The Rhode Island Prescription and Illicit Drug Study Responding to Fentanyl and Associated Harms
Phase: NA
Conditions: Opioid Overdose, Drug Overdose
Sponsor: Brown University

1.
Select the appropriate type and category number of review. See descriptions of Expedited
categories. If no expedited categories completely describe the proposed research, select “Full
Board.”) 
⚝ Expedited # 
☒ Full Board
2.
Investigator Conflict of Interest Statement:
The Brown University Conflict of Interest Policy for Officers of Instruction and Research (“COI Policy”)
defines the term “Investigator” as “the project director or principal investigator and any other
person, regardless of title or position (e.g., full or part-time faculty member, staff member,
student, trainee, collaborator, or consultant), who is responsible for the design, conduct, or
reporting of sponsored research.” Using this definition of “Investigator,” please ensure that all
Investigators on this protocol answer questions 3(a) and 3(b) below [attach additional sheets for
any Investigators who are not the PI; they only need to answer 3(a) and 3(b)]:
a.
Have you completed a conflict of interest disclosure (i.e. Annual COI Assurance Form or
COI Reporting Form) within the past 12 months and is it accurate and up-to-date as of the
time of this submission, as required by the COI Policy? (You may access the system here
to confirm.) 
☒YES ⚝ NO
b.
Do you have a significant financial interest (SFI) that is related to this research protocol?
“Related” could mean the research involves products, technology, intellectual property,
or services made, owned, or provided by the entity/ies in which you have an SFI and/or
that the SFI could be affected by the proposed research or its results. 
⚝ YES 
☒ NO 
Principal Investigator certifies to the following: (1) The rights and welfare of the participants are 
adequately protected. (2) The risks to an individual are outweighed by the potential benefits to him/her 
or by the importance of the knowledge to be gained. (3) This protocol is accurate and complete; if the 
project scope or design is later changed, the PI will resubmit for review. (4) All research personnel, 
including the PI, has been, or will be, adequately educated in human research protections prior to 
beginning work on the project. 
Protocol Title: Rhode Island Prescription and Illicit Drug Study (RAPIDS) 
Principal Investigator: Brandon DL Marshall PhD 
Department: Epidemiology, Centers for Epidemiology and Environmental Health (CEEH) 
Funding Source (if no external funding for the project, enter "University"): NIDA 
If externally funded, Coeus Institute Proposal # for the project: 
(TBD - JIT Request in-process) 
Is this an undergraduate student project? Yes 
No ☒ 
Attach to this form the information required for a complete protocol, as outlined beginning on page 3 of 
this form, Instructions & Information. Additional information about preparing a protocol can be found 
here. 
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Principal Investigator signature: 
Date: 03/31/2019 
====================================================================== 
(Advisor’s signature is required for all graduate/medical student projects.) 
Advisor certifies to the following: Advisor has read the protocol and approves of the project. 
Advisor’ name: 
Advisor's signature: 
Date:   
For IRB Use Only 
Signature of the Authorized Official of the IRB: 
Date of IRB approval: 
4/18/2019 
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Protocol component 
Included? 
Page number(s): 
1. IRB Form #1
Yes 
Cover Page 
2. Lay Summary
Yes 
4 
3. Protocol Narrative:
5-18
Aims & Methodology 
Yes 
5 
Informed consent procedure 
Yes 
16 
Consent/Assent documents/scripts 
Yes 
See Attachment A 
Risks and Benefits 
Yes 
17 
4. Attachments:
19 
a) Informed Consent & Survey
Instruments (combined)
Yes 
Attachment A 
b) Education handouts for
participants
Yes 
Attachment B 
c) Recruitment materials
(online & community-based)
Yes 
Attachment C 
d) NIDA R01 Funding
application
No 
Attachment D 
(upon request) 
Other IRB approvals** 
NA 
**Will be submitted to RIDOH 
for an IAA once Brown IRB 
approval is in place 
e) Data Use Agreements (RI
Dept of Health)
Yes 
Attachment E 
f) Data & Safety Monitoring
Plan (DSMP)
Yes 
Attachment F 
g) Stronghold MOU
Yes 
Attachment G 
h) IDE Checklist and NSR
Justification
Yes 
Attachment H 
i) Safety Protocol
Yes 
Attachment I 
j) Community Based
Resources and Referrals
Yes 
Attachment J 
k) Investigator Self-Evaluation
Checklist
Yes 
Attachment K 
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2. LAY SUMMARY: The Rhode Island Prescription and Illicit Drug Study (RAPIDS)
This study will test the efficacy of a novel drug-checking intervention to prevent fatal and non- 
fatal overdose among people who use drugs (PWUD), who are 18-65 years old at the time of 
enrollment. We will evaluate whether the incorporation of rapid fentanyl testing into a theory- 
driven overdose education and prevention intervention reduces rates of overdose compared to 
standard overdose education and naloxone distribution. Results from this study will significantly 
improve public health efforts to address the fentanyl overdose epidemic and reduce harms 
associated with exposure to drugs contaminated with fentanyl. This is a full clinical trial, building 
on our previously approved fentanyl-test-strip pilot study (2016-2017), the results of which have 
recently been published.1 
1.
1Krieger MS, Yedinak JL, Buxton JA, et al. High willingness to use rapid fentanyl test strips among young
adults who use drugs. Harm Reduct J 2018;15(1):7.
2.
Krieger MS, Goedel WC, Buxton JA, Lysyshyn M, Bernstein E, Sherman SG, Rich JD, Hadland SE, Green
TC, Marshall BDL. Use of rapid fentanyl test strips among young adults who use drugs. Int J Drug Policy.
2018 Nov;61:52-58. doi: 10.1016/j.drugpo.2018.09.009. Epub 2018 Oct 18.
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THE RAPIDS CLINICAL TRIAL: 
Appendix B: RAPIDS Protocol
PROTOCOL NARRATIVE Aims & Methodology
3.1a. Specific Aims & Methodology
In light of the urgent need for research on novel interventions to prevent illicitly-manufactured
fentanyl (IMF) exposure and overdose, we will determine whether a brief, theory-driven
overdose prevention intervention incorporating “take home” rapid fentanyl testing decreases
overdose among adults. We will enroll up to 550 PWUD at risk of overdose in a randomized
trial, hereby referred to as the Rhode Island Prescription and Illicit Drug Study (RAPIDS).
In Aim 1, we will assess the efficacy of the RAPIDS intervention on preventing overdose
among PWUD. In Aim 2, we will determine whether the intervention effects are mediated
through our model constructs, including knowledge, motivation, behavioral skills, and
self-efficacy to use the fentanyl test strips and engage in overdose risk reduction practices. In
Aim 3, we will determine whether there is heterogeneity of treatment effect related to key
participant characteristics, including age, baseline motivations to use the test strips, as well as
type and frequency of drug use. By determining the sub-groups for whom intervention efficacy
is highest, these findings will guide optimal implementation of this brief intervention to reduce
overdose among PWUD.
Eligibility criteria include reported use of heroin, illicit stimulants, counterfeit prescription pills, or
injection drug use in the past 30 days, regardless of treatment status (see Table 1). An
overview of the study design is included in section 3.1.d below. Participants will be randomized
1:1 to receive the RAPIDS intervention or the attention-matched control condition.
Experimental arm participants will receive the RAPIDS intervention, which includes education
about the dangers of IMF, motivational interviewing to increase willingness to use fentanyl test
strips and engage in overdose risk reduction behaviors, hands-on training to use the test strips,
and opportunities to plan and role- play how to implement overdose risk reduction behaviors
upon receipt of a positive or negative test result. In addition, intervention participants will
receive ten test strips for personal use. Motivational interviewing “booster” sessions will occur
at 1, 2, and 3 months post-randomization, with additional test strips provided on an as needed
basis. In the attention-matched control arm, participants will receive standardized overdose
education and naloxone distribution (OEND) training, with attention-control visits at 1, 2, and 3
months.
Participants in both arms will receive a naloxone kit after completion of the first session, and
information regarding where to obtain additional naloxone at subsequent visits. Follow-up
interviews will occur at 6 and 12 months. The primary endpoint will be the rate of self- reported
overdose over the follow-up period. Secondary endpoints (e.g., accidental overdose death and
suspected EMS runs for overdose) will be ascertained by data linkage to statewide overdose
surveillance databases maintained by the research team. Consistent with recruitment rates in
our prior studies, we aim to enroll 20 participants per month starting in Year 1 until target
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enrollment is reached.
During the baseline visit, participants in both the experimental and control arms will be given a
naloxone kit that includes two doses of intranasal naloxone along with a wallet card with
information about fentanyl and the educational flyer in a discreet pouch or bag. At all other
assessment visits participants will be referred to community locations for no-cost or low-cost
naloxone access. We have created a flyer (see Attachment B) that provides specific
information about locations where naloxone can be obtained, as well as a link to a page that
contains this information on www.PreventOverdoseRI.org. In Rhode Island, naloxone is
available via pharmacies and community organizations to anyone in the state via standing
order authorized by Dr. Rich (RAPIDS co-investigator). Additionally, all participants will be
asked to provide a urine sample for a 12-drug panel rapid urine screen plus fentanyl rapid urine
screen (one sample) at each study visit. The urine screens are not meant to determine a
participant’s eligibility based on their self-reported drug use. The urine screens will measure
fentanyl and other recent drug exposure among participants to determine if there was
unintentional exposure to fentanyl. Once a urine screen is completed, the sample will be
disposed of immediately. Finally, participants will be asked to provide dried blood spots at three
study visits (i.e., baseline, 6 months and 12 months) to confirm results from urine screening in
the 12-drug panel above, in addition to detection of novel synthetic opioid and other
psychoactive substances. Testing of dried blood spots will be undertaken routinely throughout
and at the end of the study, and will not be used to determine a participant’s eligibility. After the
samples have been analysed for the study endpoints as specified in the protocol, remaining
samples will be stored for use in future Institutional Review Board approved substance use and
infectious disease (e.g., HIV, hepatitis C, and COVID-19) related research. Additional consent
will not be sought for this storage and future use.
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Table 1. RAPIDS Clinical Trial Summary
Brown Investigative
Team
PI: Brandon Marshall, PhD
Associate Professor, Department of Epidemiology
Co-I: Katie Biello, PhD
Associate Professor, Behavioral and Social Sciences
Total Enrollment
n= 550 (maximum for all activities)
Proposed Timeline
Recruitment begins 12/01/2019 and continues until target
enrollment is reached
Clinicaltrials.gov status
Approved: NCT043772238
Intervention Name
The RAPIDS Intervention (2 arm study)
Inclusion/Exclusion
Criteria
●18 to 65 years of age;
●reside in Rhode Island;
●are able to complete interviews in English;
●self-report past 30 day use of heroin, illicit stimulants (e.g.,
powder cocaine, crack, methamphetamine), counterfeit
prescription pills, or injection drugs, regardless of treatment
status; and
●Participants who refuse consent to participate, are unable to
provide informed consent due to altered mental status, or who
cannot adequately hear and/or comprehend either consent
process, will not be enrolled.
●Participants who exclusively misuse medications obtained from a
physician or diverse of someone else’s prescription will not be
enrolled
Number of study visits
7 total over 12 months
Baseline (60 minutes) + follow-ups (60 minutes) (Follow-ups at
1mo, 2mo, 3mo, 6 mo, 12mo)
Compensation
$35 for the first and last two visits, and $25 for the three
intermediate  visits, and an opportunity to earn an additional $5 
at the visit at 3,6, and 12 months, up to $195 total if participant 
attends all sessions
3.1
b. Detailed description of the RAPIDS intervention (Experimental Arm)
The intervention is based on two behavioral frameworks: the
Information-Motivation-Behavior (IMB) model, and the self-efficacy model as applied to
addictive behaviors.
The RAPIDS intervention provides (see also Figure 4 from grant proposal):
1.
education about the dangers of IMF and how to prevent overdose (information);
2.
motivational interviewing to encourage risk reduction behaviors (motivation) and to
assess and improve participants’ confidence in implementing these behaviors (self
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efficacy);
3.
hands-on training demonstrating how to use and interpret fentanyl test strips
(behavioral skills), including opportunities to practice using the test strips; and
4.
provision of BTNX Rapid Fentanyl test strips1 (see Attachment B) for personal harm
reduction use.
Specifically, the intervention will
directly increase engagement in
the target overdose risk reduction
behaviors, and indirectly through
fentanyl test strip utilization. In
other words, we hypothesize
that fentanyl test strip
utilization is an important, but
not exclusive, behavioral
mediator through which the
intervention will prevent
overdose among PWUD.
Survey Assessment Description (for complete survey instrument see Attachment A):
Information: Participants will be assessed on their knowledge of fentanyl and overdose
prevention strategies with multi-item scales (e.g., agreement with statements such as,
“Someone is more likely to overdose when using fentanyl-laced drugs than when using drugs
that aren’t laced with fentanyl,” and, “Do you know where you buy or get Narcan™, a
medication sometimes called naloxone?”).
Motivation: Participants will be assessed on their motivation to use the rapid fentanyl tests
(e.g., agreement with a statement reading, “I am concerned about my drugs being
contaminated with fentanyl”) and engage in overdose risk reduction behaviors (e.g., agreement
with a statement reading, “I am confident that I can ask someone to check on me after I use
drugs and call 911 if they think I am overdosing”).
Behavioral Skills: Participants will be assessed on their behavioral skills related to use of the
rapid fentanyl tests (e.g., “I feel confident in my ability to use the test strips to detect if there is
fentanyl in my drugs”) and engagement in overdose risk reduction behaviors (e.g., “What do
you do to avoid an accidental overdose?” and, “Have you ever given Narcan/naloxone to
someone who you thought was overdosing?”).
Self-Efficacy: Questions about harm reduction self-efficacy will be used to assess participants’
confidence to employ specific health-preserving skills in different types of high-risk situations
1 https://www.btnx.com/files/BTNX_Fentanyl_Strips_Harm_Reduction_Brochure.PDF 
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(i.e., when experiencing withdrawal, when feeling depressed, when feeling social pressure to
use drugs in a less safe manner). This scale has shown good internal consistency and
construct and discriminant validity.
Behavioral Outcomes: Participants in the intervention arm will be asked a series of questions
regarding fentanyl test strip utilization at all follow-up assessments. These questions were used
successfully in our pilot study, and include items such as, “Of the 10 tests we gave you, how
many tests did you use?” and, “What did you do when you found out your drugs were laced
with fentanyl?” As an additional measure of test strip utilization, participants will be asked to
return unused tests to the study office. We will also assess motivations for using the test strips,
including a desire to avoid IMF-contaminated drugs or purposely identifying fentanyl.
At each time point, participants will be asked about the practices they engage in to avoid
accidental overdose. Strategies to avoid overdose include the target overdose risk reduction
behaviors:
1.
discarding IMF-contaminated drugs,
2.
not using alone (and staggering drug use with another person who is able to administer
naloxone and call 911 in the event of an overdose), and
3.
keeping naloxone nearby.
We will also assess other harm reduction practices, including taking a “tester” or lower initial
dose, avoiding injection drug use, and purchasing drugs from a consistent source.
Standard of Care (Attention-Matched Control Arm). Existing research suggests that training
people who are at risk for overdose and their peers on how to respond when witnessing an
overdose is a feasible and effective strategy for preventing overdose death. Given that this
represents current overdose prevention practice, participants in the control arm will receive the
standardized OEND training that occurs in Rhode Island. This program is based on the
common components of many community-based overdose prevention interventions in the US,
and includes information on risk factors for overdose, recognizing an overdose, performing
rescue breaths, administering naloxone, and recommendations to call 911. To ensure
equivalent attention to the RAPIDS arm, control arm participants will return for retention
visits at 1, 2, and 3 months, and will answer a series of questions regarding substance use
and overdose risk behaviors.
Potential Moderators/Other Key Measures: The RAPIDS survey instrument will contain
additional behavioral, psychological, and clinical assessments asked of everyone in the study.
Many of these questions have been piloted successfully in our prior research.
Consideration of Sex, Biological Variables, and Other Sociodemographic
Characteristics: Participants will report their age, sex at birth, current gender identity,
sexual orientation, race, ethnicity, educational attainment, employment status, and
recent and lifetime experiences of housing instability and homelessness, involvement
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with the criminal justice system, and participation in sex work.
Substance Use Experiences: Participants will report on recent and lifetime substance
use patterns (i.e., age at first use, frequency of use, polysubstance use, binge use,
social context of use, route of administration), and perceptions towards fentanyl (i.e.,
intentional use of fentanyl, suspected exposure to fentanyl-contaminated drugs). The
questionnaire will also incorporate a number of standardized instruments, including the
Addiction Severity-Index Lite (drug and alcohol section), and the Short Opiate
Withdrawal Scale (SOWS).
Healthcare Utilization: Participants will report on health insurance status; prior mental
health diagnoses, past treatment experiences, use of medications (buprenorphine,
naltrexone, or methadone), and barriers to substance abuse treatment. We will
administer a modified version of the Circumstances, Motivation, and Readiness (CMR)
scale, which has been used to assess motivation to engage in substance use
treatment.
Rapid Urine Screen Tests, Dried Blood Spot and Survey Administration Procedures:
Participants will check in at the Brown University School of Public Health Lobby - 121 South
Main Street and be escorted to a private interview room by Research Assistant A. All
consenting procedures and surveys/interviews will be conducted in the private interview room.
Each visit will last 60 minutes.
Two trained Interventionist Research Assistants (RAs) will manage the visits to 121
South Main St.:
●
The first RA, Research Assistant A, will be responsible for the informed consent
protocol and conducting the survey assessment with the participant. They will also be
responsible for administering the RAPIDS intervention for participants randomized to
the intervention, which includes the provision of 10 BTNX Rapid Test Strips for
take-home, personal harm reduction use.
●
The second RA, Research Assistant B, will be responsible for conducting the rapid drug
screen with the participant. Participants will provide a urine sample for a 12-drug panel
and fentanyl baseline urine screen.
●
Research Assistant B will record the results of the urine screen using the participant
number identifier; results will not be shared with the participant.
●
Research Assistant B will be responsible for the collection and storage of dried blood
spots using capillary finger-stick methods for the purposes of toxicology screening and
future use related to substance use and infectious diseases, results of which will not be
shared with the participant. Research Assistant B will complete required specimen
collection logs detailing the date and quantity of dried blood spot specimens collected.
Rapid Testing and Dried Blood Spot Quality Control:
Research Assistant B will follow the relevant items on the Checklist for Good Testing Practices2
2 https://wwwn.cdc.gov/clia/Resources/WaivedTests/pdf/FINAL_Self-
Assessment%20Checklist%20for%20Good%20Testing%20Practices.p 
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to ensure all procedures are followed accordingly.
●
Prior to conducting urine screens, all Research Assistants will complete an online CLIA
Testing Best Practices training through the Centers for Disease Control and Prevention,
Ready? Set? Test! Patient Testing is Important. Get the Right Results. CE Course
Number: WB2639.
●
Testing will be done in accordance with the manufacturer’s guidelines, and the Centers
for Disease Control and Prevention guidelines: Good laboratory practices for waived
testing sites.3MMWR 2005;54(No. RR-13).
●
Dried blood spots collected using capillary finger-stick methods will be undertaken
according to the WHO guidelines on drawing blood: best practices in phlebotomy
(ISBN: 978 92 4 159922 1) and the WHO manual for HIV drug resistance testing using
dried blood spot specimens (WHO reference number: WHO/HIV/2012.30).
●
Prior to collection of dried blood spots, all Research Assistants will complete “Qualified
Professional Testing Counselor” training as required in the state of Rhode Island.
3.1.c Participant Population
The target population for this trial are adults aged 18 to 65 who are at risk of overdose due to
consumption of IMF-contaminated illicit substances.
Eligibility Criteria: Participants will be enrolled in the RAPIDS trial if they are: (a) 18 to 65 years
of age; (b) reside in Rhode Island; (c) are able to complete interviews in English; (d) are able to
provide informed consent; and (e) self-report past 30 day use of heroin, illicit stimulants (e.g.,
powder cocaine, crack, methamphetamine), counterfeit prescription pills, or injection drugs,
regardless of treatment status.
These criteria are consistent with our pilot study, and were selected to capture a population of
PWUD who are at risk of being exposed to IMF-contaminated illicit substances, based on our
prior epidemiologic research and other studies. We expect that the racial and ethnic
composition of our target population will be similar to that of the samples recruited for our prior
research studies involving the target population (approximately 60% white, 20% Black or
African American, and 15% mixed race). We also anticipate that males will be
over-represented among our target population (approximately 60%). Section 3.1.d below,
outlines the methods for ensuring wide recruitment, in addition to partnering with
community-based organizations to increase enrollment.
We will exclude: persons who report exclusive misuse of medications obtained from a
physician or diversion from someone else’s prescription (e.g., family members), since these
sources are unlikely to be associated with IMF exposure.
3 https://www.cdc.gov/mmwr/PDF/rr/rr5413.pdf 
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3.1d. Recruitment, Enrollment, Randomization, and Retention procedures
Recruitment: Consistent with our previous research, we will employ a combination of
field-based recruitment techniques (e.g., targeted canvassing, word of mouth) and
Internet-based advertising to recruit potential study participants. Our team successfully 
identified locations for targeted canvassing in our pilot work. Project staff will conduct outreach 
and post study flyers in public and semi-public community venues (e.g., bus stops, parks, 
community organizations, drop-in centers, shelters, needle and syringe programs) in which 
PWUD are known to congregate. In addition, a recent spatial analysis conducted by our study 
team found that, between 2014 and 2017, fentanyl-involved overdose deaths have occurred in 
37 of 39 municipalities in RI. As such, recruitment will occur throughout Rhode Island; for 
example, we will purchase advertising on bus routes DQG UDGLR VWDWLRQV that operate 
throughout the state. Internet-based recruitment will include advertising on drug information 
websites used by PWUD (e.g., erowid.org, drugs-forum.com), online classifieds (Craigslist), 
and social media websites (e.g., Facebook), as well as Today at BrowQ
Communication resources: Sufficient iPhones, so that each research assistant has access to 
one, will be purchased through Brown University’s Computing & Information Services (CIS) to 
be used by research assistants. Throughout the study, study cell phones will only be used by 
authorized research assistants and staff members involved with participant communication. At 
the start and end of the day, the primary cell phone will be turned on or off and be checked in 
and out of a locked desk within the study office. Each cell phone will be encrypted using a 
custom alphanumeric code, with settings enabled to destroy all data on the phone after 10 
failed attempts. The second cell phone will be also be used for field visits as necessary
Both cell phones used in the study will be insured to include repairs through accidental 
damage, replacement, and theft protection. In addition, all cell phones will be installed with an 
application which allows for the remote GPS tracking of each device. Each cell phone will have 
encrypted backups of information stored on iCloud.
In the event that a cell phone is lost, stolen, or
otherwise not returned, the iPhone will be remotely
wiped of data. At the end of the study, all encrypted
cell phone data will be destroyed and all cell
phones will be wiped of data and returned to Brown
University’s Computing & Information Services
(CIS).
Enrollment and assessment will occur in two
stages: First, potential participants will text
message, email, or call a study hotline, at which
point a study staff member will screen for eligibility.
If eligible, the staff member will then schedule an
interview at the Brown University School of Public
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Health. At this time, all assessments will occur at our study offices, which are centrally located
and easily accessible to members of the study population. In some circumstances, the
interviews may occur at a semi-private location outside of BUSPH (ex. Public library study
rooms, clinics or other community partner agencies) (see Attachment I, Safety Protocol, for
field-based safety measures).
Randomization: Randomization: Participants will be randomized 1:1 using a randomization
table generated in SAS by the study’s Biostatistician,
which will be operationalized using the Randomization Generator Module in REDCap.
Randomization will be assigned during the baseline visit.4 Intervention allocations will be
maintained in REDCap by authorized users only, such as the study Statistician, and revealed
only through REDCap by prompts during the baseline survey visit and post-baseline visits (See
Figure 3).
Blinding: Staff conducting the baseline and follow- up assessments will be blinded to
intervention assignment until completion of the STUDY ENROLLMENT INFORMED
CONSENT FORM at
the Baseline visit. Intervention allocations will be maintained in REDCap by authorized users
only, such as the study Statistician, and revealed only through REDCap by prompts during the
baseline survey visit and post-baseline visits.
Retention: To maximize retention, we will employ retention strategies that are effective with
PWUD.
For example, we have found that text messages are the preferred mode of communication: over 
95% of participants in our pilot study owned a cell phone and used it daily. We have included 
study cell phones in the budget so project staff can text participants at least monthly to update 
contact information. Additional retention strategies to be employed include: (1) maintaining a 
tracking database of contact information (e.g., phone numbers, email addresses, social media 
handles SK\VLFDO DGGUHVVHV IRU VHQGLQJ DSSRLQWPHQW UHPLQGHU SRVWFDUGV); (2) conducting 
regular outreach in areas that participants are known to frequent; (3) providing honoraria for all 
study visits; (4) providing free parking to participants visiting the study office by validating garage 
parking passes; (5) searching the public RI Department of Corrections database to determine if 
a participant is incarcerated for a period of longer than 90 days, at which point they will be 
withdrawn from the study. These strategies were used effectively in our RAPIDS pilot study, 
resulting in a 90% follow-up rate.
3.1 e How confidentiality of data will be maintained (where data is kept, who has access 
to it, and how it is kept secure).The Principal Investigator, Brandon Marshall, PhD is ultimately 
responsible for data safety and monitoring of the study. This process will be monitored on a 
weekly basis by his team, including the Project Director, Data Analyst, and Senior Research 
Assistant, with quarterly updates to the entire team of Co-Investigators. The project team will be 
responsible for ensuring that all policies and processes outlined in the Data Use Agreement 
(with Rhode Island Department of Health, Attachment E) are followed accordingly, and that 
data are
4 http://cri.uchicago.edu/wp-content/uploads/2015/12/REDCap-Randomization-Module.pdf
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

transferred and shared on the agreed-upon timeline.
This study includes a Data and Safety Monitoring Board (DSMB) and Plan (DSMP).The DSMB
will meet on a semi-annual basis with the PI and Project Director to review the DSMP and
protocol adherence (see Attachment F). The DSMB will also review any adverse or severe
adverse events as outlined in the DSMP.
Stronghold computing environment: We will obtain a central storage service hosted by
Brown University’s Computing & Information Services (CIS) Stronghold project (see
Attachment G, Stronghold MOU). Stronghold is a HIPAA-aligned, secure computing
environment developed for housing, sharing, and analyzing sensitive data. The project’s Data
Analyst will oversee the database architecture, dataset storage, and all input/output (i.e.,
RIDOH data transfer) regulations. Stronghold is highly secure computer and storage
Windows-exclusive environment for research needs that involve very sensitive data needing
special handling, data usage agreements, etc.
All Stronghold users must: Be approved by the Principal Investigator, authorized in writing to
Brown University Computing & Information Services (CIS), and:
●
complete appropriate training for working with sensitive data (e.g. CITI training);
●
be in compliance with all relevant Institutional Review Board protocols;
●
be in compliance with any data use agreements or other agreements governing the
use of the data stored on Stronghold;
●
complete an on-boarding process led by the Principal Investigator or Senior Research
Assistant, which includes a review of data security protocols and a guided
walkthrough of accessing the Stronghold virtual environment.
Data Transfers – there are select methods to import data, including but not limited to:
●
Select Rhode Island state agencies and other offices using a secure VPN tunnel
●
Encrypted USB drives
●
Secure transfer through firewall exception
●
Import and export servers
For the proposed project, we will conduct and automate secure data transfer of administrative
overdose records with RIDOH on a monthly basis (according to the timeline outlined in our
existing data use agreement, see Attachment E). Any matching between personally identified
data sources is done within a secured area prior to any data (de-identified) being exported.
After the baseline survey, a separate consent procedure will be used to gain permission to
obtain information regarding overdose events (to be submitted as a future amendment, upon
RIDOH approval). To conduct the probabilistic, confidential data linkage with the RIDOH
administrative surveillance records, we will first create an encrypted, password-protected file
containing the linkage variables (e.g., sex, date of birth, zip code of residence). We will link
these surveillance datasets with participant data using a probabilistic linkage with the following
combination of identifiers: first and last name, date of birth, and sex. To conduct the
probabilistic match, we will use The Link King software. All linkages will be conducted within
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Stronghold, a HIPAA-aligned secure computing environment at Brown University. Matched
records will then be transferred to and stored on computers at the CEEH using secure
data-transfer and storage protocols.
Survey data will be collected on password-protected tablets and computers within the Centers
for Epidemiology and Environmental Health (CEEH) at the Brown University School of Public
Health. The REDCap™ platform exceeds patient confidentiality and data security requirements
for clinical trials, and are both HIPAA compliant and fully validated for FDA 21 CFR Part 11.
REDCap™ is a secure and web-based platform that allows input data from anywhere with
secure web authentication, data logging, and Secure Sockets Layer (SSL) encryption. For
remote data entry during field-based interviews, staff will be given iPads with data connectivity
that allow for direct and secure data entry into REDCap™.5
Access to project data will be restricted to individuals who are authorized to work on the
project. Access to data with identifiers is further restricted to the Systems/Data Manager alone.
Data are de-identified before analytic files are created, providing an additional level of
protection.
Furthermore, Center employees have signed an oath of confidentiality, and its violation is
sufficient grounds for immediate termination. All of our research assistants are CITI certified,
and will receive comprehensive orientation and intervention training for this research study
prior to interacting with participants or study data.
3.1f Analytic Plan
Assessing intervention efficacy in reducing emergency department (ED) presentation
for an overdose or overdose death (Aim 1, secondary endpoint). First, we will compare the
overall rate of patients experiencing this composite outcome over the 12-month follow-up
period in each group. Next, we will examine the time to first ED presentation or death using a
Kaplan- Meier analysis. Patients will be censored as of the first date of either of these
outcomes or at the end of the 12-month period. We will use Breslow’s method to test if the time
to either outcome differs between the groups, since this approach gives greater emphasis to
shorter time elapsed after the intervention, which has greater clinical significance. Third, Cox
proportional hazards modeling will be used to estimate hazard ratios for the treatment effect.
Multivariable models will be constructed to adjust for possible post-randomization confounding.
Examine whether the treatment effect is mediated by differential uptake of risk reduction
behaviors in the intervention arm (Aim 2). If the RAPIDS intervention shows efficacy in
reducing overdose rates among the sample (Aim 1), we will explore the extent to which this
relationship works through several possible mediators (see Figure 4). For mediation analyses,
first, we will examine, in multivariable regression models, which mediators, if any, are
significantly changed by the intervention (i.e., the rate of change differed by treatment
5 https://rc.partners.org/research-apps-and-services/collect-data#redcap
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

assignment). For those that are significantly impacted by the intervention, we will conduct path
analysis using structural equation modeling to determine whether the effect of the intervention
on overdose is through the hypothesized mediator(s). Structural equation modeling (SEM)
allows for the simultaneous estimation of total, direct, mediated and indirect effects of a causal
variable (i.e., the intervention) on the outcome (i.e., overdose) through a set of mediator
variables. SEM can handle outcomes and mediators with a variety of distributions (including,
Gaussian, Poisson and Binomial). Inferences for indirect effects can be estimated using
bootstrapped confidence intervals.
Determine whether intervention efficacy varies across participant subgroups (Aim 3).
We will examine if heterogeneity of intervention effect is modified by key baseline
characteristics of interest, including: age; sex; type, frequency, and route of drug use; baseline
level of overdose risk (e.g., lifetime history of overdose); and pre-intervention motivations for
fentanyl test strip utilization. We will perform stratified subgroup analyses to determine if
treatment effects vary between groups of individuals.
3.1 g COVID-19 procedures and precautions
In response to the COVID-19 pandemic, a number of cleaning, social distancing, and contact
tracing procedures are being implemented. These procedures are discussed in detail in
Attachment J, Reopening Plan. In short, research staff will take extensive measures to clean
the study space at the beginning of each day, between participants and at the end of each day.
Research staff and participants and staff will wear masks and maintain adequate distance from
each other when a door cannot be closed between them. The only time participants and staff
will be closer than 6 feet from each other is for the collection of the dried blood spot. The finger
prick will take a matter of minutes, and during that time, the research staff will wear a face
shield.
On the day prior to a study visit and on the day of, participants will be screened for COVID
exposure and risk. During the visits, surveys will be conducted over zoom with participants and
staff sitting in nearby, but separate rooms. This will ensure that staff and participants are not in
a closed space for longer than necessary.
Contact tracing logs will be kept and maintained in REDCap. In the event of participant or staff
COVID exposure, the research team follow Rhode Island Department of Health contact tracing
procedures.
We recognize that as guidance changes, safety procedures may have to be modified. At any
point, if Brown University issues additional guideless, the staff will follow those procedures in
addition to or in place of the guidelines proposed on Attachment J.
3.2 Informed Consent Procedure
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

We will obtain verbal informed consent from participants at the start of the Screening process,
and e-signed informed consent for the interviewer-administered surveys at the Baseline
enrollment visit (see Attachment A for consent forms). Participants will be asked if they would
like a copy of the consent form emailed to them. The enrollment consent form will be reviewed
with the subject in a quiet, private location at the Brown University School of Public Health at
the start of the Baseline Visit. All participants will be given detailed explanations of their rights
as human subjects, including the purpose of the study, length of time for the interview process,
study requirements, and risks and benefits of the interventions.
Participants who refuse consent to participate, are unable to provide informed consent due to
altered mental status, or who cannot adequately hear and/or comprehend either consent
process, will not be enrolled.
Participants will be asked to sign electronic copies of completed consent forms that will be
stored in the Stronghold Environment; however, if necessary, paper consent forms will be
retained by the Principal Investigator in a secure, double-locked environment. Participants will
be offered a copy of the informed consent form via email or by texting them a link to the form
online.
3.4 Risks & Benefits
Potential Risks: We recognize that participants will be asked potentially sensitive information,
including illicit drug use and injection drug use history, and therefore may experience
discomfort, anxiety, or stress in responding to certain study questions. As such, as part of the
informed consent procedure, participants will be advised that their answers will be confidential,
and issues discussed will in no way impact their ability to obtain or be referred to medical care
or social services. In addition, at the start of the interview, participants will be informed that they
can skip and refuse to answer any questions that they may find uncomfortable or
embarrassing. If concerns arise prior to, during, or after the interview, or if participants request
further information, they will be referred either to the toll-free study number, or if they prefer, will
be given the contact information of the project PI.
Among participants enrolled in the RAPIDS intervention arm, additional risks include
mistakenly believing that a substance does not contain fentanyl or a related potent analogue
after self- testing is complete. We will make every effort (through training, teach-back, and
automated text reminders) to ensure that participants understand the limitations of the rapid
tests, and specifically that a negative self-test result does not necessarily mean that overdose
risk is negligible. Interviewers will discuss and role-play how to implement overdose risk
reduction activities upon receipt of a positive or negative test. Risks and benefits of the fentanyl
test strips will also be addressed in the consent form at enrollment.
The risks to human subjects also include potential breaches of confidentiality. No names or
other identifying information will be included in the analytic files. The risk of breach of
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

confidentiality will be minimized to the greatest extent possible, including through the use of
Brown’s research protection resource, Stronghold.
There is minimal physical risk to participants from the routine finger stick(s) used for dried
blood spot collection. The finger stick may cause a small amount of pain and bruising, and the
site may bleed slightly for a time after the blood is collected. There is also a very rare chance
that the stick site could become infected. If this happens, participants might require medical
treatment.
Alternatives to enrollment in the trial may include not participating in the trial.
Protection Against Risks
Possible risks to participants will be minimized in several ways. All members of the research
team will treat all data with strict confidentiality. Questionnaires will not include participants’
name or any other identifying information. Participants’ names, other personally identifying
information, telephone numbers, and tracking information will be recorded in separate files and
will not be linked to any of the participants’ data. Access to these files will be encrypted,
password-protected and locked; access will be restricted to essential study personnel only. No
data will be reported on an individual basis; all findings will be reported in summary statistical
form only. All analyses will be presented in aggregate form with minimum cell sizes so that
individuals cannot be identified. Data will be stored and linked in the Stronghold environment.
Dried blood spots will be held in long-term storage using ultra-low temperature freezer facilities
(-70°C) managed and temperature-monitored by Brown University staff. Dried blood spot
specimens will be identified using the RAPIDS Participant ID, study visit number, date of study
visit. Multiple separate identifiers are necessary to minimize the risk of errors in specimen
handling and testing, e.g., transcription errors during specimen labelling or retrieval. As these
specimens are not collected in a clinical setting, these identifiers are not considered Protected
Health Information. Study personnel will attempt to contact participants that have preliminary
reactive results for infectious diseases from dried blood spot samples with a recommendation
for follow-up testing with a healthcare provider. Participants will be provided with a resource list
with information about where to get tested for infectious diseases at enrolment and if contacted
following infectious disease testing. A number of harm reduction and primary care services in
Rhode Island provide confidential and anonymous testing for HIV and hepatitis C virus for free
or at low cost. We will use the study retention tracking database for contact information, and
will provide participants with referral resources related to infectious disease screening during
enrolment and when reporting preliminary reactive results. At no time will participant infectious
disease and contact information be combined.
All interviews will be conducted by our Research Assistants; these staff who are trained in
issues relevant to engaging the target population such as risk reduction and drug user stigma.
Additionally, staff will go through specific training for the purposes of the intervention, including
motivational interviewing, overdose recognition and response, and naloxone administration.
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

These trainings will be conducted by the Project Director, who has previous experience as a
state and national trainer in motivational interviewing and other relevant topics. All research
personnel involved in the project will have successfully completed the Collaborative IRB
Training Initiative (CITI) at Brown University, an online human subject research protections
education program.
Individuals participating in the intervention arm will receive rigorous, comprehensive
one-on-one training regarding the procedures and limitations of the BTNX Inc. Rapid
Response™ fentanyl test strip. Participants will be informed that the test provides only a
qualitative, preliminary analytical result. We will also emphasize that the accuracy of the test’s
result may be compromised by technical or procedural errors, adulterants in the sample, or the
presence of novel fentanyl analogues that are not captured by the test. During the study
follow-up period, automated text messages will be used to remind all participants of
their next follow-up visit.
The proposed text of these messages are as follows:
■
“Don’t forget! You have plans at [time] on [date] at Brown University School of Public
Health. Does this time still work for you?” Text us if you have any questions.”
Benefits: The direct benefits to participants will include facilitated referrals to overdose
prevention services, addiction treatment programs, as well as medical care and other social
services, as appropriate. Risk reduction and motivational interviewing provided by trained
interviewers may also help individuals who may not otherwise understand how to protect
themselves from the harms of illicit drug use to elicit change behaviors and facilitate utilization
of the provided overdose education, naloxone, and (in the intervention arm) fentanyl test strips.
Finally, at the end of each interview, all study participants will receive a package of educational
material regarding overdose prevention (e.g., how to identify an overdose, where to obtain
naloxone) (see Attachment B), as well as a list of substance abuse treatment services in
Rhode Island. After the first session, all participants will also receive a naloxone kit.
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Attachment A: Study Scripts, Consent Forms & Surveys
Attachment B: Educational Handouts for Participants
•
BTNX Fentanyl Test Strips for Harm Reduction Use brochures
•
PreventOverdoseRI.org Fentanyl Test Strip testing instructions
•
Test Strip Labels (applied directly to the Rapid Test Strips)
•
BTNX Product Insert
Attachment C: Recruitment materials (online & community-based)
Attachment D: NIDA R01 Funding application (Upon Request, not included) 
Attachment E: BAA - Rhode Island Department of Health 
Attachment F: Data & Safety Monitoring Plan 
Attachment G: Stronghold / Marshall - MOU 
Attachment H: IDE Checklist and NSR Justification 
Attachment I: Safety Protocol (staff and participants) 
Attachment J: Community Based Resources and Referrals 
Attachment K: Investigator Self-Evaluation Checklist 
Attachment L: Reopening Plan 
Attachment M:Dried Blood Spot Protocol
Attachment N: Use of devices for Dried Blood Spot Protocol
**Attachments not applicable at this time: 
Letters of support/permission (NA) 
Other IRB approvals - RIDOH (To be submitted upon Brown IRB approval) 
Protocol addenda/appendices (NA) 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
THE RAPIDS CLINICAL TRIAL:
Attachment A: Study Scripts, Consent Forms & Surveys
[Project Overview – Information not shown to participants]
Last Updated:
02/01/2021
IRB History:
Approved 04/18/2019, Amendment 1 Submitted 10/31/2019, Approved
11/22/2019. Administrative amendment submitted 12/12/2019, Amendment 2 Approved
08/17/2020, Amendment 3 submitted 09/30/2020, Amendment 3 Approved 10/15/2020,
Amendment 3 submitted 02/01/2021
Principal Investigator:
Brandon DL Marshall, PhD
Associate Professor
Department of Epidemiology
Brown University School of Public Health
About this Research:
This study will test the efficacy of a novel drug-checking intervention to prevent fatal and non-fatal
overdose among adults who use drugs. We will evaluate whether the incorporation of rapid fentanyl
testing into a theory-driven overdose education and counseling program reduces rates of overdose
compared to standard overdose education and naloxone distribution. Results from this study will
significantly improve public health efforts to address the fentanyl overdose epidemic and reduce the
harms associated with exposure to drugs contaminated with fentanyl among adults ages 18-65. This
is a full clinical trial, building on the results of our fentanyl-test-strip pilot study (2016-2017). This study
is funded by the National Institute on Drug Abuse (R01-DA047975).
Page 1 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
These research materials are the property of the principal investigator and are not to be shared or used outside
of the study without specific and written permission of the Principal Investigator, Brandon DL Marshall, PhD
<brandon_marshall@brown.edu>
Page 2 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
TABLE OF CONTENTS
STUDY SCRIPTS, CONSENT FORMS, & SURVEYS
(Chronological Order)
[Project Overview – Information not shown to participants]
SECTION 1: SCREENING & SCHEDULING (Prior to enrollment)
●
SECTION 1a: PARTICIPANT SCREENING: SCRIPT (Prior to Enrollment)
●
SECTION 1b: ELIGIBILITY SCREENING: INFORMED CONSENT SCRIPT & FORM
(Prior to Enrollment)
●
SECTION 1c: PARTICIPANT SCREENING QUESTIONS
●
SECTION 1d: PARTICIPANT CONTACT AND SCHEDULING
SECTION 2: ENROLLMENT & BASELINE VISIT (VISIT 1 enrollment)
●
SECTION 2: STUDY ENROLLMENT: INFORMED CONSENT SCRIPT & FORM
(VISIT 1 ONLY – Baseline)
●
SECTION 2a: BASELINE SURVEY BEGINS
●
SECTION A: DEMOGRAPHICS
●
SECTION B: HOUSING, EMPLOYMENT & INCOME
●
SECTION C: DRUG USE
●
SECTION D: FENTANYL
●
SECTION X: MENTAL HEALTH
●
SECTION E: HEALTHCARE AND TREATMENT ENGAGEMENT
●
SECTION F: OVERDOSE
●
EGOCENTRIC NETWORK ANALYSIS TOOL (ENAT)
●
SECTION G: RAPIDS INTERVENTION (EXPERIMENTAL ARM ONLY)
●
SECTION H: STANDARD OEND (CONTROL ARM ONLY)
●
SECTION I: INTERVIEWER DATA
SECTION 3: FOLLOW UP VISITS (VISITS 2-6 follow along)
●
SECTION 3: FOLLOW UP VISIT
●
SECTION 3a: FOLLOW UP SURVEY BEGINS
●
SECTION A: HOUSING, EMPLOYMENT AND INCOME
●
SECTION B: DRUG USE
●
SECTION C: FENTANYL
●
SECTION D: RAPIDS INTERVENTION (EXPERIMENTAL ARM ONLY)
●
SECTION E: STANDARD OEND (CONTROL ARM ONLY)
●
SECTION F: OVERDOSE
Page 3 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
●
SECTION G: TREATMENT ENGAGEMENT
●
SECTION H: INTERVIEWER DATA
[This page intentionally left blank]
Page 4 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION 1a: PARTICIPANT SCREENING: SCRIPT
(Prior to Enrollment)
[Introductory Script for Potential Participants]
Hi, this is [RA name] at Brown University. Thanks for reaching out to us for more info.
Our latest study is about helping stop drug overdose in Rhode Island. People who join our
study will help us by answering questions on a survey and going through our short training on
ways to help stop accidental drug overdoses.
The research study visits will take place in person, and take up to an hour of your time at
each visit. You will be asked to visit our office SIX times total in the next 12 months, and you
will be given a survey each time. You will be asked to give a urine sample for a rapid drug
screen at each visit. The results of your drug screen do not affect your participation in the
study and will not be linked to your name.
If you qualify, you will receive $35 for the first and last visit and $25 for the four intermediate
visits visit to participate in the study. Again, there are SIX visits total that we are asking you to
do in the next 12 months. You will earn a total of $170 after all six visits. You will only be
compensated for the visits you attend.
Would you like to answer a few questions to see if you qualify? Your responses are
completely confidential. It will take about ten minutes, including the time I need to go over our
consent form with you. I will go over the consent form with you, but if you would like a copy of
the form for yourself I can email it to you or text a link to you.
[If YES, proceed to ELIGIBILITY SCREENING – INFORMED CONSENT SCRIPT &
FORM]
[If NO, thank them for their time and end the communication]
Page 5 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Page 6 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION 1c:
PARTICIPANT SCREENING QUESTIONS (REDCap)
1.a Participant ID
(R0001-R1000)
_______________
1.b Interviewer ID
(All CAPS, INITIALS ONLY)
_______________
1.1
Are you between the ages of 18 to 65 years old? [AGE]
Yes
No
1.3
Are you able to complete a survey in English? [ENGLISH]
Yes
No
1.5
Do you currently reside in Rhode Island? [RESRI]
Yes
No
1.6
In the past 30 days have you used pills that were purchased on the street?
[USEDPILLS]
Yes
No
1.7     In the past 30 days, have you bought any pills on the street? [BOUGHTPILLS]
Yes
No
RA PROMPT: Participants who exclusively misuse medications obtained from a physician or
diverted from someone else’s prescription should not be enrolled
1.8
In the past 30 days have you used heroin? [HER]
Yes
Page 7 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
No
1.9
In the past 30 days have you used cocaine, crack, or methamphetamine? [CCM]
Yes
No
1.10
In the past 30 days have you injected any drugs? [INJ]
Yes
No
[END SCREENING]
{PPT IS ELIGIBLE IF 1.1-1.5 = YES, AND, IF ANY ONE OF 1.6-1.10 =YES}
[If YES, proceed to PARTICIPANT CONTACT AND SCHEDULING]
[If NO, thank them for their time and end the communication]
Page 8 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION 1d:
PARTICIPANT CONTACT AND SCHEDULING (REDCap)
It looks like you qualify for the study! At this time we are going to ask you a few more
questions.
[Programmer note, after screening, do not store name with eligibility
information, assign participant study identification number and auto-generate
randomization. These responses are stored in the Participant Database]
1.10
Phone Number/Preferred
method of contact
1.11
Preferred email address
1.12
Alternate phone number
where we can leave a
basic/non-detailed
reminder about study
visits
If we cannot reach you by
phone is there a different
messaging application
(e.g., Facebook
Messenger, Instagram) that
we can reach you through
- note we will not mention
the study directly
1.13
First Name
1.14
Last Name
1.15
a
An address we can send a 
postcard with a
basic/non-detailed 
reminder about study 
visits
1.15
City of Residence
Page 9 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
1.16
Current Zip Code
1.17
Date of Birth
1.18
First Study Visit
1.19
How did you hear about
this study (read out list;
check all that apply)
Craigslist, Twitter, Facebook, Flyer posted
outside, Bus ad, A friend told me about it, A
family member told me about it, Flyer given to
me at an organization:______, Another
study:_____, Other:______, DK/R
Confirm the date and time of their first visit
Interviewer prompt: That’s it for questions. Just a reminder that we have you scheduled for
an interview with us on {DATE} at {TIME} at 121 South Main Street. Please bring a photo ID.
[If scheduled same day] We will see you soon. Would you like directions to our office?
[If scheduled a different day] We will be in touch before the interview to confirm. In the
meantime, let us know if you have any questions. Thanks!
 
Page 10 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION 2a:
BASELINE SURVEY BEGINS (REDCap)
(VISIT 1 ONLY – Baseline)
1.1 Participant ID
________________
(R0001-R1000)
1.2 Interviewer ID
_______________
Survey started (hidden)
(system-captured as mm/dd/yyyy hh:mm:ss AM/PM)
Survey ended (hidden)
(system-captured as mm/dd/yyyy hh:mm:ss AM/PM)
Did participant sign consent? [CONSENT]
o
Yes
o
No
To which did the participant consent?
o
Agreed to this Study Visit (must be checked to continue)
ARM ASSIGNMENT [PIPE FROM SCREENER, RA SEES ARM ASSIGNMENT]
●
ARM 1 (Control)
●
ARM 2 (Experimental)
Page 11 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Page 12 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION A: DEMOGRAPHICS
Interviewer prompt: Thank you for taking the time to complete our survey. If at any time you feel
uncomfortable responding to a question, tell the interviewer that you don’t want to answer.
A1. What is your age? [pptage]
___________
A2. What was the sex were you assigned at birth on your original birth certificate? [sexbirth]
Male
Female
DK/R
A3. What best describes your current gender identity? (Read out list; check only one) [gend]
Male [1]
Female [2]
Transgender Male/Trans Man/Female-to-male (FTM) [3]
Transgender Female/Trans Woman/Male-to-Female (MTF) [4]
Genderqueer, neither exclusively male nor female [5]
Something else [77]
DK/R [99]
A3a. If GEND = something else [77], What best describes your current gender identity?
_________ [gend_oth]
A4. Are you of Hispanic or Latino descent? [ethnic]
Yes
No
DK/R
A5. How would you describe your racial background? (Check only one) [race]
American Indian or Alaska Native
Asian
Black, African, Haitian, or Cape Verdean
Native Hawaiian or other Pacific Islander
White
Mixed, bi-racial, or multi-racial
Something else: __________
DK/R
Page 13 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
A5a. Do you speak a language other than English at home? [english]
Yes
No
DK/R
A5b. If english= “yes”: What is this language? [homeland]
_________
A6. Do you consider yourself to be... (Read out list; check only one)  [orie]
Straight
Gay
Lesbian
Bisexual
Queer
Something else: ___________
DK/R
A7. What is your current relationship status? (Read out list; check only one). [relation]
You have a spouse/partner whom you live with
You have a regular partner whom you do not live with
You are dating or seeing someone
You are single
DK/R
A8. What is the highest level of education that you have received? (Read out list; Check only
one). [educ]
Elementary or grade school
Some high school
Finished high school or GED
Some college
Trade or technical school
College or university degree
DK/R
A9. Are you currently enrolled in… [stud]
High school or a GED program
Trade or technical school
College or university degree program
None of these
Other
DK/R
Page 14 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
A9a. If stud= “other”: Are you currently enrolled in:____________ [stud_oth]
Page 15 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION B: HOUSING, EMPLOYMENT & INCOME
B1. What type of place are you living in right now? (Read all that apply, check only one). [hous]
An apartment or house that you rent or own
A parent or family member’s apartment or house
Someone else’s apartment or house short-term (like couch-surfing)
College dorm
Recovery or residential treatment center
Transitional housing program
Corrections halfway house
Drop-in center or emergency shelter
Car, abandoned building, or some other indoor public place
On the street or in another outdoor public place (like a park)
Other
DK/R
B1a. If hous= “other”: What type of place are you living in right now:____ [hous_oth]
What town do you currently live in? [town]
___________________
B1a. What is your current zip code? [zip]
_____________
No fixed address
DK/R
Interviewer prompt: We would now like to ask you about your experiences of homelessness. By
homelessness, we mean not having a regular place to stay, and living in a shelter because of
nowhere else to go, or living in a place not ordinarily used for sleeping, like an abandoned building,
car, or park.
B2. Have you ever been homeless? [hlevr]
Yes
No → skip to B4
DK/R → skip to B4
B3. If hlevr= “yes”: Have you been homeless in the last month? [hlm1]
Yes
No
Page 16 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
DK/R
B3a. If hlm1= “yes”: Are you currently homeless? [hlcr]
Yes
No
DK/R
B4. Are you currently employed full-time or part-time doing legal work for pay? This includes
work that is full-time, part-time and temporary work? [employ]
Yes
No
DK/R
B5. If employ= “yes”: Which of the following is closest to your occupation (Read out list; check all
that apply). [occu]
Manufacturer [1]
Retailer [2]
Wholesaler [3]
Service Provider [4]
Construction [5]
Mining [6]
Farming/Fishing/Forestry [7]
Government [8]
Other [77]
DK/R [99]
B5a. If occu= “other: Which of the following is closest to your occupation: _____________
[occu_txt]
B6. If employ= ”no”: If you are not employed, are you… (Read out list; check all that apply)
[unemploy]
On temporary layoff from a job [1]
Looking for work [2]
Retired [3]
Disabled [4]
A student [5]
A homemaker/caretaker [6]
Unable to work (primary reason?) [7]
Other [77]
DK/R [99]
B6a. If unemploy= “unable to work”: Unable to work, primary reason:_________ [unepmploy_una]
Page 17 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
B6b. If unemploy= “other”: If you are not employed, are you:____________ [unemploy_ot]
B7. Have you ever been turned down for a job because of current or past drug use? [nojob]
Yes
No
DK/R
B8. Are you currently receiving any disability benefits (such as workman’s compensation or
SSDI)? [incomedis]
Yes
No
DK/R
B9. What is your average take home monthly income, including public assistance or family
support (like from cash assistance, welfare, or TANF)? [income]
$0
< $1 - $500
$501 - $1500
$1501 - $3000
> $3000
DK/R
B9a. Have you ever received any of the following in exchange for sexual activities of any sort
(like a hand job, blowjob, or sex)? (Read out list; check all that apply) [sext]
Gifts or other goods [1]
Food [2]
Housing [3]
Clothes [4]
Drugs [5]
No, none of the above [6]
DK/R [99]
B9b. Have you ever received money in exchange for sexual activities of any sort (like a hand
job, blowjob, or sex)? [sexmoney]
Yes
No
B10. Have you ever been arrested? [evrarr]
Page 18 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Yes
No
DK/R
B11. If evrarr= “yes”: Have you been arrested in the last month? [m1arr]
Yes
No
DK/R
B12. If evrarr=”yes”: Have you ever been incarcerated in an adult jail or prison? [evrinc]
Yes
No
DK/R
B13. If evrinc= “yes”: Have you been incarcerated in an adult jail or prison in the last month?
[m1inc]
Yes
No
DK/R
B14. If m1inc= “yes”: Have you ever been on probation or parole? [evrprob]
Yes
No
DK/R
B15. If evrprob = “yes”: Have you been on probation or parole in the past month? [m1prob]
Yes
No
DK/R
B16. If m1prob= “yes”: Are you currently on probation or parole? [curprob]
Yes
No
DK/R
Page 19 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION C: DRUG USE
Interviewer prompt: We are now going to move on to talk about your current and past drug use. As a
reminder, your participation is voluntary and you have the right to refuse to answer a question. All
responses are strictly confidential and will not be shared with anyone outside of the study team.
C1. Have you ever snorted, smoked, swallowed, or used any of the following drugs without a
prescription or not as doctor directed? Please note that we will ask about other drugs and
injection drug use separately. (Read out list and time increments) [evpilnon]
Ever  (Y/N)
[All NO] → skip to
C5
C1a
Prescription opioids such as Percocet,
OxyContin, Dillaudid, Vicodin
C1b
Medications used for opioid use
disorder such as Methadone,
buprenorphine/Suboxone
C1c
Benzodiazepines/Benzos such as
Xanax, Ativan, Valium, Klonapin
C1d
Prescription stimulants such as
Adderall, Ritalin, Focalin, Concerta,
Dexedrine
C2. How old were you when you first snorted, smoked, swallowed, or used any of the
following drugs without a prescription or not as doctor directed? Please note that we will ask
about other drugs and injection drug use separately. (Read out list and time increments)
[yrpilnon]
C2a. Prescription opioids, such as Percocet, OxyContin, Dillaudid, Vicodin? __________
[yrpilnon_po]
C2b. Medications used for opioid use disorder such as Methadone, buprenorphine/suboxone?
_______ [yrpilnon_moud]
C2c. Benzodiazepines/Benzos such as Xanax, Ativan, Valium, Klonapin? _________
[yrpilnon_bz]
Page 20 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
C2d. Prescription stimulants such as Adderall, Ritalin, Focalin, Concerta, Dexedrine? _______
[yrpilnon_ps]
C3. How many times in the past 30 days have you snorted, smoked, swallowed, or used any of
the following drugs without a prescription or not as doctor directed? Please note that we will
ask about other drugs and injection drug use separately. (Read out list and time increments)
[m1pilnon]
C3a. Prescription opioids, such as Percocet, OxyContin, Dillaudid, Vicodin? __________
[m1pilnon_po]
C3b. Medications used for opioid use disorder such as Methadone, buprenorphine/suboxone?
_______ [m1pilnon_moud]
C3c. Benzodiazepines/Benzos such as Xanax, Ativan, Valium, Klonapin? _________
[m1pilnon_bz]
C3d. Prescription stimulants such as Adderall, Ritalin, Focalin, Concerta, Dexedrine? _______
[m1pilnon_ps]
C4. Have you first snorted, smoked, swallowed, or used any of the following drugs without a
prescription or not as doctor directed in the past 7 days or past 3 days? Please note that we
will ask about other drugs and injection drug use separately. (Read out list and time increments)
Past 7 days
(Y/N)
[d7pilnon]
Past 3 days
(Y/N)
[d3pilnon]
C4a
Prescription opioids such as Percocet,
OxyContin, Dillaudid, Vicodin
C4b
Medications used for opioid use
disorder such as Methadone,
buprenorphine/Suboxone
C4c
Benzodiazepines/Benzos such as
Xanax, Ativan, Valium, Klonapin
Page 21 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
C4d
Prescription stimulants such as
Adderall, Ritalin, Focalin, Concerta,
Dexedrine
C4e. If yes to any of C2a to C2: In the last month, who’s usually around when you’re using
these drugs without a prescription or not as a doctor directed? (Read out list; check all that
apply). [pepil]
I use alone [1]
A close friend [2]
A casual friend or acquaintance [3]
A sex partner [4]
An immediate family or household member [5]
An extended family member [6]
A Dealer [7]
Strangers/people I don’t know [8]
DK/R [99]
C5. In the last month have you used Suboxone/Subutex/Buprenorphine or methadone to
manage opioid withdrawal without a prescription? [bupself]
Yes
No
DK/R
C6. If bupself= “yes”: In the last month, how did you get Suboxone/Subutex/Buprenorphine or
methadone without a prescription? (Read out list, check all that apply) [bupbuy]
Purchased from a dealer or on the street [1]
A close friend [2]
A casual friend of acquaintance [3]
A sex partner [4]
An immediate family or household member [5]
An extended family member [6]
Purchased from the internet or “dark web” [7]
Other [77]
DK/R [99]
C6a. If bupbuy= “yes”: In last month, how did you get Suboxone/Subutex/Buprenorphine or
methadone without a prescription:______________ [bupbuy_oth]
C7. If bupbuy= “yes”: In the last month, how have you used Suboxone/Subutex/Buprenorphine
without a prescription. (Read out list, check all that apply) [buptyp]
Page 22 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
A film or tablet that dissolves under your tongue [1]
Skin patch [2]
Pills (orally) [3]
Snorting [4]
Smoking [5]
Injecting [6]
Other [77]
DK/R [99]
C7a. If buptyp = “yes”: In the last month, how have you used Suboxone/Subutex/Buprenorphine
without a prescription:__________ [buptyp_oth]
C8. Have you ever snorted, smoked, swallowed, or used any of the following drugs? Please
note that we will ask about other drugs and injection drug use separately. (Read out list and
time increments) [evdrgnon]
Ever  (Y/N)
[All NO] → skip to
C5
C8a
Marijuana or hash oil, including edibles
and synthetic marijuana
C8b
Club drugs such as Molly, MDMA,
Ecstasy, GHB, Ketamine
C8c
Psychedelics, such as Mushrooms,
Acid, LSD, DMT
C8d
Crystal methamphetamine (crystal
meth, glass, tina, crank, ice)
C8e
Powder cocaine
C8f
Crack cocaine
C8g
Heroin
C8h
Alcohol
C8i
Alcohol to intoxication
Page 23 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
C8j
Other:
C9. How old were you when you first snorted, smoked, swallowed, or used any of the
following drugs? Please note that we will ask about other drugs and injection drug use
separately. (Read out list and time increments) [yrdrgnon]
C9a. Marijuana or hash oil, including edibles and synthetic marijuana:_______ [yrdrgnon_m]
C9b. Club drugs such as Molly, MDMA, Ecstasy, GHB, Ketamine:________ [yrdrgnon_cd]
C9c. Psychedelics, such as Mushrooms, Acid, LSD, DMT:_________ [yrdrgnon_p]
C9d. Crystal methamphetamine (crystal meth, glass, tina, crank, ice):______ [yrdrgnon_cm]
C9e. Powder cocaine:________ [yrdrgnon_pc]
C9f. Crack cocaine:________ [yrdrgnon_cc]
C9g. Heroin:________ [yrdrgnon_he]
C9h. Alcohol:______ [yrdrgnon_alc]
C9i. Alcohol to intoxication:_______ [yrdrgnon_alix]
C9j. Other:_______ [yrdrgnon_oth_age]
C9k: Other drug mentioned:___________ [yrdrgnon_oth_drg]
C10. How many times in the past 30 days have you snorted, smoked, swallowed, or used any
of the following drugs? Please note that we will ask about other drugs and injection drug use
separately. (Read out list and time increments) [M1DRGNON]
C10a. Marijuana or hash oil, including edibles and synthetic marijuana:_______ [m1drgnon_m]
C10b. Club drugs such as Molly, MDMA, Ecstasy, GHB, Ketamine:________ [m1drgnon_cd]
C10c. Psychedelics, such as Mushrooms, Acid, LSD, DMT:_________ [m1drgnon_p]
C10d. Crystal methamphetamine (crystal meth, glass, tina, crank, ice):______ [m1drgnon_cm]
C10e. Powder cocaine:________ [m1drgnon_pc]
C10f.. Crack cocaine:________ [m1drgnon_cc]
C10g. Heroin:________ [m1drgnon_he]
C10h. Alcohol:______ [m1drgnon_alc]
C10i. Alcohol to intoxication:_______ [m1drgnon_alix]
Page 24 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
C10j. Other:_______ [m1drgnon_oth_age]
C10k: Other drug mentioned:___________ [m1drgnon_oth_drg]
C11. Have you snorted, smoked, swallowed, or used any of the following drugs without a
prescription or not as doctor directed in the past 7 days or past 3 days? Please note that we
will ask about other drugs and injection drug use separately. (Read out list and time increments)
[daydrgnon]
Past 7 days
(Y/N)
[d7drgnon]
Past 3 days
(Y/N)
[d3drgnon]
C11a
Marijuana or hash oil, including edibles
and synthetic marijuana
C11b
Club drugs such as Molly, MDMA,
Ecstasy, GHB, Ketamine
C11c
Psychedelics, such as Mushrooms,
Acid, LSD, DMT
C11d
Crystal methamphetamine (crystal
meth, glass, tina, crank, ice)
C11e
Powder cocaine
C11f
Crack cocaine
C11g
Heroin
C11h
Alcohol
C11i
Alcohol to intoxication
C11j
Other:
C12. If yes to number indicated for any C10a to C10j: In the last month, who’s usually around
when you’re using these drugs? (Read out list; check all that apply). [pepdrg]
Page 25 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
I use alone [1]
A close friend [2]
A casual friend or acquaintance [3]
A sex partner [4]
An immediate family or household member [5]
An extended family member [6]
A Dealer [7]
Strangers/people I don’t know [8]
DK/R [99]
C12a. Of all the drugs that you have snorted, smoked, swallowed or used in the last month,
which do you use most often? [mostnoninj]:_________
C13. Of all the drugs that you have snorted, smoked, swallowed, or used in the last month,
which is the one you prefer to use most? [prefnoninj]:_______________
Interviewer prompt: Now we would like to ask you some questions about injecting drugs. Your
responses will be kept completely confidential and will never be shared with anyone outside of the
study team.
C14. Have you ever seen anyone inject drugs? [ijsee]
Yes
No → skip to C15
DK/R → skip to C15
C14. If ijsee= “yes”: Who have you seen inject drugs? (Read out list; check all that apply) [ijw]
A close friend [1]
A casual friend or acquaintance [2]
A sex partner [3]
An immediate family or household member [4]
An extended family member [5]
Dealer [6]
Strangers (like people on the street) [7]
DK/R [99]
C15. Do you have a sex partner who currently injects drugs? [ijsexp]
Yes
No
DK/R
C16. Do you have close friends who currently inject drugs? [ijfriend]
Yes
Page 26 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
No
DK/R
C17. Have you ever used a needle to chip, fix, muscle, or inject drugs even once? [ijevr]
Yes
No
DK/R
C18. If ijevr= “yes”: The first time you injected any drug, how old were you? [ijage]
________ years old [max = age reported as in A1]
C19. If ijevr= “yes”: Have you ever injected any of the following prescription drugs?(Read out list
and time increments) [evpilij]
Ever  (Y/N)
[All NO] → skip to
C5
C19a
Prescription opioids such as Percocet,
OxyContin, Dillaudid, Vicodin
C19b
Medications used for opioid use
disorder such as Methadone,
buprenorphine/Suboxone
C19c
Benzodiazepines/Benzos such as
Xanax, Ativan, Valium, Klonapin
C19d
Prescription stimulants such as
Adderall, Ritalin, Focalin, Concerta,
Dexedrine
C20. How old were you when you first injected the following prescription drugs (Read out list
and time increments) [yrpilij]
C20a. Prescription opioids, such as Percocet, OxyContin, Dillaudid, Vicodin? __________
[yrpilij_po]
C20b. Medications used for opioid use disorder such as Methadone,
buprenorphine/suboxone? _______ [yrpilij_moud]
Page 27 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
C20c. Benzodiazepines/Benzos such as Xanax, Ativan, Valium, Klonapin? _________ [yrpilij_bz]
C20d. Prescription stimulants such as Adderall, Ritalin, Focalin, Concerta, Dexedrine?
_______ [yrpilij_ps]
C21. How many times in the past 30 days have you injected any of the following prescription
drugs. (Read out list and time increments) [m1pilij]
C21a. Prescription opioids, such as Percocet, OxyContin, Dillaudid, Vicodin? __________
[m1pilnij_po]
C21b. Medications used for opioid use disorder such as Methadone,
buprenorphine/suboxone? _______ [m1pilij_moud]
C21c. Benzodiazepines/Benzos such as Xanax, Ativan, Valium, Klonapin? _________
[m1pilij_bz]
C21d. Prescription stimulants such as Adderall, Ritalin, Focalin, Concerta, Dexedrine?
_______ [m1pilij_ps]
C22. Have you injected any of the following prescription drugs in the past 7 days or past 3
days? (Read out list and time increments) [daypilij]
Past 7 days
(Y/N)
[d7pilij]
Past 3 days
(Y/N)
[d3pilij]
C22a
Prescription opioids such as Percocet,
OxyContin, Dillaudid, Vicodin
C22b
Medications used for opioid use
disorder such as Methadone,
buprenorphine/Suboxone
C22c
Benzodiazepines/Benzos such as
Xanax, Ativan, Valium, Klonapin
C22d
Prescription stimulants such as
Adderall, Ritalin, Focalin, Concerta,
Dexedrine
Page 28 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
C23. Have you ever injected any of the following drugs? We will not be asking about fentanyl
use right now. We will be asking about that separately later on. (Read out list and time
increments) [EVDRGIJ]
Ever  (Y/N)
[All NO] → skip to
C5
C23a
Club drugs such as Molly, MDMA,
Ecstasy, GHB, Ketamine
[EvCD]
C23b
Psychedelics, such as Mushrooms,
Acid, LSD, DMT
[EvP]
C23c
Crystal methamphetamine (crystal
meth, glass, tina, crank, ice)
[EvCM]
C23d
Powder cocaine
[EvPC]
C23e
Crack cocaine
[EvCC]
C23f
Heroin
[EvHE]
C23g
Alcohol
[EvALC]
C23h
Other:
[EvOT]
C24. How old were you when you injected any of the following drugs? We will not be asking
about fentanyl use right now. We will be asking about that separately later on. (Read out list and
time increments) [YRDRGIJ]
C24a. Club drugs such as Molly, MDMA, Ecstasy, GHB, Ketamine:________ [yrdrgij_cd]
C24b. Psychedleics, such as Mushrooms, Acid, LSD, DMT:_________ [yrdrgij_p]
C24c. Crystal methamphetamine (crystal meth, glass, tina, crank, ice):______ [yrdrgij_cm]
C24d. Powder cocaine:________ [yrdrgij_pc]
C24e. Crack cocaine:________ [yrdrgij_cc]
C24f. Heroin:________ [yrdrgij_he]
C24g. Alcohol:______ [yrdrgij_alc]
Page 29 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
C24h. Other:_______ [yrdrgij_oth_age]
C9i: Other drug mentioned:___________ [yrdrgij_oth_drg]
C25. How many times in the past 30 days have you injected any of the following drugs? We
will not be asking about fentanyl use right now. We will be asking about that separately later
on. (Read out list and time increments) [M1DRGIJ]
C25a. Club drugs such as Molly, MDMA, Ecstasy, GHB, Ketamine:________ [m1drgij_cd]
C25b. Psychedelics, such as Mushrooms, Acid, LSD, DMT:_________ [m1drgij_p]
C25c. Crystal methamphetamine (crystal meth, glass, tina, crank, ice):______ [m1drgij_cm]
C25d. Powder cocaine:________ [m1drgij_pc]
C25e. Crack cocaine:________ [m1drgij_cc]
C25f. Heroin:________ [m1drgij_he]
C25g. Alcohol:______ [m1drgij_alc]
C25h. Other:_______ [m1drgij_oth_age]
C25i: Other drug mentioned:___________ [m1drgij_oth_drg]
C26. Have you injected any of the following drugs in the past 7 days or past 3 days? We will
not be asking about fentanyl use right now. We will be asking about that separately later on.
(Read out list and time increments)
Past 7 days
(Y/N)
[d7drgij]
Past 3 days
(Y/N)
[d3drgij]
C26a
Club drugs such as Molly, MDMA,
Ecstasy, GHB, Ketamine
C26b
Psychedelics, such as Mushrooms,
Acid, LSD, DMT
C26c
Crystal methamphetamine (crystal
meth, glass, tina, crank, ice)
Page 30 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
C26d
Powder cocaine
C26e
Crack cocaine
C26f
Heroin
C26g
Alcohol
C26h
Other:
C27a. Of all the drugs you have injected in the last month, which is the one that you use the
most? (Read out list; check only one) [ijmost]:____________
C27b. Of all the drugs you have injected in the last month, which is the one you prefer to use
the most? (Read out list; check only one) [ijpref]:___________
C27c. Have you ever shared a syringe, or drug using supplies like cookers water and cottons,
with someone else? [syrshare]
Yes
No
DK/R
C28. If syrshare= “yes”: In the last month, how often have you shared syringes or those
supplies with someone? [syrsharem1]
Never
Once or a couple times
At least every week
Every day
Multiple times per day
DK/R
C29. If syrsharem1= “yes”: In the last month, who have you shared syringes or supplies with?
(Read out list; check all that apply) [syrsharewho]
A close friend [1]
A casual friend or acquaintance [2]
A sex partner [3]
An immediate family or household member [PAR]
An extended family member [4]
Page 31 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Dealer [5]
Strangers (people I don’t know) [6]
DK/R [99]
C33. Have you ever needed someone to help you inject? [helpijevr]
Yes
No
DK/R
C34. If helpijevr= “yes”: In the last month, how often did you need someone to help you inject
[helpijm1]
Never
Once or a couple times
At least every week
Every day
Multiple times per day
DK/R
C35. If helpijm1= “yes”: In the last month, who helped you inject? (Read out list; check all that
apply) [helpijm1_who]
A close friend [1]
A casual friend or acquaintance [2]
A sex partner [3]
An immediate family or household member [4]
An extended family member [5]
Dealer [6]
Strangers (people I don’t know) [7]
DK/R [99]
C35a. Have you ever gone on a run or a binge, as in used a larger amount of drugs as usual
over a short amount of time? [drgbngevr]
Yes
No
DK/R
C35b. If drgbngevr= “yes”: In the last month, did you go on a run or a binge? [bngm1]
Yes
No
DK/R
Interviewer prompt: Some other countries have Supervised Consumption Rooms, which are places
where people can legally bring their own drugs, get supplies like clean needles, and use their drugs in
Page 32 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
front of staff in case they overdose. There are no places like this in the US. If there was a legal
service you could go to for free to use drugs safely indoors…
C36. Would you use this service? [sifuse]
Yes
No
DK/ R
C37. If sifuse= “yes”: How often do you think you would use this service? [siftimes]
Once or a couple of times
About once a month
At least every week
Every day
DK/ R
C38. If sifuse= “yes”: What is the longest time you would be willing to travel to use this service?
[siftra]
1-5 minutes
6-10 minutes
11-20 minutes
21-30 minutes
More than 30 minutes
DK/R [DK]
C39. If sifuse= “yes”: When would you be most likely to use this service? (Read out list; check all
that apply) [sifpref]
Mornings, like 8am-12pm [1]
Afternoons, like 12pm-4pm [2]
Evening, like 4pm-8pm [3]
Late evenings, like 8pm-12midnight [4]
Other [77]
DK/R [99]
C39a. If sifpref= “other”: When would you be most likely to use this service: __________
[sifpref_oth]
C40. Do you think that your friends (or other people you know) would use this service? [sifptp]
Yes
No
DK/ R
Page 33 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Interviewer prompt: We are now going to ask about drug dealing. By dealing, we mean giving drugs to
someone in exchange for money, food, shelter, or other goods. Please remember that all responses
are strictly confidential and will not be shared with anyone outside of the study team.
C41. Have you ever dealt drugs? [dealt]
Yes
No
DK/R
C42. If dealt= “yes”: What is the main reason you’ve dealt drugs?(Read out list; check only one)
[dealw]
Income for drugs
Income for other purposes
To clear debts
For food or shelter
Another reason
DK/R
C42a. If dealw=”another reason”: What is the main reason you’ve dealt drugs:_______
[dealw_oth]
C43. If dealt= “yes”: In the last month, have you dealt drugs? [dealtm1]
Yes
No
DK/R
C44. If dealtm1= “yes”: In the last month, have you dealt drugs that you suspected or knew had
fentanyl in them? [fentdeal]
Yes
No
DK/R
C45. If dealt= “yes”: Are you concerned about fentanyl contaminating your supply?
[fentdeal_concern]
Very concerned
A little concerned
Neutral
Not concerned
DK/R
C46. If dealt= “yes”: If given the choice, would you prefer not to deal drugs that had fentanyl in
them? [fentindrg]
Page 34 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Very concerned
A little concerned
Neutral
Not concerned
DK/R
C47. Has your drug use changed in any of the following ways because COVID-19? (Read out
list; check all that apply) [cov_use]
I use more (frequency or amount) than I did before [1]
I use less (frequency or amount) than I did before [2]
I use alone more often [3]
I use alone less often [4]
I use when naloxone is available more often [4]
I use when naloxone is available less often [5]
I taste or check drugs first more often [6]
I taste or check drugs first less often [7]
I have used different drugs because my normal supply has changed or dried up [8]
I have started methadone, buprenorphine or some other form of treatment [9]
I have stopped methadone, buprenorphine or some other form of treatment [10]
I have changed how I have used drugs (for example you have switched from inhalation to
injection) [11]
No difference [12]
Something else [77]
DK/R [99]
C47a. If covid_use="77"; Is there something else that has changed about how you use drugs
because of COVID-19?______________________ [cov_use_oth]
Page 35 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION D: FENTANYL
Interviewer prompt: Now we are going to ask you questions about fentanyl. Please answer True,
False, or Don’t know/Refuse for the next 6 questions.
D1. Fentanyl is an opioid [info1]
True
False
DK/R
D2. Fentanyl is not as strong as heroin [info2]
True
False
DK/R
D3. Fentanyl acts more quickly than heroin [info3]
True
False
DK/R
D4. Drugs that are mixed with fentanyl look different than drugs that are not mixed with
fentanyl [info4]
True
False
DK/R
D5. Someone is more likely to overdose when using drugs that contain fentanyl than when
using drugs that do not contain with fentanyl [info5]
True
False
DK/R
D6. In Rhode Island, fentanyl now causes more overdoses than heroin [info6]
True
False
DK/R
D7. Have you ever been prescribed fentanyl by a doctor? [fentrx]
Yes
No
DK/R
Page 36 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
D8. If fentrx= “yes”: In what forms have you been prescribed fentanyl? (Read out list; check all
that apply) [fentform]
Skin patch [1]
Pills [2]
Nasal spray [3]
Lozenge/lollipop [4]
A film that dissolves under your tongue [5]
A spray that goes under your tongue [6]
Other: [7]
DK/R [99]
D8a. If fentform= “other”: In what forms have you been prescribed fentanyl: _________
[fentform_oth]
D9. Have you ever used prescription fentanyl in a way that was not prescribed by a doctor
(without a prescription, or different route or different dose than as prescribed by a doctor)?
[fentnorx]
Yes
No
DK/R
D10. If fentnorx= “yes”: In the last month, how often have you used prescription fentanyl in a
way that was not prescribed by a doctor? [fentdiv6]
Never
Once or a couple times
At least every week
Every day
Multiple times per day
DK/R
D11. If fentnorx= “yes”: In the last month, what forms of prescription fentanyl have you used in a
way that was not prescribed by a doctor? (Read out list; check all that apply) [fentdivform]
Skin patch [1]
Pills (orally) [2]
Nasal spray [3]
Injecting [4]
Snorting [5]
Smoking [6]
Lozenge/lollipop [7]
A film that dissolves under your tongue [8]
Other: [77]
Page 37 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
DK/R [99]
D11a. If fentdivform= “other”: In the last month, what forms of prescription fentanyl have you
used in a way that was not prescribed by a doctor: ___________ [fentdivform_oth]
D12. If fentnorx= “yes”: In the last month, how did you get fentanyl without a prescription?
(Read out list; check all that apply) [fentbuy]
Purchased from a dealer or on the street [1]
A close friend [2]
A casual friend of acquaintance [3]
A sex partner [4]
An immediate family or household member [5]
An extended family member [6]
Purchased from the internet or “dark web” [7]
Other: [77]
DK/R [99]
D12a. If fentbuy= “other”: In the last month, who did you get fentanyl without a
prescription:______ [fentbuy_oth]
Interviewer prompt: Now we are going to be talking about drugs that contained fentanyl. For example,
you thought you were buying heroin, but it was contained fentanyl.
D13. I am confident that I have used a drug that contained fentanyl that was not sold as
fentanyl. [fentconfevr]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
For responses Strongly Disagree, Disagree, Neutral, DK/R → skip to D19
D14. In the last month, how often have you used fentanyl or drugs you were confident
contained fentanyl? [fentfreq]
Never
Once or a couple of times
About once a month
At least every week
Every day
DK/R
Page 38 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
D15. If fentfreq = “Once or a couple of times” or “About once a month” or “At least every week” or
“Every day”: What drugs have you used that you were confident contained fentanyl in the
past... (Read out list; check all that apply) [fentconfevr]
Past month
(Y/N)
Past 7 days
(Y/N)
Past 3 days
(Y/N)
D15a
Marijuana or hash oil, including
edibles and synthetic marijuana
D15b
Club drugs such as Molly, MDMA,
Ecstasy, GHB, Ketamine
OR
Molly/MDMA/Ecstasy [MO]
D15c
Psychedelics, such as Mushrooms,
Acid, LSD, DMT
OR
Mushrooms [MU]
D15d
Crystal methamphetamine (crystal
meth, tina, crank, ice)
D15e
Powder cocaine
D15f
Crack cocaine
D15h
Heroin
D15j
Prescription Opioid Pills (Vicodin,
Percocet, etc.)
D15k
Prescription Benzodiazepines
(Xanax, Klonopin, etc.)
D15l
Prescription Stimulants (Adderall,
Ritalin, etc.)
D15
m
Other:
Page 39 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
D15n
DK/R
D16. If fentfreq = “Once or a couple of times” or “About once a month” or “At least every week” or
“Every day”: The last time you used a drug you were confident contained fentanyl, did you
know that the drug that contained fentanyl before you used it? [fentconf]
Yes
No
DK/R
D17. If fentfreq = “Once or a couple of times” or “About once a month” or “At least every week” or
“Every day”: The last time you used a drug you were confident contained fentanyl, why were
you confident that it contained fentanyl? (Read out list, check all that apply) [fentwhy]
A dealer told me [1]
A sex partner told me [2]
A friend told me [3]
I overdosed [4]
A sex partner overdosed [5]
A friend overdosed [6]
I had a bad reaction [7]
Quicker onset of high [8]
Different high [9]
Differences in appearance, smell or taste [10]
Other: [77]
DK/R [99]
D17a. If fentwhy= “Other”: The last time you used a drug you were confident contained fentanyl,
why were you confident that it contained fentanyl:__________ [fentwhy_oth]
D17a. If fentfreq = “Once or a couple of times” or “About once a month” or “At least every week” or
“Every day”: The last time you used a drug that you were confident contained fentanyl, how did
you get it? [fentobt]
Purchased from a dealer or on the street
A close friend
A casual friend of acquaintance
A sex partner
An immediate family or household member
An extended family member
Purchased from the internet or “dark web”
Other
DK/R
Page 40 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
D17b. If fentobt = “other”: The last time you used a drug that you were confident contained
fentanyl, how did you get it:____________ [fentobt_why]
D18. If fentfreq = “Once or a couple of times” or “About once a month” or “At least every week” or
“Every day”: The last time you used a drug you were confident contained fentanyl, what did you
do when you found out you? (Read list out loud; check all that apply) [skill1]
Took them as I usually would [1]
Threw them out [2]
Gave them away [3]
Sold them [4]
Went slower [5]
Used less [6]
Did a tester [7]
Used with someone else around [8]
Other: [77]
DK/R [99]
D18a. If skill1= “other”: The last time you used a drug you were confident contained fentanyl,
what did you do when you found out:__________ [skill1_oth]
Interviewer prompt: Now that we have asked you what you’ve done in the past when you had drugs
that contained fentanyl, we would like to know more about what you do in the future.
D19. What would you do if you found out your drugs had fentanyl in them? (Read list out loud;
check all that apply) [motiv1]
Take them as I usually would [1]
Throw them out [2]
Give them away [3]
Sell them [4]
Go slower [5]
Use less [6]
Do a tester [7]
Use with someone else around [8]
Talk with the supplier or dealer [8]
Other [77]
DK/R [99]
D19a. If motiv1 = “Other”: What would you do if you found out your drugs had fentanyl in
them:_______ [motiv1_oth]
Page 41 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Interviewer prompt: We would like to know your thoughts about the effects of fentanyl or drugs that
have fentanyl in them. Please indicate how much you agree or disagree with the following statements:
D23. Fentanyl or drugs that have fentanyl in them are a better high than drugs that do not have
fentanyl in them [percep1]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
D24. I am concerned about my friends using drugs that contain fentanyl [motiv2]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
D25. I am concerned about my drugs having fentanyl in them [motiv3]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
D26. I prefer using fentanyl or drugs that have fentanyl in them [fentpref]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
Page 42 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
D26a. If “Agree” or “Strongly agree” to any of D26: Why do you prefer to use drugs with
fentanyl in them? (Read out list; check all that apply) [whyfentpref]
Stronger or better high [1]
Faster onset of high [2]
Easier to prepare than other drugs [3]
Cheaper than other opioids (including heroin and prescription pills) [4]
Dope sick or experiencing withdrawal symptoms [5]
That’s all my dealer was selling [6]
Curious about the effect of fentanyl [7]
It is what I am used to using [8]
Other: [77]
DK/R [99]
D26b. If whyfentpref= “other”: Why do you prefer to use drugs with fentanyl in them:_____
[whyfentpref_oth]
D27. I would like to be able to know if I recently took drugs with fentanyl in them [motiv4]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
D28. I would like to be able to know if there is fentanyl in my drugs before I take them [motiv5]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
D29. Have you heard of fentanyl test strips? [testknow]
Yes
No
DK/R
D30. Have you ever used a fentanyl test strip, either on your own or with people you use drugs
with? [testuseevr]
Yes
No
DK/R
Page 43 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
D40. If testuseevr= “yes”: Have you used a fentanyl test strip in the last month, either on your
own or with people you use drugs with? [testusem1]
Yes
No
DK/R
D41. If testusem1= “yes”: Who performed the test? [testusewho]
I did it myself
A close friend
A casual friend or acquaintance
An immediate family or household member
An extended family member
Dealer
Strangers
DK/R
D42. If testusem1= “yes”: Where did the fentanyl test strips come from? (Read out list; check all
that apply) [testgetwho]
RAPIDS clinical trial [1]
Other research study [2]
AIDS Care Ocean State (ACOS) [3]
Project Weber/RENEW [4]
Another harm reduction organization [5]
Uncertain [6]
Other: [77]
DK/R [99]
D42a. If testgetwho= “other”: Where did the fentanyl test strips come from:______
[testgetwho_oth]
D43. If testusem1= “yes”: In the last month, how many times have you tested your drugs for
fentanyl? [testnumm1]
_________
DK/R [DK]
D44. If testnumm1>0: Did any of the tests come back positive? Meaning you only saw one line
on the test strip? [testpos]
Yes
No
DK/R
Page 44 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
D45. If testpos= “Yes”: How many tests were positive for fentanyl, meaning you only saw one
line? [fentposno]
_______
DK/R
D46. If testpos= “Yes”: Which drugs that you tested came back positive for fentanyl? (Read out
list; check all that apply) [fentposdrg]
Prescription opioids such as Percocet, OxyContin, Dillaudid, Vicodin [1]
Medications used for opioid use disorder such as Methadone, buprenorphine/Suboxone [2]
Benzodiazepines/Benzos such as Xanax, Ativan, Valium, Klonapin [3]
Prescription stimulants such as Adderall, Ritalin, Focalin, Concerta, Dexedrine [4]
Marijuana or hash oil, including edibles and synthetic marijuana [5]
Club drugs such as Molly, MDMA, Ecstasy, GHB, Ketamine [6]
Psychedelics, such as Mushrooms, Acid, LSD, DMT [7]
Crystal methamphetamine (crystal meth, glass, ice, tina) [8]
Powder cocaine [9]
Crack cocaine [10]
Heroin [11]
Other [77]
DK/R [99]
D46a. If fentposdrg = “Other”: Which drugs that you tested came back positive for
fentanyl:_____ [fentposdrg_oth]
D47. If testpos= “Yes”: What did you do when you found out you had drugs containing fentanyl?
(Read out list; check all that apply). [skill1testpos]
Took them as I usually would [1]
Threw them out [2]
Gave them away [3]
Sold them [4]
Went slower [5]
Went faster [6]
Used less [7]
Used more [8]
Did a tester [9]
Used with someone else around [10]
Got naloxone [11]
Other [77]
DK/R [99]
D47a. If skill1testpos= “Other”: What did you do when you found out you had drugs containing
fentanyl:__________ [skill1testpos_oth]
Page 45 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
D47b. If testpos= “Yes”: Did you experience any of the following unwanted negative reactions
from using the drug that tested positive for fentanyl? (Read out list; check all that apply)
[fentreact]
Lost consciousness/blacked out [1]
Blue or gray lips or skin [2]
Seizure [3]
Had a hard time breathing [4]
Elevated breathing [5]
Stopped breathing [6]
Inability to talk [7]
Not responsive to stimulus (like having your name called or physical contact) [8]
Overheating [9]
Irregular heart beat (fast, slow, irregular or palpitations) [10]
Paranoia [11]
Can’t remember getting high [12]
None [13]
Other [77]
DK/R [99]
D47c. If fentreact= “Other”: Did you experience any of the following unwanted negative
reactions from using the drug that tested positive for fentanyl:______ [fentreact_oth]
D48. If testusem1= “Yes”: Did any of the tests come back negative for fentanyl, meaning you
saw two lines? [testneg]
Yes
No
DK/R
D49. If testneg= “Yes”: How many of the tests came back negative for fentanyl, meaning you
saw two lines? [fentnegno]
______________
DK/R
D50. If testneg= “Yes”: Which drugs that you tested came back negative for fentanyl? (Read out
list; check all that apply) [fentnegdrg]
Prescription opioids such as Percocet, OxyContin, Dillaudid, Vicodin [1]
Medications used for opioid use disorder such as Methadone, buprenorphine/Suboxone [2]
Benzodiazepines/Benzos such as Xanax, Ativan, Valium, Klonapin [3]
Prescription stimulants such as Adderall, Ritalin, Focalin, Concerta, Dexedrine [4]
Marijuana or hash oil, including edibles and synthetic marijuana [5]
Club drugs such as Molly, MDMA, Ecstasy, GHB, Ketamine [6]
Psychedelics, such as Mushrooms, Acid, LSD, DMT [7]
Page 46 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Crystal methamphetamine (crystal meth) [8]
Powder cocaine [9]
Crack cocaine [10]
Heroin [11]
Alcohol [12]
Other [77]
DK/R [99]
D50a. If fentnegdrg= “Other”: Which drugs that you tested came back negative for
fentanyl:_______ [fentnetdrg_oth]
D51. If testneg= “Yes”: What did you do when you found out you had drugs that did not contain
fentanyl? (Read out list; check all that apply). [skill1fentneg]
Took them as I usually would [1]
Threw them out [2]
Gave them away [3]
Sold them [4]
Went slower [5]
Went faster [6]
Used less [7]
Used more [8]
Did a tester [9]
Used with someone else around [10]
Got naloxone [11]
Other [77]
DK/R [99]
D51a. If skill1fentneg= “Other”: What did you do when you found out you had drugs that did not
contain fentanyl:________ [skill1fentneg]
D52. If testneg= “Yes”: Did you have any of the following unwanted negative reactions from
using the drug that tested negative for fentanyl? (Read out list; check all that apply) [fentreactneg]
Lost consciousness/blacked out [1]
Blue or gray lips or skin [2]
Seizure [3]
Had a hard time breathing [4]
Elevated breathing [5]
Stopped breathing [6]
Inability to talk [7]
Not responsive to stimulus (like having your name called or physical contact) [8]
Overheating [9]
Irregular heart beat (fast, slow, irregular or palpitations) [10]
Page 47 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Paranoia [11]
Can’t remember getting high [12]
None [13]
Other [77]
DK/R [99]
D52a. If fentreactneg= “Other”: Did you have any of the following unwanted negative reactions
from using the drug that tested negative for fentanyl:________ [fentreactneg_oth]
D53. IHas fentanyl changed how you think about starting methadone or buprenorphine
(Suboxone), or starting other forms of addiction treatment? [fenttotrt]
Yes, I accessed addiction treatment because of concerns about fentanyl
Yes, I am thinking about accessing treatment because of concerns about fentanyl (but haven’t
done so yet)
No
Already in some kind of addiction treatment
DK/R
D54. Has fentanyl changed how you use drugs in any of the following ways? (Read out list;
check all that apply) [fentchange]
More likely to use with others [1]
More likely to inject slowly and/or taste drugs first [2]
More likely to use in public (e.g., outside) [3]
More likely to use in places where other people are around [4]
Less likely to use alone [5]
More likely to use where naloxone is available [6]
More likely to carry take-home naloxone [7]
Using less often and/or using smaller amount of drugs each time [8]
More likely to use drugs containing fentanyl [9]
More likely to use drugs unlikely to contain fentanyl (rather than drugs that may contain
fentanyl) [10]
Other: [77]
Use hasn’t changed [11]
DK/R [99]
D54a. If fentchange= “More likely to use drugs unlikely to contain fentanyl: Specify drugs less likely
to contain fentanyl:______ [fentchange_drg]
D54b. If fentchange= “Other”: Has fentanyl changed how you use drugs in any of the following
ways:_________ [fentchange_oth]
Page 48 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION X - MENTAL HEALTH
Interviewer prompt: Now we will talk about how you are feeling right now. Rate each of the following
statements between 0 and 4. 0 = not at all; 1 = a little; 2 = moderately ; 3 = quite a bit; 4 = extremely.
In each case, you can respond that you don't know or prefer not to answer.
Not at all
[0]
A little
[1]
Moderately
[2]
Quite a bit
[3]
Extremely
[4]
X1a. I feel anxious. [sows1]
[0]
[1]
[2]
[3]
[4]
X1b. I feel like yawning.
[sows2]
[0]
[1]
[2]
[3]
[4]
X1c. I am perspiring. [sows3]
[0]
[1]
[2]
[3]
[4]
X1d. My eyes are tearing.
[sows4]
[0]
[1]
[2]
[3]
[4]
X1e. My nose is running.
[sows5]
[0]
[1]
[2]
[3]
[4]
X1f. I have goosebumps.
[sows6]
[0]
[1]
[2]
[3]
[4]
X1g. I am shaking. [sows7]
[0]
[1]
[2]
[3]
[4]
X1h. I have hot flashes.
[sows8]
[0]
[1]
[2]
[3]
[4]
X1j. I have cold flashes.
[sows9]
[0]
[1]
[2]
[3]
[4]
X1k. My bones and muscles
ache. [sows10]
[0]
[1]
[2]
[3]
[4]
X1l. I feel restless. [sows11]
[0]
[1]
[2]
[3]
[4]
X1m. I feel nauseous. [sows12]
[0]
[1]
[2]
[3]
[4]
Page 49 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
X1n. I feel like vomiting.
[sows13]
[0]
[1]
[2]
[3]
[4]
X1o. My muscles twitch.
[sows14]
[0]
[1]
[2]
[3]
[4]
X1p. I have stomach cramps.
[sows15]
[0]
[1]
[2]
[3]
[4]
X1q. I feel like using now.
[sows16]
[0]
[1]
[2]
[3]
[4]
Interviewer Prompt: Now I am going to ask you 7 questions about stress and anxiety. You can
respond with how often you have experienced these feelings in the past 2 weeks: “not sure at all,”
“several days,” “over half the days,” or “nearly every day.”
Not sure at all
[0]
Several days
[1]
Over half the
days [2]
Nearly every
day [3]
X2a. Feeling nervous,
anxious, or on edge
[gad1]
[0]
[1]
[2]
[3]
X2b. Not being able to
stop or control worrying
[gad2]
[0]
[1]
[2]
[3]
X2c. Worrying too much
about different things
[gad3]
[0]
[1]
[2]
[3]
X2d. Trouble relaxing
[gad4]
[0]
[1]
[2]
[3]
X2e. Being so restless
that it’s hard to sit still
[gad5]
[0]
[1]
[2]
[3]
X2f. Becoming easily
annoyed or irritable [gad6]
[0]
[1]
[2]
[3]
Page 50 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
X2g. Feeling afraid as if
something awful might
happen [gad7]
[0]
[1]
[2]
[3]
X2h. If you checked off any problems, how difficult have these made it for you to do your
work, take care of things at home, or get along with other people? (Read out list; check only
one). [gad8]
Not difficult at all
Somewhat difficult
Very difficult
Extremely difficult
Interviewer Prompt: Next, I will describe some feelings or behaviors you may have had in the
past week, meaning the past 7 days. Please tell me how often you have felt this way in the past
week.
Programmer note: Scoring for CESD be found in brackets in the table below. For these questions,
rarely will be 3, occasionally will be 2, some of the time will be 2 and most of the time will be 0. A
score for this can range between 0 and 60. A score of less than 16 means that symptoms do not have
clinical significance.
Rarely or
none of the
time (less
than 1 day)
[0]
Some or a
little of the
time (1-2
days) [1]
Occasionally
or a
moderate
amount of
time (3-4
days) [2]
Most or all
of the time
(5-7 days)
[3]
DK/R
[DK]
X3a. I was bothered by
things that usually don’t
bother me. [cesd1]
[0]
[1]
[2]
[3]
X3b. I did not feel like
eating; my appetite was
poor. [cesd2]
[0]
[1]
[2]
[3]
X3c. I felt that I could not
shake off the blues even
with help from my family or
friends. [cesd3]
[0]
[1]
[2]
[3]
Page 51 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
X3e. I had trouble keeping
my mind on what I was
doing. [cesd5]
[0]
[1]
[2]
[3]
X3f. I felt depressed.
[cesd6]
[0]
[1]
[2]
[3]
X3g. I felt that everything I
did was an effort. [cesd7]
[0]
[1]
[2]
[3]
X3i. I thought my life had
been a failure. [cesd9]
[0]
[1]
[2]
[3]
X3j. I felt fearful. [cesd10]
[0]
[1]
[2]
[3]
X3k. My sleep was restless.
[cesd11]
[0]
[1]
[2]
[3]
X3m. I talked less than
usual. [cesd13]
[0]
[1]
[2]
[3]
X3n. I felt lonely. [cesd14]
[0]
[1]
[2]
[3]
X3o. People were
unfriendly. [cesd15]
[0]
[1]
[2]
[3]
X3q. I had crying spells.
[cesd17]
[0]
[1]
[2]
[3]
X3r. I felt sad. [cesd18]
[0]
[1]
[2]
[3]
X3s. I felt that people
dislike me. [cesd19]
[0]
[1]
[2]
[3]
X3t. I could not get
“going.” [cesd20]
[0]
[1]
[2]
[3]
Page 52 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Rarely or
none of the
time (less
than 1 day)
[3]
Some or a
little of the
time (1-2
days) [2]
Occasionally
or a
moderate
amount of
time (3-4
days) [1]
Most or all
of the time
(5-7 days)
[0]
DK/R
[DK]
X3d. I felt I was just as
good as other people.
[cesd4]
[3]
[2]
[1]
[0]
X3h. I felt hopeful about
the future. [cesd8]
[3]
[2]
[1]
[0]
X3l. I was happy. [cesd12]
[3]
[2]
[1]
[0]
X3p. I enjoyed life. [cesd16]
[3]
[2]
[1]
[0]
X4. In general, how satisfied are you with your life? [hrqol1]
Very satisfied
Satisfied
Dissatisfied
Very dissatisfied
X5. Would you say that in general your health is… [hrqol2]
Excellent
Very Good
Good
Fair
Poor
DK/R
X5. Now thinking about your physical health, which includes physical illness and injury, for
how many days during the past 30 days was your physical health not good? [hrqol3]
_______ (integer, maximum 30)
X6. Now thinking about your mental health, which includes stress, depression, and problems
with emotions, for how many days during the past 30 days was your mental health not good?
[hrqol4]
_______ (integer, maximum 30)
Page 53 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
X7. During the past 30 days, for about how many days did poor physical or mental health keep
you from doing your usual activities, such as self-care, work, or recreation? [hrqol5]
_______ (integer, maximum 30)
Page 54 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION E: HEALTHCARE AND TREATMENT ENGAGEMENT
Interviewer prompt: We are now going to move on and talk about your experiences with drug and
alcohol treatment programs.
E1a. How troubled or bothered have you been in the past 30 days by drug problems, like
cravings, withdrawal symptoms, or wanting to stop and being unable to? [drgprob]
0 - Not at all
Slightly
Moderately
Considerably
4 - Extremely
E1b. How important to you now is treatment for these drug problems? [probimp]
0 - Not at all
Slightly
Moderately
Considerably
4 - Extremely
E1c. Have you ever tried to enroll in a substance use treatment program but were unable to?
[txacess]
Yes
No
DK/R
E2. If txacess= “yes”: What kind of addiction treatment did you try to enroll in? (Read out list;
check all that apply) . [txt]
Detox [1]
Methadone [2]
Suboxone (buprenorphine) treatment [3]
Self-help group (like 12-step AA or NA programs) [4]
Outpatient drug or alcohol treatment program [5]
Day treatment program or partial hospitalization program [6]
Residential drug treatment program [7]
Another kind of treatment [77]
DK/R [99]
E2a. If txt= “Another kind of treatment”: What kind of addiction treatment did you try to enroll
in:_________ [txt_oth]
E3. If txacess= “yes”: What were the main barriers to accessing addiction treatment? (Read out
list: check all that apply). [txb]
I couldn’t afford it [1]
There was a waiting list [2]
Page 55 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
My health insurance would not allow me to attend the program [3]
I didn’t have health insurance [4]
I didn’t know of any programs [5]
The programs weren’t youth-friendly [6]
I was turned down by a program [7]
There was no treatment program nearby [8]
There were no beds or appointments available [9]
Another reason [77]
DK/R [99]
E3a. If txb= “yes”: What were the main barriers to accessing addiction treatment:_____ [txb_oth]
E4. Have you ever been in any kind of alcohol or drug treatment program? [txprog]
Yes
No
DK/R
E5. If txprog= “yes”: Have you ever been kicked out of any drug or alcohol treatment program
because of drug or alcohol use? [txkick]
Yes
No
DK/R
E6. If txkick= “yes”: What program(s) were you kicked out of? (Read out list; check all that apply)
[txkick_prog]
Detox [1]
Methadone [2]
Suboxone (buprenorphine) treatment [3]
Self-help group (like 12-step AA or NA programs) [4]
Outpatient drug or alcohol treatment program [5]
Day treatment program or partial hospitalization program [6]
Residential drug treatment program [7]
Another kind of treatment [77]
DK/R [99]
E6a. If txprog_kick = “other”: What program(s) were you kicked out of:________ [txprog_kick_oth]
E7. If txkick= “yes”: What substance did you use that caused you to be kicked out? (Read out
list; check all that apply) [txkick_drg]
Prescription opioids such as Percocet, OxyContin, Dillaudid, Vicodin [1]
Medications used for opioid use disorder such as Methadone, buprenorphine/Suboxone [2]
Benzodiazepines/Benzos such as Xanax, Ativan, Valium, Klonapin [3]
Page 56 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Prescription stimulants such as Adderall, Ritalin, Focalin, Concerta, Dexedrine [4]
Marijuana or hash oil, including edibles and synthetic marijuana [5]
Club drugs such as Molly, MDMA, Ecstasy, GHB, Ketamine [6]
Psychedelics, such as Mushrooms, Acid, LSD, DMT [7]
Crystal methamphetamine (crystal meth, glass, ice, tina) [8]
Powder cocaine [9]
Crack cocaine [10]
Heroin [11]
Other [77]
DK/R [99]
E7a. If txkick_drg= “yes”: What substance did you use that caused you to be kicked out:_____
[txkick_drg_oth]
E8. If txprog= “yes” In the last month, have you been in any kind of alcohol or drug treatment
program? [txprogm1]
Yes
No
DK/R
E9. If txprogm1= “yes”: Are you currently in a drug or alcohol treatment program? [addictxt]
Yes
No
DK/R
E10. If addictxt= “yes”: Overall, how satisfied are you with this treatment program? [addictxt_sat]
Very
unsatisfied
Unsatisfied
Neither
satisfied nor
dissatisfied
Satisfied
Very
satisfied
DK/R
E11. If addictxt= “yes”: Why did you enter this treatment program? (Read out list; check all that
apply) [addictxt_reason]
Wanted to reduce my drug use or stop using entirely [1]
Other physical or mental health reasons [2]
Convinced by family, friends, a doctor, etc. [3]
Coerced or forced to by a doctor, the policy, courts, etc. [4]
Referred from a drug court [5]
Other [77]
DK/R [99]
Page 57 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
E11a. If adicttxt_reason= “other”: Why did you enter this treatment program:____
[addictxt_reason_oth]
E12. If addictxt= “yes”: Is this treatment program located in Rhode Island? [addictri]
Yes
No
DK/R
E13. If addictxt= “yes”: What kind of addiction treatment are you currently in? (Read out list;
check all that apply) [txtcur]
Detoxification [1]
Methadone [2]
Buprenorphine/Suboxone/Subutex treatment [3]
Self-help group (like 12-step AA, NA) [4]
Outpatient drug or alcohol treatment program [5]
Day treatment program or partial hospitalization program [6]
Residential drug treatment program [7]
Another kind of treatment: [77]
DK/R [99]
E14. If txtcur = “Methadone” or “Buprenorphine/Suboxone/Subutex treatment”: How long have you
been taking this medication for? [mattime]
_____ years
_____ months
DK/R [DK]
E15. If txtcur = “Methadone” or “Buprenorphine/Suboxone/Subutex treatment”: What is the dose of
methadone or Buprenorphine/Suboxone/Subutex that you are currently receiving? [matdose]
_____ mg (integer; if TXT_current = Methadone, allowable range 1 to 1000; If TXT_current =
Buprenorphine, allowable range 1 to 40)
DK/R
E16. If txtcur = “Methadone” or “Buprenorphine/Suboxone/Subutex treatment”: Has the dose
remained the same for the past 7 days? [txtcurstbl]
Yes
No
DK/R
E16a. If txtcurstble= “yes”: During the last 7 days, how frequently have you used heroin/opioids,
either illicit or non-medical? [odas1]
Page 58 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
1 - More
than twice
every day
2 - Every
day at least
once or
twice a day
3 - Four, five
or six times
in the last
seven days
4 - One, two
or three
times in the
last seven
days
5 - None of
the last
seven days
If [5] → skip to odas3a
E16b. How intense was the effect you felt from the dose or doses of the heroin/opioid that you
used in the last seven days on a scale of 1-5? A 1 would mean that the effect was extremely
intense and a 5 would mean that it had no effect on you. [odas2]
1 - ‘The
effect was
extremely
intense’
2 -
3 -
4 -
5 - ‘It had no
effect at all
on me’
E16c. During the last seven days, how frequently have you felt two or more of these objective
heroin/opioid withdrawal symptoms? (such as cramps and muscular pains, feeling your hair
standing on end, a runny nose, wanting to cry, yawning, stomach cramps or diarrhea,
palpitations, sweating, and generally feeling bad…) [odas3a]
1 - More
than twice
every day
2 - Every
day at least
once or
twice a day
3 - Three to
six times in
the last
seven days
4 - One or
two times in
the last
seven days
5 - None
If E16c = None [5] → skip to E16e
E16d. During the last seven days, how intense were the withdrawal symptoms you felt on a
scale of 1-5? A 1 would mean extremely intense and a 5 would mean nothing at all. [odas3b]
1 -
‘Extremely
intense’
2 -
3 -
4 -
5 - ‘Nothing
at all’
E16e. During the last seven days, how frequently have you felt two or more of these subjective
heroin/opioid withdrawal symptoms? (such as anxiety, restlessness, irritability, difficulty in
sleeping, tiredness, shivering, muscular aches and lack of appetite) [odas4a]
Page 59 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
1 - More
than twice
every day
2 - Every
day at least
once or
twice a day
3 - Three to
six times in
the last
seven days
4 - One or
two times in
the last
seven days
5 - None
If [5] NOT two or more symptoms → skip to E16g
E16f. During the last seven days, how intense were the withdrawal symptoms you felt on a
scale of 1-5? A 1 would mean extremely intense and a 5 would mean nothing at all.[odas4b]
1 -
‘Extremely
intense’
2 -
3 -
4 -
5 - ‘Nothing
at all’
E16g. During the last seven days, how frequently have you felt felt an urgent need to use
heroin/opioids? [odas5a]
1 - More
than twice
every day
2 - Every
day at least
once or
twice a day
3 - Three to
six times in
the last
seven days
4 - One or
two times in
the last
seven days
5 - None
If [5] → skip to E16i
E16h. During the last seven days, how intensely did you feel the need to use heroin/opioids,
on average on a scale of 1-5? A 1 would mean extremely intense and a 5 would mean nothing
at all.? [odas5b]
1 -
‘Extremely
intense’
2 -
3 -
4 -
5 - ‘Nothing
at all’
E16i. During the last seven days, how frequently have you had any symptoms of
overmedication of methadone? (such as feeling sleepy or sedated, difficulty in speaking,
being unusually active or, alternatively, the sensation of “being drugged”) [odas6a]
None… 5 points [5]
1-2 times… 4 points [4]
3-6 times… 3 points [3]
Every day, once or twice a day… 2 points [2]
Page 60 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
More than twice every day… 1 points [1]
E16j. During the last seven days, how intense were the overmedication symptoms you felt on
a scale of 1-5? A 1 would mean extremely intense and a 5 would mean nothing at all. [odas6b]
1 -
‘Extremely
intense’
2 -
3 -
4 -
5 - ‘Nothing
at all’
E17. What is your current health insurance coverage? [inssts]
No insurance [1]
Insurance through my workplace [2]
Medicare/Medicaid or other governmental insurance like Neighborhood Health Plan[3]
Individual/family private coverage [4]
Other [77]
DK/R [99]
E17a. If inssts= “other”: What is your current health insurance coverage:_____ [inssts_oth]
E18. Have you ever been diagnosed with a mental health or cognitive disorder? [mentdiagevr]
Yes
No
DK/R
E19. If mentdiagevr= “yes” What mental health disorder were you diagnosed with? (Read out list;
check all that apply) [mentdiagname]
Attention-Deficit/Hyperactivity Disorder (ADD/ADHD) [1]
Obsessive-compulsive disorder (OCD) [2]
Eating disorders (like anorexia or bulimia) [3]
Depressive disorder (like major depression) [4]
Bipolar disorder (like manic depressive disorder) [5]
Anxiety disorder (like panic attacks or phobias) [6]
Psychosis (like schizophrenia, brief psychotic episode, or paranoia) [7
Another diagnoses [77]
No, none of the above [0]
DK/R [99]
E19a. If mendiagname= “Another diagnoses”: What mental health disorder were you diagnosed
with:_________ [mentdiagname_oth]
Page 61 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
E20. Have you ever been hospitalized because of this mental health disorder or injuries
caused by the disorder? [hospdis]
Yes
No
DK/R
E21. Have you ever been prescribed opioids as a result of injury or acute pain? [presinj]
Yes
No
DK/R
Interviewer prompt: We are going to ask you two questions about chronic pain. When we say chronic
pain, we mean pain on most days or every day.
E21a. In the past six months, how often did you have pain? [pn6m]
Never
Some days
Most days
Everyday
DK/R
E21b. Over the past six months, how often did pain limit your life or work activities? [adl6m]
Never
Some days
Most days
Everyday
DK/R
E22. Have you been prescribed opioids in the past month? [presmnth]
Yes
No
DK/R
E23. Have you ever been denied opioid medications for painful conditions? [op_den]
Yes
No
DK/R
E24. If op_den= “yes”: What was the reason for denial? (Read out list; check all that apply)
[op_den_reason]
No reason given [1]
Being homeless [2]
Not having health insurance [3]
Page 62 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Physician denied because of diversion or substance use concerns [4]
Clinic does not prescribe narcotics [5]
Did not see my regular physician [6]
Physician said pain wasn’t serious enough or other medications are sufficient [7]
Physician concerned about adverse effects [8]
Positive drug test [9]
Other [77]
DK/R [99]
E24a. If op_den_reason= “other”: What was the reason for denial:______ [op_den_reason_oth]
Page 63 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION F – OVERDOSE
Interviewer prompt: Now we’d now like to ask you some questions about overdose.
F1. Have you ever seen someone overdose? [skill2]
Yes
No
DK/R
F1a. Have you ever performed rescue breathing on someone who you thought was
overdosing? [skill3]
Yes
No
DK/R
F2. Have you ever heard of naloxone, a medication also known as Narcan? [info7]
Yes
No
DK/R
F3. If info7= “yes”: Do you know where you can buy or get Narcan/naloxone? [info8]
Yes
No
DK/R [DK]
F4. If info7= “yes”: Have you ever given Narcan/naloxone to someone who you thought was
overdosing? [skill4]
Yes
No
DK/R
F5. If skill4= “yes”: Have you ever given Narcan/naloxone to someone who you thought was
overdosing on fentanyl? [skill5]
Yes
No
DK/R
F6. If skill4= “yes”: How many doses of Narcan/naloxone did you have to give the last time you
reversed a fentanyl overdose? [dosenarcfent]
1
2
Page 64 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
3
≥4
DK/R
Interviewer prompt: Please indicate how much you agree or disagree with the following statements:
F7. I am confident that I can recognize when someone is having an opioid overdose. [motiv11]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
F8. I am confident that I would call 911 if a friend or family member were overdosing. [motiv12]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
F9. I am confident that I would call 911 if a friend or family member were overdosing, even if
drugs or drug paraphernalia were present at the scene. [motiv13]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
F10. I am confident that I would call 911 if a friend or family member were overdosing, even if I
was high on drugs. [motiv14]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
F11. I am worried that other people might think that I am using drugs if they see me carrying
naloxone (a medicine that can reverse an overdose). [motiv15]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
F12. What do you do to avoid an accidental overdose? (Read out list; check all that apply) [skill6]
Page 65 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Nothing [1]
Avoid mixing with alcohol [2]
Avoid mixing with other drugs [3]
Smell or taste my supply [4]
Using with someone else [5]
Take smaller amounts [6]
Go slow [7]
Take a tester [8
Use a fentanyl test strip [9]
Keep Narcan/naloxone nearby [10]
Change supplier or dealer [11]
Something else [77]
DK/R [99]
F12a. If skill6= “other”: What do you do to avoid an accidental overdose:______ [skill6_oth]
F12b. Has COVID-19 changed any of the ways that you protect yourself from an overdose?
(Read out list; check all that apply) [cov_skill6]
COVID-19 has not changed how I protect myself from an overdose [1]
I have not been able to get naloxone [2]
I have not been able to get fentanyl test strips [3]
I have started using with different people[4]
I have had to use alone [5]
I have not been able to buy from my usual dealer [6]
Something else [77]
DK/R [99]
F12c. If cov_skill6="Something else": How has COVID-19 impacted the ways that you protect
yourself from an overdose?_________________ [cov_skill6_oth]
Interviewer prompt: We’d now like to ask you about your own experience with accidental overdose.
By accidental overdose we mean taking too much of a drug such that someone is no longer able to
respond or breathe adequately. Other symptoms of an accidental overdose can include loss of
consciousness, lips turning black or grey, gurgling noises, blacking out, or others. An overdose can
occur with prescription or illicit drugs, or a combination of both.
F13. Have you ever overdosed by accident? [skill7]
Yes
No
DK/R
Page 66 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Interviewer prompt: We’d like to ask you a little more about your experiences of overdosing by
accident.
F14. If skill7= “yes”: Has anyone ever given a dose of naloxone/Narcan to you because they
thought you had overdosed by accident? [narcevr]
Yes
No
DK/R
F14a. If skill7= “yes”: Have you accidentally overdosed in the last month? [skill8]
Yes
No
DK/R
F15. If skill8= “yes”: In the last month, have you experienced any of the following unwanted
negative reactions from using too much of any of the drugs that you have used? (Read out list;
check all that apply) [odsymptij]
Lost consciousness/blacked out [1]
Blue or gray lips or skin [2]
Seizure [3]
Had a hard time breathing [4]
Elevated breathing [5]
Stopped breathing [6]
Inability to talk [7]
Not responsive to stimulus (like having your name called or physical contact) [8]
Overheating [9]
Irregular heart beat (fast, slow, irregular or palpitations) [10]
Paranoia [11]
Can’t remember getting high [12]
None [0]
Other [77]
DK/R [99]
F15a. If odsymptij= “other”: In the last month, have you experienced any of the following
unwanted negative reactions from using too much of any of the drugs that you have
used:________ [odsymptij_oth]
F16. If skill8= “yes”: How many times have you overdosed in the last month? [odnumb]
_______ (integer, allowable range 1 to 30)
DK/R
Page 67 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
F17. If skill8= “yes”: Now we want to ask you about the most recent time you overdosed. Who
was with you the last time you overdosed? (Read out list; check all that apply) [odw]
A close friend [1]
A casual friend or acquaintance [2]
A sex partner [3]
An immediate family or household member [4]
An extended family member [5]
A dealer [6]
A stranger (like people on the street) [7]
I was alone [8]
DK/R [99]
F17a. If skill8= “yes”: The last time you overdosed, what drug(s) did you intend to take? (Read
out list; check all that apply) [drgintend]
Prescription opioids such as Percocet, OxyContin, Dillaudid, Vicodin [1]
Medications used for opioid use disorder such as Methadone, buprenorphine/Suboxone [2]
Benzodiazepines/Benzos such as Xanax, Ativan, Valium, Klonapin [3]
Prescription stimulants such as Adderall, Ritalin, Focalin, Concerta, Dexedrine [4]
Marijuana or hash oil, including edibles and synthetic marijuana [5]
Club drugs such as Molly, MDMA, Ecstasy, GHB, Ketamine [6]
Psychedelics, such as Mushrooms, Acid, LSD, DMT [7]
Crystal methamphetamine (crystal meth, glass, ice, tina) [8]
Powder cocaine [9]
Crack cocaine [10]
Heroin [11]
Other [77]
DK/R [99]
F17aa. If drgintend= “other”: The last time you overdosed, what drug(s) did you intent to
take:_____ [drgintend_oth]
F17b. If skill8= “yes”: The last time you overdosed, did you overdose on a drug that you thought
might have contained fentanyl? [odfentsuspect]
Yes
No
DK/R
F17c. If odfentsuspect= “yes”: The last time you overdosed on a drug that might have contained
fentanyl, did you know it had fentanyl in it before you used it? [fentknwbfr]
Yes
No
Page 68 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
DK/R [DK]
F17d. If odfentsuspect= “yes”: The last time you overdosed, what reaction did you have to the
drug or drugs mentioned above? (Read out list; check all that apply) [drgrct]
Lost consciousness/blacked out [1]
Blue or gray lips or skin [2]
Seizure [3]
Had a hard time breathing [4]
Elevated breathing [5]
Stopped breathing [6]
Inability to talk [7]
Not responsive to stimulus (like having your name called or physical contact) [8]
Overheating [9]
Irregular heart beat (fast, slow, irregular or palpitations) [10]
Paranoia [11]
Can’t remember getting high [12]
None [0]
Other [77]
DK/R [99]
F17da. If drgrct= “other”: The last time you overdosed, what reaction did you have to the drug or
drugs mentioned above:______ [drgrct_oth]
F17e. Where were you the last time you overdosed? [odplc
Own place (room or apartment)
Partner’s place
Friend’s place
Dealer’s place
Street (alley, doorway, etc.)
Bathroom (any public washroom)
Park
Youth drop-in center
Parking lot
Car
Inside club or bar
House party
School
Abandoned house or building
Jail or prison
Crack house/shooting gallery
Other:______
DK/R
Page 69 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
F18. If skill8= “yes”: The last time you overdosed, did someone with you call 911? [odcall]
Yes
No
DK/R
F19. If skill8= “yes”: The last time you overdosed, did someone administer naloxone/Narcan?
[odnarc]
Yes
No
DK/R
F20. If odnarc= “yes”: The last time you overdosed, who gave you naloxone/Narcan? (Read out
list; check all that apply). [narcw]
A police officer [1]
An ambulance official [2]
A health professional [3]
A friend [4]
A parent or relative [5]
Another person using drugs [6]
A stranger [7]
Someone else [77]
DK/R [99]
F20a. If narcw= “other”: The last time you overdosed, who gave you naloxone/Narcan:_____
[narcw_oth]
F21. If skill8= “yes”: The last time you overdosed, were you taken to the hospital? [odhosp]
Yes
No
DK/R
F22. If odhosp= “yes”: The last time you overdosed and were taken to a hospital, were you
offered referral to an addiction treatment program before discharge? [hoptxt]
Yes
No
DK/R
F23. If odhosp= “yes”: The last time you overdosed and were taken to a hospital, were you given
naloxone/Narcan at discharge? [hospnx]
Yes
No
DK/R
Page 70 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
F24. If odhosp= “yes”: The last time you overdosed and were taken to a hospital, did you see a
peer recovery specialist, also known as a peer recovery coach? [peernx]
Yes
No
DK/R
F24a. If skill8= “yes”: In the month before your last overdose, were you in any of the following
programs? (Read out list; check all that apply) [trtdurod]
Detoxification [1]
Methadone [2]
Buprenorphine/Suboxone/Subutex treatment [3]
Self-help group (like 12-step AA, NA) [4]
Outpatient drug or alcohol treatment program [5]
Day treatment program or partial hospitalization program [6]
Residential drug treatment program [7]
Another kind of treatment [8]
Jail or prison [8]
None of the above [10]
DK/R [99]
F27. I am concerned about my friends overdosing [motiv16]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
F28. I am concerned about overdosing [motiv17]
Programmer Note: PIPE response to free text before intervention, G0.
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
F29. I get the support and resources I need from others to help me avoid an overdose. [skill9]
Programmer Note: PIPE response to free text before intervention, G0.
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
Page 71 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
F30. I am confident that I can ask someone to check on me after I use drugs, and call 911 if
they think I am overdosing. [motiv18]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
Egocentric Network Assessment Tool (ENAT)
Nomination question:
Interviewer prompt: Next, I have a few questions about people in your social network. People who are
part of your social network are people you know. This may include friends, family members,
coworkers, sexual partners, or people you use drugs with.
ENAT1. In the past 90 days, did someone you know experience an overdose? [enat_nom]
Yes
No → skip to Overdose Education
DK/R → skip to Overdose Education
ENAT1a. If enat_nom=”Yes”; In the past 90 days, how many people did you know who
experienced an overdose? [enat_num]
___________
ENAT 2. Could you tell me the first name of any person you know who overdosed in the past
90 days?
Interviewer prompt: Anything you tell me is entirely confidential, but you are welcome to give me
nicknames or initials if you would feel more comfortable.
(Interviewer: If the respondent lists more than three people, please ask them to name the three most
recent). [enat_name]
________________ [person1]
________________ [person2]
________________ [person3]
Interviewer prompt: Next, I have a few questions about your relationship with [pipe person1].
Page 72 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
ENAT 3. How long have you known [pipe person1]? [enat_durat]
_____ years
_____ months
DK/R [DK]
ENAT 4. What age is [pipe person1]? (Respondent may provide estimate) [enat_age]
___________
ENAT 5. What is [pipe person1]’s gender? (Check only one) [enat_gend]
Male [1]
Female [2]
Transgender Male/Trans Man/Female-to-male (FTM) [3]
Transgender Female/Trans Woman/Male-to-Female (MTF) [4]
Genderqueer, neither exclusively male nor female [5]
Something else [77]
DK/R [99[
ENAT5a. If enat_gender=”Something else”: What is [pipe person1]’s gender?:_________
[enat_gend_oth]
ENAT 6. What is your relationship to [pipe person1]? (Read out list, check all that apply):
[enat_rel]
A close friend [1]
A casual friend or acquaintance [2]
A sex partner [3]
An immediate family or household member [4]
An extended family member [5]
A Dealer [6]
Strangers/people I don’t know [7]
DK/R [99]
ENAT 7. How close do you feel emotionally to [pipe person1]? (Read out list; check only one)
[enat_close]
Not close at all [1]
Somewhat close [2]
Very close [3]
Extremely close [4]
DK/R [99]
ENAT 8. How much do you depend on [pipe person1] for things like money or a place to live or
stay? (Read out list; check only one) [enat_depend]
Not dependent at all [1]
Somewhat dependent [2]
Page 73 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Very dependent [3]
Extremely dependent [4]
DK/R [99]
ENAT 9. In the month before the overdose occurred, how often did you spend time with [pipe
person1]? (Read out list; check only one) [enat_time]
Never [0]
Once or a couple times [1]
At least every week [2]
A couple of times per week [3]
Every day [4]
Multiple times per day [4]
DK/R [99]
ENAT 10. In the month before the overdose occurred, how often did you and [pipe person1]
share drugs or use drugs from the same supplier? [enat_share]
Never [0]
Once or a couple times [1]
At least every week [2]
A couple of times per week [3]
Every day [4]
Multiple times per day [4]
DK/R [99]
ENAT 11. Did you witness the most recent overdose that [pipe person1] experienced?
[enat_witness]
No [0]
Yes [1]
DK/R [99]
ENAT 12. The most recent time [pipe person1] overdosed, can you tell me whether the
overdose was fatal or nonfatal? [ENAT_fatal]
Nonfatal [1]
Fatal [2]
DK/R [99]
Interviewer prompt: I am going to read a series of statements about how [pipe person1]’s overdosed
might have impacted your own drug use.
Page 74 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
ENAT 13. Since [pipe person1]’s overdose, which of the following are true for you? (Read out
list; check all that apply) [enat_effect]
I use more (frequency or amount) than I did before [1]
I use less (frequency or amount) than I did before [2]
I use alone more often [3]
I use alone less often [4]
I use when naloxone is available more often [4]
I use when naloxone is available less often [5]
I taste or check drugs first more often [6]
I taste or check drugs first less often [7]
I use more types of drugs [8]
I use fewer types of drugs [9]
I mix drugs more often [10]
I mix drugs less often [11]
No difference [12]
Something else [77]
DK/R [99]
ENAT 13a. If enat_effect= “77”; Is there something else that I didn’t ask you about?: ______
[enat_effect_oth]
Page 75 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
BREAK FOR EDUCATION/INTERVENTION
Pipe in response from (ASSIGNED ARM) and answers from questions F12, F27 and F28.
If Arm = Control then skip to H1
If Arm = Intervention then proceed to G0.
PIPE
Interviewer prompt: We are now going to train you on how to use rapid drug tests and decrease your
risk for drug overdose. You will be given 10 rapid fentanyl drug tests to use at home. Additional
fentanyl test strips will be provided to you at each follow-up visit if requested.
G.0. Now I am going to show you two videos and have a short discussion about overdose
prevention with you….(insert links)
INSERT OPEN ENDED TEXT BOX G.0.a
Interviewer Notes: Please summarize the participant’s behavior change goals in the open
ended text box. Please format them in the manner shown below.
Participant feels confident doing x, y, z
Participant would like to continue doing z
Participant rated themselves as X out of 10 in readiness to change
Participant chose this number on the readiness scale because of X
Participant rated themselves as X out of 10 in confidence to change
Participant said that X would make them more confident
Page 76 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION G: RAPIDS INTERVENTION
(EXPERIMENTAL ARM ONLY)
G.0. PROMPT: Now I’m going to show you a video about how to respond to an overdose and
how to use naloxone. (https://vimeo.com/365544296/6685863a30) I’ll also show you how to use
naloxone and answer any questions you might have.
Next, we are going to watch a video about fentanyl test strips.
(https://vimeo.com/365544764/298315ea7e) I’ll also show you how to use the test strips and let
you practice using them.
Distribute Product and Product Flyer Insert for Arm 2.
G1. I feel confident in my ability to test my own drugs for fentanyl. [motiv6_in]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
G2. I feel confident in my ability to read the results of the fentanyl test strips. [motiv7_in]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
G2a.I know what to do once I get results from the fentanyl rapid tests [resultsstrips_in]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
G3. It will be easy for me to use the fentanyl test strips in the next month. [motiv8_in]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
Page 77 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
G4. I plan to use the testing strips. [motiv9_in]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
G5. How many strips do you think you might use over the next month? [fen_str_in]
_______ (0-10)
DK/R [DK]
G6. Do you think your friends would be interested in using the fentanyl test strips?
[fen_friends_in]
Yes
No
Not sure
DK/R [DK]
G8. Is there anything else you’d like to tell us today?
(Interviewer: Not required.  Do not record identifying information here) [PPTNOTES]
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
Interviewer prompt: Thank you for participating in our survey. Your answers will help us . If you have
remaining questions or concerns please contact a member of our study team. (Interviewer: Provide
contact information.  Then click Next to enter your Interviewer Data.)
Page 78 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION H: STANDARD OEND
(CONTROL ARM ONLY)
H.0. Now I’m going to show you a video about how to respond to an overdose and how to use
naloxone. (https://vimeo.com/365544296/6685863a30) I’ll also show you how to use naloxone
and answer any questions you might have.
Programmer prompt: If D30=YES  for a participant in the control arm, these additional questions will
be asked at the end of the survey.
Interviewer prompt: We wanted to ask you a few questions about your experiences using fentanyl
test stips because you told us that you used test strips earlier in the survey. For the first XX questions,
please tell us how much you disagree or agree  with the following statements on a scale of strongly
disagree to strongly agree
H1. I feel confident in my ability to test my own drugs for fentanyl. [motiv6_ctl]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
H2. I feel confident in my ability to read the results of the fentanyl test strips. [motiv7_ctl]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
H2a.I know what to do once I get results from the fentanyl rapid tests [resultsstrips_ctl]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
H3. It will be easy for me to use fentanyl test strips in the next month. [motiv8_ctl]
Page 79 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
H4. I plan to use fentanyl test strips in the next month. [motiv9_ctl]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
H6. Do you think your friends would be interested in using the fentanyl test strips?
[fenfriend_ctl]
Yes
No
Not sure
DK/R [DK]
H8. Is there anything else you’d like to tell us today?
(Interviewer: Not required.  Do not record identifying information here) [pptnotes_ctl]
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
Interviewer prompt: Thank you for participating in our survey. Your answers will help us . If you have
remaining questions or concerns please contact a member of our study team. (Interviewer: Provide
contact information.  Then click Next to enter your Interviewer Data.)
Page 80 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION I: INTERVIEWER DATA
I1. How would you rate the overall quality of the interview? [QUALITY]
High [H]
Medium [M]
Low [L]
Very low [VL]
I2. Interview notes: (Not required.  Do not record identifying information here.) [INTNOTES]
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
Remember to click the Submit button!
[END BASELINE ASSESSMENT]
Page 81 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
RAPIDS STUDY ASSESSMENT: FOLLOW UP VISITS
Page 82 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION 3a: FOLLOW UP VISIT - SURVEY BEGINS
Participant ID
________________
(R0001-R1000)
Interviewer ID
Survey started (hidden)
(system-captured as mm/dd/yyyy hh:mm:ss AM/PM)
Survey ended  (hidden)
(system-captured as mm/dd/yyyy hh:mm:ss AM/PM)
Did participant sign consent? [CONSENT]
o
Yes
o
No
To which did the participant consent?
o
Agreed to this Study Visit (must be checked to continue)
ARM ASSIGNMENT [PIPE FROM SCREENER, RA SEES ARM ASSIGNMENT]
●
ARM 1 (Control)
●
ARM 2 (Experimental)
Page 83 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION A: HOUSING, EMPLOYMENT & INCOME
A1. What type of place are you living in right now? (Read all that apply, Check only one).
[hous_fu]
An apartment or house that you rent or own
A parent or family member’s apartment or house
Someone else’s apartment or house short-term (like couch-surfing)
College dorm
Recovery or residential treatment center
Transitional housing program
Corrections halfway house
Drop-in center or emergency shelter
Car, abandoned building, or some other indoor public place
On the street or in another outdoor public place (like a park)
Other: __________
DK/R
A1a. If hous_fu= “other”: What type of place are you living in right now:____ [hous_oth_fu]
A2. What town do you currently live in? [town_fu]
___________________
A3. What is your current zip code? [zip_fu]
_____________
No fixed address [FA]
DK/R [DK]
Interviewer prompt: We would now like to ask you about your experiences of homelessness. By
homelessness, we mean not having a regular place to stay, and living in a shelter because of
nowhere else to go, or living in a place not ordinarily used for sleeping, like an abandoned building,
car, or park.
A4. Have you been homeless in the last month? [hlm1_fu]
Yes
No
DK/R
A5. If hlm1_fu= “other”: Are you currently homeless? [hlcr_fu]
Page 84 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Yes
No
DK/R
A6. Are you currently employed full-time or part-time doing legal work for pay. This includes
work that is full-time, part-time and temporary work? [employ_fu]
Yes
No
DK/R
A7. If employ_fu= “other”: Which of the following is closest to your occupation (Read out list;
check all that apply). [occu_fu]
Manufacturer [1]
Retailer [2]
Wholesaler [3]
Service Provider [4]
Construction [5]
Mining [6]
Farming/Fishing/Forestry [7]
Government [8]
Other [77]
DK/R [99]
A7a. If occu_fu= “other: Which of the following is closest to your occupation: _____________
[occu_txt_fu]
A8. If employ_fu= “no”: If you are not employed, are you… (Read out list; check all that apply)
[unemploy_fu]
On temporary layoff from a job [1]
Looking for work [2]
Retired [3]
Disabled [4]
A student [5]
A homemaker/caretaker [6]
Unable to work (primary reason?) [7]
Other [77]
DK/R [99]
A8a. If unemploy_fu= “unable to work”: Unable to work, primary reason:_________
[unepmploy_una_fu]
Page 85 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
A8b. If unemploy_fu= “other”: If you are not employed, are you:____________ [unemploy_ot_fu]
A9. In the last month, have you received any of the following in exchange for sexual activities
of any sort (like a hand job, blowjob, or sex)? (Read out list; check all that apply) [sext_fu]
Gifts or other goods [1]
Food [2]
Housing [3]
Clothes [4]
Drugs [5]
No, none of the above [6]
DK/R [99]
A10. In the last month, have you received money in exchange for sexual activities of any sort
(like a hand job, blowjob, or sex)? [sexmoney_fu]
Yes
No
DK/R
A12. In the last month, have you been turned down for a job because of current or past drug
use? [nojob_fu]
Yes
No
DK/R
A13. Are you currently receiving any disability benefits (such as workman’s compensation or
SSDI)? [incomedis_fu]
Yes
No
DK/R
A14. What is your average take home monthly income, including public assistance or family
support (like from cash assistance, welfare, or TANF)? [Iincome__fu]
$0
< $1 - $500
$501 - $1500
$1501 - $3000
> $3000
DK/R
Page 86 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
A15. Have you been arrested in the last month? [m1arr_fu]
Yes
No
DK/R
A16. If m1arr_fu= “yes”: Have you been incarcerated in an adult jail or prison in the last month?
[m1inc_fu]
Yes
No
DK/R
A17. If m1arr_fu= “yes”: Have you been on probation or parole in the past month? [m1prob]
Yes
No → skip to B1
DK/R → skip to B1
A18. If m1prob_fu= “yes”: Are you currently on probation or parole? [curprob_fu]
Yes
No
DK/R
A19. What is your current relationship status? (Read out list; check only one). [relation_fu]
You have a spouse/partner whom you live with
You have a regular partner whom you do not live with
You are dating or seeing someone
You are single
DK/R
Page 87 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION B: DRUG USE
Interviewer prompt: We are now going to move on to talk about your current and past drug use. As a
reminder, your participation is voluntary and you have the right to refuse to answer a question. All
responses are strictly confidential and will not be shared with anyone outside of the study team.
B1. How many times in the past 30 days have you snorted, smoked, swallowed, or used any of
the following drugs without a prescription or not as doctor directed? Please note that we will
ask about other drugs and injection drug use separately. (Read out list and time increments)
[m1pilnon_fu]
B1a. Prescription opioids, such as Percocet, OxyContin, Dillaudid, Vicodin? __________
[m1pilnon_po_fu]
B1b. Medications used for opioid use disorder such as Methadone, buprenorphine/suboxone?
_______ [m1pilnon_moud_fu]
B1c. Benzodiazepines/Benzos such as Xanax, Ativan, Valium, Klonapin? _________
[m1pilnon_bz_fu]
B1d. Prescription stimulants such as Adderall, Ritalin, Focalin, Concerta, Dexedrine? _______
[m1pilnon_ps_fu]
B2. Have you first snorted, smoked, swallowed, or used any of the following drugs without a
prescription or not as doctor directed in the past 7 days or past 3 days? Please note that we
will ask about other drugs and injection drug use separately. (Read out list and time increments)
Past 7 days
(Y/N)
[d7pilnon_fu]
Past 3 days
(Y/N)
[d3pilnon_fu]
B2a
Prescription opioids such as Percocet,
OxyContin, Dillaudid, Vicodin
B2b
Medications used for opioid use
disorder such as Methadone,
buprenorphine/Suboxone
B2c
Benzodiazepines/Benzos such as
Xanax, Ativan, Valium, Klonapin
Page 88 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
B2d
Prescription stimulants such as
Adderall, Ritalin, Focalin, Concerta,
Dexedrine
B3. If yes to any of B1a to B1d: In the last month, who’s usually around when you’re using these
drugs without a prescription or not as a doctor directed? (Read out list; check all that apply).
[pepil_fu]
I use alone [1]
A close friend [2]
A casual friend or acquaintance [3]
A sex partner [4]
An immediate family or household member [5]
An extended family member [6]
A Dealer [7]
Strangers/people I don’t know [8]
DK/R [99]
B3a. If yes to any of B1a to B1d: In the last month have you used
Suboxone/Subutex/Buprenorphine or methadone to manage opioid withdrawal without a
prescription? [bupself_fu]
Yes
No
DK/R
B4. If yes to any of B1a to B1d: In the last month, how did you get
Suboxone/Subutex/Buprenorphine or methadone without a prescription? (Read out list, check
all that apply) [bupbuy_fu]
Purchased from a dealer or on the street [1]
A close friend [2]
A casual friend of acquaintance [3]
A sex partner [4]
An immediate family or household member [5]
An extended family member [6]
Purchased from the internet or “dark web” [7]
Other [77]
DK/R [99]
B5a. If bupbuy_fu= “yes”: In last month, how did you get Suboxone/Subutex/Buprenorphine or
methadone without a prescription:______________ [bupbuy_oth_fu]
Page 89 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
B5. If bupbuy_fu= “yes”: In the last month, how have you used
Suboxone/Subutex/Buprenorphine without a prescription (Read out list, check all that apply)
[buptyp_fu]
A film or tablet that dissolves under your tongue [1]
Skin patch [2]
Pills (orally) [3]
Snorting [4]
Smoking [5]
Injecting [6]
Other [77]
DK/R [99]
B5a. If buptyp_fu = “yes”: In the last month, how have you used
Suboxone/Subutex/Buprenorphine without a prescription:__________ [buptyp_oth_fu]
B6. How many times in the past 30 days have you snorted, smoked, swallowed, or used any of
the following drugs? Please note that we will ask about other drugs and injection drug use
separately. (Read out list and time increments) [m1drgnon_fu]
B6a. Marijuana or hash oil, including edibles and synthetic marijuana:_______
[m1drgnon_m_fu]
B6b. Club drugs such as Molly, MDMA, Ecstasy, GHB, Ketamine:________ [m1drgnon_cd_fu]
B6c. Psychedelics, such as Mushrooms, Acid, LSD, DMT:_________ [m1drgnon_p_fu]
B6d. Crystal methamphetamine (crystal meth, glass, tina, crank, ice):______ [m1drgnon_cm_fu]
B6e. Powder cocaine:________ [m1drgnon_pc_fu]
B6f. Crack cocaine:________ [m1drgnon_cc_fu]
B6g. Heroin:________ [m1drgnon_he_fu]
B6h. Alcohol:______ [m1drgnon_alc_fu]
B6i. Alcohol to intoxication:_______ [m1drgnon_alix_fu]
B6j. Other:_______ [m1drgnon_oth_age_fu]
B6k: Other drug mentioned:___________ [m1drgnon_oth_drg_fu]
B7. Have you snorted, smoked, swallowed, or used any of the following drugs without a
prescription or not as doctor directed in the past 7 days or past 3 days? Please note that we
will ask about other drugs and injection drug use separately. (Read out list and time increments)
Page 90 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Past 7 days
(Y/N)
[d7drgnon_fu]
Past 3 days
(Y/N)
[d3drgnon_fu]
B7a
Marijuana or hash oil, including edibles
and synthetic marijuana
B7b
Club drugs such as Molly, MDMA,
Ecstasy, GHB, Ketamine
B7c
Psychedelics, such as Mushrooms,
Acid, LSD, DMT
B7d
Crystal methamphetamine (crystal
meth, glass, tina, crank, ice)
B7e
Powder cocaine
B7f
Crack cocaine
B7g
Heroin
B7h
Alcohol
B7i
Alcohol to intoxication
B7j
Other:
B8. If yes to any of B6a to B6j: In the last month, who’s usually around when you’re using
these drugs? (Read out list; check all that apply). [pepdrg_non]
I use alone [1]
A close friend [2]
A casual friend or acquaintance [3]
A sex partner [4]
An immediate family or household member [5]
An extended family member [6]
A Dealer [7]
Strangers/people I don’t know [8]
Page 91 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
DK/R [99]
B8a. Of all the drugs that you have snorted, smoked, swallowed or used in the last month,
which do you use most often? [mostnononj_fu]:_______
B9. Of all the drugs that you have snorted, smoked, swallowed, or used in the last month,
which is the one you prefer to use most? [prefnoninj_fu]:_______
Interviewer prompt: Now we would like to ask you some questions about injecting drugs. Your
responses will be kept completely confidential and will never be shared with anyone outside of the
study team.
B10. In the last month, have you seen anyone inject drugs? [Iijsee_fu]
Yes
No
DK/R
B11. If ijsee_fu= “yes”: Who have you seen inject drugs? (Read out list; check all that apply)
[ijw_fu]
A close friend [1]
A casual friend or acquaintance [2]
A sex partner [3]
An immediate family or household member [4]
An extended family member [5]
Dealer [6]
Strangers (like people on the street) [7]
DK/R [99]
B12. Do you have a sex partner who currently injects drugs? [ijsexp_fu]
Yes
No
DK/R
B13. Do you have close friends who currently inject drugs? [ijfriend_fu]
Yes
No
DK/R
B14. In the last month, have you used a needle to chip, fix, muscle, or inject drugs even once?
[ijm1_fu]
Page 92 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Yes
No
DK/R
B15. If ijmi_fu= “yes”: How many times in the past 30 days have you injected any of the
following prescription drugs. (Read out list and time increments) [m1pilij_fu]
B15a. Prescription opioids, such as Percocet, OxyContin, Dillaudid, Vicodin? __________
[m1pilnij_poj_fu]
B15b. Medications used for opioid use disorder such as Methadone,
buprenorphine/suboxone? _______ [m1pilij_moudj_fu]
B15c. Benzodiazepines/Benzos such as Xanax, Ativan, Valium, Klonapin? _________
[m1pilij_bzj_fu]
B15d. Prescription stimulants such as Adderall, Ritalin, Focalin, Concerta, Dexedrine?
_______ [m1pilij_psj_fu]
B16. If ijmi_fu= “yes”: Have you injected any of the following prescription drugs in the past 7
days or past 3 days? (Read out list and time increments)
Past 7 days
(Y/N)
[d7pilij_fu]
Past 3 days
(Y/N)
[d3pilij_fu]
B16a
Prescription opioids such as Percocet,
OxyContin, Dillaudid, Vicodin
B16b
Medications used for opioid use
disorder such as Methadone,
buprenorphine/Suboxone
B16c
Benzodiazepines/Benzos such as
Xanax, Ativan, Valium, Klonapin
B16d
Prescription stimulants such as
Adderall, Ritalin, Focalin, Concerta,
Dexedrine
Page 93 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
B17. How many times in the past 30 days have you injected any of the following drugs? We
will not be asking about fentanyl use right now. We will be asking about that separately later
on. (Read out list and time increments) [m1drgij_fu]
B17a. Club drugs such as Molly, MDMA, Ecstasy, GHB, Ketamine:________ [m1drgij_cd_fu]
B17b. Psychedelics, such as Mushrooms, Acid, LSD, DMT:_________ [m1drgij_p_fu]
B17c. Crystal methamphetamine (crystal meth, glass, tina, crank, ice):______ [m1drgij_cm_fu]
B17d. Powder cocaine:________ [m1drgij_pc_fu]
B17e. Crack cocaine:________ [m1drgij_cc_fu]
B17f. Heroin:________ [m1drgij_he_fu]
B17g. Alcohol:______ [m1drgij_alc_fu]
B17h. Other:_______ [m1drgij_oth_age_fu]
B17i: Other drug mentioned:___________ [m1drgij_oth_drg_fu]
B18. Have you injected any of the following drugs in the past 7 days or past 3 days? We will
not be asking about fentanyl use right now. We will be asking about that separately later on.
(Read out list and time increments)
Past 7 days
(Y/N)
[d7drgij_fu]
Past 3 days
(Y/N)
[d3drgij_fu]
B18a
Club drugs such as Molly, MDMA,
Ecstasy, GHB, Ketamine
B18b
Psychedelics, such as Mushrooms,
Acid, LSD, DMT
B18c
Crystal methamphetamine (crystal
meth, glass, tina, crank, ice)
B18d
Powder cocaine
B18e
Crack cocaine
B18d
Heroin
Page 94 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
B18e
Alcohol
B18f
Other:
B19. Of all the drugs you have injected in the last month, which is the one that you use the
most? (Read out list; Check only one) [Iijmost_fu]:________
B19a. Of all the drugs you have injected in the last month, which is the one you prefer to use
the most? (Read out list; Check only one) [ijpref_fu]:_______
B19c. If ijm1_fu= “yes”: In the last month, how often have you shared syringes? [syrsharem1_fu]
Never
Once or a couple times
At least every week
Every day
Multiple times per day
DK/R
B20. If syrsharem1_fu<> (doesn’t equal) “never” or “DK/R” Who have you shared a syringe with?
(Read out list; check all that apply) [syrsharewho]
A close friend [1]
A casual friend or acquaintance [2]
A sex partner [3]
An immediate family or household member [PAR]
An extended family member [4]
Dealer [5]
Strangers (people I don’t know) [6]
DK/R [9]
B23. If ijm1_fu= “yes”: In the last month, how often did you need someone to help you inject
[helpijm1_fu]
Never
Once or a couple times
At least every week
Everyday
Multiple times per day
Page 95 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
DK/R
B24. If helpijm1_fu <> “Never” or “DK/R”: In the last month, who helped you inject? (Read out list;
check all that apply) [helpijm1_who_fu]
A close friend [1]
A casual friend or acquaintance [2]
A sex partner [3]
An immediate family or household member [4]
An extended family member [5]
Dealer [6]
Strangers (people I don’t know) [7]
DK/R [99]
B25. In the last month, did you go on a run or a binge, as in used a larger amount of drugs as
usual over a short amount of time? [bngm1_fu]
Yes
No
DK/R
Interviewer prompt: We are now going to ask about drug dealing. By dealing, we mean giving drugs to
someone in exchange for money, food, shelter, or other goods. Please remember that all responses
are strictly confidential and will not be shared with anyone outside of the study team.
B26. In the last month, have you dealt drugs? [dealt_fu]
Yes
No
DK/R
B27. If dealt_fu= “yes”: What is the main reason you’ve dealt drugs? (Read out list; check only
one) [dealw_fu]
Income for drugs
Income for other purposes
To clear debts
For food or shelter
Another reason
DK/R
B27a. If dealw=”another reason”: What is the main reason you’ve dealt drugs:_______
[dealw_oth_fu]
Page 96 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
B28. If dealt_fu= “yes”: In the last month, have you dealt drugs that you suspected or knew had
fentanyl in them? [fentdeal_fu]
Yes
No
DK/R
B29. If dealt_fu= “yes”: Are you concerned about fentanyl contaminating your supply?
[fentdeal_concern_fu]
Very concerned
A little concerned
Neutral
Not concerned
DK/R
B30. If dealt_fu= “yes”: If given the choice, would you prefer not to deal drugs that had fentanyl
in them? [fentindrg_fu]
Very concerned
A little concerned
Neutral
Not concerned
DK/R
Page 97 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION C: FENTANYL
Interviewer prompt: Now we are going to ask you questions about fentanyl. Please answer True,
False, or Don’t know/Refuse for the next 6 questions.
C1. Fentanyl is an opioid [info1_fu]
True
False
DK/R
C2. Fentanyl is not as strong as heroin [info2_fu]
True
False
DK/R
C3. Fentanyl acts more quickly than heroin [info3_fu]
True
False
DK/R
C4. Drugs that are mixed with fentanyl look different than drugs that are not mixed with
fentanyl [info4_fu]
True
False
DK/R
C5. Someone is more likely to overdose when using drugs that contain fentanyl than when
using drugs that do not contain with fentanyl [info5_fu]
True
False
DK/R
C6. In Rhode Island, fentanyl now causes more overdoses than heroin [info6_fu]
True
False
DK/R
C7. In the last month, have you been prescribed fentanyl by a doctor? [fentrxm1_fu]
Yes
No
DK/R
Page 98 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
C8. If fentrxm1_fu= “yes”: In what forms have you been prescribed fentanyl? (Read out list; check
all that apply) [fentform_fu]
Skin patch [1]
Pills [2]
Nasal spray [3]
Lozenge/lollipop [4]
A film that dissolves under your tongue [5]
A spray that goes under your tongue [6]
Other: [7]
DK/R [99]
C8a. If fentform_fu= “other”: In what forms have you been prescribed fentanyl: _________
[fentform_oth_fu]
C9. If fentrxm1_fu= “yes”: In the last month, have you used prescription fentanyl in a way that
was not prescribed by a doctor (without a prescription, or different route or different dose than
as prescribed by a doctor)? [fentnorx_fu]
Yes
No
DK/R
C10. If fentnorx_fu= “yes”: In the last month, how often have you used prescription fentanyl in a
way that was not prescribed by a doctor? [fentdiv6_fu]
Never
Once or a couple of times
About once a month
At least every week
Every day
DK/R
C11. If fentnorx_fu= “yes”: In the last month, what forms of prescription fentanyl have you used
in a way that was not prescribed by a doctor? (Read out list; check all that apply) [fentdivform_fu]
Skin patch [1]
Pills (orally) [2]
Nasal spray [3]
Injecting [4]
Snorting [5]
Smoking [6]
Lozenge/lollipop [7]
A film that dissolves under your tongue [8]
Page 99 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Other: [77]
DK/R [99]
C11a. If fentdivform_fu= “other”: In the last month, what forms of prescription fentanyl have you
used in a way that was not prescribed by a doctor: ___________ [fentdivform_oth_fu]
C12. If fentnorx_fu= “yes”: In the last month, how did you get fentanyl without a prescription?
(Read out list; check all that apply) [fentbuy_fu]
Purchased from a dealer or on the street [1]
A close friend [2]
A casual friend of acquaintance [3]
A sex partner [4]
An immediate family or household member [5]
An extended family member [6]
Purchased from the internet or “dark web” [7]
Other: [77]
DK/R [99]
C12a. If fentbuy_fu= “other”: In the last month, who did you get fentanyl without a
prescription:______ [fentbuy_oth_fu]
Interviewer prompt: Now we are going to be talking about drugs that contained fentanyl. For example,
you thought you were buying heroin, but it was contained fentanyl.
C13. In the last month, how often have you used fentanyl or drugs you were confident
contained fentanyl? [fentfreq_fu]
Never
Once or a couple of times
About once a month
At least every week
Every day
DK/R
C14. If fentfreq_fu <> “never” or “DK/R”: What drugs have you used that you were confident
contained fentanyl in the past... (Read out list; check all that apply) [fentdrgconf_fu]
Past month
(Y/N)
Past 7 days
(Y/N)
Past 3 days
(Y/N)
Page 100 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
C14a
Marijuana or hash oil, including
edibles and synthetic marijuana
C14b
Club drugs such as Molly, MDMA,
Ecstasy, GHB, Ketamine
OR
Molly/MDMA/Ecstasy [MO]
C14c
Psychedelics, such as Mushrooms,
Acid, LSD, DMT
OR
Mushrooms [MU]
C14d
Crystal methamphetamine (crystal
meth, tina, crank, ice)
C14e
Powder cocaine
C14f
Crack cocaine
C14h
Heroin
C14j
Prescription Opioid Pills (Vicodin,
Percocet, etc.)
C14k
Prescription Benzodiazepines
(Xanax, Klonopin, etc.)
C14l
Prescription Stimulants (Adderall,
Ritalin, etc.)
C14
m
Other:
C14n
DK/R
C15. If fentfreq_fu <> “never” or “DK/R”: The last time you used a drug you were confident
contained fentanyl, did you know that the drug that contained fentanyl before you used it?
[fentconf_fu]
Yes
No
Page 101 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
DK/R
C16. If fentfreq_fu <> “never” or “DK/R”: The last time you used a drug you were confident
contained fentanyl, why were you confident that it contained fentanyl? (Read out list; check all
that apply) [fentwhy_fu]
A dealer told me [1]
A sex partner told me [2]
A friend told me [3]
I overdosed [4]
A sex partner overdosed [5]
A friend overdosed [6]
I had a bad reaction [7]
Quicker onset of high [8]
Different high [9]
Differences in appearance, smell or taste [10]
Other: [77]
DK/R [99]
C16a. If fentwhy_fu= “Other”: The last time you used a drug you were confident contained
fentanyl, why were you confident that it contained fentanyl:__________ [fentwhy_oth_fu]
C17. The last time you used a drug that you were confident contained fentanyl, how did you
get it? [fentobt_fu]
Purchased from a dealer or on the street
A close friend
A casual friend of acquaintance
A sex partner
An immediate family or household member
An extended family member
Purchased from the internet or “dark web”
Other
No
DK/R
C17b. If fentobt_fu = “other”: The last time you used a drug that you were confident contained
fentanyl, how did you get it:____________ [fentobt_why_fu]
C18. The last time you used a drug you were confident contained fentanyl, what did you do
when you found out you? (Read out list; check all that apply) [skill1_fu]
Took them as I usually would [1]
Threw them out [2]
Page 102 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Gave them away [3]
Sold them [4]
Went slower [5]
Used less [6]
Did a tester [7]
Used with someone else around [8]
Other: [77]
DK/R [99]
C18a. If skill1_fu= “other”: The last time you used a drug you were confident contained fentanyl,
what did you do when you found out:__________ [skill1_oth_fu]
Interviewer prompt: Now that we have asked you what you’ve done in the past when you had drugs
that contained fentanyl, we would like to know more about what you do in the future.
C19. What would you do if you found out your drugs had fentanyl in them? (Read out list; check
all that apply) [motiv1_fu]
Take them as I usually would [1]
Throw them out [2]
Give them away [3]
Sell them [4]
Go slower [5]
Use less [6]
Do a tester [7]
Use with someone else around [8]
Talk with the supplier or dealer [8]
Other [77]
DK/R [99]
D19a. If motiv1_fu = “Other”: What would you do if you found out your drugs had fentanyl in
them:_______ [motiv1_oth_fu]
Interviewer prompt: We would like to know your thoughts about the effects of fentanyl or drugs that
have fentanyl in them. Please indicate how much you agree or disagree with the following statements:
C20. Fentanyl or drugs that have fentanyl in them are a better high than drugs that do not have
fentanyl in them [precep1_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
Page 103 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
C21. I am concerned about my friends using drugs that contain fentanyl [motiv2_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
C22. I am concerned about my drugs having fentanyl in them [motiv3_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
C23. I prefer using fentanyl or drugs that have fentanyl in them [fentpref]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
C24. If “Agree” or “Strongly agree” to any of D26: Why do you prefer to use drugs with
fentanyl in them? (Read out list; check all that apply) [whyfentprep_fu]
Stronger or better high [1]
Faster onset of high [2]
Easier to prepare than other drugs [3]
Cheaper than other opioids (including heroin and prescription pills) [4]
Dope sick or experiencing withdrawal symptoms [5]
That’s all my dealer was selling [6]
Curious about the effect of fentanyl [7]
It is what I am used to using [8]
Other: [77]
DK/R [99]
C24a. If whyfentpref_fu= “other”: Why do you prefer to use drugs with fentanyl in them:_____
[whyfentpref_oth]
C27. Have you used a fentanyl test strip in the last month, either on your own or with people
you use drugs with? [testusem1_fu]
Yes
Page 104 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
No
DK/R
C28. If testusem1_fu= “yes”: Who performed the test? [teseusewhom1_fu]
I did it myself
A close friend
A casual friend or acquaintance
An immediate family or household member
An extended family member
Dealer
Strangers
DK/R
C29. Where did the fentanyl test strips come from? (Read out list; check all that apply)
[testgetwho_fu]
RAPIDS clinical trial [1]
Other research study [2]
AIDS Care Ocean State (ACOS) [3]
Project Weber/RENEW [4]
Another harm reduction organization [5]
Uncertain [6]
Other: [77]
DK/R [99]
C29a. If testgetwho_fu= “other”: Where did the fentanyl test strips come from:______
[testgetwho_oth_fu]
C30. If testusem1_fy= “yes”: In the last month, how many times have you tested your drugs for
fentanyl? [testnumm1_fu]
_________
DK/R
C31. If testusem1_fu>0: Did any of the tests come back positive? Meaning you only saw one
line on the test strip? [testpos_fu]
Yes
No
DK/R
C32. If testpos_fu= “yes”: How many tests were positive for fentanyl, meaning you only saw one
line? [fentposno_fu]
_______
Page 105 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
DK/R
C33. If testpos_fu= “yes”: Which drugs that you tested came back positive for fentanyl? (Read
out list; check all that apply) [fentposdrg_fu]
Prescription opioids such as Percocet, OxyContin, Dillaudid, Vicodin [1]
Medications used for opioid use disorder such as Methadone, buprenorphine/Suboxone [2]
Benzodiazepines/Benzos such as Xanax, Ativan, Valium, Klonapin [3]
Prescription stimulants such as Adderall, Ritalin, Focalin, Concerta, Dexedrine [4]
Marijuana or hash oil, including edibles and synthetic marijuana [5]
Club drugs such as Molly, MDMA, Ecstasy, GHB, Ketamine [6]
Psychedelics, such as Mushrooms, Acid, LSD, DMT [7]
Crystal methamphetamine (crystal meth, glass, ice, tina) [8]
Powder cocaine [9]
Crack cocaine [10]
Heroin [11]
Other [77]
DK/R [99]
C33a. If fentposdrg_fu = “Other”: Which drugs that you tested came back positive for
fentanyl:_____ [fentposdrg_oth_fu]
C34. If testpos_fu= “yes”: What did you do when you found out you had drugs containing
fentanyl? (Read out list; check all that apply). [skill1testpos_fu]
Took them as I usually would [1]
Threw them out [2]
Gave them away [3]
Sold them [4]
Went slower [5]
Went faster [6]
Used less [7]
Used more [8]
Did a tester [9]
Used with someone else around [10]
Got naloxone [11]
Other [77]
DK/R [99]
C34a. If skill1testpos_fu= “Other”: What did you do when you found out you had drugs
containing fentanyl:__________ [skill1testpos_oth_fu]
Page 106 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
C35.If testpos_fu= “Yes”: Did you experience any of the following unwanted negative reactions
from using the drug that tested positive for fentanyl? (Read out list; check all that apply)
[fentreact_fu]
Lost consciousness/blacked out [1]
Blue or gray lips or skin [2]
Seizure [3]
Had a hard time breathing [4]
Elevated breathing [5]
Stopped breathing [6]
Inability to talk [7]
Not responsive to stimulus (like having your name called or physical contact) [8]
Overheating [9]
Irregular heart beat (fast, slow, irregular or palpitations) [10]
Paranoia [11]
Can’t remember getting high [12]
None [13]
Other [77]
DK/R [99]
C25. If fentreact_fu= “Other”: Did you experience any of the following unwanted negative
reactions from using the drug that tested positive for fentanyl:______ [fentreact_oth_fu]
C36. Did any of the tests come back negative for fentanyl, meaning you saw two lines?
[testneg_fu]
Yes
No
DK/R
C37. How many of the tests came back negative for fentanyl, meaning you saw two lines?
[fentnegno_fu]
______________
DK/R
C38. Which drugs that you tested came back negative for fentanyl? (Read out list; check all that
apply) [fentnegdrg_fu]
Prescription opioids such as Percocet, OxyContin, Dillaudid, Vicodin [1]
Medications used for opioid use disorder such as Methadone, buprenorphine/Suboxone [2]
Benzodiazepines/Benzos such as Xanax, Ativan, Valium, Klonapin [3]
Prescription stimulants such as Adderall, Ritalin, Focalin, Concerta, Dexedrine [4]
Marijuana or hash oil, including edibles and synthetic marijuana [5]
Club drugs such as Molly, MDMA, Ecstasy, GHB, Ketamine [6]
Page 107 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Psychedelics, such as Mushrooms, Acid, LSD, DMT [7]
Crystal methamphetamine (crystal meth) [8]
Powder cocaine [9]
Crack cocaine [10]
Heroin [11]
Alcohol [12]
Other [77]
DK/R [99]
C38a. If fentnegdrg_fu= “Other”: Which drugs that you tested came back negative for
fentanyl:_______ [fentnetdrg_oth_fu]
C39. If testneg_fu= “Yes”: What did you do when you found out you had drugs that did not
contain fentanyl? (Read out list; check all that apply). [skill1fentneg_fu]
Took them as I usually would [1]
Threw them out [2]
Gave them away [3]
Sold them [4]
Went slower [5]
Went faster [6]
Used less [7]
Used more [8]
Did a tester [9]
Used with someone else around [10]
Got naloxone [11]
Other [77]
DK/R [99]
C39a. If skill1fentneg_fu= “Other”: What did you do when you found out you had drugs that did
not contain fentanyl:________ [skill1fentneg_fu]
C40. If testneg_fu= “yes”: Did you experience any of the following unwanted negative reactions
from using the drug that tested negative for fentanyl? (Read out list; check all that apply)
[fentreactneg_fu]
Lost consciousness/blacked out [1]
Blue or gray lips or skin [2]
Seizure [3]
Had a hard time breathing [4]
Elevated breathing [5]
Stopped breathing [6]
Inability to talk [7]
Page 108 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Not responsive to stimulus (like having your name called or physical contact) [8]
Overheating [9]
Irregular heart beat (fast, slow, irregular or palpitations) [10]
Paranoia [11]
Can’t remember getting high [12]
None [13]
Other [77]
DK/R [99]
C40a. If fentreactneg_fu= “Other”: Did you have any of the following unwanted negative
reactions from using the drug that tested negative for fentanyl:________ [fentreactneg_oth_fu]
C43. Has fentanyl changed how you think about starting methadone or buprenorphine
(Suboxone), or starting other forms of addiction treatment? [fentottrt_neg]
Yes, I accessed addiction treatment because of concerns about fentanyl
Yes, I am thinking about accessing treatment because of concerns about fentanyl (but haven’t
done so yet)
No
Already in some kind of addiction treatment
DK/R
C44. Has fentanyl changed how you use drugs in any of the following ways? (Read out list;
check all that apply) [fentchange_fu]
More likely to use with others [1]
More likely to inject slowly and/or taste drugs first [2]
More likely to use in public (e.g., outside) [3]
More likely to use in places where other people are around [4]
Less likely to use alone [5]
More likely to use where naloxone is available [6]
More likely to carry take-home naloxone [7]
Using less often and/or using smaller amount of drugs each time [8]
More likely to use drugs containing fentanyl [9]
More likely to use drugs unlikely to contain fentanyl (rather than drugs that may contain
fentanyl) [10]
Other: [77]
Use hasn’t changed [11]
DK/R [99]
C44a. If fentchange_fu= “More likely to use drugs unlikely to contain fentanyl: Specify drugs less
likely to contain fentanyl:______ [fentchange_drg_fu]
Page 109 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
C44b. If fentchange_fu= “Other”: Has fentanyl changed how you use drugs in any of the
following ways:_________ [fentchange_oth_fu]
Page 110 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION D - MENTAL HEALTH
Interviewer prompt: Now we will talk about how you are feeling right now. Rate each of the following
statements between 0 and 4. 0 = not at all; 1 = a little; 2 = moderately ; 3 = quite a bit; 4 = extremely.
In each case, you can respond that you don't know or prefer not to answer.
Not at all
[0]
A little
[1]
Moderately
[2]
Quite a bit
[3]
Extremely
[4]
D1a. I feel anxious. [sows1_fu]
[0]
[1]
[2]
[3]
[4]
D1b. I feel like yawning.
[sows2_fu]
[0]
[1]
[2]
[3]
[4]
D1c. I am perspiring.
[sows3_fu]
[0]
[1]
[2]
[3]
[4]
D1d. My eyes are tearing.
[sows4_fu]
[0]
[1]
[2]
[3]
[4]
D1e. My nose is running.
[sows5_fu]
[0]
[1]
[2]
[3]
[4]
D1f. I have goosebumps.
[sows6_fu]
[0]
[1]
[2]
[3]
[4]
D1g. I am shaking. [sows7_fu]
[0]
[1]
[2]
[3]
[4]
D1h. I have hot flashes.
[sows8_fu]
[0]
[1]
[2]
[3]
[4]
D1j. I have cold flashes.
[sows9_fu]
[0]
[1]
[2]
[3]
[4]
D1k. My bones and muscles
ache. [sows10_fu]
[0]
[1]
[2]
[3]
[4]
D1l. I feel restless. [sows11_fu]
[0]
[1]
[2]
[3]
[4]
D1m. I feel nauseous.
[sows12_fu]
[0]
[1]
[2]
[3]
[4]
Page 111 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
D1n. I feel like vomiting.
[sows13_fu]
[0]
[1]
[2]
[3]
[4]
D1o. My muscles twitch.
[sows14_fu]
[0]
[1]
[2]
[3]
[4]
D1p. I have stomach cramps.
[sows15_fu]
[0]
[1]
[2]
[3]
[4]
D1q. I feel like using now.
[sows16_fu]
[0]
[1]
[2]
[3]
[4]
https://www.integration.samhsa.gov/clinical-practice/gad708.19.08cartwright.pdf
Interviewer Prompt: Now I am going to ask you 7 questions about stress and anxiety. You can
respond with how often you have experienced these feelings in the past 2 weeks: “not sure at all,”
“several days,” “over half the days,” or “nearly every day.”
Not sure at all
[0]
Several days
[1]
Over half the
days [2]
Nearly every
day [3]
D2a. Feeling nervous,
anxious, or on edge
[gad1_fu]
[0]
[1]
[2]
[3]
D2b. Not being able to
stop or control worrying
[gad2_fu]
[0]
[1]
[2]
[3]
D2c. Worrying too much
about different things
[gad3_fu]
[0]
[1]
[2]
[3]
D2d. Trouble relaxing
[gad4_fu]
[0]
[1]
[2]
[3]
D2e. Being so restless
that it’s hard to sit still
[gad5_fu]
[0]
[1]
[2]
[3]
Page 112 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
D2f. Becoming easily
annoyed or irritable
[gad6_fu]
[0]
[1]
[2]
[3]
D2g. Feeling afraid as if
something awful might
happen [gad7_fu]
[0]
[1]
[2]
[3]
D2h. If you checked off any problems, how difficult have these made it for you to do your
work, take care of things at home, or get along with other people? (Read out list; check only
one). [gad8_fu]
Not difficult at all
Somewhat difficult
Very difficult
Extremely difficult
Interviewer Prompt: Next, I will describe some feelings or behaviors you may have had in the past
week. Please tell me how often you have felt this way in the past week.
Programmer note: Scoring for CESD be found in brackets in the table below. For these questions,
rarely will be 3, occasionally will be 2, some of the time will be 2 and most of the time will be 0. A
score for this can range between 0 and 60. A score of less than 16 means that symptoms do not have
clinical significance.
Rarely or
none of the
time (less
than 1 day)
[0]
Some or a
little of the
time (1-2
days) [1]
Occasionally
or a
moderate
amount of
time (3-4
days) [2]
Most or all
of the time
(5-7 days)
[3]
DK/R
[DK]
D3a. I was bothered by
things that usually don’t
bother me. [cesd1_fu]
[0]
[1]
[2]
[3]
D3b. I did not feel like
eating; my appetite was
poor. [cesd2_fu]
[0]
[1]
[2]
[3]
Page 113 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
D3c. I felt that I could not
shake off the blues even
with help from my family or
friends. [cesd3_fu]
[0]
[1]
[2]
[3]
D3e. I had trouble keeping
my mind on what I was
doing. [cesd5_fu]
[0]
[1]
[2]
[3]
D3f. I felt depressed.
[cesd6_fu]
[0]
[1]
[2]
[3]
D3g. I felt that everything I
did was an effort.
[cesd7_fu]
[0]
[1]
[2]
[3]
D3i. I thought my life had
been a failure. [cesd9_fu]
[0]
[1]
[2]
[3]
D3j. I felt fearful.
[cesd10_fu]
[0]
[1]
[2]
[3]
D3k. My sleep was
restless. [cesd11_fu]
[0]
[1]
[2]
[3]
D3m. I talked less than
usual. [cesd13_fu]
[0]
[1]
[2]
[3]
D3n. I felt lonely.
[cesd14_fu]
[0]
[1]
[2]
[3]
D3o. People were
unfriendly. [cesd15_fu]
[0]
[1]
[2]
[3]
D3q. I had crying spells.
[cesd17_fu]
[0]
[1]
[2]
[3]
D3r. I felt sad. [cesd18_fu]
[0]
[1]
[2]
[3]
D3s. I felt that people
dislike me. [cesd19_fu]
[0]
[1]
[2]
[3]
Page 114 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
D3t. I could not get
“going.” [cesd20_fu]
[0]
[1]
[2]
[3]
Rarely or
none of the
time (less
than 1 day)
[3]
Some or a
little of the
time (1-2
days) [2]
Occasionally
or a
moderate
amount of
time (3-4
days) [1]
Most or all
of the time
(5-7 days)
[0]
DK/R
[DK]
D3d. I felt I was just as
good as other people.
[cesd4_fu]
[3]
[2]
[1]
[0]
D3h. I felt hopeful about
the future. [cesd8_fu]
[3]
[2]
[1]
[0]
D3l. I was happy.
[cesd12_fu]
[3]
[2]
[1]
[0]
D3p. I enjoyed life.
[cesd16_fu]
[3]
[2]
[1]
[0]
D4. In general, how satisfied are you with your life? [hrqol1_fu]
Very satisfied
Satisfied
Dissatisfied
Very dissatisfied
D5. Would you say that in general your health is… [hrqol2_fu]
Excellent
Very Good
Good
Fair
Poor
DK/R
D5. Now thinking about your physical health, which includes physical illness and injury, for
how many days during the past 30 days was your physical health not good? [hrqol3_fu]
Page 115 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
_______ (integer, maximum 30)
D6. Now thinking about your mental health, which includes stress, depression, and problems
with emotions, for how many days during the past 30 days was your mental health not good?
[hrqol4_fu]
_______ (integer, maximum 30)
D7. During the past 30 days, for about how many days did poor physical or mental health keep
you from doing your usual activities, such as self-care, work, or recreation? [hrqol5_fu]
_______ (integer, maximum 30)
Page 116 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION E: HEALTHCARE AND TREATMENT ENGAGEMENT
Interviewer prompt: We are now going to move on and talk about your experiences with drug and
alcohol treatment programs.
E1a. How troubled or bothered have you been in the past 30 days by drug problems, like
cravings, withdrawal symptoms, or wanting to stop and being unable to? [drgprob_fu]
0 - Not at all
Slightly
Moderately
Considerably
4 - Extremely
E1b. How important to you now is treatment for these drug problems? [probimp_fu]
0 - Not at all
Slightly
Moderately
Considerably
4 - Extremely
E1c. Have you tried to enroll in a substance use treatment program but were unable to in the
last month? [txcaccess_fu]
Yes
No
DK/R
E2. If txacess_fu= “yes”; What kind of addiction treatment did you try to enroll in? (Read out list;
check all that apply) . [txt_fu]
Detox [1]
Methadone [2]
Suboxone (buprenorphine) treatment [3]
Self-help group (like 12-step AA or NA programs) [4]
Outpatient drug or alcohol treatment program [5]
Day treatment program or partial hospitalization program [6]
Residential drug treatment program [7]
Another kind of treatment [77]
DK/R [99]
E2a. If txt_fu= “Another kind of treatment”; What kind of addiction treatment did you try to enroll
in:_________ [txt_fu]
E3. What were the main barriers to accessing addiction treatment? (Read out list: check all that
apply). [txb_fu]
I couldn’t afford it [1]
There was a waiting list [2]
Page 117 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
My health insurance would not allow me to attend the program [3]
I didn’t have health insurance [4]
I didn’t know of any programs [5]
The programs weren’t youth-friendly [6]
I was turned down by a program [7]
There was no treatment program nearby [8]
There were no beds or appointments available [9]
Another reason [77]
DK/R [99]
E3a. If txb= “yes”: What were the main barriers to accessing addiction treatment:_____
[txb_oth_fu]
E5. Have you been kicked out of any drug or alcohol treatment program because of drug or
alcohol use in the last month? [tx_kick_fu]
Yes
No
DK/R
E6. If txkick_fu= “yes”: What program(s) were you kicked out of? (Read out list; check all that
apply) [txkick_prog_fu]
Detox [1]
Methadone [2]
Suboxone (buprenorphine) treatment [3]
Self-help group (like 12-step AA or NA programs) [4]
Outpatient drug or alcohol treatment program [5]
Day treatment program or partial hospitalization program [6]
Residential drug treatment program [7]
Another kind of treatment [77]
DK/R [99]
E6a. If txprog_kick_fu = “other”: What program(s) were you kicked out of:________
[txprog_kick_oth_fu]
E7. What substance did you use that caused you to be kicked out? (Read out list; check all that
apply) [txkick_drg_fu]
Prescription opioids such as Percocet, OxyContin, Dillaudid, Vicodin [1]
Medications used for opioid use disorder such as Methadone, buprenorphine/Suboxone [2]
Benzodiazepines/Benzos such as Xanax, Ativan, Valium, Klonapin [3]
Prescription stimulants such as Adderall, Ritalin, Focalin, Concerta, Dexedrine [4]
Marijuana or hash oil, including edibles and synthetic marijuana [5]
Club drugs such as Molly, MDMA, Ecstasy, GHB, Ketamine [6]
Page 118 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Psychedelics, such as Mushrooms, Acid, LSD, DMT [7]
Crystal methamphetamine (crystal meth, glass, ice, tina) [8]
Powder cocaine [9]
Crack cocaine [10]
Heroin [11]
Other [77]
DK/R [99]
E7a. If txkick_drg_fu= “yes”: What substance did you use that caused you to be kicked
out:_____ [txkick_drg_oth_fu]
E8. If txprog_fu= “yes”; In the last month, have you been in any kind of alcohol or drug
treatment program? [txprogm1_fu]
Yes
No
DK/R
E9. If txprogm1= “yes”: Are you currently in a drug or alcohol treatment program? [addictxt_fu]
Yes
No
DK/R
E10. Overall, how satisfied are you with this treatment program? [addictxt_sat_fu]
Very
unsatisfied
Unsatisfied
Neither
satisfied nor
dissatisfied
Satisfied
Very
satisfied
DK/R
E11. If addictxt_fu= “yes”: Why did you enter this treatment program? (Read out list; check all that
apply) [addictxt_reason_fu]
Wanted to reduce my drug use or stop using entirely [1]
Other physical or mental health reasons [2]
Convinced by family, friends, a doctor, etc. [3]
Coerced or forced to by a doctor, the policy, courts, etc. [4]
Referred from a drug court [5]
Other [77]
DK/R [99]
Page 119 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
E11a. If adicttxt_reason_fu= “other”: Why did you enter this treatment program:________
[addictxt_reason_oth_fu]
E12. If addictxt_fu= “yes”: Is this treatment program located in Rhode Island? [addictri_fu]
Yes
No
DK/R
E13. If addictxt_fu= “yes”: What kind of addiction treatment are you currently in? (Read out list;
check all that apply) [txtcur_fu]
Detoxification [1]
Methadone [2]
Buprenorphine/Suboxone/Subutex treatment [3]
Self-help group (like 12-step AA, NA) [4]
Outpatient drug or alcohol treatment program [5]
Day treatment program or partial hospitalization program [6]
Residential drug treatment program [7]
Another kind of treatment: [77]
DK/R [99]
E14. If txtcur_fu = “Methadone” or “Buprenorphine/Suboxone/Subutex treatment”: How long have
you been taking this medication for? [mattime_fu]
_____ years
_____ months
DK/R [DK]
E15. If txtcur_fu = “Methadone” or “Buprenorphine/Suboxone/Subutex treatment”: What is the dose
of methadone or Buprenorphine/Suboxone/Subutex that you are currently receiving?
[matdose_fu]
_____ mg (integer; if TXT_current = Methadone, allowable range 1 to 1000; If TXT_current =
Buprenorphine, allowable range 1 to 40)
DK/R
E16. If txtcur_fu = “Methadone” or “Buprenorphine/Suboxone/Subutex treatment”: Has the dose
remained the same for the past 7 days? [txtcurstbl_fu]
Yes
No
DK/R
Page 120 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
E16a. If txtcurstble_fu= “yes”: During the last 7 days, how frequently have you used
heroin/opioids, either illicit or non-medical? [odas1_fu]
1 - More
than twice
every day
2 - Every
day at least
once or
twice a day
3 - Four, five
or six times
in the last
seven days
4 - One, two
or three
times in the
last seven
days
5 - None of
the last
seven days
If [5] → skip to odas3a_fu
E16b. How intense was the effect you felt from the dose or doses of the heroin/opioid that you
used in the last seven days on a scale of 1-5? A 1 would mean that the effect was extremely
intense and a 5 would mean that it had no effect on you. [odas2_fu]
1 - ‘The
effect was
extremely
intense’
2 -
3 -
4 -
5 - ‘It had no
effect at all
on me’
E16c. During the last seven days, how frequently have you felt two or more of these objective
heroin/opioid withdrawal symptoms? (such as cramps and muscular pains, feeling your hair
standing on end, a runny nose, wanting to cry, yawning, stomach cramps or diarrhea,
palpitations, sweating, and generally feeling bad…) [odas3a_fu]
1 - More
than twice
every day
2 - Every
day at least
once or
twice a day
3 - Three to
six times in
the last
seven days
4 - One or
two times in
the last
seven days
5 - None
If E16c = None [5] → skip to E16e
E16d. During the last seven days, how intense were the withdrawal symptoms you felt on a
scale of 1-5? A 1 would mean extremely intense and a 5 would mean nothing at all. [odas3b_fu]
1 -
‘Extremely
intense’
2 -
3 -
4 -
5 - ‘Nothing
at all’
Page 121 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
E16e. During the last seven days, how frequently have you felt two or more of these subjective
heroin/opioid withdrawal symptoms? (such as anxiety, restlessness, irritability, difficulty in
sleeping, tiredness, shivering, muscular aches and lack of appetite) [odas4a_fu]
1 - More
than twice
every day
2 - Every
day at least
once or
twice a day
3 - Three to
six times in
the last
seven days
4 - One or
two times in
the last
seven days
5 - None
If [5] NOT two or more symptoms → skip to E16g
E16f. During the last seven days, how intense were the withdrawal symptoms you felt on a
scale of 1-5? A 1 would mean extremely intense and a 5 would mean nothing at all.[odas4b_fu]
1 -
‘Extremely
intense’
2 -
3 -
4 -
5 - ‘Nothing
at all’
E16g. During the last seven days, how frequently have you felt felt an urgent need to use
heroin/opioids? [odas5a_fu]
1 - More
than twice
every day
2 - Every
day at least
once or
twice a day
3 - Three to
six times in
the last
seven days
4 - One or
two times in
the last
seven days
5 - None
If [5] → skip to E16i
E16h. During the last seven days, how intensely did you feel the need to use heroin/opioids,
on average on a scale of 1-5? A 1 would mean extremely intense and a 5 would mean nothing
at all.? [odas5b_fu]
1 -
‘Extremely
intense’
2 -
3 -
4 -
5 - ‘Nothing
at all’
E16i. During the last seven days, how frequently have you had any symptoms of
overmedication of methadone? (such as feeling sleepy or sedated, difficulty in speaking,
being unusually active or, alternatively, the sensation of “being drugged”) [odas6a_fu]
Page 122 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
None… 5 points [5]
1-2 times… 4 points [4]
3-6 times… 3 points [3]
Every day, once or twice a day… 2 points [2]
More than twice every day… 1 points [1]
E16j. During the last seven days, how intense were the overmedication symptoms you felt on
a scale of 1-5? A 1 would mean extremely intense and a 5 would mean nothing at all.
[odas6b_fu]
1 -
‘Extremely
intense’
2 -
3 -
4 -
5 - ‘Nothing
at all’
E17. What is your current health insurance coverage? [inssts_fu]
No insurance [1]
Insurance through my workplace [2]
Medicare/Medicaid or other governmental insurance like Neighborhood Health Plan[3]
Individual/family private coverage [4]
Other [77]
DK/R [99]
E17a. If inssts_= “other”: What is your current health insurance coverage:_____ [inssts_oth_]
E18. Have you been diagnosed with a mental health or cognitive disorder in the last month?
[mentdiagevr_fu]
Yes
No
DK/R
E19. If mentdiagevr= “yes” What mental health disorder were you diagnosed with? (Read out list;
check all that apply) [mentdiagname_fu]
Attention-Deficit/Hyperactivity Disorder (ADD/ADHD) [1]
Obsessive-compulsive disorder (OCD) [2]
Eating disorders (like anorexia or bulimia) [3]
Depressive disorder (like major depression) [4]
Bipolar disorder (like manic depressive disorder) [5]
Anxiety disorder (like panic attacks or phobias) [6]
Psychosis (like schizophrenia, brief psychotic episode, or paranoia) [7
Another diagnoses [77]
Page 123 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
No, none of the above [0]
DK/R [99]
E19a. If mendiagname_fu= “Another diagnoses”: What mental health disorder were you
diagnosed with:_________ [mentdiagname_oth_fu]
E20. Have you ever been hospitalized because of this mental health disorder or injuries
caused by the disorder? [hospdis_fu]
Yes
No
DK/R
E21. Have you ever been prescribed opioids as a result of injury or acute pain? [presinj_fu]
Yes
No
DK/R
Interviewer prompt: We are going to ask you two questions about chronic pain. When we say chronic
pain, we mean pain on most days or every day.
E21a. In the past six months, how often did you have pain? [pn6m_fu]
Never
Some days
Most days
Everyday
DK/R
E21b. Over the past six months, how often did pain limit your life or work activities? [ald6m_fu]
Never
Some days
Most days
Everyday
DK/R
E22. Have you been prescribed opioids in the past month? [presmnth_fu]
Yes
No
DK/R
E23. Have you been denied opioid medications for painful conditions in the last month?
[op_den_fu]
Yes
No
Page 124 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
DK/R
E24. What was the reason for denial? (Read out list; check all that apply) [op_den_reason_fu]
No reason given [1]
Being homeless [2]
Not having health insurance [3]
Physician denied because of diversion or substance use concerns [4]
Clinic does not prescribe narcotics [5]
Did not see my regular physician [6]
Physician said pain wasn’t serious enough or other medications are sufficient [7]
Physician concerned about adverse effects [8]
Positive drug test [9]
Other [77]
DK/R [99]
E24a. If op_den_reason_fu= “other”: What was the reason for denial:______
[op_den_reason_oth_fu]
Page 125 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION F – OVERDOSE
Interviewer prompt: Now we’d now like to ask you some questions about overdose.
F1. In the last month, have you seen someone overdose? [skill2_fu]
Yes
No
DK/R
F1a. In the last month, have you performed rescue breathing on someone who you thought
was overdosing? [skill3_fu]
Yes
No
DK/R
F4. In the last month, have you given Narcan/naloxone to someone who you thought was
overdosing? [skill4_fu]
Yes
No
DK/R
F5. If skill4_fu= “yes”; In the last month, have you given Narcan/naloxone to someone who you
thought was overdosing on fentanyl? [sill5_fu]
Yes
No
DK/R
F6. If skill5_fu= “yes”; How many doses of Narcan/naloxone did you have to give the last time
you reversed a fentanyl overdose? [dosenarcfent_fu]
1
2
3
≥4
DK/R
Interviewer prompt: Please indicate how much you agree or disagree with the following statements:
Page 126 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
F7. I am confident that I can recognize when someone is having an opioid overdose.
[motiv11_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
F8. I am confident that I would call 911 if a friend or family member were overdosing.
[motiv12_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
F9. I am confident that I would call 911 if a friend or family member were overdosing, even if
drugs or drug paraphernalia were present at the scene. [motiv13_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
F10. I am confident that I would call 911 if a friend or family member were overdosing, even if I
was high on drugs. [motiv14_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
F11. I am worried that other people might think that I am using drugs if they see me carrying
naloxone (a medicine that can reverse an overdose). [motiv15_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
F12. What do you do to avoid an accidental overdose? (Read out list; check all that apply)
[skill6_fu]
Nothing [1]
Avoid mixing with alcohol [2]
Avoid mixing with other drugs [3]
Smell or taste my supply [4]
Page 127 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Using with someone else [5]
Take smaller amounts [6]
Go slow [7]
Take a tester [8
Use a fentanyl test strip [9]
Keep Narcan/naloxone nearby [10]
Change supplier or dealer [11]
Something else [77]
DK/R [99]
F12a. If skill6_fu= “other”: What do you do to avoid an accidental overdose:______ [skill6_oth_fu]
Interviewer prompt: We’d know like to ask you about your own experience with accidental overdose.
By accidental overdose we mean taking too much of a drug such that someone is no longer able to
respond or breathe adequately. Other symptoms of an accidental overdose can include loss of
consciousness, lips turning black or grey, gurgling noises, blacking out, or others. An overdose can
occur with prescription or illicit drugs, or a combination of both.
F13. Since your last visit, have you accidentally overdosed? [odsincevist]
Yes
No
DK/R
F14. Was this in the last month? [skill8_fu]
Yes
No
DK/R
F15. If skill8_fu= “yes”; In the last month, have you experienced any of the following unwanted
negative reactions from using too much of any of the drugs that you have used? (Read out list;
check all that apply) [odsymptij_fu]
Lost consciousness/blacked out [1]
Blue or gray lips or skin [2]
Seizure [3]
Had a hard time breathing [4]
Elevated breathing [5]
Stopped breathing [6]
Inability to talk [7]
Not responsive to stimulus (like having your name called or physical contact) [8]
Overheating [9]
Irregular heart beat (fast, slow, irregular or palpitations) [10]
Page 128 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Paranoia [11]
Can’t remember getting high [12]
None [0]
Other [77]
DK/R [99]
F15a. If odsymptij_fu= “other”: In the last month, have you experienced any of the following
unwanted negative reactions from using too much of any of the drugs that you have
used:________ [odsymptij_oth_fu]
F16. If skill8_fu= “yes”: How many times have you overdosed in the last month? [odnumb_fu]
_______ (integer, allowable range 1 to 30)
DK/R
F17. If skill8_fu= “yes”; Now we want to ask you about the most recent time you overdosed.
Who was with you the last time you overdosed? (Read out list; check all that apply)[odw_fu]
A close friend [1]
A casual friend or acquaintance [2]
A sex partner [3]
An immediate family or household member [4]
An extended family member [5]
A dealer [6]
A stranger (like people on the street) [7]
I was alone [8]
DK/R [99]
F17a. If skill8_fu= “yes”: The last time you overdosed, what drug(s) did you intend to take?
(Read out list; check all that apply) [drgintend_fu]
Prescription opioids such as Percocet, OxyContin, Dillaudid, Vicodin [1]
Medications used for opioid use disorder such as Methadone, buprenorphine/Suboxone [2]
Benzodiazepines/Benzos such as Xanax, Ativan, Valium, Klonapin [3]
Prescription stimulants such as Adderall, Ritalin, Focalin, Concerta, Dexedrine [4]
Marijuana or hash oil, including edibles and synthetic marijuana [5]
Club drugs such as Molly, MDMA, Ecstasy, GHB, Ketamine [6]
Psychedelics, such as Mushrooms, Acid, LSD, DMT [7]
Crystal methamphetamine (crystal meth, glass, ice, tina) [8]
Powder cocaine [9]
Crack cocaine [10]
Heroin [11]
Page 129 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Other [77]
DK/R [99]
F17aa. If drgintend_fu= “other”: The last time you overdosed, what drug(s) did you intent to
take:_____ [drgintend_oth_fu]
F17b. If skill8_fu= “yes”: The last time you overdosed, did you overdose on a drug that you
thought might have contained fentanyl? [odfentsuspect_fu]
Yes
No
DK/R
F17c. If odfentsuspect_fu= “yes”: The last time you overdosed on a drug that might have
contained fentanyl, did you know it had fentanyl in it before you used it? [fentknwbfr_fu]
Yes
No
DK/R [DK]
F17d. If odfentsuspect_fu= “yes”: The last time you overdosed, what reaction did you have to the
drug or drugs mentioned above? (Read out list; check all that apply) [drgrct_fu]
Lost consciousness/blacked out [1]
Blue or gray lips or skin [2]
Seizure [3]
Had a hard time breathing [4]
Elevated breathing [5]
Stopped breathing [6]
Inability to talk [7]
Not responsive to stimulus (like having your name called or physical contact) [8]
Overheating [9]
Irregular heart beat (fast, slow, irregular or palpitations) [10]
Paranoia [11]
Can’t remember getting high [12]
None [0]
Other [77]
DK/R [99]
F17da. If drgrct_fu= “other”: The last time you overdosed, what reaction did you have to the drug
or drugs mentioned above:______ [drgrct_oth_fu]
F17e. Where were you the last time you overdosed? [odplc_fu]
Own place (room or apartment)
Partner’s place
Page 130 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Friend’s place
Dealer’s place
Street (alley, doorway, etc.)
Bathroom (any public washroom)
Park
Youth drop-in center
Parking lot
Car
Inside club or bar
House party
School
Abandoned house or building
Jail or prison
Crack house/shooting gallery
Other:______
DK/R
F19. If skill8_fu= “yes”: The last time you overdosed, did someone with you call 911? [odcall_fu]
Yes
No
DK/R
F19. If skill8_fu= “yes”: The last time you overdosed, did someone administer naloxone/Narcan?
[odnarc_fu]
Yes
No
DK/R
F20. If odnarc_fu= “yes”: The last time you overdosed, who gave you naloxone/Narcan? (Read
out list; check all that apply). [narcw_fu]
A police officer [1]
An ambulance official [2]
A health professional [3]
A friend [4]
A parent or relative [5]
Another person using drugs [6]
A stranger [7]
Someone else [77]
DK/R [99]
F20a. If narcw_fu= “other”: The last time you overdosed, who gave you naloxone/Narcan:_____
[narcw_oth_fu]
Page 131 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
F21. If skill8_fu= “yes”: The last time you overdosed, were you taken to the hospital? [odhosp_fu]
Yes
No
DK/R
F22. If odhosp_fu= “yes”: The last time you overdosed and were taken to a hospital, were you
offered referral to an addiction treatment program before discharge? [hoptxt_fu]
Yes
No
DK/R
F23. If odhosp_fu= “yes”: The last time you overdosed and were taken to a hospital, were you
given naloxone/Narcan at discharge? [hospnx_fu]
Yes
No
DK/R
F24. If odhosp_fu= “yes”: The last time you overdosed and were taken to a hospital, did you see
a peer recovery specialist, also known as a peer recovery coach? [peernx_fu]
Yes
No
DK/R
F24a. If skill8= “yes”: In the month before your last overdose, were you in any of the following
programs? (Read out list; check all that apply) [trtdurod_fu]
Detoxification [1]
Methadone [2]
Buprenorphine/Suboxone/Subutex treatment [3]
Self-help group (like 12-step AA, NA) [4]
Outpatient drug or alcohol treatment program [5]
Day treatment program or partial hospitalization program [6]
Residential drug treatment program [7]
Another kind of treatment [8]
Jail or prison [8]
None of the above [10]
DK/R [99]
F27. I am concerned about my friends overdosing [motiv16_fu]
Page 132 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
F28. I am concerned about overdosing [motiv17_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
F29. I get the support and resources I need from others to help me avoid an overdose.
[skill9_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
F30. I am confident that I can ask someone to check on me after I use drugs, and call 911 if
they think I am overdosing. [motiv18_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
Page 133 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION G: RAPIDS INTERVENTION
(EXPERIMENTAL ARM ONLY)
Break for intervention booster session:
Pipe in response from F12, F28, and F29.
PIPE
G.0. Now I would like to talk to you about how you are doing with the change goals that we
talked about the last time you were here.
INSERT OPEN ENDED TEXT BOX G.0.a
Interviewer Notes: Please summarize the participant’s behavior change goals in the open
ended text box. Please format them in the manner shown below.
Participant feels confident doing x, y, z
Participant would like to continue doing z
Participant rated themselves as X out of 10 in readiness to change
Participant chose this number on the readiness scale because of X
Participant rated themselves as X out of 10 in confidence to change
Participant said that X would make them more confident
Interviewer prompt: We would now like to ask you about your experiencing testing your drugs with the
test strips we’ve given you. At the end of the interview, we can give you additional test strips for
personal use. .
G1. I feel confident in my ability to test my own drugs for fentanyl. [motiv6_in_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
G2. I feel confident in my ability to read the results of the fentanyl test strips. [motiv7_in_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
Page 134 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
G2a.I know what to do once I get results from the fentanyl rapid tests [resultsstrips_in_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
G3. It will be easy for me to use the fentanyl test strips in the next month. [motiv8_in_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
G4. I plan to continue to use the testing strips. [motiv9_in_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
G5. Have you used a fentanyl test strip in the last month, either on your own or with people
you use drugs with?? [usetest_in_fu]
Yes
No  → skip to G8
DK/R  → skip to G8
G6. In usetest_in_fu= “yes”; Of the 10 tests we gave you, how many tests did you use?
[fen_str_in_fu]
_______
DK/R
G7. Who performed the test? (Read out list; check all that apply) [test_use_who_in_fu]
I did it myself [1]
A close friend [2]
A casual friend or acquaintance [3]
A sex partner [4]
An immediate family or household member [5]
An extended family member [6]
A dealer [7]
Page 135 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
A stranger (like people on the street) [8]
Other [77]
DK/R [99]
G7a. If test_use_who_in_fu= “other”: Who performed the test:_______ [test_use_who_in_oth_fu]
G8.In usetest_in_fu= “yes”; In the last month, did you give any of the fentanyl test strips to
someone else? [givetest_in_fu]
Yes
No
DK/R
G9. If givetest_in_fu= “yes”; Who did you give the fentanyl test strips to? (Read out list; check all
that apply) [give_test_who_in_fu]
A close friend [1]
A casual friend or acquaintance [2]
A sex partner [3]
An immediate family or household member [4]
An extended family member [5]
A dealer [6]
A stranger (like people on the street) [7]
Other [77]
DK/R [99]
G9a. If give_test_who_in_fu= “other”; Who did you give the fentanyl test strips to:____
[give_test_who_in_oth_fu]
G10. In the last month, did you use want to use a fentanyl test strip, but were unable to?
[testunbl_in_fu]
Yes
No
DK/R
G11. If testunbl_in_fu= “yes”; What got in the way of using the rapid fentanyl test strips (read out
list, check all that apply) [testunable_why_in_fu]
I did not have them on me [1]
I did not want to use any of my drug [2]
I did not have access to a private location to use them in [3]
I did not have the time to use them [4]
They were confiscated by a police officer [5]
They were taken by a friend, family member, or acquaintance [6]
I lost them [7]
Page 136 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
I was told not to use them by somebody that I inject with [8]
The person who prepares drugs for me doesn’t like/use test strips [9]
The person who prepares drugs for me did not have any at the time [10]
I didn’t know how to use them properly [11]
The ones I had were messed up or damaged [11]
They were not convenient to use [12]
I felt embarrassed/stigma [13]
Other [77]
DK/R [99]
G11a. If testunable_why_in_fu= “other”; What got in the way of using the rapid fentanyl test
strips:_________ [testunable_why_in_oth_fu]
G12. In the last month, did you get any fentanyl test strips in addition to the 10 that we gave
you? [test_get_in_fu]
Yes
No
DK/R
G13. If test_get_in_fu= “yes”; Where did the fentanyl test strips come from? (Read out list; Check
all that apply) [test_get_who__in_fu]
RAPIDS clinical trial [1]
Other research study [2]
AIDS Care Ocean State (ACOS) [3]
Project Weber/RENEW [4]
Another harm reduction organization [5]
Uncertain [6]
Other: [77]
DK/R [99]
G13a. If test_get_who_fu= “Other”; Where did the fentanyl test strips come from:________
[test_get_who_in_oth]
G14. How many strips do you think you might use over the next month? [fenstr_in_fu]
_______ (0-10)
DK/R
G15. How much money are you willing to spend on a fentanyl test strip? [sepndtest_in_fu]
___________
DK/R
Page 137 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
G16. Where would you be most comfortable getting more fentanyl tests? (Read out list; check
all that apply) [gettest_in_fu]
A pharmacy [1]
An online store [2]
A needle exchange Program [3]
A community-based organization [4]
A community health clinic [5]
A health department office [6]
Other [77]
DK/R [99]
G17. Do you think your friends would be interested in using the fentanyl test strips?
[fen_friends_in_fu]
Yes
No
Not sure
DK/R
G18. Is there anything else you’d like to tell us today?
(Interviewer: Not required.  Do not record identifying information here) [pptnotes_in_fu]
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
Interviewer prompt: Thank you for participating in our survey. Your answers will help us . If you have
remaining questions or concerns please contact a member of our study team. (Interviewer: Provide
contact information.  Then click Next to enter your Interviewer Data.)
Page 138 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION H: STANDARD OEND
(CONTROL ARM ONLY)
Programmer prompt: ONLY IF C27 = YES , these questions will be asked at the end of the survey.
Interviewer prompt: We wanted to ask you a few questions about your experiences using fentanyl
test stips because you told us that you used test strips earlier in the survey. For the first four
questions, please tell us how much you disagree or agree with the following statements on a scale of
strongly disagree to strongly agree.
H1. I feel confident in my ability to test my own drugs for fentanyl. [motiv6_ctl_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
H2. I feel confident in my ability to read the results of the fentanyl test strips. [motiv7_ctl_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
H2a.I know what to do once I get results from the fentanyl rapid tests [resultsstrips_ctl_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
H3. It will be easy for me to use the fentanyl test strips in the next month. [motiv8_ctl_fu]
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
H4. I plan to continue to use the testing strips. [motiv9_ctl_fu]
Page 139 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Strongly
disagree
Disagree
Neutral
Agree
Strongly
agree
DK/R
H5. Have you used a fentanyl test strip in the last month, either on your own or with people
you use drugs with? [usetest_ctl_fu]
Yes
No  → skip to H8
DK/R  → skip to G8
H6. Who performed the test? (Read out list; check all that apply) [testusewho_ctl_fu]
I did it myself [1]
A close friend [2]
A casual friend or acquaintance [3]
A sex partner [4]
An immediate family or household member [5]
An extended family member [6]
A dealer [7]
A stranger (like people on the street) [8]
Other [77]
DK/R [99]
H6a. If testusewho_ctl_fu= “other”; Who performed the test:_______ [testusewho_ctl_oth_fu]
H7. Where did the fentanyl test strips come from?? (Read out list; Check all that apply)
[test_get_who_ctl_fu]
RAPIDS clinical trial [1]
Other research study [2]
AIDS Care Ocean State (ACOS) [3]
Project Weber/RENEW [4]
Another harm reduction organization [5]
Uncertain [6]
Other: [77]
DK/R [99]
H7a. If test_get_who_ctl_fu= “Other”; Where did the fentanyl test strips come from:________
[test_get_who_ctl_oth]
H8. In the last month, did you give any of the fentanyl test strips to someone else? [GIVETEST]
Page 140 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Yes
No → skip to H10
DK/R → skip to H10
H9. Who did you give the fentanyl test strips to? (Read out list; check all that apply)
[give_test_who_ctl_fu]
A close friend [1]
A casual friend or acquaintance [2]
A sex partner [3]
An immediate family or household member [4]
An extended family member [5]
A dealer [6]
A stranger (like people on the street) [7]
Other [77]
DK/R [99]
H9a. If give_test_who_ctl_fu= “other”; Who did you give the fentanyl test strips to:____
[give_test_who_ctl_oth_fu]
H10. In the last month, did you use want to use a fentanyl test strip, but were unable to?
[testunbl_ctl_fu]
Yes
No → skip to G12
DK/R → skip to G12
H11. If testunbl_ctl_fu= “yes”; What got in the way of using the rapid fentanyl test strips (read out
list, check all that apply) [testunable_why_ctl_fu]
I did not have them on me [1]
I did not want to use any of my drug [2]
I did not have access to a private location to use them in [3]
I did not have the time to use them [4]
They were confiscated by a police officer [5]
They were taken by a friend, family member, or acquaintance [6]
I lost them [7]
I was told not to use them by somebody that I inject with [8]
The person who prepares drugs for me doesn’t like/use test strips [9]
The person who prepares drugs for me did not have any at the time [10]
I didn’t know how to use them properly [11]
The ones I had were messed up or damaged [11]
They were not convenient to use [12]
I felt embarrassed/stigma [13]
Page 141 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
Other [77]
DK/R [99]
H11a. If testunable_why_in_fu= “other”; What got in the way of using the rapid fentanyl test
strips:_________ [testunable_why_ctl_oth_fu]
H14. How much money are you willing to spend on a fentanyl test strip? [spendtest_ctl_fu]
___________
DK/R
H15. Where would you be most comfortable getting more fentanyl tests? (Read out list; check
all that apply) [gettest_ctl_fu]
A pharmacy [1]
An online store [2]
A needle exchange Program [3]
A community-based organization [4]
A community health clinic [5]
A health department office [6]
Other [77]
DK/R [99]
H15a. If gettest_ctl_fu= “other”; Where would you be most comfortable getting more fentanyl
tests:_______ [gestest_ctl_oth_fu]
H16. Do you think your friends would be interested in using the fentanyl test strips?
[fen_friends_ctl_fu]
Yes
No
Not sure
DK/R
H17. Is there anything else you’d like to tell us today?
(Interviewer: Not required.  Do not record identifying information here) [pptnotes_ctl_fu]
_____________________________________________________________
_____________________________________________________________
Page 142 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
_____________________________________________________________
Interviewer prompt: Thank you for participating in our survey. Your answers will help us . If you have
remaining questions or concerns please contact a member of our study team. (Interviewer: Provide
contact information.  Then click Next to enter your Interviewer Data.)
Page 143 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT A
RAPIDS: CONSENT & SURVEY INSTRUMENT
Revised & Approved 11/22/2019
Revised & Approved 12/09/2019
Administrative correction submitted 12/12/2019
Revised & Approved 08/17/2020
Revised and Approved: 10/15/2020
Revised and Approved 02/01/2021
Revised and Approved: 09/01/2021
SECTION I: INTERVIEWER DATA
I1. How would you rate the overall quality of the interview? [quality_fu]
High
Medium
Low
Very low
I2. Interview notes: (Not required.  Do not record identifying information here.) [intnotes_fu]
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
Remember to click the Submit button!
[END FOLLOW-UP ASSESSMENT]
Page 144 of 144
Brown University IRB Original Approva: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Review Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

EXTERNAL RESEARCH STUDY 
ICELAND 
IRELAND 
DENMARK 
GEORGIA 
MOROCCO GERMANY 
KUWAIT 
PUERTO RICO 
TRINIDAD AND 
JORDAN 
SAUDI 
QATAR 
 
TAIWAN 
Fentanyl Strips 
PANAMA 
CHILE 
TOBAGO 
ARABIA 
UNITED
YEMEN EMIRATES MYANMAR 
SOUTH 
AFRICA 
FOR HARM REDUCTION USE 
As tested by Johns Hopkins Bloomberg 
School of Public Health 
BTNX FENTANYL ANALOGUE LIST 
Brown University IRB Original Approval: 4/18/2019 
ARAB 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

C
O
N
T
A
C 
T 
U
S 
E
m
a
i
l
: 
i
n
f
o
@ 
b
t
n
x
. 
c
o
m 
Toll Free: 1 - 888 - 339 - 9964 ( US & Canada) 
Website: www. btnx. com 
Join Us on Facebook: 
https:// bit. ly/ 2 HC 7 u Hn 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Positive for fentanyl e 
Use caut·on & 
No drug u:se is 100o/o safe. 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Use with som 
1 eone else around ,and alw·ays ha·v
1 e n,1 aloxone 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Step 1 -Add water 
Testing residue 
Testing pills or powder 
cocaine, and ills. 
Fentanyl test strips can 
tell you whether or not 
you have fentanyl in 
your drugs. You can 
follow these steps to 
use a fentanyl test strip 
to prevent overdose. 
Step 2 -Test 
Hold the blue end of your test 
strip and dip it into the water 
for 15 seconds. Be sure you 
only dip up to the wavy lines. 
' 
Add 10 drops of sterile 
water to your cooker after 
you have drawn your shot 
and stir well. 
Step 3 - Wait 
Wait two minutes until you 
can see lines show up in 
the middle. 
Add water to an empty bag 
with residue in it  and  mix 
well. If you have pills, break a 
piece off and stir it into water. 
Step 4 - Results 
1 line  -  Posit ,ive for fentanyl 
2 lines - Use caution 
Read your test results. One 
line means that your drugs 
have fentanyl in them. No 
drugs are 100°/o safe. 
at can I o a ter 
I et m test resu t? 
1. I can have naloxone with me
2. I can have someone with me who can call
911 and give me naloxone if I overdose
3. I can go slow and use less
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Opioid overdose occurs when a person is unresponsive and not breathing or struggling to breathe. 
Signs of opioid overdose: 
•
Does not wake up, even if you shake them or call their name
•
Small pupils
•
Slow or no breathing
•
Snoring sound
•
Blue, grey, or pale skin color
STEP 2: CALL 9-1-1 
STEP 3: GIVE NALOXONE 
INJECTION INTO MUSCLE 
Needle-Syringe and Vial: 
1.
Open cap of naloxone vial.
2.
Remove cap of needle, and insert into vial.
3.
With the vial upside down, pull backplunger and draw
up 1mL (1cc) of naloxone. Naloxone vial may only have
one dose, or may be a multi-dose vial.
4.
Using a needle at least 1 inch long, inject into muscle in
the upper arm.
OR 
Auto-injector: Follow visual and voice instructions. Package 
contains instructions anda training device. 
NASAL SPRAY 
Multi-step nasal spray: 
1. 
Remove yellow caps from ends of applicator.
2. 
Twist nasal adapter on tip of applicator until tight.
3. 
Take purple cap off of naloxone syringe, insert in other side 
of applicator and twist in until tight.
Push half of the naloxone (1mL/1cc) into each nostril. The 
naloxone vial contains 2mL, so you are giving one half in one 
nostril and one half in the other nostril. 
Applicator 
Nasal Adapter 
Prefilled 
OR 
Naloxone Syringe 
Single-step nasal spray: Peel back tab with circle to open, insert 
tip into either nostril and administer full dose. Entire dose is 
administered with one spray. 
STEP 4: GIVE CPR AND/OR RESCUE BREATHING 
STEP 1: IDENTIFY OVERDOSE 
STEPS OF NALOXONE ADMINISTRATION 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

PREVENT OVERDOSE: 
•
Only take medication prescribed to you, and take it as
directed
•
Don’t mix opioids with drugs or alcohol
•
Store your medication in a safe and secure place and dispose
of any unused medication
•
Not taking opioids for a while changes tolerance levels, which
For more information about 
means if you restart you need to start at a lower dose
•
Teach your family and friends how to respond to an overdose
naloxone and opioid safety please 
visit, www.prescribetoprevent.org 
RESCUE POSITION: 
If you have to leave someone alone at any time, like to 
call for help or to get naloxone, make sure that they are 
in the rescue position. Put the victim on his/her side 
with the top leg and arm crossed over the body. This 
makes it difficult for the victim to roll over, and lessens 
the chances that he/she will choke on vomit. 
RESCUE BREATHING: 
•
Make sure nothing is in the person’s mouth
blocking their breathing.
•
Place one hand on the chin and tilt the head
back. With the other hand pinch the nose closed.
•
Administer two slow breaths and look for the chest
to rise. 
•
Continue administering 1 breath every 5 seconds
until the person starts breathing on his or her own.
•
If the victim is not responding in 3-5 minutes, give a
second dose of naloxone and continue CPR/rescue
breathing until help arrives.
For assistance with finding addiction treatment, 
support groups, or recovery support services in your 
community please call Rhode Island’s 
dedicated hotline at 
1-401-942-STOP, or 1-401-942-7867
WHO SHOULD GET NALOXONE? 
•
A person overdosing on opioids
o
Not responding to yelling or shaking
o
Not breathing or struggling to breath
•
Overdose risk is greater when
o
People take increased amounts of
opioids
o
Mix opioids with other drugs or alcohol
o
Have changes in opioid tolerance
The Rhode Island Good Samaritan 
Overdose Prevention Law protects 
people who overdose or seek help for 
someone overdosing from being charged 
or prosecuted for drug possession. 
Protection does not extend to drug 
trafficking or distribution charges. 
EXAMPLES OF OPIOIDS: 
MORPHINE (MS Contin®) 
CODEINE 
HYDROCODONE (Vicodin®, Norco®) 
HYDROMORPHONE (Dilaudid®) 
OXYCODONE (Percocet®, OxyContin®) 
OXYMORPHONE (Opana®) 
FENTANYL (Duragesic®) 
METHADONE 
WHAT IS NALOXONE? 
Naloxone is a special medication used to stop an 
overdose. Opioid pain medications or drugs such as 
heroin can slow breathing and cause overdose. 
Naloxone is safe, effective, and easy to use. 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT C: RECRUITMENT TEXT
Proposed text for online advertising and printed flyers:
Brown University Research Study: 18-65 year olds
Call or Text to see if you qualify: 401-441-9367
Are you 18-65 years old?
Do you live in Rhode Island?
Have you used drugs in the past 30 days?
If so, you might qualify for a research study about overdose in Rhode Island.
For this study, we are asking for SIX visits in person over the next year to meet with our trained
research staff. Each visit will last one hour.
If you participate, you will get $35 for first and the last two visits, and $25 for the other three. You
will get a total of $180 if you complete all visits. You will also get an additional $5 at three of the
study visits if you agree to provide us with a blood sample from a finger stick. You will be
compensated up to $195 for your participation. Participation is voluntary. You can find out more
at sites.brown.edu/rapidsstudy.
Call or Text to see if you qualify: 401-441-9367
Email: rapids@brown.edu
If you have any questions about the study, Protocol# 1904002388, you can email Dr. Brandon
Marshall at Brandon_Marshall@brown.edu
Brown University IRB Original Approval: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Alternative text proposed for online advertising and printed flyers?
Are you interested in participating in a research study about overdose in
Rhode Island?
Call or Text to see if you qualify: 401-441-9367
We are looking for people who:
●
Are 18-65 years old
●
Live in Rhode Island
●
Have used drugs in the past 30 day
To participate in a research study about overdose in Rhode Island.
For this study, we are asking for SIX visits in person over the next year to meet with our trained
research staff. Each visit will last one hour.
If you participate, you will get $35 for first and the last two visits, and $25 for the other three. You
will get a total of $180 if you complete all visits. You will also get an additional $5 at three of the
study visits if you agree to provide us with a blood sample from a finger stick.  You will be
compensated up to $195 for your participation. Participation is voluntary. You can find out more
at sites.brown.edu/rapidsstudy.
Call or Text to see if you qualify: 401-441-9367
Email: rapids@brown.edu
If you have any questions about the study, Protocol# 1904002388, you can email Dr. Brandon
Marshall at Brandon_Marshall@brown.edu
Brown University IRB Original Approval: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Alternative text proposed for online advertising and printed flyers
Would you like to learn of ways to better protect yourself from an overdose?
The RAPIDS study, a Brown University research study is seeking to help stop drug overdoses in
Rhode Island. Adults 18-65 who live in Rhode Island and have used drugs in the last 30 days
are invited. We will meet with you in person six times for about an hour over the course of a
year. There is no cost for participation, and volunteers will be compensated up to $195 for
participating in this research study. You can find out more at sites.brown.edu/rapidsstudy.
Or you can contact us by call, text, or email to see if you qualify to participate: (401) 441-9367,
rapids@brown.edu
If you have questions about the protocol #1904002388, you can email Dr. Brandon Marshall, at
Brandon_marshall@brown.edu
Alternative text proposed for online advertising and printed flyers
Are you interested in learning ways to better protect yourself from an overdose?
The RAPIDS team at Brown University is seeking to help stop drug overdoses in RI. Adults who
have used drugs in the last 30 days and live in RI are invited. We will meet with you in person
six times for about an hour over the course of a year. Participation is free and volunteers will be
compensated up to $195 for participating in the study. You can find out more at
sites.brown.edu/rapidsstudy.
Or you can contact us by call, text, or email to see if you qualify: (401) 441-9367,
rapids@brown.edu
If you have questions about the protocol #1904002388, you can email Dr. Brandon Marshall, at
Brandon_marshall@brown.edu
Brown University IRB Original Approval: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Alternative text proposed for online advertising and printed flyers
Do you use drugs and wonder how you can better protect yourself from an overdose?
Do you have thoughts on fentanyl you’d like to share?
The RAPIDS team at Brown University is seeking to help stop drug overdoses in RI. Adults who
have used drugs in the last 30 days and live in RI are invited. We will meet with you in person
six times for about an hour over the course of a year. Participation is free and volunteers will be
compensated up to $195 for participating in the study. You can find out more at
sites.brown.edu/rapidsstudy.
Or you can contact us by call, text, or email to see if you qualify: (401) 441-9367,
rapids@brown.edu
If you have questions about the protocol #1904002388, you can email Dr. Brandon Marshall, at
Brandon_marshall@brown.edu
Alternative text proposed for online advertising and printed flyers
The RAPIDS Brown University research study is seeking to help stop drug overdoses in RI.
Adults who have used drugs in the last 30 days and live in RI are invited. We will meet with you
in person six times for about an hour over the course of a year. Participation is free and
volunteers will be compensated up to $195 for participating in the study.
Brown University IRB Original Approval: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Text to be used for Today@Brown
Subject line: Would you like to learn of ways to better protect yourself from an overdose?
The RAPIDS study, a Brown University research study is seeking to help stop drug overdoses in
Rhode Island. Adults 18-65 who live in Rhode Island and have used drugs in the last 30 days
are invited. We will meet with you in person six times for about an hour over the course of a
year. There is no cost for participation, and volunteers will be compensated up to $195 for
participating in this research study. You can find out more at sites.brown.edu/rapidsstudy.
Or you can contact us by call, text, or email to see if you qualify to participate: (401) 441-9367,
rapids@brown.edu
If you have questions about the protocol #1904002388, you can email Dr. Brandon Marshall, at
Brandon_marshall@brown.edu
Use of Today@Brown for recruiting participants has been approved by Brown’s Human
Research Protection Program.
Alternative text for Today@Brown
Subject line: Are you interested in sharing your thoughts on fentanyl?
The RAPIDS team at Brown University is seeking to help stop drug overdoses in RI. Adults who
have used drugs in the last 30 days and live in RI are invited. We will meet with you in person
six times for about an hour over the course of a year. Participation is free and volunteers will be
compensated up to $195 for participating in the study. You can find out more at
sites.brown.edu/rapidsstudy.
Or you can contact us by call, text, or email to see if you qualify: (401) 441-9367,
rapids@brown.edu
If you have questions about the protocol #1904002388, you can email Dr. Brandon Marshall, at
Brandon_marshall@brown.edu
Use of Today@Brown for recruiting participants has been approved by Brown’s Human
Research Protection Program.
Brown University IRB Original Approval: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Alternative text for Today@Brown
Subject line: Do you wonder how you can better protect yourself from an overdose?
Do you have thoughts on fentanyl you’d like to share?
The RAPIDS team at Brown University is seeking to help stop drug overdoses in RI. Adults who
have used drugs in the last 30 days and live in RI are invited. We will meet with you in person
six times for about an hour over the course of a year. Participation is free and volunteers will be
compensated up to $195 for participating in the study. You can find out more at
sites.brown.edu/rapidsstudy.
Or you can contact us by call, text, or email to see if you qualify: (401) 441-9367,
rapids@brown.edu
If you have questions about the protocol #1904002388, you can email Dr. Brandon Marshall, at
Brandon_marshall@brown.edu
Use of Today@Brown for recruiting participants has been approved by Brown’s Human
Research Protection Program.
Alternative text proposed for Today@Brown
Subject line: Brown University Research Study: 18-65 year olds
The RAPIDS Brown University research study is seeking to help stop drug overdoses in RI.
Adults who have used drugs in the last 30 days and live in RI are invited. We will meet with you
in person six times for about an hour over the course of a year. Participation is free and
volunteers will be compensated up to $195 for participating in the study. You can find out more
at sites.brown.edu/rapidsstudy.
Use of Today@Brown for recruiting participants has been approved by Brown’s Human
Research Protection Program.
Brown University IRB Original Approval: 04/18/2019
Brown University IRB Amendment Approval: 11/22/2020
Brown University IRB Amendment Approval: 08/10/2020
Brown University IRB Amendment Approval: 10/15/2020
Brown University IRB Amendment Approval: 02/26/2021
Brown University IRB Continuing Approval: 03/18/2021
Brown University IRB Amendment Approval: 06/15/2021
Brown University IRB Amendment Approval: 09/01/2021
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Text for radio advertisement
Brown University is recruiting for a Research Study. Are you 18-65 years old? Do you live in
Rhode Island? Have you used drugs in the past 30 days? If so, you may qualify for a research 
study about overdose in Rhode Island. The study includes six in person meetings for an hour
over the course of a year. Study participants will be compensated up to $195 for participating in 
this research study. Call or Text to see if you qualify: 401-441-9367 that’s 441-9367.
 
 
 
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021

Revised Fliers 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

 
 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

 
 
 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

 
 
 
 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

New pull tab flier:  
 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Appointment cards: 
(Front) 
 
 
(Back) 
 
 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Call, text, or email to reschedule: 401-441-9367, rapids@brown.edu
Or visit us at 121 S. Main Street, Providence, RI, 02912
Hello,
We have tried to reach you about the 
RAPIDS study at Brown University to 
schedule your next study visit. Please 
give us a call or come to our oﬃce at 
121 S. Main Street, Providence so we 
can schedule your visit.
From,
The RAPIDS Study
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Call, text, or email: 401-441-9367, rapids@brown.edu
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Screenshots from Website:  
 
 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

 
 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Facebook page: 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ADDENDUM XIX 
BUSINESS ASSOCIATE  AGREE MENT 
Ex:cept as othe rwise provided in this Business Associate Agreement Addendum, BROWN UNIVERSITY, (hereinafter 
refened to as "Bus in ess Associate"), may use, access or disclose Protected Health Information to perfmm functions, 
activities or services for or on behalf of the State of Rhode ls land, Department of Health (hereinafter referred to as the 
" C overed Ent ity"), as specified herein and the attached Agreement between the Business Associate and the Covered Entity 
(hereinafter referred to as "the Agreement"), which this addendum supplements and is made part of, provided such use, 
access, or disclosure does not violate the Health Insurance Portability and Accountability Act (HIPAA), 42 USC 1320d et 
seq., and its implementing regulations includ in g, but not limited to, 45 CFR, parts 160, 162 and 164, hereinafter referred to 
as the Privacy and Security Rules and patient confidentiality regulations, and the requirements of the Health Information 
Tec hnology for Economic and Clinical Health Act, as incorporated in the American Recovery and Reinvestment Act of 
2009, Public Law 111-5 (HITECH Act) and any regulations adopted or to be adopted pursuant to the HITECH Act that 
relate to the obligations of business associates, Rhode Island Mental Health Law, R.l. General Laws Chapter 40.1-5-26, 
and Confidenti ali ty of Health Care Communica tions and Tnfonnation Act, R.I. General Laws Chapter 5-37.3-1 et seq. 
Business Associate recognizes and agrees it is obligated by law to meet the applicable provisions of the HITECH Act. 
1.
Definitions
A.
Generally:
(1) Terms used, but not otherwise defined, in this Addendum sha11 have the same meaning as those terms in 45
C.F.R. §§ 160.103, 164.103 , and 164 .304, 164.501 and 164.502.
(2) The following terms used in this Addend um shall have the same meaning as those tenns in the HIPAA, the
Privacy and Security Rules and the HlTECH Act: B reach, Data Aggregation, Designated Record Set,
Disclosure,  Heal th Care Opei•a tions , Individual, Minllnum Necessary,  Notice of Privacy Practices, Protec ted
Health Infonnatibn, RequiredBy Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health
Information, and Use.
B.
Specific:
(1) "Addendum " means this Business Associate Agreement Addendum .
(2) "Agreement" means the contractual Agreement by and between . the State of Rhode  Island, Department  of Health and
Business Associate, awarded pursuant to State of Rhode Island ' s Purchasing Law (Chapter 37-2 of the Rhode Island
General Laws) and Rhode Isla nd Depaitment of Administration, Division of Purcb ases, Purchasing Rules, Regulations
, and General Conditions of Purchasing.
A.
"Business Associate" generally has the same meaning as the tenn "b usiness associate" at 45 CFR 160.103, and in
reference to the party to this Addendum, shall mean BROWN UNTVERSJT Y .
B.
"Client/Patient" means Covered Entity funded person who is a recipient and/or tbe client or patient of the Bus iness
Associate.
C.
"Covered Entity" generally has the .same meaning as the term "covered entity" at 45 CFR 160.103 , and in reference to
the party to this Addendum, shall mean Department of Health.
D.
"Elect ronic Health Record " means an electronic record of hea lth-related info1mation on an indiv idual that is created,
gathered, managed or consulted by authorized health care clin icians and staff.
E.
"Electronic Protected Health Information" or "El e ctron ic PHI" means PHI that is transmitted by or mainta.ined in
electronic media as defined in the HIPA Security Regulat ions.
F.
"HIPAA" means the Health Insurance Portability and Accountability Act of 1996, Public Law 10.4-191.
G.
"HIPAA Privacy Rule" means the regulations promulgated under HlPAA by the United States Depmtment  of  Health
and Human Services to protect the privacy of Protected Health Infom1ation in cluding, the Privacy,  Sec urity, Breach
Noti fication, and Enforcement Rules at 45 CFR Part 160 and Part 164.
H.
"HJTECH Act" means the privacy, security and security Breach notification provisions applicable to Business
Associate under Subtitl e D of the Health lnfortnation  Technology  for Economic  and Clinical  Health  Act, which
is Title XU of the American Recovery and Reinvestment Act of 2009, Publ ic Law I 11-5, and any regulations
promulgated thereunder and as amended from time to time.
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

XIX-1
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

I.
"Secured PHl" means PHI that was rendered unusable, unreadable or indecipherable to unauthorized individuals
through the use of technologies or methodologies specified under or pursuant to Section 13402 (h)(2) of the
HITECH Act under ARRA.
J.
"Security Incident" means any known successful or unsuccessful attempt by an authorized or unauthorized
individual to inappropriately use, disclose , modi fy, access, or destroy any information.
K.
"Security Rule" means the Standards for the security of Electronic Protected Health lnfonnation found at 45 CFR
Parts 160 and 162, and Part 164, Subparts A and C. The application of Security provisions Sections 164 .308,
164.310, 164.312, and I 64.316 of title 45, Code of Federal Regulations shall apply to Business Associate of Covered
Entity in the same manner that such sections apply to the Covered Entity.
L.
"Suspected breach" is a suspected acquisition, access, use or disclosure of protected health information (''PHl") in
violation of HIPPA privacy rules, as referenced above, that compromises the security or privacy of PH1.
M. "Unsecured PHl" means PHI that is not secure, d  as defined in this section, through the use of a technology
or methodology specified by the Secretary of the U.S. Department of Health and Human Services.
2.
Obligations and Activities of Business Assocjate
A.
Business Associate agrees to not use or further disclose PHI other  than as permitted or  requlred  by this  Addendum
or as required by Law, provided such use or disclosure would also be permissible by law by Covered Entity.
B.
Business Associate agrees to use appropriate safeguards to prevent use or disclosure of the Pffi other than as
provided for by this Addendum. Business Associate agrees to implement Administrative Safeguards, Physical
Safeguards and Technical Safeguards ("Safeguards") that reasonably and appropriately protect the confidentiality,
integrity and
availability of PHT as required by the "Security Rule."
C.
Business Associate agrees to mitigate, to the extent practicable, any harmful effect that is known to Business
Associate of a use or disclosure of PHI by Business Associate in violation of the requirements of this
Addendum.
D.
Business Associate agrees to report to Covered Entity any use or disclosure of the PH[ not provided for by this
Addendum, including breaches of unsecured PHI as required by 45 C.F.R. § 164.410, and any Security Incident
ofwhicb it becomes aware, within five (5) days of the incident.
E.
Business Associate agrees to ensure that any agent, including a subcontractor or vendor, to whom it provides PHI
received from, or created or received by Business Associate on behalf of Covered Entity agrees to the same
restrictions and conditlons that apply through this Addendum  to Business  Associate  with respect to  such
information through a contractual an-angement that complies with45 C.F.R. § 164.314.
F.
Business Associate agrees to provide paper or electronic ae-cess, at the request of Covered Entity and in the time and
manner designated by Covered Entity, to PHI in a Designated Record Set to Covered Entity or, as di rected by
Covered Entity, to an Individual in order to meet the requirements under 45 C.F.R. § 164.524. lfthe Individual
requests an electronic copy of the information, Business Associate must provide Covered Entity with the
infonnation requested in the electronic form and format requested by the Individual and /or Covered Entity if it is
readily producible in such form and format; or, if not, in a readable electron ic form and format as requested by
Covered Entity.
G.
Business Associate agrees to make any amendment(s) to PHI in a Designated Record Set that Covered Entity
directs or agrees to pursuant to 45 C.F .R. §164.526 at the request of Covered Entity or an Individual, and in the time
and manner designated by Covered Entity. If Business Associate receives a request for amendment to PHI directly
from an l□dividua l, Business Associate shall notify Covered Entity upon receipt of such request.
H.
Business Associate agrees to make its internal practices, books, and records relating to the use and disclosure of PHI
received from, created or received by Business Associate on behalfof Covered Entity available to Covered Entity, or
at the request of Covered Entity to the Secretary, in a time and manner designated by Covered Entity or the
Secretary, for the purposes of the Secretary determining compliance with the Privacy Rule and Security Rule.
I.
Business Associate agrees to document such disclosures of PHI and information related to such disclosures as
would be required for Covered Entity to respond to a request by an Individual for an accounting of disclosures of
PHI in accordance with 45 C.F.R. §164.528.
J.
Business Associate agrees to provide to Covered Entity or an Individual, in a time and manner designated by
Covered Entity, infonnation collected in accordance with this Addendum, to pe1mit Covered Entity to respond to a
request by an individual for an accounting of disclosures for PHI in accordance with 45 §C.F.R. 164.528.
K.
If Business Associate accesses, maintains, retains, modifies, records, stores, destroys, or otherwise holds, uses, or
discloses Unsecmed Protected Health Information (as defined in 45 C.F.R. § 164.402) for Covered Entity, it sha ll,
following the discovery of a breach of such info rmation, notify Covered Entity of such breach within a period of
five
(5) days after discovery of the breach . Such notice shall include: a) the identification of each individual whose
XIX-2
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

I 
f,
Unsecured Protected Health Infonnation has been, or is reasonably believed by Business Associate to have been 
accessed, acquired or disclosed during such breach; b) a brief description of what happened, including the date of the 
reach and discovery of the breach; c) a description of the type of Unsecured PHI that was involved in the breach; d) 
XIX-3
a description of the investigation into the breach, mitigation of harm to the individuals and protection against further 
breaches; e) the results of any and all investigation performed by Business Associate related to the breach; and t) 
contact information of the most knowledgeable individual for Covered Entity to contact relating to the breach and its 
investigation into the breach. 
L.
To the extent the Business Associate ,is c arryin g out an obligation of the Covered Entity's under fhe Privacy Rule, the
Business Associate must comply with the requirements of the Privacy Rule that apply to the Covered Entity in the
performance of such obligation.
M.
Business Associate agrees that it will not receive remuneration directly or indirectly in exchange for PHI without
authorization unless an exception under 45 C.F.R. § 164.502(a)(5)(ii)(B)(2) applies.
N.
Business Associate agrees that it will not receive remuneration for certain communications that fall within
the exceptions to the definition of Marketing under 45 C.F.R. §164.501, unless permitted by 45 C.F.R. §
l 64. 508(a)(3)(A)-(B).
0.
If applicable, Business Associate agree-s  that it will not use or disclose genetic information for underwriting
purposes, as that term is defined in 45 C.F.R. § 164.502.
P.
Business Associate hereby agrees to comply with state laws and rules and regulations applicable to PHJ and personal
information of individuals' information it receives from Covered Entity during the term of the Agreement.
i.
Business Associate agrees to: (a) implement and maintain appropriate physical, technical and administrative
security measures for the protection of personal information as required by any state law and rules and
regulations ; including, but not limited to: (i) encrypting all transmitted records and files containing personal
infonnation that will travel across public networks, and encryption of all data containing personal infonnation
to be transmitted wirelessly; (ii) prohibiting the transfer of personal information to any portable device unless
such transfer has been approved in advance; and (iii) encrypting any personal information to be transferred to a
portable device; and (b) implement and maintain a Written Information Security Program as required by any
state law as applicable. 
·
ii.
The safeguards set forth in this Addendum shall apply equally to PHI, confidential and "personal information."
Personal information means an individual's first name and last name or first initial and last name in combination
with any one or more of the following data elements that relate to such resident: (a) Social Security number; (b)
driver's  license number or state
0   issued  identification card number; or (c) financial account number, or credit or
debit card number, with or without any required security code, access code, personal identification number or
password, that would permit access to a resident's financial account; provided, however, that "personal
information" shall not include information that is lawfully obtained from publicly available information, or from
federal, state or local government records lawfully made available to the general public.
3. Permitted Uses and Disclosures by Business Associate
A.
Except as otherwise limited to this Addendum, Business Associate may use or disclose PHI to perform funct ions ,
activi ties, or services for, or on behalf of, Covered Entity as specified in the Service Arrangement, provided that
such use or disclosure would not vioJate the Privacy Rule if done by Covered Entity or the minimum necessary
policies and procedures of Covered Entity required by 45 C.F.R. § 164.514 (d).
B.
Except as otherwise limited in this Addendum, Business Associate may use PHI for the proper management
and administration of the Business Associate or to can-y out the legal responsibilities of the Business Associate.
C.
Except as otherwise limited in this Addendum, Business Associate may disclose PHI for the proper management and
administration of the Business Associate, provided that disclosures are Required By Law, or Business Associate
obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential
and used or further disclosed only as Required By Law or for the purpose for which it was disclosed to the person,
and the person notifies the Business Associate of any instances of which it is aware i:n which the confidentiality of
the information has been breached.
D.
Except as otherwise limited in this Addendum , Business Associate may use PHI to provide Data Aggregation services
to Covered Entity as permitted by 45 C.F.R. §164.504 (e)(2)(i)(B).
E.
Business Associate may use PHI to report violations oflaw to appropriate Federal and State authorities,
consistent with 45 C.F.R. §164.502U)(l).
I 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

4. Obligations of Covered Entity
A. Covered Entity shall notify Business Associate of any limitation(s) in its notice of privacy practices of Covered
Entity in accordance with 45 C.F.R. § 164.520 , to the extent that such limitation may affect Business Assoc.iate's use
or disclosure of PHI.
XIX-4
B.
Covered Entity shall notify Business Associate of any changes in, or revocation of, pe1mission by an Individual to use
or disclose PHl to the extent that such changes may affect Business Associate's use or disclosure of PHI.
C.
Covered Entity shall notify Business Associate of any restriction to the use or disclosure of Pl-II that Covered
Entity has agreed to in accordance with 45 C.F.R. § 164.522, to the extent that such restriction may affect Business
Associate's use or disclosure of PHI.
5.
Permissible Requests by Covered Entity
Covered Entity shall not request Business Associate to use or disclose PHI in any manner that would not be pem,issible 
under the Privacy Rule if done by Covered Entity, provided that, to "the extent permitted by the Service A1Ta ngement , 
Business Associate may use or disclose PHI for Business Associate's Data Aggregation activities or proper management 
and administrative activities. 
6. Term and Termination
A.
The term of this Addendum shall begin as of the effective date of the Service Arrangement and shall terminate when
all of the PHI provided by Covered Entity to Business Associate, or created or received by Business Associate on
behalf of Covered Entity, is destroyed or returned to Covered Entity, or, if it is infeasible to return or destroy PHI,
protections are extended to such information, in accordance with the termination provisions of this Section.
B.
Upon Covered Entity's knowledge of a material breach by Business Associate, Covered Entity shall either:
i.
Provide an opportunity for Business Associate to ci.ire the breach or end the violation and terminate this
Addendum and the Service Arrangement if Business Associate does not cure the breach or end the
violation within the time specified by Covered Entity .
ii.
Immediately terminate this Addendum and the Service arrangement if Business Associate has breached a
material term of this Addendum and cure is not possible .
C.
Except as provided in paragraph (d) ofthis Section, upon any termination or expiration ofthis Addendum, Business
Associate shall return or destroy all Pm received from Covered Entity, or created or received by Business Associate
on behalf of Covered Entity. This provision shall apply to PHI that is in the possession of subcontractors or agents of
Business Associate. Business Associate shall retain no c;opies of the PHI. Business Associate shall ensure that its
subcontractors or vendors return or destroy any of Covered Entity's PHI received from Business Associate.
D. In the event that Business Associate determines that returning or destroying the PHI is infeasible , Business Associate
shall provide to Covered Entity notification of the conditions that make return or destruction infeasible. Upon
Covered Entity's written agreement that return or destruction of PHI is infeasible, Business Associate shall extend the
protections of this Addendum to such PHI and limit further uses and disclosures of such PHI to those purposes that
make the return or destruction infeasible, for so long as Business Associate maintains such PHI.
7. Miscellaneous
A.
A reference in this Addendum to a section in the Privacy Rule or Security Rule means the section as in effect or
as amended.
B.
The Parties agree to take such action as is necessary to amend this Addendum from time to time as is necessary for
Covered Entity to comply with the requirements of HIPAA, the Privacy and Security Rules and HITECH.
C.
The respective rights and obligations of Business Associate under Section 6 (c) and (d) of this Addendum
shall survive the termination of this Addendum.
D.
Any ambiguity in this Addendum shall be resolved to pe1mit Covered Entity to comply with HIP AA and HiTECH.
E.
Business Associate is solely responsible for all decisions made by Business Associate regarding the safeguarding
of PHI.
F.
Nothing express or implied in this Addendum is intended to confer, nor shall anything herein confer upon any
person other than Covered Entity, Business Associate and their respective successors and assigns, any rights,
remedies, obligations or liabilities whatsoever.
G.
Modification ofthe terms of this Addendum shall not be effective or binding upon the parties unless and until
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

12: 
suc;h modification is committed to writing and executed by the parties hereto. 
H.
This Addendum shall be binding upon the parties hereto, and their respective legal representatives, trustees,
receivers, successors and permitted assigns.
XIX-5
I.
Should any provision of this Addendum be found unenforceable, it shall be deemed severable and the balanc e of the
Addendum shall continue in full force and effect as if the unenforceable provision had never been made a part hereof.
J.
This Addendum and the rights and obligations of the patiies hereunder shall in all respects be governed by, and
construed in accordance with, the law s of the State of Rhode Tsland, including all matters of construction, validity
and per formance.
K.
Al l notices and comm unications required or permitted to be given hereunder shall be sent by certified or regular
mail, addressed to the other part as its respective address as shown on the signature page, or at such other address as
such party shall from time to time designate in writing to the other party, and shall be effective from the da-te of
mailing .
L.
This Addendum , including such portions as are incorporated by reference herein , c onsti tutes the entire agreement by,
between and among the parties, and such parties acknowledge by their signature hereto that they do .not rel y upon any
representations or undertakings by any person or party, past or future, not expressly set forth in writing herein.
M.
Busi11ess Associate shall maintain or cause to be maintained sufficient insurance coverage as shall be necessary to
insure Business Associate and its employees, agents, representatives or subcontractors against any and all claitns or
claims for damages arising under this Addendum and such insurance coverage shall apply to all services provided
by Business Associate or its agents or subcontractors pursuant to this Addendum . Business Associate shall
indemnify, hold hannless and defend Covered Entity from and agains t any and all claims, losses, liabilities, costs
and other expenses (including but not limited to, reasonable attorneys' fees and costs, administrative penalties and
fines, costs expended to notify individuals and/or to prevent or remedy possible identity theft, financial hann,
reputation al haim , or any other claims of ham1 related to a bre ach) incurred as a result of, or arising directly or
indirectly out of or in connection with any acts or ornissions of Business Associate, its employees, agents,
repres e ntatives or subcontractors, under this Addendum, including, but not limited to, negligent or intentional acts
or omissions. This provision shall survive termination ofthis Addendum.
8. Acknowledgment
The undersigned affirms that he/she is a duly authorized representative of the Business Associate for which he/she is 
signing and has the authority to execute this Addendum on behalfofthe Business Ass ociate. 
Acknowledged and agreed to by: 
Rhode Island Department of Health 
. N-- 
Nicole Alexander-Scott, MD, MPH 
Director of Health 
Date: 
\..J. l  L{ lt
BROWN UNIVERSITY 
- --=? 
(
Patrice A. Carroll, Director 
Patrice Carroll 
Office of Sponsored Projects 
Brown University 
Browh University 
Date: 
2ft2a £1
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

DATA AND SAFETY MONITORING PLAN 
Protocol Title: The Rhode Island Prescription and Illicit Drug Study 
(RAPIDS): Responding to Fentanyl and Associated Harms 
NIH Grant Application Number: R01DA047975-01 
Institution: BROWN UNIVERSITY 
Principal Investigator: Brandon DL Marshall, PhD 
IRB STATUS: Submitted 12/13/2018, Revised 03/31/2019, Conditionally Approved 04/18/2019, Resubmitted 
5/20/2019 
TABLE OF CONTENTS 
Section 
Page 
number(s): 
A.1. Summary of the Protocol
3 
Study Design 
Primary and Secondary Outcome Measures 
Inclusion/Exclusion Criteria 
Power Calculation and Sample Size 
B.1 Trial Management
4 
List of Data Collection Centers 
Data Collection Procedures 
Target Population Distribution 
Projected Timetable 
C.1 Data Management and Analysis
5 
Data Acquisition and Transmission 
Data Entry Methods 
Data Analysis Plan 
D.1 Quality Assurance
8 
Quality Assurance Plan 
Data Quality and Data Protocol Monitoring 
Protocol Deviations and Noncompliance Reporting 
Staff Training & Training/Response for Overdose 
E.1 Regulatory Issues
11 
Reporting of Unanticipated, Adverse, or Severe Adverse Events (SAEs) 
Report of Changes or Amendments to the Protocol 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Trial Stopping Rules 
Disclosure of any Conflict of Interest 
Data Safety 
F.1 Trial Safety
13 
Potential Risks and Benefits for Participants: Loss of Confidentiality 
Potential Risks and Benefits for Participants: Referrals for Services or Treatment 
Potential Risks and Benefits for Participants: Fentanyl Test Strips 
Research Database Infrastructure 
Stronghold Data Security Policies for Investigators 
Collection and Reporting of Adverse Events (AEs) and Severe Adverse Events (SAEs) 
G.1 Trial Efficacy
16 
Plans for Interim Analysis of Efficacy Data 
H.1 Data and Safety Monitoring Plan for Administration
16 
Responsibility for Data and Safety Monitoring 
Content of the Annual DSM Report 
I.1 Data Safety Monitoring Board (DSMB) Plan
17 
Members and Affiliation, Conflict of Interest 
Frequency of Meetings & Protection of Confidentiality 
Monitoring Activities 
Communication Plan to IRB, NIDA 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

A1. Summary of the Protocol 
Study Design 
We will enroll 550 adults into a two-arm, randomized clinical trial. Interviewer-administered questionnaires will 
be conducted at baseline, along with follow-up visits at 4-, 8-, and 12- months post-randomization. 
Experimental arm participants will receive the RAPIDS intervention and will be provided with ten fentanyl test 
strips for personal use. Motivational interviewing “booster” sessions (with additional test strips distributed on an 
as-needed basis) will be conducted a 1, 2, and 3, months. Participants in the attention-matched control arm will 
be followed at the same intervals and will receive a standard overdose education and naloxone distribution 
(OEND) training program. To meet our recruitment goals, we aim to conduct 20 baseline visits per month 
starting in Year 1, Quarter 3 and continuing until full enrollment is reached. 
Primary and Secondary Outcome Measures 
The primary outcome will be the rate of self-reported overdose observed over the 12-month follow up period. 
We will supplement the primary endpoint with data on fatal overdose events ascertained through a CDC- 
funded statewide overdose surveillance system. 
Inclusion/Exclusion Criteria 
Inclusion Criteria: We will enroll adults who: (a) are 18 to 65 years of age; (b) reside in Rhode Island; (c) are 
able to complete interviews in English; (d) are able to provide informed consent; and (3) self-report use of 
heroin, illicit stimulant use (e.g., powder cocaine, crack, methamphetamine), injection drug use, or use of 
counterfeit prescription pills (defined as prescription pills obtained through the illicit drug market) in the past 30 
days (regardless of treatment status). Participants who refuse consent to participate, are unable to provide 
informed consent due to altered mental status, or who cannot adequately hear and/or comprehend either 
consent process, will not be enrolled. To assess counterfeit prescription pill use, participants will be asked if 
they purchased any prescription medications “on the street” (e.g., from a drug dealer), including opioids, 
benzodiazepines, and stimulants. We will not enroll vulnerable populations such as prisoners, children, etc. 
Exclusion Criteria: We will exclude participants who exclusively misuse medications obtained from a physician 
or diversion from someone else’s prescription. 
Power Calculation and Sample Size 
We are seeking IRB approval for n=550 participants enrolled in the study. We provide power calculated for key 
outcomes below, based on an enrollment of 500 participants (n=250 per arm) to account for attrition. The 
following assumptions are based on findings from our pilot intervention study. First, at baseline, 37% of 
participants reported a lifetime history of overdose, and 11% reported an overdose in the past six months. As 
such, for the primary analyses, we assumed that 20% of participants in the control arm will experience an 
overdose during the 12-month follow-up period. Second, we conservatively assumed an 80% retention rate in 
the trial, although we were able to retain 90% of pilot participants. 
Given these assumptions, we have >80% power to detect a 50% reduction in overdoses (i.e., the primary 
endpoint for Aim 1, see Research Strategy section C.9, Figure 6A). Similar effect sizes were assumed for an 
ED-based overdose prevention intervention,214 and have been deemed as a benchmark for success by key 
stakeholders. For the second endpoint in Aim 1 (time to first fatal overdose or ED visit related to an overdose), 
we conservatively assumed that only 38% of self-reported overdoses would result in death or presentation to 
the ED, based on previously published data,65 for a rate of 8 per 100 person-years in the control arm. As 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

shown in Figure 6B (see section C.9), we have ≥80% power to detect a 50% reduction in the hazard of fatal 
overdose or ED visit for an overdose. Finally, we used a method to estimate sample size for evaluating 
mediation by joint testing of both links in an indirect pathway from exposure to mediator to outcome (Aim 2).215
Given the assumptions described above, we have >80% power to detect a statistically significant mediated 
effect for a coefficient for exposure on mediator and mediator on outcome of at least 0.8, respectively. 
B1. Trial Management 
List of Data Collection Centers 
The study will consist of interviewer-administered, computer-assisted surveys conducted by professionally 
trained and supervised interviewers at the centrally located Brown University School of Public Health in 
Providence, Rhode Island. 
Target population distribution (eg women, minorities, etc) 
(Also included in the Inclusion and Enrollment Report of the PHS Human Subjects and Clinical Trials form) 
Based on preliminary data, we predict the following enrollment: 
Race: 
American Indian/Alaska Native 
2% (n=10) 
Asian 
1.5% (n=8) 
Native Hawaiian/Other Pacific Islander 
1% (n=5) 
Black or African American 
20% (n=100) 
White 
60% (n=302) 
Mixed race 
15% (n=75) 
Ethnicity: 
Hispanic/Latino Ethnicity 
15% (n=75) 
Gender: 
Female 
Table 1. Projected Timetable 
33% (n=165) 
(Also included in section 2.7 of the PHS Human Subjects and Clinical Trials form) 
Table 1. Project Timeline 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Key Activities 
(Quarters) 
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 
Phase 1: Trial Preparation 
x 
x 
Hiring & training of Interventionists (i.e., trainings 
include motivational interviewing, drug user stigma, 
Human Subjects Research Protection-CITI Training, 
survey administration for RAPIDS intervention, 
overdose prevention and response, naloxone 
administration) 
x 
x 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Finalize survey instruments, build participant 
databases, and develop online survey tools 
x 
Finalize project protocols, register as clinical trial 
x 
x 
Finalize IRB certification, finalize Data Safety 
Monitoring Board (DSMB) and establish 
quarterly meetings 
x 
x 
Develop and purchase advertising (field & internet) 
x 
Phase 2: Implementation 
x 
x 
x 
x 
x 
x x 
x 
x 
x 
x 
x 
x 
Recruitment and screening of potential participants 
x 
x 
x 
x 
x 
x x 
x 
Randomization of participants to Arm 1 or Arm 2 at 
baseline visit 
x 
x 
x 
x 
x 
x x 
x 
Annual IRB re-certification, quarterly progress 
reporting to NIDA and DSMB 
x 
x 
x 
x 
Booster sessions at 1mo, 2mo, 3mo (post-baseline) 
x 
x 
x 
x 
x x 
x 
x 
x 
x 
x 
Assessment at 4mo, 8mo, 12mo (post-baseline) 
x 
x 
x 
x x 
x 
x 
x 
x 
x 
Phase 3: Analyses 
x 
x 
x 
x 
x x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Data cleaning and management 
x 
x 
x 
x 
x x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Prepare & submit abstracts for scientific 
conferences and meetings 
x 
x 
x 
x 
x 
x 
x 
Write and submit manuscripts (Aim 1: assess 
efficacy of RAPIDS intervention—baseline and final 
at 12 months) 
x 
x 
x 
x 
x 
x 
x 
x 
Write and submit manuscripts (Aim 2: mediation 
analysis) 
x 
x 
x 
x 
x 
Write and submit manuscripts (Aim 3: treatment 
heterogeneity analyses) 
x 
x 
x 
x 
C1. Data Management and Analysis 
The primary source of data will be survey responses, including self-reported behaviors. Surveys will be 
conducted on touch-screen tablets using REDCap™ (Research Electronic Data Capture) software, 
which allow for direct, secure, and remote data entry. Similar to other studies, we have found the 
combined computer-assisted personal interview and computer-assisted self-interview (CAPI/CASI), 
conducted by trained, in-person interviewers, acceptable to the study population and efficient to 
administer. These procedures will protect against loss of confidentiality, improve reporting of sensitive 
behaviors, and reduce participant burden. 
A second source of data will be datasets owned by the Rhode Island Department of Health (RIDOH). 
Specifically, secondary outcomes will include fatal overdose events among participants during the study 
period, as determined through linkage to administrative records. All fatal overdose events occurring in 
the state are certified and investigated by the Rhode Island Office of State Medical Examiners. These 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

administrative records are reviewed regularly as part of ongoing surveillance efforts and represent 
comprehensive sources regarding overdose events occurring in Rhode Island. We will adhere to strict 
data security and confidentiality protocols when accessing administrative datasets, as outlined in our 
existing BAA with RIDOH and as approved by the Brown IRB. 
Data acquisition and transmission: 
Stronghold computing environment: We will obtain a central storage service hosted by Brown 
University’s Computing & Information Services (CIS) Stronghold project. Stronghold is a HIPAA-aligned 
(Health Insurance Portability and Accountability Act), secure computing environment developed for 
housing, sharing, and analyzing sensitive data. The project’s Biostatistician will oversee the database 
architecture, dataset storage, and all input/output (i.e., RIDOH data transfer) regulations. Stronghold is 
highly secure computer and storage Windows-exclusive environment for research needs that involve 
very sensitive data needing special handling, data usage agreements, etc. See section F1. Trial Safety 
for additional information about Stronghold security. 
All Stronghold users must: 
●
be approved by the Principal Investigator, authorized in writing to Brown University Computing &
Information Services (CIS);
●
complete appropriate training for working with sensitive data (e.g. CITI training);
●
be in compliance with all relevant Institutional Review Board protocols;
●
be in compliance with any data use agreements or other agreements governing the use of
the data stored on Stronghold; and
●
complete an on-boarding process led by the Principal Investigator or Senior Research
Assistant, which includes a review of data security protocols and a guided walkthrough of
accessing the Stronghold virtual environment.
Data Transfers – there are select methods to import data, including but not limited to: 
●
Select Rhode Island state agencies and other offices using a secure VPN tunnel
●
Encrypted USB drives
●
Secure transfer through firewall exception
●
Import and export servers
For the proposed project, the Senior Research Assistant will conduct and automate secure data 
transfer of administrative overdose records with RIDOH on a monthly basis (according to the timeline 
outlined in our existing data use agreement). 
Data Entry Methods 
Survey data will be collected on password-protected tablets and computers within the Centers for 
Epidemiology and Environmental Health (CEEH) at the Brown University School of Public Health. The 
REDCap™ platform exceeds patient confidentiality and data security requirements for clinical trials, and 
are both HIPAA compliant and fully validated for FDA 21 CFR Part 11. 
The project’s Biostatistician will manage the REDCap™ database architecture, dataset storage, and all 
input/output (i.e., data transfer) regulations. 
Data Analysis Plan 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

For all analyses, a series of routine procedures will first be conducted to ensure data 
accuracy/adequacy. Descriptive statistics will provide examination of the variables’ distributional 
properties; if required, data will be transformed to achieve normality. For all analyses, we will adopt an 
intention-to-treat (ITT) approach to address potential problems inherent in following only intervention 
completers (e.g., self-selection effects, differential attrition across groups). Prior to examining 
intervention effects, we will first assess the success of randomization on pre-intervention characteristics 
using one-way analysis of variance (ANOVA), with intervention group as the predictor variable. The 
extent to which groups differ on baseline characteristics will determine whether any of these should be 
included as covariates in the primary analyses (see below). Missing covariate data will be handled 
using multiple imputation performed in two stages using chained equations that specify the conditional 
models for all of the variables with missing values.207-209
Assessing intervention efficacy in reducing self-reported overdose (Aim 1, primary endpoint). 
First, in the ITT analysis, we will determine the efficacy of the intervention by comparing self-reported 
rates of overdose among those assigned to the intervention arm versus the control group. First, we will 
use logistic regression to determine the independent effect of the intervention on the proportion 
reporting an overdose over the follow-up period, adjusting for baseline covariates as needed. Second, 
we will use generalized linear mixed effects models (GLMMs) with a logit link function to examine 
differences in self-reported overdose rates at each time point by incorporating fixed effects representing 
time, an intervention assignment indicator, and an interaction term that assesses the significance of the 
intervention influence over time. Third, in a per-protocol sub-analysis, we will determine the effect of the 
intervention on self-reported overdoses among those who used the fentanyl test strips. 
Per-protocol analyses will be based on principal stratification. Principal stratification is a statistical 
technique that is used to adjust for a post-treatment variable (e.g., utilization of fentanyl test strips), and 
treatment effects are estimated within each stratum of that variable.210 We can then estimate the effect 
of the intervention in reducing rates of self-reported overdoses, conditional on whether participants 
used the test strips. 
Examine whether the treatment effect is mediated by differential uptake of risk reduction 
behaviors in the intervention arm (Aim 2). If the RAPIDS intervention shows efficacy in reducing 
overdose rates among the sample (Aim 1), we will explore the extent to which this relationship works 
through several possible mediators (see Figure 4). For mediation analyses, first, we will examine, in 
multivariable regression models, which mediators, if any, are significantly changed by the intervention 
(i.e., the rate of change differed by treatment assignment). For those that are significantly impacted by 
the intervention, we will conduct path analysis using structural equation modeling to determine whether 
the effect of the intervention on overdose was through the hypothesized mediator(s). Structural 
equation modeling (SEM) allows for the simultaneous estimation of total, direct, mediated and indirect 
effects of a causal variable (i.e., the intervention) on the outcome (i.e., overdose) through a set of 
mediator variables.211 SEM can handle outcomes and mediators with a variety of distributions 
(including, Gaussian, Poisson and Binomial).212 Inferences for indirect effects can be estimated using 
bootstrapped confidence intervals.213
Determine whether intervention efficacy varies across participant subgroups (Aim 3). We will 
examine if heterogeneity of intervention effect is modified by key baseline characteristics of interest, 
including: age; sex; type, frequency, and route of drug use; baseline level of overdose risk (e.g., lifetime 
history of overdose); and pre-intervention motivations for fentanyl test strip utilization. We will perform 
stratified subgroup analyses to determine if treatment effects vary between groups of individuals. 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

D1. Quality Assurance 
Quality Assurance Plan 
Prior to making any changes to the protocol, we will seek approval from the NIDA program officer (PO) 
as well as the Brown University IRB. Significant protocol changes will be uploaded to clinicaltrials.gov 
upon IRB and NIDA approval. 
The project’s Biostatistician will manage the database architecture, dataset storage, and all input/output 
regulations for the RIDOH data transfers and storage, as well as storage of the the primary data from 
the trial. The database will be maintained under several firewalls, with restricted access to the Internet 
except for data imports and software installations. Control systems will be implemented to prevent data 
migration without authorization, complete with real time notifications of breaches. The data will routinely 
undergo backup procedures to ensure in the event of system failure, the data is recoverable. 
Data Quality and Data Protocol Monitoring 
Frequent scanning of Stronghold servers will be done to identify potential security vulnerabilities. The 
Stronghold Team will attempt to make this service available as requested 24 x 7 x 365 at all times 
outside of the planned maintenance window. 
The Stronghold Team monitors and records all activity on the Stronghold system, including networking 
and access events, which may depend on classification of the data and any applicable regulations. 
Project staff receive notification of any activity on the Stronghold system. Notifications include alerts 
when data is imported to or exported from the transfer server. These alerts are emailed to the Principal 
Investigator and other project staff on fifteen minute intervals, detailing the name of the person who 
transferred the data, as well as the file description. Automated reports are also sent out monthly which 
detail the users who are currently approved to access Stronghold. There reports also include 
information about which users have read and write permissions to the secure transfer server. 
All Center for Epidemiology and Environmental Health (CEEH) offices are connected into a single 
virtual local area network (LAN) by the central Brown Computing and Information Services group. 
Servers are located in a physically secured, temperature-controlled environment. All external network 
access is limited to a single gateway. Network traffic is filtered by type. Network traffic that would 
present a major security risk is disallowed. Protocol filters that limit the nature and type of network 
traffic likewise defend the servers. These machines host a complete suite of Internet-working facilities 
as well as data storage and backup. The CEEH uses a variety of security techniques including firewalls 
and antivirus software to maintain a secure and reliable computer environment. 
Protocol Deviations and Noncompliance Reporting 
Protocol deviations and noncompliance reporting will be the responsibility of the Project Investigator 
and Project Director. Such issues will be monitored on a consistent basis, and if any deviations are 
found they will be reported promptly to the Brown IRB. 
Staff Training: Research Protections 
All staff will receive Brown’s mandated CITI online training for all Human Subjects Research, as well as 
additional HIPAA-specific training, Clinical Trials with Investigational Drugs and Medical Devices (U.S. 
FDA Focus), and Social and Behavioral Research Best Practices for Clinical Research. All training will 
occur prior to working with study data or research participants. 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Staff Training: Overdose Response (see also: Safety Protocol) 
Additional in-person training will be provided to all staff by the community-based partner Rhode Island 
Disaster Medical Assistance Team's Medical Reserve Corps (RIDMAT), or the Project Director or RA 
who as attended the RIDMAT Train the Trainer program, on the following topics: 
●
Overdose recognition and response (1 hour)
●
How to administer naloxone (1 hour)
Program-specific trainings will be offered by the RAPIDS Project Director on the following: 
●
Safety Procedures and Response (see procedures below) (1 hour)
●
Motivational Interviewing and Brief Intervention for RAPIDS (6 hours)
All research staff will be trained on how to recognize and response to a drug overdose prior to working 
directly with participants, as well as how to administer naloxone in the event of a suspected overdose. 
NOTE: we are NOT clinicians or medical professionals and so we are limited in the scope of what we are 
able to offer someone in these circumstances, but we are expected to call for immediate medical help if 
someone is unresponsive. If you or another staff are trained on recognizing and responding to an 
overdose, then you may proceed with the protocol for responding to a suspected overdose using a 
“naloxone kit.”** 
In the event of an overdose, the primary staff person is responsible for documenting the situation 
thoroughly and following-up with the Principal Investigator and Project Director immediately. 
All staff persons involved in witnessing or responding to an overdose should check in and debrief with the 
Project Director as soon as possible or before they leave for the day. 
**The Naloxone Kit: Includes two naloxone vials for administration, accompanied by latex gloves and an 
infographic on how to administer the naloxone. These items are kept in a pouch, clearly labeled 
“Naloxone Kit,” and there will be one at each study staff workstation in an unlocked drawer, and in each 
interview room at the School of Public Health. The RAPIDS Research Assistant is responsible for 
monitoring the expiration dates of naloxone, discarding all naloxone doses as the law allows, as they 
expire, and re-ordering new Naloxone Kits from their community partner or supplier. The School of Public 
Health also has a publicly-accessible naloxone kit on the 3rd floor, directly across from the elevators. 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

OVERDOSE RESPONSE INSTRUCTIONS 
If you witness a participant as suddenly unconscious, not breathing, cannot be woken, or is turning 
blue, you are expected to respond immediately. 
•
You are now the “PRIMARY STAFF PERSON” and are the main person responsible for getting medical
help.
o
Your role is to find one other staff person nearby and tell them how to help you respond to the
medical situation (specifically, ask them to call 911).
o
Your role is to stay with the participant until medical help arrives.
o
Disclose at least the first name of the participant to First Responders, as well as any relevant
health information (if received), and that this may be an opiate overdose.
o
Ensure that the participant receives thorough care and has all of their belongings prior to leaving
by ambulance if possible.
•
The other staff person is now the “SECONDARY STAFF PERSON” and they are responsible for calling
911 and making sure the First Responders can find the participant.
o
They should also notify a supervisor or Full Time staff person immediately to support the Primary
Staff Person.
A Naloxone Kit** may be administered under the following circumstances: 
•
When a participant cannot be woken,
•
When medical help is on the way,
•
The staff person is trained to recognize an overdose AND administer naloxone,
•
The staff person follows instructions using bullets 1-8 below.
OVERDOSE RESPONSE WITH NALOXONE INSTRUCTIONS: 
•
Primary Staff Person:
o
Verify that the participant cannot be woken up by yelling their name loudly.
o
Then do a sternum rub on the participant’s chest using your knuckles.
o
Loudly announce to the participant, “I am going to call 911 to get you medical help.”
•
Primary Staff Person: Ask a nearby staff person to be in the “Secondary Staff” role.
o
Tell them to “Call 911” and report, “a person is unconscious/not breathing” and give the
location at 121 South Main Street, 2nd floor.
•
Secondary Staff Person:
o
“Call 911” and report, “a person is unconscious/not breathing” and give the location at 121
South Main Street, 2nd floor.
o
Give First Responders and Building Security the exact location of the participant within the
building.
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

o
Notify the Project Coordinator or another Full Time staff person on the team to stay with the
participant and the primary staff person.
o
Go to the building entrance to meet EMS and direct them to the participant.
•
Primary Staff Person:
o
You are to stay with the participant until help arrives.
o
Please clear the immediate area so First Responders have room to respond and get to the
participant when they arrive.
o
Please limit the number of people near the participant so there is room for the first responders
when they arrive. No crowds.
•
Primary Staff Person (IF trained on naloxone administration):
o
If you assess the participant according to your training and determine that they meet the
criteria for naloxone, loudly announce to the participant, “I am going to give you naloxone
now.”
o
You may administer the Naloxone Kit** according to the instructions, starting with one dose of
naloxone. The administration of the Naloxone Kit covers up to two doses.
•
Primary Staff Person:
o
Notify the First Responders immediately if naloxone is administered, and how much was
administered.
o
Disclose at least the first name of the participant to First Responders, as well as any relevant
health information (if received), and that this may be an opioid overdose.
•
All Staff Involved:
o
Once the First Responders arrive to the location and have located the participant, these
professional medical staff become immediately responsible for all first aid procedures.
o
Back away and give the First Responders space. Make sure the area is clear so they can
leave quickly if needed.
E1. Regulatory Issues 
Reporting of Unanticipated, Adverse, or Severe Adverse Events (SAEs)1 
The overall data and safety monitoring will be the responsibility of the Principal Investigator (PI), Dr. 
Brandon DL Marshall, PhD. The PI is also responsible for executing the Data and Safety Monitoring Plan 
(DSMP), and complying with the reporting requirements. The PI will provide a summary of the DSMP 
report to the National Institute on Drug Abuse (NIDA) on an annual basis as part of the progress report. 
The PI will ensure that all study procedures are in place prior to the initiation of the protocol, and that all 
study procedures and reporting of adverse events are performed according to the protocol. Severe 
adverse events (SAEs) will be monitored by the investigative team in near real-time throughout the trial. 
In addition, a Data Safety Monitoring Board (DSMB) will also provide independent study monitoring 
during all patient recruitment activities as described below. 
The PI will monitor for adverse events that change study risk level. If an adverse event occurs which 
changes the study risk level, the Study PI will immediately report this event to the IRB (Brown 
University), DSMB, and NIDA, and will oversee the process of modifying the study as appropriate to 
1 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.32 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

address the change in risk. The PI will also provide annual reports summarizing SAE data to the IRB. 
Given the nature of our eligibility criteria, the most severe adverse event may include fatal overdose 
among participants in the clinical trial. Overdose fatalities in Rhode Island are at crisis levels. Therefore, 
we may reasonably expect an outcome of fatal overdose among some participants. Given the severity of 
such an event, the PI will also monitor for self-reported, nonfatal overdoses (at follow-up visits). Each 
self-reported or fatal overdose will qualify for review by the DSMB to ensure any overdoses among our 
participants are not related to their participation in the research and are not more prevalent than 
expected (see below: Collection and Reporting of Adverse Events [AE] and Severe Adverse Events 
[SAEs]). All fatal overdose events occurring in the state are certified by the Office of State Medical 
Examiners within 90 days. To ascertain fatal overdose events, we will obtain consent from participants at 
the start of the trial to link to overdose surveillance datasets with participant data using a probabilistic 
linkage with the following combination of identifiers: first and last name, date of birth, and sex. 
Report of Changes or Amendments to the Protocol 
All changes or amendments to the protocol will be submitted in writing and will receive prior approval 
from the Brown University IRB. We will also seek approval from the NIDA program officer (PO) as well. 
Significant protocol changes will be uploaded to clinicaltrials.gov upon IRB and NIDA approval. 
Trial Stopping Rules 
Interim analyses of study data are planned according to the alpha spending rule [Lan and DeMets, 
1994]2. The proportion of expected events (i.e., self-reported non-fatal overdose) is considered as the 
information statistic. The p-values will be constructed to maintain the overall study power of 0.05, two- 
sided. If the test statistic exceeds the boundary, then the study could be considered for early 
termination due to emerging differences between the two arms. The PI will recommend to the DSMB 
that two interim analyses should be conducted over the course of the study. 
The study investigators will report all adverse events and significant adverse events to the DSMB (see 
below). Moreover, all adverse and significant adverse events will be summarized by the study 
Biostatistician each quarter, and all categories with a statistically significant (at a p < 0.05, two-sided) 
excess incidence in the intervention group will be flagged. These flags will be reviewed and commented 
on by the DSMB, which may recommend early termination of the trial given evidence of harm based on 
these and other safety data. 
Finally, the entire trial will stop if any investigator judges it necessary for medical, safety, regulatory, or 
other reasons consistent with applicable laws, regulations, or good clinical practice. Once a concern of 
this proportion is raised, the decision to stop the trial will be made through immediate consultation with 
the IRB, the DSMB, and NIDA. 
Disclosure of any Conflict of Interest 
All data sharing partners (e.g., RIDOH) and project investigators will agree to specific terms of use for 
the data according to a signed Data Use Agreement, which includes a request to disclose any potential 
conflicts of interest. 
All individuals who meet the definition of Investigator will participate in Brown’s FCOI or equivalent 
2 https://www.ncbi.nlm.nih.gov/pubmed/7973215 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

training, and sign all necessary forms related to disclosure of conflicts of interest. 
Data Safety 
This project will use Brown University’s Stronghold secure computing environment. As described in 
section F1, this computing environment is HIPAA aligned, and developed for housing, sharing, and 
analyzing sensitive data. 
F1. Trial Safety 
Potential Risks and Benefits for Participants: Loss of Confidentiality 
This project uses primary and secondary data regarding illicit drug use and overdose events; therefore, 
confidentiality of study data is of utmost importance. Access to such records for legitimate research 
purposes has been approved by our data sharing partner, RIDOH, and our team has worked carefully 
to ensure the protection of these data. 
We recognize that a loss of confidentiality may also result in psychological harm to individuals or in 
social harm. As such, the research team will be using Brown’s state of the art Stronghold computing 
environment for the transfer, analysis, and protection of all research data. Data sharing partners will 
share only the required datasets and variables. Additionally, only select members of the analytic team 
will have access to any identifiable datasets. All data transfer procedures, analytic plans, and use of 
administrative datasets will be approved by the Brown IRB. 
Potential Risks and Benefits for Participants: Referrals for services or treatment 
To determine if participants would benefit from referrals for treatment or social services, we will offer all 
participants a community resources packet at the end of the baseline visit. These resources will include 
information regarding addiction treatment (including MAT), syringe exchange, peer counseling, and 
mental health care. We will then ask if they would be willing to hear about programs or organizations 
pertaining to those services most important to them. Based on their responses, we can then refer them to 
those specific organizations. 
Potential Risks and Benefits for Participants: Fentanyl Test Strips 
This study will use Fentanyl Test Strips purchased from BTNX, Inc. These are single-use, lateral flow 
immunoassay test strips for the qualitative detection of fentanyl in liquid and powder substances at the 
cut-off concentration of 20 ng/mL. 
BTNX, Inc. is aware of the research study and have pledged their support. Additionally, they have 
offered to individually number test strips for use in the study as well as provide technical expertise and 
assistance to ensure that the diagnostic abilities and limitations of the test strips are communicated 
effectively to participants. In addition, they will ensure that our team is kept abreast of new information 
regarding the ability of the test strips to detect additional novel fentanyl analogs. 
All participants in the Intervention Arm will receive face-to-face training on how to use the test strips, and 
the risks of using the test strips. Participants will be given plain-language handouts to take with them at 
each visit that reiterate the main training points and risks. 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

The study will also include information in the consent form that will detail the use of fentanyl test strips, 
sample text is below: 
·
RISKS: ….If you are in the group that receives fentanyl test strips, the test strips do not guarantee 
your safety against an overdose as they are not always 100% accurate. 
·
BENEFITS .........If you are in the group that receives fentanyl test strips, the strips may provide 
you with additional information about what is in your drugs. 
Research Database Infrastructure: 
This project will benefit from data security resources provided by the Brown University “Stronghold” 
computing system. Stronghold is a secure computing and storage environment that enables Brown 
researchers to analyze sensitive data, while complying with regulatory or contractual requirements. 
Stronghold is currently self-certified to meet the security requirements and controls for HIPAA (Health 
Insurance Portability and Accountability Act) and is undergoing the certification process for FISMA 
(Federal Information Security Management Act) and CJIS (Criminal Justice Information Security). We 
will use the Stronghold secure computing environment to store, maintain, and transfer dataset between 
Brown University and RIDOH. 
Stronghold is a secure virtual compute environment designed for remotely analyzing sensitive data. It 
uses encrypted SSH (Secure Shell) with two-factor authentication for remote access. Access to each 
virtual network is limited to a single PI and any additional students or staff who the PI authorizes in 
writing to Brown University Computing & Information Services (CIS). The PI enters into a written 
agreement with CIS that authorized users must comply with all necessary training requirements. CIS 
staff who have access to Stronghold have completed CITI course modules for working with human 
subject data as required by Brown’s Office of Research Protection. 
Stronghold is accessible only from within the Brown campus network and by Virtual Private Network 
connections (using two-factor authentication) from outside the campus network. All network 
connections to Stronghold pass through at least two firewalls: a dedicated firewall on the Brown 
campus network and a host-based firewall in the Stronghold environment. Stronghold uses a Windows- 
exclusive virtual environment when accessed through a Virtual Private Network (VPN). 
The Stronghold system is physically located in a locked rack in a CCTV monitored data center on the 
Brown campus. Only certain authorized CIS staff have access to this locked rack. Entry to the data 
center is limited to authorized Brown IT personnel and their guests, and all entries are logged. 
This service is customized to the needs of individual users and their data use agreements. Each 
investigator is given a dedicated environment for their project to support their co-investigators, graduate 
students, research assistants, interviewers, and other collaborators. Access to the Internet is restricted 
except for required locations for data imports or necessary software downloads. Import and export 
controls are in place to limit who can perform data migration, where sensitive data can come from and 
where desensitized or anonymized data can be moved to. Sensitive data is subject to file system 
auditing, and real-time alerting is available at the request of the PI. 
Stronghold Data Security Policies for Investigators: 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

The PI may impose additional requirements regarding credentials, connections methods, or 
clients based on the nature of the data. 
1.
All systems (workstations, laptops, etc.) used to connect to Stronghold-must have the
following security precautions in place:
a.
A password-protected lock-out screen that appears after inactivity of 5 minutes or less.
b.
Up-to-date antivirus and malware installed.
c.
An up-to-date operating system with all currently available updates installed.
d.
Physical security (either card access or keyed locks) that prevents unauthorized
users from physically accessing the system while it is connected to Stronghold.
e.
All connections to Stronghold-will be through a Virtual Private Network (VPN).
Currently, Stronghold supports the OpenVPN client.
2.
Restricting the import and export servers to the Principal Investigator and Senior Research
Assistant.
3.
Removal of previously authorized Stronghold users if they leave the research team. The
Principal Investigator will contact Brown University Computing & Information Services (CIS) to
authorize the removal of Stronghold users.
4.
Study reports, results, and published manuscripts will suppress all identifiable
information, and include only aggregated results.
Collection and Reporting of Adverse Events (AE) and Severe Adverse Events (SAEs)3
FDA Definitions 
SAEs must be reported to the NIDA PO within 24 hours of the event by email. At a minimum this 24 hour 
notification should include a brief explanation of the SAE and when it occurred. A written follow up must 
be received within 72 hours of the event. The written follow up should include information on the date of 
the event, what occurred, actions taken by project staff, planned follow up (if any), the intervention 
group/study arm of the affected participant, whether the event appears to be related to the intervention, 
and whether participant will continue in the study). 
AEs must be reported to the NIDA PO at least once per year and can be reported as a part of the annual 
progress report. At a minimum, this report should describe the event, when it occurred, the study arm of 
the participant, and the outcome/resolution. If there were no AEs, a statement that no AEs occurred 
should be included in the progress report or communicated to the PO in writing. 
Our research team will follow FDA federal guidelines for reporting of all Adverse Events and Severe 
Adverse Events. The level of study risk, Adverse Events, and Severe Adverse Events will all be 
monitored and managed throughout the study by the Project Investigator with support from the Project 
Director. 
Consultation from the Brown IRB will be immediately available to the PI to address any required actions, 
investigations, or changes to the risk level of the study. 
3 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.32 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

The DSMB will be notified within 24 hours of any severe adverse events, and will be asked to convene at 
the earliest possible time to discuss, but no greater than 30 days from the time of the severe adverse 
event notification. A detailed summary of AEs will be reported to the DSMB on a quarterly basis. 
The following AEs will be reported to the DSMB: 
●
Participant concerns or complaints regarding the fentanyl test strip devices
●
Findings from other studies regarding device risk
●
Self-reported nonfatal overdose (determined through study assessments)
●
Severe discomfort due to assessment procedures
●
Significant embarrassment in disclosing sensitive personal information
The following SAEs will be reported to the NIDA PO and the DSMB: 
●
Violation of confidentiality or breach of participant records with PII
●
Overdose death (determined through record linkage)
●
Death from other causes (determined through participant follow-up procedures)
●
Overdose on-site at the research study
●
Unanticipated adverse device effects
●
Disclosure of information about current and/or intended physical harm to persons; current and/or
intended abuse of children that would be reported to a child welfare agency; and/or an
investigation of such allegations(s) that could ensue
G1. Trial Efficacy 
Plans for Interim Analysis of Efficacy Data 
The primary data will be analyzed and reviewed on a monthly basis by the Biostatistician, and on 
quarterly intervals by the project Investigators. For the overdose surveillance data that are provided by 
RIDOH, the Data Analyst and Senior Research Assistant will analyze and clean those data on a 
monthly basis and present summarized results to the project investigators quarterly. 
H1. Data and Safety Monitoring Plan for Administration 
Responsibility for Data and Safety Monitoring 
The Principal Investigator, Brandon Marshall, PhD is ultimately responsible for data safety and 
monitoring. This process will be monitored on a weekly basis by his team, including the Project 
Director, Data Analyst, and Senior Research Assistant, with quarterly updates to the entire team of 
Co-Investigators. The project team will be responsible for ensuring that all policies and processes 
outlined in the Data Use Agreements are followed accordingly, and that data are transferred and 
shared on the agreed-upon timeline, using the IRB-approved data transfer methods. Additional 
reporting for data and safety monitoring include quarterly updates to the DSMB, and annual reports 
to the IRB and NIDA. 
Content of the Annual DSM Report: 
a.
Brief description of the trial
b.
Summary of qualifying data events observed during the annual time period
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

c.
Q.A. issues
d.
Regulatory issues
e.
AEs
f.
SAEs
g.
Efficacy of the trial, interim analyses
I1. Data Safety Monitoring Board (DSMB) Plan 
●
Members and Affiliation, Conflict of Interest
A single Data Safety Monitoring Board (DSMB) will be appointed to oversee this project. The DSMB
must include a minimum of 3 individuals with expertise relevant to the research. Board members must 
have no direct involvement with the intervention or study and no other conflict of interest with the 
intervention or study. The PI will consider the inclusion of a statistician/methodologist and/or ethicist as 
part of the board. Any potential conflicts of interest must be disclosed during the application process. 
The NIDA PO will ultimately approve the membership and Safety Monitoring Plan for the DSMB, which 
will also be included in the IRB application/amendment. 
●
Frequency of Meetings & Protection of Confidentiality
The DSMB will meet on a quarterly basis with the PI and Project Director present to review DSMP
protocol adherence. All members of the DSMB will receive a copy of the protocol. The protocol includes 
the data safety monitoring plan, which is to be used as a guide during the DSMB meetings. In addition, 
the DSMB will be responsible for the following: 
●
Review any issues related to deviations from the protocol and reported adverse events.
●
Review and approve the study protocol prior to the start of the study, and review
major amendments to the protocol.
A report on DSMB meetings and activities should be sent to the NIDA PO by the PI within 30 
days of each DSMB meeting. The update will include the following: 
●
meeting dates (past and upcoming if known)
●
meeting minutes or summary
●
current board membership
●
changes in membership (if applicable)
●
information about any new member(s) (if applicable) including statement that new
members have no conflict of interest specific board recommendations regarding the
research project (if any)
●
Monitoring Activities
The DSMB will be notified within 24 hrs of any serious adverse event (e.g., breach of confidentiality,
overdose death) and the DSMB will convene at the earliest possible time to discuss, but no greater 
than 30 days from the time of the adverse event notification. At the conclusion of each meeting, the 
DSMB will make a recommendation on study continuation, with a particular regard to safety and 
confidentiality issues. The DSMB will also provide written reports to be shared with the IRB which 
summarizes oversight activities and recommendations, and any concerns regarding study safety. 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

The DSMB will provide this recommendation in the form of study comments to the Co-PIs and IRB. IN 
addition, the DSMB will determine if there is sufficient concern to stop the trial. 
●
Communication Plan to IRB, NIDA
The Principal Investigator and the Project Director will coordinate all communication and grant reporting
to the necessary parties, with the goal of transparency across oversight boards (IRB, DSMB) and the
funding institution. Examples of communication shared by the PI include annual progress reports to
NIDA, annual recertification of the IRB protocol, and quarterly updates to the DSMB. Any Adverse
Effects or Severe Adverse Effects will be reported by the PI to the DSMB, and if required, the program
officer at NIDA. Results of any DSMB or IRB comments will be shared as needed. If there were no AEs,
a statement that no AEs occurred should be included in the progress report or communicated to the PO
in writing. Any changes to the protocol we will seek approval from the NIDA program officer (PO) as well
as Brown University’s IRB. Significant protocol changes will be uploaded to clinicaltrials.gov upon IRB
and NIDA approval.
The DSMB will be asked to provide written documentation confirming review of the protocol and
agreement with the study design and the data safety monitoring plan (DSMP). The DSMB will assure
that all severe adverse events are reported to the IRB by the Project Investigator, according to policies
and procedures.
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Stronghold-PORI 
MOU Table of Contents 
Brown University Memorandum of Understanding 
Signatories 
Service Description & Scope of Agreement 
Stakeholders 
Primary Stakeholders: 
Brown Community Environment Governance 
Terms of Service 
Remote Connections 
Unplanned Outages and Communication Procedures 
During Business Hours 
During Non-Business Hours 
Contact points 
Monitoring 
Change Management / Planned Outages 
Security 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Stronghold-PORI 
Memorandum of Understanding-2018 
Last Updated: 06/27/2018 
Prod Services Completion Date: 06/27/2018 
Expiration Date: 06/27/2019 
Brown University Memorandum of Understanding 
This agreement is made between Stronghold researchers and Computing and Information Services 
(CIS). There are Memorandum of Understanding documents for each environment in separate 
documents. 
This agreement remains valid from the dates signed below until one year. The agreement will be 
reviewed annually. Minor changes may be recorded on the form at the end of the agreement, providing 
they are mutually endorsed by all parties and managed through the Change Management process. 
Signatories 
Name: Brandon Marshall 
Position: Principal Investigator 
Department: Public Health-Epidemiology 
Signature: 
   Date: _6/28/2018 
Name: Mete Tunca 
Position: Assistant Director, Research Data Services 
Department: Computing and Information Services 
Signature: 
Date: 
Name: Geoffrey Greene 
Position: Director, Departmental Systems 
Department: Computing and Information Services 
Signature: 
Date: 
Service Description & Scope of Agreement 
Stronghold is a highly secure compute and storage Windows & Linux environment for research needs 
that involve very sensitive data needing special handling, data usage agreements, etc. 
Stronghold Technical Diagram 
This agreement covers system support for the production Stronghold environment. 
Stakeholders 
CIS / IT Service owner: Mete Tunca 
IT Service Owner Responsibilities 
CIS / IT Contract owner: No contract at this time 
CIS Technical Support Teams: CIS-Stronghold@Brown.edu and designated administrator (if 
applicable) 
Business Service Owner: Brandon Marshall 
Primary Stakeholders: 
Principal Investigator and all users with accounts on the system 
Stronghold-PORI@brown.edu 
Stronghold - Tenant Information 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

CIS holds standup meetings, technical meetings and architecture meetings at regular frequencies. 
Terms of Service 
1.
Access and User Accounts – The PI is responsible for maintaining an up-to-date list of accounts that
should be able to log into Stronghold, and to communicate this to CIS through the Administrative
Contact and to alert the contact when a user should no longer be allowed access. Users that leave
the university will have access terminated along with their Brown account, per CIS Policies:
Computing Privileges: Access to Electronic Services. All users must:
●
complete appropriate training for working with sensitive data (e.g. CITI training);
●
be in compliance with all relevant Institutional Review Board protocols;
●
be in compliance with any data use agreements or other agreements governing the use of
the data stored on Stronghold.
2.
Data Transfers – There are select methods to import data, including but not limited to:
●
Select State offices use a VPN tunnel
●
Encrypted USB drives
●
Secure transfer through firewall exception
●
Import and export servers
3.
Backups – For information regarding Stronghold data protection, please reference the document
below: 
●
https://docs.google.com/document/d/16b0PyaLgIbiYiyfibQvWsKe2eC6qzUI0y1b68Hj41DQ/e
dit#heading=h.lp9x2xwxtn1v
4.
Termination of Service – Requests for termination of services should be made to the Administrative
Contact. Services will be terminated by the next business day following the request.  All data
stored on Stronghold that is associated with the terminated account will be deleted upon
termination of services.
5.
Denial of Access – In the event that a user fails to comply with the policies and procedures for
accessing and using Stronghold, or in the case of a suspected or real security breach, CIS staff can
temporarily deny access to Stronghold for the user and suspend all retrieval of information until
approval is received from a designated authority.
6.
Research with Human Participants – PIs must be in compliance with all Institutional Review Board
requirements (if applicable). 
Remote Connections 
●
Users connect to Stronghold using their existing Brown credentials and must comply with CIS
Policies: Computing Privileges: Access to Electronic Services.
●
Users must also use a two-factor mechanism for additional security. Currently, Stronghold
supports DUO as the two-factor client.
●
CIS may impose additional requirements regarding credentials, connections methods, or clients.
In this case, CIS will provide at least 7 days notice to the user of these additional requirements.
●
All systems (workstations, laptops, etc.) used to connect to Stronghold-must have the following
security precautions in place:
i. A password-protected lock out screen that appears after inactivity of 5 minutes or less.
ii. Up-to-date antivirus and malware installed.
iii. An up-to-date operating system with all currently available updates installed.
iv. Physical security (either card access or keyed locks) that prevents unauthorized
users from physically accessing the system while it is connected to Stronghold.
●
All connections to Stronghold-will be through a Virtual Private Network (VPN). Currently,
Stronghold supports the OpenVPN client.
Unplanned Outages and Communication Procedures 
Unless otherwise specified in this MOU, the CIS Incident Manager will communicate all unplanned 
outages of this service as specified below. 
If a stakeholder becomes aware of a system outage (e.g., web server or application down) or 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

During Business Hours 
1.
Send email to CIS-Stronghold@Brown.edu
2.
Call or email:
CIS-Production-Services@brown.edu (401) 863-7562 who will immediately take the following
actions: 
a.
issue an Internal Service Alert which will notify all technical teams, Operations, the IT
Service Center, Production Services, and CIS Directors, Administrative Contact and
stakeholders
b.
after stakeholders / CIS validate that the service is incurring an outage, Production
Services issues an external CIS Service Alert to all customers and stakeholders
c.
Start a bridge line, if needed.
During Non-Business Hours 
1.
Send email to CIS-Stronghold@Brown.edu
2. Call the IT Service Center at (401) 863-4357 to report the outage. The number still works
and redirects to different people depending on the time - just listen to the menu and press 0 at
the appropriate time to report the outage.
3.
The CIS Incident Manager will take the same actions as defined in number 2 above under
“During Business Hours”.
Contact points 
Production Services team at CIS-Production-Services@brown.edu @ (401) 863-7562 
Karen Sylvester 
(401) 863-7376 
cell: (401) 935-9325 
Laura Dark 
(401) 863-7473 
cell: (401) 338-9352 
Jennifer Germano 
(401) 863-7262
cell: (401) 368-9185 
Steve Lawton 
(401) 863-7380
cell: (401) 225-9164 
IT Service Center at cis-helpdesk@brown.edu @ (401) 863-4357 
Don Rogers 
(401) 863-7319 
cell: (401) 339-1810 
Gena Burke 
(401) 863-2094 
cell: (401) 368-8703 
Monitoring 
●
Monitor and record all activity on the Stronghold system, including networking and access
events, which may depend on classification of the data and any applicable regulations
●
CIS defines monitoring with a specific level of criticality that is defined in the doc Operations
Escalation & Support Info. Monitoring for the Stronghold service are or will defined at this
level of criticality: Critical 
●
CIS-OPS & CIS-Stronghold will receive email notification
●
If predictive trending is showing potential issues
●
Outage occurs
Change Management / Planned Outages 
CIS conducts extensive change management procedures for all changes related to infrastructure and 
applications. All changes to infrastructure that support the Stronghold application will be conducted in 
the following established maintenance windows: 
●
Monday through Friday, 5:00 am to 8:00 am
●
Saturday 3:30 am to 8:00 am
●
Sunday 5:00 am to noon
CIS Maintenance Definitions: 
●
Heavy Usage maintenance period - during a heavy usage maintenance period CIS may
perform maintenance as needed without obtaining proper signoff from all primary stakeholders
as long as maintenance is completed in established maintenance windows
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

●
Frozen maintenance period - during a frozen maintenance period CIS may only perform
maintenance after obtaining proper signoff from all primary stakeholders
●
Critical time period - during a critical time period no maintenance may be done to any
application or service. During critical maintenance time periods, no people are allowed in the
data center to perform any maintenance on any infrastructure for any application or service.
●
For this reason, CIS limits the length of a critical time period to as short as possible, usually an
hour or two.
There are no heavy, frozen or critical maintenance periods at this time. 
CIS will communicate all proposed changes prior to the maintenance window, detailing the work to be 
done and the expected impact. 
Certain system work will require validation from primary stakeholders. In those instances CIS will 
reach out to those who will need to be included in the validation process, supplying the necessary 
information. 
SYSCHG Requirements 
No SYSCHG required 
●
notifications will be sent to appropriate users, scmt@brown.edu and CIS-Stronghold@brown.edu
●
install new software
●
install addon package
●
update to newer version of software package
●
firewall changes (bastion)
SYSCHG Required 
●
server changes
●
notification required beyond CIS-Stronghold group, notification will be sent to the Principal
Investigator and all users with accounts on the system
●
any change that affects all users of Stronghold
Windows patches/upgrades (if applicable) 
●
Will be done monthly and require reboots.
PRD patching always occurs on the Thursday following the 4th Tuesday of every month. Now and 
again, this will be the 5th Thursday, the Monday and Tuesday will follow that Thursday. 
Upgrades/patches are accessed from the central server located in Data Center. 
Linux (if applicable) 
●
Upgrades/patches will be done on the first Tuesday of each month during the maintenance
window. If a reboot is required it will occur on the second Tuesday of the month. Production
Services will be notify Stronghold-Linux@brown.edu, Stronghold-Windows@brown.edu,
CIS-DBA@brown.edu in advance for patching and reboot. SYSChange tickets will be created for
patching and reboot 
●
Upgrades/patches are accessed from the central server located in Data Center
●
The latest version will be limited to whatever version the central server is using
●
If a tenant desires a more recent version of Linux that exists on red hat, but does not yet exist
on our central service, this will be addressed on case by case basis
●
For major upgrades we will need to coordinate with the tenants on appropriate day/time, this
will require user validation
●
For minor versions and security patches, CIS will notify tenants that work will be done during
the maintenance window
Non-standard software 
●
For non-standard end user requested software, it will be downloaded, tested and copied to
requested Stronghold environment and install
Oracle Patching (if applicable) 
●
Will be completed as needed
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

●
No upgrades/patching from internet
●
CIS DBA team downloads file
●
File manually copied to Stronghold environment to execute database upgrade
Researchers Software package 
●
Researchers need latest version, cutting edge of software packages (python, etc) - open source
software
●
Will be upgraded strictly based on end user request; unless existing version is being sunsetted
Periodic Scanning 
●
Periodic scanning of Stronghold servers will be done to identify potential security vulnerabilities.
CIS will attempt to make this service available 24 x 7 x 365 at all times outside of the planned 
maintenance window. 
Certain system work will require validation from primary stakeholders. In those instances CIS will 
reach out to those who will need to be included in the validation process, supplying the necessary 
information to them so they can participate in the validation process and confirm that application 
Stronghold is back up and running after maintenance has been performed. 
Security 
Authentication Method: Application specific-Gatekeeper 
Access Request Form: Yes 
Authorization: 
●
How is authorization handled: Requested
●
Who administers authorization: Unix or Windows teams
●
Contains Data Sensitivity or Confidentiality: Yes
●
Security Policies: Authorized users are reminded of Brown University’s Acceptable Use Policy,
as well as the Computing Passwords Policy
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT H 
RAPIDS JUSTIFICATION FOR NSR DETERMINATION 
JUSTIFICATION FOR NON-SIGNIFICANT RISK (NSR) DETERMINATION (21 CFR812.2b) 
Protocol Title: “Rhode Island Prescription and Illicit Drug Study (RAPIDS)” ** title change 
Device Name: BTNX Inc. Rapid Response™ Single Drug Test Strip 
Justification for NSR Determination 
Description of the Device: The purpose of this study is to determine whether a fentanyl 
overdose prevention intervention involving the use of take-home fentanyl test strips reduces the 
risk of overdose among people who use drugs. The device, known as the BTNX Inc. Rapid 
Response™ Single Drug Test Strip, is a rapid, qualitative test for the detection of a selected 
drug in human urine. We propose to use the product off-label by asking study participants to test 
a small amount of an illicit drug sample dissolved in water. The fentanyl (FYL) test strip is a 
lateral flow chromatographic immunoassay for the qualitative detection of fentanyl, fentanyl 
metabolites (i.e., norfentanyl), and related analogues (e.g., carfentanil). Prior research 
conducted by researchers at Johns Hopkins University and Brown University has shown that the 
product has a detection limit of 0.13 micrograms/mL when used to test illicit drug samples 
dissolved in water (see Attachment B). The product has >90% specificity and >96% sensitivity 
when compared to a gold standard.1 The test results appear on the strip within two minutes (see 
Attachment B). 
Reports of Prior Investigations: To examine the feasibility and acceptability of using test strips to 
identify fentanyl contamination of illicit drugs prior to consumption, we conducted a pilot study 
involving 93 participants. After a brief training and being offered 10 test strip to use at home, 
willingness to use the test strips was high; overall, 95% agreed or strongly agreed that they 
planned to use the tests.2 Almost all pilot study participants (99%) reported that it would be easy 
to use the test strips to identify fentanyl contamination in illicit drugs prior to consumption. 
Among persons who returned for follow-up, a total of 62 participants (77%) reported using at 
least one test strip.3 Of these, 31 (50%) received at least one positive result. A positive result 
was associated with older age, homelessness, heroin use, injection drug use, ever witnessing 
an overdose, and concern about overdose or drugs being laced with fentanyl (all p < 0.05). 
Receiving a positive result was significantly associated with reporting a positive change in 
overdose risk behavior between baseline and follow-up (p ≤ 0.01). Among all participants, 79 
(98%) reported confidence in their ability to use the test strips and 77 (95%) wanted to use them 
in the future. A subsequent qualitative study found that the vast majority of participants found 
1 Johns Hopkins University. The FORECAST Study. Available from: 
https://americanhealth.jhu.edu/sites/default/files/inline-files/Fentanyl_Executive_Summary_032018.pdf 
2 Krieger MS et al. High willingness to use rapid fentanyl test strips among young adults who use drugs. 
Harm Reduction Journal. 2018;15:7. 
3 Krieger MS et al. Use of fentanyl test strips among young adults who use drugs. International Journal of 
Drug Policy. 2018:61:52-58. 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT H 
RAPIDS JUSTIFICATION FOR NSR DETERMINATION 
the fentanyl test strips to be straightforward to use and did not cite significant barriers to use.4 
The most challenging aspect of the test strips reported by participants was correctly reading the 
results, with one line indicating a positive and two lines indicating a negative. To avoid 
confusion, we affixed labels to every package that visually show how to properly interpret a 
result (see Attachment B). We will do so in the proposed clinical trial. After receiving a positive 
test result, many participants described precautions that they believed would prevent an 
overdose, such as using a drug with others around, keeping naloxone nearby, or using a “tester” 
(a small amount of drugs). We found no evidence to suggest that the test strips were used to 
purposely “seek out” fentanyl, or result in other drug-using behaviors that may increase 
overdose risk. 
Proposed Investigational Plan: The clinical trial described herein proposes to use the fentanyl 
test strips in the same manner as that tested during the pilot study, but incorporates the product 
into a broader overdose prevention intervention that involves educational components, 
motivational interviewing, etc. (see Clinical Trial Protocol). The consent form clearly explains the 
potential risks and benefits of using the test strips to prevent accidental exposure to illicitly 
manufactured fentanyl. All study procedures involving the product are described in detail within 
the Clinical Trial Protocol. 
Summary of NSR Determination: The results of our pilot study provide compelling evidence that 
fentanyl test strips may be a useful harm reduction intervention to reduce fentanyl overdose risk 
among people who use drugs. These results are consistent with a recently published study of 
125 people who inject drugs in North Carolina.5 The evidence collected to date strongly 
suggests that fentanyl test strips do not increase overdose risk or otherwise provide a false 
sense of security for the user. Therefore, we believe the study meets the criteria for an 
non-significant risk (NSR) device study under IDE regulations (21 CFR 812.b2). Nonetheless, 
we will carefully monitor the safety of all participants and will report adverse and severe adverse 
events to the Data Safety Monitoring board on a regular basis (see Attachment F - Data Safety 
Monitoring Plan). 
4 Goldman JE et al. Perspectives on rapid fentanyl test strips as a harm reduction practice among young 
adults who use drugs: A qualitative study. Harm Reduction Journal. 2019;16:3. 
5 Peiper NC et al. Fentanyl test strips as an opioid overdose prevention strategy: Findings from a syringe 
services program in the Southeastern United States. International Journal of Drug Policy. 
2019;63:122-128. 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Page 2 of 2 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT I 
RAPIDS SAFETY PROTOCOL 
Rhode Island Prescription and Illicit Drug Study (RAPIDS) 
SAFETY PROTOCOL 
Safety Policies & Procedures - The following are guidelines to help ensure the safety of all project 
staff on Dr. Marshall’s research team. The safety of our staff remains our top priority as well as the 
safety of our research participants. 
General Safety Procedures 
● All staff will be familiar with the safety protocol and will be given a copy of this protocol. 
● Primarily, participant visits for this research study will take place at the centrally 
located Brown University School of Public Health. However, visits may also take place in 
semi-private locations outside of BUSPH where organizations have sufficient space and 
insurance coverage to comply with Brown University health and safety and social distancing 
standards (such as clinics or community partner agencies). The Project Coordinator or lead 
Research Assistant (RA) must be aware of scheduled participant visits and the room at 
BUSPH where they will take place. 
● The Primary Staff (e.g. research assistant/interventionist) is the staff person conducting the 
interview and is responsible for overseeing the participant throughout the visit. 
● A Back-up, or Secondary, staff person must be available and in close vicinity in the event 
of the Primary staff needing support. If a participant is scheduled outside of normal business 
hours, there must be two project staff on-site during the visit. 
o   Under no circumstances are research staff to conduct a research study visit at 
a private residence or other private location. 
● Primary and Secondary staff are to always carry a cell phone with them, which is to remain 
turned on during participant sessions, regardless of location. Please monitor the battery 
level and charge when necessary. 
● Primary staff must check in with the Project Coordinator or Lead RA at the beginning and 
end of a scheduled session. 
Field-Based Safety Measures 
● There may be instances in which participant visits occur outside of the BUSPH. These 
visits will occur in locations that meet health, safety, insurance and social distancing 
standards of the IRB, IBC and other regulatory bodies. 
Page 1 of 9 
 
 
 
 
 
 
 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT I 
RAPIDS SAFETY PROTOCOL 
● Visits that occur outside of BUSPH must follow all of the same safety protocols that have 
been outlined for visits occurring on-site. 
● Additionally, Research Assistants performing study visits in the field will go out in pairs 
so that no staff will ever be alone during a study visit. Research Assistants will also 
communicate with the Project Coordinator or Project Manager and check in at the 
beginning and end of each visit. 
Bathroom Safety Procedures 
● The Primary staff should chaperone the participant at all times while they are at the School 
of Public Health, including while in the elevator. One exception is when a participant is using 
the bathroom, when the staff person will remain outside the bathroom. Primary staff are to 
remind participants of the bathroom rules: 
o 
o 
● If the 
Personal belongings are not allowed in the bathroom. 
Substance use is not allowed on-site or during the study visit. 
participant is in the bathroom for more than 5 minutes, the Primary staff will 
knock on the bathroom door and ask if the participant is ok. 
o If there is no verbal response, or if there is a staff concern about participant 
safety, then the Primary staff will ask the Secondary staff for immediate 
support. The Primary staff will proceed by issuing a verbal warning and 
opening the bathroom door. 
o If there appears to be an emergency situation, the Secondary staff will assist 
with enacting the Medical Response Procedure outlined on Page . 
Session Delivery Safety Procedures 
● When in a respondent’s presence, the Primary staff should: 
o Sit near the exit and in a location where you can leave quickly if needed. Keep 
all personal and study items close to you and within sight. Be aware of your 
environment at all times. If you have concerns about a situation, call the 
Project Coordinator and follow the “Dr. West” procedures outlined in this 
document (see below). 
o With the exception of your cell phone and study equipment, never take 
anything into a participant session that you do not absolutely need for the 
session (e.g., limit carrying personal items, extra cash, etc.). 
o Ensure that you have the Project Coordinator, Project Director, and study 
clinicians’ cell phone numbers programmed into your cell phone for quick use. 
If there is a landline present in the study rooms, cell phone numbers for the 
Project Coordinator and Program Director are pre-programmed. 
● If a respondent becomes agitated or confrontational with you about the study, try to 
address his/her concerns. If he/she still seems uncertain, direct them to the Project 
Coordinator. However, don’t push the issue if you feel unsafe. If appropriate, offer to 
Page 2 of 9 
 
 
 
 
 
 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT I
RAPIDS SAFETY PROTOCOL 
call and reschedule for another time with the participant and leave the situation.
 
 
 
 
 
 
 
 
 
 
 
 
 
Always call the Project Coordinator afterward to notify them of the situation and
 
 
 
 
 
 
 
 
 
 
 
 
 
document the details of the event.  
●
If at any point during a participant session you feel you are in ​immediate danger​,
 
 
 
 
  
 
 
 
 
 
 
 
 
leave the situation immediately; no explanation to the respondent(s) is required. Once
 
 
 
 
 
 
 
 
  
 
you are in a safe area, call the Secondary staff and Project Coordinator to inform
 
 
  
 
 
 
 
 
 
 
 
 
 
them of the situation. ​You are in ​no way expected to stay in an unsafe situation in
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
order to complete a research study visit.
Calling “Dr. West” Safety Procedure 
●
If you do not feel that you are in immediate danger but feel uneasy about the situation,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
you should place a call to “Dr. West” (a study supervisor) to review the circumstances.
 
 
  
 
 
 
 
 
 
 
 
 
 
We use the term “Dr. West” to immediately notify study supervisors of a possible serious
 
 
 
 
 
 
 
 
 
 
 
  
 
situation.
○
To do this, you can say something like, “​It looks like I may be missing an
 
 
 
 
 
 
 
 
 
 
  
 
 
 
important study document, will you hold on one moment while I place a call to my
 
 
 
 
 
 
 
 
 
  
  
 
 
supervisor?​” When making the call to the Project Coordinator, you would say “​I
 
 
 
 
 
 
 
 
 
 
 
 
need to speak with Dr, West​..​”
●
The Project Coordinator or staff who answers the call will then use YES/NO questions to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
understand the situation and determine the best course of action.
○
If the Project Coordinator determines you should end the interview prematurely,
 
 
 
 
 
 
 
 
 
 
you then calmly explain to the respondent that you need to reschedule the
 
 
 
 
 
 
 
 
 
 
 
 
interview. You can use any reason that seems plausible such as, the equipment
 
 
 
 
 
 
 
 
 
 
 
 
isn’t working properly, you don’t have the proper consent form, or that you are
 
 
 
 
 
 
 
 
 
 
 
 
 
just not feeling well.
○
Calmly apologize for the inconvenience and let them know that we will have to
 
 
 
 
 
 
 
 
 
 
 
 
 
reschedule for another time. Follow up with the Project Coordinator immediately
 
 
 
 
 
 
 
 
 
 
and document the incident.
Some examples of dangerous or unsafe situations might be: 
●
Drug use/sales
●
Observation that respondent is high or intoxicated
●
Violence or threats of violence toward you or others in the environment
●
General sense of hostility or aggressiveness toward you
●
Inappropriate language directed to you
●
Sexual advances
●
Any perceived threat or inappropriate behavior
Angry Respondents Procedure 
●
It is rare that the Primary Staff will encounter a situation where the respondent becomes
  
 
 
 
 
 
 
  
 
 
 
 
angry. However, in the case that a respondent becomes angry, it is the role of the
 
 
 
 
 
  
 
 
  
 
 
 
 
​Page 3 of 9 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT I
RAPIDS SAFETY PROTOCOL 
Primary staff to evaluate the situation and employ de-escalation techniques. The goal in
 
 
 
 
 
 
 
 
 
 
 
  
these situations is to calm the respondent down: 
●
Remain calm yourself.
●
Try to find out what they are angry about.
●
Listen.
●
Acknowledge their concerns, by saying things such as, “Okay, I understand
 
 
 
 
 
 
 
 
  
how that would be upsetting.”
●
Apologize for any inconvenience, discomfort, etc.
●
Validate their feelings.
●
Let them know what you will do to address their concerns, such as, “Talk to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
your supervisor immediately,” or “Make the researchers aware of the
 
 
 
 
 
 
 
 
 
problem”, etc.
●
Actually write the concerns down in your notes in front of the respondent.
●
Offer to have your Project Coordinator call them to discuss the situation
 
 
 
 
 
 
 
 
 
 
 
further.
●
Call or text the Secondary staff or Project Coordinator if you feel the situation
 
 
 
 
 
 
 
 
  
 
 
 
is not calming down.
●
No matter how angry or insulting a respondent may be, the Primary staff must remain
 
 
 
 
 
  
 
 
 
 
 
 
 
polite and professional. They are not, however, required to remain in such a situation. If
 
 
 
 
 
 
 
 
 
 
 
  
 
a participant is very angry, their participation is not likely going to be valid. Furthermore,
 
  
 
 
 
  
 
 
 
 
 
 
we do ​NOT​, at any point, want someone’s personal safety to be at risk.
●
The Primary staff will end the conversation with a brief thank you, and leave the situation
 
 
 
 
 
 
 
  
 
 
 
 
 
 
as unobtrusively as possible.
Participant Safety Planning Procedure 
●
If the Primary staff observe behavior where they feel the participant’s safety is at risk, or
 
 
 
 
 
 
 
 
 
 
 
  
 
 
that the safety of others may be at risk, we encourage them to quickly involve the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Secondary staff member, the Project Coordinator or Project Director. This includes
 
 
 
 
 
 
 
 
 
 
observing behaviors that indicate the respondent may be high or intoxicated to the point
 
 
 
 
 
 
 
 
 
 
 
 
 
of not being able to participate in the study, and/or are unable to leave the study site
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
safely.
●
When the Primary staff observes what they consider to be impaired functioning, visible
 
 
 
 
 
 
 
 
 
 
 
 
intoxication, or concerning behaviors, they should:
○
Conduct a brief verbal assessment using the “Alert & Oriented X4” as outlined
  
 
 
 
 
 
 
 
 
 
 
below in Section 4 to generate a discussion regarding their ability to be alert and
 
 
  
 
  
 
 
 
 
 
 
 
oriented. This can be done at any point during the participant visit, including prior
 
 
 
 
 
 
 
 
 
 
 
 
 
to a participant leaving the building. Staff may also express concern for the
 
 
 
 
 
 
 
 
 
 
 
 
participant’s well-being.
​Page 4 of 9 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT I
RAPIDS SAFETY PROTOCOL 
○
If the participant struggles to answer the AOx4 questions or engage in a coherent
 
 
 
 
 
 
 
 
 
 
   
discussion about the concerning behaviors, the Primary staff will engage the
 
 
 
 
 
 
 
 
 
 
Secondary staff or other staff leadership.
■
The Secondary staff member will assist by reaching out for additional
 
 
 
 
 
 
 
 
 
 
clinical input. This will be a phone call to the on-call clinician, BH Link, or
 
 
 
 
  
 
 
 
 
 
 
 
 
9-1-1, depending on the severity of the situation.
■
If there is an immediate threat to their safety, the Primary staff is
 
 
 
 
 
 
 
 
 
 
 
 
instructed to always call 911, or directly ask the Secondary staff to
 
 
 
 
 
 
 
 
 
 
 
call 9-1-1. The Primary staff should stay with the participant, and, if
 
 
 
 
 
 
 
 
 
 
 
necessary, the Secondary staff should go down to the Lobby to
 
 
 
 
 
 
 
 
 
 
direct first responders to the necessary location.
○
The Primary staff will explain to the participant their concerns about safety, and
 
 
 
 
 
 
 
 
 
 
 
 
help them engage with the clinician via phone or video chat. The clinician will
 
 
 
 
 
 
 
 
 
 
 
 
 
support the participant by creating a safety plan with the participant prior to them
 
 
 
 
  
 
 
 
 
 
 
 
leaving the building. The Primary staff will support the safety plan by arranging
 
 
 
 
 
 
 
 
 
 
 
 
alternative transportation and/or placing additional phone calls to BH Link mobile
 
 
 
 
 
 
 
 
 
 
crisis unit or 9-1-1 if needed. All related transportation costs will be charged to
 
 
 
  
 
 
 
 
 
 
 
 
the study.
○
The Project Director will ensure all documentation policies are followed as
 
 
 
 
 
 
 
 
 
 
needed (e.g. DSMB or IRB reporting and follow-up).
●
All research staff will be trained on how to respond to suicidal ideation/threats prior to
 
 
 
 
 
 
 
 
 
 
 
 
 
 
their work with research study participants.
Harm to Self or Others Safety Procedure 
NOTE: we are NOT clinicians and so we are limited in the scope of what we are able to offer
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
someone in these circumstances.
However we should be empathetic and non-judgmental in
 
 
 
 
 
 
 
 
 
 
 
 
our response to this information, and offer the best available resources. 
●
If the Primary research staff observe behavior where they feel the participant’s
 
 
 
 
 
 
 
 
 
 
 
safety is at risk due to suicidal ideation or threat of self-harm, or that the safety of
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
others may be at risk due to threat of harm, we encourage them to quickly involve
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the Secondary staff member, the Project Coordinator or Project Director as
 
 
 
 
 
 
 
 
 
 
available.
●We will not be collecting any information regarding suicidal ideation or behavior in
 
 
 
 
 
 
 
 
 
 
 
 
this study. However, if a respondent indicates that they are suicidal, or you feel
like they may harm themselves, ask if there is someone they can speak to about
feeling that way and/or if there is someone you can call for them.
​Page 5 of 9 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT I
RAPIDS SAFETY PROTOCOL 
●
The Primary staff will express concern for the participant by saying,
 
 
 
 
 
 
 
 
 
 
“What you have told me is very heavy. I feel that it is important for us to
 
 
 
 
  
 
  
 
   
 
 
 
call someone to talk to about these things.”
●
The Primary staff will instruct the Secondary staff to call the study
 
 
 
 
 
 
 
 
 
 
 
clinician or BH link immediately. The Primary staff will stay in the room to
 
 
 
 
 
 
 
 
 
  
 
 
support the participant.
●
If the participant refuses, the Primary staff will again express concern
 
 
 
 
 
 
 
 
 
 
and care for their safety and restate the ability to call a clinician or other
 
 
 
 
 
 
 
 
 
 
  
 
 
support for them. The Primary staff can also suggest a referral to a
 
 
 
 
 
 
 
 
  
 
 
medical or triage center where they can get the proper level of care,
 
 
 
 
 
 
 
 
 
 
 
 
such as BH link.
●
The Primary staff will offer transportation options to a referral
 
 
 
 
 
 
 
  
location, or offer to engage a mobile crisis unit that may come
 
 
 
 
  
 
 
 
 
 
directly to the study site. All related transportation costs will be
 
 
 
 
 
 
 
 
 
 
charged to the research study as needed.
●
If there is an immediate threat to their safety, the Primary Staff is
 
 
 
 
 
 
 
 
 
 
 
 
instructed to always call 911.
●
The Primary staff in this situation is responsible for expressing empathy and
 
 
 
 
 
 
 
 
 
 
 
concern for their safety, and for ensuring another staff person is with them to
 
 
 
 
 
 
 
 
 
 
 
 
 
support the next steps. Encourage them to speak with someone about their
 
 
 
 
 
 
 
 
 
 
 
feelings and provide them with the phone number for RI’s 24hr mental health and
 
 
 
 
 
 
 
 
 
 
 
 
 
substance use triage center, ​BH Link: ​401-414-LINK(545). Other resources
 
 
 
 
 
 
 
 
include the Samaritans – a suicide prevention hotline: (401) 272-4044, or any of
 
 
   
 
 
 
 
 
 
 
the mental health and substance use resources listed in the Community Based
 
 
 
 
 
 
 
 
 
 
 
Resources and Referrals handout.
●
The Primary staff will let the participant know that they will inform the Project
 
 
 
 
 
 
 
 
 
 
 
 
 
Director and Study Clinician about any safety procedures that were enacted. The
 
 
 
 
 
 
 
 
 
 
 
Primary staff may tell the participant that they are doing so out of concern for
 
 
 
 
 
 
 
 
 
 
 
 
 
 
their wellbeing.
●
The Primary staff is responsible for documenting the situation thoroughly and
 
 
 
 
 
 
 
 
 
 
following-up with the Project Director and Study Clinician immediately.
●
The Project Director will ensure all documentation policies are followed as
 
 
 
 
 
 
 
 
 
 
needed (e.g. DSMB or IRB reporting and follow-up).
Overdose Response/Medical Issue Response Procedure 
All research staff will be trained on how to recognize and respond to a drug overdose
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
prior to working directly with participants, as well as how to administer naloxone.  
​Page 6 of 9 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT I
RAPIDS SAFETY PROTOCOL 
NOTE: we are NOT clinicians or medical professionals and so we are limited in the scope of
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
what we are able to offer someone in these circumstances, but we are expected to call for
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
immediate medical help if someone is unresponsive. If you or another staff are trained on
 
 
  
 
 
  
 
 
 
 
 
 
 
recognizing and responding to an overdose, then you may proceed with the protocol for
 
 
 
 
 
 
 
 
 
 
 
 
 
 
responding to a suspected overdose using a “naloxone kit.”  
In the event of an overdose, the primary staff person is responsible for documenting the
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
situation thoroughly and following-up with the Principal Investigator and Project Director
 
 
 
 
 
 
 
 
 
 
 
immediately. The Project Director will ensure all documentation policies are followed as needed
 
 
 
 
 
 
 
 
 
 
 
 
 
(e.g. DSMB or IRB reporting and follow-up). 
All staff persons involved in witnessing or responding to an overdose should check in and
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
debrief with the Project Director as soon as possible or before they leave for the day​.  
If you witness a participant as suddenly unconscious, not breathing, cannot be woken, or
 
 
  
 
 
 
 
 
 
 
 
 
 
is turning blue, you are expected to respond immediately. (See OVERDOSE RESPONSE
 
 
 
 
 
 
 
 
 
 
 
 
INSTRUCTIONS below) 
●
You are now the ​“PRIMARY STAFF PERSON” and are the main person responsible for
 
 
 
 
 
 
 
 
 
 
 
 
 
getting medical help.
o
Your role is to find one other staff person nearby and tell them how to help you
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
respond to the medical situation (specifically, ask them to call 911).
o
Your role is to stay with the participant until medical help arrives.
o
Ensure that the participant receives thorough care and has all of their belongings
 
 
 
 
 
 
 
 
 
 
 
 
prior to leaving by ambulance if possible.
●
The other staff person is now the ​“SECONDARY STAFF PERSON” and they are
 
 
 
 
 
 
 
 
 
 
 
 
responsible for calling 911 and making sure the First Responders can find the
 
 
 
 
 
 
 
 
 
 
 
 
participant.
o
They should also notify a supervisor or Full Time staff person immediately to
 
 
 
  
 
 
 
 
 
 
 
support the Primary Staff Person.
A Naloxone Kit** may be administered under the following circumstances: 
●
When a participant cannot be woken,
●
When medical help is on the way,
●
The staff person is trained to recognize an overdose AND administer naloxone,
●
The staff person follows instructions using bullets 1-8 below.
1.
OVERDOSE RESPONSE WITH NALOXONE INSTRUCTIONS:
●
Primary Staff Person​:
o
Verify that the participant cannot be woken up by yelling their name loudly.
o
Then do a sternum rub on the participant’s chest using your knuckles.
o
Loudly announce to the participant, ​“I am going to call 911 to get you
 
 
 
 
 
 
 
 
 
 
 
 
 
​Page 7 of 9 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT I
RAPIDS SAFETY PROTOCOL 
medical help.” 
●
Primary Staff Person: ​Ask a nearby staff person to be in the ​“Secondary Staff”​ role.
o
Tell them to “Call 911” and report, “a person is unconscious/not breathing”
 
 
 
 
 
 
 
 
 
 
 
and give the location at 121 South Main Street, 2​nd​ floor.
●
Secondary Staff Person​:
o
“Call 911” and report, “a person is unconscious/not breathing” and give the
 
 
 
 
 
 
 
 
 
 
 
location at 121 South Main Street, 2​nd​ floor.
o
Give First Responders and Building Security the exact location of the
 
 
 
 
 
 
 
 
 
 
participant within the building.
o
Notify the Project Coordinator or another Full Time staff person on the team
 
 
 
 
 
 
 
 
 
 
 
 
to stay with the participant and the primary staff person.
o
Go to the building entrance to meet EMS and direct them to the participant.
●
Primary Staff Person:
o
You are to stay with the participant until help arrives.
o
Please clear the immediate area so First Responders have room to respond
 
 
 
 
 
 
 
 
 
 
 
and get to the participant when they arrive.
o
Please limit the number of people near the participant so there is room for the
 
 
 
 
 
 
 
 
 
 
  
 
 
first responders when they arrive. No crowds.
●
Primary Staff Person (IF trained on naloxone administration):
o
If you assess the participant according to your training and determine that
 
 
 
 
 
 
 
 
 
 
 
they meet the criteria for naloxone, loudly announce to the participant, ​“I am
 
 
 
 
 
 
 
 
 
 
  
going to give you naloxone now.”
o
You may administer the Naloxone Kit** according to the instructions, starting
 
 
 
 
 
 
 
 
 
 
with one dose of naloxone. The administration of the Naloxone Kit covers up
 
 
 
 
 
 
 
 
 
 
 
 
to two doses.
●
Primary Staff Person:
o
Notify the First Responders immediately if naloxone is administered, and how
 
 
 
 
  
  
 
 
much was administered.
o
Disclose at least the first name of the participant to First Responders, as well
 
 
 
 
 
 
 
 
 
 
 
 
 
as any relevant health information (if received), and that this may be an
 
 
 
 
 
 
 
 
 
 
 
 
opioid overdose.
●
​All Staff Involved:
o
Once the First Responders arrive to the location and have located the
 
 
 
 
 
 
 
 
 
 
 
participant, these professional medical staff become immediately responsible
 
 
 
 
 
 
 
for all first aid procedures.
o
Back away and give the First Responders space. Make sure the area is clear
 
 
 
 
 
 
 
 
 
 
 
  
so they can leave quickly if needed.
**The Naloxone Kit includes two naloxone vials for administration, accompanied by latex gloves
 
 
 
 
 
 
 
 
 
 
 
 
 
and an infographic on how to administer the naloxone. These items are kept in a pouch, clearly
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
labeled “Naloxone Kit,” and there will be one at each study staff workstation, and in each
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
interview room at the School of Public Health. The RAPIDS Research Assistant is responsible
 
 
 
 
 
 
 
 
 
 
 
  
 
for monitoring the expiration dates of naloxone, discarding all naloxone doses as the law allows,
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
​Page 8 of 9 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT I
RAPIDS SAFETY PROTOCOL 
as they expire, and re-ordering new Naloxone Kits from their community partner or supplier. The
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
School of Public Health also has a publicly-accessible naloxone kit on the 3rd floor, directly
 
 
 
 
 
  
 
 
 
 
 
 
 
 
across from the elevators.  
​Page 9 of 9 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Medical Devices/ Investigator Checklist 
Protocol title: Rhode Island Prescription and Illicit Drug Study (RAPIDS) 
PI name: Brandon DL Marshall, PhD 
Date: March 31, 2019 
A device will NOT fall under the FDA regulations if all of the following statements are true: 
1)
Data will not be submitted to the FDA
2)
Safety and/or effectiveness data will not be collected about the device
3)
The device is used only as a tool to collect data to examine a physiologic principle
If ALL statements above are true, please initial here: 
Please include this form and the device manual in your protocol submission to the IRB. No further information is required at 
this time. 
This checklist serves as a guide to Sponsor-Investigators in determining and documenting information required by the IRB related to 
the use of a medical device which falls under the FDA regulations (21 CFR812) in a human subjects’ research study and requires an 
Investigational Device Exemption (IDE). *Sponsor-Investigator is the individual who initiates and also conducts the 
study/clinical investigation. Typically this is the Principal Investigator (PI). A sponsor-investigator must comply with 
regulatory requirements applicable to both sponsors and clinical investigators (21 CFR312.3). A device will fall under the FDA 
regulations if data will be submitted to the FDA OR safety and/or effectiveness data are collected about the device. 
The IDE regulations (21 CFR812) describe three types of device studies: significant risk (SR), which require an IDE application 
approved by the FDA, non-significant risk (NSR) which must follow the abbreviated IDE requirements (21 CFR812.2b) and do not 
require a submission of an IDE application to the FDA or exempt from IDE regulations (21 CFR812.2b30. Please consult the cited 
regulations for additional information on these types of device studies. 
Attached to this form is a flowchart that may also be helpful in determining if an IDE is required. 
HRPP USE ONLY: 
Confirm information 
I. 
Device name_BTNX Inc. Rapid Response(TM) Single Drug Test Strip (Investigations with multiple 
devices must submit a separate form for each device) 
Please include device information/manual or other documentation that 
describes the device/usage. 
for IRB review, 
(based on protocol 
submission and 
checklist) noting a 
check mark 
. 
a. 
Studies considered exempt from IDE regulations include: 
•
A legally marketed device when used in accordance with its’
labeling.
Yes 
X No 
•
A diagnostic device if it complies with labeling in 809.10(c) and the
testing is noninvasive, does not require an invasive sampling
procedure that presents significant risk, does not by design or
intention introduce energy into a subject, and is not used a
diagnostic procedure without confirmation by another medically
established diagnostic product or procedure.
Yes 
X No 
•
Consumer preference testing, testing of a modification or testing of a
combination of devices if the device(s) have an approved Premarket
Notification 510(k), or are exempt from 510(k) AND if the testing is
not for the purpose of determining safety or effectiveness and does
not put subjects at risk.
Yes 
X No 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

If “Yes” to one of the bulleted items, the study is exempt from IDE regulations. 
Please provide/attach supporting documentation, e.g., letter from the FDA, or 
other information used to make this exempt determination. This form is 
complete. If “No” to all bulleted items, continue to next item. 
b 
Does the research collect safety and/or efficacy data on medical devices in 
human participants or on human specimens? 
(An IDE must be submitted to the FDA if the sponsor-investigator intends to 
conduct a clinical investigation with an investigational new device to 
determine safety and effectiveness unless the investigation is considered to 
have an approved application for an IDE, or is exempt from the IDE 
requirements. ( 21 CFR 812.2) 
X Yes 
No 
c 
Has the FDA assessed the device for a risk determination? 
If yes, Please indicate if the FDA determination is: 
NSR  
(non-significant risk) 
SR  
 (significant risk) 
*If “yes”, provide the IRB with a copy of the FDA documentation, and this
form is complete, the remaining items do not apply.
* 
Yes 
X No 
d 
Has the sponsor-investigator made a risk determination? 
If yes, Please indicate if the determination is: 
NSR  X 
(non-significant risk) 
SR  
 (significant risk) 
Please provide the IRB with a description of the device, reports of prior 
investigations with the device, the proposed investigational plan, and any 
other information that will assist the IRB in the review of this determination. 
X Yes 
No 
e 
Please provide the plan to securely obtain store, dispense/use, and 
dispose of the device. Attach a separate document that includes this 
information or note the location/section/page # where this information 
may be found in the protocol 
f 
The informed consent process/document must include a statement 
describing the extent, if any, to which confidentiality of records 
identifying the subject will be maintained and the possibility that the 
FDA may inspect the records. (21 CFR 50.25 (a) (5)) 
g 
Is the study an applicable clinical trial? 
“Applicable clinical trials” generally include: 
(1) Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase 1
investigations, of a product subject to FDA regulation;
(2) Trials of Devices: Controlled trials with health outcomes, other than small feasibility
studies, and pediatric post-market surveillance.
Complete statutory definitions and more detailed information on the NIH’s current
thinking about the meaning of “applicable clinical trials” may be found in the
“Elaboration of Definitions of Responsible Party and Applicable Clinical Trial”.
(if No, skip h) 
X Yes 
No 
h 
Is the clinical trial registered in Clinicaltrials.gov? 
X Yes 
No 
•
Under federal regulation 21 CFR 50.25(c) the following statement
must be reproduced word-for-word in informed consent documents
for applicable clinical trials begun after March 7, 2012:
“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as
required by US Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this Web site 
at any time” 
Notes: The trial will be registered in ClinicalTrials.gov following IRB approval 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

1 
Medical Device/IDE effective 3/16/16 
Appendix D: Use of Devices Investigator Checklist
Protocol title: 
PI name: 
Date: 
A device will NOT fall under the FDA regulations if all of the following statements are true: 
1)
Data will not be submitted to the FDA
2)
Safety and/or effectiveness data will not be collected about the device
3)
The device is used only as a tool to collect data to examine a physiologic principle
_________________________________________________________________________________________________________ 
This checklist serves as a guide to Sponsor-Investigators in determining and documenting information required by the IRB related to 
the use of a medical device which falls under the FDA regulations (21 CFR812) in a human subjects’ research study and requires an
Investigational Device Exemption (IDE). *Sponsor-Investigator is the individual who initiates and also conducts the
regulatory requirements applicable to both sponsors and clinical investigators (21 CFR312.3). A device will fall under the FDA 
regulations if data will be submitted to the FDA OR safety and/or effectiveness data are collected about the device. 
The IDE regulations (21 CFR812) describe three types of device studies: significant risk (SR), which require an IDE application 
approved by the FDA, non-significant risk (NSR) which must follow the abbreviated IDE requirements (21 CFR812.2b) and do not 
require a submission of an IDE application to the FDA or exempt from IDE regulations (21 CFR812.2b30. Please consult the cited 
regulations for additional information on these types of device studies.  
HRPP USE ONLY: 
Confirm information 
for IRB review, 
(based on protocol 
submission and 
checklist) noting a 
check mark 
. 
a. 
Studies considered exempt from IDE regulations include: 

A legally marketed device when used in accordance with its’
labeling.
 Yes 
 No 

A diagnostic device if it complies with labeling in 809.10(c) and the
testing is noninvasive, does not require an invasive sampling
procedure that presents significant risk, does not by design or
intention introduce energy into a subject, and is not used a
diagnostic procedure without confirmation by another medically
established diagnostic product or procedure.
 Yes 
 No 

Consumer preference testing, testing of a modification or testing of a
combination of devices if the device(s) have an approved Premarket
Notification 510(k), or are exempt from 510(k) AND if the testing is
not for the purpose of determining safety or effectiveness and does
not put subjects at risk.
 Yes 
 No 
Investigations with multiple devices must submit a separate form for each device.
Device name: ____________________________________________________________________________________________
If ALL statements above are true, please initial here: __________
Please include this form and the device manual in your protocol submission to the IRB. No further information is required 
at this time.
For additional guidance, 
this flowchart may be helpful 
in determining if an IDE is required.
ZŚŽĚĞ/ƐůĂŶĚWƌĞƐĐƌŝƉƚŝŽŶĂŶĚ/ůůŝĐŝƚƌƵŐ^ƚƵĚǇ
Brandon DL Marshall, Phd
10/07/2020
Whatman 903 Protein Saver Card
BDLM
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

2 
Medical Device/IDE effective 3/16/16 
If “Yes” to one of the bulleted items, the study is exempt from IDE regulations. 
Please provide/attach supporting documentation, e.g., letter from the FDA, or 
other information used to make this exempt determination.  This form is 
complete. If “No” to all bulleted items, continue to next item. 
b 
Does the research collect safety and/or efficacy data on medical devices in 
human participants or on human specimens? 
(An IDE must be submitted to the FDA if the sponsor-investigator intends to 
conduct a clinical investigation with an investigational new device to 
determine safety and effectiveness unless the investigation is considered to 
have an approved application for an IDE, or is exempt from the IDE 
requirements. ( 21 CFR 812.2) 
 Yes 
 No 
c 
Has the FDA assessed the device for a risk determination? 
If yes, Please indicate if the FDA determination is: 
NSR______(non-significant risk) 
SR________(significant risk)   
*If “yes”, provide the IRB with a copy of the FDA documentation, and this
form is complete, the remaining items do not apply.
*
 Yes 
 No 
d 
Has the sponsor-investigator made a risk determination? 
If yes, Please indicate if the determination is: 
NSR______(non-significant risk) 
SR________(significant risk) 
Please provide the IRB with a description of the device, reports of prior 
investigations with the device, the proposed investigational plan, and any 
other information that will assist the IRB in the review of this determination. 
 Yes 
 No 
e 
Please provide the plan to securely obtain store, dispense/use, and 
dispose of the device.  Attach a separate document that includes this 
information or note the location/section/page # where this information 
may be found in the protocol 
f 
The informed consent process/document must include a statement 
describing the extent, if any, to which confidentiality of records 
identifying the subject will be maintained and the possibility that the
FDA may inspect the records.  (21 CFR 50.25 (a) (5)) 
g 
 Is the study an applicable clinical trial? 
“Applicable clinical trials” generally include: 
(1) Trials of Drugs and Biologics:  Controlled, clinical investigations, other than Phase 1
investigations, of a product subject to FDA regulation;
(2) Trials of Devices:  Controlled trials with health outcomes, other than small feasibility
studies, and pediatric post-market surveillance.
Complete statutory definitions and more detailed information on the NIH’s current
thinking about the meaning of “applicable clinical trials” may be found in the
“Elaboration of Definitions of Responsible Party and Applicable Clinical Trial”.
 (if No, skip h) 
 Yes 
 No 
h 
Is the clinical trial registered in Clinicaltrials.gov? 
 Yes 
 No 

Under federal regulation 21 CFR 50.25(c) the following statement
must be reproduced word-for-word in informed consent documents
for applicable clinical trials begun after March 7, 2012:
“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by US Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results.  You can search this Web site 
at any time”
Notes: 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

RHODE ISLAND 
RHODE ISLAND 
RESOURCE LIST
RESOURCE LIST
    In this guide, you will find
    many local and statewide
    resources. 
    These are for you and we
    encourage you to reach out.
1   Get Help
2   Safer Use
3   Learn About Recovery
4   Get Health Care
     1   Get Help
BH Link
National Suicide 
Prevention 
Hotline
Rhode Island 
Coalition Against 
Domestic 
Violence 
Sojourner House
Women’s 
Resource Center
401-414-5465
http://bhlink.org
975 Waterman Ave
East Providence, RI
BH Link is a behavioral health facility designed 
to provide immediate assistance to a person 
in crisis by providing innovative crisis inter-
vention services, and connecting people to 
ongoing treatment and care.
1-800-273-8255
Te National Suicide Prevention Lifeline is a 
national network of local crisis centers that 
provides free and conﬁdential emotional sup-
port to people in suicidal crisis or emotional 
distress 24 hours a day, 7 days a week.
Hotline: 1-800-494-8100
www.ricardv.org
An organization dedicated to ending domestic 
violence through advocacy, 
community organizing, and resource sharing.
401-658-4334; 401-765-3232
www.sojournerri.org
A comprehensive domestic violence agency 
which provides shelter, advocacy, education 
and support services.
Hotline: 1-800-494-8100
www.wrcmbc.org
An organization working to end domestic by 
providing advocacy, education, and support 
services.
The Providence 
Center
401-766-0900
www.providencecenter.org
info@provctr.org
Te Providence Center provides comprehen-
sive services to all individuals experiencing 
mental health, substance abuse, emotional and 
behavioral diﬃculties.
     2   Safer Use
Project 
Weber/RENEW
ENCORE
401-383-4888
http://weberrenew.org
640 Broad Street
Providence, RI 02907
A non-proﬁt oﬀering sexual health, harm- 
reduction and recovery support services in 
Rhode Island, with a focus on individuals who 
engage in sex work.
401-781-0665
rayj@aidscareos.org
557 Broad Street
Providence, RI 02907
Provides comprehensive care to persons living 
with HIV/AIDS in Rhode Island. No medical 
coverage necessary.
Community 
Care Alliance
401-235-7000
401-766-0900
http://communitycareri.org
Oﬀers more than 50 services and programs 
including addictions treatment, HIV/AIDS 
support, employment development and more. 
A hotline providing information about HIV/
AIDS, treatment and services.
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

    3   Learn About Recovery
    4   Get Health Care
Providence 
Community 
Health 
Center
Butler Hospital
The Kent Center
www.providenceehc.org
401-433-0200
Tere are 13 locations
around Providence
Providence Community Health Centers provide aﬀordable, quality, pri-
mary health care to meet the community’s medical needs. Patients receive 
coordinated physical, mental health and substance abuse care under one 
roof with access to community supports that promote a healthy lifestyle.
844-401-0111
www.butler.org
345 Blackstone Boulevard,
Providence RI
A psychiatric and substance abuse hospital located on Blackstone Bou-
levard in Providence. Butler odders a wide variety of services including 
inpatient, outpatient and partial hospital programs.
Emergency Services Program: 
401-738-4300
Non-emergency services:
401-732-5656
A non-proﬁt community based provider of mental health, substance 
abuse, and educational services aﬃliated with Brown University. Located 
on Post Road in Warwick.
CODAC 
Behavioral 
Healthcare of 
Rhode Island 
Anchor 
Recovery 
Community 
Center
1-877-805-0152
www.codacinc.org
A non-proﬁt based in Cranston which provides treatment, 
recovery and prevention services.
www.anchorrecovery.org
Pawtucket: 401-721-5100
Warwick: 401-615-9956
info@anchorrecovery.org
Anchor Recovery provides a safe, welcoming environment for all individuals in 
recovery from substance use disorders. Anchor oﬀers a community center where 
members and recovery support specialists share their recovery experience, provide 
support through various peer-led groups, and oﬀer resources to empower others in 
ﬁnding their pathway in recovery. Tey oﬀer locations in Pawtucket and Warwick.
RICARES
401-475-2960
Ricares.org
134 Mathewson St. 3rd ﬂoor
Providence, RI
RICARES views recovery as a social justice issue. We bring trauma, recovery, and 
social justice together. We view a Rhode Island where recovery is a mainstream 
lifestyle and we live free from stigma and discrimination.
RICARES asserts that all pathways lead to recovery. Recovery does not require 
forced or coerced abstinence and is sustained as a chosen identiﬁcation.
VICTA
401-300-5757
Victalife.com
110 Elmwood Ave
Providence, RI 02907
VICTA is a privately owned outpatient substance abuse and mental health 
treatment program. VICTA if sounded by people that worked in this ﬁeld for an 
extended period of time and wanted to make a diﬀerence in someone’s life using 
their expertise and care. 
Hope Recovery 
Alliance
401-619-1343
Hoperecoverycenter.org
50 Washington Square
Newport, RI
At Hope Recovery Center of Newport County our approach is to oﬀer support for 
people to choose recovery as an achievable way out of substance use and mental 
health challenges.
Rhode Island 
Free Clinic
401-274-6347
www.rifreeclinic.org
655 Broad Street
Providence, RI
Provides coordinated health services comprised of primary care, labs and 
diagnostics, specialty care, prescription medications, follow-up visits, 
counseling and wellness programs that help uninsured adults get and stay 
healthy.
Clinica Esperanza/
Hope Clinic
https://www.aplacetobe-
healthy.org/
60 Valley Street, Suite 104
Providence, RI
Oﬀers primary medical care to RI residents without health insurance, 
with an emphasis on Spanish-speaking and culturally accustomed care
Thundermist Health 
Center
401-615-2800
http://thundermisthealth.org
450 Clinton Street
Woonsocket, RI
186 Providence Street, West 
Warwick, RI
1 River Street Wakeﬁeld, RI
Tundermist provides primary medical care to Rhode Island residents 
without health insurance, with speciality in Trangender health care, HCV 
treatment, and substance use.
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

ATTACHMENT J: REOPENING PLAN 
Description of the research to be done 
We would like to resume in-person survey questionnaires with participants at SPH 121 South Main St. 
for our NIH-funded, R01 clinical trial, The Rhode Island Young Adult Prescription and Illicit Drug Study 
(RAPIDS). This study involves recruiting individuals for six in-person contacts over the course of one 
year. Each visit is approximately 60 minutes, with the initial baseline visit lasting up to 90 minutes. 
Participants are asked a series of questions, some are randomized to a 15-minute behavioral 
intervention session, and all participants are asked to give a urine sample for a drug screen. 
Participants are given a bag at the end of each session with naloxone and some also receive fentanyl 
test strips.  
Justification for reopening the research space 
The nature of the intervention is such that in-person participation is required. In particular, the 
fentanyl test strips and naloxone must be given to each participant at the end of an intervention 
session. Many participants do not have a regular address, so mailing these materials would be 
challenging, if not impossible. In addition, urine sample collection would be infeasible remotely, and 
would compromise the scientific rigor of the work, since past three-day drug use reported during the 
survey component will be correlated with the urine sample results. Urine samples provided several 
days after the self-reported data is ascertained would not provide the same level of fidelity and 
information. 
List of personnel who will work in the research space 
Only the fewest number of research staff necessary to conduct the research will work in person at 
121 South Main.  Specifically, two research assistants (Jackie Goldman, Tania Lobo Paz) will be asked 
to return to in-person work.  Their supervisor (Jesse Yedinak) and the PI (Brandon Marshall) will 
continue to work remotely during this period, but will be available by email or phone during all 
scheduled participant visits.  Please see the lab density sheet for more information. 
Lab safety plan 
General procedures:  
Risks to staff and participants will be mitigated through the use of personal protective equipment 
(masks, gloves for handling study equipment, including distribution urine tests, naloxone to 
participants etc.), regular sanitizing of spaces after each participant, and by bringing back the fewest 
staff needed to complete the study visits (2). Social distancing guidelines will be followed by the 2 
staff who are on-site, and they will wear masks whenever they are in a common space or near other 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

people. They will be the only staff on the 2nd floor of SPH. Staff will be required  to stay home and 
cancel study visits if they show any signs or symptoms of illness, and will contact their supervisor that 
same day to discuss their symptoms.  
Work shift: 
භ
On days where participant visits are scheduled, research staff will be working in-person. They
will arrive an hour before the first participant visit in order to prepare for the study visit and
perform requisite cleaning.
භ
When scheduling multiple visits in a day, there must be at least an hour in between visits to
allot for disinfection procedures, to ensure that participant visits do not overlap should
participant visits run overtime or a participant arrive early.
භ
After the final visit for the day, staff should plan to stay on site for an hour to clean and
disinfect the study space as well as personal work space.
භ
Staff will only work in the building on days when participant visits are scheduled. Otherwise,
staff will work remotely. If there are multiple visits during the day, that staff will stay on site
between visits and be allowed to conduct their non-participant facing work, such as phone
screens, attend zoom meetings related to this project or others, and perform other
administrative work related to this project and others.
භ
Staff will be requested to eat in either rooms 240 or 247. Staff must maintain social distancing
measures when they eat and wipe down high-touch surfaces before and after eating.
Procedures for social distancing: 
භ
Each staff will have their own office in which to conduct their work and participant visits.
භ
Each staff will have their own laptop and phone. No other study equipment will be shared.
භ
Staff will agree to stay more than 6 ft apart when in a shared space.
භ
Participants will be given a disposable mask by staff in the Lobby if they did not bring their
own.
භ
Participants will be instructed by staff on the social distancing procedures for the buildingand
research study.
භ
Participants will be screened for all potential COVID-19 symptoms in the Lobby, per building
guidelines.
භ
Participants will be escorted in the elevators or given the option to take the stairs. If only one
person is allowed in the elevator at a time, one of the staff will greet the participant in the
lobby and press the button for the second floor. The second staff member will wait on the
second floor and escort the participant to the proper room. The first staff member will then
meet the participant.
භ
In order to minimize time spent in direct proximity with participants, Staff will employ a
mixture of in-person and virtual research methods. Participants and Staff will sit in separate
rooms with a laptop. Survey administration and overdose education will occur over Zoom. The
final piece of the intervention, which lasts between 10-15 minutes will take place in person.
For the in-person parts of the study visit, both Staff and Participants will wear masks and use
hand sanitizer before sitting in the same room.
භ
&ŽƌƚŚĞĚƌŝĞĚďůŽŽĚƐƉŽƚĐŽůůĞĐƚŝŽŶ͕ƐƚĂĨĨĂŶĚƉĂƌƚŝĐŝƉĂŶƚƐǁŝůůďĞĐůŽƐĞƌƚŚĂŶϲĨĞĞƚ͘dŚŝƐ
ŝŶƚĞƌĂĐƚŝŽŶǁŝůůƚĂŬĞŶŽŵŽƌĞƚŚĂŶĂĨĞǁŵŝŶƵƚĞƐ͘ƵƌŝŶŐƚŚĂƚƚŝŵĞ͕ƐƚĂĨĨǁŝůůďĞǁĞĂƌŝŶŐĨĂĐĞ
ƐŚŝĞůĚƐ͘
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

භ
Each staff person will be limited to no more than 3 participant visits per day during Stage II of
Brown University reopening. This will ensure that there will be ample time to disinfect the
study space between visits and will minimize the number of interactions that the research
staff have in the course of a day. We will re-evaluate the number of participant interactions in
a day as the university transitions to different stages of re-opening.
භ
In order to adhere to Stage II building density guidelines, the portion of the study visit that will
take place in person will occur in room 259. This will be reevaluated as Brown University
moves to other stages of reopening.
Additional procedures for participant encounters/sessions: 
භ
Staff will ensure there are sufficient cleaning supplies and personal protective equipment on-
site at all times.  Cleaning equipment will be stored in room 256.
භ
Staff will disinfect their work space upon entering the building and upon completion of their
work day.
භ
At all times, participants will be seated more than 6ft apart from the research staff.
භ
Staff will conduct a health pre-screening with research participants prior to their study visits.
භ
Participants will enter and exit 121 South Main Street through the main entrance.
භ
Participants will be asked to use hand sanitizer immediately upon entering the building or will
need to wash their hands when they arrive at the second floor. If the participant does not
arrive wearing a mask, the participant will need to wash their hands or use hand sanitizer
immediately after putting their mask on.
භ
Research staff will ask all questions out loud and will do all data entry for participants.
භ
All consent forms will be completed electronically.
භ
All surfaces will be disinfected after each participant visit. Additionally, all surfaces will be
disinfected before the first visit and at the completion of the final study visit each day.
භ
Signs will be posted reminding participants of how to properly wear their masks and
reminding them to wash their hands thoroughly after their visits.
Additional procedures for urine screening: 
භ
There will be one dedicated restroom for participants to use for urine screens. No other staff
or participants are allowed to use that restroom.
භ
Protective equipment, such as masks and gloves, will be worn at all times during urine drug
screening, in accordance with the prior-approved protocols.
භ
The restroom will be wiped down with disinfectant after each use.
Finally, as the research involves in-person, on-campus human subjects research activities, the 
following is attested:  
1) I affirm that the study team will conduct a health pre-screening with research participants at
least a day prior to and on the same day as their study visits. If the health pre-screening and
research participants’ on-campus study visit are not within close proximity to one another, it
is advised that the study team conduct another health screening when the research
participant arrives for the study visit.
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

2) I affirm that the study team will discuss with research participants the safety protocols
implemented at Brown to reduce risk of transmission of COVID-19 prior to their study visit.
This must include any Expectations of study participants.
3) I affirm that the study team will inform research participants of the Brown University
requirement that they wear a face covering during their study visit.
4) I affirm that the study team will provide research participants with information about
the Centers for Disease Control and Prevention groups determined to be at higher risk for
severe illness, either verbally via a script or via an electronic method (for example, sent via
email or Qualtrics). This will enable participants to make an informed decision about personal
risks related to COVID-19.
5) I affirm that the study team will remind research participants of the following Phase I State of
Rhode Island guidance: “Older adults (65+) and those with underlying health conditions can go
to work and go out for food or medicine. But in accordance with federal public health
guidance, vulnerable individuals are strongly encouraged to otherwise stay home.”
Contact tracing plan 
භ
Contact tracing will be performed in accordance with the Brown University policy.
භ
Staff will log all participant’s full name, phone number, location, date and time of contact.his
log will be updated daily. This log will also include staff encounters for each day.
භ
Contact logs will be stored in the study team’s REDCap database that is only accessible
through Stronghold. Participants will be assured that all contact information will be stored
behind two-step authentication.  Participants'  personal information will only be accessed by
the study team and the Rhode Island Department of Health as needed. Contact tracing logs
will be stored and maintained separate from research data collected as part of the RAPIDS
study.
භ
Contact logs will be destroyed 30 days after the participant's study visit.
භ
Once the staff has been made aware of COVID-19 exposure, staff will contact participants
immediately, and no later than 72 hours after the known exposure. Staff will contact HR
immediately and follow HR’s direction about how to proceed.
භ
At any point, if Brown University issues additional guidelines, the staff will follow those
procedures in addition to/in place of these written guidelines, whichever are more strict.
Yours sincerely, 
Brandon DL Marshall, PhD 
Associate Professor 
Department of Epidemiology 
Brown University School of Public Health 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

THE RAPIDS CLINICAL TRIAL: 
Appendix C: Dried Blood Spot Protocol 
Dried Blood Spot Collection Policies & Procedures - The following are instructions to guide 
the collection, handling and storage of dried blood spots.  
When collecting blood samples, always use Universal Safety Precautions. These include: 
භ
Treating all blood samples as though they are infectious;
භ
Washing hands;
භ
Wearing gloves;
භ
Taking precaution to avoid needle-stick injury; and
භ
Disposing of contaminated sharps and waste appropriately
1. Materials required
භ
Whatman 903 Protein Saver cards (DBS collection card)
භ
Sterile, disposable lancets
භ
Specimen bags (sealable plastic bags)
භ
Humidity indicator cards
භ
Desiccant packs
භ
Absorbent underpads
භ
Sterilising alcohol wipes
භ
Gauze pads, cotton ball, and plaster/band-aid
භ
Safety and clean-up materials including gloves,
a 
sharps 
container, 
sani-cloth 
wipes,
concentrated bleach for 10% bleach solution.
2. Sample collection and testing procedure
This section presents detailed instructions for collecting and storing a DBS sample. Please 
ensure that you read and understand the steps involved and collect each sample in accordance 
with these instructions. A simplified graphical representation of this procedure (Annex 1) is 
presented on page 4 for your future reference. 
Please examine Annex 2 (page 5) to familiarize yourself with the appearance of a valid versus 
invalid DBS sample, and take note of the following tips for sample collection: 
භ
Apply blood to only one side of the filter paper (DBS card)
භ
DO NOT press the filter paper against the puncture site
භ
DO NOT layer successive drops of blood or apply blood more than once in the same
collection circle
භ
DO NOT “milk” the finger as excessive milking or squeezing the puncture site might
cause hemolysis of the specimen (destruction of red blood cells) or result in collection
of tissue fluids with the specimen, which might adversely affect the test result.
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Note: Three complete circles are better than five incomplete ones! While the collection card may 
include 5 circles, only one participant’s blood may be collected on any given card. 
3. General test preparation
a) Gather the required materials and find a suitable surface to take the samples before
putting on the gloves
b) Label the DBS card with the encrypted study ID code and complete any clinical
information required on the card.
4. Fingerstick performed by the study team
a) Explain the procedure to the participant so that they know what to expect. Ask which
finger they would like to use, noting that the ring finger (fourth from the thumb) is most
practical for the procedure.
b) Warm the participant’s hands and fingers to increase blood circulation if possible. To
further increase blood circulation, it sometimes helps to massage the whole hand and
finger to be stuck, not just the fingertip. While the tester is organizing the specimen
collection materials, they can also have the participant open and close (“pump”) their
hand or squeeze and release a stress ball several times to increase blood circulation.
Having the participant hold their hand below the level of their heart before performing
the collection increases blood circulation as well.
c) Position the hand palm-side up. Choose the fingertip of the ring, or middle finger,
whichever is the least calloused. You can also use the index finger or thumb if it’s the
least calloused finger.
d) Clean that finger with the alcohol pad.
e) Using a sterile contact activated lancet, puncture the skin just off the center of the
finger pad. Hold the finger downward and apply gentle pressure beside the point of
the puncture. Avoid squeezing the finger to make it bleed.
f)
Wipe away the first drop of blood, which tends to contain excess tissue fluid, with a
sterile gauze or cotton ball. Allow a new drop of blood to form before collecting the
blood specimen.
g) Allow a large drop of free-flowing blood to collect at the puncture site. Working
quickly, hold the DBS card by the edges, touch the filter paper gently against the large
drop of blood, and in one step allow a sufficient quantity of blood to soak through and
completely fill or saturate a circle.
DO NOT allow the finger to touch the card;  
DO NOT layer successive drops of blood or apply blood more than 
once in the same collection circle. 
h) Repeat Step g), collecting enough blood on the DBS
card to fill each of the 5 circles completely.
i)
Give the participant a gauze pad and ask them to apply pressure to their finger.
j)
Take the DBS card to a secure drying rack, ensuring it is labeled with the participant’s
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

encrypted study ID code, and allow it to dry for a minimum of four hours before 
packing for storage.  
k) Once the bleeding has stopped, use a Band Aid to bandage the participant’s finger.
l)
Discard your gloves in a biohazard container after the sample collection and don a
fresh pair for each new participant.
5. Cleanup and decontamination
a) Dispose of used lancets and gloves in a sharps container.
Once the sharps container is full, close firmly, and set in the
designated area for pick up and destruction.
b) Due to the small amounts of blood being collected from each
participant, it is unlikely that large spills will occur. However, it
is important to treat any blood spilled as potentially infectious. Use a sani-cloth wipes
to wipe up the blood. If more than a few drops of blood are spilled, use the 10%
bleach solution and the sani-cloth wipes to clean the area. Dispose of the clinical
wipes in a sharps container.
c) At the end of each day, wipe down completely all surfaces using Clorox Clinical
Wipes, including tabletops, collection station chairs, and empty drying racks.
. Packaging DBS samples for long-term storage
a) Once the DBS card has been allowed to dry
for a minimum of four hours, follow the steps
depicted in the figure to prepare the DBS kit for
long-term storage
b) Fold the DBS card to protect the collected
samples
c) Insert the DBS card into the sealable plastic
bag, ensuring that the participant identification
label will be visible without opening the bag
d) Add two desiccant packets to the plastic bag.
These serve as a drying agent to protect the
sample
e) Add a humidity indicator card, ensuring that it
will be visible without opening the bag
f)
Seal the bag and store in a cool, dry, dark
place until it can be shipped to the
biospecimen bank at Rhode Island Biobank.
Humidity and UV light can damage the DBS
samples so it is important they are stored
appropriately.
Note: DBS samples can be stored at room temperature for a maximum of 14 days from the date 
of collection. After 14 days the samples must be transferred to a -70˚C freezer. The total time at 
ambient / room temperature should be minimised as much as possible 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Annex 1: Summary of dried blood spot collection 
STEP 1 
Clean the ﬁnger and wipe with alcohol swab, then 
using a sterile lancet, puncture the skin just oﬀ the 
center of the 3rd or 4th ﬁnger pad 
STEP 2 
Wipe away the first drop using gauze or cotton 
ball. Apply gentle pressure to the ﬁnger and allow 
a large drop of free ﬂowing blood to collect at the 
puncture site. Drip enough blood onto the DBS 
card to ﬁll each of the 5 circles completely 
STEP 3 
Label the card with the participant’s ID sticker and 
take the DBS card to a secure drying rack 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Before sticking the finger« 
ඵ
Set out all supplies needed to collect
blood; open band aid and alcohol pad
ඵ
Ask the participant which is their non- 
dominant hand
ඵ
Assess positioning of you and the
participant to decide the easiest way to
collect blood for the rapid test and DBS
ඵ
Assess which finger is free of callouses
and has the softest skin – this is typically
the ring finger
ඵ
Even if the participant’s hands are warm,
massage the whole hand to increase
circulation; hold participant’s hand
downward (below the heart) while
massaging. Circulation can also be
increased by asking the participant to
pump their hand or squeeze a stress ball
ඵ
Ask participant to flick their hand in a
downward motion
ඵ
Clean the finger with an alcohol pad
The stick« 
ඵLay the hand against a hard, flat surface
ඵHold the lancet just off from the center of
the fingertip pad and perpendicular to the
ridges of the fingerprint; DO NOT STICK
THE FINGER ON THE SIDE
ඵMassage from the base of the finger using
a squeeze-release motion; it works well to
wrap your fingers around the stuck finger
and the finger next to it
ඵDO NOT SQUEEZE the tip of the finger
ඵWipe away the first drop of blood with a
cotton ball
ඵIf blood is not readily flowing:
ඵMassage entire hand using both of your
hands; one hand should continue with the
squeeze-release of the fingers
ඵIf participant is feeling okay, ask him to
stand up to allow the hand to be held
much lower than the heart
ඵBe patient and keep massaging;
sometimes it takes time for the blood to
start flowing
Specimen collection« 
ඵAllow a new drop of blood to for
the first drop with a cotton ball
ඵCollect specimen for rapid test
ඵFlip the hand downward towar
card, continue massaging, allo
time for a very large drop of blo
before applying to the first circl
ඵTouch the drop of blood to the
NOT TOUCH THE FINGER TO
the card will wick the drop of b
from the finger
ඵIf one drop of blood does not fi
entire circle, immediately apply
drop of blood to that same circ
ඵContinue above procedures as
move to next circle
ඵUpon completion, the circles sh
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Annex 2: Examples of valid and invalid dried blood spot specimens 
Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021 

Brown University IRB Original Approval: 4/18/2019 
Brown University IRB Amendment Approval: 11/22/2019 
Brown University IRB Amendment Approval: 8/10/2020 
Brown University IRB Amendment Approval: 10/15/2020 
Brown University IRB Amendment Approval: 02/26/2021 
Brown University IRB Continuing Review Approval: 03/18/2021 
Brown University IRB Amendment Approval: 06/15/2021 
Brown University IRB Amendment Approval: 09/01/2021 
Brown University IRB Amendment Approval: 10/05/2021
Brown University IRB Amendment Approval: 11/09/2021 
Brown University IRB Amendment Approval: 12/13/2021