A Pilot SMART Pre- and Post-testing of an Integrative Mindfulness-Based Smoking Cessation Intervention for HIV Patients
Phase: PHASE4
Conditions: Smoking, Smoking Cessation, HIV Infections
Sponsor: University of Miami

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Protocol Title
A Pilot SMART Testing an Integrative Smoking Cessation Intervention for 
HIV Patients 
Protocol Number:
20201296
Protocol Version
12
Protocol Version Date
10/6/23
Principal Investigator
Taghrid Asfar, MSPH, MD
NCT Number 
NCT05030766
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1)
Objectives*
We will conduct a pilot Sequential, Multiple Assignment randomized clinical trial 
(SMART) incorporating nicotine replacement treatment (NRT), contingency 
management (CM), and mindfulness training (MT) to identify the optimal 
dynamic strategy to promote biomarker-confirmed smoking abstinence among 
people living with HIV (PLWH). 
2)
Background*
Mindfulness training (MT) is an approach that has become more widely used for 
the purposes of smoking cessation. MT can operationalized into two components: 
1) maintaining attention on immediate experience, and 2) maintaining an attitude 
of acceptance toward that experience, which can improve individuals’ ability to 
avoid absorption in maladaptive mental patterns, behaviors, and emotional 
reactions that lead to depression.[1,2]_ENREF_40  MT is effective in reducing 
both self-report and objective indices of negative affect and psychological 
stress.[3,4] MT also can help smokers control craving by being less emotionally 
reactive and less prone to relapse related to avoidance of distressing symptoms.[5] 
The use of MT for smoking cessation, however, has not been tested among 
Hispanics HIV patients who smoke. We, therefore, propose to test the feasibility, 
acceptability, and potential efficacy of a mindfulness smoking cessation 
intervention among Hispanics HIV patients that smoke. CM is an evidence-based 
behavioral intervention where individuals receive escalating tangible 
reinforcement for biologically confirmed substance abstinence.[6] CM has been 
successful in retaining patients in treatment and fostering stable periods of 
abstinence in substance use behavioral research, including tobacco.[7-9] In HIV 
patients, CM was feasible and effective in improving compliance to ART[10] and 
reducing HIV risk behaviors (e.g., unprotected sex, injection drug use).[11] CM 
may as well reduce the economic stressor for smoking cessation (e.g., 
unemployment) in HIV patients. [12,13] Yet, no studies to date tested CM to 
promote smoking cessation among HIV smokers. In our survey among HIV 
smokers, 45.7% were interested in CM to quit smoking. Therefore, CM may serve 
as an ideal adjunct intervention to MT to promote long-term abstinence in HIV 
smokers.
3)
Inclusion and Exclusion Criteria*
A. Inclusion Criteria
To be eligible participants should:
•
Diagnosed with HIV (based on self-report).
•
Be 18 years and older 
•
Have smoked ≥ 5 cigarettes/day in the past year
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•
Be interested in making a quit attempt in the next 30 days
•
Own a smartphone (apple/android), and plan to keep it active for 
the next 6 months
•
Able to consent
•
Have no plans to move in the next 6 months
•
Are not pregnant or planning to be pregnant in the following 6 
months
•
Have any condition that, in the opinion of the investigator, would 
compromise the well-being of the patient or the study or prevent 
the patient from meeting or performing study requirements
B. Exclusion Criteria
Participants would be excluded if they:
•
Have contraindication to NRT (past month myocardial infarction, 
history of serious arrhythmias/or unstable angina pectoris, 
dermatological disorder) 
•
 Are currently being treated for a psychiatric condition.
•
Are currently being treated for smoking cessation, alcoholism, or 
illicit drug use
•
Are adults unable to consent
•
Are individuals who are not yet adults
•
Are pregnant women
•
Are prisoners
4)
Study Design
a.
Study Type – Interventional
b. Primary Purpose – Other 
c.
Interventional Study Model – Sequential
d. Number of Arms – 2
e.
Randomized or not – Randomized
f.
Open label or if blinded – Not blinded
g. Number of participants – 100 
5)
Procedures Involved*
We will recruit participants via community and clinic flyers and among participants of 
another on-going survey who smoke (IRB#20180269). In Stage 1, participants will be 
randomized into one of two groups: 1) a group mindfulness training (MT) for smoking 
cessation, or 2) contingency management (CM) for smoking cessation. In Stage 2 non-
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responders (those who have not quit at 1 month evaluation) will be randomized to: 1) 
Switch to sequentially receive the other intervention (i.e., CM or MI) and complete the 3-
month assessment; or 2) Continue without further intervention and complete the 3-month 
assessment only. 
In stage 1, both groups will do the following:
•
Complete a baseline survey. 
•
Receive 6 weeks of Nicotine Replacement Treatment (NRT) via mail
•
Receive reminder/encouragement calls or texts the day before their quit 
date and 2 weeks after their quit date.
Arm 1:  The MT smoking cessation intervention: 
Participants will attend an orientation session via Zoom or in person to introduce 
them to mindfulness, smoking cessation, and what is covered in the group 
sessions. This orientation will last 60-90 minutes. They will receive twice weekly 
group sessions (eight total during 4 weeks) via Zoom or in person that were 
manualized and will be delivered in Spanish or English by a Hispanic instructor(s) 
experienced in MT (a single therapist with >4 years of training in MT). We will e-
mail participants study materials ahead of the first group session, such as the 
participant study booklet. We will also communicate with participants using 
WhatsApp to send them reminders and links to mindfulness recordings.
The overarching theme of momentary awareness and acceptance of cravings and 
affect (e.g., stress, anxiety etc.) will be introduced and reinforced in 
complementary ways throughout the training. Each session will last 45-60 
minutes.
a.
Session (1): Will introduce participants to the concept of how smoking can 
become a habituated behavior triggered by an environmental, physical, or mental 
stimulus through associative learning. It also will explore how cravings feel in the 
body and how MT can help individuals become more aware of these processes. 
b. Session (2): Will examine how thoughts, emotions and body sensations 
become triggers for craving and smoking and introduce a technique to ‘mindfully’ 
work with cravings (Recognize, Accept, Investigate and Note what cravings feel 
like as they arise; acronym: RAIN). 
c.
Session (3): Will introduce how difficult emotions perpetuate smoking as well 
as a standard meditation technique called loving-kindness as a way to work with 
them. Loving-kindness is practiced through directed well wishing, typically by 
repetition of phrases such as ‘may X be happy.’ 
d. Session (4) (quit date): Will teach participants how cravings thwart long-term 
goals, and reinforce mindfulness techniques as a way to help individuals 
disengage from habitual responding and realign with their goals. 
e.
Session (5): Will introduce participants to mindfulness practice in everyday 
life, including “awareness of breath” meditation and mindful walking (“four 
modes of walking”, during which individuals practice systematically noting 
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objects that they see, and then objects that they hear, then objects that they smell, 
and then tactile objects such as the pressure of their feet on the ground). 
f.
Session (6): Will explore the automaticity of thought, and how thoughts can 
lead to habitual behaviors. 
g. Session (7): Will reinforce the concept of acceptance and its role in changing 
habits. It will also explore how both mental and physical actions can “plant seeds” 
for future actions and habits. 
h. Session (8): Will summarize the course tools and explore ways of maintaining 
these in the future. Home practice will be suggested after each session as a 
combination of formal MT meditations (the “body scan” which teaches 
individuals to systematically pay attention to different parts of their bodies as a 
way to reduce habitual mind-wandering and strengthen their attentional 
capacities, loving-kindness, and awareness of breath, which through focused 
attention on the breath also is intended to help individuals retrain their minds from 
habitually engaging in self-related pre-occupations -such as thinking about the 
past or future, or reacting to stressful stimuli- to more present moment 
awareness), and informal practices (four modes of walking, mindfulness of daily 
activities, mindfulness of smoking, RAIN). Participant will receive meditation 
recordings to practice.
Participants will receive a weekly phone call to ask a few questions on their use of 
the mindfulness practices taught in the sessions. This will take about 5 minutes.
Participants will receive $20 for completing the baseline assessment, $10 for 
attending each of the 8 sessions, $10 for the end of the treatment assessment, and 
$25 for the 3-month follow up assessment (a total of $135).
Arm 2:  Contingency Management (CM) Smoking Cessation Intervention
Participants in this arm will attend an orientation session via Zoom that will last 
60-90 minutes. They will connect with a research associate 3 times per week for 3 
weeks after quit date via zoom where they will answer a few questions about their 
quitting progress, report on past 7-day smoking, and provide a sample of CO to 
verify their smoking status after their quit date using a portable CO monitor 
(coVita iCO™ Smokerlyzers®) and/or NicoTests saliva screen test that has been 
mailed to them. Those who proved their abstinence (CO< 8 ppm using coVita 
iCO™ Smokerlyzers®) and/or 30 ng/mL using NicAlert) [14] will receive a cash 
reward. The first successful CO sample earns $5 cash, and then the reward 
increases by $2 for each consecutive successful CO and/or saliva sample (e.g., $5, 
$7, $9...). Participants also earn $2 bonus for 4 consecutive successful CO and/or 
saliva samples (total=$4). In all, participants can earn a maximum of $176. 
Participant who fail the CO and/or saliva test will not receive reinforcement and 
the value of the next payment will be reset to the one that was missed.
 
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All participants will be asked to complete an end of treatment assessment 2 weeks after 
the intervention ends, which will be the same as the 3-month follow-up described below. 
Breath CO and/or saliva sample test (for cotinine analysis) will be collected at the end of 
treatment assessment via Zoom for participants who report they have quit.
All participants will be asked to complete a follow-up assessment 3 months after their 
quit date to assess their smoking status as well as get information about concomitant 
smoking and NRT use, use of additional NRT or cessation drugs (e.g., bupropion), and 
use of other tobacco methods.  Breath CO and/or saliva sample test (for cotinine analysis) 
will be collected at the 3-month follow-up points for participants who report abstinence. 
The breath sample will be collected with the portable CO monitor (coVita iCO™ 
Smokerlyzers®) and/or NicoTests saliva screening test. A cut-off of 8 ppm for CO test 
(using coVita iCO™ Smokerlyzers®) and/or ≤ 30 ng/mL for the saliva sample test 
(using NicoTests) will be used to determine abstinence (Benowitz et al 2002).
 
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Study measures
1. Baseline Assessment: All study materials and instrument will be translated into 
Spanish.
•
Demographics and HIV history: Age, race/ethnicity, birth origin, years in 
USA, relationship status, education, employment, income, acculturation, discrimination, 
self-identity, time since HIV diagnosis, HIV treatment.
Smoking status will be verified using breath carbon monoxide (CO [< 8 parts per million 
(ppm)], which can be determined quickly through a small, hand-held monitor and/or 
using a saliva screening test (cutoff concentration of ≤ 30 ng/mL), which can be 
determined quickly through a NicoTests saliva sample.
•
Smoking: Smoking history, past quit attempt, motivation to quit, confidence in 
quitting, Fagerström test for nicotine dependence,[15] 12-item smoking self-efficacy to 
resist urge to smoke,[16] and 15-item Minnesota nicotine withdrawal scale (i.e., craving, 
irritability, anxiety, depression).[17]
•
Mindfulness skills: The 15-item short form five facets of mindfulness 
questionnaire that measures MT skills related to observing, describing, acting with 
awareness, non-judging of inner experience, and non-reactivity to inner experience.[18] 
•
Others: The 20-item Centers for the Epidemiologic Study of Depression (CES-
D) scale,[19] social support,[20] quality of life,[21] and alcohol and substance use 
(ASSIST).[22]
2. End-of treatment assessment (one month after quit date):
•
The follow up assessment will occur at 1 months after quit date. The visit will 
last approximately 45 minutes. 
•
Information on number of sessions that was attended.
•
Acceptability: The acceptability will be assessed by 3 items “How satisfied 
were you with the intervention?”, “How likely are you to recommend this intervention to 
a friend?” and “How useful was the intervention?” 
Smoking Cessation:  Main smoking cessation outcome is 7-day point-prevalence 
abstinence (defined as self-report of not smoking in the past 7-days; not even a puff) and 
confirmed smoking cessation by expired carbon monoxide (CO) level cutoff of <  8 ppm 
using a coVita iCO™ Smokerlyzer® and/or NicoTests saliva sample of  ≤ 30 ng/mL at 
the 1-month follow up. Secondary outcomes include the reduction in number of cigarettes 
smoked per day.[23,24] Relapse is defined as smoking at least once/week on two 
consecutive weeks.[25] These are described in more detail below.
3. Three-month Follow-up Assessment (3-month after quit date): 
•
The follow up assessment will occur at 3 months (+30 days) after quit date. 
The visit will last approximately 45 minutes. 
•
All baseline assessment will be re-administered except demographics.
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•
Information on number of sessions that was attended.
•
Acceptability: The acceptability will be assessed by 3 items “How satisfied 
were you with the intervention?”, “How likely are you to recommend this intervention to 
a friend?” and “How useful was the intervention?” 
•
Smoking Cessation:  Main smoking cessation outcome is 7-day point-
prevalence abstinence (defined as self-report of not smoking in the past 7-days; not even 
a puff) and confirmed smoking cessation by expired carbon monoxide (CO) level cutoff 
of < 8 ppm using a coVita iCO™ Smokerlyzer® and/or NicoTests saliva sample of  ≤ 
30 ng/mL at the 3-month follow up. Secondary outcomes include the reduction in number 
of cigarettes smoked per day.[23,24] Relapse is defined as smoking at least once/week on 
two consecutive weeks.[25] These are described in more detail below.
•
Process evaluation: Semi-structured post-intervention evaluation interviews will 
be conducted with randomly selected participants to further inform our assessment of 
acceptability and perceived helpfulness of interventions, and identifying key areas for 
refining the intervention protocols (e.g., improving access, content, usability). These will 
be conducted in-person or via Zoom and participants will receive $25 for completing the 
interview.
Primary Outcome Measure Title:  Smoking cessation - 7-day point-prevalence 
abstinence.
Outcome Measure Description: 
Defined as self-report of not smoking in the past 7-days, not even a puff and 
confirmed by expired carbon monoxide (CO) level cutoff of < 8 ppm using a 
coVita iCO™ Smokerlyzer® and/or NicoTests saliva sample of ≤ 30 ng/mL. 
Outcome Measure Timeframe: 
4 weeks (end of treatment), and 3 months
Secondary Outcomes
1. Treatment-specific retention rates for study measures.
o
Defined as: Percentage  of participants completing all study procedures 
divided by total enrolled. Coded reasons for dropouts.
o
Timeframe: 3 months
2. Treatment-specific adherence rates to study protocol 
o
Defined as number of  phone-call check-ins attended by each participant 
(4 for mindfulness training, 12 for contingency management). 
o
Timeframe: 3 months
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6)
Data and Specimen Banking*
 There will be no data or specimen banking.
7)
Data Management*
The analysis of the feasibility and acceptability outcomes will be mainly 
descriptive. We will calculate differences in pre and post intervention 
measures of baseline characteristics, indices of treatment implementation, 
adherence, retention, and treatment perceptions and compare the 
differences between arms 1 and 2. Attrition analyses will compare 
respondents who complete all measurements to those who do not based on 
baseline characteristics. Direct maximum likelihood estimation and 
multiple imputation will be used to address incomplete data. Univariate 
and multivariable logistic regression models will be used to explore 
baseline predictors of 3-month smoking cessation and the acceptability 
and feasibility of the intervention. Cross-tabulations for ordinal variables 
and mean and corresponding 95% confidence intervals for continuous 
variables will be used to explore secondary outcomes including 
improvement in depression, smoking self-efficacy, craving, quality of life, 
and mindfulness skills. Although we are unpowered to detect differences 
by gender, we will consider exploring the gender effect on our main 
outcomes in our analysis. Data management for preparing data for 
statistical analysis and statistical analysis will be performed with SAS or R 
statistical software.
Qualitative analyses of semi-structured post-intervention evaluation 
interviews will identify emergent themes related to acceptability and 
specific targets for refinement of content and delivery. Interviews will be 
audio-recorded, transcribed verbatim, and analyzed using Nvivo. This 
program is designed for the storage, coding, retrieval, and analysis of 
qualitative data. Two complementary coding schemes will be used: 1) 
descriptive, which uses words or short phrases to summarize passages of 
data and 2) in Nvivo, in which actual language from participants is used to 
name concepts and themes. Extensive analytic memos will be written after 
each interview is conducted, coded, and throughout the analysis process to 
reflect on code choices, emergent themes and patterns, and conceptual 
models. Finally, the data will be themed, in which the final sets of codes 
and their meanings will be transformed into longer and more descriptive 
themes to organize recurrent meanings and patterns. Themes and 
definitions will be compared across interviews to ensure consistency and 
reliability.  
Statistical analyses will be done using SPSS, V21, 
(https://www.ibm.com/analytics/spss-statistics-software). 
All study data will be entered and captured by REDCap, which provides secure 
data capture for clinical and non–clinical research studies. 
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8)
Risks to Subjects*
The risks to subjects, immediate and long range, are considered minimal. Study 
participants will be asked to complete questionnaires before and after receiving 
advice to quit smoking, either self-help materials to quit or a behavioral 
intervention, as well as nicotine replacement for smoking cessation. It is possible 
that subjects might become psychologically distressed while completing the 
questionnaires or be dissatisfied with the self-help information or intervention. 
They will be provided with transdermal nicotine patches that are available over-
the-counter. Participants will be required to indicate whether they have any health 
conditions that may negatively interact with the patches. 
To minimize the risk of psychological distress due to questionnaire completion, 
the measures do not contain private or potentially embarrassing items, and will 
take about 30-45 minutes for completion time per assessment. To minimize the 
risk of dissatisfaction with the intervention, we will use an established 
intervention that has high efficacy. To minimize risks associated with the nicotine 
patches, subjects will be provided with thorough education of the indications for 
the nicotine patch, possible side effects, and known health conditions that 
preclude patch use. The patches are available over the counter; thus, they do not 
pose a significant health risk to most people. They contain minimal amounts of 
nicotine (which are much less than they get from smoking), and are absent the 
remaining 7,000 toxins contained in cigarettes. In addition, we will refer patients 
with a questionable medical history to their physician or to Jackson Memorial 
Hospital for consultation.    
Though we regard the risks of participating in this study as low, we will take 
every measure to ensure that every recruiter, interviewer or project personnel, is 
trained to handle situations sensitively and with empathy. All research staff are 
required to complete site mandated training on the Protection of Human Research 
Participants. 
9)
Adverse Events (AE) and Serious Adverse Events (SAE)
Adverse events for this study may include the following:
EXPECTED:
a.
Symptoms of nicotine withdrawal, such as headaches, cravings, insomnia, 
anxiety, or depression.
b. Side effects of using the nicotine replacement patches, such as minor skin 
irritation or rash).
These expected AE will be recorded in the participant tracking database. Participants will 
be advised to review the materials they received on nicotine withdrawal and proper 
use of NRT patches. If unmanageable symptoms persist of withdrawal or NRT use 
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persis, participants will be advised to discontinue use of NRT and see their 
physician.
UNEXPECTED
c.
Unexpected negative psychological reactions to practicing mindfulness.
These unexpected AE will also be recorded in the participant tracking database. If 
negative reactions to the mindfulness practice cannot be resolved within the group 
session by the trained mindfulness expert, participants will be advised see their 
physician. If severe reactions occur and cannot be resolved, study staff will call 
911. We do not expect this SAE to occur, nor are any other SAE anticipated.
10) Potential Benefits to Subjects*
Individual subjects can potentially benefit from participating in the study because 
they will have the opportunity to make a quit attempt and the possibility of long-
term smoking cessation. This is associated with a number of additional benefits 
including improved health, economic savings, the confidence and happiness 
associated with becoming an ex-smoker, and reducing their stress as a result to 
practicing mindfulness.
11) Vulnerable Populations*
This research study does not include vulnerable populations.
12) Setting
The primary study site is the University of Miami Miller School of Medicine 
Campus. Recruitment will mostly take place at UHealth and community clinics, 
social media (e.g., Facebook), and organizations serving people living with HIV. 
The consent process, participant assessments, and group meetings will take place 
via Zoom. 
13) Resources Available
Our team of multi-disciplinary experts in smoking cessation, MT, and analysis is a 
pioneer in developing and testing novel smoking cessation interventions among 
high-risk populations. Drs. Asfar and Lee have long-term collaboration on several 
epidemiological studies and community-based cessation trials.[26-28] Dr. Asfar 
(PI) is a Research Assistant Professor in the Department of Public Health Sciences 
at the University of Miami (UM). She has more than 10 years of experience in 
tobacco research. She had led several clinical- and community-based smoking 
cessation trials.[29-32] Dr. Lee (Co-I) has been involved in tobacco research for 
over 20 years. Recently, he has been evaluating mindfulness-based interventions 
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targeting high-stress occupational groups, and he will assist Dr. Asfar in the 
development and testing of the proposed intervention. 
14) Prior Approvals
N/A
15) Recruitment Methods
Our target sample size is up to 100 HIV patients who smoke (50 in each 
arm). Flyers will also be distributed at UM/HIV clinics and various 
community-based clinics/organizations not directly affiliated with 
UM/HIV, such as Jackson Health System (JHS). We will also recruit via 
advertisements on social media platforms. 
Those interested will contact our research team to first determine 
eligibility or they may scan the QR code included on the study flyer to 
complete the screening questions independently via REDCap. Those 
completing the screening questions independently via REDCap will be 
assigned a subject ID and will then be directed to a separate form asking 
for their name and contact information, in case needed to be reached. If 
eligible, the research staff will provide an overview of the research study, 
and if the participant wants to participate, we will send them a link to 
complete the electronic informed consent and baseline survey via 
REDCap. 
We are requesting permission to collaborate with another study, Project 
CHARM (IRB#20160911), which serves as a consent to contact database, 
to contact eligible participants. They will provide us with contact 
information for participants in their study who might be eligible for our 
study and have consented to be contacted by other studies. 
Participants in arm 1 (mindfulness) will receive $20 for completing the 
baseline questionnaire, $10 for each session they attend, and $10 for 
completing the end of treatment assessment and $25 for completing the 3-
month follow-up. Participants who complete the process evaluation will 
receive another $25.
Participants in arm 2 (CM) will receive $20 for completing the baseline, 
and at first successful CO and/or saliva sample earns $5 cash, and then the 
reward increases by $2 for each consecutive successful CO and/or saliva 
sample (e.g., $5, $7, $9...). Participants also earn $2 bonus for 4 
consecutive successful CO and/or saliva samples (total=$4). In all, 
participants can earn a maximum of $176 in rewards. Participant who fail 
the CO and/or saliva test will not receive reinforcement and the value of 
the next payment will be reset to the one that was missed. Participants will 
receive $10 for completing the end of treatment assessment and $25 for 
completing the 3-month follow-up, and those who complete the process 
evaluation will receive another $25.
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To improve recruitment, participants will be given a $10 incentive via 
cash, gift card, or electronic cash transfer, for each participant they refer 
who enrolls in the study.
To improve retention rates, participants will be contacted via text, mail, or 
email for study follow up reminders. 
Participants can expect to be in the study for 3 months (+/- 2 months). 
16) Local Number of Subjects
Our target sample size is up to 100  HIV patients who smoke.
17) Confidentiality
Multiple steps will be taken to guarantee confidentiality. All electronic surveys 
and forms will be entered and uploaded using REDCap. All REDCap data is 
securely hosted by the University of Miami’s IT Department. Research IT 
administers project creation, user account management, and movement of projects 
from development to production. Authentication is performed via CaneID 
Authentication Service (CAS), the same institution-wide system used for a variety 
of applications such as mum.  Other electronic data will be stored in password-
protected files that only the PI and study staff will be able to access. Participants 
will be assigned an ID# in REDCap and a master key linking names and ID# will 
be kept in a separate location accessible only approved study personnel.
There are multiple levels of security once placed on the local network.  All study 
personnel will be certified to conduct human subjects’ research by the University 
of Miami Institutional Review Board. All data will be inspected for quality 
assurance prior to analysis. Prior to performing statistical analyses on quantitative 
data, the data will be checked, screened and verified.
Jackson Health System additional requirement
 This section is not applicable because the research is not collecting health information 
from JHS under a waiver of authorization (without obtaining a HIPAA authorization 
from the participant)
If health information, including Protected Health Information and/or Personally 
Identifiable Information are collected from JHS without a signed authorization from the 
subject (with a waiver of authorization from an IRB or Privacy Board), you must agree to 
the following:  
 JHS data, including Protected Health Information (PHI) and/or Personally 
Identifiable Information (PII), acquired from JHS for this research with a 
waiver of the requirement for an authorization under HIPAA shall only be 
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stored on the secured JHS SharePoint environment made available by JHS. 
I and the Study Team members shall not copy or store the JHS sourced 
personally identifiable information (PII), including protected health 
information (PHI) data to any other system, including any systems 
maintained or provided by the University of Miami. I and the Study Team 
shall only copy or transfer JHS-sourced data that has been properly de-
identified in accordance with all requirements contained in the HIPAA 
Rules by removing all of the identifiers listed in the instructions for Section 
15 of this protocol.
If the data obtained for this research will be acquired from a retrospective “chart review” 
involving health information from JHS with a waiver of authorization (without obtaining 
an signed HIPAA authorization from the subject) then the data and the link and/or key to 
each subject’s identity shall only be maintained in the secure JHS SharePoint environment 
made available by JHS. 
18) Provisions to Protect the Privacy Interests of Subjects
Participants can be assured that the personal information they provide will only be 
seen by approved research staff and that in the data their name will be replaced by 
an ID number. The key linking names and ID numbers will be accessed only by 
the PI.
In order to enhance privacy when conducting the sessions via Zoom, participants 
will be instructed not to share the meeting link with anyone; for the privacy of all 
participants to attend the session in a private setting without others in the 
background; to change their location if it other people come into the area; to not 
discuss anything shared in the session with others; and to not share any sensitive 
personal data during the session. Participants will be also placed in the Zoom 
waiting room and admitted only by the research staff.
19) Consent Process
Informed consent will be obtained electronically via REDCap prior to the 
beginning of the sessions. In the event that participants have difficulty 
completing the electronic consent in REDCap via Zoom, we will mail them a 
copy, have them sign while on Zoom, and ask them to mail it back to us. All 
participants will be offered a copy of the informed consent for their records. 
20) Process to Document Consent in Writing
Participants will electronically consent to participate in this study, which will be 
documented in the study database kept in REDCap. A copy of consent will be 
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provided to participants if requested. The consent will also include information 
regarding who they can call if they have any questions regarding their 
participation in the study. 
21) Withdrawal of Subjects
Participation in study is voluntary. Participants can elect not to answer any 
specific question on the survey or interview and can elect not to participate in any 
procedures or all procedures of the study.
22) Waiver of Authorization for Use and Disclosure of Protected 
Health Information (HIPAA) 
 This section is not applicable, we are not requesting a waiver of authorization.  
If the research team will access patient medical records or other identifiable health 
information for this research without or prior to obtaining a signed HIPAA 
authorization from the subject or the subject’s legally authorized representative 
(LAR), you must obtain a waiver of the requirement for written authorization from 
the patients to access their medical records. 
Confirm that you will destroy the Protected Health Information (PHI) you and/or 
your Study Team acquire receive from JHS and/or UHealth at the earliest 
opportunity. 
☒    I confirm 
Confirm that the Protected Health Inform (PHI) you acquire from JHS and/or 
UHealth will not be re-used or disclosed to any other person or entity, except as 
required by law or for authorized oversight of the research study or for other research 
for which the use or disclosure of PHI is permissible.           
☒     I confirm  
       1/3/2023
PI Signature                                                               Date
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