!
8.2! Classification!of!an!Adverse!Event!
8.2.1! Severity!of!Event!
!
For!AEs!not!included!in!the!protocol!defined!grading!system,!the!following!guidelines!will!be!used!to!
describe!severity.!
!
•! Mild!–!Events!require!minimal!or!no!treatment!and!do!not!interfere!with!the!participant’s!daily!
activities.!
•! Moderate!–!Events!result!in!a!low!level!of!inconvenience!or!concern!with!the!therapeutic!
measures.!Moderate!events!may!cause!some!interference!with!functioning.!
•! Severe!–!Events!interrupt!a!participant’s!usual!daily!activity!and!may!require!systemic!drug!
therapy!or!other!treatment.!Severe!events!are!usually!potentially!lifeJthreatening!or!incapacitating.!
!
8.2.2! Relationship!to!Study!Agent!
!
!
For!all!collected!AEs,!the!clinician!who!examines!and!evaluates!the!participant!will!determine!the!AE’s!
causality!based!on!temporal!relationship!and!his/her!clinical!judgment.!The!degree!of!certainty!about!
causality!will!be!graded!using!the!categories!below.!

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•! Definitely!Related!–!There!is!clear!evidence!to!suggest!a!causal!relationship,!and!other!possible!
contributing!factors!can!be!ruled!out.!The!clinical!event,!including!an!abnormal!laboratory!test!
result,!occurs!in!a!plausible!time!relationship!to!drug!administration!and!cannot!be!explained!by!
concurrent!disease!or!other!drugs!or!chemicals.!The!response!to!withdrawal!of!the!drug!
(dechallenge)!should!be!clinically!plausible.!The!event!must!be!pharmacologically!or!
phenomenologically!definitive,!with!use!of!a!satisfactory!rechallenge!procedure!if!necessary.!
•! Probably!Related!–!There!is!evidence!to!suggest!a!causal!relationship,!and!the!influence!of!other!
factors!is!unlikely.!The!clinical!event,!including!an!abnormal!laboratory!test!result,!occurs!within!a!
reasonable!time!after!administration!of!the!drug,!is!unlikely!to!be!attributed!to!concurrent!disease!
or!other!drugs!or!chemicals,!and!follows!a!clinically!reasonable!response!on!withdrawal!
(dechallenge).!Rechallenge!information!is!not!required!to!fulfill!this!definition.!
•! Possibly!Related!–!There!is!some!evidence!to!suggest!a!causal!relationship!(e.g.,!the!event!
occurred!within!a!reasonable!time!after!administration!of!the!trial!medication).!However,!other!
factors!may!have!contributed!to!the!event!(e.g.,!the!participant’s!clinical!condition,!other!
concomitant!events).!Although!an!AE!may!rate!only!as!“possibly!related”!soon!after!discovery,!it!
can!be!flagged!as!requiring!more!information!and!later!be!upgraded!to!“probably!related”!or!
“definitely!related,”!as!appropriate.!
•! Unlikely!to!be!related!–!A!clinical!event,!including!an!abnormal!laboratory!test!result,!whose!
temporal!relationship!to!drug!administration!makes!a!causal!relationship!improbable!(e.g.,!the!
event!did!not!occur!within!a!reasonable!time!after!administration!of!the!trial!medication)!and!in!
which!other!drugs!or!chemicals!or!underlying!disease!provides!plausible!explanations!(e.g.,!the!
participant’s!clinical!condition,!other!concomitant!treatments).!
•! Not!Related!–!The!AE!is!completely!independent!of!study!drug!administration,!and/or!evidence!
exists!that!the!event!is!definitely!related!to!another!etiology.!There!must!be!an!alternative,!
definitive!etiology!documented!by!the!clinician.!
!
8.2.3! Expectedness!
!
Benjamin!Eckhardt!will!be!responsible!for!determining!whether!an!AE!is!expected!or!unexpected.!An!AE!
will!be!considered!unexpected!if!the!nature,!severity,!or!frequency!of!the!event!is!not!consistent!with!the!
risk!information!previously!described!for!the!study!agent.!
!
8.3! Time!Period!and!Frequency!for!Event!Assessment!and!FollowWUp!
!
The!occurrence!of!an!AE!or!SAE!may!come!to!the!attention!of!study!personnel!during!study!visits!and!
interviews!of!a!study!participant!presenting!for!medical!care,!or!upon!review!by!a!study!monitor.!All!AEs!
including!local!and!systemic!reactions!not!meeting!the!criteria!for!SAEs!will!be!captured!on!the!
appropriate!RF.!Information!to!be!collected!includes!event!description,!time!of!onset,!clinician’s!
assessment!of!severity,!relationship!to!study!product!(assessed!only!by!those!with!the!training!and!
authority!to!make!a!diagnosis),!and!time!of!resolution/stabilization!of!the!event.!All!AEs!occurring!while!on!
study!must!be!documented!appropriately!regardless!of!relationship.!All!AEs!will!be!followed!to!adequate!
resolution.!
!
Any!medical!condition!that!is!present!at!the!time!that!the!participant!is!screened!will!be!considered!as!
baseline!and!not!reported!as!an!AE.!However,!if!the!study!participant’s!condition!deteriorates!at!any!time!
during!the!study,!it!will!be!recorded!as!an!AE.!UPs!will!be!recorded!in!the!data!collection!system!
throughout!the!study.!
!
Changes!in!the!severity!of!an!AE!will!be!documented!to!allow!an!assessment!of!the!duration!of!the!event!
at!each!level!of!severity!to!be!performed.!AEs!characterized!as!intermittent!require!documentation!of!
onset!and!duration!of!each!episode.!
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The!PI!will!record!all!reportable!events!with!start!dates!occurring!any!time!after!informed!consent!is!
obtained!until!7!(for!nonJserious!AEs)!or!30!days!(for!SAEs)!after!the!last!day!of!study!participation.!At!
each!study!visit,!the!investigator!will!inquire!about!the!occurrence!of!AE/SAEs!since!the!last!visit.!Events!
will!be!followed!for!outcome!information!until!resolution!or!stabilization.!!
!
All!unresolved!adverse!events!should!be!followed!by!the!investigator!until!the!events!are!resolved,!the!
subject!is!lost!to!followJup,!or!the!adverse!event!is!otherwise!explained.!!At!the!last!scheduled!visit,!the!
investigator!should!instruct!each!subject!to!report!any!subsequent!event(s)!that!the!subject,!or!the!
subject’s!personal!physician,!believes!might!reasonably!be!related!to!participation!in!this!study.!!The!
investigator!should!notify!the!study!sponsor!of!any!death!or!adverse!event!occurring!at!any!time!after!a!
subject!has!discontinued!or!terminated!study!participation!that!may!reasonably!be!related!to!this!study.!!
The!sponsor!should!also!be!notified!if!the!investigator!should!become!aware!of!the!development!of!
cancer!or!of!a!congenital!anomaly!in!a!subsequently!conceived!offspring!of!a!subject!that!has!participated!
in!this!study.!!
!
8.4! Reporting!Procedures!–!Notifying!the!IRB!!
8.4.1! Adverse!Event!Reporting!
Immediately!report!any!harm!experienced!by!a!participant!or!other!individual,!whether!occurring!to!a!subject!
enrolled!related!to!the!human!research!procedure(s),!and/or!intervention(s)when!ALL!of!the!following!three!
(3)!conditions!are!met:!!
1.!The!harm!is!“unexpected”!when!its!specificity!and!severity!are!not!accurately!reflected!
in! the! WCM! consent! document,! Investigator’s! Brochure! (if! applicable),! or! package! insert! (if!
applicable)l!AND!!
2.!The!harm!is!“related”!or!“possibly!related”,!where!there!is!a!reasonable!possibility!that!
the!harm!may!have!been!caused!by!the!research!procedure(s),!or!intervention(s)!AND!!
3.! The! harm! suggests! that! the! research! places! WCM! subjects! at! greater! risk! of! harm!
(including! physical,! psychological,! economic! or! social! harm)! than! was! previously! known! or!
recognized.!!
If! ALL! of! the! three! (3)! conditions! are! met,! submit! the! Immediate! Report! within! 7! calendar! days! of! PI!
awareness.!!
At!the!time!of!IRB!Continuing!Review,!an!Adverse!Event!Reporting!Cumulative!Table!will!be!submitted!
listing!adverse!events!from!the!study!site!that!are!both!expected!and!unexpected!and!for!which!ANY!of!the!
following!apply:!!
1.!Severe!or!medically!significant,!but!not!immediately!lifeJthreateningl!hospitalization!or!
prolongation!of!hospitalization!indicatedl!disablingl!limiting!self!care!activities!of!daily!living!(Grade!
3)*!!
2.!LifeJthreatening!consequencesl!urgent!intervention!indicated!(Grade!4)!!
3.!Death!related!AE!(Grade!5)!Serious!Adverse!Event!Reporting!
!
!
8.5! Safety!Oversight!
!

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It!is!the!responsibility!of!the!Principal!Investigator!to!oversee!the!safety!of!the!study!at!his/her!site.!!This!
safety!monitoring!will!include!careful!assessment!and!appropriate!reporting!of!adverse!events!as!noted!
above,!as!well!as!the!construction!and!implementation!of!a!site!data!and!safetyJmonitoring!plan.!Medical!
monitoring!will!include!a!regular!assessment!of!the!number!and!type!of!serious!adverse!events.!
!
Safety!oversight!will!be!under!the!direction!of!a!Weill!CornellJbased!DSMB!composed!of!individuals!with!
the!appropriate!expertise,!including!hepatitis!C!and!substance!use!disorder.!The!DSMB!will!meet!at!least!
semiannually!to!assess!safety!and!efficacy!data!on!each!arm!of!the!study.!The!DSMB!will!operate!under!
the!rules!of!an!approved!charter!that!will!be!written!and!reviewed!at!the!organizational!meeting!of!the!
DSMB.!At!this!time,!each!data!element!that!the!DSMB!needs!to!assess!will!be!clearly!defined.!The!DSMB!
will!provide!its!input!to!the!study!sponsor!(NIDA).!
!
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9! Statistical!Considerations!
9.1! Statistical!and!Analytical!Plans!(SAP)!
We!will!examine!a!series!of!study!outcomes!in!both!study!arms!in!order!to!evaluate!the!effectiveness!of!
the!Accessible!Care!(AC)!intervention!as!compared!with!Usual!Care!(UC).!Our!three!Aims!are!to!compare!
hepatitis!treatment,!substance!use,!and!HIV!and!HCV!prevention!outcomes!in!the!two!arms!in!order!to!
answer!three!fundamental!questions!about!the!AC!intervention:!(1)!Is!it!sufficiently!safe!and!effective!to!
allow!active!PWID!in!appreciable!numbers!to!be!successfully!treated!for!hepatitis!C?!(2)!Does!it!reduce!
substance!use?!(3)!Does!it!reduce!HIV!and!HCV!risk!behaviors?!We!will!assess!a!multiplicity!of!outcome!
measures!in!order!to!fully!describe!the!experience!of!participants!in!each!arm.!
9.2! Statistical!Hypotheses!
Specific!Aim!1:!Hepatitis!C!Outcomes.!!
Hepatitis!C!treatment!engagement.!We!will!assess!the!proportion!of!patients!in!each!arm!who!(a)!
referred!to!a!hepatitis!C!treatment!provider,!(b)!attend!an!initial!visit!with!a!hepatitis!treatment!provider,!
and!(c)!complete!a!medical!evaluation!for!antiviral!treatment,!including!a!history,!physical!examination,!
and!laboratory!evaluation.!!Proportions!with!95%!confidence!intervals!(CIs)!calculated!using!the!exact!
binomial!method!will!be!reported.!!Persons!who!are!lost!to!followJup!will!be!considered!in!each!analysis!
as!not!having!reached!the!outcome,!according!to!intentJtoJtreat!principles.!
!
Hepatitis!C!treatment!success.!We!will!compare!the!frequency!of!two!hepatitis!C!treatment!endpoints!in!
the!two!arms!in!an!intentJtoJtreat!fashion,!in!order!to!evaluate!the!hypotheses!that!PWID!in!the!
intervention!arm!will!be!more!likely!than!those!in!the!control!arm!to!begin!treatment!and!achieve!virologic!
responses!to!antiviral!treatment!for!hepatitis!C.!The!two!endpoints!will!be!defined!as!follows.!Antiviral!
treatment!initiation!will!be!defined!as!physically!receiving!the!first!dose!of!antiviral!medication.!!Sustained!
virologic!response!(SVR)!will!be!defined!as!testing!HCV!RNA!negative!12+!weeks!after!treatment!
completion.!
!
Cost!of!intervention:!The!HCCC!and!the!Clinician!will!log!time!spent!providing!services,!excluding!
research!activities.!Costs!will!be!assigned!to!staff!time!based!on!prevailing!national!wage!rates.!Patient!
time!costs!will!also!be!estimated!based!on!time!spent!with!staff!members!and!will!be!valued!based!on!the!
minimum!wage!because!most!patients!are!likely!to!be!unemployed.!We!will!describe!patientJreported!
health!care!visits,!employment,!and!incarceration!that!will!be!used!as!inputs!to!future!cost!or!costJ
effectiveness!studies.!
!
Reinfection:!We!will!report!reinfection!rates!in!all!patients!in!both!arms!who!achieve!SVR!using!timeJ
toevent!methods.!If!150!participants!initiate!antiviral!therapy!(50%!overall)!and!120!(80%)!of!those!
achieve!SVR,!with!2%/month!attrition!(21.5%/yr),!we!will!have!198.3!personJyears!of!followJup!when!data!
collection!is!concluded,!enough!for!a!reasonably!robust!estimate.!
!
Specific!Aim!2:!Substance!use.!We!will!report!rates!of!addiction!treatment!entry!and!retentionl!
changes!in!levels!of!selfJreported!alcohol!and!illicit!drug!consumptionl!and!urine!toxicology!results.!
Outcomes!will!be!examined!at!3,!6,!and!9!months!after!randomization,!to!assess!the!magnitude!and!
durability!of!intervention!effects.!Effect!sizes!and!95%!CIs!will!be!reported.!
!
!
Specific!Aim!3:!HIV!and!HCV!risk!behaviors.!We!will!report!changes!in!frequency!of!three!injection!
related!and!three!sexual!HIV!risk!behaviors:!(a)!injection!drug!use,!(b)!use!of!a!syringe!previously!used!by!
another!person,!and!(c)!use!of!any!injection!equipment!(cooker,!cotton,!mixing!water,!mixing!syringe,!
rinse!water)!previously!or!simultaneously!used!by!another!person,!(d)!condomless!vaginal!or!anal!sex,!(e)!
sex!with!multiple!partners!(≥!2!in!past!6!months),!and!(f)!sex!in!exchange!for!money!or!drugs.!Outcomes!

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will!be!reported!at!3,!6,!and!9!months!after!randomization,!to!assess!the!possibility!of!transient!
intervention!effects.!
!
Subgroup!Analyses.!We!will!conduct!exploratory!analyses!of!group!assignment!effects!on!study!
outcomes!with!95%!confidence!intervals!in!the!following!subgroups!that!we!hypothesize!may!differ!in!their!
ability!to!benefit!from!the!AC!intervention:!(1)!men!and!women!(2)!older!and!younger!than!sample!median!
(3)!homeless!and!housed!(4)!cocaine!use!and!none!(5)!daily!and!less!frequent!illicit!drug!injection!(6)!
heavy!alcohol!use!(≥5!drinks/day)!and!less!or!none!(7)!health!care!utilization!in!past!6!months!and!none!
(8)!psychiatric!diagnosis!and!none.!In!the!event!of!statistically!significant!interactions!we!will!report!
treatment!group!assignment!effects!in!subgroups!only.!
9.3!!!Analysis!Datasets!
Outcomes!will!be!compared!using!intentJtoJtreat!analyses!!
!
9.4!Sample!Size!
Using!standard!methods!for!power!calculations!and!α=.05,!a!randomized!trial!comparing!two!arms!with!
150!participants!in!each!arm!will!have!80%!power!to!detect!the!differences!in!proportions!of!study!
endpoints!in!the!two!arms!shown!in!Figure!3.!This!power!will!be!sufficient!to!detect!meaningful!differences!
between!the!study!arms!and!achieve!our!study!aims.!For!example,!we!will!have!80%!power!to!detect!a!
difference!if!66%!of!participants!initiate!antiviral!therapy!in!an!intervention!arm!and!50%!in!the!control!arm!
do.!Differences!between!the!arms!of!20%!or!more!in!any!outcome!will!be!detectable!(see!Figure!3).!
These!are!clinically!meaningful!differences!and!are!conservative!estimates!of!our!anticipated!effect!
sizes.!sert!Text>!
!
9.5!!Measures!to!Minimize!Bias!
As!described!above,!participants!will!be!randomized!after!conducting!baseline!survey!to!either!the!
Accessible!Care!or!Usual!Care!arms.!!If!a!participant!withdrawals!from!the!study,!no!replacement!will!be!
made.!!!
!
The!study!is!not!blinded.!
!
10! Source!Documents!and!Access!to!Source!Data/Documents!
!
Source!data!is!all!information,!original!records!of!clinical!findings,!observations,!or!other!activities!in!a!
clinical!trial!necessary!for!the!reconstruction!and!evaluation!of!the!trial.!!Source!data!are!contained!in!
source!documents.!!Examples!of!these!original!documents,!and!data!records!include:!hospital!records,!
clinical!and!office!charts,!laboratory!notes,!memoranda,!subjects’!diaries!or!evaluation!checklists,!
pharmacy!dispensing!records,!recorded!data!from!automated!instruments,!copies!or!transcriptions!
certified!after!verification!as!being!accurate!and!complete,!microfiches,!photographic!negatives,!microfilm!
or!magnetic!media,!xJrays,!subject!files,!and!records!kept!at!the!pharmacy,!at!the!laboratories,!and!at!
medicoJtechnical!departments!involved!in!the!clinical!trial.!It!is!acceptable!to!use!CRFs!as!source!
documents.!If!this!is!the!case,!it!should!be!stated!in!this!section!what!data!will!be!collected!on!CRFs!and!
what!data!will!be!collected!from!other!sources.!
!
The!study!case!report!form!(CRF)!is!the!primary!data!collection!instrument!for!the!study.!!All!data!
requested!on!the!CRF!must!be!recorded.!!All!missing!data!must!be!explained.!!If!a!space!on!the!CRF!is!
left!blank!because!the!procedure!was!not!done!or!the!question!was!not!asked,!write!“N/D”.!!If!the!item!is!
not!applicable!to!the!individual!case,!write!“N/A”.!!All!entries!should!be!printed!legibly!in!black!ink.!!If!any!
entry!error!has!been!made,!to!correct!such!an!error,!draw!a!single!straight!line!through!the!incorrect!entry!
and!enter!the!correct!data!above!it.!!All!such!changes!must!be!initialed!and!dated.!!DO!NOT!ERASE!OR!

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WHITE!OUT!ERRORS.!!For!clarification!of!illegible!or!uncertain!entries,!print!the!clarification!above!the!
item,!then!initial!and!date!it.!
!
!
Access!to!study!records!will!be!limited!to!IRBJapproved!members!of!the!study!team.!The!investigator!will!
permit!studyJrelated!monitoring,!audits,!and!inspections!by!the!IRB/EC,!the!sponsor,!government!
regulatory!bodies,!and!University!compliance!and!quality!assurance!groups!of!all!study!related!
documents!(e.g.!source!documents,!regulatory!documents,!data!collection!instruments,!study!data!etc.).!!
The!investigator!will!ensure!the!capability!for!inspections!of!applicable!studyJrelated!facilities!(e.g.!
pharmacy,!diagnostic!laboratory,!etc.).!
!
Participation!as!an!investigator!in!this!study!implies!acceptance!of!potential!inspection!by!government!
regulatory!authorities!and!applicable!University!compliance!and!quality!assurance!offices.!
!
11! Ethics/Protection!of!Human!Subjects!
11.1! Ethical!Standard!
!
The!investigator!will!ensure!that!this!study!is!conducted!in!full!conformity!with!Regulations!for!the!
Protection!of!Human!Subjects!of!Research!codified!in!45!CFR!Part!46,!21!CFR!Part!50,!21!CFR!Part!56,!
and/or!the!ICH!E6.!
!
11.2! Institutional!Review!Board!
!
The!protocol,!informed!consent!form(s),!recruitment!materials,!and!all!participant!materials!will!be!
submitted!to!the!IRB!for!review!and!approval.!Approval!of!both!the!protocol!and!the!consent!form!must!be!
obtained!before!any!participant!is!enrolled.!Any!amendment!to!the!protocol!will!require!review!and!
approval!by!the!IRB!before!the!changes!are!implemented!to!the!study.!All!changes!to!the!consent!form!
will!be!IRB!approvedl!a!determination!will!be!made!regarding!whether!previously!consented!participants!
need!to!be!reJconsented.!
!
11.3! Informed!Consent!Process!
11.3.1! Consent/Assent!and!Other!Informational!Documents!Provided!to!Participants!
!
Consent!forms!describing!in!detail!the!study!agent,!study!procedures,!and!risks!are!given!to!the!
participant!and!written!documentation!of!informed!consent!is!required!prior!to!starting!
intervention/administering!study!product.!The!following!consent!materials!are!submitted!with!this!protocol.!
J!
Screening!Consent!
J!
Accessible!Care!Consent!
!
11.3.2! Consent!Procedures!and!Documentation!
!
Informed!consent!is!a!process!that!is!initiated!prior!to!the!individual’s!agreeing!to!participate!in!the!study!
and!continues!throughout!the!individual’s!study!participation.!Extensive!discussion!of!risks!and!possible!
benefits!of!participation!will!be!provided!to!the!participants!and!their!families.!Consent!forms!will!be!IRBJ
approved!and!the!participant!will!be!asked!to!read!and!review!the!document.!The!investigator!will!explain!
the!research!study!to!the!participant!and!answer!any!questions!that!may!arise.!All!participants!will!receive!
a!verbal!explanation!in!terms!suited!to!their!comprehension!of!the!purposes,!procedures,!and!potential!

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risks!of!the!study!and!of!their!rights!as!research!participants.!Participants!will!have!the!opportunity!to!
carefully!review!the!written!consent!form!and!ask!questions!prior!to!signing.!The!participants!should!have!
the!opportunity!to!discuss!the!study!with!their!surrogates!or!think!about!it!prior!to!agreeing!to!participate.!
The!participant!will!sign!the!informed!consent!document!prior!to!any!procedures!being!done!specifically!
for!the!study.!The!participants!may!withdraw!consent!at!any!time!throughout!the!course!of!the!trial.!A!
copy!of!the!signed!informed!consent!document!will!be!given!to!the!participants!for!their!records.!The!
rights!and!welfare!of!the!participants!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.!
!
A!copy!of!the!signed!informed!consent!document!will!be!stored!in!the!subject’s!research!record.!The!
consent!process,!including!the!name!of!the!individual!obtaining!consent,!will!be!thoroughly!documented!in!
the!subject’s!research!record.!Any!alteration!to!the!standard!consent!process!(e.g.!use!of!a!translator,!
consent!from!a!legally!authorized!representative,!consent!document!presented!orally,!etc.)!and!the!
justification!for!such!alteration!will!likewise!be!documented.!!
!
11.4! Participant!and!Data!Confidentiality!
!
Information!about!study!subjects!will!be!kept!confidential!and!managed!according!to!the!requirements!of!
the!Health!Insurance!Portability!and!Accountability!Act!of!1996!(HIPAA).!!Those!regulations!require!a!
signed!subject!authorization!informing!the!subject!of!the!following:!!
•! What!protected!health!information!(PHI)!will!be!collected!from!subjects!in!this!study!
•! Who!will!have!access!to!that!information!and!why!
•! Who!will!use!or!disclose!that!information!!
•! The!rights!of!a!research!subject!to!revoke!their!authorization!for!use!of!their!PHI.!!
!
In!the!event!that!a!subject!revokes!authorization!to!collect!or!use!PHI,!the!investigator,!by!regulation,!
retains!the!ability!to!use!all!information!collected!prior!to!the!revocation!of!subject!authorization.!!For!
subjects!that!have!revoked!authorization!to!collect!or!use!PHI,!attempts!should!be!made!to!obtain!
permission!to!collect!at!least!vital!status!(i.e.!that!the!subject!is!alive)!at!the!end!of!their!scheduled!study!
period.!
!
Participant!confidentiality!is!strictly!held!in!trust!by!the!participating!investigators,!their!staff,!and!the!
sponsor(s)!and!their!agents.!This!confidentiality!is!extended!to!cover!testing!of!biological!samples!and!
genetic!tests!in!addition!to!the!clinical!information!relating!to!participants.!Therefore,!the!study!protocol,!
documentation,!data,!and!all!other!information!generated!will!be!held!in!strict!confidence.!No!information!
concerning!the!study!or!the!data!will!be!released!to!any!unauthorized!third!party!without!prior!written!
approval!of!the!sponsor.!
!
The!study!monitor,!other!authorized!representatives!of!the!sponsor,!representatives!of!the!IRB!or!
pharmaceutical!company!supplying!study!product!may!inspect!all!documents!and!records!required!to!be!
maintained!by!the!investigator,!including!but!not!limited!to,!medical!records!(office,!clinic,!or!hospital)!and!
pharmacy!records!for!the!participants!in!this!study.!The!clinical!study!site!will!permit!access!to!such!
records.!
!
The!study!participant’s!contact!information!will!be!securely!stored!at!each!clinical!site!for!internal!use!
during!the!study.!At!the!end!of!the!study,!all!records!will!continue!to!be!kept!in!a!secure!location!for!as!
long!a!period!as!dictated!by!local!IRB!and!Institutional!regulations.!
!
Study!participant!research!data,!which!is!for!purposes!of!statistical!analysis!and!scientific!reporting,!will!
be!transmitted!to!and!stored!at!NYU!Langone!Medical!Center.!This!will!not!include!the!participant’s!
contact!or!identifying!information.!Rather,!individual!participants!and!their!research!data!will!be!identified!
by!a!unique!study!identification!number.!The!study!data!entry!and!study!management!systems!used!by!
clinical!sites!and!by!NYU!Langone!Medical!Center!research!staff!will!be!secured!and!password!protected.!

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At!the!end!of!the!study,!all!study!databases!will!be!deJidentified!and!archived!at!the!NYU!Langone!
Medical!Center.!
!
!
11.4.1! Research!Use!of!Stored!Human!Samples,!Specimens,!or!Data!
!
•! Intended!Use:!Samples!and!data!collected!under!this!protocol!may!be!used!to!study!the!
heterogeneity!of!hepatitis!C!virus!within!our!population,!and!other!viral!characteristics.!No!genetic!
testing!will!be!performed.!
•! Storage:!Access!to!stored!samples!will!be!limited!using!stored!plasma.!!!Samples!and!data!will!be!
stored!using!codes!assigned!by!the!investigators.!Data!will!be!kept!in!passwordJprotected!
computers.!Only!investigators!will!have!access!to!the!samples!and!data.!
•! Tracking:!Data!will!be!tracked!using!deJidentified!participants!codes.!
o!
Disposition!at!the!completion!of!the!study:!All!stored!samples!will!be!sent!to!a!Weill!
Cornell!Clinical!and!Translational!Science!Center!for!Storage.!Study!participants!who!
request!destruction!of!samples!will!be!notified!of!compliance!with!such!request!and!all!
supporting!details!will!be!maintained!for!tracking.!
11.5! Future!Use!of!Stored!Specimens!
!
Data!collected!for!this!study!will!be!analyzed!and!stored!at!the!Weill!Cornell!Medicine!(clinical!data)!and!
the!National!Development!and!Research!Institutes!(behavioral!data).!!After!the!study!is!completed,!the!
deJidentified,!archived!data!will!be!transmitted!to!and!stored!at!the!National!Development!and!Research!
Institute,!under!the!supervision!of!Pedro!MateuJGelabert,!for!use!by!other!researchers!including!those!
outside!of!the!study.!Permission!to!transmit!data!to!the!data!repository!will!be!included!in!the!informed!
consent.!
!
With!the!participant’s!approval!and!as!approved!by!local!IRs,!deJidentified!biological!samples!will!be!
stored!at!the!Weill!Cornell!Clinical!and!Translational!Science!Center.!!These!samples!could!be!used!for!
research!into!the!causes!of!hepatitis!C,!its!complications!and!other!conditions!for!which!individuals!with!
hepatitis!C!are!at!increased!risk,!and!to!improve!treatment.!The!Weill!Cornell!Clinical!and!Translational!
Science!Center!will!also!be!provided!with!a!codeJlink!that!will!allow!linking!the!biological!specimens!with!
the!phenotypic!data!from!each!participant,!maintaining!the!masking!of!the!identity!of!the!participant.!
!
During!the!conduct!of!the!study,!an!individual!participant!can!choose!to!withdraw!consent!to!have!
biological!specimens!stored!for!future!research.!However,!withdrawal!of!consent!with!regard!to!biosample!
storage!will!not!be!possible!after!the!study!is!completed.!
!
When!the!study!is!completed,!access!to!study!data!and/or!samples!will!be!provided!through!the!Weill!
Cornell!Clinical!and!Translational!Science!Center.!
!
12! Data!Handling!and!Record!Keeping!
12.1! Data!Collection!and!Management!Responsibilities!
!
Data!collection!is!the!responsibility!of!the!clinical!trial!staff!at!the!site!under!the!supervision!of!the!site!PI.!
The!investigator!is!responsible!for!ensuring!the!accuracy,!completeness,!legibility,!and!timeliness!of!the!
data!reported.!
!
All!source!documents!should!be!completed!in!a!neat,!legible!manner!to!ensure!accurate!interpretation!of!
data.!Black!ink!is!required!to!ensure!clarity!of!reproduced!copies.!When!making!changes!or!corrections,!

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cross!out!the!original!entry!with!a!single!line,!and!initial!and!date!the!change.!DO!NOT!ERASE,!
OVERWRITE,!OR!USE!CORRECTION!FLUID!OR!TAPE!ON!THE!ORIGINAL.!
!
Copies!of!the!electronic!CRF!(eCRF)!will!be!provided!for!use!as!source!documents!and!maintained!for!
recording!data!for!each!participant!enrolled!in!the!study.!Data!reported!in!the!eCRF!derived!from!source!
documents!should!be!consistent!with!the!source!documents!or!the!discrepancies!should!be!explained!
and!captured!in!a!progress!note!and!maintained!in!the!participant’s!official!electronic!study!record.!
!
Clinical!data!(including!AEs,!concomitant!medications,!and!expected!adverse!reactions!data)!and!clinical!
laboratory!data!will!be!entered!into!ONA,!a!21!CFR!Part!11Jcompliant!data!capture!system!provided!by!
the!National!Development!and!Research!Institute.!The!data!system!includes!password!protection!and!
internal!quality!checks,!such!as!automatic!range!checks,!to!identify!data!that!appear!inconsistent,!
incomplete,!or!inaccurate.!Clinical!data!will!be!entered!directly!from!the!source!documents.!
!
12.2! Study!Records!Retention!
!
Study!documents!will!be!retained!for!the!longer!of!3!years!after!closeJout,!5!years!after!final!
reporting/publication,!or!2!years!after!the!last!approval!of!a!marketing!application!is!approved!for!the!drug!
for!the!indication!for!which!it!is!being!investigated!or!2!years!after!the!investigation!is!discontinued!and!
FDA!is!notified!if!no!application!is!to!be!filed!or!if!the!application!has!not!been!approved!for!such!
indication.!No!records!will!be!destroyed!without!the!written!consent!of!the!sponsor,!if!applicable.!It!is!the!
responsibility!of!the!sponsor!to!inform!the!investigator!when!these!documents!no!longer!need!to!be!
retained.!
!
12.3! Protocol!Deviations!
!
A!protocol!deviation!is!any!noncompliance!with!the!clinical!trial!protocol,!GCP,!or!Manual!of!Procedures!
(MOP)!requirements.!The!noncompliance!may!be!either!on!the!part!of!the!participant,!the!investigator,!or!
the!study!site!staff.!As!a!result!of!deviations,!corrective!actions!are!to!be!developed!by!the!site!and!
implemented!promptly.!
!
These!practices!are!consistent!with!ICH!E6:!
•! 4.5!Compliance!with!Protocol,!sections!4.5.1,!4.5.2,!and!4.5.3!
•! 5.1!Quality!Assurance!and!Quality!Control,!section!5.1.1!
•! 5.20!Noncompliance,!sections!5.20.1,!and!5.20.2.!
!
It!is!the!responsibility!of!the!site!PI/study!staff!to!use!continuous!vigilance!to!identify!and!report!deviations!
within!five!working!days!of!identification!of!the!protocol!deviation,!or!within!five!working!days!of!the!
scheduled!protocolJrequired!activity.!
!
All!protocol!deviations!must!be!addressed!in!study!source!documents,!and!reported!to!NIDA!Program!
Official.!
!
Protocol!deviations!must!be!reported!to!the!local!IRB!per!their!guidelines.!The!site!PI/study!staff!is!
responsible!for!knowing!and!adhering!to!their!IRB!requirements.!Further!details!about!the!handling!of!
protocol!deviations!will!be!included!in!the!MOP.!
!
12.4! Publication!and!Data!Sharing!Policy!
!
This!study!will!comply!with!the!NIH!Public!Access!Policy,!which!ensures!that!the!public!has!access!to!the!
published!results!of!NIH!funded!research.!It!requires!scientists!to!submit!final!peerJreviewed!journal!

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manuscripts!that!arise!from!NIH!funds!to!the!digital!archive!PubMed!Central!upon!acceptance!for!
publication.!
!
The!International!Committee!of!Medical!Journal!Editors!(ICMJE)!member!journals!have!adopted!a!clinical!
trials!registration!policy!as!a!condition!for!publication.!The!ICMJE!defines!a!clinical!trial!as!any!research!
project!that!prospectively!assigns!human!subjects!to!intervention!or!concurrent!comparison!or!control!
groups!to!study!the!causeJandJeffect!relationship!between!a!medical!intervention!and!a!health!outcome.!
Medical!interventions!include!drugs,!surgical!procedures,!devices,!behavioral!treatments,!processJofJcare!
changes,!and!the!like.!Health!outcomes!include!any!biomedical!or!healthJrelated!measures!obtained!in!
patients!or!participants,!including!pharmacokinetic!measures!and!adverse!events.!The!ICMJE!policy,!and!
the!Section!801!of!the!Food!and!Drug!Administration!Amendments!Act!of!2007,!requires!that!all!clinical!
trials!be!registered!in!a!public!trials!registry!such!as!ClinicalTrials.gov,!which!is!sponsored!by!the!National!
Library!of!Medicine.!Other!biomedical!journals!are!considering!adopting!similar!policies.!For!interventional!
clinical!trials!performed!under!NIH!IC!grants!and!cooperative!agreements,!it!is!the!grantee’s!responsibility!
to!register!the!trial!in!an!acceptable!registry,!so!the!research!results!may!be!considered!for!publication!in!
ICMJE!member!journals.!The!ICMJE!does!not!review!specific!studies!to!determine!whether!registration!is!
necessaryl!instead,!the!committee!recommends!that!researchers!who!have!questions!about!the!need!to!
register!err!on!the!side!of!registration!or!consult!the!editorial!office!of!the!journal!in!which!they!wish!to!
publish.!
!
FDAAA!mandates!that!a!"responsible!party"!(i.e.,!the!sponsor!or!designated!principal!investigator)!register!
and!report!results!of!certain!"applicable!clinical!trials":!
!
•! Trials!of!Drugs!and!Biologics:!Controlled,!clinical!investigations,!other!than!Phase!I!investigations!
of!a!product!subject!to!FDA!regulationl!
•! Trials!of!Devices:!Controlled!trials!with!health!outcomes!of!a!product!subject!to!FDA!regulation!
(other!than!small!feasibility!studies)!and!pediatric!postmarket!surveillance!studies.!
•! NIH!grantees!must!take!specific!steps!to!ensure!compliance!with!NIH!implementation!of!FDAAA.!
!
13! Study!Finances!
13.1! Funding!Source!
National!Institute!on!Drug!Abuse!
!
13.2! Costs!to!the!Participant!
None!
!
13.3! Participant!Reimbursements!or!Payments!
Participants!will!receive!cash!compensation!for!completing!the!research!questionnaires!(and,!if!
applicable,!providing!blood)!that!are!a!part!of!this!study,!of!which!there!will!be!at!least!four.!The!first!
research!visit!is!the!longest!and!is!anticipated!to!take!between!60J90!minutes.!The!subsequent!research!
visits!should!take!between!60!and!75!minutes.!Participants!will!not!be!compensated!for!seeing!the!care!
coordinator,!attending!medical!visits,!or!undergoing!hepatitis!C!treatment.!Participants!will!be!
compensated!for!each!of!the!research!visits!which!include!questionnaire!and,!if!applicable,!drawing!blood.!
The!compensation!schedule!is!as!follows:!$60!for!first!research!visitl!$50!for!the!second!and!third!
research!visit!(approximately!at!3!and!6!months!of!first!research!visit)l!$60!for!the!forth!research!visit!
(approximately!at!9!months!of!first!research!visit/interview)l!and!$70!for!the!fifth!research!Page!8!of!37!
10/31/17!10:51!AM!visit!(approximately!at!12!months!of!first!research!visit/interview).!$40!for!subsequent!
research!visits,!if!any.!$50!for!qualitative!interview!if!the!participant!is!asked!and!agrees!to!participate.!$5!
for!each!monthly!checkJin!visit!These!compensations!will!be!received!in!cash!at!the!study!visit.!
!

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Participants!will!be!compensated!$20!for!referral!of!a!new!participant.!!Participates!will!be!eligible!for!this!
compensation!regardless!of!whether!the!new!participant!enrolls!in!the!study.!
!
!
14! Conflict!of!Interest!Policy!
!
The!independence!of!this!study!from!any!actual!or!perceived!influence,!such!as!by!the!pharmaceutical!
industry,!is!critical.!Therefore!any!actual!conflict!of!interest!of!persons!who!have!a!role!in!the!design,!
conduct,!analysis,!publication,!or!any!aspect!of!this!trial!will!be!disclosed!and!managed.!Furthermore,!
persons!who!have!a!perceived!conflict!of!interest!will!be!required!to!have!such!conflicts!managed!in!a!
way!that!is!appropriate!to!their!participation!in!the!trial.!The!study!leadership!in!conjunction!with!the!NIDA!
has!established!policies!and!procedures!for!all!study!group!members!to!disclose!all!conflicts!of!interest!
and!will!establish!a!mechanism!for!the!management!of!all!reported!dualities!of!interest.!!
!
Any!investigator!who!has!a!conflict!of!interest!with!this!study!(patent!ownership,!royalties,!or!financial!gain!
greater!than!the!minimum!allowable!by!their!institution,!etc.)!must!have!the!conflict!reviewed!by!the!NYU!
Langone!Conflict!of!Interest!Management!Unit!(CIMU)!with!a!CommitteeJsanctioned!conflict!management!
plan!that!has!been!reviewed!and!approved!by!the!study!sponsor!prior!to!participation!in!this!study.!All!
NYULMC!investigators!will!follow!the!applicable!conflict!of!interest!policies.!
!
!
!

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15! Attachments!
These!documents!are!relevant!to!the!protocol,!but!they!are!not!considered!part!of!the!protocol.!!They!are!
stored!and!modified!separately.!As!such,!modifications!to!these!documents!do!not!require!protocol!
amendments.!
!
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