Peer-Delivered Behavioral Activation Intervention to Improve Adherence to MAT Among Low-Income, Minority Individuals With OUD - Pilot Phase
Phase: NA
Conditions: Substance Use, Substance Use Disorders, Opioid-use Disorder, Peer Delivered, Medication for Opioid Use Disorder (MOUD), Methadone Treatment, Retention in Care, Behavioral Activation
Sponsor: University of Maryland, College Park

 
 
 
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Study Protocol 
Project Title: Adapting a Peer-Delivered Behavioral Activation Intervention to Improve Adherence to 
MAT among Low-Income, Minority Individuals with OUD 
Principal Investigator: Jessica F. Magidson, PhD 
Grant: R61AT010799 
Version Date: 07/16/2021 
Contents 
Abstract ................................................................................................................................................... 2 
Subject Selection ..................................................................................................................................... 4 
Recruitment ......................................................................................................................................... 4 
Eligibility Criteria ................................................................................................................................ 6 
Rationale ............................................................................................................................................. 7 
Enrollment Numbers............................................................................................................................ 7 
Rational for Enrollment Numbers ........................................................................................................ 7 
Procedures............................................................................................................................................... 8 
Recruitment and Screening .................................................................................................................. 8 
Intervention and Assessments ............................................................................................................ 10 
Risks ..................................................................................................................................................... 14 
Benefits ................................................................................................................................................. 17 
Confidentiality ...................................................................................................................................... 17 
Consent Process .................................................................................................................................... 19 
Conflict of Interest ................................................................................................................................ 20 
HIPAA Compliance .............................................................................................................................. 20 
 
 
 

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Abstract 
The opioid use disorder (OUD) crisis has been considered an “epidemic of poor access to care” that 
disproportionately affects low-income, racial/ethnic minoritized individuals (Mitchell et al., 2012; Stahler 
et al., 2018; Samples & Mennis, 2018; Saloner et al., 2017). Recent efforts to identify gaps in OUD care 
using a cascade of care framework (Williams et al., 2017; Williams et al., 2018; Johnson et al., 2018) 
have highlighted the need to improve retention in medication for opioid use disorder (MOUD), with six 
month retention often below 50% (Williams et al., 2017; Williams et al., 2018; Johnson et al., 2018; 
Morgan et al., 2018) and even lower rates among low-income, racial/ethnic minoritized individuals 
(Stahler et al., 2019; Samples & Mennis, 2018; Manhapra et al., 2018; Weinstein et al., 2017). There is an 
urgent need to develop and evaluate innovative strategies to address barriers to MOUD retention for low-
income, racial/ethnic minoritized individuals, given that retention is highly predictive of future relapse, 
functioning, quality of life, and mortality (Hser et al., 2007; Timko et al., 2009; Stotts et al., 2009; 
SAMHSA, 2014).  
 
Peer recovery specialists (PRSs), trained individuals with their own lived experience with substance use 
disorder (SUD), are a promising strategy to improve MOUD retention for low-income, minoritized 
individuals with OUD. Utilizing peers to improve MOUD retention offers a flexible approach to address 
common barriers to MOUD retention, including stigma, challenges navigating services, housing 
instability, and other structural and psychosocial factors (Jack et al., 2017; Bassuk et al., 2016). Rapid 
increases in the use of PRSs nationwide demonstrates the appeal of employing them as a potentially 
sustainable solution to support the behavioral treatment needs in OUD care.  
 
Yet, few evidence-based interventions (EBIs) have been evaluated for PRS delivery to promote MOUD 
retention. Prior research has been inconclusive regarding psychosocial interventions to support MOUD 
retention (Timko et al., 2016; Carrol & Weiss, 2017); to date reinforcement-based approaches, such as 
contingency management, have empirical support for improving MOUD retention, yet also have low 
adoption in community settings due to organizational and provider barriers, including cost in medically 
underserved areas (Timko et al., 2016; Carroll, 2015). Prior research suggests the relevance of a 
reinforcement-based approach to improve MOUD retention, yet the need to identify an approach that is 
feasible and sustainable to deliver for underserved populations (Timko et al., 2016; Dunn et al., 2013). 
 
Behavioral activation (BA) may be a feasible, scalable, reinforcement-based approach for improving 
MOUD retention for low-income, minoritized individuals with OUD. BA, originally developed as an 
efficacious treatment for depression (Lejuez et al., 2011), aims to increase positive reinforcement by 
promoting engagement in adaptive, valued behaviors. By targeting increases in positive reinforcement, 
BA has since been found to be effective for improving SUD treatment retention (Magidson, Gorka, 
MacPherson  et al., 2011) and preventing future relapse (Mimiaga et al., 2012; Mimiaga et al., 2019; 
Daughters et al., 2017) among low-income, minoritized individuals with SUD. Further, BA has improved 
medication adherence (i.e., for HIV) among low-income, minoritized populations with SUD (Magidson et 
al., 2014; Magidson et al., 2018; Daughters et al., 2010; Tull et al, 2018) as well as depression, which is a 
barrier to MOUD retention (Carroll, Nich, Frankforter, et al., 2018). Importantly for implementation, BA 
also is feasible and cost-effective using lay counselor delivery (Magidson, Lejuez, Kamal, et al., 2015; 
Ekers et al., 2011; Ekers et al., 2014; Richards, Ekers, McMilllan et al., 2016). Following from this prior 
research, BA is an ideal EBI to evaluate for improving MOUD retention using a PRS-delivered model.  
 
This study builds upon our team’s formative work (Magidson, Gorka, MacPherson, et al., 2011; 
Magidson et al., 2018; Satinsky, Doran, Felton et al., 2019) to adapt and evaluate BA delivered by PRSs 
(“Peer Activate”) to support MOUD retention for low-income, minoritized individuals initiating MOUD 
at an outpatient, opioid treatment program in a medically underserved community in Baltimore City. 
Baltimore is a prime location to test innovative strategies to combat the OUD crisis, as its overdose 

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fatality rate is among the highest in the US, particularly for low-income, African Americans (Hogan, 
Rutherford, & Neall, 2017; KFF, 2017; Baltimore City Health Department, 2018). Guided by Aarons’ 
stage model (Aarons, Hurlburt & McCue Horwitz, 2011) and Proctor’s model of implementation (Proctor 
et al., 2011), we propose a mixed methods, hybrid Type 1 effectiveness-implementation study:  
 
Aim: To refine a PRS-delivered Peer Activate approach for delivery at a methadone treatment (MT) 
program. Specific aims are:  
 
1. To establish feasibility (primary), acceptability, and fidelity of Peer Activate in an open-label 
trial (n=40), and to pilot assessment procedures, including collecting preliminary MOUD 
outcomes (retention, abstinence). We hypothesize Peer Activate will be feasible (≥75% of 
patients agree to participate), acceptable (≥75% of those enrolled complete ≥75% of the 5 core 
sessions) and delivered by PRSs with fidelity (≥75% of a randomly selected 20% of session 
delivered as intended). 
 
2. To refine and finalize training and therapy manuals/procedures based on findings. 
 
Changes following COVID-19. On March 13th, 2020, the rapid spread of the global novel coronavirus 
(COVID-19) pandemic led to new emergency procedures at UMDTC which altered various clinic 
processes, including the frequency of MOUD distribution. Under non-emergency circumstances, 
methadone treatment adherence and retention must be observed in the context of daily observed dosing 
(i.e., daily medication dispensed at the clinic and taken by patients in front of clinic staff); however, the 
outbreak of the COVID-19 pandemic has given way to extreme and necessary measures of social 
distancing which aim to limit the transmission of this deadly virus. These widespread precautions have 
led to dramatic changes to MOUD dosing procedures at many treatment facilities, where supervised 
dosing has shifted to extended periods of take-home bottles for some patients in order to ensure the safety 
of the patients, treatment staff, and the wider community. As such, there is an urgent need to support 
MOUD adherence and retention during the unprecedented new circumstances prompted by the outbreak 
of COVID-19. We will administer this hybrid (remote and in-person) study in line with UMCP’s human 
subjects research policies, Maryland state regulations, and federal guidelines surrounding safe social 
practices in response to COVID-19. As such, this protocol outlines distinct procedures for a hybrid 
delivery of the Peer Activate intervention.  
 
Updates to COVID-19-related changes: In June 2021, UMDTC modified its guidelines regarding MOUD 
dosing procedures, relaxing social distancing requirements and switching many patients from extended 
take-home dosing to daily supervised methadone dosing. We will continue to administer this hybrid 
(remote and in-person) study in line with UMCP’s human subjects research policies, UMDTC 
requirements, Maryland State regulations, and federal guidelines surrounding safe social practices in 
response to COVID-19. 
 
The University of Maryland College Park (UMCP) is collaborating with the University of Maryland 
Baltimore (UMB) on this project. After this project received the initial IRB approval, an Authorization 
Agreement was put into place to cover IRB approval for UMB.  
 
As we will be collecting information about illegal behavior and substance use, the NIH provides us with a 
Certificate of Confidentiality. 

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Subject Selection 
Recruitment 
The University of Maryland Drug Treatment Center (UMDTC) is located at 1001 W. Pratt St., Baltimore, 
MD 21223. The UMDTC MOUD program receives new admissions to the clinic Monday through Friday 
(excluding holidays). During the ongoing COVID-19 period, patients continue to visit the treatment 
center in-person for appointments such as dosing, take-home bottle collections, medical visits, and 
counseling sessions. While at UMDTC, patients are led to a private, sanitized room to meet with intake 
coordinators, doctors, and counselors or meet with these providers in sanitized space with enough room to 
allow for appropriate physical distancing. Throughout this study, patients will have the option to engage 
with researchers in-person at 1001 and/or to perform study activities by phone or computer at their home 
or another private location. 
Patients who express interest in participating in research provide consent at intake (through UMDTC) for 
chart review to determine eligibility for research studies taking place at the center. All patients in the 
program who agree to this use of medical charts for research will be screened for study eligibility. 
Screening will include review of routinely collected patient information from program intake charts: 
intake date, age, pregnancy status, and dosing history. Patients who approach researchers directly with 
interest in the study or who are referred to the study by their counselors or medical providers and express 
interest can also be screened. Patients who are at least 18 years old, not pregnant (based on routinely 
performed pregnancy test at treatment intake), have expressed interest in participating in research, and 
meet at least one of the following eligibility criteria will have the opportunity to learn about the study: 
a. have started MOUD treatment in the last 3 months, AND/OR 
b. are demonstrating challenges with methadone adherence in the last 3 months, with 
nonadherence defined as one of the following: 
a. at least one missed methadone dose in the past 3 months as identified through 
clinic records, patient self-report (which can be indicated using a visual analogue 
scale rating of methadone adherence from 0-100%, and corroborated by a clinic 
counselor or provider), or counselor/provider report, 
b. at least one missing take-home bottle at the time of bottle return, 
c. screened negative for methadone in routinely administered clinic urinalysis tests, 
d. transitioned from an extended take-home bottle schedule to daily dosing 
schedule. 
Due to variable access to communication technologies across the patient population at UMDTC (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 researchers 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) A pre-

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recorded video introduction to the study during routine visits to UMDTC to outline the basic information 
regarding study participation and working with a peer; 3) A study flyer provided to eligible individuals at 
their dosing time 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; 4) Flagging patients through the 
medical record system to be informed of research team in-person presence at UMDTC and instructing 
them to meet researchers at the research location if they would like more information about participation. 
Direct communication via telephone, texting, or email utilizes contact information provided to UMDTC 
by the patient. In the case that a patient does not have reliable access to their own phone, 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 follow the specified recruitment 
script to 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 at dosing and to deposit this flyer in a secure lockbox for the 
research team to contact them. The research team will screen and flag eligible individuals who should 
receive this flyer at dosing using the treatment center’s HIPAA compliant softwares, Methasoft and EPIC. 
Inclusion of the flyer helps make sure that patients with unreliable contact details in Methasoft/EPIC or 
who present for dosing when researchers are not on-site still receive study information and can indicate 
their interest in further contact (indicating preferred contact details). Prior to and during active 
recruitment for this study, a researcher will occasionally be posted at the study site in order to provide 
information about this study to drug treatment center patients. In addition to dedicated space at the study 
site, the researcher may also be posted at the outdoor research booth near the front of the UMDTC 
building where flyers may be posted to be accessible to answer questions about the study. The researcher 
will be wearing a face mask and gloves and will maintain six feet of distance from other individuals at all 
times. A sign will be posted at the research booth instructing patients to wear a mask at all times and 
maintain six feet of distance when engaging with the researcher. The researcher will follow all necessary 
UMDTC COVID-19 precautions for in-person interaction indoors and at the outdoor research booth/tent. 
COVID-19 precautions outlined in the approved in-person human subjects research plan. 
Before engaging in any in-person research activities on-site, all enrolled participants and patients 
interested in the study will be double screened for COVID-19 risk and will be required to wear the 
appropriate personal protective equipment (PPE). All visitors at UMDTC (including staff, patients, and 
visitors) are screened for COVID infection or exposure risk by the UMDTC staff using up-to-date UMMS 
ambulatory site protocols including temperature check. Visitors are required to wear a facemask and to 
pass the screener in order to gain access to the UMDTC building. In addition to this routine screening, 
research staff will screen study participants at all in-person visits by asking about specific symptoms of 
COVID-19 and possible exposure. Therefore, double screening will take place for all participants who 
medication in-person at 1001 before commencing any research activities. Any participant who screens 
positive for COVID-19 will be temporarily excluded from in-person study engagement until a later date 
decided upon by the research team. 
Enrolled participants who experience circumstances that make them unable to regularly attend visits at 
UMDTC (e.g. transfer to other clinics, extended hospitalizations or time in rehabilitation facilities) may 
be considered for off-site, in-person encounters. The population served in this study can also experience 
varying phone and remote technology access, making it challenging to retain contact when they are no 

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longer visiting the clinic in person, even if they have expressed interest in continuing to seek peer support 
through this study. In order to meet needs of these research participants and support participant retention 
in this study, study visits may be conducted in the following ways: 
-In-person encounters with participants at outdoor locations near their home, hospital, residential 
treatment facility, or other local setting (socially distanced with PPE use by both researcher and 
participant) 
- In-person encounters with participants at indoor location that meets the current in-person plan space 
requirements (while socially distanced with PPE use by both researcher and participant) 
Off-site visits will follow all of the same COVID-19 precautions as on-site visits, including screening for 
COVID-19 symptoms before (at scheduling) and at the time of study visit.  
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 gift card compensation for participation. The study team member will 
reiterate that participation in the study will in no way affect any services that they receive at UMDTC or 
elsewhere. They will also make the participation options, remote or in-person, clear and answer any 
question about 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 dosing 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 UMCP REDCap 
database (non-identifiable information only) and in a HIPAA-compliant, UMB-based Microsoft Teams 
spreadsheet (includes identifiable contact information). As needed, the research team will provide 
information on/assistance with applying for a phone through public assistance programs and other 
resources available at UMDTC. 
Eligibility Criteria 
Participants must (1) be 18 or older and (2) have initiated MOUD at the community-based site within 
three months prior to study enrollment OR are demonstrating challenges with methadone adherence 
within the last three months indicated by one of the following: 
a. at least one missing take-home bottle at the time of bottle return, 
b. screened negative for methadone in routinely administered clinic urinalysis tests, 
c. transitioned from an extended take-home bottle schedule to daily dosing schedule due to 
autonomous medication management challenges, or 
d. at least one missed methadone dose in the past 3 months as identified through clinic 
records or patient- or counselor- report. Patients’ self-reported missed doses will be 
corroborated with patients’ counselors and/or clinic providers for consensus that the 
patient is struggling with methadone adherence. Patients referred to our study by their 
counselors will be asked if they have missed any methadone doses in the last 3 months 

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using a visual analogue scale to identify their level of methadone adherence from 0-
100%, with below 100% indicating challenges with adherence. 
Exclusion criteria will be (1) demonstrating active, unstable or untreated psychiatric symptoms, including 
mania and/or psychosis; (2) inability to understand the study and give informed consent in English; or (3) 
being pregnant at enrollment. 
 
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 OUD 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 assess for active, 
unstable or untreated psychiatric symptoms as the presence of these symptoms during study procedures 
would interfere with participation. Assessment 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. 
 
Pregnant Women. Pregnant women receive a different standard of care than non-pregnant patients, 
including more intensive services. Pregnant women are also more likely to be referred out to another 
program with specialized services during pregnancy. Therefore, pregnant women are excluded from this 
study. 
Rationale 
The UMDTC is a community-based, outpatient substance use treatment center affiliated with the 
University of Maryland (directed by co-I Dr. Aaron Greenblatt). The program provides MT to over 700 
adults living in Baltimore. The program serves many people of low-income, racial/ethnic minoritized 
patients with OUD who struggle with MT retention. There over 500 active patients in the MT program, 
the majority of whom (65%) identify as Black or African American, and 83% report having earned less 
than $15,000 in the past twelve months. Thus, recruiting from this population is appropriate, given the 
aims of our study. 
Enrollment Numbers 
For the open-label trial, our goal is to have at least 30 patients initiate the intervention, and at least 24 
completers. 
Rationale for Enrollment Numbers 
We will enroll at least 30 patients because we expect to have an attrition rate of approximately 20% based 
upon current retention rates in other research at this site and significant attrition between baseline and 
initiating the intervention. The minimum target size (n=30) is of patients who are receiving the 
intervention to be large enough to allow us to demonstrate feasibility, implementation, acceptability, and 

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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.  
Procedures 
This section outlines procedures starting with recruitment and screening, and describes the approach to 
intervention and assessment.  
Recruitment and Screening 
As stated above, recruitment will take place at the University of Maryland Drug Treatment Center 
(UMDTC). All patients in MOUD treatment who consent to use of medical records for research (that is, 
have already expressed interest in participating in research) will be screened for study eligibility by 
reviewing routinely collected information such as age, pregnancy status, and dosing record through chart 
review conducted remotely using UMDTC’s medical record databases, Methasoft and EPIC. Patients who 
approach researchers directly with interest in learning more about the study or who are referred to the 
study by their counselor/provider and express interest will also be screened. Following initial intake 
procedures, patients who found to be eligible will have the opportunity to speak further with researchers. 
Eligible patients must be age 18 or older, not pregnant, interested in research, and either recently starting 
treatment (within the last three months), or demonstrating challenges with methadone in the last three 
months as indicated by one of the following: 
a. have started MOUD treatment in the last 3 months, AND/OR 
b. are demonstrating challenges with methadone adherence in the last 3 months, with 
nonadherence defined as one of the following: 
a. at least one missing take-home bottle at the time of bottle return, 
b. screened negative for methadone in routinely administered clinic urinalysis tests, 
c. transitioned from an extended take-home bottle schedule to daily dosing schedule 
due to autonomous medication management challenges, or 
d. at least one missed methadone dose in the past 3 months as identified through 
clinic records or patient- or counselor- report. Patients’ self-reported missed 
doses will be corroborated with patients’ counselors and/or clinic providers in 
order for consensus that the patient is struggling with methadone adherence. 
Patients referred to our study by their counselors will be asked if they have 
missed any methadone doses in the last 3 months using a visual analogue scale to 
identify their level of methadone adherence from 0-100%, with below 100% 
indicating challenges with adherence. 
Patients will have the opportunity to speak with researchers in several ways. Patients may 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. Alternatively, patients may be given the opportunity to view 
a pre-recorded video of the team introducing the study and inviting the participant to contact the research 

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team by phone to indicate their interest to participate. This video will be made available on a computer 
located in a sanitized, private room at the treatment center during patients’ routine visits to UMDTC. 
Interested individuals will also have the opportunity to write their name and contact details on a research 
study flyer at dosing and to deposit this flyer in a secure lockbox for the research team to contact them. 
The research team will screen and flag eligible individuals who should receive this flyer at dosing using 
the treatment center’s HIPAA compliant softwares, Methasoft and EPIC. Researchers will use the same 
flagging system to indicate participants who should be informed of researcher on-site presence for in-
person description of the research opportunity, when applicable. 
Patients who are currently pregnant based on initial chart review will be considered ineligible for the 
study. Eligible patients who begin the study and become pregnant while enrolled will remain engaged in 
the study. Each participant will be engaged in the study for a maximum period of approximately three 
months; during this period, we do not expect early pregnancy (i.e. in the first trimester) to affect study 
participation and the intervention presents no additional risk to pregnant women. Standard procedures for 
pregnancy care at UMDTC will be followed and participants will be referred for subsequent care as 
needed (which typically begins starting in later pregnancy) following the three months of participation in 
this study. Patients will also be informed that the study provides gift card compensation, that their 
participation is voluntary, and that participation has no impact on their treatment at UMDTC or at any 
other location. 
After discussing the study with a research team member, and based on patient continued interest, patients 
will be invited to provide verbal consent for study participation via phone, video teleconferencing, or in-
person. In-person participants will be offered paper copies of the consent form and UMB COVID Risk 
Statement for their records. Remote participants will be offered a digital copy of the consent form and 
UMB COVID Risk Statement via text or email or a physical copy provided at the dosing window during 
a routine visit to the clinic. 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 by phone (including Google Voice), by the video-conferencing platform (e.g. Zoom), or in-
person, depending on participant availability and preference. Phone or video-based assessments may need 
to be shorter than in-person assessments; thus, we have streamlined and reordered our assessments to 
prioritize the most important measures first. This will allow us to gather the most important data earliest 
during the remote assessments in case a participant experiences difficulties with technology or is unable 
to continue the remote assessment for some other reason (such as a family emergency). Baseline measures 
can include demographic characteristics and history of substance use treatment (Demographics and Other 
Information questionnaire, Economic Resource Utilization), measures of MOUD adherence (MOUD 
Adherence and Retention: Chart Extraction, Ira Wilson's Self-Report Adherence Measure, Barriers to 
Adherence of Medication for Opioid Use), measures of problems related to substance use (Short 
Inventory of Problems-Revised and the Tobacco, Alcohol, Prescription medications, and other Substance 
Tool), substance use frequency and severity (timeline follow back [TLFB]), other mental and physical 
health characteristics (Patient Health Questionnaire-8, Generalized Anxiety Disorder 2-Item, TCU 
HIV/AIDS Risk Assessment for HIV, SF-8 Health Survey, PROMIS Pain Intensity – Scale,  PROMIS 
Pain Interference – Short Form 6b, Clinical Characteristics, and Pittsburgh Sleep Quality Index (PSQI)), 

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readiness for change (SOCRATES-8D), social support (Multidimensional Scale of Perceived Support, 
Substance Use Stigma Mechanisms Scale, and Methadone-Maintenance Treatment Stigma Mechanisms 
Scale), Mini-International Neuropsychiatric Interview (MINI) for DSM-5 Mania Module and Psychosis 
module, and current activities (Behavioral Activation for Depression Scale-Short Form, the 
Environmental Reward Observation Scale). The measures listed above can be found in the HEAL 
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 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 UMDTC.  
 
Intervention and Assessments 
Following completion of the baseline assessment, the participant can meet with the PRS for up to 12 BA 
sessions (5 core content sessions and 7 review sessions) that can be scheduled based on individual 
treatment plans and particular participant needs based on distinct methadone dosing schedules, with the 
aim of a minimum session frequency of every other week. 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 PRS 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 
methadone treatment. These sessions can be conducted via phone (including telephone, Zoom, or Google 
Voice), videoconference (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 
1001 (the drug treatment center) and follow all UMDTC COVID-19 precautions for in-person interaction 
at this site.   
The study interventionist will be a trained and supervised PRS who will receive training in protocol and 
intervention procedures. Supervision session between the PRS and a research team member (overseen by 
a licensed clinical psychologist on the research team) will take place approximately weekly. The peer 
hired as the study interventionist will be a Maryland Certified Peer Recovery Specialist (CPRS). CPRS 
certification is managed by Maryland Department of Health and requires 46 hours of training, 500 work 
hours in peer recovery support, and 25 hours of documented supervision under a registered peer 
supervisor. 
Throughout the treatment program, the PRS will attempt to work with the patient approximately twice 
monthly (at a minimum). These sessions will occur in-person or via phone or over Zoom, a cloud-based 
video-conferencing system hosted by UMCP 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 UMCP Box folder before they are deleted from the 
recording device. In order to further protect participant privacy, no audio recording will take place 
through 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 

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(refusal of audio recording does not preclude participants from continuing to be part of the study). The 
PRS 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 PRS meetings are expected to vary and 
will generally last up to half an hour to an approximate maximum of one hour. The PRS 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 PRS and participants, time of day) to further 
our understanding of how the PRS role can optimize participant engagement in treatment. 
 
In order to assess MOUD retention and treatment adherence, we will extract routinely-collected data from 
patient medical charts (maintained by UMDTC) at each BA session and assessment, with collected data 
consisting of MOUD intake date, clinic attendance, counselor appointments, dosing, dose volume, any 
notes on patient dosing, any breathalyzer results, any urinalysis or other drug testing results, and we will 
ask participants about any changes to their enrollment in treatment programs. 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 PRS 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 PRS 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. PRS can also work through BA modules during sessions and review material as 
needed. After sessions, the PRS will complete a fidelity assessment to indicate which components were 
addressed. 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 and/or dosing, the PRS will continue to follow up with the participant 
to assess barriers, concerns, and try to continue treatment.  
Members of the research team may attend regularly scheduled UMDTC “teamlett” meetings held between 
the participant’s counselor and attending physician at 1001. The purpose of these meetings is for the 
treatment team to review the patient’s case and address any challenges faced in the treatment program. 
Research team attendance at these meetings will allow researchers to track the participant’s engagement 
in the program, and may help inform how the intervention can further meet the participant’s needs. 
As part an effort to coordinate study enrollment with other IRB-affiliated research studies at the study 
site, the research team will share the enrollment status of participants with other IRB-affiliated 
researchers at the same study site. Researchers will be able to see participants’ involvement in other 

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studies at this site. This information will be shared via a secure, central UMB-hosted server that is only 
accessible to other UMB IRB-affiliated researchers at the study site. No other participant information or 
study participation details will be shared. 
 
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. The independent rater will fill out fidelity measures based on these session recordings for later 
comparison with the PRS’s self-reported fidelity.   
 
At the approximately 6-week and approximately 3-month follow-ups, a trained member of the research 
team will complete remote or in-person (depending on participant availability and 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 difficulties 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 include 
Treatment Program Status, MOUD Adherence and Retention: Chart Extraction, Ira Wilson's Self-Report 
Adherence Measure, Barriers to Adherence of Medication for Opioid Use, Short Inventory of Problems-
Revised, TLFB, Patient Health Questionnaire-9, Substance Use Stigma Mechanisms Scale, Methadone-
Maintenance Treatment Stigma Mechanisms Scale, Behavioral Activation for Depression Scale or 
Behavioral Activation for Depression Scale-Short Form, and the Reinforcement-Punishment Inventory or 
the Environmental Reward Observation Scale. The posttreatment assessment measures can include the 
same measures as the baseline assessment with the exception of no Demographic and other 
Characteristics Questionnaire and no MINI psychosis and mania modules. The posttreatment assessment 
can also include the Treatment Program Status form and the JHU Feasibility and Acceptability measure. 
The JHU Feasibility and Acceptability measure assesses for the participant’s satisfaction with working 
with the PRS and important barriers and facilitators to implementation of the intervention.  
 
After completing the posttreatment assessment (approximately 3 months after baseline), participants will 
be invited to complete a qualitative exit interview which will ask them about their experience in the 
treatment. 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 within approximately one week. Because this interview 
will ask about the participants’ experiences with the PRS, the interview will be conducted by a trained 
member of the study staff and the participants’ responses will not be shared with the PRS. 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 UMCP’s Box folder 
immediately following the session, and the audio file will be deleted from the recording device. 

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As stated above, posttreatment assessment will take place at approximately three months after baseline, at 
which point participants who have not yet completed 12 intervention sessions may choose to continue 
meeting with the interventionist approximately weekly until they reach a maximum of 12 sessions or until 
they choose to discontinue intervention (whichever occurs first). Those participants will be offered 
another, optional posttreatment assessment and exit interview, also compensated with $25 and $15 gift 
cards (respectively). 
 
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. The participant 
will receive $25 (gift certificate) for completing the baseline, $15 for completing the abbreviated 
midpoint assessment, a $25 gift certificate for completing the posttreatment assessment, and $15 for 
completing the exit interview. Compensation for the baseline and posttreatment assessments may be 
broken up into more than one day ($10 gift card for completing the first day of the assessment and $15 
gift card for completing the remainder of the assessment) if the assessment is paused and resumed another 
day for any reason. Participants may receive physical gift cards or e-gift cards via email, text, mail, or 
may pick up their gift cards through a no-contact method at UMDTC. Researchers will coordinate with 
UMD and UMDTC to determine an acceptable method of remote payment delivery to participants 
without direct social contact between researcher team and participants. 
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 dosing. 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 gift cards for each session attended to 
cover transportation and/or telecommunication costs. Gift cards of $5 per session will be provided to 
participants after each session attended for the duration of the study. Total gift card compensation for 
intervention session attendance (above the compensation for assessment participation) will have a 
maximum of $60, reflecting attendance of 12 maximum sessions.  
During this period when telecommunications are heavily relied upon due to COVID, it is increasingly 
important to ensure that patient contact details are up-to-date. In order to promote uninterrupted 
communications between researchers and participants and improve retention and tracking of a hard-to-
retain sample, we will provide incentives for participants to confirm their contact details. Participants will 
receive $5 gift cards for each week that they confirm their up-to-date contact details. These gift cards will 
be provided after each contact verification, with a total possible amount of $120 if the participant contacts 
the research team weekly for up to 24 weeks of the study. 
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 a database. For any in-person session (assessment or intervention 
session), researchers will follow procedures outlined in the IRB-approved in-person human subjects 
protocol. 

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Risks 
During the aftermath of the COVID-19 pandemic, the health and safety of participants, researchers, and 
UMDTC staff is a primary focus. The study team will work with participants to determine preference for 
in-person or remote participation 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. 
Participants will complete study sessions by phone or video conferencing at their home, preferred private 
location, or in a private room at UMDTC during routine visits to the treatment clinic for other 
appointments (intake, dosing, bottle pick-up, medical visit, telehealth visit). In-person study sessions will 
take place either in a private space (tent) outdoors or in a room at UMDTC. Any necessary changes to this 
protocol will be made based on UMCP policy and State/Federal regulations in response the status of the 
COVID-19 pandemic. 
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. Careful planning and observation of the participant's response to these sessions will allow the 
testing to be completed with a minimum of discomfort. The research team will be trained by Dr. 
Magidson to be vigilant 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 
OUD, 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. Through 
Maryland Peer Recovery Specialist Certification, the PRS 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. 
Magidson, Bennett, 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, in consultation with the on-call psychologist, determines 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 a UMDTC professionals (e.g., 
social workers, nurses, doctors) 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 1001, emergency 
services will be contacted and UMDTC 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, pregnant women, children, prisoners, and 
institutionalized individuals will not be enrolled in this study. All interventionists will be watchful 

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regarding the participant’s status, and any concerns will be discussed with the Principal Investigators 
(PIs) and MOUD 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 the University of Maryland 
College Park or the HIPAA compliant PHI software from the University of Maryland Baltimore is broken 
into. 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 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, Google Voice or 
Zoom) are breached. In order to minimize this risk, the phone number provided to participants will be a 
secure, study-only UMD line with a passcode protected voicemail system that is only accessible by the 
study team. Participants’ voice mails will be deleted once their contact details are updated on a secure, 
HIPAA compliant UMB drive (Sharepoint or Microsoft Teams). 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 University System of Maryland’s Policy on the Reporting of Suspected Child 
Abuse and Neglect and the State of Maryland’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. The small, $5 compensation for 
intervention session attendance is intended to offset any potential cost incurred as a result of participants 
using their own devices for remote communication. Participants will be reimbursed $25 for completing 
the longer assessments. Open-label trial participants will receive $25 for completing each major 
assessment, $15 for abbreviated assessments, and $15 for exit interviews for a total possible amount of 
$80 (baseline, midpoint, posttreatment assessments, and exit interview). As described above, some 
participants may also be offered another posttreatment and exit interview with an additional possible $40. 
We will support telecommunication or transportation costs with $5 gift card compensations per BA 

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session so that utilities or transportation do not present any additional cost burdens to participants, with up 
to a maximum of $60 for 12 sessions attended. We will provide participants with incentives for updating 
contact information with $5 gift cards for each week that participants contact the research team to verify 
contact details, with up to a maximum of $120 provided for up to 24 possible weekly contact 
verifications. The maximum compensation for this study accumulates to $260 with all sessions, 
assessments, and contact verifications 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 MOUD prescriber and any 
worsening of these identified by the study team or study interventionists will be reported to the MOUD 
prescriber (clinical staff at UMDTC). 
 
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 UMCP 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 (Magidson, Bennett, and 
Seitz-Brown) as well as UMDTC director (Greenblatt) who is a co-I. 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 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. Magidson or Dr. Bennett) 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 

Page 17 of 21 
 
 
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 UMCP research team. The UMCP team, under Dr. Magidson’s 
supervision, will complete UMCP 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. Magidson and Dr. Bennett) immediately, and 
undergo expedited reporting to the IRB, within one business day of being reported to the PI. 
Benefits 
There are no direct, guaranteed benefits to the participants. However, it is possible that receipt of BA will 
result in improved MOUD 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 MOUD adherence through PRS 
delivery. Supporting MOUD outcomes could help to promote greater recovery in communities hit hard by 
the opioid crisis, particularly in low-income, underserved areas, such as our study site in Baltimore.  
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 servers (e.g. REDCap and Box). At UMCP, 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. All identifiable PHI will be 
stored on Sharepoint and/or Microsoft Teams, both secure, HIPAA compliant drives at UMB. For 
participant record keeping and chart review purposes, all PHI (including date of birth) will be linked to 
participant identification numbers on Sharepoint and/or Microsoft Teams. Only the 
investigators/authorized staff will have access to the REDCap database, the Box folder, and the 
Sharepoint and/or Microsoft Teams drives. 
 
At initial screening through chart extraction, we will not collect any data for individuals who are deemed 
ineligible after MOUD program initiation (by MOUD program staff). We will only keep a record of 
number of screenings completed and reasons for ineligibility.   

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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 UMB drives. 
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 recording device. 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.  
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.  
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, determining a plan for lost contact, etc.).  
 
Audio-recordings for participant exit interviews be transcribed by trained members of the UMCP research 
team (IRB-approved staff member or student with up-to-date CITI training) or a secure transcription 
service. The study team may use one of the following transcription services to assist in transcription: 
Otter.ai, which uses artificial intelligence technology and syncs data over an encrypted connection and 
stores it in a secure data center that has both physical and electronic security. When the user deletes the 
recording, there will be no record retained by AISense; Home Row, Inc., which offers military-grade 128-
bit Secure Socket Layer (SSL) encryption security in transit and 256-bit AES at rest. Their typists are 
carefully vetted industry veterans who work under strict non-disclosure agreements, and all audio files are 
promptly and permanently deleted from servers as each project is completed. Audio files are de-
identified, saved only using participant ID numbers. Any inadvertent disclosure of personally identifiable 
information will be redacted upon transcription. A trained member of the study team will use the service 
for assistance but still check and correct any errors in the transcriptions from the service. 
 
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 Maryland law, we will disclose to the appropriate individuals and/or authorities any information 

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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. 
Consent Process 
This protocol will utilize a verbal consent process and meets criteria for a waiver of written consent as 
follows: 
(1) The research involves no more than minimal risk to the subjects. 
IRB determination of risk for initial protocol application is MINIMAL and protocol updates present no 
additional risk to participants.  
 
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects. 
Participants will receive the same information about their rights and autonomy to participate or not 
participate in research without any effect on their treatment or any other opportunities.   
 
(3) The research could not practicably be carried out without the waiver or alteration. 
Due to COVID-19 precautions, continuation of a hybrid (in-person/remove) protocol, and the time-
sensitive nature of the research question, the altered consent process remains necessary to protect the 
health and safety of both participants and study staff. Because we will continue to offer participants with 
the option to conduct study activities remotely, we will administer verbal consent consistently across all 
remote and in-person participants. In-person participants will be offered paper copies of the consent form 
for their records. Remote participants will be offered a digital copy of the consent form via text or 
email or a physical copy provided during a routine visit to the clinic. 
 
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after 
participation.  
We are requesting a verbal consent process. This process does not involve additional information given to 
participants after participation.  
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. 
A trained research staff member will conduct the informed consent. Consent will be taken by reading 
consent forms to the participants over the phone, Google Voice, virtual conferencing platform (Zoom), or 
in-person. The researcher will read the consent form and the UMB COVID Risk Statement to the 
participant “word for word” or paraphrase – whichever makes the participant most comfortable. Prior to 
providing verbal 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. 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 

Page 20 of 21 
 
 
refusal and therefore ineligible for the study. The researcher or trained designee must witness verbal 
consent by the participant during the phone, web-based call, or in person. 
Before the participant can provide verbal consent, the participant: 1) should verbalize understanding; 2) 
should be given the opportunity to ask questions; 3) should be given time to hear the consent; 4) should 
report all questions were answered to their satisfaction; and 5) must correctly answer the evaluation to 
provide consent document. When completing the evaluation to give 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 him/her, and understands that they may drop out at any point during 
the study.  
After verbal consent is provided for both the study consent form and UMB COVID Risk Statement, the 
researcher will document participant ID number, researcher initials, verbal consent date and time, location 
of research team member, location of participant, means used (telephone, computer audio at UMDTC, or 
in-person), start and end time, quality of call (if remote), alternative form of communication established 
(if remote), and any barriers to effective communication in a database. This information will be stored in 
a secure, HIPAA compliant UMB drive (Sharepoint or Microsoft Teams).  
All study personnel will be appropriately trained in the ethical conduct of human subjects research and 
will be required to recertify annually.  
Conflict of Interest 
None 
HIPAA Compliance 
All protected health information (PHI) will be stored on UMB’s HIPAA compliant data storage server or 
as paper records in double-locked space at UMCP to which only authorized research personnel have 
access. Confidentiality is assured as participants will be identified on all study materials by only a 
participant number and date of visit. By recording the electronic study data in this manner the information 
is considered ‘de-identified’, and therefore, compliant with the Standards of Privacy of Individually 
Identifiable Health Information (“Privacy Rule”) of the Health Insurance Portability Act of 1996 
(“HIPAA”). 
 
 
 
 
 
 
 

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