SMART Trial: Reducing Stigma Towards Opioid Use Disorder on the Intrapersonal and Interpersonal Levels
Phase: PHASE2
Conditions: Stigma, Social, Opioid Use, Opioid-use Disorder, Substance Use Disorders
Sponsor: University of Tennessee

 
Reducing Stigma towards Opioid Use Disorder on 
Interpersonal and Intrapersonal Levels 
Manual of Procedures: Intrapersonal Arm 
 
NCT04693416 
2/10/2021 
 
 

 
 
OVERVIEW 
3 
Objectives 
3 
Design and Outcomes 
3 
Duration 
4 
Sample Size and Population 
4 
IRB 
4 
Award Information 
4 
PROJECT ROSTERS 
5 
Investigators 
5 
Principal Investigator 
5 
Co-Investigators 
5 
Consultants 
5 
Data Safety Officer 
5 
Staff 
5 
TRAINING PLAN 
6 
Pre-Initiation Training 
6 
Ongoing Training 
6 
ELIGIBILITY CRITERIA 
6 
PROCEDURES 
6 
Cascade of Events 
6 
Baseline 
6 
Follow-Up Visit 
7 
Recruitment 
7 
Consent 
7 
Electronic Consent 
8 
Intervention 
8 
Incentives 
8 
Gift Card Distribution 
9 
Gift Card Storage 
9 
Adverse Events 
9 
Retention 
10 
MEASURES 
10 
Assessment Schedule 
10 
CONTACT INFORMATION 
11 
DEMOGRAPHICS 
12 
SU-SMS 
13 

TREATMENT INITIATION 
15 
FEEDBACK & TREATMENT SATISFACTION 
15 
OTHER DOCUMENTATION 
17 
Gift Card Log – Example 
17 
Gift Card Receipt 
19 
 
 
 
PREFACE 
The purpose of this document is to provide a Manual of Operating Procedures (MOP) for the SMART 
Supplement Project 5a — Intrapersonal Stigma Reduction. The role of the MOP is to facilitate 
consistency in protocol implementation and data collection across participants and study staff. Use of the 
MOP increases the likelihood that the results of the study will be scientifically credible and provides 
reassurance that participant safety and scientific integrity are closely monitored. 
OVERVIEW 
Objectives 
The goal of this project is to develop and evaluate the efficacy of a stigma reduction intervention 
that functions at the Intrapersonal (individual) level. Our intervention will address this 
cost/benefit evaluation among individuals known to face intersecting stigma of alcohol or 
substance use disorder and African American race, with treatment elements chosen explicitly to 
increase the value of treatment using salient forms of reward, and to ease perceived costs through 
explicit services in an effort to encourage the occurrence of the first treatment visit. 
Design and Outcomes 
This project consists of a pre-post survey, separated by a two-week interval. All elements of our 
individual intervention are based in Behavioral Economics theory, with the intention of 
increasing benefits and reducing costs to facilitate individual decision making and reduce 
subsequent experienced, anticipated, and associative stigma for the individual seeking treatment. 
The primary outcome for Project A is reduction in stigma at two weeks post intervention. This 
will be assessed by using the Substance Use Stigma Mechanisms Scale. 
Secondary outcomes include Addiction Treatment visit attendance (e.g., did they attend the visit 
that was scheduled?) and Feedback and Satisfaction with treatment. 

Duration 
Participants will be enrolled at baseline (week 0) and will have one follow-up assessment to be 
completed two weeks after enrollment. 
Sample Size and Population 
Approximately 50 participants will be recruited from the Frayser community of Memphis, at the 
recruitment site of Legacy of Legends (or associated venue, as dictated by Legacy events). 
Participants must identify as having a substance use problem and must not currently be in 
treatment. All participants must be over age 18, able to understand consent procedures, reside in 
the Frayser community, identify as African American or mixed race, and have access to a 
telephone for retention/follow up. 
IRB 
Project number: 20-07852-XP 
The University of Tennessee Health Science Center IRB (FWA00002301) is the reviewing IRB 
for this study. Initial approval was received on 02/05/2020. 
Award Information 
Funding Agency: National Center for Complementary & Integrative Health (NCCIH)  
Award number: 3R61AT010604-01S1 
Grant Title: Behavioral Economics based stigma reduction intervention for low income, African 
American individuals with Opioid Use Disorder. (3R61AT010604-01S1).  
Grant Years: 
10/1/2020 - 9/30/2021  
Supplement Grant Amount: $201,631 
 
Program Director Clinical Research  
Peter Murray, PhD 
Division of Extramural Research  
National Center for Complementary & Integrative Health (NCCIH)  
6707 Democracy Boulevard, Suite 401 Bethesda, Maryland 20892-5475  
Phone: 301-496-4054  Email: peter.murray@nih.gov 
 

PROJECT ROSTERS 
Investigators 
Principal Investigator 
Karen Derefinko, PhD 
University of Tennessee Health Science Center 
66 N. Pauline Street, Suite 649 
Memphis, TN 38163 
901-448-2526 
kderefin@uthsc.edu  
Co-Investigators 
 
James G. Murphy, PhD - University of Memphis, Department of Psychology 
jgmurphy@memphis.edu  
 
Fridtjof Thomas, PhD - UTHSC, Department of Preventive Medicine 
fthomas4@uthsc.edu  
Consultants 
Joseph Palamar, PhD, MPH - New York University Grossman School of Medicine 
Public Stigma of Substance Use 
Joseph.Palamar@nyulangone.org  
Charlie Caswell - New York University Grossman School of Medicine 
Community Integration Consultant 
legacyoflegendscdc@gmail.com  
 
Data Safety Officer 
Marion Hare, MD - UTHSC Department of Preventive Medicine 
mhare@uthsc.edu  
Staff 
Sarah Hand, MPH, CCRP 
Research Project Manager 
shand@uthsc.edu  
 
Unjanae Johnson 
Research Coordinator I 

TRAINING PLAN 
Pre-Initiation Training 
The Research Coordinator will be trained in data collection, data entry, adverse event collection, 
incentive distribution, and informed consent procedures by the Project Manager (Hand). Dr. 
Derefinko will train the coordinator on intervention delivery and fidelity. 
Ongoing Training 
Data will be monitored throughout the study so that any quality assurance issues can be handled 
in a timely manner. Any issues with data collection, data entry, informed consent, and incentive 
distribution will be monitored by Ms. Hand and will be addressed at biweekly staff meetings. 
Issues regarding study fidelity will be addressed by Dr. Derefinko as needed.  
ELIGIBILITY CRITERIA 
Participants must meet the following eligibility criteria to participate in this study:  
● Age 18 or older 
● Able to understand consent procedures 
● Identify as African American or mixed race,  
● Access to telephone for retention/follow up 
● Self-identified alcohol or substance use disorder (SUD) related issues, and  
● Not currently in treatment for SUD. 
PROCEDURES  
Cascade of Events 
Baseline 
● Engage with potential participants to provide information about participation.  
● If interested, complete screening for eligibility/exclusionary criteria.  
● Complete informed consent.  
● After participants have signed the informed consent form, we will collect the remaining 
baseline data and deliver the intervention. 
○ Administer assessments which include contact information, demographics, and 
SU-SMS (stigma scale) 
○ Deliver intervention 
○ Offer to help schedule appointment at CAS (or other clinic) 

○ Set appointment date/time for 2-week follow-up visit or call.  
● Provide a $20 Kroger gift card as compensation for enrollment.  
○ Kroger gift cards will be given via a hard copy gift card following the incentive 
procedures.  
● If the participant schedules a visit and needs transportation support, schedule a Lyft ride 
● Provide participant your contact information to ensure that the Lyft ride can be changed 
as needed (Lyft is scheduled only through us, not the participant). 
Follow-Up Visit 
● At two weeks post baseline: 
● Complete follow-up assessments including SU-SMS, attendance at physician visit, and 
treatment feedback & satisfaction 
● Provide the $20 Kroger gift card upon completion of visit 
○ Kroger gift cards will be given via a hard copy gift card following the incentive 
procedures.  
Recruitment 
Potential participants who are being referred for potential substance use disorder treatment will be 
recruited by the Research Coordinator I and Pastor Caswell through Frayser community events, 
Impact Ministries events, and Legacy of Legends CDC events. 
Recruitment Script 
This is a general script, but can be changed as needed for each situation.  
“Hi, ____! My name is ____ and I am part of the research staff with the Department of 
Preventive Medicine at the University of Tennessee Health Science Center. You’re here today 
because you agreed to speak with us about your feelings about drug and alcohol use, and you’re 
open to hearing about treatment options. We’re doing a research study where we ask people 
questions, have a discussion, and then ask a few more questions. 
If you think you might be interested in being in this study, I can ask you a few questions to see if 
you’re eligible, then we can go through a consent form with you to help you decide if you’d like to 
participate. Are you interested in seeing if you’re eligible? 
If a person does not wish to participate, we can still provide a handout or information about how 
to get treatment. 
Consent 
The consent of the adult subject will be obtained at the first study visit at baseline after assessing 
for eligibility but before any identifying data collection begins. 

Inviting the subject to read and sign the consent form is not sufficient for securing informed 
consent. Study staff will go through the consent form with the participant, reviewing all elements 
of informed consent as stated in 21 CFR 50 § B and will answer all questions regarding the study.  
A copy of the informed consent will be given to the subject and the original(s) will be placed in 
the subjects’ research record. An entry documenting informed consent must also be made in the 
subjects’ research record to confirm that informed consent was obtained prior to any study-related 
procedures and that the subject received a signed copy. The objection of any subject in word or 
action to the performance of study procedures will be sufficient for their withdrawal or exclusion 
from the study. Study procedures will not continue until a signed consent form is received.  
 
Electronic Consent 
This project received approval for alteration of consent through the UTHSC IRB. In 
circumstances where a participant is unable to consent in person due to COVID restrictions, the 
participant may be consented using DocuSign. 
All standard procedures for consent must be followed including the participant being able to view 
the document while staff reviews with them, having sufficient time to review the document and 
ask questions, etc.  
Intervention 
The Intrapersonal Stigma Reduction Intervention will address the stigma of addiction, education 
about addiction, life goals, deciding whether to disclose addiction, and links to services. These 
modules are covered in an effort to encourage the occurrence of the first treatment visit at the 
Center for Addiction Science. See Appendix A for the full intervention script. 
 
Data Collection 
Whether in-person or on the phone, research staff will read aloud the items from each measure for 
the participant to answer. The staff member will record the responses on the paper forms and will 
later enter the data electronically. 
Incentives 
Gift Card Distribution 
Participants will receive $20 upon completion of each visit (baseline and follow-up) in the form 
of a Kroger gift card. The gift cards will be photocopied or scanned onto the gift card receipt. The 
staff member will take the receipt, gift cards, and a computer back into the room with the 
participant and check the gift card balance on the Kroger website before distributing. Once the 
balance is verified, the staff member will fill out the receipt in front of the participant. Both the 

research staff and the participant will sign the receipt verifying the information to be true. We 
will provide a copy of the receipt to the participant.  
Gift Card Storage 
Since this project is remote and we will not have ready access to a safe, a minimal number of gift 
cards should be checked out each week and stored in the locked briefcase with other study 
documents. Gift cards should only be checked out of the safe when they are ready to be disbursed 
to a participant. The remaining gift cards will be kept in the safe on the 6th floor of the Pauline 
Building. The gift card log will be kept in the safe and filled out each time a gift card is moved in 
or out of the safe.  
Adverse Events 
Adverse events (AE’s) are defined as any unfavorable medical occurrence in a human subject, 
including any abnormal sign, symptom, or disease temporally associated with the subject’s 
participation in the research, whether or not considered related to the subject’s participation in the 
research. 
Serious adverse events (SAE’s) are any adverse event temporally associated with the 
subject’s participation in research that meets any of the following criteria: 
● 
 Results in death 
● 
 Is life-threatening (places the subject at immediate risk of death from the event as it 
occurred) 
● 
  Requires inpatient hospitalization or prolongation of existing hospitalization; 
●  Results in a persistent or significant disability/incapacity; 
● 
  Results in a congenital anomaly 
● Any other adverse event that, based upon appropriate medical judgment, may jeopardize 
the subject’s health and may require medical or surgical intervention to prevent one of the 
other outcomes listed in this definition 
If a participant experiences any adverse event during the course of the study, we will conduct an 
assessment, complete an Adverse Event form, and follow the adverse event reporting system as 
required by our IRB and NIH regulations. 
All SAE’s that are potentially related to the study are to be reported to the Project Coordinator 
(Sarah Hand) within one working day. The Project Coordinator will review and escalate to the PI 
via email within 48 hours of initial documentation. 

UTHSC’s IRB operating procedures regarding AE’s can be found here: 
https://www.uthsc.edu/research/compliance/irb/researchers/documents/adverse-event-
reporting.pdf 
Retention 
It is the job of the research staff to retain all participants in the study in an attempt to have all 
participants complete their follow up visit. Staff will use various retention efforts to remain in 
contact with the participants after enrollment. Staff will also send participants an appointment 
reminder via text the day before their follow up visit (or via phone if preferred by participant).  
Participants will have an additional 2 weeks to make up their missed appointment in order to 
provide us with the data and so they may receive their compensation. The following retention 
efforts should be made:  
1. Calling the participant to check in and/or offer another date to reschedule.  
2. Texting the participant to offer another date. 
3. Emailing the participant.  
4. Mailing a letter to the most recent address on file.  
The research staff will cycle through these retention efforts during the 2 weeks to ensure they are 
doing their due diligence to contact the participant. The visit can be completed over-the-phone or 
in-person. 
MEASURES 
Assessment Schedule 
Measure 
Baseline 
Follow-Up 
Contact Information 
X 
 
Demographics 
X 
 
Substance Use Stigma Mechanisms Scale (SU-SMS) 
X 
X 
Agreement to set up intake visit at Center for Addiction 
Science (or other treatment facility) 
X 
 
Attendance at intake visit at Center for Addiction Science 
(or other treatment facility) 
 
X 

Feedback & Treatment Satisfaction 
 
X 
 
CONTACT INFORMATION  
  First:   
  
Middle: 
  
Last: 
  
  
Street:   
  
Apt/Suite: 
  
City/State/Zip: 
  
  
Email: 
  
  
Primary Phone: 
  
Can we leave a voicemail? 
Yes 
No 
Can we send a text? 
Yes 
No 
Secondary Phone: 
  
Can we leave a voicemail? 
Yes 
No 
Can we send a text? 
Yes 
No 
                                        

DEMOGRAPHICS 
 
Date of Birth:   
  
Gender: 
Male 
Female 
Transgender 
Sex at birth: 
Male 
Female 
 
Race (circle all that 
apply): 
African American or 
Black 
White 
Alaskan Native 
Pacific Islander 
Native American 
Other: ______________ 
Are you of Spanish, 
Hispanic, or Latino 
origin? 
Yes 
No 
 
Current Marital 
Status: 
Married or living as 
married 
Widowed 
Divorced 
Separated 
Single, never married 
  
  
Current Household 
Income per year: 
 
 
Less than $10,000 
$10,000-19,999 
$20,000-29,999 
$30,000-39,999 
$40,000-49,999 
$50,000-59,999 
$60,000-69,999 
$70,000-79,999 
$80,000-89,999 
$90,000-99,999 
Over $100,000 
Unsure 
  
Highest level of 
schooling completed: 
 
 
8th grade or less 
9th-11th grade 
12th grade or GED Associate’s degree 
Vocational or 
Trade School 
Some college 
Bachelor’s degree 
Graduate degree 

 
 
SU-SMS 
 
How often have people treated you this way in the past because of your alcohol and/or drug use history? 
Please circle your response. 
  
  
Never 
Not 
often 
Somewhat 
often 
Often 
Very 
Often 
1. 
Family members have thought that I 
cannot be trusted. 
1 
2 
3 
4 
5 
2. 
Family members have looked down 
on me. 
1 
2 
3 
4 
5 
3. 
Family members have treated me 
differently. 
1 
2 
3 
4 
5 
4. 
Healthcare workers have not listened 
to my concerns. 
1 
2 
3 
4 
5 
  
5. 
Healthcare workers have thought that 
I’m pill shopping, or trying to con 
them into giving me prescription 
medications to get high or sell. 
  
1 
  
2 
  
3 
  
4 
  
5 
6. 
Healthcare workers have given me 
poor care. 
1 
2 
3 
4 
5 
 
 
How likely is it that people will treat you in the following ways in the future because of your alcohol 
and/or drug use history? 
  
  
Very 
unlikely 
  
Unlikely 
Neither 
unlikely nor 
likely 
  
Likely 
Very 
likely 

1. 
Family members will think that I 
cannot be trusted. 
1 
2 
3 
4 
5 
2. 
Family members will look down on 
me. 
1 
2 
3 
4 
5 
3. 
Family members will treat me 
differently. 
1 
2 
3 
4 
5 
4. 
Healthcare workers will not listen to 
my concerns. 
1 
2 
3 
4 
5 
  
5. 
Healthcare workers will think that 
I’m pill shopping, or trying to con 
them into giving me prescription 
medications to get high or 
sell. 
  
1 
  
2 
  
3 
  
4 
  
5 
6. 
Healthcare workers will give me 
poor care. 
1 
2 
3 
4 
5 
 
 
How do you feel about your alcohol and/or drug use history? 
  
  
Strongly 
disagree 
  
Disagree 
Neither 
disagree 
nor agree 
  
Agree 
Strongly 
agree 
1. 
Having used alcohol and/or 
drugs makes me feel like I’m a 
bad person. 
1 
2 
3 
4 
5 
2. 
I feel I’m not as good as others 
because I used alcohol and/or 
drugs. 
1 
2 
3 
4 
5 
3. 
I feel ashamed of having used 
alcohol and/or drugs. 
1 
2 
3 
4 
5 

4. 
I think less of myself because I 
used alcohol and/or drugs. 
1 
2 
3 
4 
5 
5. 
Having used alcohol and/or 
drugs makes me feel unclean. 
1 
2 
3 
4 
5 
6. 
Having used alcohol and/or 
drugs is disgusting to me. 
1 
2 
3 
4 
5 
 
 
TREATMENT INITIATION 
Did you go to any facility for substance 
use treatment since we last spoke? 
 Yes 
No 
If yes, where did you get treatment? 
 
 
FEEDBACK & TREATMENT SATISFACTION 
1.  How interesting did you find this study?  Totally bad, boring OK  
Excellent, it was 
great  
2.  What made you want to enroll in this 
study? (select all that apply)  
I wanted help 
getting treatment  Gift cards  
Other _____  
3.  How personally relevant did you find this 
study?  
Not at all relevant  Somewhat 
relevant  
Very relevant   
4.  How effective do you think this study was 
in helping you start treatment?  
Not at all effective  Somewhat 
effective  
Very Effective  
5.  
For those who haven’t sought treatment: 
How likely you are to seek treatment in 
the near future?  
Unlikely  
Unsure  
Likely  
6.  
How effective, overall, do you think this 
program will be in helping substance users 
seek treatment?  
1 = Not useful or effective  
 
 
10 = Highly effective. The best treatment I could imagine. 

7.  What was the most effective part of this 
study for you?  
(Open ended)  
 
 
 
8.  Can you think of any ways to make this 
study more effective and user-friendly?  
(Open ended)  
 
 

OTHER DOCUMENTATION 
Gift Card Log – Example 
 
Kroger $20 Gift Cards 
Card Number  
LOG IN 
Initials 
LOG IN 
Date 
DISPENSE 
Date 
LOG OUT 
Initials 
 
  
  
  
  
 
  
  
  
  
 
  
  
  
  
 
  
  
  
  
 
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 

Gift Card Receipt                                                                 
  
  
  
  
Study ID 
  _________ 
The participant and I, the research staff member, checked the balance of the gift card before distribution. 
We discussed that the Research Study is not responsible for and will not replace lost or stolen gift cards 
once the gift card has been disbursed. 
  
Date 
____ /____/____ 
 
 
Staff 
Initials 
________ 
GC 
Amount 
$ _______ 
Participant 
Initials 
________ 
Quantity 
  ________