Peer Recovery Coaching to Facilitate Comprehensive HCV, HIV and Opioid Use Disorder Treatment: A Pilot Study
Phase: NA
Conditions: Hepatitis C, HIV Infections, Opioid-use Disorder
Sponsor: Boston Medical Center

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 1 of 18 
 
Peer Recovery Coaching to Facilitate Comprehensive Infectious Diseases Prevention and Care 
among Patients with Opioid Use Disorder: An Open Pilot Study 
 
NCT 04314414 
Protocol Version Number: V1 
Protocol Version Date: July 07, 2020  
Funding Mechanism:  NIH CTSI 
Principal Investigator: Sabrina Assoumou, MD MPH 
 
Phone: 617-414-2896 
 
E-mail: sabrina.assoumou@bmc.org 
 
 
 
Statistical Plan page 15 
 
 
 
CONFIDENTIAL 
 
This document is confidential and the property of Boston Medical Center / Boston 
University. No part of it may be transmitted, reproduced, published, or used by 
other persons without prior written authorization from the study sponsor. 
 
 

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 2 of 18 
TABLE OF CONTENTS 
1 List of Abbreviations .............................................................................................................. 3 
2 Protocol Summary .................................................................................................................. 3 
3 Background/Rationale & Purpose ....................................................................................... 3 
3.1 Background Information .............................................................................................. 3 
3.2 Rationale and Purpose ................................................................................................ 5 
4 Objectives ................................................................................................................................ 5 
4.1 Study Objectives ........................................................................................................... 5 
4.1.1 
Primary Outcome Measures ......................................................................... 6 
4.1.2 
Secondary Outcome Measures ................................................................... 6 
5 Study Design ........................................................................................................................... 6 
6 Potential Risks and Benefits ................................................................................................. 8 
6.1 Risks ............................................................................................................................... 8 
6.2 Potential Benefits .......................................................................................................... 8 
6.3 Analysis of Risks in Relation to Benefits ................................................................... 9 
7 Study Subject Selection ........................................................................................................ 9 
7.1 Subject Inclusion Criteria ............................................................................................. 9 
7.2 Subject Exclusion Criteria ........................................................................................... 9 
8 Study Intervention .................................................................................................................. 9 
9 Study Procedures ................................................................................................................. 10 
10 Assessment of Safety and Data Safety Monitoring Plan (DSMP) ................................ 11 
10.1 Definitions .................................................................................................................... 11 
10.2 Safety Review ............................................................................................................. 12 
10.3 Reporting Plans .......................................................................................................... 12 
10.4 Stopping Rules ............................................................................................................ 12 
11 Data Handling and Record Keeping .................................................................................. 12 
11.1 Confidentiality .............................................................................................................. 13 
11.2 Source Documents ..................................................................................................... 13 
11.3 Case Report Forms .................................................................................................... 13 
11.4 Study Records Retention .......................................................................................... 14 
12 Statistical Plan ...................................................................................................................... 14 
12.1 Study Hypotheses ...................................................................................................... 14 
12.2 Sample Size Determination ...................................................................................... 14 
12.3 Statistical Methods ..................................................................................................... 15 
13 Ethics/Protection of Human Subjects ................................................................................ 15 
14 Literature References .......................................................................................................... 15 
15 Appendix ................................................................................................................................ 17 

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 3 of 18 
 
 
1 
List of Abbreviations 
 
Abbreviation 
Abbreviation definition 
HIV  
Human immunodeficiency virus 
HCV 
Hepatitis C 
PRC 
Peer recovery coach 
PrEP 
Pre-exposure prophylaxis 
 
2 
Protocol Summary 
 
Title: 
Recovery coaching for HIV, HCV and substance use 
Population: 
We will include 40 individuals with a history of substance 
use disorder who are seen at the Boston Medical 
Center’s (BMC) Faster Paths (urgent care walk-in clinic).  
Intervention: 
Peer recovery coaching (PRC) to improve linkage to HIV 
prevention in the form of HIV pre-exposure prophylaxis 
(PrEP) and hepatitis C (HCV) treatment. 
Objectives: 
Our goal is to determine if a peer recovery coaching 
intervention will help patients initiate HIV prevention in 
the form of HIV pre-exposure prophylaxis (PrEP), HCV 
treatment and substance use disorder (SUD) treatment. 
Design/Methodology: 
Participants who consent will work one-on-one with a 
peer recovery coach who will provide support and linkage 
to various HIV, HCV and SUD resources.  
Total Study Duration: 
Time from initial enrollment until completion of data 
analysis= 12 months 
 
Subject Participation 
Duration: 
Time it will take to conduct the study for each individual 
participant =6 months 
 
3 
Background/Rationale & Purpose 
 
3.1 Background Information 
 
 
The U.S. opioid epidemic is associated with a surge in human immunodeficiency 
(HIV) and hepatitis C virus (HCV) infections among persons who inject drugs (PWID).1, 2 
HIV pre-exposure prophylaxis (PrEP) and HCV curative therapy are evidence-based 
interventions that are recommended for PWID to prevent HIV and HCV transmission, 
respectively.3, 4 These evidence-based tools have, however, not been widely adopted in 

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 4 of 18 
real-world settings where individuals at-risk access care.5 We have published studies on 
models of care to improve outcomes related to infectious complications of substance 
use such as HIV and HCV. In terms of HIV prevention, we determined in a survey of 
individuals admitted to a drug detoxification center that participants had limited 
knowledge of HIV PrEP, but expressed interest in this biomedical prevention method.6 
As for our work related to HCV, we demonstrated that the majority of individuals with 
substance use disorder tested for HCV at a drug detoxification center do not link to HCV 
care and that active substance use was a major barrier to accessing curative HCV 
therapy.7, 8 Participants also reported the need for walk-in high-touch care to assist with 
navigation along the HCV continuum of care. In addition to our work related to HIV and 
HCV care, members of our team have also shown that a peer-delivered brief 
motivational intervention was effective in assisting individuals to abstain from heroin 
and/or cocaine use.9 This intervention delivered by non-professionals who are 
themselves in recovery has been widely replicated around the country to address 
substance use; however, little is known about its potential role in improving HIV and 
HCV outcomes among individuals with opioid use disorder.  
Our long-term goal is to improve HIV and HCV prevention and treatment 
outcomes among at-risk individuals with history of substance use. The goal of the 
current proposal is to determine the efficacy of a brief motivational peer recovery 
coaching (PRC) intervention to improve infectious diseases (HIV/HCV) prevention and 
care alongside substance use disorder (SUD) management for PWID. PRC will bridge 
the gap between professional assistance in clinical settings and sustainable recovery in 
the community. Our multisite study will be performed at low-barrier BMC FASTER 
PATHS bridge clinic  (the Boston Medical Center Faster Paths walk-in bridge clinic) 
which links individuals with SUD to evidence-based addiction treatment such as 
buprenorphine and methadone.10 Bridge clinics have been especially valuable for 
engaging individuals who do not always feel comfortable in traditional clinical settings. 
The central hypothesis of the current study is that a PRC intervention will be effective in 
improving HIV, HCV and substance use outcomes.  
Potential risks associated with participation in the study include risk associated 
with discussing issues related to HIV, HCV or substance use disorder and risk of breach 
in confidentially. Related to emotional risk, if any participant were to experience any 
distress we will remind him/her of his/her right to decline answering any questions. In 
terms of risk of breach in confidentiality, the research staff will be trained in the 
importance of assuring confidentiality in record keeping. In addition, all documents will 
be kept in locket cabinets and computers will be password protected. In addition, the 
study will be conducted in compliance with the protocol, applicable regulatory 

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 5 of 18 
requirements, and BMC/BU Medical Campus Human Research Protection policies and 
procedures. 
 
3.2 Rationale and Purpose  
The U.S. opioid epidemic is associated with a surge in human immunodeficiency (HIV) 
and hepatitis C virus (HCV) infections among persons who inject drugs (PWID). HIV 
pre-exposure prophylaxis (PrEP) and HCV curative therapy are evidence-based tools 
that are recommended for PWID. These evidence-based measures have, however, not 
been widely adopted in real-world settings. A peer-delivered brief motivational 
intervention was shown to be effective in assisting individuals to abstain from heroin 
and/or cocaine use, but little is known about its potential role in improving HIV and/or 
HCV-related outcomes among individuals with opioid use disorder.  
4 
Objectives 
 
4.1 Study Objectives 
 
The goal of the current proposal is to determine the feasibility and acceptability of a 
peer recovery coaching (PRC) intervention to improve infectious diseases (HIV/HCV) 
prevention and care alongside treatment for opioid use disorder.  
 
Aim 1: To implement a pilot peer recovery coaching intervention at a walk-in low-
barrier bridge clinic to increase uptake of a comprehensive intervention for HIV 
PrEP, HCV  and substance use treatment among PWID accessing care at Boston 
Medical Center (BMC). 
 
Aim 2: To determine the feasibility and acceptability of a combined PrEP, HCV 
and substance use treatment intervention at the BMC FASTER PATHS bridge 
clinic 
 
We hypothesize that the peer recovery coaching intervention will facilitate both access 
to PrEP, HCV treatment and sustained engagement with treatment for opioid use 
disorder among participants. The primary outcome is patient satisfaction as a measure 
of the intervention’s acceptability. Secondary outcomes will include (1) the proportion of 
patients with linkage to PrEP and treatment initiation within 3 months; (2) the proportion 
of patients with HCV treatment initiation within 3 months; (3) the proportion of patients 
with sustained linkage to opioid use treatment within 3 months (follow-up with at least 
one subsequent visit after the initial prescription for medication for opioid use disorder). 
 

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 6 of 18 
 
 
 
4.1.1 Primary Outcome Measures 
 
This is an open pilot study. The Primary outcome will include patient satisfaction as a 
measure of the peer recovery coach intervention’s acceptability. 
 
4.1.2 Secondary Outcome Measures 
 
Secondary outcomes will include the following: 
 
(1) The proportion of participants with linkage to care. 
(2) The proportion of participants retained in care 
(3) The following additional outcomes: 
 
HIV PrEP-related outcomes: Testing for sexually transmitted diseases including HIV, 
gonorrhea, chlamydia, syphilis, and hepatitis B and C. 
HCV continuum of care outcomes: HCV RNA testing, liver fibrosis staging, treatment 
initiation and cure. 
Opioid use disorder treatment-related outcomes: The proportion of individuals with 
repeat MOUD clinic visits and/or repeat prescriptions for opioid use disorder including 
buprenorphine and naltrexone, or linked to methadone treatment. 
 
 
5 
Study Design 
 
The study is prospective open pilot study (N=40). 
 
We will include 40 persons with a history of substance use recruited from the BMC 
FASTER PATHS bridge clinic, a facility caring for approximately 500 unique patients 
annually. The BMC FASTER PATHS bridge clinic provides universal HIV and HCV 
testing at the initial clinic intake. After reactive HCV testing, patients are linked to care at 
the BMC General Internal Medicine (GIM) primary care clinic.  
 
The goal of the current study is to determine feasibility and acceptability of a peer 
recovery coaching intervention to improve the uptake of HIV prevention, HCV treatment 

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 7 of 18 
and substance use treatment at a low-barrier bridge clinic. Along with the research 
assistant, the peer recovery coach is part of the research staff. The peer recovery coach 
will carry out the intervention (ie. use motivational interviewing to help participants 
address their history of opioid use while also accessing treatment for hepatitis C and 
HIV prevention methods). The peer recovery coach will carry out a baseline motivational 
interviewing intervention with participants and they will continue to follow the 
participants over a 6-month time frame.  Frequency of follow-up calls will vary 
depending on the participant’s need.  The recovery coach will initially start with weekly 
calls. 
 
As part of this study, we are partnering with Dr. Cruz, the PI for project RECOVER 
(Referral, Engagement, Case Management, and Overdose Prevention Education in 
Recovery), an HHS-funded study using peer recovery coaching to support individuals in 
recovery. Dr. Cruz is part of the General Internal Medicine section at BMC and he has 
experiences training recovery coaches for HHS-funded grant. He is a co-investigator on 
the current proposal. The project RECOVER team will provide assistance with hiring 
and training recovery coaches.  Recovery coach training will involve the following topics 
related to substance use: (1) Addiction 101 for recovery coaches; (2) Ethical 
considerations for recovery coaches; (3) Mental wellness and recovery coaching; (4) 
Cultural competency for recovery coaches; (5) Motivational interviewing for recovery 
coaches. In addition to the substance use related topics, we will also add information 
about HIV natural history, HIV prevention methods, PrEP efficacy studies, PrEP 
eligibility and medical management. 
 
The research assistant will be in charge of all the regulatory aspects of the research, 
recruitment (eg. approaching and consenting participants) and carrying out the baseline 
interviews to obtain demographic information. The research assistant will also review 
the participant’s electronic medical records to abstract information on key outcomes 
measures such as linkage to substance use care, HCV treatment or HIV prevention. 
 
• Recruitment: Participants will be recruited through flyers posted at the LBA walk-
in clinic and brief information provided at intake. 
 
o Flyers advertising the study will be placed in the waiting and common 
areas of the BMC FASTER PATHS bridge clinic.  
 
• Flyers advertising the study will be placed in the waiting and common areas of 
the BMC Faster Paths walk-in clinic. Patients will be approached for participation 

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 8 of 18 
after the medical provider has explained the study at length. Some participants 
will reach out to our study staff through flyer contact information, while 
other participants will be pre-screened by medical providers and referred to the 
RA.  Using an electronic medical record (EMR), the RA will notify the medical 
provider prior to the visit so proper handoff can be made. Once the RA has 
initiated contact with interested participant, the RA will provide a description of 
the study including its objectives and will provide adequate time for participants 
to ask questions and address concerns. Risks and benefits of the study will be 
discussed and interested individuals will be reminded that participation is 
voluntary. The RA will emphasize that participation in the study will not impact 
the care received at the Faster Paths clinic and that individuals may withdraw 
from the study at any time. Those who wish to be involved with the study will 
provide informed consent. The RA will obtain reason for refusal if approached 
individuals are not interested in participating in the study. After reactive HCV 
testing at the BMC Faster Paths walk-in clinic, all participants will be linked to 
care at the BMC General Internal Medicine (GIM) clinic. 
 
 
6 
Potential Risks and Benefits 
 
6.1 Risks 
 
Participation in the study includes risks associated with emotional distress related to 
discussing HIV or HCV status and history of substance use disorder. There is also a 
risk of possible breach of confidentiality. In terms of emotional distress, participants 
will be informed that they can choose to not answer some question that might be 
uncomfortable and end the interview early if he/she were to experience any 
emotional distress. 
 
There is also a potential risk of breach in confidentiality. We will take steps to 
prevent this by keeping information in locked cabinets and using computers with 
password protection. 
 
 
6.2 Potential Benefits 
 
There will be no direct benefits to participants from taking part in the study; however, 
the information collected will help improve the care of patients with a history of 
substance use disorder with or at risk for HIV and HCV.  
 
Participants will receive $20 for your participation in each interview session with the 
RA at baseline, 3-and 6 months post-enrollment.  

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 9 of 18 
 
6.3 Analysis of Risks in Relation to Benefits 
 
As noted above, the information collected will help improve the care of patients with a 
history of substance use disorder with or at risk for HIV and HCV. 
 
 
7 
Study Subject Selection 
 
7.1 Subject Inclusion Criteria 
 
• Inclusion criteria 
 
o Must be at least 18 years of age at time of enrollment. 
o Individuals with opioid use disorder, non-reactive HIV antibody test and 
reactive HCV antibody testing at the BMC low-barrier bridge walk-in clinic. 
o Participants providing contact information of two family members or 
friends. 
o Individuals signing a medical records release form. 
 
 
 
 
7.2 Subject Exclusion Criteria 
 
An individual who meets any of the following criteria will be excluded from participation 
in this study: 
o Individuals unable to provide informed consent 
o Unable to speak English 
o Individuals already linked to substance use care 
o Individuals co-infected with HIV and HCV and engaged in care. 
 
8 
Study Intervention 
 
• The intervention: The peer recovery coach with lived experience with 
recovery from substance use will deliver a semi-scripted brief motivational 
interview at the time of enrollment. The intervention will last approximately 

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 10 of 18 
20 minutes and will take place at the time of the clinical visit while 
participants are waiting to be seen by a clinician or are awaiting laboratory 
testing. The intervention will involve the following elements: establishing 
rapport, asking permission to discuss drugs, discussing the pros and cons 
associated with drug use, uncovering the gaps between current and 
desired quality of life and determining readiness to change. Participants 
will also receive a telephone booster call 5 days following enrollment. The 
RA will assemble detailed contact information for the patient and will 
record addresses of two family members or friends. The RA will also 
collect demographic information and reasons for refusal from individuals 
who do not participate in the study. Patients seen at the BMC FASTER 
PATHS bridge clinics usually follow-up at the general medicine clinics at 
BMC. Following the initial brief motivational interview, the peer recovery 
coach will remain in contact with participants by phone or in person at 
least once a week over the following 6-month period and help with 
facilitating linkage to HIV pre-exposure prophylaxis, HCV and substance 
use care and treatment. 
 
9 
Study Procedures 
 
• The study will be conducted at the low-barrier walk-in clinic at BMC. The clinic 
sees approximately 500 unique patients annually. After reactive HCV testing at 
the BMC LBA walk-in clinic, all participants will be linked to care at the BMC 
General Internal Medicine (GIM) clinic. Participants will be followed for 6 months. 
 
• Recruitment: Participants will be recruited through flyers posted at the LBA walk-
in clinic and brief information provided at intake. 
 
o Flyers advertising the study will be placed in the waiting and common 
areas of the BMC LBA clinic.  
 
A trained RA will perform baseline interviews, as well as 3- and 6-month post enrollment 
face-to-face interviews using assessments listed in Table 1. The RA will also review the 
electronic medical records (EMR) to obtain clinical data (HIV and HCV-related test 
results) as well as information on appointments. If we are not able to perform in-person 
interviews, then assessments will be performed over the phone, if possible.  For each 
participant we will determine:  
 
(1) The proportion of participants with linkage to care. 
(2) The proportion of participants retained in care 

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 11 of 18 
(3) The following additional outcomes: 
 
HIV PrEP-related outcomes: Testing for sexually transmitted diseases including HIV, 
gonorrhea, chlamydia, syphilis, and hepatitis B and C. 
HCV continuum of care outcomes: HCV RNA testing, liver fibrosis staging, treatment 
initiation and cure. 
 
Opioid use disorder treatment-related outcomes: The proportion of individuals with 
repeat medication for opioid use disorder (MOUD) clinic visits and/or repeat 
prescriptions for opioid use disorder including buprenorphine and naltrexone, or linked 
to methadone treatment. 
 
Table 1: List of data to be abstracted 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10 Assessment of Safety and Data Safety Monitoring Plan (DSMP) 
 
10.1 Definitions 
 
The following definitions will be used in the assessment of safety: 
 
Adverse Event (AE) is any untoward or unfavorable medical occurrence in a human 
subject, including any abnormal sign (for example, abnormal physical exam or 
laboratory finding), symptom, or disease, temporally associated with the subject’s 
Characteristic 
Description 
Demographics 
Age, gender, employment, housing, social support 
HIV PrEP clinical information 
HIV antibody, STI testing, prescription for PrEP 
HCV clinical information 
HCV viral load, genotype, fibrosis staging, HCV treatment 
HIV PrEP, HCV care, Addiction 
services 
Appointments attended 
Drug Use 
Types, ASI22, dependence by CIDI-SF23 
Urine testing, MOUD prescription  
Readiness to change ruler 
Self-assessment on readiness to change behavior and 
enter treatment 
Mental Health and Social 
Depression symptoms, stigma and disclosure 
*ASI=Addiction severity index; CIDI-SF=Composite International Diagnostic Interview Short 
Form; MOUD=Medication for opioid use disorder; PrEP=preexposure prophylaxis; 
STI=Sexually Transmitted Infection 

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 12 of 18 
participation in the research, whether or not considered related to the subject’s 
participation in the research. 
 
10.2 Safety Review 
 
Both the risks listed in Section 4.1 and unknown risks will be monitored as follows  
 
Data safety monitoring plan:  
 
The PI will continually monitor the safety of participants and study data.  Adverse events 
and unanticipated problems will be reviewed to detect any trends and threats to 
participant safety and concerns for breach of participant confidentiality.  Additional 
issues that arise will be routinely monitored by the PI.  Any adverse events will be 
reported to the IRB and the sponsor, as appropriate, and any necessary revisions to the 
protocol and/or standard operating procedures will be submitted for IRB review. 
 
10.3 Reporting Plans 
 
The Principal Investigator will report Unanticipated Problems and Adverse Events to 
IRB. Unanticipated Problems occurring at BMC/BU Medical Campus not involving a 
fatal or life-threatening event will be reported to the IRB within 7 days of the investigator 
learning of the event. Adverse Events (including Serious Adverse Events) will be 
reported in summary at the time of continuing review, along with a statement that the 
pattern of adverse events, in total, does not suggest that the research places subjects 
or others at a greater risk of harm than was previously known. Reports from safety 
monitors with no recommended changes will be reported to the IRB at the time of 
continuing review.  
 
10.4 Stopping Rules 
 
The study has no stopping rules.  
 
Right to Refuse or Withdraw 
 
Participation in the study is voluntary. Participants will have the right to refuse to take part in 
the study. If a participant decides to take part in the study and then were to change his/her 
mind, he/she will be able to withdraw from the research.  Withdrawing from the study would not 
impact the care received at BMC. 
 
11 Data Handling and Record Keeping 

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 13 of 18 
 
11.1 Confidentiality 
 
 
 
 
Confidentiality  
 
We will train research staff on the importance of maintaining confidentiality and assuring 
confidentiality of records.  In addition, participants will be assigned a unique study 
identifier, and their names will not be used.  All documents will be kept in locked 
cabinets in the study office. A master list of subjects’ names and code numbers will be 
stored in a locked file cabinet separate from the rest of the data. Only Dr. Assoumou 
and the study RA will have access to this information. The list will be destroyed upon 
completion of the study. All interviews and interventions will be conducted in private 
locations of the facility. All data will be kept confidential and stored in locked cabinets.  
Key drives and computers will be password protected. 
 
Certificate of Confidentiality  
 
To help us protect the privacy of participants, we have obtained a Certificate of 
Confidentiality from the National Institutes of Health. With this Certificate, the investigator 
cannot be forced to disclose information that may identify participants, even by a court 
subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other 
proceedings.  
11.2 Source Documents 
 
We will review patients’ electronic medical record at BMC to determine outcomes 
(linkage to care, initiation of HCV and HIV PrEP and substance use treatment). Data will 
be directly entered into a RedCap database including all the fields that will be necessary 
for the study. 
 
11.3 Case Report Forms 
 
The study case report form (CRF) will be the primary data collection instrument for the 
study. All data requested on the CRF will be recorded. All missing data will be 
explained. If a space on the CRF is left blank because the procedure was not done or 
the question was not asked, “N/D” will be written. If the item is not applicable to the 
individual case, “N/A” will be written. All entries will be printed legibly in black ink. If any 
entry error has been made, to correct such an error, a single straight line will be drawn 

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 14 of 18 
through the incorrect entry and the correct data will be entered above it. All such 
changes will be initialed and dated.  There will be no erasures or white-out on CRFs.  
For clarification of illegible or uncertain entries, the clarification will be printed above the 
item, then initialed and dated. The following source data will be recorded directly on the 
CRFs: data where the CRF will be the source document.   
 
See the Appendix for the following CRFs: list one or more CRF by name 
 
11.4 Study Records Retention 
 
Records will be maintained for seven years after the research is completed. 
 
12 Statistical Plan 
 
12.1 Study Hypotheses 
 
The goal of the current proposal is to determine the feasibility and acceptability of a 
peer recovery coaching (PRC) intervention to improve infectious diseases (HIV/HCV) 
prevention and care alongside treatment for opioid use disorder.  
 
Aim 1: To implement a pilot peer recovery coaching intervention at a walk-in low-
barrier bridge clinic to increase uptake of a comprehensive intervention for HIV 
PrEP, HCV and substance use treatment among PWID accessing care at BMC 
FASTER PATHS bridge clinic  
 
Aim 2: To determine the feasibility and acceptability of a combined PrEP, HCV 
and substance use treatment intervention at the BMC FASTER PATHS bridge 
clinic.  
We hypothesize that the peer recovery coaching intervention will facilitate both access 
to PrEP, HCV treatment and sustained engagement with treatment for opioid use 
disorder among participants. The primary outcome is patient satisfaction as a measure 
of the intervention’s acceptability. Secondary outcomes will include (1) the proportion of 
patients with linkage to PrEP and treatment initiation within 3 months; (2) the proportion 
of patients with HCV treatment initiation within 3 months; (3) the proportion of patients 
with sustained linkage to opioid use treatment within 3 months (follow-up with at least 
one subsequent visit after the initial prescription for medication for opioid use disorder). 
 
12.2 Sample Size Determination 
 

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 15 of 18 
Given the small sample size, we are not powered to show efficacy, but we will use 
findings to estimate the effect size for a future efficacy trial. 
 
 
12.3 Statistical Methods 
 
Primary outcome will include patient satisfaction as a measure of the PRC intervention’s 
acceptability. 
 
Qualitative semi-structured interviews will be audio recorded, professionally transcribed 
and analyzed using NVivo computer software. We will develop a codebook to determine 
acceptability and feasibility of the intervention, apply codes to all transcripts and analyze 
the data to identify emerging themes. We will also use descriptive statistics to 
summarize findings, and the Wilcoxon test to compare 5-point Likert scales between the 
two groups. For the secondary outcome, we will use descriptive statistics without 
hypothesis testing to compare outcomes in the intervention group to the current practice 
group. We will compare the two groups on demographic characteristics (age and 
gender), linkage to care, loss to follow-up and other secondary outcomes.  
 
13 Ethics/Protection of Human Subjects 
 
This study is to be conducted according to applicable US federal regulations and 
institutional policies (which are based in federal regulations, guidance, and ICH Good 
Clinical Practice guidelines). 
 
This protocol and any amendments will be submitted to the Boston Medical Center and 
Boston University Medical Campus IRB, for formal approval of the study conduct. The 
decision of the IRB concerning the conduct of the study will be made in writing to the 
investigator.  
 
All participants for this study will be provided a consent form describing this study and 
providing sufficient information for subjects to make an informed decision about their 
participation in this study. The consent form will be submitted with the protocol for 
review and approval by the IRB. The consent of a subject, using the IRB-approved 
consent form, must be obtained before that subject is submitted to any study procedure. 
Consent will be documented as required by the IRB.   
 
 
 
14 Literature References 

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 16 of 18 
 
1. 
Razavi H, Elkhoury AC, Elbasha E, Estes C, Pasini K, Poynard T, et al. Chronic 
hepatitis C virus (HCV) disease burden and cost in the United States. Hepatology. 
2013;57(6):2164-70. Epub 2013/01/03. doi: 10.1002/hep.26218. PubMed PMID: 
23280550; PubMed Central PMCID: PMC3763475. 
2. 
Hellard M, Doyle JS, Sacks-Davis R, Thompson AJ, McBryde E. Eradication of 
hepatitis C infection: the importance of targeting people who inject drugs. Hepatology. 
2014;59(2):366-9. doi: 10.1002/hep.26623. PubMed PMID: 23873507; PubMed Central 
PMCID: PMC4298812. 
3. 
Chhatwal J, Chen Q, Bethea ED, Hur C, Spaulding AC, Kanwal F. The impact of 
direct-acting anti-virals on the hepatitis C care cascade: identifying progress and gaps 
towards hepatitis C elimination in the United States. Alimentary pharmacology & 
therapeutics. 2019;50(1):66-74. Epub 2019/05/23. doi: 10.1111/apt.15291. PubMed 
PMID: 31115920. 
4. 
Epstein RL, Wang J, Hagan L, Mayer KH, Puro J, Linas BP, et al. Hepatitis C 
Virus Antibody Testing Among 13- to 21-Year-Olds in a Large Sample of US Federally 
Qualified Health Centers. JAMA : the journal of the American Medical Association. 
2019;322(22):2245-8. Epub 2019/12/11. doi: 10.1001/jama.2019.16196. PubMed PMID: 
31821424. 
5. 
Sabrina A. Assoumou, MD MPH; Samantha M. Paniagua, BA; Benjamin P. 
Linas, MD MPH; Jianing Wang, MSc; Jeffrey H. Samet, MD, MPH; Jonathan Hall, MM, 
LADC-1; Curt G. Beckwith, MD. Rapid vs. standard testing for HIV and HCV at a drug 
detox: a randomized trial (Poster Presentation). Conference on Retroviruses and 
Opportunistic Infections. March 4-7, 2018. 
6. 
Bernstein J, Bernstein E, Tassiopoulos K, Heeren T, Levenson S, Hingson R. 
Brief motivational intervention at a clinic visit reduces cocaine and heroin use. Drug and 
alcohol dependence. 2005;77(1):49-59. Epub 2004/12/21. doi: 
10.1016/j.drugalcdep.2004.07.006. PubMed PMID: 15607841. 
7. 
Hofmeister MG, Rosenthal EM, Barker LK, Rosenberg ES, Barranco MA, Hall 
EW, et al. Estimating Prevalence of Hepatitis C Virus Infection in the United States, 
2013-2016. Hepatology. 2019;69(3):1020-31. Epub 2018/11/07. doi: 
10.1002/hep.30297. PubMed PMID: 30398671; PubMed Central PMCID: 
PMCPMC6719781. 
8. 
Zibbell JE, Iqbal K, Patel RC, Suryaprasad A, Sanders KJ, Moore-Moravian L, et 
al. Increases in hepatitis C virus infection related to injection drug use among persons 
aged </=30 years - kentucky, tennessee, virginia, and west virginia, 2006-2012. MMWR 
Morbidity and mortality weekly report. 2015;64(17):453-8. Epub 2015/05/08. PubMed 
PMID: 25950251. 
9. 
Bernstein E, Bernstein J, Levenson S. Project ASSERT: an ED-based 
intervention to increase access to primary care, preventive services, and the substance 
abuse treatment system. Annals of emergency medicine. 1997;30(2):181-9. Epub 
1997/08/01. doi: 10.1016/s0196-0644(97)70140-9. PubMed PMID: 9250643. 

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 17 of 18 
10. 
Biancarelli DL, Biello KB, Childs E, Drainoni M, Salhaney P, Edeza A, et al. 
Strategies used by people who inject drugs to avoid stigma in healthcare settings. Drug 
and alcohol dependence. 2019;198:80-6. Epub 2019/03/19. doi: 
10.1016/j.drugalcdep.2019.01.037. PubMed PMID: 30884432; PubMed Central PMCID: 
PMCPMC6521691. 
11. 
Kay ES, Batey DS, Mugavero MJ. The HIV treatment cascade and care 
continuum: updates, goals, and recommendations for the future. (1742-6405 
(Electronic)). 
12. 
Orsmond Gi Fau - Cohn ES, Cohn ES. The Distinctive Features of a Feasibility 
Study: Objectives and Guiding Questions. (1539-4492 (Print)). 
13. 
McLellan At Fau - Luborsky L, Luborsky L Fau - Cacciola J, Cacciola J Fau - 
Griffith J, Griffith J Fau - Evans F, Evans F Fau - Barr HL, Barr Hl Fau - O'Brien CP, et 
al. New data from the Addiction Severity Index. Reliability and validity in three centers. 
(0022-3018 (Print)). 
14. 
Kessler RC, Andrews G, Mroczek D, Ustun B, Wittchen H. The World Health 
Organization Composite International Diagnostic Interview Short-Form (CIDI-SF). Int J 
Meth Psych Res. 1998;7(4):171-185. . 
 
 
 
15 Appendix 
 
Schedule of Events (required) 
 
As applicable: 
 
Schematic of Study Design 
Toxicity Grading Scales 
DSMB Charter 
Repository Instructions 
Biosafety Precautions 
Manual of Operations 
Laboratory Handling 
Pharmacy Manual 
IXRS Manual  
Case Report Forms (CRFs) 
Quality Management Plan 
Data Management Plan 
Clinical Monitoring Plan  
Endpoint Scales 
Other Documents 
 

BOSTON MEDICAL CENTER AND THE  
BOSTON UNIVERSITY SCHOOL OF MEDICINE 
 
H-39712: Peer Recovery Coaching for Infectious Diseases and Opioid Use Disorder 
 
 Version 1.1 07/07/2020 
 
Page 18 of 18