RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers
Phase: NA
Conditions: Tobacco Use Disorder, HIV
Sponsor: Montefiore Medical Center

Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
2. SPECIFIC AIMS 
   Tobacco use has emerged as a leading cause of death in persons living with HIV (PLWH). Improved survival 
resulting from highly active antiretroviral therapy is tempered by alarming increases in non-AIDS related 
malignancies,1-3 most notably lung cancer.2,3 Of the more than 1.1 million PLWH in the US,4 60% smoke 
cigarettes,5 and 75% are interested in quitting.6 Almost none of them are accessing behavioral cessation treatments, 
and programs targeting their specific needs are virtually non-existent.7 NIH and USPHS have highlighted this public 
health need and have identified smoking cessation in PLWH as a leading priority.8,9  
   The Internet has emerged as an important route for tobacco treatment delivery.10 Web-based interventions offer 
smokers convenience, low (or no) cost, anonymity, and are effective in promoting abstinence.11 Today, most national 
and state public health agencies (including the NCI) offer web programs as integral components of their tobacco 
treatment portfolios. [[In a national sample, 13% of US smokers reported seeking online assistance to quit within the 
past 12 months.12  With such broad potential reach (and low cost) even small increases in quit rates can have a large 
public health impact. At the time of this submission, there is not a single web-based treatment targeting PLWH 
smokers available in the US or elsewhere. This represents a health disparity of the first order, and a public 
health opportunity missed.]] 
   Positively Smoke Free on the Web (PSFW) is a static, 8-session, theory-driven, culturally-tailored web-based 
program developed by our team to address the unique needs of PLWH smokers. Our NCI-funded R21 pilot trial of 
PSFW demonstrated moderate-high levels of adherence to the program schedule, and the PSFW condition exhibited 
higher 3-month abstinence rates than standard care (10% vs. 4%).13,14 Among those who completed all 8 sessions, 
18% achieved abstinence. [[These pilot data compare favorably with web-based treatment outcomes reported from 
large, general-population studies (see 3.A.4), they support the feasibility of web-based tobacco treatment for this 
underserved and vulnerable group, and they provide justification for a more definitive study of a very promising 
intervention.]] 
   Social support is a critical component of tobacco treatment.15 Research by our team and others has demonstrated 
the positive impact of social network participation on smoking cessation.16-19 Smokers who participate in an online 
community – whether passively reading posts by others or actively engaging in online discussions – are 
more than twice as likely to achieve abstinence even after controlling for a broad range of covariates.20 
Specifically for PLWH, an online community offers an anonymous and accessible platform to exchange support, to 
share information and cessation strategies, and potentially to overcome the loneliness and lack of network support for 
quitting which we have shown to be important drivers of smoking and obstacles to quitting.21-23 Establishing a 
functional and therapeutically effective online community requires time, purposeful planning, and careful nurturing.24-26 
Behavior intervention studies that have attempted to evaluate the effectiveness of online communities created 
synchronously with trial initiation have met with limited success.27-29 In preparation for this trial,  The American Legacy 
Foundation (Legacy) – a partner on the proposal and leader in the field of online social networking for cessation – has 
already established and alpha and beta-tested a prototype online community including a core group of fully-trained 
seed users as an integrated component of PSFW (now “PSFW+”). These efforts ensure that by trial launch we will be 
prepared to achieve the following Specific Aims and test a priori hypotheses (H): 
Aim 1. To test the efficacy of PSFW+ compared to an attention-matched web-health intervention (American Heart 
Association Getting Healthy) in achieving 7-day point prevalence abstinence (ppa) at 6 months post-randomization in 
a cohort of PLWH smokers (N=550). All subjects will be offered nicotine patches. H1: PSFW+ will yield higher 
abstinence rates than the control intervention at 6 months.
Aim 2. To examine whether the impact of treatment condition on cessation is mediated by greater perceived social 
support afforded by the PSFW+ program. This central aim is supported by our work with PLWH that has shown 
strong associations between loneliness, smoking, and lack of social support for quitting.22,23 H2: Intergroup differences 
in 6-month abstinence will be mediated by greater changes in perceived social support among those in PSFW+.
Exploratory Aim: To explore moderators and additional mediators of treatment efficacy. Potential moderators of 
interest include gender, education, age, race, HIV risk category, depression, anxiety, other substance use, and 
stigmatization.30 Potential mediators identified in our previous work include nicotine replacement use, dose of 
intervention, and changes in abstinence self-efficacy.23,31-33 These analyses will draw upon the experience of the 
investigative team in assessing complex mediation effects33,34 with particular attention to PSFW+ utilization metrics. 
   This proposal brings together leaders in HIV/tobacco use and a technology team at the forefront of health-related 
social networking to leverage investments already made by NCI and Legacy in the creation and piloting of PSFW. It 
will retain all of the empirically-tested content of the original website and enhance and modernize it with the power of 
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Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
social media. Establishing the efficacy of a web-based smoking cessation program for PLWH that has broad reach 
would not only represent an enormous advance in the fight against tobacco use in PLWH, but would also provide a 
clearer understanding of the role of targeted, web-based health interventions in comprehensive HIV care.
3. RESEARCH STRATEGY
3.A. SIGNIFICANCE 
   3.A.1. Tobacco Use is a Leading Cause of Death Among Persons Living With HIV (PLWH). Since the advent 
of highly active antiretroviral therapy (HAART), deaths from AIDS-defining infections and neoplasms have diminished 
dramatically, while non-AIDS defining cancers have become increasingly important causes of morbidity and 
mortality.35 Among these, lung cancer is the leading killer, causing 22% of cancer-related deaths among PLWH in the 
US during the HAART era.2 Outside the US, a large European PLWH cohort recently reported a standardized 
mortality ratio for lung cancer of 5.85.3 The heavy toll that lung cancer exacts on PLWH is believed to be primarily 
attributable to high rates of tobacco use.36,37 More than half of US PLWH smokes cigarettes.5,6 In a cohort of 5,472 
PLWH, tobacco use accounted for 24.3% of deaths and 30.6% of all non-AIDS defining cancers (including skin 
cancers).37 On average, over 12 years of life are lost as a direct result of tobacco use in PLWH smokers.38
   3.A.2. Developing Effective Smoking Cessation Interventions for PLWH is a Priority. Smokers living with HIV 
suffer from high rates of nicotine dependence, anxiety and depression, loneliness, and comorbid substance use.39 
[[Depression and anxiety are hyperprevalent among PLWH smokers, and we have shown them to be  intertwined with 
other behavioral barriers to quitting such as low abstinence self-efficacy31 and loneliness.22]] Although most are 
interested in quitting, only a small proportion of PLWH smokers who participate in clinical trials that include nicotine 
replacement therapy (NRT) sustains abstinence at 6 months40 compared to 20-30% quit rates seen with similar 
treatments in the general population.41 To date, only a handful of sufficiently powered smoking cessation trials have 
been conducted with PLWH smokers, and abstinence outcomes at 6 months have not exceeded 12%.6,39,42-44 One 
exception was a recent 3-arm study comparing intensive individual counseling, static web-based tobacco treatment, 
and a minimal contact control that reported anomalously high 3-month quit rates in all conditions (26%, 29%, and 
24%, respectively) with no significant between group differences.45 Both NIH and USPHS have designated smoking 
cessation among PLWH as a priority given the high rates of cancer and smoking-attributable disease.8,9
   3.A.3. Web-Based Cessation Programs can Reach PLWH Smokers. Most PLWH smokers want to quit,6,39 but 
poor physical and mental health, transportation, cost, stress associated with coping with their illness, conflicting 
medical appointments, and scarcity of tobacco treatments in HIV care settings comprise a unique constellation of 
barriers that PLWH smokers face in accessing cessation programs and achieving abstinence. Web-based 
interventions could dramatically increase access for PLWH smokers: data from our previous work in 2010-2011 
revealed that over half of smokers living with HIV had home access to the Internet and that number has been growing 
rapidly (3.C.1.e.).46,47 A just-published survey of inner-city women living with HIV in 2014 reported that 75% 
participated in web-based social networking and 48% participated in health-related social networking.48 Web-based 
smoking cessation interventions have been tested in dozens of randomized trials11,49-51 but only the aforementioned 
study by Humfleet and colleagues specifically addressed PLWH smokers.45 Atypically high cessation rates in all study 
conditions (including the minimal contact control group) make it difficult to draw conclusions from this trial.45
   There is convincing evidence of the effectiveness of computer- and web-based interventions for health behavior 
change among PLWH in areas other than smoking. In a study examining the psychological effects of general online 
support group use for PLWH, subjects with higher levels of participation had better psychological health than those 
with lower levels of participation.52 Structural equation modeling revealed that greater use of an online support group 
was associated with more frequent occurrence of empowering processes as measured by receiving useful 
information, receiving social support, finding positive meaning and helping others.53 These empowering processes 
were related to higher levels of adaptive coping, which in turn were related to higher quality of life.53 Computer-based 
interventions are also effective at promoting medication adherence54-56 and depression symptom management57 
among PLWH. Meta-analytic data support the efficacy of web-based HIV-prevention for persons at risk for HIV.58 
These various studies have also reported high levels of engagement and satisfaction with web-based programs.
   [[In the general population, utilization of web-based programs dwarfs all other modes of behavioral tobacco 
treatments.27 The most recent national survey of tobacco treatment utilization, conducted in 2007, indicated that 13% 
of US smokers had sought assistance in quitting online within the past year12 – a proportion that has likely risen by 
2015 with the expansion of internet’s reach and the continued proliferation of restrictive smoking policies and tax 
increases. If 13% of the 660,000 PLWH smokers in the US were to access an effective web-based program and 
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Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
10% of them stopped smoking, this would translate into 8,580 successful quitters and (assuming a 45% 
reduction in mortality as a result of quitting38) over 47,000 years of life saved.38 At the time of this submission, 
there is not a single web-based program targeting PLWH smokers available in the US or elsewhere. This 
represents a health disparity of the first order, and a public health opportunity missed.]] 
   3.A.4. Our Web-Based Cessation Program for PLWH Showed Preliminary Evidence of Efficacy. Our R21 trial 
(R21CA163100-01) was a feasibility and efficacy pilot of Positively Smoke Free on the Web (PSFW). With input from 
HIV specialists, behavioral psychologists, graphic artists, software engineers, and PLWH smokers, we distilled the 
theory driven and culturally tailored content of our group counseling smoking cessation curriculum for PLWH21 into a 
static web-based intervention (3.C.1.e.). An intensive protocol designed to maximize engagement was implemented, 
comprised of email/text reminders to return to the program as well as clinic-based telephone outreach to participants 
who were non-adherent. The study demonstrated initial feasibility and efficacy: 2/3 of subjects logged into ≥6 
sessions, and 40% logged into all 8 sessions. Preliminary efficacy analyses suggested that higher program 
completion rates were associated with increased cessation. The majority of participants (73.9%) elected to receive 
text messages in addition to email reminders and the vast majority of users (94.2%) received live phone call 
reminders. At 3 months, 7-day point-prevalence abstinence (ppa) was 2.3 times higher in PSFW compared to SC 
(10.1% vs. 4.3%). [[Although the trial was not powered to detect a significant difference of this magnitude, these 
results are promising when viewed against the background of the available evidence base. In the largest meta-
analysis to date,59 which included 77 RCTs of computerized/electronic tobacco treatments, the odds ratio for 
successful quitting was 1.32 (1.21-1.45) for those randomized to the experimental interventions, and the rate of long-
term abstinence with these interventions (10.9%) was very similar to the 10.1% that we reported, Moreover, the dose-
response effect that we observed is further evidence of program efficacy. An effect of this size generated by a wide-
reach, low-cost intervention can have a large public health impact.60 Consistent with this view, the USPHS concluded 
that web-based tobacco treatment is “a highly promising delivery system…given the potential reach and low cost.9”]] 
The current proposal aims to conduct a definitive trial of our enhanced version of PSFW, with strong pilot evidence to 
support the hypothesis that PSFW+ will be efficacious and promises to expand the short list of evidenced-based 
treatments available to PLWH smokers. 
   3.A.4.a. PSFW Addresses Anxiety and Depression. [[The website repeatedly discusses the challenges of 
smoking cessation in the setting of psychiatric illness, urges users to seek mental health support, and emphasizes that 
smoking is an unhealthy strategy to manage these stressors. Interestingly, in the pilot trial of PSFW,14 higher anxiety 
scores were associated with greater website utilization, even when adjusted for a range of covariates. It is possible 
that a web-based intervention may offer special benefits to the 62% of PLWH smokers suffering from anxiety 
disorder.39 Both anxiety and depression are recognized as key user characteristics in the design of the 
intervention, they are specifically addressed in the didactic content and the online community, they will be 
explored as putative moderators of program efficacy in the analytic plan, and their clinical implications are 
incorporated into the Protections against Risks plan (5.B.).]]
   3.A.5. Engagement in Online Social Networks for Cessation Promotes Abstinence. Adding an online 
community to PSFW may significantly enhance its efficacy and overall impact on quit rates. Intra-treatment social 
support is a critical component of “offline” smoking cessation treatment.15 Our work in online social networks for 
cessation over the past 15 years has shown that individuals who participate in an online community in web-based 
smoking cessation programs – whether actively posting messages or passively reading communications among 
others (“lurking”) – achieve higher abstinence rates, even after controlling for a range of covariates including baseline 
motivation to quit.20,61,62  With the ubiquity of social media tools, “peer-to-peer healthcare” plays an important role in the 
healthcare landscape and health behavior change.63-67
   3.A.5.a. Social Support as Mediating Process. Online social interactions may be particularly helpful for PLWH 
smokers given that loneliness is an important driver of PLWH-smoking behavior.22 The Internet provides easy, round-
the-clock access to “expert” patients – those further ahead on the tobacco treatment trajectory – who can provide 
firsthand experience about what might happen and how things feel68 and can also provide empathic support and 
practical advice63 about such matters as coping with cravings or slips, stress, anxiety, depression, and other substance 
use,39 challenges especially common among PLWH. It transcends geography and the time constraints of traditional 
clinical scheduling to provide access to others coping with the same illness, taking the same medication, or navigating 
the same difficult behavior change. This access is especially important for PLWH who may be struggling with 
isolation and stigma related to their diagnosis.69 Forming interpersonal relationships with similar others can create 
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Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
a powerful sense of belonging, acceptance, empowerment, and comradeship, and can reduce the feelings of 
stigma.68 Whereas a partner or family members may become burned out over a period of time, the flux and 
persistence of an online community means that there is always someone available for support. The relative 
“pseudonymity”70 (disguised identity) of the Internet may also facilitate the exchange of support.71,72
   3.A.5.b. Establishing a Functional Online Social Network Prior to Evaluation is Critical. Establishing an online 
community capable of providing the support theorized to impact cessation requires time, purposeful planning, and 
careful nurturing.24-26 Simply making software available is not sufficient.73 Keys to building a successful online 
community include enabling communication tasks to be motivating and meaningful for participants; devising software, 
moderator, and community-run strategies for encouraging online participation (e.g., meeting areas for new-comers); 
making participants aware of norms and responsibilities (particularly the need to contribute as well as take); making 
the community’s purpose clear with a descriptive name and purpose statement; and facilitating the development of 
trust and empathy by allowing people to reveal themselves through stories and pictures.74 Functional online 
communities are characterized by a variety of measurable characteristics including number of posts per member, 
number of replies, latency to first reply, thread length, percentage of members posting, members active within the past 
30 days, and content popularity (e.g., ‘likes’).75-77 Legacy’s preparatory work integrating an online community prototype 
into the PSFW website and recruiting/training a critical mass of PLWH seed users to initiate and sustain community 
discussions (3.C.4.e.) will ensure the presence of a functional community in which to examine the study hypotheses.
   3.A.6. Summary of Significance. An astonishing 61.5% of deaths among PLWH are attributable to smoking-
related factors, and smoking reduces average total lifespan by 12.3 years.38 Mortality risks were almost halved in ex-
smokers.38 Extraordinary advances in virology and pharmacotherapeutics have changed the face of the HIV epidemic, 
but the science of tobacco control lags far behind. There could hardly be a more urgent cause for the PLWH 
community than the development and delivery of effective tobacco treatment strategies. Few intervention studies are 
ongoing, and centers with the expertise and resources to conduct the broad-reach, scalable intervention research 
proposed herein are rare. This study promises to establish a new model of effective treatment for PLWH smokers that 
offers broad reach at low cost, and to significantly advance the science of tobacco treatment in this vulnerable group.
3.B. INNOVATION
   Several aspects of the proposed project are innovative. 1) We are testing a new low-cost, broad-reach option for 
PLWH smokers seeking to quit. PSFW+ represents the first web-based smoking cessation program to be 
introduced into the public domain for PLWH. More than 30 years into the HIV epidemic, PLWH smokers today do not 
have ready access to a single evidence-based behavioral tobacco treatment tailored to their unique needs. If proven 
effective, PSFW+ will represent a game-changing advance offering a broad-reach, scalable treatment to PLWH 
smokers with Internet access throughout the US. This proposal assembles a uniquely qualified group of investigators 
and technical staff, and leverages years of NIH-funded formative work to translate this vision into a reality. 2) 
Programmatic content is tailored to PLWH. There is unequivocal evidence that web-based cessation interventions 
that incorporate increased message personalization and relevance are more effective than generic interventions.11,78 
PSFW session content specifically addresses the unique challenges faced by PLWH. It was developed through a 
painstaking, iterative process guided by the input of HIV-specialists, behavioral psychologists, tobacco treatment 
experts, web-developers, graphic artists, and PLWH smokers (including a Community Advisory Board). 3) A 
functional community will improve engagement and meet user expectations. [[While retaining all of the original 
content, interactivity, and graphics of the original website, PSFW+ advances the functionality and potential efficacy of 
the PSFW core intervention via the incorporation of a social network. Although the traditional approach to the 
establishment of evidence-based interventions follows a new treatment through the pilot trial->definitive trial-
>dissemination pathway, the enhancement of PSFW was carefully considered by the investigative team. It leaves the 
original intervention completely intact, adds functionality that addresses additional needs of the target population (esp. 
social support, depression, and anxiety), and optimizes state-of-the-art social networking to ensure that this program is 
innovative today and will remain technologically relevant.]] Dr. Graham and her software development team at the 
American Legacy Foundation will fully integrate social networking features into PSFW, while retaining the program’s 
fidelity to the theory-driven behavioral modeling components (esp. through observational learning and outcomes 
expectations). 4) PSFW+ is part of a suite of research-tested tobacco treatment options for PLWH. PLWH 
smokers are a heterogeneous group, and it is clear that the response to the PLWH tobacco-use epidemic cannot be 
“one-size-fits-all.” We intend PSFW+ described in this submission to be one item on a menu of smoking cessation 
treatment options for PLWH smokers. Dr. Shuter and colleagues have been funded by NCI, NIDA, and Legacy to 
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Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
develop and test a range of Positively Smoke Free (PSF) products including a self-help brochure, educational 
materials for HIV care providers, a group treatment program, and a web-based intervention (PSFW). A mobile version 
designed for smartphones (mPSF) is in the development phase. We are honored that our PSF materials received the 
official endorsement of the late C. Everett Koop, MD, former Surgeon General. We envision PSFW+ as a key 
component in a PSF treatment menu for PLWH seeking readily-accessible, proven cessation strategies.
3.C. APPROACH
   3.C.1. Prior Work. The multidisciplinary investigative team is led by Co-Principal Investigators Cassandra Stanton, 
PhD (Georgetown University; GU) and Jonathan Shuter, MD (Montefiore Medical Center; MMC, and the Albert 
Einstein College of Medicine; AECOM) who have collaborated on smoking cessation research in PLWH for the past 6 
years. Dr. Stanton is a Clinical Psychologist and leading expert in tobacco dependence treatment among PLWH. She 
has been committed to understanding and developing interventions for tobacco dependence among PLWH for over a 
decade, with continuous NIH funding to advance programs that can best reach this diverse, heterogeneous patient 
population. Dr. Shuter is an infectious diseases/HIV-specialist physician and the Director of Clinical Research in one 
of the nation’s largest HIV care centers. He has cared for his own panel of PLWH for over 25 years, and has led three 
NIH-funded tobacco treatment RCTs at his site. Co-Investigator Princy Kumar, MD (MedStar Georgetown University 
Hospital; MGUH) is the Division Chief of Infectious Disease at Georgetown University. She has developed one of the 
largest comprehensive treatment centers in DC, providing residents with multidisciplinary HIV care. She is a co-
Investigator in an ongoing trial of group tobacco treatment for PLWH smokers, and is the PI of the Georgetown 
University AIDS Clinical Trials Group unit having conducted dozens of clinical trials within the MGUH HIV Clinical 
Program. Ryung Kim, PhD (AECOM) is a Biostatistician with expertise in the design and statistical analysis of clinical 
trials and mediation models within cancer control and prevention research. Amanda Graham, PhD (American Legacy 
Foundation) is a leading expert in the development and evaluation of web-based cessation interventions and online 
social networks for cessation. She is PI of a randomized trial (R01CA155489-01A1) focused on improving adherence 
to a web-based cessation program that informs the current proposal. The Legacy software development team has 
expertise in a broad range of software applications and was solely responsible for the modernization of the original 
PSFW project and integration of the community platform. [[Clyde Schechter, MD (AECOM), is a recognized expert in 
health economics. He is working with Dr. Shuter in an ongoing trial of live group tobacco treatment and will assist the 
team in the estimation of incremental cost per quit associated with the PSFW+ intervention.]] The team and their 
respective organizations have an extensive history of productive collaboration and relevant experience. All 
investigators are NIH-funded clinical scientists with pooled expertise in HIV patient care, tobacco dependence 
treatment, clinical trials, web-based smoking cessation interventions, online social networks, and biostatistics. 
Relevant work that demonstrates their ability to achieve the aims of the study and pilot data on which the design and 
mediation models are built are summarized below.
   3.C.1.a. Smoking cessation treatment challenges and social support needs among PLWH smokers. In a 
study of 444 US PLWH,79 Stanton and colleagues reported high levels of nicotine dependence, elevated risk for 
depression, poor quality of life, and diminished social support; these findings are consistent with other studies among 
PLWH.6,39,79,80 In a separate study focused on Latino PLWH smokers, Stanton et al.81 found that heavy smoking was 
associated with low self-efficacy to quit, high nicotine dependence, high levels of depression, and low quality of life. In 
the MMC Infectious Diseases (ID) clinic, Dr. Shuter conducted in-depth interviews to explore numerous domains of 
smoking behavior among PLWH.39 Key findings included:  1) 56% desired formal cessation treatment, 2) 75% had a 
history of depression, 3) 63% had a history of anxiety disorder; 4) 67% stated that smoking helped them cope with 
depression, anxiety, and/or anger, 5) 27% thought that smoking helped them fight infections and/or increased their 
CD4+ counts, 6) 33% reported at least moderate distress due to loneliness (8% moderately, 12% very, and 13% 
extremely lonely), and 7) 38% reported using cigarettes as a means of increasing social interaction. These results 
highlighted the unique needs of PLWH smokers and guided the initial development of the PSF program. [[The 
prevalence of depression and anxiety strongly influences the content of all PSF programs, and these key parameters 
are evaluated as moderators of intervention effects in our clinical trials.]] The prevalence of loneliness and use of 
cigarettes for social interaction suggest that PLWH may benefit from the support of an online community.
   3.C.1.b. Smoking Cessation Trials among PLWH. Dr. Stanton co-authored the results of the first full-scale NIH-
funded clinical trial (R01DA12344-06) for smoking cessation among PLWH (N=444). This study compared a 
motivational enhancement intervention to brief advice. All participants were provided NRT. Using intent-to-treat 
analyses, 7-day ppa rates ranged from 9-12% at the 2, 4, and 6 month time-points with no differences between 
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Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
groups.23 Subsequent analyses led by Dr. Stanton identified key elements across interventions that mediated 
successful abstinence in the overall sample.33 At 6 months, abstinence rates improved significantly with increases in 
psychosocial factors (i.e., changes in self-efficacy); these mediators eliminated the association of NRT use with 
smoking abstinence, meeting criteria for complete mediation.33 A more recently funded R01 across 9 clinics in the 
Northeast tested a culturally tailored cessation intervention for Latinos living with HIV/AIDS (5R01DA018079; PI, 
Stanton; Co-I, Shuter) that yielded similar 7-day ppa rates (8-11% at 6 months; 6-7% at 12 months). However, 
significant reductions in cigarettes consumed per day were reported.32 Latino smokers born outside the US were 
significantly more likely to be abstinent at 6 months compared to those born in the US, who tended to be daily heavy 
smokers with a preference for mentholated cigarettes.81,82 
   3.C.1.c. Efficacy of the PSF clinic-based cessation intervention among PLWH (R21DA023362; PI, Shuter). 
This RCT tested a clinic-based, group intervention (PSF) for PLWH smokers in comparison to standard care (SC).21 
Both conditions included nicotine replacement therapy (NRT). 147 subjects were recruited over 12 months in 2009-
2010. Recruitment goals were met, and 96% completed the study. At 3 months, biochemically confirmed 7-day ppa 
was 19.2% in PSF vs. 9.7% in SC. Higher loneliness score was an independent predictor of treatment failure. 
Session attendance was a challenge, with mean attendance of 4 of 8 sessions. Abstinence rates were significantly 
higher among those who completed ≥7 sessions (42.9%). Reasons for non-attendance included difficulty traveling to 
group sessions, feeling sick, conflicts with other appointments, problems at home, forgetting about sessions, and lack 
of interest. Many of these challenges would have been mitigated by Internet access to cessation treatment.
   3.C.1.d. Technology access and use among PLWH. In 2009, an Internet use survey administered to 208 PLWH 
in the MMC ID Clinic46 reported 56% and 51% of participants had home access to computer and Internet, 
respectively. In 2010-2011, a clinic survey among 492 PLWH reported 66% had home access to the Internet.47 As part 
of our PSFW R21 feasibility study (3.C.1.e.) conducted from 2012-2013, of the 178 participants who were referred and 
screened in the MMC ID Clinic, 97% reported daily home access to the Internet. Among those who participated in the 
pilot trial, 70% endorsed looking for health or medical information on the Internet, 79% visited a social networking site 
(e.g., Facebook), 49% looked on the Internet for information or support for people living with HIV, and 81% had 
access to the Internet on their cellphone. Participants in the pilot trial were given a choice to receive text message 
reminders about coming back to the program in addition to reminder calls and 74% elected to receive texts. 
Participants were asked what features of a web-based program they thought would be most helpful: 87% reported 
that a chat room or social networking on the site with other smokers trying to quit would be helpful, 83% 
thought text message reminders about program content would be helpful, and 94% reported phone calls and emails 
would be helpful reminders to revisit the site. These data strongly dispute the presence of a “digital divide.” Our 
racial/ethnic minority, low SES sample was eager to use a web-based resource to quit, had consistent access to the 
Internet, and overwhelmingly endorsed the idea of an online community within the program.
   3.C.1.e. Efficacy of Positively Smoke Free on the Web among PLWH smokers (Shuter/Stanton MPIs, 
R21CA163100-01). This recently published14 NCI-funded pilot RCT tested a static web-based intervention (PSFW) 
derived from the content of PSF (3.C.1.c.) compared to SC.14 138 subjects were accrued over 13 months (100% of 
target) and 97% completed the study. At 3 months, biochemically confirmed 7-day ppa was 10.1% among PSFW 
subjects vs. 4.3% of SC. Of the 8 program sessions, mean number completed was 5.5 sessions, and 40% logged into 
all 8 sessions (compared to 7% who attended all 8 of the in-person group sessions of the PSF program). 18% of 
those who logged into all 8 sessions and 31% of the women who completed all 8 sessions were abstinent at 3 
months. This promising success rate for women highlights the importance of examining subgroup differences in 
engagement and efficacy as outlined in our exploratory aim. The adherence protocol was critical: all participants 
received email reminders to return to the website, and over 94% required at least one reminder phone call from study 
staff who monitored website utilization throughout the study. Over 78% of participants surveyed post-intervention 
indicated that the PSFW experience was positive in terms of being helpful, meeting expectations, leading to user 
satisfaction, and being personally relevant; 95.2% indicated that they would recommend PSFW to family or friends 
who were interested in quitting. In sum, these results demonstrate Internet access (97%), study feasibility (recruited 
100% target on-time), adherence (almost half completed all 8 sessions with mean of 5.5 sessions), efficacy (3 month 
abstinence was 2.3 times higher in PSFW compared to SC), and satisfaction (95% would refer a friend).   
   3.C.1.f. Loneliness as central challenge for PLWH smokers.22 Post-hoc analyses were performed on a 
combined sample (N=272) from the two R21 (PSF & PSFW) trials listed above to explore loneliness in PLWH 
smokers22: 63% scored above normal range on a validated loneliness scale,83 and 19% met criteria for extreme 
IRB NUMBER: 2015-4723
IRB APPROVAL DATE: 11/12/2021

Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
loneliness. Loneliness was associated with lack of a life partner, alcohol use, depression, anxiety, and lower 
educational level. Those who were abstinent at 3 months had lower loneliness scores at baseline than those still 
smoking (P=0.09). Loneliness decreased significantly over time among those in the live, group therapy condition, but 
no changes in loneliness were observed among those in the static PSFW intervention. [[These findings suggest 
that the static website failed to reach its full potential due to the absence of a social component, and they 
provide further justification for the enhancements that we propose in this submission.]]
   3.C.1.g. PSFW+. [[In early 2014, Legacy’s software development team adapted the original code base from PSFW 
(3.C.1.e.) and updated it to accommodate security enhancements, feature additions, and a legally-reviewed privacy 
statement. Online community capabilities were integrated using Vanilla Forums, an open source platform. Integration 
of this component included adding navigation links to and from the community from the static content, and enabling 
single sign-on for a seamless transition between the community and static content. We also “skinned” the Vanilla 
Forums community to maintain the same look and feel as PSFW in order to complete its integration into the 
intervention. “Seed users” are critical to launching an online community: they create content and respond to posts by 
others to circumvent the “empty room” phenomenon which is the downfall of many communities.25,27 In addition, their 
attitudes and actions set an example for new members to follow and begin to establish community roles and norms.26 
Both current and former smokers with regular Internet access were recruited to serve as seed users. In the summer of 
2014, a diverse group of 11 PLWH (8 men, 6 African American, 5 Latino) recruited from the MMC ID Clinic  completed 
an orientation to the PSFW+ site and began actively participating in the nascent community. We piloted PSFW+ to 
gain experience recruiting and training a quorum of seed users and testing the functionality of the community 
prototype. All users in this pilot visited the site and posted regularly, and numerous online discussions ensued 
pertaining to smoking and quitting among PLWH. If funded, the team will begin the study with this core software 
infrastructure to support the online community, a successful recruitment and training protocol, and a complement of  
seed users already trained and known to Legacy.]] Expansion of community functions, recruitment of additional seed 
users, and promotion of the website are planned as part of a comprehensive strategy during the start-up phase to 
ensure a functional community by trial launch. [[To ensure the ongoing growth and vibrancy of the social network, we 
have allocated significant funding throughout the grant ($14K/year) to support the efforts of a critical mass of seed 
users.]]
   Summary of Prior Work: These preliminary studies demonstrate the ability of the investigative team to 
recruit and retain subjects from a large population of PLWH smokers; conduct prospective, real-world, web-
based smoking cessation trials; adapt and optimize traditional interventions to modern, innovative 
technology-based platforms; and participate in intra- and extra-institutional collaborations to accomplish 
project goals.
   3.C.2. Overall Strategy. This is a randomized, controlled trial that will test the efficacy of PSFW+ compared to an 
attention-matched control in achieving 7-day ppa at 6 months post-randomization in a cohort of PLWH smokers 
(N=550). Assessments will occur at baseline, 1-, 3-, and 6-months post-randomization with biochemically-confirmed, 
7-day ppa at 6 months as the primary outcome (Figure 1). Secondary outcomes include quit attempts, smoking rate, 
changes in motivation, other metrics of abstinence (e.g., 30-day ppa), and estimated incremental cost per quit. All 
participants will be offered a full course of NRT and its use will 
be monitored at each assessment. 
   3.C.3. Design Considerations
   In web-based clinical trials, selection of a suitable control 
condition is a complex design issue that has both pragmatic 
and ethical dimensions.84 [[After careful consideration and in 
response to prior reviews, we have concluded that 
comparison of PSFW+ to an attention-placebo will allow us to 
demonstrate scientifically persuasive results within the 
framework of a fully-powered efficacy trial conducted against 
the backdrop of an urgent public health need. RCTs 
comparing 
web-based 
tobacco 
treatments 
(in 
other 
populations) 
to 
attention 
placebos 
maximize 
the 
demonstrated effect sizes of the experimental interventions 
according to one meta-analysis.85 Using a general health-promotion website as an attention control is a standard 
approach to study design in targeted web-health trials.86,87 We selected the AHA Getting Healthy program for 2 
IRB NUMBER: 2015-4723
IRB APPROVAL DATE: 11/12/2021

Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
primary reasons: 1) it contains subject material of relevance to our largely middle-aged population of smokers with at 
least one cardiac risk factor (i.e. tobacco use) who will participate in the trial; and 2) it consists of a similar number of 
modules (seven) to PSFW+, and although one module addresses tobacco use, this is not a central theme of the site 
(we will assess the use of the module and control for it in analyses).]]
   3.C.4. Methodology
   3.C.4.a. Study Setting. The study will be conducted at two sites: Montefiore Medical Center (MMC) in New York, 
and MedStar Georgetown University Hospital (MGUH) in Washington, DC. MMC is the main teaching hospital for the 
Albert Einstein College of Medicine. The MMC Infectious Diseases (ID) Clinic in the Bronx, NY provides care to over 
3000 PLWH, making it the largest individual HIV care site in New York. MMC also has 10 Comprehensive Health 
Care Center (CHCC) sites throughout the Bronx that provide HIV care to approximately 850 additional PLWH. MMC is 
a leader in the field of tobacco use in PLWH, having published some of the earliest work on the relationship between 
smoking, HAART non-adherence,88,89 and inferior virologic outcomes,90 as well as one of the most detailed views of 
the sociobehavioral profiles of PLWH smokers.39 MMC has participated in four NIH-funded tobacco treatment trials for 
PLWH and has distinguished itself in the areas of recruitment and retention (3.C.1.c. and 3.C.1.e.). The three trials 
that have been completed to date met accrual targets on-time and on-budget with an overall loss to follow-up of <5%. 
The MedStar Georgetown University Hospital (MGUH) HIV Clinical Program is one of the largest providers of 
comprehensive HIV care in Washington, DC, the city with the highest HIV prevalence in the nation. MGUH provides 
comprehensive HIV care to approximately 1200 PLWH, of whom 30% are women and 65% are African American. 
MGUH has a long track record of participation in multiple large clinical trials including the AIDS Clinical Trials Group, 
the Women's Interagency HIV Study, and the HIV Prevention Trials Network. All patients benefit from the medical 
home created within MGUH with access to a social worker, adherence specialist, nutritionist, and case manager.  
Patient retention within the clinic is 95% and the retention rate across various clinical trials has exceeded 95%.
   Conducting the trial at these two clinical sites strengthens the proposal in several ways: 1) it expands the overall 
PLWH recruitment pool; 2) it increases the geographic and racial/ethnic diversity of the study sample since the Bronx 
site is predominantly Latino, and the DC site is predominantly African American; 3) it adds the considerable expertise 
of physicians at each site as co-investigators; and 4) it leverages the affiliation that Georgetown has with the American 
Legacy Foundation. Both MMC and MGUH have active Consumer Advisory Boards (CABs) who represent the needs 
of clinic patients in routine care and in research.
   3.C.4.b. Subjects. We will recruit N=550 adult PLWH smokers. Inclusion criteria are: 1) age 18 or older; 2) current 
smoking as defined by a validated tobacco use measure;91 3) laboratory confirmed HIV-infection; 4) receipt of care at 
either MMC or MGUH study site; 5) English language fluency [[(a language criterion was established given concerns 
regarding the ability to maintain a Spanish language online community and the necessarily different online experience 
that a second language would engender. Less than 10% of the Latino population of the MMC ID Clinic is monolingual 
Spanish-speaking)]]; 6) motivation to quit within the next 30 days; 7) at least weekly Internet and email access;92 and 
8) REALM literacy score of 19/66 or above, indicating reading level of at least 4-6 grade61 (PSFW content was written 
for this literacy level). Exclusion criteria are: 1) previous participation in any trial of Positively Smoke Free 
interventions or use of PSFW+; 2) pregnancy; 3) contraindication to NRT; and 4) current participation in other 
cessation treatments. PSFW+ seed users will be excluded. To avoid study condition contamination and to maintain 
the statistical independence of outcomes, otherwise eligible individuals who are spouses, partners, and/or roommates 
of study participants will be excluded. All ineligible patients will receive a Positively Smoke Free smoking cessation 
brochure and will be encouraged to access nationally-available (free) quitline counseling.
   3.C.4.c. Recruitment Approach. Participants will be referred by primary care providers at the MMC ID Clinic and 
the MGUH ID Clinic. Approximately 65% of MMC ID Clinic patients are smokers representing a pool of 1950 
smokers; the MGUH ID Clinic serves an estimated 1200 patients/year, representing a pool of 780 estimated 
smokers. These are underestimates since over 500 new PLWH patients enter these care systems annually. 
Recruitment into the trial will begin in the 4th quarter of Year 1 and will continue for 38 months. Across all sites, we aim 
to enroll 14.5 subjects/month (7-8/month MGUH; 6-7/month MMC [the lower recruitment target at MMC is in 
consideration of a concurrent RCT at that site]). Study staff will be on-site full-time at each location throughout the 
project to enroll participants who are referred by their primary care providers. In our previous PSFW R21 study 
(3.C.1.e.), conducted at a single site, we recruited N=138 smokers over 13 months (10.6 per month) using the same 
primary care provider referral strategy. Thus, our target of N=550 over 38 months (14.5/month) should be attainable. 
In the event we do not meet accrual goals, research staff will directly recruit patients in clinic waiting areas. 
IRB NUMBER: 2015-4723
IRB APPROVAL DATE: 11/12/2021

Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
Table 1. An overview of Positively Smoke Free on the Web (PSFW) and Getting Healthy content.
Positively Smoke Free
Getting Healthy
Week
General Themes
HIV-Referent Themes
Module Title
1
Education about tobacco use
Role of social and buddy support
Setting quit date
Tobacco related risks in PLWH
Myths about smoking benefits for PLWH
Nutrition Center
2
Social cues of smoking and coping 
strategies
Behavioral tools to resist craving
Role of pharmacotherapy
Self-discipline, instant gratification, and 
improved health outcomes for  PLWH
Stress Management
3
Cessation as an element of a healthy 
lifestyle
Healthy lifestyle decisions in PLWH
Physical Activity
4
High risk situations
Coping with slip-ups
Comparison to high risk situations pertaining to 
HIV
Comparison of tobacco slip-ups to HAART 
slip-ups
Healthier Kids
5
Quit Day: pharmacotherapy, social 
support, coping w high risk situations 
and slips
Quit day compared to start of HAART day
Enduring temporary discomfort for the sake of 
long-term health
Weight Management
5.5
Coping with urges to smoke
Assertiveness training
Urges to skip HIV-medications or 
appointments
Assertiveness in HIV-care
6
Thoughts that lead to relapse
Maintaining abstinence
HIV, pain, tobacco use, and smoking 
cessation
Quit Smoking
7
Long-term health benefits of 
cessation
Planning for long-term abstinence
Abstinence as a major element of long-term 
health in PLWH
HIV as a chronic disease
Workplace Wellness
   3.C.4.d. Study Enrollment and Randomization. Following referral from primary care providers, research staff will 
conduct eligibility screening and informed consent. Consented participants will be randomized to one of the two study 
conditions. Based on predictors of smoking behaviors that emerged in our prior work,21,23 randomization will be 
stratified 
by 
gender 
and 
education 
level 
within 
each 
clinic. 
An 
online 
random 
plan 
generator 
(http://www.randomization.com) will be used to create an allocation schedule. The schedule will be fully documented 
with the reference citation of the pseudo-random number generator, the seed used to start the generation process, the 
number of study conditions (2), the allocation ratio (1:1), and a copy of the assignment list.
   3.C.4.e. Interventions. All subjects will be offered a 3-month supply of NRT at the enrollment visit. Subjects will
be provided an actual supply of nicotine patches or a prescription which can be filled on site (for subjects with 
insurance coverage). We will encourage study-provided patch use only during the trial.
   [Control Condition: American Heart Association Getting Healthy web-program 
   Getting Healthy is a 7-module website with interactive features aimed at reducing cardiovascular risk through 
healthier lifestyle choices. Modules are: Nutrition Center, Physical Activity, Healthier Kids, Weight Management, 
Stress Management, Quit Smoking, and Workplace Wellness. Each of the modules has a separate URL. Participants 
can sign up for a monthly e-newsletter. Getting Healthy does not have its own dedicated online community.  We will e-
mail a link to a new module weekly in order to parallel the seven weeks of PSFW+ sessions, and will send two email 
reminders and one text (if the subject agrees to receive text messages) weekly to prompt users to visit the module, as 
well as a reminder phone call after 10 days of non-use to parallel the adherence protocol in the PSFW+ condition. We 
estimate that each module will take an average reader 15-30 minutes to complete which corresponds closely to the 
time requirement for PSFW+ written content. Legacy will create a “portal page” that will require control participants to 
log in, generating data regarding website use. At the time of enrollment, the research assistant will introduce the 
participant to the portal page. Following entry of a unique username and password that will be assigned during 
enrollment, participants will be routed to the Getting Healthy module of the week. This approach  will optimize attention 
matching and will also allow the team to collect basic Getting Healthy utilization metrics.]]
   PSFW+: Positively Smoke Free on the Web plus Online Social Network PSFW+ participants will be registered 
on the website by the research assistants following randomization. Each participant’s unique Study ID will be tied to 
his/her website registration to enable linkage of website utilization metrics with other data collected during the trial. 
Registration involves creating a username and password, entering an email address, and a mobile phone number (if 
available). The participant will receive a confirmation email following registration that contains a link to the site and 
instructions to bookmark it in his/her Internet browser for easy access.
   PSFW+ Core content: An overview of PSFW content is in Table 1. With input from PLWH smokers, HIV 
specialists, psychologists, graphic artists, and software engineers, we distilled the content of the PSF social-behavioral 
group counseling curriculum21 into a web intervention. The course content has gone through multiple rounds of 
revision based on input from 
PLWH smokers, experts in 
HIV and smoking cessation, 
the MMC ID Clinic CAB, 
multiple pilot trials and usability 
testing. Themes of relevance 
to PLWH smokers permeate 
the content. The heterogeneity 
of the PLWH community and 
how this relates to smoking 
behaviors (i.e., similarities and 
differences 
between 
drug 
users, LGBT, and depressed 
individuals) 
is 
highlighted. 
“Microtargeting” of subsets of 
PLWH 
(e.g., 
LGBT) 
has 
consistently 
received 
the 
praise of participants in our 
pilot work. Consistent with 
IRB NUMBER: 2015-4723
IRB APPROVAL DATE: 11/12/2021

Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
Social Cognitive Theory,93 content focuses on providing information, increasing motivation to quit, and increasing self-
efficacy to resist smoking temptations (Table 2) via presentation of objective data as well as hypothetical “real world” 
scenarios of particular relevance to PLWH smokers. Users are given tools and options to cope with smoking urges. 
NRT use is encouraged. Online social network: The PSFW+ community runs on open source forum software by 
Vanilla Forums. We created a full-featured discussion forum with unlimited categories and user profiles that is 
customized to look like the main site. Vanilla Forums enables single sign-on for a seamless experience between the 
static content and online community. PSFW+ users can create a user profile with a unique avatar or personal photo, 
and can create a profile “wall” on which other users may post comments, images, or video. The primary interface is a 
feed of discussion threads: users create discussions or polls, and other users may post comments to the discussion or 
answer the poll. Users can also exchange private messages. The PSFW+ Community Guidelines emphasize the 
importance of creating and maintaining a safe environment for people to exchange information and support. The 
guidelines also remind users that all content posted in the community is publicly available, and that the administrator 
may remove messages that are spam or solicitations. Users who persistently violate Community Guidelines will have 
their community profile removed from the site. Our experience with several online communities with thousands of 
users is that these occurrences are infrequent; should they occur during the study period, we will account for this in 
our analyses. Involvement of an experienced administrator is integral to managing these situations proactively to 
ensure the smooth operation and success of an online community,24,94 especially during its nascent phase. The 
PSFW+ Community Administrator will monitor all public discussions and comments on the community, encourage 
interactions between community members, review all reports of inappropriate content that do not follow the 
Community Guidelines (such as spam), and serve as the main liaison between technical staff and community 
members for any technical issues. The PSFW+ Terms of Use and Privacy Policy make explicit that all content 
posted in the community is publicly available information and users are legally responsible for any content they post 
on the site. The registration page states “By clicking Submit, I agree to the Positively Smoke Free Terms of Use and 
Privacy Policy” (available via hyperlink). The treatment of the unique privacy concerns of a PLWH online community 
and its attendant legal implications have been carefully considered and are discussed in detail in the Human Subjects 
section. 
   A critical mass of 10 or more seed users will be retained on contract to ensure that active dialogue within the 
community is maintained. Seed users will be responsible for posting daily on at least 15 days a month, starting new 
discussions, and responding to posts in existing ones. As PSFW+ enters the public domain, we will promote the site 
nationally to PLWH smokers through posts on a variety of HIV/AIDS social support groups and related non-profits on 
social networking sites, and outreach to a national health communications listserv.
   PSFW+ Adherence Strategies: Intervention adherence is critical to maximizing the efficacy of Internet cessation 
interventions. Poor adherence to eHealth interventions has been documented across health behaviors, websites, and 
study populations.78,95-115 Our outcome findings in the PSFW pilot (3.C.1.e.) substantiate the importance of adherence 
in achieving abstinence. Building on Dr. Graham’s extensive experience in this area116 we will implement intensive, 
multicomponent strategies to maximize adherence to PSFW+ and examine website utilization as a predictor of 
abstinence. Our approach mimics a face-to-face treatment paradigm in which participants are given feedback about 
their treatment progress, reminded about intervention features/content they have not yet accessed, and encouraged 
to remain engaged in treatment. This kind of “dialogue support” (e.g., reminders, suggestions, praise) is one of the 
strongest predictors of website adherence.117 Building on evidence that supports the effectiveness of email109,118,119 
and text messages120-128 in improving treatment adherence, we will develop automated, personalized prompts and 
reminders that are tailored real-time to an individual user’s interaction with PSFW+. [[Similar to the control condition, 
users will be encouraged to login to a new session approximately once per week (twice during quit week), and 
reminder emails and texts will reinforce this schedule. They will be permitted to access the online community ad 
libitum.]] Email messages will be delivered after 7 consecutive days of site non-use; a text message will also be sent if 
the email does not precipitate a return visit to the site within 2 days. As in our PSFW R21, clinic staff will contact 
participants by phone after a period of 10 days of non-use. For participants who remain active on the site, weekly 
email and text messages will encourage ongoing use of all features on the site, including community participation for 
up to 8 weeks. Participants can reply STOP to the text messages at any time. We will track all adherence-promoting 
activities for analyses.
   3.C.5. Data Collection and Measures
IRB NUMBER: 2015-4723
IRB APPROVAL DATE: 11/12/2021

Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
   Assessments 
will 
be 
conducted 
via 
in-person 
interviews 
with 
biologic 
samples (exhaled carbon 
monoxide) in the respective 
clinic at baseline, 1, 3, and 6 
months post-randomization. 
Self-report measures will be 
administered 
via 
Audio 
Computer-Assisted 
Self-
Interview (ACASI). Study 
staff will assist with the 
ACASI interface as needed. 
Study measures described 
below 
are 
standard 
instruments commonly used 
in 
cessation 
treatment 
studies. If participants are 
unable to come to the 
centers to complete the 
ACASI, 
they 
may 
be 
completed 
over 
the 
telephone 
with 
the 
assistance of study staff. 
The 
relationship 
of 
the 
selected measures to the intervention’s behavioral model is summarized in Table 2. 
Tobacco Use (Aim 1 measures): Self-reported 7-day ppa will be measured at each follow-up and biochemically 
verified by exhaled carbon monoxide (ECO) at each study visit. Staff will be trained in the use, maintenance, and 
calibration of the Bedfont piCO+ Smokerlyzer. An ECO measurement of <10 ppm will be considered abstinent and of 
≥10 ppm non-abstinent.23 Discordant self-report and ECO data because of marijuana effects on ECO will be clarified 
with saliva cotinine strips.129 Secondary outcomes include standardized items from the CDC Question Inventory on 
Tobacco (CDC-QIT)91 including number of quit attempts, continuous abstinence, and 30-day ppa. Daily cigarette and 
other tobacco consumption and age at initiation will be assessed. Nicotine addiction will be measured with the 
Fagerström Tolerance Questionnaire,130 and the Contemplation Ladder will measure readiness to quit.131
Proposed Mediators (Aim 2 measures): Perceived social support will be measured with the Multidimensional 
Scale of Perceived Social Support to assess perceived general support arising from family, friends, and significant 
others.80,132,133 Smoking-specific social support will be measured with an adapted version of the Partner Interaction 
Questionnaire.19 The UCLA Loneliness Scale83 will measure subjective feelings of loneliness or social isolation. Dr. 
Graham’s Online Social Support Scale for Smokers (OS4)134 – will be adapted to assess dimensions of perceived 
support from the PSFW+ online community. 
Potential Moderators and Mediators (Exploratory Aim): Potential moderators include demographic variables 
(age, gender, race, ethnicity), clinical variables (e.g. HIV risk behavior, most recent CD4+ and viral load, histories of 
cardiovascular, pulmonary, neoplastic disease, and substance use assessed with the NIH/NIAID Baseline Substance 
Use Self-Report),135 depression (Center for Epidemiologic Studies Depression Scale),136 and anxiety (State-Trait 
Anxiety Scale).137 Potential mediators include: 1) tobacco knowledge measured using standardized items from the 
Adult Use of Tobacco Survey;91 2) self-efficacy measured with the Self-Efficacy/Temptation Scale;138 3) Smoking 
Decisional Balance (Short Form);139 4) risks and benefits of smoking measured with the Perceived Risks/Benefits 
Questionnaire,140 modified to include HIV-referent questions (e.g. “Does smoking raise/lower your CD4+ count?”); 5) 
PSFW+ and attention-placebo utilization metrics as described in the next section; and 6) use of NRT and other quit 
methods. NRT use will be assessed with the 4-item Morisky Scale;141 side effects,142 dosage, duration of use, pattern 
of use (“on and off” vs. “everyday”), and continued smoking while using NRT will be assessed. 
IRB NUMBER: 2015-4723
IRB APPROVAL DATE: 11/12/2021

Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
Additional Control and Evaluation Measures: Other treatment exposure: Using standard assessment items 
administered in previous trials,143 we will assess use of other cessation treatments including alternative smoking 
cessation websites, non-study NRT, prescription medications (e.g.varenicline), behavioral treatments (pamphlet/book, 
live and/or telephone counseling), and alternative quit methods (e.g., acupuncture, hypnosis). Individuals who report 
use of cessation websites will be asked to identify each specific website and the number of visits. [[Information about 
membership in any other health-promoting or tobacco treatment online communities will be collected from all 
subjects.]] Treatment Satisfaction Questionnaire: PSFW+ participants will be asked the number of times they 
visited the website, the approximate length of each visit, and ratings of overall satisfaction and perceived helpfulness 
of the site. Participants who report that they did not visit the website will be asked for specific reasons for non-use 
(e.g., lost Internet access, lack of interest, etc.). Similar questions will be asked regarding the Getting Healthy website. 
Additional questions will address knowledge of and familiarity with PSFW+ and Getting Healthy; these questions will 
be designed to detect potential study contamination. PSFW+ Utilization Metrics: We will extract the following 
utilization variables: date/time of registration, # site visits, date/time of each visit, # page views, date/time of each page 
view, # page views per session, # interactive component clicks, changes to personal profile (e.g., email, username), 
whether the user signed up for text messages, # text messages sent, and # emails sent to participant from the 
system. We will also extract the following variables from the Vanilla Forums database specific to community utilization: 
# clicks through to the community from PSFW+ content pages, # direct visits to the community, # discussion posts, # 
comments, # private messages sent/received, # wall posts made/received, and whether or not they customized their 
profile (e.g., photo). Getting Healthy utilization metrics will rely on data collected from the portal page (3.C.4.e.) and 
subjects’ historical recall. At the end of Visit 2, we will administer the 18-item Sense of Virtual Community scale to  
PSFW+ participants.
[[In order to calculate the incremental cost per quit, we will compile the costs of website hosting and maintenance, 
payments to the community administrator and seed users, staff support required to make reminder phone calls, and 
receipts for nicotine patches. Research costs and development costs for PSFW+ and the portal page for the Control 
condition will not be included.]]
3.C.6. Data Analysis Plan and Sample Size Calculations
   3.C.6.a. Preliminary Analyses. We will calculate descriptive statistics and perform bivariate analyses using t-tests 
(or nonparametric tests if needed), Chi Square tests (or Fisher’s exact tests if needed), and Pearson (or Spearman) 
correlation coefficients to evaluate relationships among baseline measures (e.g., demographic characteristics), 
mediating variables (e.g., perceived social support) and outcome measures (7-day ppa). Due to randomization, we 
expect the two treatment groups to be balanced with respect to the baseline measures. However, baseline measures 
identified in bivariate analyses as statistically significantly (at the 0.05 level) associated with the outcome measures will 
be included in the corresponding regression models as covariates to increase statistical power.
   3.C.6.b. Specific Aim 1: Outcome Analyses. The primary outcome is 7-day ppa at 6-months.144 The primary study 
analyses will adopt an intent-to-treat (ITT) strategy; secondary complete-case, as-treated analyses, and analyses that 
evaluate the role of treatment intensity (i.e., “dose”) will also be conducted. In ITT analyses, the association between 
treatment group and 7-day ppa at 6-months will be evaluated using a logistic regression model that will have 
abstinence as the binary outcome, treatment groups as the main predictor, and covariates identified in preliminary 
bivariate analyses. Subjects who fail to return for the 6-month visit, decline ECO testing, or have discrepant 
abstinence and ECO results (that cannot be clarified with saliva cotinine strips) will be considered non-abstinent. This 
is a standard primary outcome when measuring the efficacy of a smoking cessation intervention in a definitive 
trial.21,144 It will be defined as a negative response to the validated question Have you smoked cigarettes (even a puff) 
in the last 7 days, including today?91 combined with an ECO level <10 ppm (or negative salivary cotinine when 
applicable).23 Additional measures of abstinence or tobacco usage reduction will be similarly examined for association 
with treatment group in secondary analyses.91 Abstinence data will be collected at 1 and 3 months to assess the 
correlation between time points. [[A formal cost-effectiveness analysis that includes detailed accounting of effects on 
health-care utilization over time is beyond the scope of the project. However, we will calculate incremental cost per 
quit using our abstinence data and the economic metrics listed in 3.C.5. This is a standard cost-effectiveness metric 
for tobacco treatments,145 and it will be calculated with bootstrap 95% confidence intervals to provide a starting point 
for discussions about the cost-economics of tobacco treatment in this population. This outcome is bound to 
overestimate the ultimate cost of a widely-disseminated intervention, because web-based programs of this sort are 
scalable at low expense.]] 
IRB NUMBER: 2015-4723
IRB APPROVAL DATE: 11/12/2021

Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
   Missing data. We expect less than 10% missing data at any time. Under an intention-to-treat approach, participants 
who had been considered non-smokers up to the point of losing contact will be considered relapsers at future data 
points. Multiple imputation methods146 will be used to deal with missing data, assuming a missing at random (MAR) 
mechanism; we will generate 10 multiple imputed datasets, analyze each dataset separately, and then combine the 
results across the 10 datasets using Rubin’s method.
   3.C.6.c. Specific Aim 2: Mediator Analyses. Aim 2 hypothesizes that greater social support mediates the 
intervention-cessation relationship. Figure 3 depicts our mediational model: 
X represents treatment group, Z represents the hypothesized mediator (e.g., 
perceived social support), Y represents outcome (7-day ppa), a is the 
regression path between treatment group and mediator, b is the regression 
path between mediator and outcome, and c’ is the regression path between 
treatment group and outcome controlling for the effect of the mediator. The 
3-month assessment will be used for mediator Z and the 6-month measure 
of 7-day ppa will be used as the primary binary outcome Y. To increase 
statistical power of our mediation analysis we will use the product of 
coefficients method.147 We will estimate the coefficient a by fitting a linear 
regression model with the putative mediator as the continuous outcome, 
treatment arm as the main predictor, and covariates identified in bivariate 
analyses as being associated with social support. We will estimate the 
coefficient b by using a logistic regression model with abstinence as the 
binary outcome, Z as the main predictor, and covariates identified in 
bivariate analyses as being associated with abstinence. We will then 
calculate the mediated effect as the corresponding product of these 
coefficients with standard error and 95% confidence interval estimated according to MacKinnon.148 Since the sampling 
distribution of this product shows considerable skewness and kurtosis, interval estimation will be based upon bias-
corrected and accelerated (BCA) bootstrap confidence intervals.149 Potential mediators in Figure 1 will be analyzed 
separately, and additional analyses will be conducted to evaluate interaction effects.
   3.C.6.d. Exploratory Aim: Moderator Analyses. We will examine potential moderators of the intervention-smoking 
cessation relationship (e.g., demographics, depression, anxiety). Effect modification analyses will be conducted by 
testing interaction terms between treatment group and selected variables. Interaction terms will be added to variables 
already in the regression models (3.C.6.b.). Subsequent stratified analyses will be performed to explore specific 
moderation effects.  Mediator Analyses. Exploratory mediation analyses will follow the approach in 3.C.6.c.
   [[3.C.6.e. Sample Size Considerations: Aim 1. Using the mean abstinence rates in the SC arms in our two recent 
R21 trials (9.7%21 and 4.3%14), and up-adjusting the rate slightly in consideration of the attention-placebo, we estimate 
a 7-day ppa at 6 months in the control condition will be 7.5%. Our estimate of the efficacy of PSFW+ is based on 
research by our team20 and others62 who have demonstrated that visits to an online community increase abstinence 
rates. In the BecomeAnEX outcome evaluation,20 7-day ppa at 6 months ranged from 11.1% (ITT) to 20.7% 
(responder only); individuals who visited the online community two or more times were more than twice as likely to be 
abstinent than those who never visited (OR=2.22, 95% CI 1.34-3.69, P=.002) controlling for a broad range of 
demographic, smoking, and psychosocial covariates. These results are consistent with An et al.62 who reported a near 
doubling of abstinence rates (OR=1.91) among individuals who used individual messaging in an online cessation 
program. The benefits of an online community are not simply for the minority who actively post; reading 
communications (“lurking”) also has beneficial effects.150,151 Therefore, we estimate that PSFW+ combined with our 
intensive adherence strategies to promote engagement and utilization will increase abstinence rates by 2.05 times 
over control, yielding a 6-month quit rate of 15.4%. This estimate is deliberately conservative in that we have chosen 
to use as the base rate our estimate of control (7.5%) rather than the quit rate from our previous trial of PSFW 
(10.1%). This will ensure that we are adequately powered to detect treatment group differences between PSFW+ and 
control. Assuming abstinence rates of 15.4% and 7.5% in the PSFW+ and control conditions, 
respectively, 254 subjects in each arm will be necessary to achieve power of 0.8 with an alpha=0.05. Projecting a 
liberal 9.2% loss-to-follow-up based on our previous NIH-funded trials (R21CA163100-01, R21DA023362), we will 
randomize N=275 per arm.]] 
   Sample Size Considerations: Aim 2. We are able to detect a mediation effect (coefficient product) of small size 
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Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
(with coefficient product parameters a=0.14, b=0.14) with at least 80% power for each mediator given our expected 
sample size of N=508 at 6 months.152
   3.C.7. Potential Problems and Solutions
   Subject Attrition. Loss to follow-up will be minimized through the use of standard tracking/contact sheets, reminder 
calls/emails/texts, incentives linked to follow-up completion ($30 cash each visit), and provision of travel fare for all 
study visits. We will emphasize that incentives are not dependent on website usage or on abstinence, but rather on 
completion of study visits. Retention rates have been high in our previous clinical trials: during 7 years of participation 
in Community Programs for Clinical Research on AIDS (CPCRA) trials, MMC ranked in the top 3 sites nationally for 
retention, losing <2% of subjects from long-term follow-up. Retention rate within various clinical trials (e.g., ACTG, 
WIHS, HPTN) at MGUH are also impressively high (98%). The aggregate loss to follow-up rate in the three tobacco 
treatment RCTs conducted in the MMC ID Clinic has been 4.8%.
   Study Condition Contamination. To prevent contamination (i.e., subjects accessing non-assigned study 
websites), we will record control participants’ email address at the time of study enrollment in a database linked to the 
PSFW+ data store. Control participants who attempt to register on PSFW+ using a recorded email address will be 
redirected to the welcome page of the Getting Healthy site. It is also conceivable that control subjects will register on 
PSFW+ with a different email address. We will probe for this occurrence and for PLWH+ utilization of the Getting 
Healthy website in the Treatment Satisfaction Questionnaire at follow-up and will adjust the analyses accordingly.
   Generalizability. Once efficacy is established in this controlled trial with optimal recruitment and in-person 
assessment protocols, future dissemination studies will be conducted that will prioritize external validity.
   3.C.8. Timeline and Benchmarks for Success: Months 0-9: Modifications and enhancements to PSFW+ 
including adherence prompts, technical strategies to minimize contamination, efforts to grow and evaluate online 
community, refinement of assessment protocols, programming of ACASI systems. Months 10-54: Recruitment and 
follow-up at 1, 3- and 6-months, with the final follow-up in Month 54. Preliminary data analyses will be conducted 
throughout the 
project. 
Months 55-60: 
Final outcome 
analyses 
and 
manuscript 
preparation. 
Benchmarks 
for 
success: 
1) successful recruitment of overall sample size and racial/ethnic minorities in accordance with targeted enrollment 
projections, and 2) study completion rate of ≥ 90%. In the unlikely scenario that recruitment lags, research staff will 
recruit in clinics and extend recruitment until recruitment goals are met. MMC and MGUH both enjoy collegial 
academic relationships with nearby HIV-care centers caring for thousands of additional PLWH smokers, and these 
may serve as secondary referral sources if the need to augment recruitment arises. If follow-up rates are <90%, we 
will implement more intensive follow-up strategies and increase incentives as our budget permits.   
5. PROTECTION OF HUMAN SUBJECTS
This Human Subjects Research meets the definition of a clinical trial which will require registration in ClinicalTrials.gov.
5.A. RISKS TO HUMAN SUBJECTS
Human Subjects Involvement, Characteristics, and Design
   The MMC ID Clinic population is 43% female, 52% Latino/a, 44% African American/Caribbean, 4% White, non-
Latino/a. The patients report various overlapping transmission categories: 48% heterosexual, 16% IDU, 14% same 
sex contact, and 12% unknown. Approximately 68% of patients have CDC-defined AIDS. Of those who provided 
household income data (63% overall), 91% were living below the official poverty line. 94% are insured by Medicaid, 
Medicare, or the Ryan White AIDS Drug Assistance Program (ADAP). Based upon aggregate substance use data 
Year 1
Year 2
Year 3
Year 4
Year 5
Q1    Q2    Q3    Q4
Q1    Q2    Q3    Q4
Q1    Q2    Q3    Q4
Q1    Q2    Q3    Q4
Q1    Q2    Q3    Q4
Website 
Development
RCT Recruitment (14.5 subj/month * 38 months; N=550)
Follow-up assessments (N=550)
Manuscript preparation
IRB NUMBER: 2015-4723
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Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
from a random selection of clinic patients (N=204), 65% are current smokers (73% of males and 57% of females, Dr. 
B. Zingman, personal communication). 
MMC ID CLINIC 2013 STATISTICS (estimated summary statistics of clinic flow)*
Am. Ind.
Asian
Black
Latino/a
White
Other
Total
Adults
Female
5
2
614
644
48
1
1314
Male
3
7
709
912
76
0
1707
Total
8
9
1323
1556
124
1
3021
* Transgender individuals (approximately 1% of the overall population) are included in the gender statistics with which 
they self-identify.
   The MedStar Georgetown University Hospital (MGUH) HIV Clinical Program is one of the largest providers of 
comprehensive HIV care in Washington, DC, which has the highest HIV prevalence in the nation. The clinic structure 
is designed to overcome two important barriers which have limited access to care in Washington, DC: 1) uninsured 
rates above the national average, and 2) poverty levels. MGUH provides comprehensive HIV care to approximately 
1,200 HIV infected patients, of whom 30% are women and 65% are African American. MGUH has a long track record 
of participating in multiple large clinical trials including the AIDS Clinical Trials Group, the Women's Interagency HIV 
Study, and the HIV Prevention Trials Network. It has an established framework in which patients participate in clinical 
trials. All patients benefit from the medical home created within MGUH with access to a social worker, treatment 
adherence specialist, nutritionist, and case manager.  Retention rate within the clinic is 95% and retention rate within 
various clinical trials is 98%.
MedStar/Georgetown ID Clinic (estimated summary statistics of clinic flow)*
Am. Ind.
Asian
Black
Latino/a
White
Other
Total
Adults
Female
0
7
222
36
89
0
354
Male
0
17
485
84
223
0
809
Children
Female
0
0
15
0
0
0
15
Male
0
0
22
0
0
0
22
Total
0
24
774
120
312
0
1200
* Transgender individuals (approximately 1% of the overall population) are included in the gender statistics with which 
they self-identify.
Inclusion Criteria: We will recruit N=550 adult PLWH smokers. Inclusion criteria are: 1) age 18 or older; 2) current 
smoking as defined by a validated tobacco use measure; 3) laboratory confirmed HIV-infection; 3) receipt of care at 
either MMC or GUH study site; 4) English language fluency; 5) motivation to quit within the next 30 days; 6) at least 
weekly Internet and email access; 7)  REALM literacy score of 19/66 or above, indicating reading level of at least 4-6 
grade (PSFW content was written for this literacy level); and 8) willingness to provide informed consent and undergo 
randomization.
Exclusion Criteria: 1) previous participation in any trial of Positively Smoke Free interventions or use of PSFW+; 2) 
pregnancy; 3) contraindication to NRT; and 4) current participation in an active smoking cessation treatment (e.g., 
group therapy, use of pharmacotherapy). PSFW+ seed users will be excluded. To avoid study condition 
contamination and to maintain the statistical independence of subject outcomes, otherwise eligible individuals who are 
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Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
spouses, partners, and/or roommates of study participants will be excluded. All ineligible patients will receive a 
Positively Smoke Free smoking cessation brochure and will be encouraged to access nationally-available (free) 
quitline counseling. 
Inclusion of Women and Minorities: With the exception of pregnant and nursing women, women will be fully included 
in the study. The safety of NRT has not been established in pregnant women or women who are breastfeeding. 
Furthermore, pregnant women smokers should be referred for aggressive smoking cessation interventions with 
proven efficacy, so allocation to the control condition would conflict with best care practices. The exclusion of women 
who are breastfeeding is of little practical significance since breastfeeding is contraindicated in HIV-infected women in 
the US. The vast majority of the aggregate clinic populations belong to ethnic minority groups, and the investigators 
expect the study cohort to reflect the ethnic makeup of the clinics. Asian and Pacific Islanders and Native Americans 
will be fully eligible for enrollment but are unlikely to comprise a numerically important subset of the study sample 
because they make up less than 3% of the clinics’ populations.  
Inclusion of Children: Clinic patients aged 18 to 20 will be eligible for inclusion in the study. A small number of 
individuals in this age range typically attend the clinic site each year as they transition from pediatric/adolescent care 
settings. There were no children in the MMC ID Clinic population in 2013, although a small number are expected to 
transition from the adolescent clinic in future years. Younger children and adolescents have smoking-associated 
behaviors and risks that differ from those of the adult population. For younger children, the primary medical concern is 
exposure to environmental cigarette smoke. Adolescent smokers typically smoke fewer cigarettes than adults, with 
more irregular patterns of cigarette consumption. Because of these significant behavioral differences, and because 
they receive care in separate facilities, we will not include younger children or adolescents in the proposed project.
Randomization: Following referral from primary care providers, research staff will conduct eligibility screening and 
informed consent. Once consented, the participant will be randomized to one of the two study conditions. Based on 
strong predictors of smoking behaviors that emerged in our prior work, randomization will be stratified by gender and 
education level within each clinic. An online random plan generator (http://www.randomization.com) will be used to 
create an allocation schedule. The schedule will be fully documented with the reference citation of the pseudo-random 
number generator, the seed used to start the generation process, the number of study conditions (2), the allocation 
ratio (1:1), and a copy of the assignment list.
Collaborating Sites: Cassandra Stanton, PhD (MPI) at Westat will oversee the conduct of the study at Georgetown 
which is in close proximity to her worksite and with which she maintains an ongoing affiliation. The Georgetown site 
will recruit participants from the MGUH HIV Clinical Program. Dr. Kumar will be responsible for recruitment and follow-
up at this site, and Dr. Stanton will oversee the overall conduct of the study at Georgetown. Montefiore Medical Center 
(MMC) will recruit patients from the MMC Infectious Diseases (ID) Clinic in the Bronx, NY. Dr. Shuter from MMC will 
serve as MPI and provide expertise in HIV care and tobacco treatment. Dr. Graham and her software development 
team at the American Legacy Foundation will be responsible for delivering the PSFW+ intervention. They will be 
responsible for administering the online community and for developing and monitoring the automated tracking metrics 
on website utilization. 
Sources of Materials
Specimens, Records, or Data: Enrolled subjects will complete measures (see Table 2) in a private office using an 
ACASI interface on a password-protected study computer. Study staff will be nearby to render any assistance 
necessary. Input data will be maintained on the computer’s hard drive and will be uploaded on the day of 
questionnaire completion via a secure Sharepoint portal to the AECOM Epidemiology Informatics/Study Management 
Unit (EISMU - please see Protection of Study Data below and the AECOM Resources section). Exhaled carbon 
monoxide measurements will be performed according to manufacturer’s instructions and discordant abstinence data 
(frequently observed in marijuana users) will be clarified with saliva cotinine strips. Biochemical validation results will 
be keyed by study staff into the study databases. All locally maintained computer data will be stored on password 
protected computers/servers and backed up to encrypted Ironkey USB drives.
IRB NUMBER: 2015-4723
IRB APPROVAL DATE: 11/12/2021

Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
   Website utilization metrics will be extracted from the back end of the PSFW+ intervention. These metrics include 1) 
an event tracking database within the PSFW+ application for non-community related actions, and 2) community 
related data from the Vanilla Forums database. From the event tracking database within the PSFW+ application we 
will extract individual-level metrics utilization including the date/time of each session and page visited, date/time of 
each site login, the referring URL for each site visit, the date/time of registration, number of clicks through to the 
community (date/time stamped), number of page views per session (date/time stamped), number of interactive 
component clicked (date/time stamped), and changes to profile such as email or username. We will also track the 
number of email and text messages sent to each participant as a function of the individually tailored adherence 
strategies we will employ for this study. From the Vanilla Forums database, we will extract individual-level tracking 
metrics including (among others) visits, number of discussions participated in, number of comments made, number of 
private messages sent/received, number of profile posts made/received, and whether a custom profile photo was 
uploaded.
   
   For subjects in the control condition, time and duration of each login to Getting Healthy via the portal page will be 
recorded. Email and text message reminder data will be compiled in the same manner as the PSFW+ condition.
Materials Access: During the course of the project, the Investigators, Data Analyst, Software Development Team, 
Community Administrator, and Project Manager will have access to individually identifiable information about human 
subjects. In addition, Vanilla Forums technical and support staff will have access to registration data and any data 
arising from participation in the online community. This access is detailed in the Vanilla Forums Terms of Service and 
Privacy Policy which are referenced in the PSFW+ documents. The Getting Healthy website will have access to users’ 
IP addresses, but these users will not be distinguishable from any other user of the AHA Getting Healthy site. These 
various levels of access will also be listed in the participant informed consent document.
Protection of Study Data: All data in transit will be transmitted with security precautions. Data moving between 
application server and database or other data stores will be secured via Secure Socket Layer (SSL). Data from the 
PSFW+ application database will be transferred to Legacy’s local servers via direct SSL connection with the database 
and stored on secure servers with restricted access rights. Data from the Vanilla Forums community software will be 
transferred to Legacy’s local servers via SFTP (“Secure File Transfer Protocol” or “FTP over SSL”). Personally 
identifiable data (e.g. phone number, email address) associated with the PSFW+ application will be encrypted in the 
database.
   Each subject will be assigned a unique, randomly-generated study identification number by clinic staff. This number 
will populate the key index field in the relational database structure. The MGUH and MMC ID Clinic research staff will 
maintain a secure database that links the study number with patient identifiers. For participants randomized to the 
PSFW+ condition, research staff will enter this study identification number into the website registration form which will 
be stored by Legacy. For those in the control condition, the identification will populate the back-end table of the Getting 
Healthy portal page. This will enable individual tracking of study participants and linking of website utilization metrics to 
other study data by StudyID. The Principal Investigators, research staff, and software development team will have 
access to individually identifying information about human subjects. Electronic data files with identifying information will 
be maintained securely and separately from other data files. 
   The ACASI questionnaire result uploads will contain the participant’s unique study ID number, but no other 
personally identifying information. For these data the EISMU has implemented a comprehensive Security Program 
that conforms to the National Institute of Standards and Technology (NIST) standards and the EISMU official 
Certification and Accreditation documentation has been accepted by the NIH. The EISMU provides secure data 
hosting, access and backup services and data security provisions are applied systematically at multiple levels to 
ensure safe and accountable data storage and access. Multiple factor authentication is required for access to critical 
systems which include login and password authentication, individual token verification and IP address restrictions. The 
system complies with HIPAA requirements and utilizes a Secure Socket Layer certificate to ensure data encryption 
during data transmission. Servers maintain audit logs of all connections and data modifications with access to users 
granted after certification criteria are met. A fully virtualized environment, built on Dell’s hardware and VMware’s 
enterprise level hypervisor, is utilized to provide high performing and highly available systems.  Advanced backup and 
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Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
recovery systems are implemented to protect both complete server images and file level data.  Redundancy is built 
into the infrastructure at various levels to minimize downtime in the event of an unexpected system failure including 
RAID disk arrays, bonded network interfaces, clustered VMware hosts, and file level replication. Cisco firewalls are 
used to protect all mission critical servers.  Symantec Backup Exec and VMware Data Recovery are implemented as 
an enterprise backup/restore system. Critical database information is backed up at regular intervals to ensure minimal 
data loss in the event of a catastrophic disaster and to allow for both quick restoration of entire servers, as well as 
granular restoration of critical files.  On site and off site backups include backups to disk (storage area network) and 
tape.  A Virtual Private Network is available for remote access.  The system employs a defense in depth model to 
safeguard data ensuring that only authorized users can access the network resources.
   All personnel will receive certification in human subjects protections from the NIH Office of Human Subjects 
Research prior to beginning work on this project. Outside parties who may be afforded access include designees of 
the Institutional Review Board overseeing the study site and the National Institutes of Health and Department of AIDS. 
Potential Risks
   We anticipate four potential risks for participants in this study, though it is important to stress that the overall risk is 
judged to be low. (1) Nicotine withdrawal symptoms: Study participants who attempt to quit smoking will likely 
experience some withdrawal symptoms that may include anxiety, restlessness, anger, irritability, sadness, problems 
concentrating, appetite change and weight gain, insomnia, and decreased heart rate. There is no reason to believe 
that participation in this study would worsen nicotine withdrawal symptoms or that symptoms would differ based on 
randomization assignment. (2) Breach in data-related confidentiality/privacy precautions or through self-
disclosure of personal information in an online social network: Breach in privacy or confidentiality may occur 
related to data collection, storage, or transit, or via personally identifiable information posted by study participants in 
the PSFW+ community. (3) Emotional distress: Participants may experience emotional distress consequent to the 
data collection process since assessment measures include questions about social support, loneliness, substance 
use, and psychiatric illness. Participants may also experience emotional distress subsequent to participation in an 
online community if conflicts should arise. (4) Nicotine replacement therapy side effects: More common side 
effects of the nicotine patch include local skin irritation at the site of the patch, nausea if the dose is too large or if the 
patient continues to smoke at a high level while using the patch, and disturbed and vivid dreams. Less common side 
effects include allergic skin reactions.
Alternative Treatments and Procedures
   Alternatives to study participation include continuing to smoke and pursuing smoking cessation strategies outside of 
the study. Readily available and free cessation treatments will be described in the informed consent document.
5.B. ADEQUACY OF PROTECTION AGAINST RISKS
Recruitment and Informed Consent
   PLWH smokers without contraindications to NRT will be referred by their primary care providers to the study staff 
who will be present in the clinic to screen and then enroll patients or schedule an enrollment visit. Primary care 
providers will be alerted to the study through provider staff meetings, study flyers, and presentations at Community 
Advisory Board meetings at both clinics. In the event we do not meet accrual goals, research staff will directly recruit 
patients in clinic waiting areas. MMC and MGUH both enjoy collegial academic relationships with nearby HIV-care 
centers caring for thousands of additional PLWH smokers, and these may serve as secondary referral sources if the 
need to augment recruitment arises. Study staff will screen referred patients to determine eligibility. Individuals who 
are not eligible for the study will receive the Positively Smoke Free smoking cessation brochure. Eligible patients will 
complete the informed consent process in a private room in or nearby the clinic. The informed consent document will 
describe the randomized trial, including the possibility of being assigned to either of the study conditions and the right 
to withdraw at any time. All aspects of the study, including the informed consent document and process, will be 
approved by the governing IRB prior to study recruitment. Subjects will be provided a copy of the completed informed 
consent document, the original will be placed in each subject’s case report form, and a copy will be placed in a 
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Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
dedicated section of each subject’s medical record.
Protections Against Risk
(1) Nicotine withdrawal symptoms: All participants will be offered nicotine replacement therapy which is intended to 
reduce withdrawal symptoms. Worsening of depression and/or anxiety as a result of nicotine withdrawal is addressed 
in item 3 of this section. 
(2) Risk of breach in confidentiality/privacy: All hard copy data will be stored in locked offices at MMC and MGUH 
ID Clinics. Computerized data will be protected by maintaining the data that links study number to high level identifiers 
(e.g. full name, medical record number) in a single, secure file at both clinic locations. Study computers will be 
password protected and secured behind the respective institutional firewalls. Data transit between the PSFW+ 
application server and database or other data stores will be secured via SSL. Data from the PSFW+ application 
database will be transferred to Legacy’s local servers via direct SSL connection with the database and stored on 
secure servers with restricted access rights.  Data from the Vanilla Forums community software will be transferred to 
Legacy’s local servers via SFTP (“Secure File Transfer Protocol” or “FTP over SSL”). Data from the ACASI uploads, 
i.e. participants’ questionnaire responses, will be transferred to the AECOM EISMU via secure Sharepoint connection. 
The system interoperates with email to distribute alerts and notifications, and audits all editing and updating of 
information on the site. In addition, the collaborative portals host and integrate with Citrix XenApp as an application 
delivery system which provides end-users with a fully encrypted session. Security arrangements for data maintained 
by the EISMU are detailed in the Protection of Study Data section above. If by any chance the security of the 
databases is compromised, study data will be numerically coded and useless to someone without a data dictionary. 
Prior to data transfer to the biostatistician for analysis, personally identifying information will be removed from data 
tables. The study staff will apply to the appropriate parties for a Certificate of Confidentiality to protect subjects 
supplying study data pertaining to illicit substance use and sexual preference. There are also privacy risks related to 
participating in an online social network. The study team has sought advice and counsel from HIV specialists, 
technology specialists, PLWH, and numerous lawyers before creating the PSFW+ Terms of Use and Privacy Policy. 
Registration on the site requires accepting the conditions spelled out in each of these documents which appear next to 
the “Submit” button on the registration page as well as in the header of all content pages. Both documents emphasize 
that anything a user posts in the community should be considered public information, and that others may assume 
that they have HIV/AIDS based on personal information they post on the website since it is a quit smoking website for 
smokers living with HIV.
(3) Emotional distress: Both ID Clinics offer on-site mental health support services and are situated in close proximity 
to their respective psychiatric emergency departments. Study subjects that indicate at any time in-person, on the 
phone, or in the community that they are experiencing distress (esp. worsening of depression and/or anxiety) will be 
advised how to avail themselves of appropriate emergency clinical services if the need should arise. In addition, 
subjects scoring out of range on the depression and/or anxiety indices included in the study questionnaires will be 
contacted by study staff and offered referral to mental health services. Drs. Shuter and Kumar will monitor and strictly 
adhere to adverse events reporting procedures within their clinics and IRBs. A data safety monitoring officer will 
oversee the data safety monitoring plan. Dr. Graham will conduct weekly supervision meetings with the PSFW+ 
Community Administrator, Ms. Jacobs, to discuss any issues that arise in the community that may be of concern. Ms. 
Jacobs will alert Dr. Graham immediately if a participant posts content in the community that indicates the potential for 
harm or adverse event. Dr. Graham will attempt to contact the participant using the phone number s/he provided 
during site registration to assess the potential for harm and refer to the emergency services protocol at each clinic.  If 
the participant cannot be reached, Dr. Graham will contact hospital administration to activate the hospital's protocol for 
contacting patients about urgent matters when they are not reachable by phone. Each hospital will follow its respective 
protocol for calls to the patient's emergency contacts and/or dispatching police to locate the patient.
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Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
(4) Nicotine replacement therapy side effects: The risks of serious adverse effects of nicotine replacement therapy 
are small, and its potential health benefits far outweigh its risks. Subjects will be encouraged to review the drug 
information provided with the product and to report adverse effects to their clinic providers. Study candidates with 
contraindications to NRT or whose providers deem to be at unacceptable risk from NRT will be excluded from the 
study.
Adverse Event Response and Reporting
   The MMC ID Clinic has primary care providers on-site Monday through Friday from 9am-5pm. During off hours, 
patients may contact covering attending physicians by pager 24/7/365 through an emergency beeper system. For 
emotional/psychological issues, the ID Clinic has an on-site mental health team consisting of two psychiatrists, a 
psychologist, and a social work therapist. During off-hours, the MMC psychiatric emergency department is located in 
an adjoining area of the hospital. The Georgetown Division of Infectious Diseases has an ID Fellow on call for 
emergency issues 24/7/365 who is able to reach Dr. Kumar. All study enrollees will be given the 24 hour number for 
the participant to call in the event of an urgent or emergent issue. Additionally the Division has access to the 
Department of Psychiatry with 24 hour coverage through the Emergency Department which is located in the MedStar 
Georgetown University Hospital on the University campus. For outpatient follow-up, the Department of Psychiatry 
utilizes psychiatrists, psychologists and licensed clinical social workers based on the needs of the subject.
5.C. POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO HUMAN SUBJECTS AND OTHERS
   Subjects may benefit from participation in this research in several ways. By participating in a smoking cessation 
treatment program, subjects may increase the likelihood that they will attempt to quit smoking and be successful. 
Additionally, participants will gain a greater understanding of their smoking behavior that may help them to quit 
successfully in the future. Finally, although this is not a direct benefit, all participants will be involved in a project to 
evaluate innovative treatments for smoking cessation in this highly vulnerable population that may ultimately produce 
an enormous public health impact. If proven effective, PSFW+ could be promoted at HIV care sites throughout the 
country as a broad-reach intervention that addresses an important health disparity. The belief that the benefits of 
smoking cessation interventions outweigh their risks is an accepted principle of medical practice. The only additional 
risks to study subjects in the proposed project are the risks of breach of patient privacy and emotional distress related 
to the data collection process. The investigators believe that these small risks are outweighed by the potential benefits 
of the study.
5.D. IMPORTANCE OF THE KNOWLEDGE TO BE GAINED
   Cigarette smoking continues to be a major preventable cause of death in the United States, and improvements in 
treatment options are needed specifically for PLWH. The scope of the problem of smoking in PLWH and the limits of 
knowledge related to smoking cessation in PLWH are highlighted in Section 3.A. The Internet has the potential to 
deliver a low-cost and effective cessation intervention to PLWH smokers throughout the US. Usage data and 
satisfaction survey responses may also be useful in planning future studies and optimizing future web interventions.  
5.E. DATA AND SAFETY MONITORING PLAN
   All aspects of the data safety monitoring plan will be reviewed and approved by the governing IRB prior to study 
initiation. Drs. Shuter and Stanton will be responsible for monitoring the safety and efficacy of this minimal risk study, 
executing the data and safety monitoring plan, and reporting the findings annually to the NIH. A Data Safety 
Monitoring Officer (DSMO) will be designated at Montefiore. S/he will be a physician without direct clinical 
responsibilities in the MMC ID Clinic, and without conflicts of interest relating to the proposed study. Parameters to be 
tracked, at least quarterly, will include subjects’ sociodemographic characteristics, expected versus actual accrual 
statistics, study attrition, serious adverse events, and protocol amendments. The DSMO will receive a summary 
statement containing these data quarterly.
IRB NUMBER: 2015-4723
IRB APPROVAL DATE: 11/12/2021

Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
   Mechanisms in place to protect patient privacy are detailed in Section 5.B. Additionally, study staff will apply to the 
appropriate authorities for a Certificate of Confidentiality to protect subjects supplying study data pertaining to illicit 
substance use and sexual orientation.
   Serious adverse events (SAEs) will be defined as death, hospitalization, or immediately life-threatening illness 
(including mental illness). SAEs will be reported to the clinical site’s IRB within 72 hours of study personnel becoming 
aware of them. The relationship of each SAE to study participation will be graded by the study staff as unrelated, 
probably not related, possibly related, probably related, or definitely related. Provisions for responding to psychiatric 
SAEs have been previously detailed (see Section 5.B.). For each SAE the DSMO, PI, and the IRB will consider 
whether the risk benefit ratio of the study has been altered necessitating study discontinuation, modification of the 
informed consent document, and/or notification of current study subjects. The site PI will notify the NIH of each SAE 
that occurs within 72 hours of awareness and will file a full SAE report for each event once clinical information 
becomes available.
5.F. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
   All members of the investigative staff have completed formal training programs in the protection of human research 
participants and will maintain current certification throughout the course of the trial. Documentation of program 
completion will be supplied to the NIH prior to project initiation.
IRB NUMBER: 2015-4723
IRB APPROVAL DATE: 11/12/2021

Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
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amendment 10-4-21)
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IRB APPROVAL DATE: 11/12/2021

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amendment 10-4-21)
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IRB NUMBER: 2015-4723
IRB APPROVAL DATE: 11/12/2021

Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
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IRB NUMBER: 2015-4723
IRB APPROVAL DATE: 11/12/2021

Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
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IRB NUMBER: 2015-4723
IRB APPROVAL DATE: 11/12/2021

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amendment 10-4-21)
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IRB NUMBER: 2015-4723
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amendment 10-4-21)
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amendment 10-4-21)
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IRB NUMBER: 2015-4723
IRB APPROVAL DATE: 11/12/2021

Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
Amendment for Randomized Controlled Trial of An Internet Cessation Program Plus Online Social Network for 
HIV + Smokers (IRB# 2015-4723)
Amendment Date: 10-4-21
Overview of the proposed amendment
This amendment is being submitted to expand the scope of the previously approved study. The specific changes 
sought by this amendment include:
1) Inviting participants previously enrolled in the parent study to participate in a new telephone survey.
2) Inviting those participants reporting abstinence from cigarette smoking during the telephone survey to 
participate in an in-person study visit to measure exhaled carbon monoxide and undergo a cheek swab for 
biobanking.
Background for the amendment
The parent study of this amendment, a Randomized Controlled Trial of An Internet Cessation Program Plus 
Online Social Network for HIV + Smokers, was closed in 2020 and represents the first randomized  controlled 
trial of tobacco treatment to report abstinence efficacy at the 6-month timepoint among people with HIV (PWH) 
smoker in the US1. This well characterized cohort of study participants represents an important population for 
understanding predictors of long-term smoking cessation. Additionally, this population represents an opportunity 
to elucidate associations between smoking cessation and healthcare utilization,  outcomes related the COVID-19 
and vaccination for COVID-19, and HIV care.
Ref:
1Stanton CA GA, Kim RS, Chander G, Shuter J. Multicenter RCT of a web-based cessation program plus online 
social network for HIV+ smokers. Presented at the Society for Research on Nicotine & Tobacco 2021 annual 
meeting, Feb. 24-27, 2021.
Objectives 
The objectives of the study proposed in the amendment are to:
1. Describe rates of and duration of tobacco abstinence, and identify clinical and demographic factors associated 
with maintenance of abstinence, among participants of the parent study.
2. Identify associations between smoking status and COVID-19 related outcomes and healthcare utilization 
among participants of the parent study.
3. Identify associations between smoking status on HIV-related outcomes and healthcare utilization among 
participants of the parent study.
Methods
This will be a prospective study of participants in the trial: Randomized Controlled Trial of An Internet Cessation 
Program Plus Online Social Network for HIV + Smokers. The trial was conducted at two sites, Montefiore 
Medical Center and Johns Hopkins University Hospital.  Only the participants from the Montefiore site will be 
invited to join the follow-up study proposed in this amendment.  For the sake of the amendment, “participants” 
refers to participants at Montefiore.  All prior participants in the study are eligible for this proposed follow-up study. 
Study personnel will contact prior participants via telephone to offer participation in the follow-up study. 
IRB NUMBER: 2015-4723
IRB APPROVAL DATE: 11/12/2021

Jonathan Shuter (PI)  RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers (Version date 4/7/2015 with 
amendment 10-4-21)
The first component of the follow-up study will include a 15-20 minute IRB-approved telephone interview with 
questions related to: current smoking status; smoking quit attempts;  motivation to quit;  alcohol and drug use; 
COVID-19 illness, management, vaccination status, and attitudes toward vaccination; overall healthcare 
utilization over the prior year including visits with an HIV provider, emergency department visits, and 
hospitalizations; and questions related to perceptions of HIV care.
Participants who report tobacco abstinence during the telephone interview will be invited for an in-person visit to 
measure exhaled carbon monoxide and to submit a cheek swab for biobanking for future genetic research.  Both 
of these are painless, essentially risk-free procedures.
Data Security:
Data will be collected and stored using a secure, password protected database accessible only to authorized 
study personnel. Data will be de-identified and all participants will be assigned a unique identifier. A file linking 
identifying information to unique identifiers will be kept separately from the data itself and will be stored in a 
locked file cabinet within a locked office, only accessible to authorized study personnel. Upon completion of the 
analysis, the documents linking the identifiable data to unique study identifiers will be destroyed.
Data Analysis:
Participants achieving tobacco abstinence will be compared to those not achieving abstinence according to 
clinical characteristics, sociodemographic characteristics, and interview responses. Using standard bivariate and 
multivariate methods, we will identify factors associated with tobacco abstinence, healthcare utilization, COVID-
19 related outcomes and interview responses, and HIV-related outcomes and interview responses.
Informed Consent
All participants will undergo the process of informed consent prior to enrollment in this follow- up study. For 
participants in the telephone interview component, verbal informed consent using an IRB-approved script will be 
obtained. For participants in the in-person visit component, signed informed consent using an IRB-approved 
document will be obtained. Participants agreeing to the cheek swab for biobanking of genetic material for future 
research will also provide signed informed consent for that specific procedure.
Reimbursement:
Participants who consent to and complete the telephone interview will be reimbursed $20 for their time. 
Participants completing the in-person study visit will be reimbursed and additional $50. Participants participating 
in the in-person study visit will also be reimbursed for with a $6 Metrocard for roundtrip travel to the study site.
Risks/Benefits/Alternatives:
For participants of the telephone interview and in-person study visit, the primary risk will be loss of confidentiality. 
This risk is mitigated by the data security procedures described above. Participants may also feel uncomfortable 
with certain questions. If this occurs, participants can choose to end their participation at any time.  For 
participants of the in-person study visit, the measurement of exhaled carbon monoxide is non-invasive and the 
cheek swab is minimally invasive, both with virtually no risk.  Participants may choose to end their participation at 
any time during the study.
IRB NUMBER: 2015-4723
IRB APPROVAL DATE: 11/12/2021