Training Peer Recovery Coaches to Promote Retention and Adherence to Medications for Opioid Use Disorder Among Low-Income Adults
Phase: NA
Conditions: Opioid Use
Sponsor: Henry Ford Health System

 
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FOREward Together: Training Peer Recovery Coaches to Promote Retention and Adherence to MOUD 
NCT05098795 
Approved Protocol 
Document Date 2/8/2022 
 
 

 
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STUDY TITLE: Training Peer Recovery Coaches to Promote Retention and Adherence to Medications 
for Opioid Use Disorder among Low-Income Adults  
 
1. STUDY AIM, BACKGROUND, AND DESIGN ABSTRACT  
 
Low-income and racial/ethnic minorities suffer disproportionately from substance use disorders, evidencing 
consistently lower rates of critical treatment outcomes, including treatment engagement and retention1. While 
these individuals exhibited a need for evidence-based care prior to the pandemic2, low-income, racial/ethnic 
minority populations have been disproportionately affected by COVID-193, as have persons with SUDs4.  
Peer Recovery Coaches (PRC) are individuals with lived-experiences with substance use who have been 
certified by the state to assist in treatment recovery5. Because of similarities between PRCs and substance use 
clients, PRCs can overcome many of the barriers that clients face to engaging and staying in SUD treatment, 
such as stigma6. The goal of the current project is to conduct an open-label pilot trial to examine the feasibility, 
acceptability and accessibility of a PRC-led intervention to support retention in SUD care.  
This project proposes to develop a novel and sustainable model for improving retention in SUD treatment by 
training PRCs to deliver an evidence-based intervention (EBI), Behavioral Activation (BA). BA seeks to 
increase the positive reinforcement patients experience from their natural environment by promoting prosocial 
and valued experiences. BA has been found to improve substance use treatment retention and adherence, as 
well as medication adherence in low-income individuals with HIV/AIDS. To that end, we propose the following 
goal: to evaluate the preliminary feasibility, acceptability, and effectiveness of the PRC- delivered BA 
approach. We will conduct an open-label clinical trial (n=40) of the adapted PRC-delivered BA intervention and 
training protocol in a representative agency in Detroit, MI serving a low-income, predominantly African-
American population. Findings from this phase of the project will be used to re-adapt the manual and training 
procedures.  
 
2. SUBJECT POPULATION AND ELIGIBILITY 
The Detroit Recovery Project (DRP) is located in Detroit, Michigan. The DRP offers a variety of services to their clientele, 
including, though not limited to, case management, medication for opioid use disorder (MOUD), and peer recovery 
support. All CDC COVID-19 guidelines are practiced at the DRP. Throughout this study, patients will have the option to 
engage with researchers in-person at DRP and/or to perform study activities by phone or computer at their home or 
another private location. 
 
All DRP visitors who are at least 18 years old, and meet criteria for a SUD will have the opportunity to learn about this 
study from DRP staff, and if interested, will be referred to research staff to learn more about and potentially enroll in the 
study. Due to variable access to communication technologies across the patient population at DRP (i.e., very limited 
smart phone or A/V technology access, and limited cell phone minute access), we will offer several ways for patients 
who have indicated their interest in participating in research to connect with our team as to not exclude individuals 
based upon lack of access to technology. Options include: 1) Direct communication via telephone, text messaging, or 
email, whereby research staff can contact eligible patients who have indicated that they are interested in research 
participation to ask if they are interested in hearing information about a study that is testing a new intervention to help 
people stay in treatment; 2) Direct in-person communication; 3) A study flyer provided to eligible individuals by DRP 
staff which provides space for the individual to list their name and contact details and deposit the completed flyer in a 
lockbox checked routinely by the study staff. Direct communication via telephone, texting, or email utilizes contact 
information provided to DRP by the patient. In the case that a patient does not have reliable access to their own phone, 

 
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contact information may include an emergency/alternative contact other than the patient themselves. The research 
team may use any contact information provided by the patient, including alternative/emergency contacts. If the 
research team contacts someone other than the patient, they will provide contact information for the patient to follow 
up or otherwise coordinate direct communication with the patient. Interested individuals will also have the opportunity 
to write their name and contact details on a research study flyer and to deposit this flyer in a secure lockbox for the 
research team to contact them or give this flyer to DRP staff. 
 
Before engaging in any in-person research activities on-site, all enrolled participants and patients interested in the study 
will be screened for COVID-19 risk and will be required to wear the appropriate personal protective equipment (PPE). All 
visitors at DRP (including staff, patients, and visitors) are screened for COVID infection or exposure risk by the DRP staff 
using up-to-date protocols including temperature check. Visitors are required to wear a facemask and to pass the 
screener in order to gain access to the DRP building. Therefore, screening will take place for all participants. Any 
participant who screens positive will be excluded from in-person study engagement and will be engaged virtually. 
 
After discussing the study with the research team member by telecommunication (audio or video) or in-person and 
based on continued interest, the participant will be invited to complete the informed consent process (detailed below in 
Procedures) and to schedule the baseline assessment. In all cases, patients will be informed that the study provides 
ClinCard compensation for participation (see Recruitment Script). The study team member will reiterate that 
participation in the study will in no way affect any services that they receive at DRP or elsewhere and will emphasize 
that they may participate through tele-sessions if this would work best for them or due to COVID-19 safety concerns. 
The study team member will also work with the participant to understand their access to technology for study 
communication. The study team will work with each participant to try to accommodate their individual frequency needs 
(aiming for a minimum of every other week) for intervention and other study-related contact, with flexibility of timing 
based on each individual’s treatment schedule and needs. The study team will keep a record of participant access to 
technology (e.g. phone minutes, texting capability, video capability, WiFi, etc.) in a HFHS REDCap database (non-
identifiable information only) .As needed, the research team will provide information on/assistance with applying for a 
phone through public assistance programs and other resources available at DRP.  
 
a. Eligibility Criteria:   
Participants must (1) meet criteria for SUD; and (2) be over the age of 18. 
 
Exclusion criteria will be (1) demonstrating active, unstable or untreated psychiatric symptoms, including mania 
and/or psychosis; or (2) inability to understand the study and give informed consent in English. 
 
Active, Unstable or Untreated Psychiatric Symptoms: The study team is committed to recruiting a sample that 
reflects the complexity and likely comorbidity of people with moderate to severe SUD in this setting. Therefore, 
we will only exclude people whose concurrent mental health issues preclude ability to participate with the 
procedures in this study. Throughout the study, researchers will monitor for active, unstable or untreated 
psychiatric symptoms as the presence of these symptoms during study procedures would interfere with 
participation. Monitoring for exclusionary psychiatric symptoms can include reviewing data in medical chart (per 
protocol-approved access to medical records), observation during assessments and intervention sessions, 
and/or current symptoms detected on the MINI modules for psychosis and mania. 
 
Inability to complete informed consent/ study in English. This study/intervention will be implemented in English 
only. Therefore, the capacity and willingness to give written informed consent in English, to understand the 
study and inclusion and exclusion criteria in English. 
 

 
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b. Rationale: The DRP is a community-based, outpatient substance use resource center. The program provides 
SUD treatment services to adults living in the Detroit metropolitan area. The program serves many people of 
low-income, racial/ethnic minority patients with SUD who struggle with treatment retention. Thus, recruiting 
from this population is appropriate, given the aims of our study. 
 
c. Enrollment Numbers: For the open-label trial, we will enroll a maximum of 40 patients.  
 
d. Rationale for Enrollment Numbers: We will enroll up to 40 patients because we expect to have a 
retention rate of 80% based upon current retention rates in other research at this site. The minimum target size 
(n=32) is large enough to allow us to demonstrate feasibility, implementation, acceptability, and preliminary 
efficacy for the intervention and also allow us to make any changes to the protocol if deemed necessary prior 
to collecting the full sample.  
 
 
3. STUDY PROCEDURES 
 
Recruitment and Screening: 
As stated above, recruitment will take place at the Detroit Recovery Project (DRP). All patients with SUD will be 
given the opportunity to learn more about this study from DRP staff, who will refer patients to research staff if 
interested.  Patients will be contacted by a member of the research study team by phone, text, email, or in-
person (during routine visit to the treatment center) and asked if they are interested in hearing about a study 
that is testing a new intervention to help people stay in treatment. Interested individuals will also have the 
opportunity to write their name and contact details on a research study flyer and to deposit this flyer in a secure 
lockbox for the research team to contact them.  
 
Patients will be informed that the study provides ClinCard compensation, that their participation is voluntary, 
and that participation has no impact on their treatment at DRP or at any other location. 
 
All DRP patients who present with SUD are referred at intake; for new patients, a small battery of assessments 
will be integrated into the intake in order to assess eligibility. The baseline will then be finished by a researcher if 
the potential participant is eligible, interested and consents to participation. After discussing the study with a 
research team member, and based on patient continued interest, participants will be offered paper copies of 
the consent form for their records.. Eligible participants who successfully complete the informed consent 
process will be given a unique identification number. This number will be used in place of their name for the 
remainder of the study.   
 
Interested, eligible, and consented participants will then be scheduled to complete the Baseline assessment. 
Baseline measures can include demographic characteristics and history of substance use treatment, measures of 
treatment adherence, measures of problems related to substance use, substance use frequency and severity, 
other mental and physical health characteristics, readiness for change, quality of life, social support and current 
activities. The measures to assess the topics listed above can be found in the Measures document. Please also 
reference the Intervention Flow Diagram for a visual timeline of measure use. Patients who are deemed 
ineligible following the full baseline assessment due to lower than moderate opioid use or current psychotic or 
manic symptoms will be provided additional resources (see Resource List document) and may continue with 
usual care at the center.  
 
At all stages of recruitment, we will reiterate that participation or non-participation will not influence the 
patient’s treatment, resources, or other relationships with DRP.  

 
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Intervention and Assessments: 
Following completion of the baseline assessment, the participant can meet with the PRC approximately 8 BA 
sessions that can be scheduled based on individual treatment plans and particular participant needs, with the 
aim of a minimum session frequency of every other week. Following treatment completion, participants will be 
able to schedule up to 4 booster sessions to provide further assistance with addressing barriers to treatment. 
These sessions will be held either remotely or in-person at the drug treatment center, depending on participant 
availability and preference. Based on participant needs and preferences, the PRC may provide a second check-in 
between BA sessions. The additional check-in will focus on challenges and barriers that participants are 
experiencing in their SU treatment. These sessions can be conducted via phone (including telephone, 
Zoomvideoconference (Zoom), or in-person at the drug treatment center. Participants can conduct remote 
sessions from their homes or other preferred private locations. In-person sessions will take place at DRP or other 
mutually convenient locations and follow all necessary COVID-19 precautions outlined in the approved in-person 
human subjects research proposal. Participants may also choose to participate in these virtual sessions at DRP 
during routine visits to the treatment center with the peer at a separate location. These procedures will follow 
the current telehealth practices and protocols being used at DRP.   
 
The study interventionist will be a trained and supervised PRC who will receive training in protocol and 
intervention procedures. Supervision sessions between the PRC and DRP clinical supervision staff will take place 
approximately weekly, with inclusion of key personnel as needed (I.e. Drs. Felton, Magidson and/or Seitz-
Brown). The supervisor will utilize recordings of intervention sessions while supervising the PRS. The peer hired 
as the study interventionist will be a Michigan Certified Peer Recovery Specialist (CPRS). CPRS certification is 
managed by Michigan Department of Health and requires 56 hours of training. 
 
Throughout the treatment program, the PRC will attempt to work with the patient weekly. These sessions will 
occur in-person or via phone or over Zoom, a cloud-based video-conferencing system which allows for 
participants to call-in via phone or computer. Call administrators are able to record and store audio from a call 
on a local drive. Phone sessions will be recorded using Zoom or a hand-held recorder, in-person sessions will be 
recorded using a hand-held recorder, and all recordings will be saved to UMB Box folder before they are deleted 
from the recording device. In order to further protect participant privacy, no audio recording will be saved to a  
cloud platform. Sessions will be audio-recorded for supervision and to assess for treatment fidelity. This is noted 
in the consent process, and participants can refuse audio-recording at any time (refusal of audio recording does 
not preclude participants from continuing to be part of the study). The PRC will reiterate before conducting each 
session that the audio-recording is for research purposes only, will not include any identifiable information, and 
will be kept confidential.  Zoom security functions include a Waiting Room in which individuals can be screened 
before the call administrator allows them to join the call, and a Lock Meeting function which allows the 
administrator to block new participants from joining. Depending on different participants’ needs, the timing of 
PRC meetings are expected to vary and will generally last up to half an hour to an approximate maximum of one 
hour. The PRC role is often flexible, particularly for patients who are poorly engaged in care. We will document 
how and when sessions take place (method of communication, locations of PRC and participants, time of day) to 
further our understanding of how the PRC role can optimize participant engagement in treatment. 
 
In order to assess SUD retention and treatment adherence, research staff will extract routinely-collected data 
from patient medical charts (maintained by DRP) at each BA session and assessment, with collected data 
consisting of intake date, clinic attendance, counselor appointments, engagement in psychosocial services,  any 
breathalyzer results, any urinalysis or other drug testing results, and, when applicable, MOUD dosing, dose 
volume and any notes on patient dosing. We will ask participants about any changes to their enrollment in 

 
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treatment programs (see Treatment Program Status, MOUD Adherence and Retention: Chart Extraction in 
Measures document). This use of medical records is outlined in the consent form. At each BA session, 
participants will complete two items on the Ira Wilson’s Self Report Adherence Measure.  
 
During the approximately weekly or biweekly sessions, the PRC will determine the participants’ specific 
circumstances and needs and will draw upon intervention components accordingly. Intervention components 
can include: Life Steps to identifying and overcoming day-to-day barriers to treatment, SMART goal 
identification and work, case management with the treatment facility, and modified Behavioral Activation (BA) 
to support retention in treatment. The PRC will complete/update the intake goals and follow-up goals with the 
participant during sessions to keep track of the participants’ individual plans moving forward. The PRC can also 
work through BA modules during sessions and review material as needed. After sessions, the PRC will complete 
a fidelity assessment to indicate which components were addressed (see the Fidelity measure guide in the 
Measures document). Specifically, the approach can focus on the following six elements: (1) psychoeducation 
regarding substance use, (2) treatment rationale, (3) identification of treatment barriers and solution planning, 
(4) identification of valued life areas to guide activity selection, (5) monitoring of current activities, (6) 
scheduling of new activities, and (7) tracking of actual behaviors and subsequent substance use behaviors.  
 
If a participant misses BA sessions, the PRC will continue to follow up with the participant to assess barriers, 
concerns, and try to continue treatment.  
 
With participant permission, all sessions will be audio recorded for supervision purposes and for fidelity 
assessments. A trained, independent rater will review approximately 20% of audio-recordings from sessions. 
This rater may be a research team member who is located at the University of Maryland, College Park. The 
independent rater will fill out fidelity measures based on these session recordings for later comparison with the 
PRC’s self-reported fidelity (see Fidelity measure in Measures document).   
 
At the approximately mid intervention and post-intervention, a trained member of the research team will 
complete remote or in-person (depending on participant availability, COVID-19 protocols, and participant 
preference) assessments with the participant. We anticipate that phone or video-based assessments may need 
to be shorter than in-person assessments; thus, we have streamlined and reordered our assessment measures 
to prioritize the most important measures for this study. This will allow us to gather the most important data 
earliest during the remote assessments in case a participant experiences difficulty with technology or is unable 
to continue the remote assessment for some other reason (such as a family emergency). The approximately 6-
week midpoint assessment will be a brief assessment of factors that we hypothesize may change during the 
course of the intervention. Measures that can be used in this assessment are listed in the Intervention Flow 
document. The post-treatment assessment measures can include the same measures as the baseline 
assessment with the exception of no Demographic and other Characteristics Questionnaire. The post-treatment 
assessment can also include the Treatment Program Status form, Working Alliance Inventory Short Revision and 
the JHU Feasibility and Acceptability measure, to assess the participant’s satisfaction with working with the PRC 
and important barriers and facilitators to implementation of the intervention.  
 
After completing the posttreatment assessment, participants will be invited to complete a qualitative exit 
interview which will ask them about their experience in the treatment (see Exit Interview Guide). Exit interview 
can take place by phone, video, or in-person. Participants who have dropped out of the program early will also 
be invited to complete the midpoint assessment, posttreatment assessment, and exit interview over the 
remaining period of the planned study timeframe (an intent-to-treat approach) or at their earliest convenience. 
The exit interview will take place immediately following the posttreatment assessment or may be scheduled 

 
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within approximately one week. Because this interview will ask about the participants’ experiences with the 
PRC, the interview will be conducted by a trained member of the study staff and the participants’ responses will 
not be shared with the PRC. The participant will be asked for their consent for the interview to be recorded. 
They will be assured that audio recording will be used for research purposes only. The recording will be 
uploaded to UMB’s Box folder immediately following the session, and the audio file will be deleted from the 
recording device. 
 
It will take approximately 30-60 minutes to complete the baseline assessment, approximately 15-30 minutes to 
complete the midpoint assessment, approximately 30-60 minutes to complete the posttreatment assessment, 
and approximately 30 minutes to complete the posttreatment exit interview. All compensation for study related 
activities will be in the form of a reloadable ClinCard. The participant will receive $10 (ClinCard) for completing 
the baseline, $15 for completing the midpoint assessment, a $25 ClinCard for completing the posttreatment 
assessment, and $25 for completing the exit interview. Total compensation for baseline assessment, midpoint 
assessment, posttreatment assessment, and exit interview will be up to $75. 
 
We recognize that meeting with participants remotely or in person may both present new challenges to 
participation, including cost associated with using their own device for session contact or cost of attending 
sessions when not scheduled for other services at DRP. We also understand that participants may also face 
additional transportation costs when presenting in-person to the drug treatment center during COVID-19. As 
such, participants will receive compensation in the form of ClinCards for each session attended to cover 
transportation and/or telecommunication costs. $10-25 per session will be provided to participants after each 
session attended for the duration of the study. We have chosen to incrementally increase compensation as 
sessions persist in order to encourage long-term retention. Participants will receive $10 per session for BA 1-2, 
$15 per session for BA 3-4, $20 per session for BA 5-7, and $25 for BA 8. Total compensation for intervention 
session attendance (above the compensation for assessment participation) will have a maximum of $135, 
reflecting attendance of the 8 sessions.  
 
For any remote call with the participant, the research team will document the participant ID number, researcher 
name, location of research team member, location of participant, means used (telephone or computer), start 
and end time, quality of call (excellent, minor issues, significant impediment), and any barriers to effective 
communication in RedCap. For any in-person session (assessment or intervention session), researchers will 
follow procedures outlined in the IRB-approved in-person human subjects protocol. 
 
Data analysis: 
 
Quantitative data will involve pre- to-post t-tests and will utilize multiple imputation to handle missing data if 
deemed appropriate and necessary.  
 
Qualitative data will be analyzed using thematic analysis, and the coding team will iteratively develop a 
codebook outlining themes, sub-themes, and definitions in the transcripts. The codebook will be modified as 
new concepts arise. 
 
 
 
4. ANTICIPATED RISKS  
 
During the COVID-19 pandemic, the health and safety of participants, researchers, and DRP staff is a primary 
focus. The study team will work with participants to determine preference for in-person or remote participation 

 
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in assessment and intervention sessions. Participants will have the option of either in-person or remote 
engagement throughout the study. The study team will also ensure that remote interviews are conducted within 
the participant’s existing daily routine, ensuring participants are not exposed to settings or situations that will 
put them at any additional risk for viral exposure. If participants elect to meet remotely with the peer, they will 
complete remote study sessions by phone or video conferencing at their home, or other preferred private 
location. 
 
The risk from research interviews is minimal and relatively uncommon. During assessments, participants may be 
uncomfortable discussing their drug use, depression, and other mental health symptoms. Participants may 
become frustrated and tense when they encounter difficulty when completing these measures.. The research 
team will be trained by Dr. Felton to be vigilante and sensitive to these signs of participant distress using role 
plays, didactics, and ongoing supervision and training in order to minimize any potential discomfort at ensure 
staff competence to detect and address participant distress. Participants will take breaks when necessary to help 
alleviate any discomfort. Participants will be reminded that they can refuse to answer any questions that make 
them uncomfortable and may take breaks whenever they are needed. 
 
Behavioral Activation (BA) is a minimal risk intervention; however, the study population, adults with problematic 
substance use/SUD, is a group with potential to report symptoms of depression or anxiety. BA sessions may 
cause some temporary anxiety or distress due to discussing drug use and attempts to maintain abstinence. 
ThroughMichigan Peer Recovery Specialist Certification, the PRC interventionist will have received training to 
recognize signs of distress. We will take specific precautionary steps to protect against related risks to 
participant wellbeing. Researchers will contact one of the licensed psychologists on the team (Drs. Felton, 
Magidson, or Seitz-Brown) if a participant is in distress or reports current suicidality during interviews at any of 
the study assessment time-points or BA sessions (in-person or remote). If a research staff member, suspects that 
a participant is at active and imminent risk for suicide (determined using the Suicide Risk Assessment form), we 
will follow the preferred safety procedures at the treatment center including contacting DRP staff while the 
participant waits with the researcher (in person) or the participant remains on the phone with the researcher 
(remote). In the unlikely event that the research team is concerned about the participant’s immediate safety 
while the participant is not at DRP, emergency services will be contacted and DRP staff will be notified. The 
researcher will work to stay in direct communication with the participant until emergency services have arrived 
at their location. The study PI will be immediately notified of any such occurrence once the participant is safe. 
 
Special vulnerable populations, such as fetuses, neonates, children, prisoners, and institutionalized individuals 
will not be enrolled in this study. All interventionists will be watchful regarding the participant’s status, and any 
concerns will be discussed with the Principal Investigators (PIs) and treatment team as needed. It will be made 
clear to participants during informed consent that they are free to terminate participation in the project at any 
time without any penalty. 
 
There is a risk of breach of confidentiality if the online REDCap system at Henry Ford Health Systems, or Box 
through the University of Maryland, College Park. We will take the necessary precautions to minimize these risks 
to the best of our ability. All data will be coded with an ID number that is unique. All data including information 
from chart reviews, therapist reports and laboratory results will be labeled by ID only. Only the study team will 
have access to the link between the ID and participant’s name. Data containing names and personal information 
will never be included in published materials. Electronic data files with identifiable information will be 
maintained separately from other data files and will only be used for administrative purposes (e.g., preparing 
aggregate reports to share with the study team). Participant identifiers and related PHI will be stored on secure 
servers, in a password protected file, accessible only by study staff and via a password protected computer. All 

 
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personnel will receive certification in human subjects’ protection prior to beginning work on this project.   
 
There is a possible risk to confidentiality if telecommunication services (telephone, or Zoom) are breached. In 
order to minimize this risk, the phone number provided to participants will be a secure, study-only issued 
phone. Only study personnel will have access to the phone. Participants’ voice mails will be deleted once their 
contact details are updated on a secure, HIPAA compliant HFHS drive (Box). When using Zoom, security features 
will be in place to ensure that only the intended participant are allowed to join the call. All recordings of Zoom 
calls will be recorded to a local drive, uploaded into a secure UMCP Box folder, and deleted from the local drive 
upon upload. Prior to recording sessions, researchers and participants will discuss telecommunication guidelines 
to agree on appropriate behaviors and privacy expectations (e.g. remaining in one place during the session, 
ensuring both researcher and participant are in private spaces, etc.).  
 
During trial assessments or BA sessions, it is possible that information may be disclosed about childhood abuse 
and neglect experiences and/or alleged perpetrators of abuse. We are aware of our obligation to report, and will 
follow the State of Michigan’s mandatory child maltreatment reporting laws to the extent that reporting does 
not violate any applicable federal rules or policies. For this study, we state explicitly our responsibility to report 
in the body of the consent form.  
 
There is a slight risk of potential for coercion (compensation). Compensation is linked to completion of research 
assessments as well as attendance of intervention sessions. Participants will be paid $10 for the baseline 
assessment and intervention sessions 1-2, $15 for intervention sessions 3-4 and the midpoint assessment, $20 
intervention sessions 5-7, and $25 for intervention session 8, the post-treatment assessment and exit interview. 
The maximum compensation for this study accumulates to $260 with all sessions, assessments, and the exit 
interview completed. This compensation is modest and reasonable for the tasks being requested and are 
consistent with other clinical intervention research trials.  
 
Other risks: One risk in this study related to SUD and its treatment is the stress of and symptoms associated with 
withdrawal; these will be monitored and treated by the participant’s treatment team at the DRP and any 
worsening of these identified by the study team or study interventionists will be reported to the DRP. 
 
Throughout the study, the PIs and members of the research team will ensure strict adherence to study 
procedures according to the IRB-approved protocol. Should there be any protocol deviations or unanticipated 
problems, a PI will notify the HFHS IRB.  
 
Because study sessions may be conducted virtually with participants and researchers at separate locations, the 
research team will be trained to exhibit hypervigilance when monitoring verbal, audible, and visual signs of 
participant distress. Researchers will discuss these signs in trainings and during weekly meeting discussions. The 
study interventionist will be a trained and supervised PRS who will receive training in procedures for responding 
to symptoms and in safety protocols designed as part of this study. Close supervision will be provided by the PI 
and co-Is who are licensed psychologists (Felton or Magidson) as well as DRP clinical supervisor (Walker). The 
PRS will be watchful regarding the participant’s status, and any concerns will be discussed with the Principal 
Investigator (PI) and treatment center as needed.  It will be made clear to participants during informed consent 
that they are free to terminate participation in the project at any time without any penalty. 
 
Adverse Events (AEs) are any untoward or unfavorable occurrence in a study participant, including any abnormal 
signs, symptoms, or disease, temporally associated with the participants’ involvement in the research, whether 
or not considered related to participation in the research. Serious Adverse Events (SAEs) include any adverse 

 
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event that results in death, is life threatening, or places the participant at immediate risk of death from the 
event as it occurred, requires or prolongs hospitalization, causes persistent or significant disability or incapacity, 
results in congenital anomalies or birth defects, or is another condition which investigators judge to represent 
significant hazards. Unanticipated Problems (UPs) are defined as any incident, experience, or outcome that is 
unexpected (in nature, severity, or frequency), related or possible related to participation in the research, and 
suggests that the research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized.  
 
For reporting of AEs and SAEs, the interventionist or other member of the research team will immediately notify 
a principal investigator. The investigator (Dr. Felton or Dr. Magidson) will determine how to classify the event. 
AEs or SAEs will be classified according to severity, expectedness, and potential relatedness to the study 
intervention. Severity classifications will be: mild, moderate, or severe. Classification will be informed by the 
severity of the event and the degree of inconvenience or interruption of the participant’s daily activities. 
Expectedness classifications will be: unexpected or expected. Unexpected classification will occur when the 
nature or severity of the event is not consistent with the information about the individual, the population, or the 
intervention. Relatedness classifications will be: definitely related, probably related, possibly related, or not 
related. Classification will be informed by temporal sequence and known/expected response patterns.  
 
After determining the severity of the event and whether study-related, this information will be communicated 
to the rest of the research team. The research team, under Dr. Felton’s supervision, will complete HFHS IRB’s 
Problem Event Form and submit to the IRB. Unanticipated SAEs that are definitely or possible related to the 
study will be reported to the IRB within two business days once reported to the PI. The expedited Problem Event 
report will be followed by a detailed, written report as soon as possible. All other AEs will be collected on an AE 
form. AEs will be communicated to the PIs during weekly study meetings and a summary will be reported to the 
IRB with annual review. UPs that impact risks to study participants or others will be reported to the IRB within 
two business days. Deaths will be reported by study staff to the PIs (Dr. Felton and Dr. Magidson) immediately, 
and undergo expedited reporting to the IRB, within one business day of being reported to the PI. 
 
5. ANTICIPATED BENEFITS 
 
 
There are no direct, guaranteed benefits to the participants. However, it is possible that receipt of BA will result 
in improved treatment outcomes and reduce drug use for participants.  
From a broader perspective, this study may significantly add to the field by increasing our understanding of ways 
to integrate evidence-based behavioral interventions to support treatment adherence through PRC delivery. 
Supporting SUDoutcomes could help to promote greater recovery in communities hit hard by substance use, 
particularly in low-income, underserved areas, such as our study site in Detroit.  
 
6. RENUMERATION/COMPENSATION 
 
Open-label trial participants will receive $10 for the baseline assessment and intervention sessions 1-2, $15 for 
intervention sessions 3-4 and the midpoint assessment, $20 intervention sessions 5-7, and $25 for intervention session 
8, the post-treatment assessment and exit interview. The maximum compensation for this study accumulates to 
$260with all sessions, assessments, and the exit interview completed. This compensation is modest and reasonable for 
the tasks being requested and are consistent with other clinical intervention research trials. 
7. COSTS 
Participation in this study may involve transportation and parking costs. These costs will not be the 
responsibility of the investigator, however, we will compensate participants per session in order to indirectly 
offset costs.  

 
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8. ALTERNATIVES 
 
The alternative is that subjects do not have to participate in the research and continue in treatment as 
usual.   
 
9. CONSENT PROCESS AND DOCUMENTATION 
 
 
A trained research staff member will conduct the informed consent. The researcher will read the consent form 
aloud to the participant and ensure that the participant understands key points from the consent form and what 
is being asked of them in participation. Participants may also choose to read the consent form themselves. Prior 
to giving their informed consent, participants will be given the chance to ask questions, and the researcher or 
trained designee will answer all the questions, making sure that the participants are satisfied and comprehend 
study procedures (see Evaluation to Sign Consent Form). Participants will also be informed about the voluntary 
nature of the study, and their right to withdraw at any point. If the participant refuses to consent, they will be 
considered a refusal and therefore ineligible for the study.  
 
Before written consent is given, the participant: 1) should verbalize understanding; 2) should be given the 
opportunity to ask questions; 3) should be given time to read the consent; 4) should report all questions were 
answered to their satisfaction; and 5) must correctly answer the questions on the evaluation to sign consent 
document. When completing the evaluation to sign consent form, the researcher or trained designee will ask 
questions 1 through 3 to ensure that the participant understands the risks, understands what will be expected of 
them, and understands that they may drop out at any point during the study.  
 
After written consent is given, the participant will be given a copy of consent form with signature blocks 
removed. Consent forms will be locked in a secure location at the Detroit Recovery Project.  
 
The consent process will take place after a participant is deemed potentially eligible based on initial screening 
questions and expressed interest in participation and before a potentially eligible participant proceeds with the 
baseline assessment. Participants will be reminded that they can stop participating in the study at any time, and 
that all aspects of this study are voluntary. 
 
10. WITHDRAWAL OF SUBJECTS 
 
Subjects may voluntarily withdraw from the study at any time with no penalty themselves or their healthcare or 
insurance plans/benefits. In the event of safety concerns and/or due to the participant having exceptional difficulties 
with completing the questionnaires, the PI may decide to withdraw the   participant from the study. 
11. PRIVACY AND CONFIDENTIALITY  
 
For this study, we will ensure the separation of de-identified participant data from protected health information 
(PHI) by storing data in separate locations. De-identified data will be stored using secure, password-protected 
software hosted on UMCP and HFHS servers (e.g. REDCap and Box) and in double-locked rooms at the DRP. At 
DRP, all participant information will be referenced using participant identification numbers. De-identified 
participant responses to study measures will be collected and stored using REDCap, a software toolset and 
workflow methodology for electronic collection and management of data. De-identified audio recordings and 
transcripts will be stored on secure, password-protected UMCP Box folders. Only the investigators/authorized 

 
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staff will have access to the REDCap database and the Box folder. 
 
We will immediately destroy initial screening checklists for individuals who are deemed ineligible after DRP 
program initiation. We will only keep a record of number of screenings completed and reasons for ineligibility.   
 
We will need to collect names and demographic information for participants who complete consent. Once 
collected, data will be de-identified. The file containing the information that links participant names to their IDs 
will again be stored in password-protected files on the HIPAA compliant, secure RedCap file. Only investigators 
will have access to this file. The key linking identifiable information to the participant ID will be destroyed five 
years after publication of study results.  
 
Audio-recordings will be uploaded to UMCP’s Box folder immediately following the session, and the audio file 
will be deleted from the digital recorder. These computer audio files will be secured by Box dual authentication 
and only accessible by authorized study personnel. The purpose of the audio-recordings will be explained to all 
participants and we will obtain both informed consent and authorization for recording. Participant 
confidentiality will be respected.  
 
All physical data, including filled out questionnaires, will be stored at the DRP in locked drawers. Once data are 
collected, all data will be de-identified, i.e. names will be removed and participants will be assigned ID numbers.  
 
As part of the informed consent process, participants will be advised that they may decline to answer any 
questions. This will provide participants with the assurance of confidentiality around sensitive personal 
information relating to substance use and mental health. All personnel working on the project will be educated 
about the importance of respecting participants’ rights to confidentiality. Investigators will all complete and 
maintain ethical and CITI training. All study personnel will be appropriately trained in the ethical conduct of 
human subjects’ research.  
 
Audio-recordings for participant exit interviews be transcribed by trained members of the research team (IRB-
approved staff member or student with up-to-date CITI training). Any inadvertent disclosure of personally 
identifiable information will be redacted upon transcription.  
 
Study files will be maintained until five years after the publication of study results in line with the guidelines of 
the American Psychological Association.   
 
Due to Michigan law, we will disclose to the appropriate individuals and/or authorities any information that 
comes to our attention concerning child abuse or neglect, or thoughts of harm to self or others, or if a court of 
law ensures, a subpoena for the research records. 
 
Important HIPAA Concerns 
If you will be using, disclosing or accessing the health record (medical record, mental health or 
substance abuse records, etc) for research purposes, then HIPAA applies. If you are accessing medical 
records or PHI for screening purposes, HIPAA regulations apply and investigators will need to obtain 
prospective HIPAA authorization or apply for a waiver of HIPAA authorization for the screening 
activities, as applicable, depending on the nature of the study.  
 
If accessing PHI for screening purposes and providing written authorization, describe how authorization 
will be obtained for the screening portion, who will obtain it or request and justification for a request for 
HIPAA waiver for recruitment purposes. If you are requesting waiver of HIPAA for screening purposes, 

 
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describe the confidentiality procedures that will be used. 
 
For more information on HIPAA authorization guidance, visit: https://www.hhs.gov/hipaa/for-
professionals/privacy/guidance/research/index.html 
 
NOTE: You may also need to obtain a waiver of documentation of informed consent (ie, signed 
consent) for screening purposes if you do not meet the requirements for waiving consent provided in 
the Consent Process section.   
 
 
12. DATA AND SAFETY MONITORING PLAN 
 
All of the materials collected are for research purposes only, and data will be kept in strict confidence. No 
information will be given to anyone without permission from the subject. Confidentiality will be ensured by use 
of unique identification codes. All data, whether generated in the laboratory or at the bedside, will be identified 
with a randomly generated identification code unique to the subject. 
  
In the course of conducting the questionnaires, we may learn about mental illness symptoms including suicidal 
ideation and/or intent, or other risks of harm. A research emergency protocol will be followed to detect, assess, 
and refer/triage persons to the most appropriate existing, non-research crisis resource available to them. In 
addition, the PI will be responsible for internal data monitoring on a scheduled basis including review of 
protocol deviations, adverse events, unanticipated problems, eligibility/screening and the informed consent 
process. Finally, the project team will meet regularly to assure that all confidentiality procedures are being 
maintained. 
  
 
Data security will be maintained by limiting access to the minimum number of research team members 
required to complete the aims.  A secure computer folder and password protected files, maintained on a 
secure server, will be used to store data. Data will be accessed any time a new participant enrolls or completes 
an assessment and we will ensure no identifying information is linked to answers. No identifiable data will be 
published or disclosed to third parties. At the end of the study, identifying information will be destroyed. Data 
collected from interviews and surveys will be stored until after all publications are completed. 
  
The research team will be thoroughly trained on the research protocol and procedures. A Manual of 
Procedures will be developed for project staff to reference. Protocol deviations/violations and Unanticipated 
Adverse Events will be communicated to the IRB per HFHS IRB policy by the Project Coordinator or PI and 
again reported at continuing review. The Project Coordinator will maintain records of approved protocol, initial 
IRB submission, and approved materials and tracking system and will make amendments to protocol/materials 
for approval by IRB when warranted. 
 
 
Unanticipated Problems and Adverse Events   
If applicable, describe process for reporting any unanticipated problems and adverse events to the IRB 
 
Adverse Events (AEs) are any untoward or unfavorable occurrence in a study participant, including any abnormal signs, 
symptoms, or disease, temporally associated with the participants’ involvement in the research, whether or not 
considered related to participation in the research. Serious Adverse Events (SAEs) include any adverse event that results 
in death, is life threatening, or places the participant at immediate risk of death from the event as it occurred, requires 
or prolongs hospitalization, causes persistent or significant disability or incapacity, results in congenital anomalies or 
birth defects, or is another condition which investigators judge to represent significant hazards. Unanticipated Problems 
(UPs) are defined as any incident, experience, or outcome that is unexpected (in nature, severity, or frequency), related 

 
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or possible related to participation in the research, and suggests that the research places participants or others at a 
greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or 
recognized.  
 
For reporting of AEs and SAEs, the interventionist or other member of the research team will immediately notify a 
principal investigator. The investigator (Dr. Felton or Dr. Magidson) will determine how to classify the event. AEs or SAEs 
will be classified according to severity, expectedness, and potential relatedness to the study intervention. Severity 
classifications will be: mild, moderate, or severe. Classification will be informed by the severity of the event and the 
degree of inconvenience or interruption of the participant’s daily activities. Expectedness classifications will be: 
unexpected or expected. Unexpected classification will occur when the nature or severity of the event is not consistent 
with the information about the individual, the population, or the intervention. Relatedness classifications will be: 
definitely related, probably related, possibly related, or not related. Classification will be informed by temporal 
sequence and known/expected response patterns.  
 
13. QUALIFICATIONS OF THE INVESTIGATOR(S) 
 
• 
Dr. Julia Felton – Licensed clinical psychologist; Multiple funded research projects; published 
research work on PRCs 
• 
Dr. Jessica Magidson (University of Maryland, College Park - Collaborator) – Licensed clinical 
psychologist; Multiple funded research projects published research work on PRCs 
• 
Dr. CJ Seitz-Brown (University of Maryland, College Park - Collaborator) – Licensed clinical 
psychologist; Multiple funded research projects published research work on PRCs 
 
14. REFERENCES 
 
1. Mennis, J., & Stahler, G. J. (2016). Racial and ethnic disparities in outpatient substance use disorder 
treatment episode completion for different substances. Journal of substance abuse treatment, 63, 
25-33. 
2.  SAMHSA. (2019). Key Substance Use and Mental Health Indicators in the United States: Results 
from the 2018 National Survey on Drug Use and Health. Retrieved 
from https://www.samhsa.gov/data/sites/default/files/cbhsq-
reports/NSDUHNationalFindingsReport2018/NSDUHNationalFindingsReport2018.pdf 
3. Shah, M., Sachdeva, M., & Dodiuk-Gad, R. P. (2020). COVID-19 and racial disparities. Journal of the 
American Academy of Dermatology, 83(1), e35.  
4. Wang, Q. Q., Kaelber, D. C., Xu, R., & Volkow, N. D. (2020). Correction: COVID-19 risk 
and outcomes in patients with substance use disorders: analyses from electronic health records in 
the United States. Molecular psychiatry, 1. Advance online 
publication. https://doi.org/10.1038/s41380-020-00895-0  
5. Bassuk, E. L., Hanson, J., Greene, R. N., Richard, M., & Laudet, A. (2016). Peer-delivered recovery 
support services for addictions in the United States: A systematic review. Journal of Substance 

 
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Abuse Treatment, 63, 1–9. https://doi-org.proxy-
um.researchport.umd.edu/10.1016/j.jsat.2016.01.003  
6. Cabral, R. R., & Smith, T. B. (2011). Racial/ethnic matching of clients and therapists in mental health 
services: a meta-analytic review of preferences, perceptions, and outcomes. Journal of 
Counseling Psychology, 58(4), 537. 
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