Feasibility, Acceptability, and Piloting of a Virtual Counselor Tobacco Cessation Intervention With Community Health Worker Linkage to Lung Cancer Screening
Phase: PHASE4
Conditions: Tobacco Dependence
Sponsor: Johns Hopkins University

Testing C-Raven, a Virtual Tobacco Cessation 
Intervention, in the Community
 
    
NCT06289192
8/16/2024

 
Date: ___08/16/24_________________ 
Principal Investigator: ___Alejandra Ellison-Barnes_____________ 
Application Number: _IRB00396489____________ 
 
 
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JHM IRB - eForm A – Protocol 
 
 
• Use the section headings to write the JHM IRB eForm A, inserting the appropriate 
material in each. If a section is not applicable, leave heading in and insert N/A. 
• When submitting JHM IRB eForm A (new or revised), enter the date submitted to 
the field at the top of JHM IRB eForm A. 
 
******************************************************************************************** 
 
 
1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the 
research hypothesis, and the importance of the research. 
 
In Baltimore City public housing units, smoking prevalence often exceeds 30%, but access to 
cessation services can be limited by numerous barriers including time constraints, limited 
transportation, and associated costs. One solution to increasing access to cessation services and 
cancer screening is to offer tobacco cessation interventions at the housing sites. Computer-
delivered interventions (CDI) for tobacco cessation are effective, and provide accessible, 
replicable, and scalable interventions that can be tailored to patients and delivered in non-clinical 
settings. Augmentation of CDI with community health workers (CHW) can extend the 
intervention beyond the computer-delivered services, including connecting patients with lung 
cancer screening and visits with primary care clinicians. Our team has developed a two-session 
virtual counselor-led CDI for tobacco cessation (VCTC) that includes in-session/experiential use 
of nicotine replacement therapy and CHW support. This intervention has been found to be both 
acceptable and feasible among individuals in two Baltimore City clinics. We now plan to transfer 
this intervention out of clinical settings to the communities where people live, in this case low-
income housing units. 
 
In anticipation of a future two-arm type 1 hybrid effectiveness-implementation randomized 
controlled trial comparing a VCTC augmented with CHW support to a waitlist control in low-
income housing units in Baltimore City, we propose a pilot study consisting of two phases: 1) 
focus groups and 2) an intervention feasibility pilot that will generate preliminary data to inform 
our proposed intervention. Specifically, we will first develop a shared decision-making approach 
to low-dose chest CT (LDCT) lung cancer screening with community focus group feedback. We 
propose to conduct focus groups (N=2) with the target population of individuals who smoke and 
live in public housing in Baltimore to collect acceptability data on LDCT shared decision-
making and an existing tool, as well as the proposed intervention. We will also collect 
information about sociocultural and personal barriers to LDCT screening and management of 
LDCT outcomes. We will then conduct a feasibility pilot study of the entire VCTC and CHW 
intervention with a sample of participants (N=15) to collect data on the feasibility of recruitment, 
intervention engagement and completion, and short-term smoking cessation outcomes. 
Individuals will be assessed at baseline, one month, and three months. At the end of three 
months, we will conduct follow-up interviews with a subset of pilot participants to collect 
qualitative data on intervention acceptability. We will also conduct exit interviews with housing 

 
Date: ___08/16/24_________________ 
Principal Investigator: ___Alejandra Ellison-Barnes_____________ 
Application Number: _IRB00396489____________ 
 
 
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staff to gather qualitative feedback on intervention implementation and community attitudes 
toward smoking, lung cancer screening, and VCTC. Based on the information collected in these 
efforts, we will make iterative improvements to the existing intervention, aligned with user-
experience design procedures. 
 
 
2. 
Objectives (include all primary and secondary objectives) 
 
Phase 1: To obtain feedback on an existing tool for shared decision-making for LDCT so that it 
can be tailored to Baltimore City residents with current or former tobacco use, as well as to gain 
insight on smoking and smoking cessation in the community of interest through focus groups 
(N=2) with individuals currently living in public housing in Baltimore City. 
 
Phase 2: To conduct a feasibility pilot study of a VCTC and CHW intervention with a sample of 
participants (N=15) to evaluate feasibility, recruitment strategies, intervention engagement and 
completion, and short-term (3-month) smoking cessation and lung cancer screening outcomes. 
We will also interview housing staff at the end of three-month follow-up to gather qualitative 
feedback on intervention implementation and community attitudes toward smoking, lung cancer 
screening, and VCTC. 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with 
procedures, drug or device, and any other relevant information to justify the research) 
 
The deleterious effects of smoking on health are well established, yet smoking rates remain high 
among low-income and minority populations. In Baltimore City, 36% of low-income residents 
and 52% of African Americans smoke, rates that are exceptionally high compared with the 
national smoking prevalence of 11.5% among US adults in 2021. Numerous barriers impede 
uptake and delivery of smoking cessation services, including access to medical care, 
transportation barriers, and cost. Even within health care settings, there are barriers including 
lack of provider time to address tobacco use, insufficient staff training, and lack of replicability 
of intervention content. To address these barriers, computer-delivered interventions (CDI) show 
promise in providing accessible, replicable, scalable interventions that can be tailored to patients 
and potentially at reduced cost compared with person delivered interventions.     
 
With prior Maryland Cigarette Restitution Funding (CRF), we developed a 2-session virtual 
counselor led tobacco cessation intervention (VCTC) to deliver evidence-based smoking 
cessation counseling.  VCTC content follows the information, motivation, and behavioral skills 
model with systematic content adaptation for low-income smokers in Baltimore City. The 
VCTC software structure uses treatment algorithms allowing client preference to drive content 
presentation and approximate MI style by providing choice. In cooperation with a user 
experience designer, we also added a virtual counselor, an avatar named Edna Poe “trained” in 
MI to improve engagement and interest, and improve health outcomes. The counselor was 
tailored, tested, and approved by our target population in Baltimore City. Intervention 
development went through a 5-step process: 1) The development process began with a review of 
evidence-based core components of smoking interventions. 2) To gather tailoring information, 
we conducted 14 in-depth interviews and 2 focus groups with low-income smokers from an 
urban HIV clinic and two Churches in Baltimore City. These revealed that participants 

 
Date: ___08/16/24_________________ 
Principal Investigator: ___Alejandra Ellison-Barnes_____________ 
Application Number: _IRB00396489____________ 
 
 
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perceived little health benefit in smoking cessation, and were unaware that many smoking-
related health consequences were reversible. All participants noted that smoking was their only 
way to cope with stress and that the stress in their lives was substantial. Finally, participants 
noted the lack of available resources and social support for smoking cessation. 3) The 
qualitative data were used to tailor and program VCTC and text messages (TM). 4) Using 
established measures to assess human computer interaction, we then tested VCTC for usability, 
acceptability, and usefulness in smoking cessation (8 individuals, thematic saturation achieved). 
Overall satisfaction with the intervention was high, with a mean score of 4.75/5 on a 1-5 Likert 
scale with 1 being “not at all” and 5 “very much”.  Participants found the system easy to use, all 
noted that they planned to use some of the information from the intervention to change how 
much or often they smoked (mean score 5/5 on 5-point Likert scale), and expressed interest in a 
follow-up computerized counseling session (4.75/5). On qualitative feedback, participants noted 
that the virtual counselor was less judgmental than a human. They specifically liked a) the 
“Turn Back the Clock” video that was created to describe the reversible effects of smoking 
noting that it was very inspirational and provided new information, and b) the “3-D’s,” --Delay, 
Discuss, Do Something Else--a behavioral technique to manage cravings. 5) We integrated this 
community feedback for final modifications. 
 
We pilot tested the first session of the intervention among 40 people with HIV receiving in an 
urban clinic in East Baltimore. Participants were randomized to intervention or usual care. Our 
primary outcomes were readiness to change, and confidence in changing tobacco use, using a 
visual analog scale at one and two months post intervention. At one month, 89% of intervention 
participants compared to 74% of control participants had a quit attempt (p=0.21). Based on 
these results demonstrating increased readiness and confidence, we developed a second session 
focused on use of pharmacotherapy that presents information on craving, the cycle of addiction, 
the effects of smoking on health, and various pharmacotherapies. This session also includes an 
experiential guide for using pharmacotherapies that reviews proper use of nicotine replacement 
therapy (NRT), and real-time application of patch and use of gum or lozenge. As part of this 
intervention package, we trained and provided ongoing supervision to CHWs in motivational 
interviewing to extend the VCTC beyond the two sessions, provide cessation support, and to 
provide linkage to tobacco treatment services including the local Quitline. We created two 
manuals: 1) Tobacco Training Manual for CHWs and 2) a CHW Counseling Guide developed 
with CHWs.   
 
The C-Raven package was piloted in two clinics: The Tobacco Treatment and Lung Cancer 
Screening Clinic (TTLCSC) at Bayview Medical Center and the Johns Hopkins Broadway 
Program for Addictions. The rationale for implementation in the tobacco treatment clinic was to 
determine whether current services could be augmented with behavioral counseling to enhance 
retention on NRT and/or varenicline and other pharmacotherapy among individuals in this 
program. The rationale for implementing the intervention at the Johns Hopkins Broadway 
Program for Addiction was to test the intervention in a community-based setting where there is a 
high need for smoking cessation programs. 
 
Outside of the C-Raven project, a member of our study team, Dr. Panagis Galiatsatos, has 
previously implemented a tobacco cessation program in two Baltimore City housing units with 
high Area Deprivation Indices. The intervention included training of healthcare providers to 
deliver 90-minute group sessions on tobacco dependence management, followed by 20-minute 

 
Date: ___08/16/24_________________ 
Principal Investigator: ___Alejandra Ellison-Barnes_____________ 
Application Number: _IRB00396489____________ 
 
 
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individual sessions as requested by participants. Linkages were established with the state’s 
QuitLine and primary care providers for medication, if desired. Forty-seven individuals 
participated in that intervention, and 75% started pharmacotherapy, with an overall 38% quit rate 
at 6 months. This demonstrates the feasibility of delivering a tobacco cessation intervention in 
housing unit in Baltimore. 
 
In terms of lung cancer screenings with low-dose CT scans, Dr. Galiatsatos has developed a 
facilitated referral process as part of a tobacco treatment clinic within the Johns Hopkins 
Healthcare System that has yielded high rates of screening completion. This experience will 
inform the LDCT shared decision-making component of the proposed study. 
 
Proposed Next Step: Expanding on this prior work, we propose to assess acceptability of and to 
pilot the C-Raven VCTC, CHW intervention, and LDCT shared decision making directly in the 
community, in a public housing setting. If successful, the intervention could be eventually be 
deployed in housing units across the city, making it available to many more individuals in 
communities with high rates of smoking. 
 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
 
Phase 1: To obtain feedback on an existing tool for shared decision-making for LDCT so that it 
can be tailored to Baltimore City residents with current or former tobacco use, as well as to gain 
insight on smoking and smoking cessation in the community of interest through focus groups 
(N=2) and individual or small group meetings with individuals currently living in public housing 
in Baltimore City. 
 
Study design: Qualitative via focus groups (N=2) and individual meetings 
 
Setting: The focus groups will take place virtually with residents of two public housing units in 
Baltimore City. Potential recruitment sites with whom we have established contacts include: 
Monument East Apartments, Chase House Apartments, McCulloh Homes, City Arts 1&2, and/or 
Foxwell Memorial Apartments. A member of our study team has longstanding experience with 
community engagement around tobacco cessation in the city’s housing units. The individual or 
small group meetings will take place in the community room or other public area with reasonable 
privacy at the public housing unit.  
 
Eligibility: Inclusion Criteria are: 1) Age 50 or older, 2) Current tobacco use with >100 
cigarettes smoked in their lifetime, 3) English speaking (intervention currently in English only 
and housing units are in largely English-speaking neighborhoods). Exclusion Criteria are: 1) 
Current engagement in formal smoking cessation program, 2) Major cognitive or psychiatric 
impairment, 3) Severe hearing impairment or communication difficulty 
 
Recruitment: We aim to recruit a total of 12-16 participants (6-8 participants per focus group). 
Participants will be recruited through flyers posted in and around the housing units describing the 
study and distributed to tenants by housing unit staff. Flyers will describe the study and contain a 

 
Date: ___08/16/24_________________ 
Principal Investigator: ___Alejandra Ellison-Barnes_____________ 
Application Number: _IRB00396489____________ 
 
 
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study phone number to call. Information may also be distributed by study staff during non-study-
related health and wellness activities conducted at the sites. At initial contact, a study staff 
member will discuss the study purpose and determine study eligibility. If eligible, the staff 
member will proceed to discuss requirements, review risks and benefits, and obtain verbal 
informed consent from interested participants. After the focus groups, we propose to reach out by 
phone to those who originally consented to schedule an additional time to get more detailed 
feedback specifically on the guide. 
 
Consent process: After confirming eligibility with screening questions, teleconsent (via Zoom 
video conferencing) will be obtained prior to the focus groups. Teleconsent will be used instead 
of in person consent to avoid unnecessary in-person encounters specifically for a consent 
procedure. A consent script describing the study will be read to participants by the consenting 
study staff. After the consent script has been read, participants will be given adequate time to 
consider the research study and ask questions prior to verbally consenting; we will not proceed 
with the verbal consent until the potential participant affirms that they do not require more time 
and that all questions have been answered. Participants will be asked to summarize their 
understanding of the study and associated risks. The consent process is estimated to last 
approximately 10-15 minutes or as much time will as needed to ensure participants’ 
understanding of the study purpose, requirements, risks and benefits. Participants will be 
informed that the focus groups will be recorded and transcribed. Group leaders will not use 
names during the focus groups. Participants will also be asked not to use names to refer to each 
other, and personal identifiers will be excluded from the transcript. Following consent, additional 
demographic and smoking history questions will be asked to characterize the participants. 
Finally, they will be scheduled to participate in one of the focus groups. For the individual or 
small group meetings, we do not propose additional consent.  We would remind the person of 
what they had agreed to and ask them if they would be willing to have a follow-up meeting given 
the limitations of the focus group setting for them to see, read and comment on the guide. 
 
Focus group procedures: Focus groups will be conducted via Zoom video conferencing and 
will be recorded. The automatic transcription feature of Zoom will be used and then transcripts 
reviewed for completeness and accuracy. The groups will be run by Dr. Ellison-Barnes. No 
names will be used during the focus groups and participants will be specifically asked not to use 
names to refer to each other. Names and any personal identifiers will be excluded from the 
transcripts. We will discuss attitudes toward and prior experiences with lung cancer screening, as 
well as specific feedback on an existing shared decision-making tool. We will also query 
participants regarding smoking in the community, ways to engage the community in smoking 
cessation efforts, thoughts about computer delivered interventions for smoking, and the best 
places to deliver the intervention. The focus group guide has been uploaded into the IRB 
application. Notes will be taken during the group by the research assistant. Participants will 
receive $50 via a Visa Gift Card for focus group participation.  
 
Individual or small group meeting procedures:  Individual or small group meetings would be 
conducted in person with 2-4 participant(s) and 2 study team members. The meeting would not 
be recorded; however, the staff would take detailed notes and ask the participant to make 
notes/suggestions directly on the decision guide which will be printed out on paper.  The notes 
on both would be labeled only with the individual’s study id and for used tracking purposes only.  

 
Date: ___08/16/24_________________ 
Principal Investigator: ___Alejandra Ellison-Barnes_____________ 
Application Number: _IRB00396489____________ 
 
 
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We anticipate the meeting will take about 1 hour.  We would give them a $50 Visa Gift Card for 
participation in this meeting. 
 
Focus group analysis: Two investigators will independently review focus group transcripts for 
major themes. Inconsistencies will be examined and resolved through consensus. We anticipate 
holding two focus groups of 6-8 participants each to achieve thematic saturation. From these 
themes, the VCTC and CHW intervention and LDCT shared decision-making approach will be 
modified to address the needs of this particular population and setting.  
 
Individual/small group meeting analysis:  The study team will review and discuss the 
feedback and suggestions from each participant who is interviewed and revise the decision guide 
until consensus is reached by the study team.  The revised materials will be submitted for IRB 
review before use in Phase 2. 
 
Phase 2: To conduct a feasibility pilot study of a VCTC and CHW intervention with a sample of 
participants (N=15) to evaluate feasibility, recruitment strategies, intervention engagement and 
completion, and short-term (3-month) smoking cessation and lung cancer screening outcomes. 
At the end of three-month follow-up, we will also conduct exit interviews with housing staff to 
gather qualitative data on intervention implementation and housing community attitudes toward 
smoking cessation, LDCT, and VCTC. 
 
 
Study design: Intervention pilot (N=15 participants) 
 
Setting: As in Aim 1, the pilot will take place with residents from select public housing sites in 
Baltimore City. 
 
Eligibility: Inclusion Criteria are: 1) Age 50 or older, 2) Current tobacco use with >100 
cigarettes smoked in their lifetime, 3) English speaking (intervention currently in English only 
and housing units are in largely English-speaking neighborhoods, 4) Considering smoking 
cessation, and 5) Planning to remain in current housing unit for 6 months. Exclusion Criteria are: 
1) Current use of pharmacological treatment for tobacco cessation, 2) Contraindication to 
nicotine replacement therapy, 3) Current engagement in formal smoking cessation program, 4) 
Major cognitive or psychiatric impairment, 5) Severe hearing impairment or communication 
difficulty, and 6) Investigator discretion 
 
Recruitment: We aim to recruit a total of 15 participants. Participants will be recruited through 
flyers posted in and around the housing units and distributed to tenants by housing unit staff. 
Flyers will describe the study and contain a study phone number to call. Information may also be 
distributed by study staff during non-study-related health and wellness activities conducted at the 
sites. At initial contact, a study staff member will discuss the study purpose and determine 
eligibility. If eligible, the staff member will proceed to discuss requirements, review risks and 
benefits, and obtain informed consent from interested participants. 
We also aim to recruit 2-4 housing staff (one from each site/community). Study staff will discuss 
the study purpose, requirements, risks, and benefits of participation. We will then obtain 
informed consent from interested housing staff. 

 
Date: ___08/16/24_________________ 
Principal Investigator: ___Alejandra Ellison-Barnes_____________ 
Application Number: _IRB00396489____________ 
 
 
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Consent process: After confirming eligibility with screening questions via phone, potential 
participants will be offered the option of reviewing the study information and consent form over 
a Zoom video conference. Regardless of whether they choose to review this information in 
advance, all potential participants will complete the consent process and sign the consent form at 
the beginning of their first in-person visit, which will be conducted on-site at their housing 
community. Participants will be offered the option to receive an electronic copy of the consent 
form via email ahead of the in-person meeting. After the study information and consent form 
have been reviewed, participants will be given adequate time to consider the research study and 
ask questions prior to signing the consent form; we will not proceed with having them sign the 
form until the potential participant affirms that they do not require more time and that all 
questions have been answered. Participants will be asked to summarize their understanding of 
the study, its purpose, and associated risks. The consent process is estimated to last 
approximately 10-15 minutes or as much time will as needed to ensure participants’ 
understanding of the study purpose, requirements, risks and benefits. After informed consent is 
obtained, the participant will answer additional screening questions to determine study eligibility 
and, if eligible, be offered the opportunity to participate in the pilot intervention.  
We will also obtain informed consent (either in-person or by tele-consent) from housing staff to 
participate in a virtual, 1-hour exit interview conducted at the end of three-month follow-up. 
Baseline Assessment: This will occur on the same day as the in-person portion of the consent 
process. Initial evaluation will comprise the research assessments detailed in Table 1, including 
demographics, a clinical history, a tobacco use history, and a number of tobacco-related 
measures. Assessments will be self-administered via tablet computer. 
Intervention: 
Computer-Delivered Intervention (CDI) Session 1: Following the baseline assessment, 
participants will receive computer-delivered counseling via a study-provided iPad delivered in a 
private room. VCTC consists of 1) a menu-driven, web-based intervention that is delivered by a 
virtual counselor. The intervention takes 20 minutes to complete. At the conclusion of session 1, 
the participant will be offered nicotine patches provided by the study (1 month supply, remainder 
given at follow-up visits). The initial dosing of the nicotine patches will be determined based on 
cigarettes consumed per day (>10: 21mg patch, 5-10: 14mg patch, <5: 7mg patch). If there is any 
question regarding eligibility or appropriate dosing, the CHW will consult with a study physician 
(Dr. Ellison-Barnes or Dr. Galiatsatos). With the CHW, the participant will learn correct 
application, and will monitor their NRT experience in discussion with the CHW.  
Computer-Delivered Intervention (CDI) Session 2: Session 2, delivered approximately one week 
later, focuses on the cycle of addiction and use of pharmacotherapy (e.g., NRT, bupropion, 
varenicline). This intervention also takes about 20 minutes to complete. At the conclusion of 
session 2, the participant will be offered nicotine gum or lozenges provided by the study (1 
month supply, remainder given at follow-up visits). This session also includes an in-session 
experience of using NRT gum or lozenge, with CHW guidance to ensure correct use.   
Community Health Workers (CHWs): A CHW will meet with each participant for both Sessions 
1 and 2 and will do the following: 1) Teach appropriate NRT use technique as above, 2) Follow 
up with patients remotely via phone or video conference whenever possible, up to twice weekly 
for 12 weeks, to discuss barriers/facilitators to maintenance of NRT use and tobacco cessation; 
3) Review the modified lung cancer shared decision-making guide from Phase 1 and provide 
linkage to lung cancer screening if the participant is eligible and interested, including linkage to 
insurance enrollment assistance, if needed; 4) For individuals requiring follow up for positive 

 
Date: ___08/16/24_________________ 
Principal Investigator: ___Alejandra Ellison-Barnes_____________ 
Application Number: _IRB00396489____________ 
 
 
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findings on lung CT, work with participants to navigate the process; 5) Link interested 
participants to the QuitLine; 6) At the end of the study, link to medical providers for additional 
tobacco cessation therapy if participant interested (e.g., varenicline, bupropion).  
Linkage to Lung Cancer Screening: Participants eligible for and interested in CT Lung cancer 
screening (age ≥50, ≥20 pack year smoking history) will be referred to their primary care 
physician (PCP) or existing specialist for further discussion and ordering. The CTs are optional 
and will not be provided as part of the research study. The CHW will assist with linking patients 
without a PCP or existing specialist with resources to establish care. For participants who choose 
to proceed with screening, we will request the results of the CT scan to track completion and 
general result category (Normal/Normal with Minor Findings/Abnormal Needing Short-Term 
Follow-Up/Abnormal Needing Immediate Follow-Up).  
Intervention Retention and Follow-Up: We have protocols in place to maximize intervention 
retention and follow-up. At the time of enrollment, we will obtain contact information of the 
participant as well as three alternate contacts. In addition, participants will receive remuneration 
via Visa Gift Cards for each research assessment ($25 each at baseline, one month, and three 
months, $25 additional for completion of all three visits). 
Research Assessments and Data Elements Collected: We will collect data on participant 
demographics, smoking history, and clinical history (e.g., tobacco related comorbidities). We will 
use well-validated instruments to obtain information on tobacco use, nicotine dependence, attitudes 
towards nicotine replacement therapy, readiness and confidence to quit, nicotine withdrawal, alcohol, 
other drug use, mental health,  quality of life, and self-efficacy (Table 1). Each follow-up assessment 
will also collect data on recent quit attempts and methods used to quit, use of NRT, adverse events 
from NRT, and use of the QuitLine. Moreover, follow-up assessments will assess potential study 
contamination by asking questions specific to the computer delivered intervention (assess key 
information and skills discussed in CDI). The baseline data collection is expected to take 
approximately 1 hour. Follow-up data collection will take about 45 minutes.  
 
In terms of lung cancer screening, we will record whether participants were eligible, whether they 
chose to proceed with screening through their PCP or specialist, and a general indicator of results 
(Normal/Normal with Minor Findings/Abnormal Needing Short-Term Follow-Up/Abnormal 
Needing Immediate Follow-Up); full imaging reports will not be retained. 
 
At the end of three months we will conduct follow up interviews with pilot participants to collect 
qualitative data on intervention acceptability. We will also conduct exit interviews with housing staff 
to collect qualitative data on intervention implementation and housing community attitudes toward 
smoking cessation, LDCT, and VCTC. 
 
Table 1: Schedule of study evaluations 
Measure 
Months 
Baseline 
1 
3 
Demographics 
X 
 
 
Smoking History 
X 
 
 
Clinical History 
X 
 
 

 
Date: ___08/16/24_________________ 
Principal Investigator: ___Alejandra Ellison-Barnes_____________ 
Application Number: _IRB00396489____________ 
 
 
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Tobacco Use History (Smoking Behaviors Questionnaire) 
X 
 
 
Nicotine Dependence (Heaviness of Smoking Index) 
X 
 
 
Lung Cancer Screening Belief Scales 
X 
X 
X 
Attitudes Towards NRT 
X 
X 
X 
Nicotine Withdrawal Symptoms 
X 
X 
X 
Motivational Assessment (Readiness Ruler) 
X 
X 
X 
Alcohol Use (Alcohol Use Disorders Identification Test C) 
X 
X 
X 
Drug Use (NIDA Quick Screen) 
X 
X 
X 
Depression/Anxiety/Quality of Life (PHQ-4, EQ-5D Instrument) 
X 
X 
X 
Smoking Abstinence Self-Efficacy Questionnaire (SASEQ) 
X 
X 
X 
Tobacco Outcomes 
 
X 
X 
Study Contamination Measures 
 
X 
X 
Adverse Events 
 
X 
X 
Post-Intervention Interviews 
 
 
X 
 
Analytic Plan: Statistical analyses will be carried out as detailed below in section 7. 
 
 
a. If your study involves data/biospecimens from participants enrolled under other 
research studies with a written consent or under a waiver of consent, please list the 
IRB application numbers for those studies.  Please note:  Certificate of 
Confidentiality (CoC) protections applied to the data in source studies funded by NIH 
or CDC will extend to this new study if the funding was active in 2016.  If this 
situation applies, Section 36, question 6 in the application will need to be answered 
“Yes” and “Hopkins Faculty” should be selected in question 7. No other documents 
are required. 
 
Not applicable. 
 
b. Study duration and number of study visits required of research participants. 
 
Phase 1: Participants will participate in one focus group. 
Phase 2: Participants will have 3 formal study visits over 3 months, plus one 
additional visit for completion of the second session of the VCTC. Additionally, 
interested housing staff will participate in one virtual exit interview (approximately 
one hour) conducted at the end of three-month follow-up. 
 
c. Blinding, including justification for blinding or not blinding the trial, if applicable. 
 
Not applicable. 
 
d. Justification of why participants will not receive routine care or will have current 
therapy stopped. 
 
Not applicable. 
 
e. Justification for inclusion of a placebo or non-treatment group. 
 
Not applicable. 
 

 
Date: ___08/16/24_________________ 
Principal Investigator: ___Alejandra Ellison-Barnes_____________ 
Application Number: _IRB00396489____________ 
 
 
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f. Definition of treatment failure or participant removal criteria. 
 
Participants may withdraw from the program at any time. 
 
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
 
Through CHWs, patients will be offered connections to primary care providers, the 
Tobacco Treatment and Cancer Screening Clinic (Johns Hopkins Bayview Medical 
Center), or the Maryland QuitLine to continue nicotine replacement therapy, if 
desired. 
 
h. If biological materials are involved, please describe all the experimental procedures 
and analyses in which they will be used. 
 
Not applicable. 
 
5. 
Inclusion/Exclusion Criteria 
Phase 1 
Inclusion Criteria: 1) Age 50 or older, 2) Current tobacco use with >100 cigarettes 
smoked in their lifetime, 3) English speaking (intervention currently in English only and 
housing units are in largely English-speaking neighborhoods). 
Exclusion Criteria are: 1) Current engagement in formal smoking cessation program, and 
2) Major cognitive or psychiatric impairment, 3) Severe hearing impairment 
 
Phase 2 
Inclusion Criteria: 1) Age 50 or older, 2) Current tobacco use with >100 cigarettes 
smoked in their lifetime, 3) English speaking (intervention currently in English only and 
housing units are in largely English-speaking neighborhoods, 4) Considering smoking 
cessation, and 5) Planning to remain in current housing unit for 6 months.  
Exclusion Criteria: 1) Current use of pharmacological treatment for tobacco cessation, 2) 
Contraindication to nicotine replacement therapy, 3) Current engagement in formal 
smoking cessation program, 4) Major cognitive or psychiatric impairment, 5) Severe 
hearing impairment, and 6) Investigator discretion 
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
Nicotine replacement therapy will be used in combination with the computer-
delivered intervention. The choice of NRT is based on established evidence of its 
effectiveness in smoking cessation. This study is NOT testing effectiveness of NRT 
itself, but rather the effect of the VCTC and CHW intervention on enhancing uptake 
and duration of use of NRT. The initial dosing of the nicotine patches will be 
determined based on cigarettes consumed per day (>10: 21mg, 5-10: 14mg patch, <5: 
7mg patch). If there is any question regarding appropriate dosing, the CHW will 
consult with a study physician (Dr. Ellison-Barnes or Dr. Galiatsatos). 
 

 
Date: ___08/16/24_________________ 
Principal Investigator: ___Alejandra Ellison-Barnes_____________ 
Application Number: _IRB00396489____________ 
 
 
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b. Justification and safety information if FDA approved drugs will be administered for 
non-FDA approved indications or if doses or routes of administration or participant 
populations are changed. 
Not applicable. 
 
c. Justification and safety information if non-FDA approved drugs without an IND will 
be administered.  
Not applicable. 
 
7. 
Study Statistics 
a. Primary outcome variable. 
For both phases, our primary outcome will be intervention acceptability and 
feasibility. We will examine intervention acceptability and feasibility using both 
quantitative and qualitative measures described in Table 2 below. Our approach will 
follow the RE-AIM framework.  
 
Table 2: Measures that will inform acceptability and feasibility 
Outcomes 
Quantitative Measures 
Sampling of qualitative interview content 
Reach 
1. Feasibility and Acceptability 
Implementation measure 
1. Reasons for engagement or non-
engagement [e.g. structural (transportation), 
social/personal (stigma/family), patient 
preferences for treatment (where to receive 
treatment)] (participant) 
2. What could be done to increase 
participation (participant, CHW, study 
team) 
Effectiveness 
1. Effectiveness outcomes 
Including by intervention dose 
received) 
1. Perceptions of why intervention did or 
did not work (participant, CHW, study 
team) 2. Barriers/Facilitators to use of 
individual intervention components 
(participant)  
3. Barriers/Facilitators to intervention 
participation (participant) 
Adoption 
1. Measures on adoption, 
feasibility, acceptability, and 
appropriateness 
1. Barriers to adoption (intervention 
uptake), steps to enhance uptake, perceived 
need for intervention, perceived fit in 
current residential life structure (CHW, 
study team),  
Implementation  1. Number of intervention 
sessions and phone calls 
delivered 
1. How intervention will need to be 
adapted; challenges to implementing the 
intervention per protocol, perceptions of 
training (CHW, study team)  
2. Advantages/disadvantages to delivery in 
setting, resources and burden of 
intervention (CHW, study team),   

 
Date: ___08/16/24_________________ 
Principal Investigator: ___Alejandra Ellison-Barnes_____________ 
Application Number: _IRB00396489____________ 
 
 
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Maintenance 
1. Effectiveness outcomes, as 
described under effectiveness 
2. Program Sustainability 
Assessment Tool 
  
1. Factors that influence sustained behavior 
change (participant, CHW) and sustained 
use of the intervention in residential setting 
(CHW, study team) 2. What would be 
required for scale-up, external policies and 
incentives that may influence scale up 
(CHW, study team) 
 
 
b. Secondary outcome variables. 
1) Readiness to quit smoking and confidence in ability to quit smoking, 2) uptake of 
nicotine replacement therapy, 3) continued use of NRT at one month and three 
months, 4) number of quit attempts, 5) 7-day point prevalence smoking 
abstinence at 1 month and 3 months, 7) Quit Line uptake, 7) patient engagement 
with CHW, 8) patient satisfaction 
 
c. Statistical plan including sample size justification and interim data analysis. 
 
Descriptive analyses of quantitative data will be used to investigate the RE-AIM dimensions and 
constructs of reach/penetration, adoption, appropriateness, acceptability, feasibility, and 
sustainability across stakeholder levels. Qualitative interviews will be transcribed and based on 
domains and content on Table 2, we will perform both deductive and inductive coding. The 
qualitative data will provide context to the quantitative data and in-depth understanding of 
barriers and facilitators to program implementation in the local context. We will merge and 
integrate quantitative and qualitative data. Merging will follow a simultaneous bidirectional 
framework, where both data types are analyzed separately and weighed equally. The qualitative 
themes will be compared to quantitative assessment results, combined and jointly displayed. We 
will create a matrix relating qualitative themes to quantitative variables. Findings will inform 
adaptation of the shared decision-making tool for lung cancer screening, delivery of the CDI 
intervention in community settings, the role of the CHW in the intervention, and future 
programming efforts. 
 
Our proposed sample size for the pilot (n=15) is guided by pilot study goals to assess feasibility, 
acceptability, and ease of implementation of our intervention and to estimate possible effect sizes 
for future large scale clinical trials, if warranted. The proposed sample size should provide a 
representative group of individuals living in Baltimore City public housing who are currently 
smoking to enable examination of recruitment strategies and rates, consent rates, intervention 
and research follow-up retention rates, data collection and analysis procedures, variance 
estimates and effect sizes. 
 
d. Early stopping rules. 
We will not have early stopping rules. 
 
8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected 
frequency. 

 
Date: ___08/16/24_________________ 
Principal Investigator: ___Alejandra Ellison-Barnes_____________ 
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During both phases of the project, individuals may experience psychological distress 
when discussing their smoking or while participating in the smoking cessation 
intervention. While we expect this risk to be infrequent, we have procedures in place 
to address this, as below. 
 
During the pilot intervention phase, there is also a risk of nicotine withdrawal 
symptoms or nicotine replacement therapy side effects. Study participants who 
attempt to quit smoking will likely experience some withdrawal symptoms that may 
include anxiety, restlessness, anger, irritability, sadness, problems concentrating, 
appetite change and weight gain, insomnia, and decreased heart rate. There is no 
reason to believe that participation in this study would worsen nicotine withdrawal 
symptoms. Common side effects of the nicotine patch include local skin irritation at 
the site of the patch, nausea if the dose is too large or if the patient continues to 
smoke at a high level while using the patch, and disturbed and vivid dreams. Less 
common side effects include allergic skin reactions. For nicotine gum or lozenges, 
additional side effects can include mouth sores, hiccups, nausea, or heartburn. 
 
If the participant chooses to proceed with optional low-dose CT for lung cancer 
screening through their PCP or existing specialist, they face the additional risks of 
radiation exposure and anxiety associated with waiting for results or further 
confirmatory testing following a positive screen. 
 
b. Steps taken to minimize the risks. 
There are two primary risks to both phases of this study: breach of confidentiality and 
psychological distress. Participants will be asked to provide sensitive information 
related to smoking. Efforts will be made to ensure confidentiality. Psychological or 
emotional distress may occur during focus groups or during pilot testing of the VCTC 
and CHW intervention given discussions of smoking and cancer risk.  
 
1) Confidentiality: Participants will be asked to provide sensitive information related 
to smoking. All participants will be assigned unique study identification numbers that 
will be used for their surveys. No personal identifiers will be revealed in the focus 
group notes. We will only collect identifying information for 1) the purpose of 
documenting participant remuneration on receipts and 2) contacting a participant for 
follow-up during the pilot intervention. Unique study IDs will be created for 
participants in the pilot; the key linking IDs to identifiers will be stored on the Johns 
Hopkins secure server, in a file only the study coordinator and investigators have 
access to. All remuneration receipts will be stored in a locked file cabinet. In addition, 
all paper files including consent forms and data will be kept in a locked filing cabinet. 
All study outcomes will be reported as aggregate data. In addition, all investigators 
and members of the research team will have completed Johns Hopkins University on-
line modules on Human Subjects Research and HIPAA. Data from the pilot will be 
stored in Red Cap, on a secure server.  
 
2) Psychological distress: A participant may become uncomfortable while answering 
sensitive questions related to tobacco use or cancer risk or while participating in the 
CDI program. If a person experiences significant distress during the focus group or 

 
Date: ___08/16/24_________________ 
Principal Investigator: ___Alejandra Ellison-Barnes_____________ 
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during the counseling, the research assessment or focus group will be stopped, and 
Dr. Ellison-Barnes or another study physician/psychologist will evaluate the 
participant, and assess if the participant is at risk for harming herself or others. If 
necessary, emergency medical services will be called. 
 
Additional risks associated with Phase 2 of the study, the pilot intervention, include 
nicotine withdrawal symptoms or side effects of nicotine replacement therapy. To 
manage withdrawal, all participants will be offered nicotine replacement therapy 
which is intended to reduce withdrawal symptoms. The risks of serious adverse 
effects of nicotine replacement therapy, which is widely available over-the-counter, 
are small, and its potential health benefits far outweigh its risks. Subjects will be 
encouraged to review the drug information provided with the product (and offered to 
review with the CHW) and to report adverse effects to the study team. 
 
For participants who choose to proceed with low-dose CT screening for lung cancer, 
we will attempt to minimize risk by counseling all participants in advance to prepare 
them for the process, ordering only low-dose CTs to reduce radiation exposure, and 
ensuring timely follow-up of any positive screens. 
 
c. Plan for reporting unanticipated problems or study deviations. 
Safety and oversight of the study will be provided by the principal investigator, Dr. 
Ellison-Barnes, and the study team. Any unanticipated problems or deviations from 
the study protocol will be reported to the Johns Hopkins IRB. 
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
If participants disclose information about tobacco use in restricted areas of the 
housing units, they could potentially face consequences of having violated their lease 
agreement if there were a breach of confidentiality. However, personal identifiers will 
not be used for the focus groups, and we be using study IDs rather than identifying 
information for the pilot intervention. We will keep participant contact information in 
a password protected file on the Johns Hopkins Server. 
 
e. Financial risks to the participants. 
There may be costs associated with lung cancer screening if the participant chooses to 
proceed with this via their PCP or existing specialist; we are unable to offer CT scans 
as part of the study. Participants without insurance or existing primary/specialty care 
will be linked with appropriate guidance regarding enrollment and any available 
financial resources. 
 
9. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
Participants may reduce their tobacco smoking, which may improve their overall 
health and quality of life. Interventions that reduce tobacco use also benefit 
society, in reducing secondhand smoke exposure as well as tobacco-related 
morbidity and mortality, which have tremendous societal costs. 
 
10. 
Payment and Remuneration 

 
Date: ___08/16/24_________________ 
Principal Investigator: ___Alejandra Ellison-Barnes_____________ 
Application Number: _IRB00396489____________ 
 
 
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a. 
Detail compensation for participants including possible total compensation, 
proposed bonus, and any proposed reductions or penalties for not completing the 
protocol. 
Participants will receive remuneration for participation in both the focus groups 
($50) and the pilot intervention ($25 each at baseline, one month, and three 
months, and additional $25 for completion of all three visits).  
Housing staff will receive $30 for participating in exit interviews at the end of 
three-month follow-up. 
 
11. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and 
identify who will pay for them. 
There will be no required costs to participants for participation in this program. 
Nicotine replacement therapy for those who opt to use it during the intervention 
will be provided through the study. There may be costs associated with the 
optional lung cancer screening done through their PCP or existing specialist; we 
are unable to offer the CT scan as part of the study. Participants without insurance 
will be linked with appropriate guidance regarding enrollment.  
 
12. 
Transfer of Materials 
Transfer of biospecimens from Johns Hopkins to another organization for research 
purposes and receipt of biospecimens from an outside organization for your research 
must adhere to JHU policies for material transfer (https://ventures.jhu.edu/faculty-
inventors/forms-policies/ ) and biospecimen transfer 
(https://hpo.johnshopkins.edu/enterprise/policies/176/39187/policy_39187.pdf?_=0.622
324232879).  
 
Please complete this section if your research involves transfer or receipt of biospecimens. 
 
a. Will you receive biospecimens from an external entity for this research? [Yes/No].  
 
If “Yes”, please confirm you will secure an MTA/research agreement from the 
appropriate office  (JHTV/ORA) prior to transfer.  
 
See: https://ventures.jhu.edu/technology-transfer/material-transfer-agreements/ . 
 
b. Will you transfer biospecimens to an external entity as part of this research? [Yes/No] 
 
If “Yes”, please address each of the following: 
1) Describe the nature of the research collaboration with the external entity and the 
rationale for the transfer. (Include an explanation of your intellectual contribution to 
the design of the research study, resulting data and sharing, and participation in the 
planned publications.) 
2) Please confirm you will secure an MTA through the appropriate office (JHTV or 
ORA) prior to transfer. 
(See: https://ventures.jhu.edu/technology-transfer/material-transfer-agreements/.) 
  

 
Date: ___08/16/24_________________ 
Principal Investigator: ___Alejandra Ellison-Barnes_____________ 
Application Number: _IRB00396489____________ 
 
 
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3) If the biospecimens you intend to transfer were obtained through clinical or research 
procedures at Johns Hopkins and “Other” is selected in Item 4, Section 23, please 
submit the following items in that Section: 
 
a. A pdf version of a completed JHTV Online “Material Transfer Agreement 
Request Form for Outbound Material” https://ventures.jhu.edu/technology-
transfer/material-transfer-agreements/ OR a copy of the COEUS PD (Proposal 
Development Summary). 
b. A completed Biospecimen Transfer Information Sheet 
https://www.hopkinsmedicine.org/institutional_review_board/forms/.   
c. A signed and dated “De-identified Human Subject Certification” 
https://www.hopkinsmedicine.org/institutional_review_board/forms/  
d. Approval documents from recipient site, if applicable. 
e. Copies of the consent forms associated with the IRB protocols under which 
the biospecimens were collected, with language appropriate to this transfer 
highlighted.  
f. The name of the specialist you are working with in ORA to complete a 
contract/MTA. 
Please see the following website for more information about transferring human 
biospecimens to outside entities: 
https://www.hopkinsmedicine.org/institutional_review_board/news/announcement_transf
er_human_biospecimens_outside_entities.html/ .