Project STAMINA (Syringe Service Telemedicine Access for Medication-assisted Intervention Through NAvigation): Development and Testing of a Health Navigation Approach for Linking Syringe Service Program Clients to Medication Assisted Treatment
Phase: NA
Conditions: Opioid-use Disorder
Sponsor: Chestnut Health Systems

 
 
 
 
 
 
Project STAMINA  
(Syringe service Telemedicine Access for Medication-assisted Intervention through 
Navigation) 
Protocol Number:  1138-0420 
 
Principal Investigators:  
Dennis Watson, PhD, Chestnut Health Systems; Chicago, IL 
James Swartz, PhD, University of Illinois Chicago; Chicago, IL 
 
Sponsor: Chestnut Health Systems  
Funded by: Arnold Ventures 
 
V11 
02/17/2022 
[V1 approved 01/30/2020] 
 
 

NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by 
the recipient that no unpublished information contained herein will be published or disclosed without 
prior approval of the Principal Investigator or other participating study leadership and as consistent with 
the NIH terms of award.  
 

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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
INVESTIGATOR’S SIGNATURE .............................................................................................................................. 2 
1 
PROTOCOL SUMMARY ............................................................................................................................... 3 
1.1 
Synopsis ................................................................................................................................................ 3 
1.2 
Schema ................................................................................................................................................. 5 
1.3 
Schedule of Activities .......................................................................................................................... 6 
2 
INTRODUCTION ............................................................................................................................................ 6 
2.1 
Study Rationale .................................................................................................................................... 6 
2.2 
Background........................................................................................................................................... 7 
2.3 
Risk/Benefit Assessment .................................................................................................................... 7 
2.3.1 
Known Potential Risks ..................................................................................................... 7 
2.3.2 
Known Potential Benefits ................................................................................................ 7 
2.3.3 
Assessment of Potential Risks and Benefits ................................................................ 7 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 8 
4 
STUDY DESIGN ............................................................................................................................................. 8 
4.1 
Overall Design ...................................................................................................................................... 8 
4.2 
Scientific Rationale for Study Design................................................................................................ 9 
4.3 
Justification for Intervention ............................................................................................................. 10 
4.4 
End-of-Study Definition ..................................................................................................................... 10 
5 
STUDY POPULATION ................................................................................................................................ 10 
5.1 
Inclusion Criteria ................................................................................................................................ 10 
5.2 
Exclusion Criteria ............................................................................................................................... 10 
5.3 
Lifestyle Considerations .................................................................................................................... 11 
5.4 
Screen Failures .................................................................................................................................. 11 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 11 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ............................................ 12 
6.1 
Study Intervention(s) or Experimental Manipulation(s) Administration ...................................... 12 
6.1.1 
Study Intervention or Experimental Manipulation Description ................................. 12 
6.1.2 
Administration and/or Dosing ....................................................................................... 13 
6.2 
Fidelity ................................................................................................................................................. 14 
6.2.1 
Interventionist Training and Tracking .......................................................................... 14 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 14 
6.4 
Study Intervention/Experimental Manipulation Adherence.......................................................... 14 
6.5 
Concomitant Therapy ........................................................................................................................ 14 
6.5.1 
Rescue Therapy ............................................................................................................. 14 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL ......................................................................................... 15 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation ............................................. 15 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 15 
7.3 
Lost to Follow-Up ............................................................................................................................... 15 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 16 
8.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 16 
8.2 
Safety Assessments .......................................................................................................................... 18 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 18 
8.3.1 
Definition of Adverse Events ........................................................................................ 18 
8.3.2 
Definition of Serious Adverse Events .......................................................................... 18 

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8.3.3 
Classification of an Adverse Event .............................................................................. 19 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 20 
8.3.5 
Adverse Event Reporting .............................................................................................. 21 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 21 
8.3.7 
Reporting Events to Participants ................................................................................. 21 
8.3.8 
Events of Special Interest ............................................................................................. 21 
8.3.9 
Reporting of Pregnancy ................................................................................................ 21 
8.4 
Unanticipated Problems .................................................................................................................... 21 
8.4.1 
Definition of Unanticipated Problems .......................................................................... 21 
8.4.2 
Unanticipated Problems Reporting .............................................................................. 21 
8.4.3 
Reporting Unanticipated Problems to Participants ................................................... 22 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 22 
9.1 
Statistical Hypotheses ....................................................................................................................... 22 
9.2 
Sample Size Determination .............................................................................................................. 22 
9.3 
Populations for Analyses .................................................................................................................. 23 
9.4 
Statistical Analyses............................................................................................................................ 23 
9.4.1 
General Approach .......................................................................................................... 23 
9.4.2 
Analysis of the Primary Endpoint(s) ............................................................................ 23 
9.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 23 
9.4.4 
Safety Analyses .............................................................................................................. 24 
9.4.5 
Baseline Descriptive Statistics ..................................................................................... 24 
9.4.6 
Planned Interim Analyses ............................................................................................. 25 
9.4.7 
Sub-Group Analyses ..................................................................................................... 25 
9.4.8 
Tabulation of Individual Participant Data .................................................................... 25 
9.4.9 
Exploratory Analyses ..................................................................................................... 25 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 25 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 25 
10.1.1 
Informed Consent Process ........................................................................................... 25 
10.1.2 
Study Discontinuation and Closure ............................................................................. 26 
10.1.3 
Confidentiality and Privacy ........................................................................................... 26 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 27 
10.1.5 
Key Roles and Study Governance .............................................................................. 28 
10.1.6 
Safety Oversight ............................................................................................................. 28 
10.1.7 
Clinical Monitoring .......................................................................................................... 28 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 28 
10.1.9 
Data Handling and Record Keeping ............................................................................ 29 
10.1.10 
Protocol Deviations ........................................................................................................ 30 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 30 
10.1.12 
Conflict of Interest Policy .............................................................................................. 30 
10.2 
Additional Considerations ................................................................................................................. 31 
10.3 
Abbreviations and Special Terms ................................................................................................... 31 
10.4 
Protocol Amendment History ........................................................................................................... 32 
11 
REFERENCES ............................................................................................................................................. 36 
 

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STATEMENT OF COMPLIANCE 
 
The trial will be conducted in accordance with International Council on Harmonisation Good Clinical 
Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and the Arnold 
Ventures Terms and Conditions of Award. The Principal Investigator will assure that no deviation from, 
or changes to the protocol will take place without prior agreement from the funding agency and 
documented approval from the Institutional Review Board (IRB). All personnel involved in the conduct of 
this study have completed Human Subjects Protection and Good Clinical Practice Training. 
 
The protocol, informed consent documents, 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 consented. 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 approved; a determination will be made regarding whether a new consent needs to be 
obtained from participants who provided consent, using a previously approved consent form. 
 
 

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INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary assurances 
that this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigator or Clinical Site Investigator: 
Signed: 
 
Date: 
2/17/2022 
 
Name*:  Dennis P. Watson 
 
Title*: Principal Investigator  
 
Investigator Contact Information 
Affiliation*: Chestnut Health Systems, Senior Research Scientist 
Address: 221 W. Walton St. Chicago, IL 60610 
Telephone: 312-274-5316 
Email: dpwatson@chestnut.org  
 
 
 
 
 

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1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
Project STAMINA (Syringe Service Telemedicine Access for Medication-
assisted Intervention Through NAvigation): Development and Testing of 
a Health Navigation Approach for Linking Syringe Service Program 
Clients to Medication Assisted Treatment 
 
Grant Number: 
 
Not applicable (the funder does not use grant numbers) 
 
Study Description: 
 
This clinical trial utilizes two study arms: (1) a treatment arm consisting 
of immediate telemedicine linkage and (2) a control arm consisting of 
standard referral to treatment. Half of the study participants are 
randomly enrolled in each arm. The study utilizes questionnaire data, 
drug test results, and administrative treatment data at multiple time 
points to determine what effect telemedicine linkage has on clients in 
relation to the comparison group. The primary hypothesis is that (1) 
STAMINA will be more effective at improving MOUD linkage than 
standard referral. Secondary hypotheses are: (2) the STAMINA 
participants will have greater MOUD engagement than participants 
who receive standard referral; (3) STAMINA participants 
will have greater MOUD retention than participants who 
receive standard referral; (4) STAMINA participants will 
have used less illicit opioids at follow-up than participants 
who received standard referral. 
 
Objectives*: 
 
 
The primary goal of this project is to establish effectiveness of a 
telemedicine approach for linking syringe exchange clients to 
medications for opioid use disorder. 
 
Endpoints*: 
 
Primary Outcome Measure: 
1. Linkage to medication for opioid use disorder (MOUD) 
Secondary Outcome Measures: 
2. Medication for opioid use disorder (MOUD) treatment 
engagement 
3. Medication for opioid use disorder (MOUD) treatment retention 
4. Self-report non-medication for opioid use disorder (MOUD) 
opioid use 
5. Detected non-prescribed opioids 

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Study Population: 
Inclusion criteria: (a) be able to communicate in English; (b) be at least 
18 years of age; (c) reside in Cook County, Illinois; (d) demonstrate 
criteria for past year opioid use disorder as result of preliminary 
assessment; (e) express interest in receiving medication for an opioid 
use disorder (MOUD). Exclusion criteria: (a) have plans to move outside 
of Cook County, Illinois within the next 6 months; (b) have plans to 
serve a sentence that requires reporting to jail or prison within the next 
6 months; (c)  demonstrate severe opioid withdrawal symptoms at the 
time of enrollment as indicated by preliminary screening; (d) currently 
taking any form of medication that has been prescribed by a healthcare 
provider to treat opioid use disorder; (e) demonstrate inadequate 
ability to provide informed consent. 
 
Phase* or Stage: 
 
N/A  
 
Description of 
Sites/Facilities Enrolling  
 
Participants: 
 
University of Illinois Chicago Community Outreach Intervention Projects 
(COIP) Northwest and West Field Sites; Chicago, Illinois 
Description of Study 
Intervention/Experimental 
Manipulation: 
Participants in the telemedicine linkage intervention are immediately 
linked to telemedicine care with a physician waivered to prescribe 
medication for opioid use disorder (MOUD). The physician completes a 
virtual appointment, provides personalized care, and has the ability to 
prescribe MOUD that fits the patient’s preferences and needs. 
Depending on the outcome of the telemedicine appointment, the 
participants is offered immediate transportation via ride share 
assistance to complete the initial steps related to their MOUD (i.e., pick 
up an initial buprenorphine prescription from a pharmacy, attend a 
methadone intake appointment, or receive an initial vivitrol injection). 
 
Study Duration*: 
 
28 months (August 24th, 2020-December 30th, 2022)  
 
Participant Duration: 
 
6 months  
 
 
 
 
 
 
 
 

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1.2 
SCHEMA  
 
 
 
 
 
 
 
 

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1.3 
SCHEDULE OF ACTIVITIES  
 
Table 1: Schedule of Activities  
 
 
Time point:  
Procedures: 
Enrollment 
3 months post-
enrollment 
6 months post-
enrollment 
Eligibility Assessment 
x 
 
 
Informed Consent 
x 
 
 
Contact & Locator Questionnaire 
x 
 
 
Structured Questionnaire 
-Demographics 
-Social Support 
-Child Welfare 
-Housing 
-Alcohol Use 
-Opioid Cravings 
-Overdose Experiences 
- Drug Use & Treatment 
-Chronic Health Conditions 
-Psychological Health & Treatment 
-Trauma Exposure 
-Criminal Justice  
x 
x 
 
Urine Drug Screen 
x 
x 
 
Administrative/Secondary Data  
 
 
x* 
*Data are pulled at a single time point and reflect the 6-month study duration for each participant.  
 
2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
 
Project STAMINA (Syringe Service Telemedicine Access for Medication-Assisted Intervention through 
Navigation) is a research study aiming to test the effectiveness of a linkage intervention that connects 
people with an OUD to MOUD using telehealth in a syringe service program (SSP) setting. STAMINA was 
conceptualized as a way to utilize a setting that is familiar to patients with an OUD to offer rapid access 
to care while removing barriers related to comfort.  
 
The primary hypothesis is that (1) STAMINA will be more effective at improving MOUD linkage than 
standard referral. Secondary hypotheses are: (2) the STAMINA participants will have greater MOUD 
engagement than participants who receive standard referral; (3) STAMINA participants will have greater 
MOUD retention than participants who receive standard referral; (4) STAMINA participants will have 
used less illicit opioids at follow-up than participants who received standard referral. 
 

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2.2 
BACKGROUND  
 
U.S. opioid-related overdose deaths have more than quadrupled over the past 16 years, leading to an 
unprecedented rise in mortality rates [1, 2, 3]. Efforts to reverse these trends and reduce overdoses and 
associated fatalities have included expansion of medication for opioid use disorder. This includes 
Methadone, Suboxone®, and Vivitrol®, which have all been shown to improve recovery [4]. Despite 
efforts at expansion, people who use opioids experience considerable difficulties accessing MOUD 
because of long wait lists or lack of insurance that prevent immediate intake at a time when the patient 
is ready [5]. Syringe service programs (SSPs) are an excellent setting for linking those with an OUD to 
care, as they are judgement-free areas where people who use opioids feel more comfortable accessing 
services than they do in other healthcare settings [6]. SSPs have also already been demonstrated to lead 
to significant improvements in a number of other opioid-use related outcomes such as reduced 
transmission of communicable diseases (e.g., HIV), costs associated with treating them, and linkage to 
recovery-oriented services. Further, telemedicine will provide a way to immediately connect patients to 
a provider, thus eliminating the window between referral and appointment time where many patients 
are lost to treatment [6]. 
2.3 
RISK/BENEFIT ASSESSMENT  
 
2.3.1 KNOWN POTENTIAL RISKS  
 
The primary risks to participants of this study are (a) breaches of privacy (i.e., others would learn that 
participants are receiving treatment for an opioid use disorder) and (b) breaches of confidentiality (i.e., 
others would know the information obtained during data collection), which could result in stigma or 
criminal prosecution if it were discovered that the participant is an illegal opioid user. Additional risks to 
participants include (c) the possibility that they feel uncomfortable sharing information about 
themselves related to their current drug use or history with drug use and treatment, criminal justice 
involvement, or child welfare involvement or that (d) the questions may cause participants distress, 
particularly as these instruments include multiple items regarding sensitive issues. 
2.3.2 KNOWN POTENTIAL BENEFITS  
 
The possible benefits that participants might gain are (a) the opportunity to discuss and reflect on their 
recent experiences and (b) the opportunity to inform research that may lead to the future development 
of improved linkage to treatment for individuals with opioid use disorder.  
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 
The collection of sensitive data (e.g., data pertaining to illicit drug use) and identifiable data is necessary 
to assess the proposed outcomes and examine the effect of the telemedicine linkage intervention. Study 
procedures aim to minimize risks associated with the collection of these data through the following 
ways: (a) all data collected during participant interactions (i.e., structured interviews and drug screens) 
will be entered directly into Research Electronic Data Capture (REDCap) to ensure secure data storage 
that is HIPPA compliant and that that only relevant research team members have access to this 

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information; (b) all administrative MOUD treatment data and vital records data collected on participants 
will be stored in a HIPPA compliant Box Health folder that only relevant research team members can 
access or entered and stored in REDCap or; (c) all paper forms used in the consent process will be 
temporarily stored in a locked cabinet at the enrollment sites and then transferred by the study’s 
Project Manager for long-term (i.e., three years) storage in a locked cabinet within the Principal 
Investigator’s office; (d) research staff will assure all participants throughout the structured interviews 
that they may choose to skip any questions they do not want to answer and will end the interview or 
skip a question if a participant seems distressed about sharing the information requested.  
 
3 
OBJECTIVES AND ENDPOINTS  
 
 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
Primary  
 
 
Assess the intervention’s 
effectiveness at linking clients to 
MOUD treatment.  
 
Linkage to MOUD 
treatment 
 
The primary goal of the intervention as it is 
designed is to link clients to MOUD 
treatment.   
 
 
Secondary  
 
 
 
 
Assess the intervention’s 
effectiveness at improving 
MOUD treatment-related 
outcomes. 
MOUD treatment 
engagement 
These outcomes should improve following 
linkage to MOUD treatment.     
MOUD treatment 
retention 
 
Assess the intervention’s 
effectiveness at decreasing illicit 
opioid use. 
Self-report non-
medication for opioid 
use disorder (MOUD) 
opioid use 
These outcomes should improve following 
MOUD treatment engagement and 
retention.   
Detected non-
prescribed opioids 
4 
STUDY DESIGN 
4.1 
OVERALL DESIGN 
Our primary long-term goal is to establish an effective telemedicine method for linking individuals with 
OUD to MOUD from the SSP. The primary hypothesis is that (1) STAMINA will be more effective at 

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improving MOUD linkage than standard referral. We expect the program will have a positive effect on 
client recovery outcomes, and we will be able to identify specific program elements or processes that 
drive these outcomes. 
 
For the study, syringe exchange clients at any of two SSP sites operated by the University of Illinois 
Chicago who express interest in participating in the research study are first screened for eligibility by an 
onsite research assistant. If eligibility criteria are met, the research assistant completes the informed 
consent process and obtains a signature of consent. Participants are subsequently assigned to one of 
two study arms using randomization with stratification by study site and whether or not they indicate a 
strong preference for methadone treatment, which is determined during the eligibility screening. Study 
arms include: (1) the intervention arm, in which participants are immediately linked to telemedicine care 
with a physician waivered to prescribe medication for opioid use disorder treatment and (2) the control 
arm, in which participants receive a standard referral to an in-person appointment-as would normally 
happen in the SSP sites.  
 
To randomize participants, an offsite research assistant is immediately alerted of the new enrollment 
and informed of their medication preference, checks the pre-established randomization lists, and 
requests a telemedicine appointment when applicable. Meanwhile, the onsite research assistant 
responsible for enrolling the participant conducts all baseline data collection, including a structured 
interview and urine drug screen. At the completion of baseline data collection, the onsite research 
assistant and participant are informed of the study arm assignment and move forward with completing 
or scheduling the appropriate appointment type.  
 
For participants of the intervention arm, the research assistant prepares the participant for their 
telemedicine appointment, assists in completion of the appointment, and offers a ride share for the 
participant to pick up their prescription or initiate dosing. For participants of the control arm, the 
research assistant schedules an in-person appointment and offers bus passes for their first appointment.  
 
Participants are asked to return to the study site to complete follow-up data collection, including 
another structured interview and urine drug screen, at 3 months.  
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
The control condition was defined in consultation with our SSP partner based on usual services they 
provide to clients they serve. Therefore, the control reflects real-world service options that would be 
available to participants outside of the study’s conditions.  
Despite the benefits of utilizing a control arm that is representative of the typical care, it is difficult to 
identify to where SSP staff refer clients, as it is not ethical to require them to send patients to providers 
the research team has relationships with if they are not the best fit for the patient’s needs. Additionally, 
with the onset of the pandemic, and loosening of treatment regulations, many patients have 
telemedicine MOUD linkage options available to them that are similar to the treatment condition (the 
study was conceived of and funded prior to the start of the COVID-19 pandemic, but data collection did 
not start until after).  
 

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4.3 
JUSTIFICATION FOR INTERVENTION 
 
The telemedicine linkage intervention being tested in this study aims to provide a solution to access-
related barriers experienced by patients with opioid use disorder who are seeking treatment. The 
rational for implementing telemedicine linkage within a syringe service program (SSP) is because these 
sites are considered trusted settings in which high-risk opioid users feel comfortable obtaining care 
while also offering the potential for rapid connection to care following an interest in treatment. It is 
important to note, the intervention was developed in collaboration with medical and SSP partners as a 
potential solution to access barriers existing prior to the loosening of telemedicine treatment 
regulations that occurred with the onset of the COVID-19 pandemic.  
 
4.4 
END-OF-STUDY DEFINITION 
 
A participant is considered to have completed the study if they have completed the baseline assessment 
and the 3-month follow-up assessment.  
 
The end of the study is defined as the end of the 6-month period for which we have permission to 
access the participant’s administrative health data, as shown in the Schedule of Activities (SoA), Section 
1.3. 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
 
Inclusion criteria for the study includes:  
1. communicate in English 
2. be at least 18 years of age 
3. reside in Cook County, Illinois 
4. demonstrate clinical criteria for a past year opioid use disorder  
5. express interest in receiving medication for an opioid use disorder (MOUD) 
 
5.2 
EXCLUSION CRITERIA 
 
Exclusion criteria for the study includes: 
1. have plans to move outside of Cook County, Illinois within the next 6 months 
2. have plans to serve a sentence that requires reporting to jail or prison within the next 6 months 
3. be experiencing severe opioid withdrawal symptoms (that would indicate the need for more 
immediate intervention) at the time of enrollment 
4. currently taking any form of medication that has been prescribed by a healthcare provider to treat 
opioid use disorder 
5. demonstrate inadequate ability to provide informed consent, as indicated by poor understanding 
of research protocols explained to them 

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5.3 
LIFESTYLE CONSIDERATIONS 
 
Not applicable.  
 
5.4 
SCREEN FAILURES 
 
Screen failures are defined as participants who consent to participate in this study but are not entered 
into the study because they do not meet the inclusion or exclusion criteria (i.e., failure of screening). If 
research staff learn that the information provided by someone previously consented to the study was 
inaccurate (for example, if a research staff member learns from a participant during their baseline or 
follow-up assessment that they do not use opioids or are already receiving a medication for opioid use 
disorder) then data collection will be discontinued, and the participant will be excluded from the study. 
The patient will still be provided with the related study compensation for their time. 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Strategies for Recruitment  
 
Potential participants will be recruited one of the following ways: (1) individuals will see the STAMINA 
poster within the SSP service site and be able to ask SSP staff where to get more information, (2) current 
syringe service clients will be able to inform staff that they are interested in treatment for an opioid use 
disorder, and staff will inform them of the study opportunity, (3) individuals will see a STAMINA flyer at 
another social service program in the city or on social media platforms and be able to call study 
personnel for more information on the study, or (4) individuals will be introduced to the study by 
Chestnut Health street outreach staff. Details on each method of recruitment are provided below.  
 
(1 or 2) For individuals already on site, any interested SSP client will be informed by SSP staff that a 
study possibility exists for individuals interested in medication for opioid use disorder and if they would 
like to learn more information about the study, the staff can introduce the client to the research 
personnel. They will utilize the SSP recruitment script to explain the study. With their verbal permission, 
they will be introduced to the research staff who can complete the full recruitment script, eligibility 
assessment, and enrollment process with a research assistant.  
 
(3) For individuals offsite that see a flyer from another social service provider or through a social media 
platform, they will first briefly speak with a research assistant by telephone to complete initial screening 
and then be scheduled for an in-person time at SSP to complete the full recruitment script, eligibility 
assessment, and enrollment process with a research assistant.  
 
(4) Chestnut Health Systems’ Lighthouse Institute staff will utilize their street outreach procedures, 
during which they enter communities and engage community members to inform people of the study 
opportunity. For STAMINA, the street outreach workers will stay within Chicago’s Austin and Humboldt 
Park neighborhoods since that is where our two SSP study sites are located. The street outreach will (a) 
approach people in public areas, such as street corners, bus stops, and parks. They will then (b) 
implement the study recruitment script, which is written broadly enough that it does not assume the 
person they are approaching is an opioid user and therefore, allows them to openly introduce the study 

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opportunity without needing to specifically look for any signs of opioid use prior to approaching 
individuals. For anyone who does indicate that they are interested, the street outreach worker will then 
(c) assess for initial eligibility and (d) offer immediate transportation back to the SSP site. Once they 
arrive at SSP, they will meet with a study research assistant to complete the full recruitment script, 
eligibility assessment, and enrollment process. 
 
If an individual is at an SSP and is interested in participating in the study but does not have the available 
time that day or does not feel ready to begin treatment that day, we will offer for them to sign a 
“Consent to Contact” form. The form will give us permission to contact them within the next few days-
weeks to see if they are interested in participating. If so, we will be able to schedule a time for them to 
come in and complete the enrollment process. This will ensure that there is availability, and that the 
client has time in their schedule. This form will be offered but not required; they will only sign if 
interested.  
 
Strategies for Retention  
 
Regarding participant retention related to the follow-up data collection, research staff will make every 
effort to contact participants and schedule them for their 3-month survey and urine drug screen. This 
includes the collection of multiple forms of contact information (details can be found under Section 8.1 
Endpoint and Non-Safety Assessments), as well as continuous attempts throughout the allowable 
follow-up window (i.e., 1 month prior the 3-month due date - 2 months following the 3-month due 
date).  
 
Participant retention related to the intervention is not applicable, as it is left to the discretion of the 
participant whether they complete steps related to their MOUD care.  
 
Participant Incentive  
 
Participants will be compensated for both baseline data and follow-up data collection at the conclusion 
of each visit. At baseline, participants will receive $50 for completing all study activities. At the 3-month 
time point, participants will receive $25 for completing the questionnaire and an additional $10 for 
completing the urine drug screen. All payments will be given to participants in the form of a VISA gift 
card. Should the participant be unable to visit on-site and complete data collection only by phone, their 
gift card will be mailed to them at an address they provide. 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
 
6.1 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
 
This study includes both an intervention and control condition.  
 

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Intervention Arm (1): Participants enrolled into the telemedicine linkage intervention will be 
immediately linked to telemedicine care with a physician waivered to prescribe MOUD treatment. All 
enrollment and telemedicine care will occur at the University of Illinois Chicago (UIC)'s School of Public 
Health's Community Outreach Intervention Project (COIP) SSP sites. On-site, the participant will have 
their vitals checked (i.e., temperature, blood pressure) by a research team member and be connected 
with a University of Illinois (UI) Health Mile Square Health Center physician (Chicago, Illinois) via 
telemedicine linkage on a tablet computer. The research assistant will share the participant’s vitals with 
the physician, and the physician will complete a virtual appointment and assessment during which they 
will provide personalized care. Related to the appointment, the physician will make notes in the 
patient's electronic medical records of their treatment plan. The physician will have the ability to 
prescribe buprenorphine. Should the participant receive an induction prescription for buprenorphine or 
naltrexone, it will be sent to the Mile Square Health Center (MSHC) pharmacy or a pharmacy of the 
participant’s choice. If the participant does not have medical insurance, the MSHC pharmacy will be able 
to assist with prescription costs. Additionally, the participant will be provided with instructions for how 
to locate the pharmacy on-site at the FQHC and how to complete induction steps. 
 
Depending on the MOUD preference and whether any medications are prescribed on the telemedicine 
visit, the research assistant will offer the participant transportation via ride share to complete their 
initial steps in the process of beginning MOUD. If the participant is prescribed buprenorphine on the 
telemedicine visit, they will be provided with a rideshare to the pharmacy to pick up the prescription. If 
the participant is referred to methadone, they will be provided with a ride share for their first in-person 
appointment for the methadone intake. If the participant is scheduled for a vivitrol injection, they will be 
provided with a rideshare to the pharmacy to pick-up any medication prescribed for injection 
preparation or to their initial injection.  
 
All follow-up OUD care and prescribing will be conducted based on the provider’s standards and may 
include in-person or telemedicine appointments. Should the provider deem an in-person intake 
appointment clinically necessary for any participant assigned to the treatment arm, the research 
assistant will provide a full-day bus pass to assist with transportation.  
 
Standard Care Arm (2): Participants enrolled in the control arm will receive a standard referral to an in-
person appointment with an MOUD provider, which will typically occur within 24-72 hours of the 
enrollment time, depending on provider and participant availability. Regarding scheduling, this will 
include UI Health MSHC healthcare providers for participants interested in discussing their MOUD 
options, or who are open to receiving buprenorphine or vivitrol.  For participants who are strictly 
interested in methadone, this will include UI Health MSHC’s Family Guidance methadone providers, 
additional Family Guidance methadone providers across Chicago, or another methadone provider with a 
location convenient to the participant. The research assistant will provide two bus passes to cover the 
transportation to and from the appointment.  
 
All follow-up OUD care and prescribing will be conducted based on the provider’s standards and may 
include in-person or telemedicine appointments.  
 
6.1.2 ADMINISTRATION AND/OR DOSING 
 
Not applicable.  

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6.2 
FIDELITY 
 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
 
Fidelity assessments with the research assistants will ensure compliance with the study procedures and 
adherence to the intervention design. A checklist of critical components and their associated tasks will 
guide the fidelity audits. The project manager will conduct virtual or in-person fidelity assessments with 
research assistants monthly. Any concerns or issues will be reviewed with the research assistant and 
corrected.  
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
Participants will be assigned to one of the two study arms (i.e., telemedicine or standard in-person 
referrals) using randomization with stratification by site and whether they indicate a strong preference 
for methadone treatment. The reason for stratifying assignment on this second condition is to avoid 
potential confounding of the results since methadone treatment might be administered by a different 
provider and would require different linkage procedures after the telemedicine call. Arm allocation will 
be determined in advance of enrollment by randomizing pre-established study identification numbers 
that will be sequentially assigned to participants as they are enrolled. 
 
To minimize bias during data collection, two research assistants (one offsite and one onsite) will share 
the enrollment responsibilities. During enrollment, the onsite research assistant will screen the client for 
eligibility, which includes an assessment of the client’s interest in MOUD and determination of their 
preferred medication. Due to the need for scheduling a telemedicine appointment at least 1 hour in 
advance, an offsite research assistant will then be notified that a client is consented to the study, of 
their enrollment site, and of their specific medication preference. The onsite research assistant and 
participant will move forward with baseline data collection remaining blinded to the study arm 
assignment while the offsite research assistant checks the pre-established randomization list and 
schedules a telemedicine appointment when necessary. The offsite research assistant will inform the 
onsite research assistant of the arm assignment once baseline data collection is complete.   
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
 
Not applicable; The intervention focus is linkage and does not require participants to adhere to any 
protocols.   
 
6.5 
CONCOMITANT THERAPY 
 
Not applicable.  
6.5.1 RESCUE THERAPY 
 
Not applicable.  

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7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
This linkage intervention aims to connect participants to MOUD treatment, but the completion of the 
telehealth appointment, in-person MOUD appointment(s), or accessing prescriptions is at the discretion 
of the participant. Participants may choose not to take part in the initial linkage appointment (i.e., 
telehealth or in-person) or to adhere to any subsequent treatment-related activities (e.g., prescription 
pick-up, follow-up appointments) and still remain a participant of this study.  
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants are free to withdraw from participation in the study at any time upon request. If a 
participant wishes to discontinue their involvement with the study or forgo follow-up data collection 
activities, they are able to notify any study team member or the IRB at any time to withdraw.  
 
Investigators may discontinue a participant from the study for the following reasons: 
• 
The participant (a) does not meet an inclusion criterion or (b) meets an exclusion criterion 
(either newly developed or not previously recognized) that precludes further study 
participation. 
 
Withdrawal from the study will not adversely affect the participant. Participants are free to continue to 
receive their MOUD treatment or SSP services even if withdrawn. Should a participant withdraw, we will 
not request further data collection activities and will remove any existing data from the sample. 
 
The reason for participant discontinuation or withdrawal from the study will be recorded. Subjects who 
sign the informed consent form and are randomized but do not receive the study intervention may be 
replaced.  Subjects who sign the informed consent form, are randomized, and receive the study 
intervention, and subsequently withdraw, or are discontinued from the study will not be replaced.  
7.3 
LOST TO FOLLOW-UP 
 
A participant will be considered lost to follow-up if he or she fails to return for their 3-month study visit 
within 5 months of their enrollment date (i.e., 2 months following their 3-month follow-up date).   
 
The following actions will be taken to improve the likelihood that participants will complete their 3-
month study visit within the permitted window.  
 
• 
Research staff will collect at least 3 sources of contact information at enrollment and will verify 
its accuracy before the participant leaves the enrollment site.  

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• 
Research staff will complete contact verification checks leading up to the 3-month study visit 
and begin attempting to schedule the follow-up visit 1 month prior to the 3-month post-
enrollment date.  
• 
Research staff will provide reminder calls/texts/emails/mail, reschedule missed visits, and 
discuss the importance of follow-up data collection with the participants.  
• 
If necessary, research staff will complete follow-up data collection by telephone and forgo the 
urine drug screen data collection if the participant refuses travel, proves to be difficult to 
contact, or no-shows scheduled appointment(s).   
• 
Before a participant is deemed lost to follow-up, research staff will make every effort to regain 
contact with the participant.  
• 
All contact attempts will be documented in the participant’s study file.   
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
 
The study will utilize the following procedures, measures, and assessments during eligibility screening 
and data collection.  
 
Following recruitment, research staff will be responsible for completing an assessment of eligibility for 
each potential participant. In doing so, they will assess language spoken, age, county of residence, plans 
for relocation, and plans for serving criminal sentence(s). If the client reports that they have plans to 
move outside of Cook County or to serve a prison or jail sentence within the next 6 months, they will be 
excluded. Research staff will clarify with the client that, for the purpose of this study, place of residence 
refers to where the client most often sleeps. If clients have unstable housing or have a permanent 
mailing address that is different from where they regularly sleep, we will refer to where they sleep most 
days as their county of residence.   
 
Next, the research assistant will administer the DSM-5 for Opioid Use Disorder [7]. The client must 
answer “yes” to at least 2 items on the scale, indicating signs of a mild opioid use disorder within the 
past 12 months. The research assistant will also administer the Clinical Opioid Withdrawal Scale (COWS) 
[8], for which we have developed protocols with input from an addiction medicine specialist to ensure it 
can be administered easily by non-clinician research assistants. Clients who score 36 or more on the 
scale will be excluded, as this is an indication of severe withdrawal. [Note: These clients will be provided 
an immediate referral to care with a physician despite being excluded from the study.] 
 
The research assistant will then discuss the Opioid Use Disorder Treatment Comparison Overview, which 
is a shared decision-making tool created by the research team that provides a visual explanation of all 3 
MOUDs (i.e., buprenorphine, naltrexone, and methadone). During this discussion, the research assistant 
and client will walk through the treatment options and confirm the client’s MOUD treatment interest. As 
long as the client expresses interest in at least 1 of the 3 medication types then they meet eligibility 
requirements. It is also at this point that the research assistant will clarify which type of MOUD the client 
is initially interested in (though they will be allowed to change their minds). The research assistant will 
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these MOUDs, OR only initially interested in methadone. [This clarification will be used in the blocking 
randomization described previously under “6.3 Measures to minimize bias: Randomization and 
blinding”.]  
 
Finally, the research assistant (i) asks the client to take a urine drug screen. If they are negative for 
buprenorphine or methadone, the research assistant will move forward. If they are positive for either 
medication, the research assistant will ask the client if they are currently taking “x” medication as a part 
of a prescribed treatment plan. If they are taking medication they purchased through the illicit drug 
market, then the research assistant will move forward. If they are already taking medication that is 
prescribed, they will be excluded.  
 
Research assistants will continue to read the full recruitment script with eligible clients and complete 
the informed consent process for anyone meeting all criteria and interested in participating. The 
research assistant will begin data collection with all consented participants. This includes a 45–60-
minute structured interview that is collected in the Research Electronic Data Capture (REDCap) data 
collection system. This interview covers the following topics:  
1. Full name, Date of Birth, SSN (used for locating purposes), and UI Health Medical Record 
Number (MRN) 
2. Demographic information  
3. Social support 
4. Child welfare involvement 
5. Housing and homelessness 
6. Alcohol use 
7. Drug use 
8. Heroin cravings 
9. Opioid withdrawal symptoms 
10. Overdose experiences 
11. Physical and mental health 
12. Trauma exposure 
13. Criminal justice involvement 
14. Treatment motivation  
15. Quality of life 
 
The interview will also request participant contact information (i.e., Client Contact & Locator Form). This 
information will not be used as research data, but rather, will aid the scheduling of research follow-up 
visits. The form will ask participants for (1) their contact information, (2) the contact information for 
others who might be able to help in reaching the participant, (3) the contact information for providers 
whose services they utilize and might be able to help reach the participant. Additionally, all participants 
will have submitted a urine drug screen during recruitment, and this will also be used as a form of data. 
The results of the screen will be entered into REDCap with the participant’s interview data. All 
participants will be asked to complete the REDCap interview and a second urine drug screen at 3-
months. Participants will be asked to return to the recruitment site to complete these activities; 
however, participants can be accommodated to complete the interview by phone and forgo the drug 
screen when necessary.  
 
Lastly, as part of data collection, we will access the participant’s protected health information (PHI) from 
the four sources listed below.  

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• 
(1) Mile Square Health Center and (2) Family Guidance Center Records: We will request MOUD 
treatment data from Mile Square Health Center and Family Guidance Center. These data will be 
used to understand participant MOUD linkage, engagement, and retention. These data will 
include dates of service, medications prescribed, and treatment details to understand 
compliance. The same data will be pulled for participants in both arms. Note: We recognize that 
not all patients will go to Mile Square Health Center or Family Guidance Center after their 
appointment or referral, but we plan to access these medical records for any consented 
participant. Participants will not be withdrawn from the study should they not be treated at 
MSHC or Family Guidance, as this is an intent to treat study. Thus, we will have to rely on self-
report data for participants who choose to be treated elsewhere.  
 
• 
(3) Illinois Prescription Monitoring Program (PMP) Records: We will request dispensation data 
for buprenorphine from the Illinois Prescription Monitoring Program. Though we ask 
participants to self-report whether they have engaged in medication for opioid use disorder 
treatment, the PMP data will allow us to verify whether they have been dispensed any of the 
prescriptions. This helps us to understand the nature of whether a participant is involved in 
treatment.  
 
• 
(4) Illinois Vital Records: We will collect Vitals Record data for the purpose of verifying whether a 
participant passed away. We understand that individuals who use drugs are at the risk of 
overdose, or other drug-related health issues which can lead to death, and while our goal is to 
enroll these clients in treatment, the possibility of relapse or health issues remain present. Thus, 
we are obtaining this data to verify if a participant disengaged from the study because of death 
and to understand whether that death was caused by drug use. 
8.2 
SAFETY ASSESSMENTS 
 
Not applicable.  
 
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
8.3.1 DEFINITION OF ADVERSE EVENTS 
 
This protocol uses the definition of adverse event from 21 CFR 312.32 (a): any untoward medical 
occurrence associated with the use of an intervention in humans, whether or not considered 
intervention related. 
 
This will include the following: mental health-related outpatient treatment; criminal arrests, bookings, 
or charges; criminal detainment or imprisonment; new chronic health condition. 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
 
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following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of 
existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to 
conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not 
result in death, be life-threatening, or require hospitalization may be considered serious when, based 
upon appropriate medical judgment, they may jeopardize the participant and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition. 
 
This will include the following: death; attempted suicide; overdose-related ER visit; overdose-related 
hospitalization; mental health-related hospitalization. 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 SEVERITY OF EVENT 
For adverse events (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 life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”. 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
All adverse events (AEs) will have their relationship to study procedures, including the intervention, 
assessed by an appropriately trained clinician based on temporal relationship and his/her clinical 
judgment. The degree of certainty about causality will be graded using the categories below.  
 
• 
Related – The AE is known to occur with the study procedures, there is a reasonable possibility 
that the study procedures caused the AE, or there is a temporal relationship between the study 
procedures and the event. Reasonable possibility means that there is evidence to suggest a 
causal relationship between the study procedures and the AE. 
• 
Not Related – There is not a reasonable possibility that the study procedures caused the event, 
there is no temporal relationship between the study procedures and event onset, or an 
alternate etiology has been established. 
 
OR 
 
• 
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 study procedures administration and cannot be 
explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the 
study procedures should be clinically plausible. The event must be pharmacologically or 
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• 
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 study procedures, is unlikely to be attributed to 
concurrent disease or other drugs or chemicals, and follows a clinically reasonable response on 
withdrawal.  
• 
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of study procedures). 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 study procedures administration makes a causal relationship improbable 
(e.g., the event did not occur within a reasonable time after administration of the study 
procedures) 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 procedures 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. 
 
8.3.3.3 EXPECTEDNESS  
 
Unanticipated AEs are events that are not consistent with the foreseeable risk associated with research 
procedures or are not expected in the natural progression of any underlying condition of the sample. 
The AEs and SAEs identified in Sections 8.3.1 and 8.3.2 are anticipated as they are commonly associated 
with the course of OUD. Per Chestnut Health IRB policies, all deaths are considered unanticipated 
events. 
 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel when (a) attempting to contact the participant to schedule their 3-month follow-up or 
(b) during the 3-month study follow-up. 
 
(a) If study staff are notified of a participant death while attempting to make contact for their 
follow-up data collection, they will complete an “Adverse Event Form” for submission to the IRB. 
Per the Chestnut Health IRB policies, all studies are to report unanticipated events to the IRB’s 
Human Protections Administrator within 2 business days of PI notification.  
(b) Study staff will learn of other AEs or SAEs during the 3-month study follow-up. For anticipated 
events, information will be reported at study-end reporting on Clinical Trials.gov. For 
unanticipated events, information will be reported to the IRB’s Human Protections 
Administrator within 2 business days. With the assistance of a clinician with expertise in opioid 
use disorder, it will be determined whether the adverse event is related or unrelated to the 
study procedures or intervention.  

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Additionally, subject withdrawals and complaints will be monitored by the PIs with assistance from the 
Project Manager to ensure study procedures designed to protect the privacy and confidentiality of 
participants are adequate and no unanticipated distress or unintended outcomes have resulted from 
any of the study procedures. 
 
8.3.5 ADVERSE EVENT REPORTING  
 
Unanticipated adverse events will be reported to the IRB within 2 business days. Adverse events related 
to the study will be reported in annual reporting to the IRB. All adverse events, whether related or 
unrelated and anticipated or unanticipated, will be reported at the study conclusion on Clinical 
Trials.gov.   
 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
 
Unanticipated serious adverse events will be reported to the IRB within 2 business days. All deaths will 
be considered unexpected. Serious adverse events related to the study will be reported in annual 
reporting to the IRB. All adverse events, whether related or unrelated and anticipated or unanticipated, 
will be reported at the study conclusion on Clinical Trials.gov.   
 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
 
Not applicable.  
 
8.3.8 EVENTS OF SPECIAL INTEREST  
 
Not applicable.  
 
8.3.9 REPORTING OF PREGNANCY  
 
Not applicable.  
 
8.4 
UNANTICIPATED PROBLEMS 
 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
 
Not applicable.  
 
8.4.2  UNANTICIPATED PROBLEMS REPORTING  

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Not applicable.  
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
 
Not applicable.  
 
9 
STATISTICAL CONSIDERATIONS  
 
9.1 
STATISTICAL HYPOTHESES 
• Primary: 
o Null: No difference in treatment linkage rates will be observed between the treatment 
and control arms. 
o Alternative: There will be a difference in treatment linkage rates between the treatment 
and control arms.  
• Secondary 1: 
o Null: There will be no difference in MOUD treatment engagement between the 
treatment and control arms. 
o Alternative: There will be a difference in MOUD treatment engagement between the 
treatment and control arms.  
• Secondary 2:  
o Null: No difference in MOUD treatment retention will be observed between the 
treatment and control arms. 
o Alternative: There will be a difference in treatment linkage rates between the treatment 
and control arms.  
• Secondary 3:  
o Null: No difference in illicit opioid use will be observed between the treatment and 
control arms. 
o Alternative: A difference in illicit opioid use between treatment and control arms will be 
observed. 
9.2 
SAMPLE SIZE DETERMINATION 
 
A power analysis determined a minimum sample size of n = 273 is needed to detect an odds ratio of 2.0 
for a binary predictor (the intervention effect) in a logistic regression with 80% power. The control 
group’s proportion of successful treatment initiation was set at 0.35. Assuming an 80% study retention 
rate across all three waves of data collection, the recruitment goal has been set at n = 350 total 
participants (n = 175 for each arm).  
 
Due to circumstances encountered during the study period (i.e., disruptions due to COVID-19 
pandemic), study recruitment did not reach the target sample size. The final sample included 274 
baseline participants and 221 follow-up interviews (80% retention). With a sample size of N=221, the 
minimum detectable odds ratio at alpha=.05 and 80% power is 2.16. 
 
 

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9.3 
POPULATIONS FOR ANALYSES 
 
Primary outcome analyses of treatment engagement will be conducted on the sample of all randomized 
participants, i.e., intention-to-treat (ITT) sample. Analyses of treatment retention will include all 
participants who initiated treatment within 14 days of the baseline visit. Sensitivity analyses will test 
alternative treatment initiation cutoffs. 
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
 
We will compute descriptive statistics on quantitative measures, reporting frequencies and percentages 
for categorical variables, and means and standard deviations, or medians and interquartile ranges for 
continuous variables. All inferential tests will be 2-tailed; we will report 95% confidence intervals and 
exact p-values. Pre-specified covariates are listed in the sections below. 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
 
Primary Outcome: Linkage to medication for opioid use disorder (MOUD) 
 
We will use multivariable, binary logistic regression models with linkage to MOUD (yes/no) as the 
dependent variable. Linkage will be defined as visiting the treatment provider within 14 days post-
enrollment, based on electronic medical records (EMR). In the event that EMR data is not available for 
some participants (i.e., participants who received care at a clinic without a study affiliation), we will 
substitute self-report data for those records and conduct a sensitivity analysis. Participants lost to 
follow-up will be coded as not linked to treatment. 
 
The primary independent variable in these models will be a dichotomous indicator for treatment 
condition (0 = CC; 1 = TC). Control variables will include at a minimum: demographics (age, sex, 
race/ethnicity), baseline severity of substance use disorder, baseline severity of psychological distress, 
and past overdose experiences. We will also control for treatment preference (methadone only vs. any 
MOUD), and location (a dichotomous variable representing each of the COIP sites.)  If covariate 
missingness is greater than 10% we will use multiple imputation; otherwise, we will use complete case 
analysis. Results will be presented as odds ratios with 95% confidence intervals, and predicted 
probabilities. Alternatively, the outcome can be modeled using robust Poisson regression to obtain risk 
ratios with 95% confidence intervals.  
 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
Secondary Outcome Measures: 
• 
Medication for opioid use disorder (MOUD) treatment engagement 
• 
Medication for opioid use disorder (MOUD) treatment retention 
• 
Self-report non-medication for opioid use disorder (MOUD) opioid use 
• 
Detected non-prescribed opioids 

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The analytic sample for secondary outcomes will include participants linked to treatment after the 
baseline visit. We will use multivariable, binary logistic regression models with engagement (yes/no) and 
retention (yes/no) as dependent variables. Engagement will be defined as making at least 2 visits to the 
treatment provider within 34 days post-enrollment. Retention will be defined as going no more than 14 
days without medication for opioid use disorder or being discharged from care within 3 months post-
enrollment.  
 
The primary independent variable in these models will be a dichotomous indicator for treatment 
condition (0 = CC; 1 = TC). Control variables will include at a minimum: demographics (age, sex, 
race/ethnicity), baseline severity of substance use disorder, baseline severity of psychological distress, 
and past overdose experiences. We will also control for treatment preference (methadone only vs. any 
MOUD), and location (a dichotomous variable representing each of the COIP sites.) If covariate 
missingness is greater than 10% we will use multiple imputation; otherwise, we will use complete case 
analysis. Results will be presented as odds ratios with 95% confidence intervals, and predicted 
probabilities. Alternatively, the outcome can be modeled using robust Poisson regression to obtain risk 
ratios with 95% confidence intervals.  
 
Illicit drug use at follow-up will be measured as a dichotomous variable (presence/absence in urine), and 
modeled in a similar fashion using multivariable, binary logistic regression models.  
 
Treatment engagement at follow-up can also be modeled as a count variable (number of sessions 
attended per unit time) using Poisson or negative binomial regression; or treated as continuous if 
normality assumptions are met and modeled using ordinary least squares regression.  
 
An alternate measure of engagement is to assess how long each participant remained in treatment 
defined as being either the last treatment appointment kept, or participant’s self-report of the date they 
discontinued using buprenorphine. The time to discontinuation of treatment/medication can then be 
modeled using survival analysis or proportional hazard models. These models provide information on 
how long persons remain in treatment allowing comparisons of the survival times (or conversely, 
periods of highest risk for dropping out of treatment) by study condition. If the proportional hazards 
assumption is met, we will use Cox regression; otherwise, we will use an accelerated failure time model 
such as Weibull regression. 
 
9.4.4 SAFETY ANALYSES 
 
Not applicable.  
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
We will compare the intervention groups on demographics (age, sex/gender, race/ethnicity, education), 
socioeconomic indicators (employment, housing, insurance), baseline substance use (self-report and 
urine test), overdose, substance use treatment history, chronic health conditions, criminal-legal system 
involvement (arrest, jail/prison, probation/parole), and psychosocial measures (trauma symptoms, 
depression, serious mental illness). We will compute chi-square tests and report exact p-values. 
 

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9.4.6 PLANNED INTERIM ANALYSES  
 
Not applicable.  
9.4.7 SUB-GROUP ANALYSES 
 
We will conduct sub-group analyses on primary and secondary endpoints by treatment preference 
(methadone only vs any MOUD), and by race/ethnicity (Black/African American vs. other). Sub-groups 
for other characteristics (e.g. sex/gender) are not likely to have sufficient numbers. 
 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
 
Individual participant data will not be listed. 
9.4.9 EXPLORATORY ANALYSES 
 
Not applicable.  
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
10.1.1 INFORMED CONSENT PROCESS 
 
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS 
 
Consent forms describing in detail the study intervention, study procedures, and risks will be given to 
the participant, and written documentation of informed consent will be completed prior to starting the 
study intervention. The following consent materials are used during this process: (1) consent form, (2) 
list of competency questions, (3) health information release form, (4) locator release form.  
 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Once the initial eligibility has been determined during the screening process, the research assistant will 
provide the client with a copy of the consent form and keep one for themselves. Consent documents will 
be provided in English only, as English-speaking abilities are required for eligibility. Together, they will 
discuss the consent form in detail. Once the consent document has been fully reviewed, the research 

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assistant will check for the final eligibility criteria by asking three questions to the client to verify that the 
client is able to participate per their level of competency. The questions include:  
 
a) Can you repeat to me the purpose of the study? (Participant must indicate they know we are 
interested in treatment linkage or studying linkage to medication.) 
b) Do you remember how long this process (i.e., enrollment and intervention) could take today? 
(Participant must indicate 2-3 hours.) 
c) Do you remember what you should do if you decided you no longer wish to take part in the 
study after leaving here? (Participants must indicate that they know to contact the research 
team or IRB and let them know.) 
 
If the client is able to answer these questions, they will be deemed eligible. The research assistant will 
ask the client to print, sign, and date the form; the research assistant will do the same. 
  
In addition to the consent form, the research assistant will also review two additional forms: a (1) health 
information release for the methadone provider, which permits the study team to access methadone 
treatment data from the external methadone provider (i.e., Family Guidance) for the participant’s study 
6-month window, and (2) locator release form for participant tracking purposes, which permits the 
study team to speak with the contacts provided by the participant about the participant’s whereabouts 
and latest contact information. The research assistant will go through the forms’ contents in full detail 
and allow the participant to ask questions. The participant will be asked to sign each form at the 
conclusion of the review.  
 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
 
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, and/or regulatory 
authorities. If the study is prematurely terminated or suspended, the principal investigators will 
promptly inform the Institutional Review Board (IRB) and sponsor/funding agency 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 
• Insufficient compliance of study staff to the protocol (i.e., significant protocol violations) 
 
The study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the funding agency, sponsor, IRB, or other relevant regulatory or oversight bodies 
(DSMB). 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their 
staff, the safety and oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is 
extended to the data being collected as part of this study. Data that could be used to identify a specific 
study participant will be held in strict confidence within the research team. No personally identifiable 

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information from the study will be released to any unauthorized third party without prior written 
approval of the sponsor/funding agency.  
 
We will collect the questionnaire data in REDCap and keep it stored there through the duration of the 
study. REDCap is password protected and HIPAA compliant; user access to this database will be 
restricted to those who collect, manage, or clean this data. Additionally, we will store the urine drug 
screen drug screen in this same REDCap database for the duration of the study. The participant IDs will 
be connected to the participant’s name within REDCap.  
 
Secondary data will be obtained from each source utilizing secure procedures. We will provide the 
designated data manager with an Excel spreadsheet containing Name, DOB, gender, race, and last 4 of 
SSN of individuals we are requesting data for. We will upload this file to a UIC Box Health folder, which 
will be separate for each organization and created specifically for data sharing related to the study that 
we will give the data manager access to. We will inform them when the file is uploaded and ask them to 
inform us when they have downloaded it. After they have downloaded the file, we will delete it from the 
Box Health folder. After pulling these data, the data manager will send it back to us, using a secure ID as 
the only identifier. They will inform us when they have uploaded the data to the Box Health folder and 
we will then move the data to another Box Health study folder that only appropriately designated study 
personnel will have permissions to access. They will send the master list of secure ID linked with the 
identifiers in a separate file, which will be stored in the same manner. Identifiers will be removed once 
the data are linked. Data will be stored using the participant study ID, only.  
 
For Chestnut Health Systems analysts involved in the various outcomes analyses, the data will be shared 
via a Chestnut Box Health folder. This will exclude contact or identifying information. We will upload the 
dataset to the folder, provide them with access, and then they will be able to download the file to 
conduct the analyses. All analysts will follow measures to ensure the confidentiality of the data, as 
outlined in their contracts.  At the end of the study, all study databases will be de-identified and 
archived by a study team member.  
 
Further, all research activities, including baseline and follow-up data collection, will be conducted in as 
private a setting as possible so that answers shared with the research assistant cannot be overheard by 
others.  
 
Additionally, we have received a Certificate of Confidentiality (COC) from NIH to provide an additional 
layer of protection for participants. This certificate protects identifiable research information from 
forced disclosure. It allows the investigator and others who have access to research records to refuse to 
disclose identifying information on research participation in any civil, criminal, administrative, legislative, 
or other proceedings, whether at the federal, state, or local level. By protecting researchers and 
institutions from being compelled to disclose information that would identify research participants, 
Certificates of Confidentiality help achieve the research objectives and promote participation in studies 
by helping assure confidentiality and privacy to participants. 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
 
Interview and secondary data collected for this study will be analyzed and stored by UIC and Chestnut 
Health Systems researchers. After the study is completed, the de-identified, archived data will be stored 

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with Chestnut Health Systems for use by other researchers including those outside of the study 
following the rules and procedures established in Chestnut Health System’s data sharing policies.  
 
Specimens collected for the urine screens will not be stored long-term; results of the screens will be 
entered into REDCap, and specimens will be immediately discarded.  
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
 
Principal Investigator 
Principal Investigator 
Dennis Watson, PhD 
James Swartz, PhD 
Chestnut Health Systems  
University of Illinois Chicago  
221 W. Walton St. Chicago, IL 
1040 W. Harrison St. Chicago, IL 
312-274-5316 
312-996-8560 
dpwatson@chestnut.org 
jaswartz@uic.edu 
 
10.1.6 SAFETY OVERSIGHT 
 
Safety oversight will be under the direction of a Data and Safety Monitoring Board (DSMB), which will 
include local experts on treatment for opioid use disorder, specifically medications for opioid use disorder 
(MOUD). 
 
The DSMB will meet quarterly to ensure participant safety and review study conduct and progress. They 
will (a) review research protocols and plans for data safety and monitoring; (b) review clinical trial 
progress, including data analysis quality and timeliness, subject recruitment, subject risk versus benefit, 
and other factors that may influence outcomes; (c) review serious adverse event reports and provide 
feedback and oversight they are reported properly to the appropriate Institutional Review Boards (IRB) 
and the Office of Human Research Protections (OHRP); (d) make determinations as to whether the study 
should be continued, changed, or terminated based on the data. An analysis of key variables at each of 
our administrative data pulls will be reviewed for any significant negative outcomes that might result from 
participation in the POINT arm. 
 
Data Safety Monitoring Board Members: 
• 
Juleigh Nowinski-Konchak; Addiction Medicine and Public Health Physician, Cook County Health 
• 
Brad Ray; Associate Professor, Wayne State University; Director, Center for Behavioral Health and 
Justice. 
• 
Karla Wagner; Associate Professor, University of Nevada Reno 
 
10.1.7 CLINICAL MONITORING 
 
Not applicable.  
 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 

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The project manager and principal investigators will perform internal quality management of study 
conduct, data and specimen collection, documentation and completion.  
 
Quality control (QC) procedures will be implemented as follows: 
 
Informed consent --- The project manager will review the documentation of the consenting process with 
a subset of participant enrollments (as described in Section 6.2.1. Interventionist Training and Tracking), 
and all completed consent documents will be reviewed. This review will evaluate compliance with GCP, 
accuracy, and completeness.  Feedback will be provided to the study team to ensure proper consenting 
procedures are followed.  
 
Electronic data --- Data will be entered directly into the study database. To ensure accuracy 
completeness, records will be reviewed by the project manager. Data checks will also be conducted by 
the principal investigator. The process of data collection will be reviewed by the project manager with a 
subset of enrollments (as described in Section 6.2.1. Interventionist Training and Tracking).  
 
Intervention Fidelity — Consistent delivery of the study interventions will be monitored throughout the 
intervention phase of the study by the project manager and principal investigator. Procedures for 
ensuring fidelity of intervention delivery are also described in Section 6.2.1, Interventionist Training and 
Tracking.  
 
Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern. 
 
10.1.9 DATA HANDLING AND RECORD KEEPING  
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Data collection will be the responsibility of the research assistants at the site under the supervision of 
the project manager and principal investigator. Original data will be entered directly into the REDCap 
data collection system, which is accessible by team members only and can be immediately reviewed by 
the project manager. The research assistants will be responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported, and the project manager will review each 
electronic record.  
 
All source documents will be completed in a neat, legible manner to ensure accurate interpretation of 
data. Hardcopies of the enrollment documents (consent form, competency questions, and health 
information release forms) will be kept for each participant consented/enrolled in the study. Each 
document will also be scanned and electronically uploaded to a secure Box Health folder so that they 
can be reviewed for completeness.  
 
10.1.9.2 STUDY RECORDS RETENTION  

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Study documents will be retained for 3 years after the final patient is enrolled. 
 
10.1.10 
PROTOCOL DEVIATIONS   
 
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol or 
International Council on Harmonisation Good Clinical Practice (ICH GCP) 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 will be developed by the site and implemented promptly. 
These practices are consistent with ICH GCP: 
 
• Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3 
• Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1 
• Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2. 
 
It will be the responsibility of the principal investigator to use continuous vigilance to identify and report 
deviations. All major deviations will be reported to the IRB promptly, within 5 business days. 
Minor protocol deviations will be reported at the time of the subsequent IRB renewal or closure. 
 
10.1.11 
PUBLICATION AND DATA SHARING POLICY  
 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (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 peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-
reviewed journals.  A limited data set with all identifiers removed may be requested from researchers. 
Considerations for ensuring confidentiality of these shared data are described in Section 10.1.3. 
 
10.1.12 
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, 

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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 design and conduct of this trial.  
10.2 ADDITIONAL CONSIDERATIONS 
 
Not applicable.  
 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
 
AE 
Adverse Event 
CC 
Control Condition 
CFR 
Code of Federal Regulations 
COC 
Certificate of Confidentiality 
COIP 
Community Outreach & Intervention Projects 
CONSORT 
Consolidated Standards of Reporting Trials 
COVID 
Coronavirus Disease  
DSMB 
Data Safety Monitoring Board 
FQHC 
Federally Qualified Health Center 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
HIV 
Human Immunodeficiency Virus  
ICH 
International Council on Harmonisation  
IRB 
Institutional Review Board 
ITT 
Intention-To-Treat 
MSHC 
Mile Square Health Center 
MOUD 
Medications for Opioid Use Disorder 
MRN 
Medical Record Number 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
OUD 
Opioid Use Disorder 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
REDCap 
Research Electronic Data Capture 
SAE 
Serious Adverse Event 
SOA 
Schedule of Activities 
SSP 
Syringe Service Program 
STAMINA 
Syringe Service Telemedicine Access for Medication-Assisted Intervention through 
Navigation 
TC 
Treatment Condition  
UP 
Unanticipated Problem 
UIC 
University of Illinois Chicago 
US 
United States 
 
 
 

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10.4 PROTOCOL AMENDMENT HISTORY 
 
Version 
Date 
Description of Change  
Brief Rationale 
2 
7/20/2020 
The “Follow-Up Contact Information 
Card” was removed from the 
protocols and replaced with a “Client 
Contact and Locator” information 
form was added to the enrollment 
procedures. Chestnut Health 
research staff will also review this 
form via telephone with each 
participant during the baseline visit. 
 
Questions concerning comfort levels 
of different appointment modalities 
were added to baseline data 
collection.  
 
UI Health Medical Record Number 
(MRN) has been added as a recorded 
variable to baseline data collection. 
 
Protocols were amended to permit 
research staff, rather than only COIP 
staff, to schedule MOUD 
appointments for the control arm 
participants.  
Chestnut Health research staff 
will now be responsible for 
scheduling all follow-up 
interviews and additional 
contact information is being 
collected to assist with these 
processes.  
 
 
 
Due to COVID-19, telemedicine 
appointments are more 
common and accepted. Thus, 
we want to measure 
participants’ comfort associated 
with different modalities.  
 
The MRN will permit research 
staff to obtain administrative 
MOUD treatment data.  
 
Research staff will schedule 
appointments to improve the 
client flow and decrease 
confusion.  
3 
8/10/2020 
SSN has been added as a recorded 
variable to baseline data collection. 
 
The inclusion criteria were amended 
to require participants to reside in 
Cook County, IL. The exclusion 
criteria were amended to require 
participants not to have plans to 
move outside of Cook County, IL in 
the next 6 months or have to serve a 
criminal sentence in the next 6 
months.  
 
The follow-up data collection 
location was amended from 
Lighthouse Institute to COIP field 
sites.  
 
The SSN will assist with locating 
participants for follow-up. The 
use of the last 4 will also be 
necessary for obtaining 
administrative records.  
 
The eligibility criteria were 
amended to increase the 
likelihood that participants are 
accessible for follow-up 
interviews.  
 
 
The follow-up data collection 
was amended because 
Lighthouse Institute no longer 
permits in-person interactions 
due to COVID-19.  

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The payment form was amended 
from cash to VISA gift card and 
clarified that the $35 follow-up 
payment includes $25 for the 
interview and $10 for the drug 
screen. 
 
Additional COVID-19-related 
disclaimers were added to the 
consent form that permit changes to 
the follow-up data collection.  
The payment form and 
breakdown clarification were 
amended to permit telephone 
data collection, without drug 
screen, due to COVID-19.  
4 
08/25/2020 
The eligibility screener for opioid 
withdrawal was changed from the 
Subjective Opioid Withdrawal Scale 
(SOWS) to the Clinical Opioid 
Withdrawal Scale (COWS), with the 
“extreme” range still being excluded 
and offered immediate treatment. 
The screener amendment was a 
result of advice from the clinical 
team at MOUD treatment 
provider. The providers 
indicated the COWS provides 
better accuracy.  
5 
09/09/2020 
Block randomization was added to 
our protocols (i.e., one block for 
people interested solely in 
methadone treatment, one block for 
people open to any medication).  
 
Family Guidance was added to the 
list of administrative data sources.  
The block randomization will 
permit us to examine the two 
sets of participants individually, 
if needed, given that the 
treatment linkage for 
methadone and 
suboxone/vivitrol is different.  
 
Family Guidance was added to 
the list of administrative data 
sources because Mile Square 
has not yet been able to offer 
methadone due to COVID-19 
related delays in the approval 
process.    
6 
10/14/2020 
A “Consent to Contact” form was 
added to our recruitment protocols. 
The form permits us to gather 
someone’s contact information 
if they indicate interest and 
schedule them for a time that 
works for their schedule or 
when they are ready for 
treatment. 
7 
1/11/2021 
The consent form was amended to 
more clearly describe the duration of 
baseline activities.  
 
The “Consent Competency Checklist” 
was also amended to include a 
The consent form and 
“Competency Checklist” 
amendments aim to ensure 
participants understand the 
length of the baseline activities 
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question on how long the baseline 
activities take.  
 
The consent form was amended to 
request permission to audio record 
the discussion between research 
staff and participants regarding their 
preferred medication. Further 
permissions are requested to use the 
audio recording as data for the 
study.  
only by those who have the 
time to complete all activities.  
 
The audio recording of the 
MOUD discussion will be used 
for quality assurance to ensure 
research staff explain the 
medications accurately. The 
addition of the research data 
permission will provide insight 
on client opinions on the 
different medications.  
8 
4/22/2021 
The drug screen type at the follow-
up interview was amended from 
saliva to urine.  
 
The 6-month follow-up interview 
was eliminated.  
 
The recruitment protocols were 
amended to include assistance from 
a company that provides specialized 
study recruitment.  
 
The consent form was amended to 
request permission to obtain a 
picture of participants for locating 
purposes only.   
The drug screen type was 
amended because the urine 
screen provides better 
accuracy.  
 
Due to slow enrollment, the 
removal of the 6-month 
interview will allow for an 
extended recruitment period. 
The addition of the recruitment 
company assistance is also to 
improve enrollment rates.  
 
The photo of participants will 
be used to improve tracking 
abilities and increase rates of 
follow-up interviews.  
 
 
 
9 
5/17/2021 
The saliva drug screen at baseline 
has been eliminated (leaving only 
the urine drug screen at both time 
points).  
 
The consent form was amended to 
better explain possible costs 
associated with treatment. 
The removal of the saliva drug 
screen occurred because the 
tests proved to be unreliable 
and challenging to use.  
 
The consent form was amended 
to ensure that participants 
understand that there are 
possible costs associated with 
treatment should they decide 
to receive treatment outside of 
Mile Square, which is an FQHC 
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insurance and covering 
treatment costs.   
10 
6/24/2021 
The baseline incentive amount was 
increased from $25 to $50. 
 
The recruitment protocols were 
amended to include assistance from 
a Lighthouse Institute outreach.  
 
Questions from the baseline and 
follow-up questionnaires were 
removed to shorten the interview 
length.  
The baseline interview is more 
intensive and time-consuming 
than the follow-up interview, 
and feedback from participants 
indicated that the discrepancy 
in payment between baseline 
($25) and follow-up ($35) was 
unfair.  
[Note: All previously consented 
participants will be offered the 
compensation difference.] 
 
The addition of the outreach 
team is to improve enrollment 
rates.  
 
Unnecessary questions were 
removed from the instruments 
to decrease the time burden on 
participants.  
 
 
 
11 
2/17/2022 
The eligibility assessment was 
amended to include the urine drug 
screen, which was previously only 
used during data collection.  
Implementing the drug screen 
during the eligibility assessment 
allowed for confirmation that 
participants are not already 
prescribed MOUD at 
enrollment.  
 
 

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11 REFERENCES  
 
1. Kelty E, Hulse G. Fatal and non-fatal opioid overdose in opioid dependent patients treated with 
methadone, buprenorphine or implant naltrexone. Int J Drug Policy. 2017;46:54–60. 
2. National Academies of Sciences E, Division H and M, Policy B on HS, Abuse C on PM and RS to 
APO, Phillips JK, Ford MA, et al. Trends in Opioid Use, Harms, and Treatment. National 
Academies Press (US); 2017. https://www.ncbi.nlm.nih.gov/books/NBK458661/. Accessed 25 
Oct 2019. 
3. Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid 
pain relievers---United States, 1999--2008. MMWR Morb Mortal Wkly Rep. 2011;60:1487–92. 
4. Connery HS. Medication-Assisted Treatment of Opioid Use Disorder: Review of the Evidence and 
Future Directions. Harv Rev Psychiatry. 2015;23:63. 
5. Knudsen HK, Abraham AJ, Oser CB. Barriers to the implementation of medication-assisted 
treatment for substance use disorders: The importance of funding policies and medical 
infrastructure. Eval Program Plann. 2011;34:375–81. 
6. Watson DP, Duwve J, Greene M, Weathers T, Huynh P, Nannery R. The changing landscape of 
the opioid epidemic in Marion County and evidence for action. Indianapolis, IN; 2018. 
 
7. Criteria from American Psychiatric Association (2013). Diagnostic and Statistical Manual of 
Mental Disorders, Fifth Edition,. Washington, DC, American Psychiatric Association page 541.  
 
8. Wesson, D. R., & Ling, W. (2003). The Clinical Opiate Withdrawal Scale (COWS). J Psychoactive 
Drugs, 35(2), 253–9