Development and Pilot Testing of the Sense2Quit App
Phase: NA
Conditions: Smoking Cessation, HIV Infections
Sponsor: Columbia University

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Stand Alone Protocol Title: Development and Pilot Testing of the Sense2Quit App 
MPIs: Drs. Schnall and Huang 
Version: 9.18.2023 
NCT05609032

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SPECIFIC AIMS 
Of the approximately one million persons living with HIV (PLWH) in the United States (U.S.), it is estimated that 
between 40-70% smoke cigarettes1, 2, at least three times the prevalence observed in the general U.S. adult population 
(14%)3. Consequently, PLWH experience substantial tobacco-related morbidityand mortality. For PLWH, apart from 
achieving and maintaining a suppressed viral load, tobacco cessation is the most important health behavior they can 
undertake to maximize both quality of life and life expectancy4. Indeed, PLWH who quit smoking upon entering HIV 
care gain greater than 5 years of life expectancy as compared to those who enter HIV care and continue smoking5, 6. 
Given the high prevalence of cigarette smoking among PLWH and the benefit of smoking cessation, there is an urgent 
need to intervene to reduce tobacco use rates. However, the currently available evidence for improving tobacco cessation 
among PLWH is inadequate. Few tobacco cessation interventions have been tested among PLWH, and of those which 
have, there is ‘very low’ quality evidence that they were effective in the short‐term and ‘moderate’ quality evidence 
indicating similar outcomes to controls in the long-term7. 
Given the few randomized controlled trials (RCTs) examining smoking cessation interventions for PLWH and 
the major methodological limitations of many of these studies (e.g., lack of randomization, comparison conditions, 
treatment fidelity assessments, abstinence verification tests), it is critical to develop evidence-based tobacco cessation 
interventions to address the complex and unique needs of PLWH (e.g., risk factors, treatment needs). Tailored cessation 
interventions for PLWH need to focus on the factors specific to PLWH which are associated to date with poor success 
with tobacco cessation efforts. For example, neurocognitive deficits are common among PLWH and are associated with 
poor quit rates and relapse, supporting the need for unique interventions for PLWH8. Additionally, specific factors such 
as self-efficacy and decisional balance have been shown to decrease the likelihood of relapse9. 
In recent years, use of mobile health (mHealth) technologies for tobacco cessation has gained popularity, such as 
Text2Quit10 and the National Cancer Institute’s (NCI’s) SmokeFree Text11. While these programs have demonstrated 
positive effects in some populations12-15, their functionality is limited because text messaging is unable to automatically 
capture instances when assistance resisting cravings is needed or when relapses occur. To address this need, our study 
team proposes to capitalize on sensor and mHealth technologies to integrate both behavioral assessment and a just-in-time 
cessation intervention for smokers. Our Sense2Quit App builds on the extant evidence that text messaging can be an 
effective tool for improving smoking cessation in the general population. However, text messaging as a stand-alone 
intervention has limited efficacy for PLWH who smoke16. To address this limitation, our team proposes to develop and 
pilot test the Sense2Quit App which specifically addresses challenges to tobacco cessation for PLWH: slips, relapses, and 
difficulties associated with neurocognitive deficits8 and supports both self-efficacy and decisional balance9. Sense2Quit is 
a multi-component intervention that links a smartphone app to a smartwatch to provide real-time quit reminders to curtail 
relapses and avoid potential triggers. The artificial intelligence algorithm (validated by Multiple Principal Investigator 
[MPI] Huang) interprets time-series wearable sensor data to detect smoking gestures and motions – a technology with 
more than 98% accuracy in differentiating “lighting up” from other similar motions17. Sense2Quit leverages low-cost 
smartwatches to detect when smoking activity occurs so that an intervention message can be sent in real time to the 
participant via a linked smartphone app to help prevent the slip (a puff or two) from becoming a full-fledged relapse. 
This real-time feedback is critical especially in the first few weeks of a quit attempt. Additionally, Global Positioning 
System (GPS) data can help participants deal with geographical triggers (e.g., coffee shops, smoking relatives, friends’ 
homes, etc.). Reminders to take nicotine replacement when around geographic triggers will be sent to participants instead 
of suggesting complete avoidance (e.g., ‘You are now in a trigger area. Please take a moment to have a nicotine 
replacement/substitute.’) Finally, Sense2Quit provides information on how well they are progressing through their quit 
plan as well as motivational tools (i.e., badges). Our MPI team brings unique and complementary expertise in each of the 
areas necessary (mobile health, health disparities, tobacco cessation intervention, software engineering, human computer 
interaction, and health behavior change interventions with PLWH) to develop and pilot test an innovative tobacco 
cessation intervention for PLWH. Participants will be recruited from clinics and community-based organizations in New 
York City (NYC). The specific aims of the study are to: 
AIM 1: Explore and identify, using qualitative methods, acceptable and appropriate app content and features of 
the Sense2Quit App to support smoking cessation and relapse prevention in PLWH who smoke. We will conduct 
focus groups, design sessions, and usability assessments with HIV-positive daily smokers, former smokers, and usability 
experts. This feedback will guide tailoring of the app to this population of smokers. 
AIM 2: Conduct a pilot randomized controlled trial to examine the feasibility, acceptability, and preliminary 
efficacy of the Sense2Quit App. We will randomize 60 HIV-positive smokers to the Sense2Quit App plus the Fossil 
Gen5E smartwatch, standard smoking cessation counseling, and nicotine replacement therapy (active condition) versus 

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standard smoking cessation counseling plus referral to NYC Quitline (control) in order to examine group differences in 
rate of quit attempts, 7-day point prevalence abstinence, and sustained abstinence. 
 
AIM 3: Employ the RE-AIM framework to assess the potential scale-up of the Sense2Quit App. 
IMPACT: Given the high rates of tobacco use among PLWH, the Sense2Quit App has considerable potential for 
reducing morbidity and mortality among PLWH who smoke. 
AIM 4: Testing with Confounding Gestures. To improve the accuracy of smartwatch smoking detection within 
the current version of the app, we will perform additional testing on the smartwatch with participants who will 
complete a set of hand gestures to distinguish them from smoking gestures. 
 
STUDY TIMELINE 
We will implement a 2-year timeline to accomplish study specific aims. The details of the study activities, including 
development of the Sense2Quit App and the detailed timeline for the clinical trial, are listed in Table 1. 
 
Table 1. 
Timing 
Enrollment 
Milestones 
(Year/Month) 
Target 
“Just 
in 
Time”
• 
Protocol & manual of procedures finalized Institutional 
• 
Review Board (IRB) approvals 
1-3 
• 
Recruitment: Pre-screen potential participants, contact participants from 
database, advertisements/brochures in local clinics, provider meetings, 
presentations to community groups about study 
4-6 
• 
Aim 1 – Focus Group Sessions 
• 
Coding of qualitative data begins 
7-8 
• 
Aim 1 – Design Sessions 
• 
Code and analyze qualitative data 
9-10 
• 
Aim 1 – Usability Testing 
• 
Complete qualitativeanalyses 
• 
Disseminate findings from Aim 1 through presentations and publications 
11 
• 
Prepare/submit Year 1 progress report & IRB continuing review 
12 
Begins 
• 
Pilot Trial enrollment begins 
• 
Prepare/meet with safety officer for every 6-month review (after first patient 
enrolled) 
13-15 
20 
• 
Enrollment continues 
16-18 
40 
• 
Revisit enrollment progress and recruiting strategies; readdress as needed 
• 
Enrollment, study visits continue 
19-21 
60 
• 
Prepare/submit IRB continuing review to complete data analyses 
• 
Aim 3 – Follow-Up Interviews 
22-24 
• 
Last participant completes all study procedures 
• 
Data cleaned, code transcripts for Aim 3, data analyses for Aim 1, begin Aim 
2, 3 and 4 submit manuscript Dissemination of results 
• 
Study completed, results disseminated to the research and participant community 
• 
Submit R01 study to test the intervention in fully-powered efficacy trial. 

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SIGNIFICANCE 
 
Cigarette smoking is highly prevalent among PLWH. The 
prevalence of smoking in the general U.S. population has 
gradually declined to 14% in 2017 – the lowest rate ever 
recorded3. However, this has not been true for PLWH who 
have disproportionately high smoking rates (40-70%)1, 2. In 
our studies across more than 550 PLWH in NYC, 47.1% of 
our participants are cigarette smokers (see Table 1), 
highlighting the need for interventions to improve tobacco 
cessation in this group. Tobacco use causes morbidity and 
mortality in PLWH, and tobacco-related harm is 
substantially higher in PLWH than smokers in the general 
population. 
High 
rates of smoking have grave health implications for PLWH, placing them at increased risk for bacterial pneumonias18, 
acute bronchitis and tuberculosis19-26, early development of emphysema27-32, and lung and cervical cancers at a younger 
age than the general population33-38. These disparities are partly due to a higher prevalence of tobacco use in PLWH than 
the general population and partly attributable to exacerbated co-morbidities such as cardiovascular disease, lung cancer, 
and diabetes in PLWH who smoke compared to non-HIV-positive smokers39-41. 
Smoking cessation efforts have largely been aimed at the general population. Consequently, it is not clear whether 
they are suitable or effective for cohorts with population-specific concerns and clinical issues such as PLWH1, 21, 32, 42. 
Further, three specific factors have been identified as contributing to poor quit rates and relapse in PLWH. First, 
 
 
or 
perception of the pros versus cons of smoking43, and self-efficacy through the provision of success experiences can do 
more to support long-term tobacco cessation in PLWH than motivational interviewing. Building on these three factors 
which contribute to slips, relapses, and poor quit rates in PLWH, our study will develop and test an mHealth intervention, 
the Sense2Quit App, which specifically targets these factors by providing just-in-time feedback through a sensor  
detection system, reminders, and information about the benefits of tobacco cessation to improve decisional balance44. 
Importantly, mHealth is a feasible platform for delivering this intervention since there is extremely high mobile phone 
penetration in the U.S.45, especially among racial/ethnic minority groups46. mHealth technology can be used for achieving 
health equity in vulnerable groups because it is a widely available and relatively inexpensive tool for health behavior 
change47 and can be adapted to meet the needs of its end-users48-51. Our work has shown that even the lowest income 
and most health disparate persons own and use smartphones (Table 1)52. Therefore, our mHealth intervention, the 
Sense2Quit App, is timely, relevant, scalable, and likely to improve health outcomes in our health disparate study 
population – PLWH who smoke. Even when successful, however, there are barriers to widespread adoption and 
successful scale-up of tobacco interventions53, 54. Therefore, we will use implementation science in Aim 3 to understand 
and address the well-documented gap between ‘research’ and ‘practice’55. To accelerate and improve the translation of 
research into widespread, routine practice, implementation will be actively considered and evaluated during the 
translational process56. Thus, this study will overcome the limitations of incremental, stepwise progressions of research 
(i.e., efficacy to implementation), reducing the length of the traditional research pipeline and yielding much richer data to 
directly inform more widespread scale-up efforts of the Sense2Quit App for tobacco cessation in PLWH. 
 
INNOVATION 
 
1) The Sense2Quit App uses a validated sensor to detect participants’ smoking behaviors in real-time. The algorithm for 
detecting the smoking arm movement can be used to interpret data from a smartwatch17. Testing with confounding 
gestures will be completed as part of aim 4 to improve this algorithm. 
2) We will combine biometric data with behavioral interventions specific to smoking behavior, an advancement and 
innovation not previously tested in PLWH. 
3) The Sense2Quit App is a multicomponent intervention addressing each slip and craving, having the potential to 
empower smokers to succeed without relapse. 
Table 1. Sample of Smokers among Studies of PLWH (PI: Schnall) 
(Funding) 
Period 
Owner 
Gender Supplement 
(R01NR015737-02S1)
Apr. 2017 – 
Mar. 2018 
100 
44% 
94% 
Wise App 
(R01HS025071) 
Oct. 2017 – 
Aug. 2020 
172 
60% 
100% 
VIP-HANA 
(R01NR015737) 
Nov. 2017 – 
Oct. 2018 
105 
47% 
100% 
mVIP 
(R21HS023963) 
Sept. 2016 – 
Feb. 2017 
80 
23% 
100% 
InternationalHIV 
Network 
Dec. 2015 – 
Sept. 2016 
101 
49 % 
92% 
Total 
558 
47% 
neurocognitive deficits are common among PLWH and are a unique barrier to their smoking cessation, increasing the 
likelihood of relapse8. Mediators to tobacco cessation through nicotine replacement therapy such as self-efficacy and 
decisional balance have been more effective than motivational interviewingin PLWH.Therefore,
decisional balance,

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4) The ability for a mobile app to deliver content that would otherwise require staff and clinician time and resources, as 
well as burden participants, is an innovative approach to the delivery of a tobacco cessation intervention. 
 
INVESTIGATORS 
 
The investigative team has previously worked together. Formative focus groups were conducted with African American 
PLWH in NYC, and findings were disseminated by MPIs Drs. Schnall and Huang57. Further, Drs. Schnall and Cioe (Co- 
Investigator) have been long-time colleagues as Editorial Board members of the Journal of the Association of Nurses in 
AIDS Care (JANAC); additionally, they work closely on a small committee to determine the JANAC Article of the Year. 
 
Case Western Reserve University (CWRU). Dr. Ming-Chun Huang, PhD, will commit his effort in the research activities 
in the CWRU site and will be responsible for designing and optimizing Sense2Quit sensors, app interfaces, and advanced 
data analytics methodology to improve performance and user-friendly operation of mobile and wearable devices. Our 
sponsored GRA will focus on the aims including wearable system interfacing, App integration, algorithm development 
under the supervision of Dr. Huang and also help in research dissemination by publishing research results from this 
project to peer-reviewed journals, and present at premier conferences. Dr. Huang has an over six-years of dedicated 
research on wearable sensors and mobile sensing technologies development with 20+ conference and journal 
publications. He led a well-established research team in terms of solid theoretical, technological, experimental, and 
societal foundations to contribute to this project. 
 
Brown University. Patricia A. Cioe, PhD, will serve as Co-Investigator and will be responsible for assisting the Principal 
Investigator with planning and oversight of study procedures, data collection, and use of instruments for measurement of 
smoking cessation outcomes throughout the course of the study period. Dr. Cioe will assist with interpretation of the 
study results and will contribute to publications and dissemination of data. 
 
APPROACH 
 
Theoretical Framework for Developing the mHealth Decision Support Tool. This study is guided by the Information 
System Research (ISR) Framework (Figure 1) that will inform the design of the Sense2Quit App. The ISR framework has 
Figure 1. ISR Framework for developing the Sense2Quit App      been used to design two mobile apps for ongoing studies 
(R01HS025071, U01MD011279), and has been cited 
over 200 times in the past four years to support the 
design of mobile apps58. The ISR Framework employs 
three research cycles to build a product such as an 
mHealth app: 1) the Rigor Cycle - to evaluate and 
update the knowledge base; 2) the Relevance Cycle - to 
understand the environment of the end-user by 
determining requirements through a series of focus 
group interactions with stakeholders (PLWH current 
and 
 
former smokers); and 3) the Design Cycle in which artifacts 
Figure 2. (a) Visual reminders, (b) Motivational messages will be 
produced and evaluated59. The cycles do not need to be 
conducted linearly, and it may be preferable to conduct them 
in an iterative process. 
 
Overview: 
A research study involving a mobile technology intervention 
for persons living with HIV (PLWH). The research activities 
will take place in New York City, and data collection will 
take place at Columbia University. Participants will be 
recruited online and offline through social networking 
websites and apps and through local community-based 

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organizations, health centers, and local events. The study will test the Sense2Quit App for smokers living with HIV. 
 
Participants in the intervention arm will receive Nicotine replacement therapy (NRT). Participants will be provided with 
an 8- week supply of combination NRT that they will begin after the baseline visit. The quit date will be the date of their 
baseline visit. Participants will be offered all 3 forms of NRT (patch, lozenge, gum) and will be allowed to choose 2 
forms (combination: patch/lozenge or patch/gum) to use. 
 
Participants who smoke 10 or more cigarettes per day will receive the following dosage for their NRT patch: one 21 
milligram patch per day for 4 weeks; one 14 milligram patch per day for 2 weeks; and one 7 milligram patch per day for 2 
weeks. Participants who smoke less than 10 cigarettes per day will receive the following dosage: one 14 milligram patch 
per day for 6 weeks and one 7 milligram patch per day for 2 weeks. This is considered the standard clinical treatment, 
and participants will receive additional instructions on usage of the patch. Participants will be told the risks of using 
the patch, which include skin irritation, itching, dizziness, headache, rapid heartbeat, and nausea. Participants will 
also be advised that they can curb additional cravings with their choice of Nicotine gum or lozenge available for purchase 
over-the-counter. 
 
Setting. The study will be conducted at Columbia University which provides HIV care for a diverse group of more than 
2,000 PLWH. A recruitment plan, which outlines how participants will be recruited through the clinic and community- 
based organizations, is outlined below. 
 
Participants. 
Inclusion criteria: For Aim 1, (1) PLWH; (2) ≥ 18 years of age; (3) current or former smoker (where smoking is defined 
as ≥5 cigarettes a day for the past 30 days, past smoker is defined as having at one point smoked a minimum of >5 
cigarettes per day for a period of at least 30 days) and (4) understand and read English; Aims 2 and 3 follow the same 
inclusion criteria with the added criteria that (1) PLWH will be confirmed through medical records or pill bottles for ART 
medications; (2) onlycurrent smokers are eligible (where smoking is defined as ≥ 5 cigarettes a day for the past 30 days); 
(3) own an Android smartphone (if they do not have a phone compatible with the app, they will be provided with one to 
use during the study); (4) not pregnant or breastfeeding(due to contraindications for Nicotine Replacement Therapy 
[NRT]); (5) permanent contact information;(6) interested in quitting smokingwithin 30 days; and (7) blows ≥ 
5  CO intoa breath  analyzer at baseline. For Aim 4) participants will be PWH who smoke cigarettes and will either be 1) 
enrolled participants at their 12-week follow-up visit; 2) participants who are initially eligible for the study after 
completing the screener but do not qualify based on eCO levels; or 3) participants who already finished Aim 2 (and 3, if 
applicable).  
Exclusion criteria. For Aim 1, participants will be excluded if they do not meet the defined inclusion criteria. For Aims 2 
and 3, the exclusioncriteria will be (1) use tobacco products other than cigarettes (i.e., cigars, piped tobacco, chew, snuff); 
(2) planning to move within 6 months of enrollment; (3) alcohol dependence measured through the AUDIT-C60; (4) 
positive history of a medical condition that precludes nicotine patch use; (5) current use of NRT or other smoking 
cessation medications (e.g., Chantix or Zyban); (6) current enrollment in another smoking cessation program; and (7) 
household member is also participating in the Sense2Quit study (due to study contamination). For Aim 4, participants will be 
excluded if they fail to meet the inclusion criteria. 
Inclusion of Individuals  
 
Across the Lifespan: Our study will not include children. All participants in this study will be 18 years or older. Given the 
current age breakdown of the epidemic with approximately 2.5% or less of new diagnoses of HIV infection occurring in 
those who are under 18 years of age, children (under 18 years of age) are not a major epidemiologic concern for this 
study. Further, given that most children 18 years of age are newly diagnosed (within the past 1-2 years) with the infection 
and there could be many psychological implications of a new HIV diagnosis, tobacco cessation is a secondary concern 
to sustaining these children and participation in this study may divert their focus from their need to focus on 
starting HIV treatment. 
There is no upper-age limit for participation in this study. Based on our past studies with persons living with HIV, we 
anticipate that ~5% of our study sample will be over 65 years of age. 
Inclusion of women: 
The aims of this proposal are geared towards improving tobacco cessation in persons living with HIV (PLWH) who 
smoke. We will enroll at least 40% women in this study to ensure that we can compare differences in the intervention 
effect between men and women. Our study team has extensive experience recruiting and enrolling PLWH into study 
trials. More specifically, Dr. Schnall has experience and success recruiting women living with HIV into her studies 

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(R01NR015737, R21HS023963, R01HS025071). 
We will purposefullyenroll a minimum of 40% females and stop enrollment of males at 60% of the sample to force 
female enrollment. We will also track refusals, reasons, and demographic characteristics of those refusing to participate 
and examine those data as part of our ongoing data safety and monitoring activities. 
Inclusion of Minorities 
Dr. Schnall has extensive experience recruiting PLWH of diverse racial and ethnic backgrounds in her prior 
investigations. It is planned for this investigation that at least 75% of the enrolled participants will be of diverse racial and 
ethnic backgrounds, largely from Latino and Black/African American backgrounds. In our past work in New York City 
(NYC), nearly 90% of our study participants are Black, Latino, or Black and Latino. 
Several strategies will be employed at both study sites to maximize the potential of enrolling many racial and ethnic 
minorities in the study. The strategies that will be employed are: 
1. 
Partner with PLWH of diverse racial and ethnic backgrounds at HIV clinics and community organizations to 
identify successful strategies to promote engagement of diverse populations of PLWH. Dr. Schnall has an ongoing 
relationship with community-based organizations throughout NYC and has worked closely with these community-
based organizations (e.g., Gay Men’s Health Crisis, Alliance for Positive Change, LGBT Center, Iris House, Callen 
Lorde) during her past and ongoing studies to recruit study samples and has consistently met her recruitment goals 
across all studies per project timelines. 
2. 
Host tables with information about our study at health fairs in diverse neighborhoods and at churches, 
community organizations, and wellness events. 
3. 
Present an overview of the study at invited patient-centered presentations at HIV community organizations in 
areas that are comprised of participants of diverse racial and ethnic backgrounds. 
4. 
In addition to posting study flyers, we will use previously successful online recruitment methods such as 
online postings and social media. Specifically, we will post our study ads on Craigslist, a free online classified 
service that is one of the most popular websites in the United States. It has been used successfully in online work, 
including our own current National Institutes of Health- and Agency for Healthcare Research and Quality-funded 
HIV self-management studies (U01PS003715, R01NR015737, R21HS023963, R01HS025071, R01MH118151; 
PI: Schnall) which have all been completed per project timelines. 
5. 
Recruitment through clinics and community-based organizations. One of our primary clinic sites is the 
Comprehensive Health Program of New York-Presbyterian/Columbia (NYP-CHP). The NYP-CHP is a Ryan 
White funded, bilingual, patient-centered clinic that emphasizes sexual health, hepatitis management, and HIV 
care. It primarily serves Upper Manhattan and the South Bronx where residents are disproportionately affected by 
HIV. NYP-CHP’s large multidisciplinary team provides HIV care to a population of more than 2,300 children, 
adolescents, and adults through more than 16,000 visits per year. NYP-CHP clients are 58% male, 40% female, 
and 2% male to female transgender. 
 
 
RECRUITMENT AND RETENTION PLAN 
 
Study Settings. 
This study will be conducted at the Columbia University School of Nursing in collaboration with the Comprehensive Health 
Program of New York-Presbyterian/Columbia (NYP-CHP). The NYP-CHP is a Ryan White funded, bilingual, patient-
centered clinic that emphasizes sexual health, hepatitis management, and HIV care. It primarily serves Upper Manhattan and 
the South Bronx where residents are disproportionately affected by HIV. NYP-CHP’s large multidisciplinary team provides 
HIV care to a population of more than 2,300 children, adolescents, and adults through more than 16,000 visits per year. 
NYP-CHP clients are 40% female. In addition to the clinic, Dr. Schnall has an ongoing relationship with community-based 
organizations throughout New York City (NYC) and has worked closely with these community-based organizations (e.g., 
Gay Men’s Health Crisis, Alliance for Positive Change, LGBT Center, Iris House, Callen Lorde) during her past and 
ongoing studies to recruit her study sample and has consistently met her recruitment goals across all studies per project 
timelines. Recruitment for participation in the study will occur following approval by the CUIMC IRB. 
 
Recruitment Challenges. 
If recruitment for this study proves difficult, in addition to posting study flyers, online recruitment methods will be used such 
as online postings, Recruitme and social media which the study team has used successfully in the past. Specifically, study 
flyers  will be posted on Craigslist (a free online classified service that is one of the most popular websites in the United 
States)  and POZ.com which have been used successfully in online work, including the study team’s current National 
Institutes of  Health and Agency for Healthcare Research and Quality-funded HIV self-management studies (U01PS003715,  

Page 8 
 
R01NR015737, R21HS023963, R01HS025071; PI: Schnall) that have all been completed per project timeline. Craigslist  is 
widely used in NYC. Each Craigslist has a Volunteers section. The research assistant will post numerous ads per week.  
This will be repeated each week to reach and recruit a diverse sample. 
Facebook and Instagram. The study team had great success in recruiting diverse samples from social networking sites, 
like Facebook and Instagram, where psychographic targeting (in-depth publicly available consumer data such as interests, 
occupation, and city) is used, as well as boosting posts and asking colleagues to post campaigns to their pages. 
 
Retention Plan 
Our study team has developed several successful strategies for retaining study participants during our study period. 
Strategies used successfully in our previous studies include confirming contact information at each assessment and 
obtaining contact information of two or more people who will know how to contact them. In addition, a token of 
appreciation will be provided for completion of all study questionnaires. Importantly, our team has a strong track record 
of retention of study participants across past trials. Notably these participants are typically those who are most difficult to 
retain in studies (e.g., low income, unstable housing, co-morbid psychiatric conditions, illicit substance use). We have 
conservatively estimated an 80% retention rate at the follow-up assessment for each study arm based on our past work 
with this study population. Specifically, our R21HS023963 study had a 5% attrition rate at 12 weeks, and our current 
R01NR015737 has an attrition rate of 12% at 3 months and 14% at 6 months. 
 
The foremost important retention strategy will be the personalized attention participants receive from the research staff 
from the first visit forward. Participants interact with staff members during each of their visits and phone calls, thus 
providing the opportunity for frequent assessments of engagement with the mobile Health app and to discuss other study 
related concerns. Information that is to be recorded by the participants (e.g., assessments) is reviewed by staff members 
(and clarified, if necessary). Participants will be provided opportunities to communicate, either verbally or in writing, 
any concerns they have regarding participation in the study. During the intervention, an unexpected absence from 
scheduled assessment appointments generates a phone call to the participant. If contact with the participant is not 
established after several attempts by telephone or letter, a certified letter is sent. Failure to receive a reply to the certified 
letter would result in the participant being designated as having dropped from the study. 
 
The retention plan harnesses the previously used retention strategies including phone calls, texts, emails, and/or letters to 
participant to remind themabout their upcoming appointment; providing bus or parking validation/vouchers for study 
visits; and hiring professional staff with whom many of the participants will have a long-standing and trusting 
relationship. Additionally, each of our sites will provide compensation (amount determined by site-specific norms and in 
collaboration with the local Community Advisory Boards) for the additional time to complete the study-specific research 
procedures. 
 
STUDY PROCEDURES 
 
 
 
be extended through machine learning to interpret data from 
a smartwatch to detect smoking hand gestures and motions 
and differentiate themfrom other common daily activities 
(e.g., drinking from a cup, answering the phone, etc.)17 and 
 
 
Intervention: The Sense2Quit App 
Sense2Quit is a multi-component intervention that links a 
smartphone app to a smartwatch and addresses tobacco 
cessation challenges for PLWH, namely providing real-time 
quit reminders to curtail the urge to smoke and avoid 
potential relapses (validated by MPI Huang). Sense2Quit will 
Figure 3. Smartwatch screenshots, (a) daily progress summary, 
(b) detecting smoking motions, (c) motivational messages to show 
(c) motivational messages to show how long the user has 
maintained the quit plan 

aid with PLWH-specific daily activities such as taking medicines and tracking hygiene habits. Our pilot data has shown 
that our developed smoking gesture detection algorithm can be used among various wearable brands including Myo, 
Moto360, Misfit Vapor 2, and Skagen Falster 2 (unpublished). Sense2Quit leverages smartwatch data (Figure 3) and 
detects when smoking activity occurs so that a message can be sent in real time to the participant via a linked smartphone 
app to help prevent the slip (a puff or two) from becoming a full-fledged relapse. This real-time feedback is critical 
especially in the first few weeks of a quit attempt. The base algorithm for the Sense2Quit App has been validated and 
pilot tested, but the user interface of the App, PLWH-specific daily activities, the alerts, and the just-in-time intervention 
message delivery service have not been developed or tailored for PLWH. This will be achieved through Aim 1 described 
below with methods summarized in Table 2. 
 
Informed Consent 
The study team under the direction of the MPIs will determine eligibility for inclusion, explain the purpose of the study, 
answer any questions, and obtain written consent from the participants. Informed consent will be obtained for each of the 
study components in Aims 1 and 2, and 4. Interested volunteers who agree to participate will sign an electronic consent 
form. Potential risks and strategies for managing risks will be carefully explained as part of informed consent procedures. 
The study team will use REDCap’s E-Consent Framework to electronically collect and store consent documents. 
REDCap uses survey features to consent research participants and forms can be completed via computer, mobile phone or 
tablet. CUMC- approved REDCap is secure with restricted access that ensure confidentiality of a participant’s identity, 
study participation and personal information. Additionally, REDCap is easy to navigate, and information will be on one 
scroll-able page. 
There is functionality within the system and to stop and continue at a later time. REDCap also allows for generation of a 
copy of the informed consent form signed by the study participant, which can be downloaded at any time. In REDCap, all 
versions of the IRB-approved e-Consent Form and all signed e-Consent Forms can be accessed and retrieved easily. 
 
AIM 1. Explore and identify, using qualitative methods, acceptable and appropriate app content and features of 
the Sense2Quit App for smoking cessation and relapse prevention in PLWH who smoke. 
 
 
Table 2. Overview of Aim 1 Research Design and Methods 
Cycle I:
Cycle II: Design Cycle:
Cycle III: Design Cycle: Evaluate
Relevance Cycle 
Develop/Build 
Sample 
• 40 PLWH who 
smoke or are 
former smokers 
• 10 PLWH who smoke 
• 5 experts in human computer interaction 
for heuristic evaluation 
• Usability Testing: 20 PLWH who 
smoke or are former smokers 
Instruments 
• Focus Group 
Guide 
• Interview guide 
• Preliminary designs of mobile 
apps 
• Usability Testing Survey 
• Heuristic Evaluation Survey 
• Health-ITUES61, 62 
Procedures 
• Four focus group 
sessions 
(N=40) 
Session 1: 
1. Review content, features, & 
functions from focus group 
sessions & literature review 
2. Discussion based on structured 
questions 
3. Brainstorm functional 
requirements 
Session 2: 
1. Reviewpotential app designs 
& confirm/revise them 
2. Sketch user interface 
• Heuristic evaluation 
• Usability testing 
Analysis 
Thematic analysis Descriptive analysis 
Descriptive analysis 
 
The Relevance Cycle: 
Procedures. We will conduct focus groups with 40 intended e-users (see inclusion criteria). Prior to the start of the focus 
group session, we will collect demographic information. Focus groups will be 60-90 minutes. Following informed 

consent, sessions will commence and be audio-recorded. Dr. Schnall, who has conducted focus groups for requirements 
analysis in the past56, 58, 63-66, will facilitate the sessions with project staff as note-takers. 
 
Sample focus group questions for PLWH who smoke are: 
1) What are the barriers to quitting smoking? 
2) What messages would motivate you to not light up your cigarette? 
3) What information would you like to see included in an app? 
4) What messages would deter you if were about to start smoking a cigarette? 
5) How frequently do you want to receive reminders about your quit plan? 
6) How frequently do you want alerts about your accomplishments? 
7) What are your triggers? And what is the best time for you to receive an alert about the trigger? 
 
The team will adhere to qualitative research processes to ensure the credibility, confirmability, and transferability of the 
data from these analyses. To support the data credibility, we will conduct peer debriefing and triangulate findings. We 
will also use member checks, i.e., sharing of initial data interpretations with participants to ensure accurate 
interpretations. Triangulation of findings, along with reflexivity, will enhance confirmability of the interpretations. 
Compensation: Eligible participants will be able to receive $35 for participating in the focus groups. 
Data Analysis. All qualitative data will be transcribed verbatim and then coded. Thematic analysis will be used for the 
development of a coding scheme, which is an integral component of the data analysis process. It enables the systematic 
examination and interpretation of data related to the primary analytic foci. The coding scheme is conceptualized as a 
multilevel structure. At the highest level are the primary analytic foci coded as headings. Specific aspects or dimensions  
of the headings are assigned core codes. Specific aspects or dimensions of the core codes are assigned sub-codes. We will 
use Nvivo™ (QSR International, Victoria, Australia) software program for qualitative analysis. The following seven steps 
will be used to develop the coding scheme: 
• 
Step 1: Identify the principal issues discussed by participants; 
• 
Step 2: Construct definitions of the primaryanalytic themes; 
• 
Step 3: Develop and apply core codes and sub-codes to the initial set of data; 
• 
Step 4: Develop a provisional coding scheme; 
• 
Step 5: Test and refine the provisional coding scheme; 
• 
Step 6: Reconcile coding differences and construct an updated and final coding scheme; 
• 
Step 7: Apply the coding scheme to the full data set and assess inter-coder reliability. After all transcripts have 
been coded, we will extract and examine the content of text segments linked to core codes and sub-codes relevant 
to understanding barriers and facilitators to the use of the App and its content. 
 
The Design Cycle: Develop/Build Phase: In this phase, focus is on creation of a highly usable artifact (mHealth app). 
To achieve this, we will incorporate findings from the earlier parts of our study, including a list of content, features, and 
functions from the focus groups. We will conduct two design sessions. 
 
Design Session I: We will recruit 10 PLWH who smoke to participate, and each will be expected to attend two sessions. 
Sample: Focus group methodology will be used as it permits participants to use their own words to answer open-ended 
questions and react to each other’s responses67. This interaction should elicit the most useful information. 
Procedures. The goal of the first design session will be to identify optimal features for the Sense2Quit App. Each session 
will be audio recorded and is anticipated to last 60-90 minutes. Building on focus group findings and the extant literature 
and mobile apps, we will develop an initial list of content, features, and functions prior to the design session. We will ask 
participants to imagine each of the broad categories, identified from our focus group analysis, as a separate screen on a 
mobile app. We will present this information and ask participants to discuss the content and features they think should be 
included as functionality in a mobile app. Because we do not want to stifle creativity, we will not show existing apps or 
prototypes except when participants have difficulty envisioning the content or features of the app. Participants will be 
encouraged to draw sketches of the app, which has been successfully completed in our past work with PLWH. 
Compensation: Eligible participants will be able to receive $35 for participating in design session I. 
 
Design Session II: 
Procedures: The goal is to gain information about the user interface to inform the development of prototypes. We will 
audio record the session, which is anticipated to last 60-90 minutes. We will divide participants into two groups and ask 

each group to sketch a user interface of the desired mobile app. We will present findings from the first design session as 
categories along with pictures of existing nutrition apps. Participants will be asked to identify the components to include 
under each topic area and will be reminded that each category would be a screen on the App. They will also be asked to 
describe the organization of the content and features and the desired “look” of the user interface they would want to see in 
an app. After participants share ideas, we will follow up with questions to stimulate discussion about the existing apps and 
the need for refined content, features, and interface design. We will ensure that the App is usable and will ask 
questions such as, “Are the alerts useful to you?” 
Compensation: Eligible participants will be able to receive $35 for participating in design session II. 
Data Analysis of the data collected in the design sessions will be the same as the procedures described for data analysis of 
the Relevance Cycle data. 
 
The Design Cycle: Evaluate: The goal of this phase is to improve the App design and increase the likelihood of 
technology acceptance68. We will evaluate the user interface and system functions of the prototype and assess whether 
they are consistent with the end-user’s needs. We will conduct two types of usability assessments: 1) heuristic evaluation 
of the prototype using informaticians with experience in interface design and/or human-computer interaction, and 2) end- 
user usability testing with PLWH. We will use an iterative process in which one heuristic evaluator and four end-users 
will evaluate the Sense2Quit App for PLWH and then changes will be made based on recommendations. Five versions of 
the app will be created, each building on an earlier version. 
 
Heuristic Evaluation. 
Participants. Five experienced informaticians will participate as usability experts, based on the number recommended by 
Nielsen69. Each expert will have training in human-computer interaction, hold at least a master’s degree, and have 
published in the field of informatics. 
Procedures. Usability experts will be provided with a description of the full functionality of the prototype App. Each 
human-computer interface expert will test the prototype user interface with use case scenarios for approximately 45-90 
minutes on Zoom alongside research staff. Because the visits will be remote, a research staff member will share their 
screen so that the experts are able to view the app. Experts will instruct the research staff member which tabs or buttons 
they should click on to perform specific tasks on the app. They will be asked a series of interview questions regarding the 
app’s usefulness and appropriateness for people living with HIV who want to quit smoking. The process will be audio and 
video recorded using Zoom. Recording the users’ interactions and vocalizations provides additional feedback to 
highlight problems that would not be identified with static screenshots70. Experts will evaluate the App using a think- 
aloud protocol as they perform the assigned use case scenarios, and then complete a Heuristic Evaluation Survey to 
evaluate the extent to which the user interface violates a set of usability heuristics. They will indicate specific areas of 
usability problems and rate the severity of each problem73, 74. 
Compensation: Usability experts will be able to receive $150 for participating in the 2-2.5 hour heuristic evaluation 
session. 
Data Analysis. Mean severity scores will be calculated for each heuristic principle. Evaluators’ comments about usability 
problems on the evaluation form and the recordings will be used to refine the prototype App. 
 
Usability Testing with End-Users (PLWH). 
Participants. We will recruit 20 PLWH who are either current or former smokers and have not participated in the earlier 
phases of the study activities to evaluate the prototype user interface screens. Eligibility criteria will be the same as 
described above for Aim 1. We will use similar recruitment methods as those used for the other study aims. 
Procedures. Participants will be assigned  tasks to perform on all screens of the app and their use of the App will be 
recorded using an audio recording device. After the usability evaluation, participants will rate the prototype’s usability 
using the Health Information Technology (IT) Usability Evaluation Scale (Health-ITUES)61, 62. This tool differs from 
traditional scales as it is designed to support customization at the item level to match the specific task/expectation and 
health IT system while retaining standardization at the construct level; it has been validated for mHealth technology 
evaluation63. Compensation: Eligible participants will be able to receive $40 for participating in the 2-hour usability 
testing evaluation. Data Analysis. Analysis will be based on recordings of user sessions, transcriptions, notes, and the 
user survey. The team will search for critical incidents characterized by comments, silence, and repetitive actions. We 
will review these using the recordings and summarize incidents and written comments. Descriptive statistics of the 
Health-ITUES will be calculated. 
 
AIM 2: Conduct a pilot randomized clinical trial to examine the feasibility, acceptability, and preliminary efficacy 

of the Sense2Quit App. 
 
Purpose: The purpose of this aim is to conduct a pilot feasibility study of the preliminary efficacy of the Sense2Quit App 
for improving tobacco cessation in PLWH who smoke. 
Study Design: The study will be conducted with 60 PLWH who smoke and will be randomized to two arms. Participants will 
be randomly assigned to receive the Sense2Quit App (active) or a control condition (standard smoking cessation counseling 
session). Participants will also receive a survey at baseline, 4, and 12 weeks post-baseline. 
Sample Size and Power: The goal of this pilot study is to estimate the cessation rates in each arm to obtain an effect size for 
future larger studies. To conduct a hypothesis test for the comparison of cessation rates between the two intervention arms 
will require a minimum 199 people in each arm (total sample=398) for at least 80% power. This calculation was based on a 
2-sided test with the type I error of 0.05, and assuming a 20% cessation rate in the Sense2Quit App group (intervention) and a 
10% cessation rate in the control arm. The 10% difference would be equivalent to a medium effect size (Cohen’s d=0.45). In 
this pilot study, we propose a total sample of 60 (30 per group) of whom we expect there to be 20% attrition. Therefore, this 
study is not powered to detect a significant difference between study arms. Instead, for the sample size (30 per group), this 
study will have at least 80% probability that the standard error of the cession rate estimates ≤7%, We assume that the 
expected cessation rates range from 10% to 20%, and therefore the sample size is sufficient to provide a power estimation for 
a larger trial with acceptable reliability. 
Recruitment and Retention: Strategies for recruitment and retention are described in the Recruitment and Retention attachment. 
We will enroll 60 PLWH who smoke tobacco. Inclusion/exclusion criteria are described above. 
Screening: Potential study participants will provide verbal informed consent by phone or complete an eConsent form through 
REDCap prior to completing a phone screening process that assesses eligibility. If eligible, participants will attend a 
baseline session described below. 
Procedures: Eligible participants will attend a baseline visit at Columbia University School of Nursing. On the day of their 
baseline  appointment, study participants will meet a study staff member who is trained by a nurse. The study staff member 
will  run  the baseline appointment. Upon arrival, participants will be asked to blow into a breath analyzer to complete 
assessment of  their study eligibility. Breath samples will be analyzed for exhaled carbon monoxide (CO) levels (in ppm) using 
a  breathalyzer (Micro+TM basic Smokerlyzer®). After providing written consent, participants will complete a baseline 
questionnaire (See Table 3). They will be asked complete a timeline to follow  back to track their cigarette use for the 
previous 30 days and to complete the Fagerstrom Test for Nicotine Dependence. Survey instruments will be collected through 
Qualtrics at baseline, and 4 weeks, and 12 weeks after baseline. 
Following completion of baseline study instruments, participants will be randomized (1:1) to the App arm or the control arm, 
stratified by sex assigned at birth. Participants in both arms will undergo a smoking cessation counseling session. Notes from 
the counseling session will be recorded on RedCap. Participants will receive an informational packet during the counseling 
session which will consist of: 1) an appointment reminder sheet, nicotine patch information, nicotine gum information, nicotine 
lozenge information and smoking substitutionideas (Intervention) or 2) a reminder sheet, NYS Quitline information, and 
smokingsubstitution ideas (control). Participants in the control arm will be referred to the New York State Smoker’s Quitline. 
Throughthe Quitline, participants in the control arm can receive NRT if desiredand receive additional smokingcessation 
counseling. A studystaff member willfollow up to see how manyparticipants called, textedand/or visited the Quitlinewebpage. 
Participants in the interventionarm (App arm) will be provided with combination NRT. Participants will be given an 8-week 
supply of combination NRT and will be instructed to begin using their NRT supply directly after their baseline visit. 
Participants will be offered all 3 forms of NRT (patch, lozenge, gum) and will be allowed to choose 2 forms (combination: 
patch/lozenge or patch/gum) to use. Also for those in the intervention arm, study staff will provide participants with a Fossil 
Gen5E or TicWatch smartwatch and initiate the Sense2Quit App on the participant’s smartphone. If a participant’s 
smartphone is not compatible with the Sense2Quit app, they will be provided with a smartphone to be used during the 12-week 
long study. 
 
The Sense2Quit App will passively collect smoking data, such as when the user smokes (time of day, day of week, 
before/after eating, after waking up/before going to sleep, before driving to/from work, while driving), where the user 
smokes, and who is nearby. The Sense2Quit App will provide real-time feedback to participants, providing them with tips 
and messages to urge them to quit smoking when they lift their hand up for a smoke. The Sense2Quit App will be paired 
with the smartwatch so that smoking will be detected by the smartwatch and will be sent directly to the App. The Sense2Quit 
App will reliably predict cravings, target users with notifications to prevent individuals from smoking, refine notifications for 
each user, and display their change in smoking behavior in a smoking graph and money spent in a cash spent graph. Users 
will also be able to see their quit plan with their assigned quit date which will be baseline or another set date within a short 
period after baseline (i.e. within a week of completing the baseline visit), along with smoking trends, supporting tips, videos 
and games. The study staff member will show the participant how to use the app, and will also help them set up a reminder 
to take their daily HIV medication and use NRT at their baseline appointment. Participants will wear the smartwatch and 

use the app for the duration of the study period. Two days after baseline, a study team member will reach out to the 
intervention arm study participant to see if they have any questions or issues with the Sense2Quit App and/or watch. The 
study coordinator will be able to access smoking behaviors and subject information through the online dashboard. The 
study coordinator will also reach out to participants in both arms once a week through phone call to check-in about their 
quitting process. At 4 and 12 weeks after baseline, participants in both study arms will attend a follow-up visit at the study 
site.  Participants will report a 7-day point prevalence abstinence of smoking cigarettes76 and provide a breath sample using   
Micro+TM basic Smokerlyzer®. They will also be given a follow-up survey with questions asked at baseline and process  
questions dictated by the primary outcomes that assess usability and acceptability of Sense2Quit   (see Table 3). We will   
use skip logic features in our study surveys to identify subjects who select certain responses indicating depression, substance 
abuse, and/or alcohol abuse and referral information will be presented at the end of the survey. Referral information will 
include contact information for the Comprehensive HIV Program (CHP) at New York- Presbyterian/Columbia University 
Irving Medical Center, which offers comprehensive care and services for people living with HIV. Participants completing 
the survey(s) on-site will be asked if they want to be escorted by staff to CHP. 
 
Table 3. Study Measures 
Construct 
Measures 
Demographics 
Gender, age, education, income, employment, health insurance, 
housing, time since diagnosis with HIV, health literacy (measured 
byS-TOFHLA),75 andco-morbidconditions
Tobacco Use History 
Age ofinitiation, current smoking, dailysmoking, e-cigarette use, 
types of products used, historyof quit attempts, prior use of 
quitline/telephonecounselingservices 
Tobacco Cessation 
CO lung/blood concentration, 7-daypoint prevalence abstinence – 
Timeline follow-back 76, 77 (confirmed with saliva cotinine); number 
ofquit attempts; days of continuous abstinence 
Illicit Substanceand Alcohol Use 
NIDAASSIST78, 79, AUDIT-C60 
Predictors of Tobacco Cessation 
FagerstromTestfor Cigarette Dependence,80 Readiness to quit81 
Cravings and Withdrawal 
MinnesotaWithdrawalScale82 
Psychosocial Factors 
Depression: CESDscore83; Anxiety: STAI score84, Social support85 
Marker of HIV/AIDSimmune status 
CD4, viral load (chart review), Case Adherence Index (self-report)86 
Follow Up Visit Only 
Pharmacotherapy Use 
Nicotinereplacementtherapy   Adherence 
Intervention Quality 
Health-ITUES63;Post-SystemStudyUsability  (PSSUQ)  87, 
Intervention ratings 
Operationalization of Outcome Measures: 
The primary outcome for determining preliminary efficacy will be biochemically(saliva cotinine) validated 7-day point 
prevalence abstinence. 
Subjective Data (e.g., health status, quality of life) and system use will be obtained from subjects for the specific research 
purposes of this study. Follow-up visits will be completed on-site at the study location. 
Carbon Monoxide Monitoring. We will be using a carbon monoxide detector to biochemically verify tobacco use. Medical 
Records. We will be reviewing patient records to assess participants’ CD4 and viral loads. For participants who are not  
patients at CUIMC, they will be asked to bring in their most recent CD4/viral load laboratory data from their last visit to their 
healthcare provider. 
Compensation: Eligible participants will be able to receive $40 for completing baseline study procedures, $50 at the 4-week 
follow-up study visit, and $60 at the 12-week follow-up study visit. 
Data Analysis: This is a pilot study to assess preliminary feasibility, acceptability, and efficacy. Descriptive statistics will be   
used for all analyses. The rate of quit attempts will be calculated as the proportion of smokers who attempt to quit (i.e., no 
smoking during a 24 hours period); 7-day point prevalence abstinence will be calculated as the proportion of smokers who   are 
biochemically verified (saliva cotinine) 7-day abstinence at a given time point; and sustained abstinence will be  calculated as 
proportion of days of no smoking starting on the quit date among those who attempt to quit. We will provide  point estimates 
and corresponding confidence intervals of these measures for each arm. Because of our small sample  sizes,  we will obtain 
Clopper-Pearson exact confidence intervals based on the binomial distribution. Given the small sample size,  the purpose of the 
arms is to monitor for unexpected, gross differences between the two groups. To determine acceptability,   we will ask 
participants in both arms how useful each of the intervention components were (1 =Not at all useful  to 7 = Extremely useful) 
and whether they would recommend the program to a friend (1 = Definitely would not recommend  to 7 = Definitely would 
recommend). For the intervention to be deemed acceptable, the mean level for each of these  measures would have to be five or 

higher. The efficacy of the intervention will be based on saliva- confirmed 7-day point 
prevalence abstinence at the final study visit. Lost-to-follow-up participants will be included as smokers. 
NOT-OD-15-102: Consideration of Sex as a Biological Variable: In accordance with NIH guidance, we will include sex  
as a biological variable in the study design (enroll equal numbers of males and females), analyses, and reporting. We 
will report all primary and secondary outcomes separately by sex to enhance rigor and transparency of our findings in 
addition to including sex in all multivariate models. 
 
AIM 3: Employ the RE-AIM framework to assess the potential scale-up of the Sense2Quit App. 
 
In addition to testing the Efficacy of the Sense2Quit App, we will concurrently measure the four remaining RE-AIM 
dimensions88 as follows: 
Reach –1) percent and demographic and clinical 
characteristics of those who joined the study 
based on current national statistics of PLWH, 
and 2) percent and demographic and clinical 
characteristics of those randomized to the 
intervention who used the app compared to 
those who did not. 
Adoption – We will recruit study participants 
from the intervention arm (N=30) to assess 
acceptability and perceived usefulness of the 
Sense2Quit App (see Table 4). Interviews will 
be collected until saturation is reached, but we 
estimate up to 30 participants. 
Implementation and Maintenance will be evaluated through interview data gathered from intervention arm 
participants (N=30) (Table 4). Finally, we will meet with other key stakeholders (N=10) (e.g., health care payers, 
city health officials) to determine what they may need to implement the Sense2Quit App and their willingness to 
partner and cost-share; implementation strategies will also be developed with them. 
Compensation: Participants will be able to receive $30 for completing an interview session. 
In-depth Interview Data Analysis: We will use the same analytic plan as described in Aim 1 for analyzing the 
qualitative data. 
Paradata Data Analysis: At the individual level, we will understand participants’ use of the App over time through the 
collection of paradata89 which is “free” in that it does not require any additional effort from the user90. To explore 
barriers and facilitators to widespread implementation of Sense2Quit App, we will collect data during intervention, 
implementation, and after the trial has ended. The primary paradata to be collected are page accessed, time stamp, and 
device type. From these data, we will derive the following use of data for each session: duration on each page, page 
progression through the application, time from login to result, and total time from login to logout. We will analyze the 
data at the individual-level (i.e., user-level), application-level, page-level, and session-level and assess how these differ  
by demographic characteristics, technology use, and outcome measures. Additionally, we will measure the amount in 
bytes of user data transmitted. Importantly, longitudinal analysis will determine if the user experience changes with 
repeated use. The paradata collected from each page will be analyzed to generate a “heatmap” of user-interaction (i.e., 
the distribution of activity for each link/button) that will inform user duration on each page of the App and user 
interaction with App content, contact pages, and the help page. We will explore usability issues with consideration for 
how many times users accessed help and what page of the App referred themto the help, implying the need for 
clarification. We will analyze differences in aggregated data by demographic group (e.g., age) to better understand 
engagement with the intervention and potential facilitators and barriers to App use. 
Plan for Future Fully Powered RCT of Sense2Quit. At the end of Year 2, we will write an R01, which will include a 
full- scale trial of the final Sense2Quit App with the same sample. Importantly, process evaluation interviews will 
allow us to refine the intervention in preparation for the RCT. We will also assess the intervention’s sustainability, 
and with key stakeholders, develop specific strategies to scale up the intervention to reach more PLWH who smoke 
within additional community-based and clinical settings. 
 
AIM 4: Testing with Confounding Gestures 
We recognized confounding effects as a range of gestures and actions that mimic the motion associated with smoking. 
To enhance the accuracy of smoking detection, the capability to discern these confounding effects is essential. For 
example, a typical smoking gesture involves the user bringing their hand to their mouth for a puff, subsequently shifting 
Describe your general perceptions of the Sense2Quit App and its usefulness 
for helping with tobacco cessation. 
How helpful was the Sense2Quit App for improving your tobacco cessation? 
What would you change or improve about the Sense2Quit App? 
How did the Sense2Quit App help you gain information about your tobacco 
cessation? 
How comfortable were you in using the Sense2Quit App in social settings? 
Probe: where and when did you use it mostly? 
How often did you use the Sense2Quit App in a typical week? Would you 
recommend it to a friend? 
Did you stop using the App altogether at some point? (If yes) Why? 
Describe the usefulness of the reminders to overcome your triggers. 
Table 4. Follow-up Sample Interview Guide 

the hand to a resting position, and then returning it to the mouth for another puff. This particular sequence of actions is 
not exclusive to smoking, and parallels can be drawn with other activities that we investigate, such as drinking and 
answering a phone call. To improve precision and accuracy of smartwatch smoking detection, for Aim 4 we will conduct 
additional testing with PWH who will be performing smoking and additional confounding gestures. This process, which 
has been demonstrated in past studies[93-96], will help us improve the current algorithm for smoking detection 
associated with the Sense2Quit app.  
  
Recruitment and Consent:  
Aim 4 participants will be PWH who smoke cigarettes. We will enroll 30 people who will consist of 1) enrolled 
participants at their 12-week follow-up visit; 2) participants who are initially eligible for the study after completing the 
screener but do not qualify based on eCO levels; or 3) participants who already finished Aim 2 (and 3, if applicable).  
  
All participants will sign informed consent prior to participating in Aim 4 procedures.   
  
Procedures:  
 Participants who have not yet participated in Aim 2 will complete the baseline survey prior to participating in Aim 4 
procedures. All Aim 4 participants will complete the required hand gestures (See table below) as well as smoking gestures 
for a total of approximately 30 minutes. Study staff will 1) connect the watch with the smartphone; 2) have participant 
wear the watch on their smoking hand; 3) open the smartphone to start data collection by pressing the start button and 
assigning the label for the particular activity they are about to perform; 4) repeat each activity listed above in three 
postures (sitting on a char, standing, walking around) for a duration of 5 seconds; and 5) stop data collection by pressing 
the stop button after 5 seconds of the activity being performed. Participants will also complete the optional actions with 
the opportunity to omit some of them.  
  
  
Action  
Required?  
1  
Drinking a beverage without a straw  
Yes  
2  
Drinking beverages with a straw  
Yes  
3  
Eating a meal with a spoon or fork  
Yes  
4  
Eating a snack with a hand  
Yes  
5  
Talking with a hand gesture  
Yes  
6  
Using a phone (making a phone call)  
Yes  
7  
Adjusting glasses  
Yes  
8  
Arm cross  
No  
9  
Brushing teeth  
No  
10  
Gym activity (e.g. lifting, Zumba)  
No  
11  
Scratching face  
No  
12  
Applying lipstick  
No  
13  
Coughing  
No  
14  
Yawning   
No  
15  
Whistling  
No  
16  
Eating a lollipop  
No  
17  
Playing harmonica  
No  
19  
Pinching the chin  
No  
20   
Wiping the nose  
No  
21  
Massaging somewhere on the head  
No  
22  
Waving   
No  
  
 Compensation:   
 Participants will receive $30 in the form of a Bank of America pay card following the completion of the Aim 4 activities. 
 
 
LIMITATIONS AND ALTERNATIVES 
 

1) An important limitation is that we are relying on self-report of NRT use among study participants, and while we 
will track our administration of NRT to study participants, we are limited in our ability to validate whether 
participants have used the NRT. 
2) We carefully considered our control condition and although referring control arm participants to the NYC quitline, 
which will therefore give them access to an NRT supply may underestimate the effect of the Sense2Quit App, we 
believe that it is imperative to offer NRT/access to NRT to both arms since this is standard of care for persons who 
are trying to quit smoking. 
3) While leveraging accessible mHealth technologies is a strength, our study team acknowledges the target population 
may not have access to smartwatches outside of the research study. Nonetheless, if efficacious, the cost of the 
smartwatch is half of the cost of purchasing cigarettes for 1 month in NYC, estimated at $320/month91 and even more 
minimal in comparison to the annual cost ($170 billion) for direct medical care for persons who smoke in the US92. 
 
POTENTIAL RISKS AND ADEQUATE PROTECTIONS 
The investigators will follow all required policies related to the protection of human subjects. All investigators have 
fulfilled Human Subjects Protection and Health Insurance Portability and Accountability Act (HIPAA) training 
requirements (including CITI basic and refresher courses, Good Clinical Practices, and conflicts of interest) and are up to 
date with these certifications. All prospective participants will be fully informed of the intent of the study, expectations of 
participants, and risk to participants prior to enrollment using an IRB-approved informed consent form. 
 
Potential Risks 
 
There is no more than a minimal risk associated with any of the study activities. The study activities meet the general 
definition found in Subpart A (46.102) that the probability and magnitude of harm or discomfort anticipated in the 
research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of 
routine physical or psychological examinations or tests. 
 
The risks of participating in this study are few. Potential risks consist of discomfort with interview questions and potential 
breaches of confidentiality. It is possible that certain questions on the questionnaires (e.g., drug use) may make 
participants feel uncomfortable, but the subject is free to decline to answer any questions. Participation in research can 
involve loss of privacy. All study data including App data will be maintained on CUIMC servers that are completely 
secure and HIPAA compliant. All signed consent forms and payment receipts used in this study will be kept in locked 
files which only the investigators can access. We will also apply for a Federal Certificate of Confidentiality, which will 
protect against attempts by law enforcement or other government agencies to access our data. 
Nicotine Replacement Therapy. Participants will be told the risks of using NRT, which include skin irritation (patch), 
itching (patch), dizziness, headache, rapid heartbeat, and nausea. 
FDA Regulatory Pathway. The CUIMC IRB will make the final determination if this App is subject to FDA regulation. 
Nonetheless, the Sense2Quit App is not subject to FDA regulation within the category of Software as a Medical Device 
because this device does not function as a medical device (meaning such software functions do not meet the definition of a 
device under section 201(h) of the Federal Food, Drug, and Cosmetic Act), and therefore the FDA does not regulate it as a 
device. Since the software function does not meet the definition of a device, even though it is deployed on a mobile 
platform, the FDA oversight would not be applicable. This is consistent with the FDA's existing oversight approach that 
considers functionality of the software rather than platform, and the FDA will apply its regulatory oversight to only those 
software functions that are medical devices and whose functionality could pose a risk to a patient's safety if the device were 
to not function as intended. 
 
Adequacy of Protections Against Risks 
 
Confidentiality and Privacy. Risks will be minimized by not including personal identifying information on the forms, when 
possible, and by conducting interviews and collection of personal information in a private setting. Reminder text messages 
will make no mention of HIV. All data will be collected using unique patient identification codes. All laboratory specimens, 
evaluation forms, reports, and other records will be identified by a coded number to maintain participant 
confidentiality. All records will be stored in a locked file cabinet. Study data from all sites will be collected and managed 
using Research Electronic Data Capture (REDCap). REDCap is a secure web application designed to support data capture 
for research studies, providing user-friendly web-based case report forms, real-time data entry validation (e.g., for data types 
and range checks), audit trails, and a de-identified data export mechanism to common statistical packages (e.g., SPSS, 
SAS, Stata, R/S-Plus). REDCap data collection projects rely on a thorough, study-specific data dictionary defined in an 
iterative self-documenting process by all members of the research team. This iterative development and testing process 

results in a well-planned data collection strategy for individual studies. REDCap also includes a powerful tool for building 
and managing online surveys. The research team can create and design surveys in a web browser and engage potential 
respondents using a variety of notification methods. REDCap is flexible enough to be used for a variety of types of research 
and provides an intuitive user interface for database and survey design and data entry. Lastly, clinical information will not 
be released without written permission of the participant, except as necessary for monitoring by the IRB or the National 
Institutes of Health (NIH). 
 
Plan for Privacy and Data Security of the Sense2Quit App. Beginning with the development process and throughout the 
research project, we will follow the privacy and security principles set forth at healthhit.gov. Our team is familiar with the 
importance of the privacy and security of personal health information to engender individual trust in the use of health IT 
applications. We have expertise and experience in this domain as we have developed a number of health IT systems funded 
through NIH and the Agency for Healthcare Research and Quality for PLWH whose personal health information is usually 
held to higher security standards than traditional patients as HIV has historically been a stigmatized disease. 
 
The App will be stored on a secure HIPAA compliant server. 
 
Further, CUIMC has an Information Security Office (ISO) that facilitates all aspects of information security risk 
management at CUIMC, with a particular focus on threat management and HIPAA compliance. This includes 
administration and enforcement of information security policies on campus. ISO also provides guidance to CUIMC Schools 
and Departments regarding any information security concerns they may have. The ISO collaborates with the entire CUIMC 
community to protect the confidentiality, integrity, and availability of our critical information and computer resources. The 
ISO strives to implement secure computing infrastructure and practices with sensitivity to CUIMC's educational and 
research environment. Columbia University has an information security charter which is the foundation of all the work 
carried out by Dr. Schnall and her research team. In specific, the Multiple Principal Investigator (MPI) team will work with 
the CUIMC ISO to protect the confidentiality, integrity, and availability of participants’ data. 
Confidentiality means that information is only accessible to authorized users. Integrity means safeguarding the accuracy 
and completeness of data and processing methods. Availability means ensuring that authorized users, such as research 
participants, have access to data and associated information resources when required. 
 
To protect the integrity of participants’ data, the Project Coordinator will assign an ID number to all participants. The 
participant ID number will be used to identify data collected. Since the study has repeated follow-up visits, we will 
maintain a list of participants which link identifying information to study ID numbers. Only a limited number of staff 
members will have access to this list, which will be kept in locked files and in a password-protected computer file. De- 
identified data will be accessible by all members of the research team involved in the data analysis, unless study 
personnel needs access to individually identifiable information to perform their duties. Access to individually  
identifiable private information about human subjects will be limited to research team members who collect and manage 
the data, the project coordinator, and the MPIs. 
 
All research personnel will complete extensive training before they are granted access to this identifying information. Study 
personnel will complete Human Subjects Protection Training which complies with federal guidelines delineated in 45 CFR 
Part 46. Personnel will also sign confidentiality statements that specify that if the participants’ confidentiality is breached 
unintentionally that personnel will follow the procedures for reporting this breach to the MPIs. The confidentiality statement 
also indicates that unintentional or deliberate violations of participants’ confidentiality may result in demotion or 
termination depending upon the severity of the event. Personnel will also participate in training with the Investigators 
and/or Project Coordinator regarding data safety, confidentiality of participants, limits of confidentiality, and proper 
administration of the study protocol. 
 
We will store all personally identifiable data on secure, HIPPA compliant servers. All electronic forms containing personally 
identifiable information, including participant locator forms (i.e., containing contact information), will be maintained in a 
password-protected computer files. Data that are entered into computer files will be de-identified and maintained on a 
subdirectory of an institutional server with password-protected access. The MPIs will review all requests, current and future, 
to use the data, and any data files that are provided to other individuals will be de-identified. Data files will contain code 
numbers in order to make reference to particular cases across multiple assessment waves. 
 
We will maintain a Federal Certificate of Confidentiality throughout the life of the research project. We will inform study 
participants of the above procedures and the limits of confidentiality during the consent process prior to data collection. 

Specifically, we will warn participants that state law mandates reporting of abuse and/or neglect of children, and that threat 
of harm to self or others requires intervention by clinical staff. We will inform participants that criminal behavior (i.e., 
drug use) is not reported to authorities, and that the security of this information is protected by the Federal Certificate of 
Confidentiality. 
 
Plan for Privacy and Security Protections in the Development and Implementation of the Sense2Quit App System. 
Beginning with the development process and throughout the research project, we will follow the privacy and security 
principles set forth at healthhit.gov. Our team is familiar with the importance of the privacy and security of personal health 
information to engender individual trust in the use of health information technology applications. We have expertise and 
experience in this domain as we have developed a number of health information technology systems for persons from 
high-risk populations, including PLWH, whose personal health information is usually held to higher security standards 
than traditional patients. We will be housing the App on a secure server hosted by Amazon Web Services. All servers 
have HIPAA compliant security. Data will be encrypted and stored securely on the Amazon Web Services servers. Prior 
to consent, study participants will be informed as to what data the Sense2Quit App will collect (including location/GPA 
information). Study staff will explain to study participants that data will be encrypted and stored securely on the Amazon 
Web Services servers. As a starting point for ensuring privacy and security, all smartphones will be password–protected. 
In addition, there will be an additional password for the Sense2Quit App so that only study subjects will be able to open 
the app and/or view their personal health information. 
 
Procedures for Monitoring Adverse Events. Should any physical or psychological manifestation be exhibited at any time 
during the study, Dr. Schnall will consult with her Co-Investigators regarding clinical situations as they arise. If an urgent 
clinical situation should arise, Dr. Schnall or a designee will access an urgent appointment at the Columbia University 
School of Nursing Nurse Practitioners Primary Care Clinic or the emergency department at CUIMC. Dr. Schnall will 
complete an adverse event form and report it to the CUIMC IRB. If there are any serious adverse events, they will be 
reported within 48-72 hours to the CUIMC IRB. The CUIMC IRB is responsible for reporting any serious adverse events 
to the NIH, Office for Human Research Protections, Food and Drug Administration, and other federal, State and local 
agencies. 
 
BENEFITS 
 
Potential Benefits to Research Participants and Others 
 
The purpose of this study is to test the Sense2Quit App for improving tobacco cessation in PLWH. The knowledge gained 
from the research will enable the scientific community and patients to improve tobacco cessation in communities and 
persons who are most in need in the United States. There may be a benefit to participants after use of the intervention as 
they will be more likely to stop smoking and more likely to have sustained tobacco cessation. More broadly, the 
knowledge gained will contribute to the body of knowledge regarding the use of health information technology for 
improving the lives of persons with chronic illnesses. Possible risks (i.e., discomfort answering questions, potential 
confidentiality breaches) are outweighed by the potential for improving tobacco cessation rates in a health disparate group 
of PLWH. 
 
Importance of the Knowledge to be Gained 
 
The knowledge gained from this research will enable the scientific community, clinicians, and PLWH to improve tobacco 
cessation. The Sense2Quit App is a scalable, low-cost intervention which does not require provider resources. Findings 
from our study will provide timely and important information on the use of mobile technology for the delivery of an 
evidence-based tobacco cessation intervention for PLWH. 
 
DATA SAFETY AND MONITORING PLAN 
Data Management and Data Quality. Columbia University will be responsible for computerized survey programming, 
data capture, management, and analysis. All study information will be identified through the Participant Identification 
Number (PID) on all forms and computerized files. Data files will be exported from the Qualtrics program and imported 
into the SPSS statistics software database for storage. Computer data files never have any identifying information and are 
encrypted prior to transfer between study sites. 
Data entered into the SPSS database will not include any identifying information. Only authorized users with a login name 
and password will be able to open the computerized survey, and only those with administrative privileges will be able to 

access data. The study research assistant will use a login name and password to gain access to the software in order to 
administer it to a participant, but they will have no ability to access the saved data. The database, data structure, and data 
quality will be routinely reviewed by the contact Principal Investigator (PI), Dr. Schnall. Dr. Schnall will work closely to 
plan analyses for various purposes, including for hypothesis testing and manuscript development and reports. Data quality 
will be examined before statistical analyses are conducted, including examination of missing data, assessment of 
distributional assumptions, and identification of outliers. In addition to data quality, the comparability between  
intervention and control groups will be carefully examined, including baseline balance and differential attritions at all 
waves of follow-up. While differences are not expected from the randomized design, it is prudent to plan for this 
contingency so that sufficient follow-up data and appropriate statistical methods can be used for intent-to-treat analyses. 
The psychometric properties of instruments will also be examined, as will the patterns of missing data. 
 
Training on human subjects and data safety and monitoring. All staff will participate in the National Institutes of 
Health (NIH) required trainings for the conduct of studies that involve human subjects, and any future study staff will do 
so upon hiring. Training for all staff includes (but is not limited to) Human Subjects, Informed Consent, Good Clinical 
Practice, Quality Management, Confidentiality, and Reporting of Adverse Events. If any study staff discovers any 
untreated condition (e.g., onset of physical or mental health condition), they will refer participants to appropriate treatment 
immediately. 
 
Data Safety and Monitoring Committee. This study will also have a data safety monitoring committee (DSMC) which 
will meet yearly via Zoom. The DSMC will consist of individuals who are not otherwise associated with the study. The 
DSMC will meet at least yearly to review study progress, adequacy of randomization, and, at their discretion, adverse 
events or differential outcomes. For randomization, we will tabulate the number of individuals who have been randomly 
assigned to each condition at each of the DSMC meetings. Before the DSMC meeting, relevant information will be 
tabulated to report to the DSMC, and after the meeting, staff of the management core will collect minutes and distribute to 
the board for sign-off. The final report will be submitted to the Institutional Review Board (IRB) on an annual basis. 
 
Procedures for Monitoring Adverse Events. Per guidance provided by the Office of Human Subjects Research at the 
NIH, an adverse event (AE) is any unfavorable and unintended diagnosis, symptom, sign (including an abnormal 
laboratory finding), syndrome, or disease which either occurs during the study, having been absent at baseline, or, if 
present at baseline, appears to worsen. A serious adverse event (SAE) is defined as an untoward medical occurrence that: 
1) results in death, 2) is life threatening, 3) requires (or prolongs) hospitalization, 4) causes persistent or significant 
disability/incapacity, 5) results in congenital anomalies or birth defects, or 6) is another condition which in the judgment of 
the investigators represents significant hazards. 
 
Possible AEs that are anticipated include the need to violate the confidentiality of the participants. All study personnel will 
be trained regarding the limits of confidentiality. The training will include reviewing possible scenarios and knowledge of 
key questions to assess risk. We will train staff to err on the side of caution and to contact the clinical supervisor as needed. 
Coordinators will be available on site or via phone after hours should staff need consult regarding an emergency. In this 
situation, we will train all staff to immediately contact clinical supervisors, and under the guidance and direction of clinical 
supervisors, study staff will be trained when to either contact police to ensure the safety of participants. 
 
Possible AEs that are unanticipated will be brought to the attention of the Coordinators and reported immediately to both 
site IRBs. All study staff will be trained to recognize and report AEs and SAEs. Possible AEs will immediately (within 24 
hours) be brought to the attention of the Lead at each site by study staff who identify the event. The Site Lead will report 
the AEs and SAEs to the IRB in writing as soon as possible, but within 7 calendar days for death or life-threatening events 
and within 15 calendar days for all other AEs or SAEs. The IRBs will determine whether it is appropriate to stop the study 
protocol temporarily or will provide suggestions/modifications to the study procedures as necessary. Possible 
modifications include adding these possible adverse events to the consent form and re-consenting all study participants. 
The PIs will be responsible for monitoring participant safety on a monthly basis at regularly scheduled research meetings. 
They will keep a written log of all events and ensure that the IRB is contacted immediately. They will also keep a log of 
the outcome of IRB decisions regarding AEs and apprise the research team of any changes that need to occur because of 
IRB decisions 

STATISTICAL DESIGN AND POWER 
 
Sample Size and Power. The goal of this pilot study is to estimate the smoking cessation rates in each arm to obtain an 
effect size for future larger studies. To conduct a hypothesis test for the comparison of cessation rates between the two 
intervention arms, it requires a minimal sample size of 199 per group (total 398) for at least 80% power. This calculation 
was based on a 2-sided test with the type I error of 0.05, and assuming a 20% cessation rate in the Sense2Quit App group 
(intervention) and a 10% cessation rate in the control arm. The 10% difference would be equivalent to a medium effect 
size (Cohen’s d=0.45). In this pilot study, we propose a total sample of 60 (30 per group). Therefore, this study is not 
powered to detect a significant difference between arms. Instead, we estimated the minimal sample size for the estimation 
of cessation rates in each arm with acceptable reliability. For the sample size (30 per group), this study will have at least 
80% probability that the standard error of the cessation rate estimates ≤7%, assuming expected cessation rates ranging 
from 10% to 20%. Therefore, the sample size is sufficient to provide estimation with acceptable reliability. 
 
Statistical Design and Data Analysis: This is a pilot study to assess preliminary feasibility, acceptability, and preliminary 
efficacy. Descriptive statistics will be used for all analyses. The rate of quit attempts will be calculated as the proportion of 
smokers who attempt to quit (i.e., no smoking during a 24-hour period); 7-day point prevalence abstinence will be 
calculated as the proportion of smokers who are biochemically verified 7-day abstinence at a given time point; and 
sustained abstinence will be calculated as proportion of days of no smoking starting on the quit date among those who 
attempt to quit. We will provide point estimates and corresponding confidence intervals of these measures for each arm. 
Because of small sample sizes, we will obtain Clopper-Pearson exact confidence intervals based on the binomial 
distribution. Given the small sample size, the purpose of the arms is simply to monitor for unexpected, gross differences 
between the two groups. To determine acceptability, we will ask participants in both arms how useful each of the 
intervention components were (1 = Not at all useful to 7 = Extremely useful) and whether they would recommend the 
program to a friend (1 = Definitely would not recommend to 7 = Definitely would recommend). For the intervention to be 
deemed acceptable, the mean level for each of these measures would have to be 5 or higher. The efficacy of the 
intervention will be based on saliva-confirmed 7-day point prevalence abstinence at the follow-up survey. Lost-to-follow- 
up participants will be included as smokers. 
 
DISSEMINATION PLAN 
 
Tools developed and evaluated during this project have the potential to extend the impact and reach of tobacco cessation 
for all smokers but specifically for persons living with HIV (PLWH) who smoke. Per the RFA, this study was designed 
for dissemination (e.g., feasibility/acceptability of the intervention for PLWH) and suitable for the intended context. 
Therefore, a multi-faceted dissemination plan targeting various stakeholders is proposed. We will disseminate our 
findings to technology-oriented and clinical management- oriented audiences. For technology audiences, we will provide 
enough detail to enable the Sense2Quit App to be constructed and used within an appropriate context. 
We propose the following dissemination strategies: 
1. Members of the research teamwill present the results of this study in several different venues targeting different 
audiences, including conferences such as the American Public Health Association and Society for Behavioral 
Medicine. 
2. We will seek out appropriate organizations that are influential in HIV and tobacco cessation public health practice 
(e.g., International AIDS Society, Society for Research on Nicotine and Tobacco). We will provide these 
organizations with an executive summary, press releases, and/or published papers and present study findings at local 
community-based organizations. 
3. We plan to publish our results in appropriate high-impact, peer-reviewed academic journals such as the American 
Journal of Public Health, AIDS and Behavior, and Nicotine and Tobacco Research. 
4. We will work with our local community-based organizations (e.g., Alliance for Positive Change, Gay Men’s Health 
Crisis, LGBT Center) to disseminate our study findings to the community. 
 
All informed consent documents for this clinical trial will include a specific statement relating to posting of clinical trial 
information at ClinicalTrials.gov. We will register this study with ClinicalTrials.gov. Finally, the recipient institution 
(Columbia University) has an internal policy in place to ensure that clinical trials registration and results reporting occur in 
compliance with policy requirements. Specifically, the Human Research Protection Office and Institutional Review Boards 
have policies to ensure that clinical trials registration reporting occurs in compliance with policy requirements. 
Specifically, the Human Research Protections Office and Institutional Review Boards have policies to ensure that clinical 
trials registration reporting occurs in compliance with policy requirements. 

Presentations at national scientific meetings. It is expected that we will present our findings at HIV, tobacco-cessation, 
behavioral health, informatics, and engineering related scientific meetings. We will also disseminate the findings through 
relevant newsletters and websites of related interest groups. 
 
We will also make de-identified data from our study available. Researchers interested in replicating our methods and study 
findings will have full access to the study protocol, analytic methods, and codebook of qualitative data analysis. We will 
deliver versions of our protocol with our first 12-month progress report. We will deliver our final protocol, codebook 
documents, and instructions regarding how other researchers can access our study documents to the NIH within 12 months 
of the end of the funding period. In addition to the documents mentioned above, de-identified transcripts from our in-depth 
interviews will be available at the conclusion of the study. The de-identified transcripts will be archived on the secure 
network server provided to the Contact PI at Columbia University Irving Medical Center. A Data Use Agreement will be 
implemented for other researchers interested in using our data for replication of research findings or for additional areas of 
research. We will request that outside investigators discuss their manuscript ideas with the PIs before proceeding. 
Furthermore, we will request that manuscripts using data from our project be approved by the PIs prior to submission for 
publication. Members of this project team may contribute as co-authors when data from this study are used. We will 
request that manuscripts, abstracts, presentations, and chapters developed by other investigators credit this study and credit 
NIH as the funding source for the data. This process will allow for a central repository and access point for all papers, 
abstracts, posters, and presentations by any individual or organization using our data. 
 
Our plan for sharing research data and resources is designed to assure that data generated in this project are made as widely 
and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary 
information. 
 
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