Social Media Intervention to Promote Smoking Treatment Utilization and Cessation Among Alaska Native Smokers
Phase: NA
Conditions: Tobacco Use, Tobacco Smoking, Tobacco Use Cessation, Smoking Cessation, Smoking, Cigarette, Smoking, Tobacco, Smoking
Sponsor: Mayo Clinic

 
 
Social Media Intervention to Promote 
Smoking Treatment Utilization and 
Cessation Among Alaska Native Smokers 
 
NCT03645941 
 
September 30, 2021 

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Study Title: Social Media Intervention to Promote Smoking Treatment Utilization and 
Cessation among Alaska Native Smokers 
Funding, National Institute on Drug Abuse, application # 1 R34 DA046008-01 
 
Principal Investigator: Christi Patten, PhD 
 
Study team: Kathryn Koller, PhD (Co-Investigator), ANTHC; Zoe Merritt (Study Coordinator), 
ANTHC; Timothy Thomas, MD (Co-Investigator), ANTHC; Clara McConnell (Facebook Group 
Moderator), ANTHC; Judith Prochaska, PhD (Co-Investigator), Stanford University; Christine Hughes 
(Study Coordinator), Mayo Clinic; Jeremy Weiss (Study Coordinator), Mayo Clinic; Nicole Reinicke 
(Study Coordinator), Mayo Clinic; Paul Decker, MS (Co-Investigator), Mayo Clinic; Pamela Sinicrope, 
PhD (Co-Investigator), Mayo Clinic; Martha Bock (Study Coordinator), Mayo Clinic; Tabetha Brockman 
(Study Coordinator), Mayo Clinic; and Kenneth Resnicow, PhD (Consultant), University of Michigan, Ann 
Arbor. 
Developing effective interventions to decrease tobacco use among Alaska Native people is a national 
priority. The prevalence of smoking among US adults is highest among American Indians and Alaska 
Native (AI/AN) persons; however, there are a lack of tobacco cessation interventions developed specific 
to this disparity group.1,2 Social media holds promise as a scalable intervention strategy to promote 
engagement in treatment and cessation outcomes for AN people. 
We plan to develop and pilot test a culturally relevant, Facebook delivered intervention to promote 
smoking treatment uptake and cessation among AN people who smoke. The Facebook content will 
include a digital storytelling approach adapted from the effective CDC Tips™ from Former Smokers 
educational mass media campaign.3 The project builds on our team’s longstanding tobacco control 
research partnership with the AN community and was informed by our understanding of cultural factors 
that can both impede and encourage cessation in this population. If the pilot intervention is successful, 
we will have a blueprint to conduct a large randomized controlled trial. Our long-term objective is to 
develop interventions for AN tobacco users that will ultimately reduce their risk of tobacco-caused 
disease and mortality. 
 
Hypothesis: 
Phases 1-3 are exploratory and developmental phases, therefore there are no hypothesis to report. For 
Phase 4, we hypothesize that the intervention will be feasible and the biochemically-verified smoking 
abstinence rate at1, 3 and 6 months follow-up will be greater in the intervention versus control condition. 
 
Aims, purpose, or objectives: 
Specific Aim 1 (phases 1-3): To develop a culturally relevant, Facebook delivered intervention to 
promote smoking treatment utilization and cessation among AN adult smokers. This formative 
research phase will use the cultural variance and surface/deep structure frameworks4,5 to address the 
influence of culture in designing health messages, and adopt qualitative (phase 1) and quantitative (phase 
2) pre-testing methods to develop and beta-test the intervention prototype (phase 3). 
 
Specific Aim 2 (phase 4): To conduct a randomized pilot trial to evaluate feasibility, uptake, consumer 
response, and potential efficacy of the Facebook intervention compared with a control condition. In the 
pilot trial, 60 adult AN people who smoke will be randomized to the Facebook intervention or to a 
Research Question and Aims 

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control condition (quitline/treatment referral). Assessments will occur at baseline, 1, 3 and 6 
months follow-up. 
Our sub-aims are to: 
a. Examine feasibility of delivering an intervention through social media as determined by 
recruitment and retention rates, treatment acceptability ratings, and Facebook 
intervention exposure and engagement. 
b. Estimate potential magnitude of the intervention effect compared to the control condition on 
biochemically verified, 7-day point prevalence smoking abstinence rate at 1, 3, and 6 months 
follow- up. 
c. Explore intervention effects on secondary outcomes: self-reported abstinence from any tobacco or 
nicotine product, quit attempts, and use of the state quitline or any evidence-based smoking 
cessation treatment (pharmacological or behavioral) through 6 months follow-up. 
d. Explore sex, age, and region (urban/rural) effects on Facebook exposure and engagement, 
smoking abstinence, smoking treatment utilization, and quit attempts. 
e. Explore interdependence (relationship orientation and collaborative efforts in decision making and 
lifestyle changes) as a culturally relevant mediator of intervention efficacy. 
f. Since the pilot testing period took place over the COVID-19 pandemic, we will explore the self- 
reported impact of COVID-19 perceived risks, severity, and COVID-19-related anxiety, stress, 
financial impacts, social isolation, and social support on our primary outcome of smoking treatment 
utilization and cessation at 6-months follow-up. 
g. Adapt the intervention and procedures in preparation for a future large-scale efficacy randomized trial. 
 
Supplemental Specific Aim: To assess the perceived effectiveness of social media content and 
communication non COVID-19 and smoking. We will use existing content on COVID-19 (e.g., CDC 
Tips™ campaign videos) for adaptation. Potential content adaptations for COVID-19 messaging that may 
impact treatment utilization and quitting as barriers or facilitators include stress, anxiety, perceived risks, 
social isolation, and social support. We will conduct quantitative pre-testing of content using an online 
survey of a new sample of 40 AN smokers recruited statewide, with stratifications based on audience 
segment (sex, age, and location – rural or urban). 
 
We are submitting materials for approval for all phases of the research. All phase 1 materials are 
developed and submitted for review. We are submitting for review all materials for phases 2-4 with the 
exception of the intervention materials. This is because these subsequent phases of the research are each 
dependent on the previous phases, as one of the goals of this study is to conduct formative work to 
develop the intervention materials. Thus, before commencing phases 2-4 we will submit a modification 
for IRB review and approval of all intervention materials including the Facebook group postings when 
developed. 
This project is innovative for developing a new behavioral intervention to reach AN people statewide to 
promote smoking treatment utilization and cessation using social media communication tools that are 
culturally relevant and already adopted. The proposed study is significant because it will advance 
research on population-specific treatments for an underserved AN tobacco use disparity group. This 
pilot study is the first step to an intervention that could ultimately be widely disseminated through social 
media, internet, and mass media channels, and serve as a model for interventions in other populations 
such as AI smokers, enhancing overall reach and impact. 6 Future dissemination efforts also have 
relevance to the Food and Drug Administration (FDA) tobacco control regulatory science research to 
understand effective risk communication strategies in vulnerable groups. 7 

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Nationally, the prevalence of tobacco use is highest among Alaska Native (AN) people and tobacco 
cessation interventions developed specifically for this disparity group are lacking. Geographic 
remoteness, climate, and travel costs are key barriers to treatment delivery. Social media has promise as 
a scalable intervention strategy to promote smoking treatment utilization and cessation for AN people 
who smoke. 
 
Background (Include relevant experience, gaps in current knowledge, preliminary data, etc.): 
Cigarette Smoking among Alaska Native People 
Cigarette smoking is the most important preventable cause of morbidity, mortality, and excess health 
cost in the U.S., accounting for 480,000 premature deaths yearly.8 In 2015, smoking prevalence was 15% 
among U.S. adults.8 At 22%, AI/AN persons had the highest smoking prevalence; and within this group, 
AN residents of Alaska (AK) had a prevalence more than double that of Alaskan Whites (42% vs. 17%).9 
Some rural AK regions also have high smokeless tobacco (ST) use rates including a homemade product, 
iqmik.10-12 Developing effective strategies to decrease tobacco use among AN people will contribute to 
the U.S. public health objective of reducing tobacco-caused health disparities13,14; and to the Healthy 
Alaskans 2020 target of decreasing smoking prevalence among AN adults to 17%.15 There is a lack of 
tobacco cessation interventions tailored for AN people. To address this gap, we propose to develop and 
pilot test a culturally relevant, Facebook intervention to promote smoking treatment utilization and 
cessation that builds on our longstanding tobacco control research partnership with the AN community. 
Social Media as a Feasible Intervention Delivery Platform among Alaska Native People 
Our previous research utilized intensive, face-to-face tobacco cessation interventions that targeted AN 
pregnant women and youth; these individual-based approaches had limited reach and efficacy. 16,17 AK, 
the largest state in the U.S., has 178 communities not connected to a road system and separated from 
regional hospitals by vast stretches of tundra, water, glaciers, and mountains. Geographic remoteness, 
climate, and travel costs are key barriers restricting access to a full spectrum of health care services for 
AN people. Online social networks (i.e., social media) such as Facebook, are potentially powerful tools 
for reaching, engaging, and connecting AN people who smoke in cessation efforts. 18 Social network 
platforms have a large reach at a relatively low cost, representing a distinct advantage over face-to-face 
approaches. Research indicates Internet (web)-based interventions are effective for smoking cessation, 
but are associated with very low utilization. 19-21 Highly interactive social media (i.e., web 2.0 
technologies), in contrast, can increase the depth of engagement and connection with an extensive reach 
to underserved, diverse populations22,23 using evidence-based content. 
Nationally, Facebook is the dominant social networking platform used by 68% of U.S. adults, more than 
double the proportion on Twitter (21%), Instagram (28%), Pinterest (26%), or LinkedIn (25%).24 Of 
Facebook users, 75% engage with the site on a daily basis. 24 Among U.S. adults online, Facebook use 
indicates similar high rates of engagement by sex (75% of females and 83% of males use Facebook), 
income (84% engagement among those with less than 30K/year vs. 77% for those reporting 75K+/year) 
and age groups (88%: 18-29, 84%: 30-49, 72%: 50-74 years), except for slightly less use (62%) among 
those 65 and older. 
Of importance for the reach of our intervention is the adoption of social media and other digital 
technologies among AN people. The Alaska Federal Health Care Access Network (AFCAN) is a leader 
in providing innovative technologies and expanding telemedicine use to physicians and mid-level 
providers statewide to improve isolated rural community access. Moreover, Facebook and other social 
Literature Review 

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media use and the use of the internet to access health information has increased among AN people, even 
in remote regions. Facebook is most commonly accessed on mobile phones, but also on computers and 
iPads. Broadband internet is needed to access social media and to upload and download videos and 
other links; 91% of Alaskans have access to mobile broadband service, 25 while household broadband 
access (excluding mobile phones) is 65% (84% of urban and 47% of rural AN households). 26 With 
federal stimulus funding, initiatives are underway to greatly expand home-based access to broadband 
internet in rural AK. 26 In a representative survey of 340 households in rural 
southwest AK (73% AN adults), 87% had at least one cell phone and 60% had a smartphone. Most 
common reported uses were text messaging; taking or sending photos or videos; and 81% used 
Facebook, Twitter or other social media sites. 27,28 A survey of 362 AN females from a rural census area 
reported 80% used Internet, 78% had smartphones, and 90% used Facebook. 29 Rural, village-specific 
Facebook pages exist and are popular. We have successfully used Facebook to recruit AN tobacco users 
for research projects (CA164533, HL117736). 
In contrast to individual-based treatments, social media platforms could lead to greater adoption and 
sustainability by encouraging collaborative efforts across adult generations that resonate with the AN 
cultural value of interdependence, defined as relationship-oriented and collaborative in decision making 
and lifestyle changes. 30-32 We plan to explore interdependence as a culturally relevant mediator of 
Facebook intervention engagement and efficacy. However, it is important to note that traditional AN 
lifestyle, culture, and holistic worldview are intertwined and extend beyond mere social collectivism to 
include interconnectedness of people with nature, the environment, and all elements of the universe. 33,34 
A qualitative study assessed the acceptability of using social media for smoking cessation among Latino 
adults, which is of relevance because Latinos similarly conceptualize culture, health decisions, and 
lifestyle changes as a family or group (versus self) effort. 35 Participants valued communal aspects of 
social media and preferred visual, educational, and motivational messages to connect them with quitlines 
and other existing tobacco treatment services. 
Social Media Interventions for Smoking Cessation 
The importance of social network influences and social support on smoking cessation are established.36- 
39 Although interventions designed to enhance social support for smokers already in treatment have 
found mixedresults,40,41 a body of literature supports the efficacy of network interventions in real-world 
settings.36,42,43 Further, the potential for social-media formed networks to enhance smoking cessation is 
an understudied and priority research area.18,44,45 
There are only three reported trials using social media platforms for smoking cessation. An intervention 
with both a website and a Facebook group evaluated in a quasi-experimental design among 238 young 
adult smokers resulted in greater self-reported 7- and 30-day smoking abstinence rates and quit attempts, 
compared to an unmatched comparison group of quitline users at 3-month follow-up.46 Participants 
interacted significantly more with Facebook than with the website; of Facebook users, 56% were men 
and 44% were women; women were more active in the group than men with respect to postings and 
other engagement. An analysis of sex differences in communication styles on the Facebook group 
revealed women emphasized support and connecting with others, while men expressed strong assertions 
about quitting smoking.47 
A second study evaluated a 100-day Twitter intervention (Tweet2Quit).48 Among 160 smokers aged 18- 
59 years, Tweet2Quit doubled the rate of self-reported sustained abstinence at 2-months post-quit date 
compared toa control condition (smokefree.gov cessation website referral + nicotine patches), 40% vs. 
20%. Sex, but not age, was related to treatment outcome with women less likely to quit smoking than 
men in both treatment and control conditions, though both genders were highly engaged with 
Tweet2Quit. 
The third study was uncontrolled; it was designed to test whether monetary incentives enhanced 
Facebook intervention engagement in a young adult smoker sample.49 Overall engagement was high and 

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did not differ by incentive groups, and overall self-reported smoking abstinence rate at 6 months was 
18%. 
We identified only three ongoing NIH-funded randomized trials of social media interventions for 
smoking cessation (http://projectreporter.nih.gov): (1) Twitter supportive intervention to prevent smoking 
relapse in postpartum women (R21CA198036; Wen, PI), (2) Twitter intervention comparing women- 
only groups vs. coed groups with usual care (R01CA204356; Pechmann & Prochaska, MPI), and (3) 
Facebook intervention to reduce smoking and heavy drinking in young adults (R34DA04163; Ramo, PI 
& Prochaska, Co-I). 
Three other feasibility studies examined Facebook use among smokers. Haines-Saah et al.50 found more 
postings to the “Picture Me Smokefree” Facebook page among women than men (i.e., 189 total photos 
posted among women [mean 9.5] vs. 94 posted by men [mean 4.2]). However, content analysis revealed 
postings were 
of similar quality for both sexes; sharing of photos and captions about experiences with tobacco use and 
struggles with quitting in the context of family life and relationships were the main themes. Evaluation of 
the Facebook page smokefreewomen.gov51 found that increased frequency of moderator postings to 
facilitate dialogue and to provide support engaged existing and new users, resulting in a marked increase 
in user postings and reach (i.e., unique views). Finally, a Facebook intervention using health 
communication messaging and supportive moderator postings was associated with a decrease from 
baseline in cigarettes smoked per day at 2- week follow-up; increased engagement was associated with 
greater smoking reduction.52 
The proposed study, focusing on AN smokers, advances the methods of published social media 
intervention studies through the use of biochemical verification of smoking abstinence and extended 
duration of follow-up. Previously, most studies have targeted only young adults, whereas we plan to 
include a wide age range. We will also explore potential sex, age, and regional (urban/rural) effects on 
Facebook engagement and quitting, as there is limited research exploring these variables within the 
context of social media platforms for smoking cessation.46,48 Within smoking cessation intervention 
efficacy and effectiveness trials generally, a recent literature review on sex/gender differences found that 
of 126 tests conducted, only 2 observed that women were significantly more likely to quit smoking than 
men, compared to 59 that found women were significantly less likely to quit smoking than men; the 
remaining 65 studies reported no difference by gender.53 
CDC Tips from Former Smokers (Tips™) Educational Campaign 
The content for the proposed Facebook intervention will be culturally relevant, adapting the storytelling 
approach used by the effective CDC Tips™ educational, national, general audience, mass media 
campaign.3 Based on factual health communication messaging, Tips™ features graphic, emotional, true 
stories told by former smokers to increase awareness of the harms of smoking and to encourage quitting. 
It has a specific call to action to use free, evidence-based state quitlines and smoking cessation website 
resources (www.smokefree.gov). The campaign was effective for increasing quitline utilization and quit 
attempts on a population-level. 3,54 Number of calls to the national quitline portal (1-800-QUIT-NOW) 
increased 75% over the 16-week campaign compared to pre-campaign levels, resulting in 151,536 
additional quitline callers. 54 Among 4,248 smokers nationwide, the proportion making a quit attempt in 
the past 3 months significantly increased from 37% at baseline to 42% post-campaign (applied on a 
population basis, an estimated 1.83 million additional smokers made a quit attempt). 55 No sex 
differences were found on quit outcomes, but those with less education and African Americans were 
more likely to report a quit attempt compared to White smokers and those with higher education levels. 
The Tips™ education campaign has not been adapted for nor evaluated among AI/AN people; only 2 of 
the 31 available stories feature an AI/AN former smoker. 
The personal story format of the Tips™ campaign promotes salience and reduces the tendency for 

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smokers to generate counterarguments or discount adverse health outcomes as uncommon because the 
stories feature real people – not actors. 56 Numerous studies, including prior work by our team, 11 
suggest that storytelling is culturally congruent, making the Tips™ format ideal for social media content 
development. Digital storytelling and other narrative forms of communication (e.g., photonovela, 
photovoice) have emerged as important tools for health behavior change. 57-59 Storytelling is especially 
effective for AN people with a strong oral tradition60- 
62 as it reinforces traditional AN knowledge systems, promotes cross-generational learning, and builds 
social connections. 33,63 Also of relevance to Tips™ is work conducted by our team indicating AN 
adults preferred graphic, factual messages on tobacco use harms compared with other appeals, but this 
research was limited to interventions communicating risks during pregnancy. 64,65 
Development of social media-based interventions with consideration of cultural factors (beliefs, norms 
and values) could lead to greater treatment participation and acceptability in AI/AN communities. 66-72 A 
systematic review found that indigenous smokers prefer culturally-targeted media messages. 69 Cultural 
tailoring increases attention to health risk messages, creates more effortful processing, and results in 
fewer counterarguments and greater perceived credibility of the message. 73,74 The Institute of Medicine 
has promoted the importance of culture as part of an integrated framework for interventions75; and, in 
particular, documented its importance for leveraging strengths and voices within AI/AN communities. 76 
The Alaska Native Tribal Health Consortium (ANTHC) conducted three focus groups of AN tobacco 
users (9 men, 18 women) to assess perceived effectiveness of statewide tobacco prevention and cessation 
media for encouraging smoking cessation. 77 Seven video concepts were reviewed, of which two featured 
AN people who smoke and family members (one came from Tips™: Michael, AN former smoker) and 5 
targeted a general audience. The highest ratings were for the 2 videos featuring AN people. Participants 
reported greater cultural relevance of these two ads compared with other media because these portrayed 
AN individuals, communities, and activities they were familiar with; addressed the impact of tobacco use 
not only for themselves but for others they cared about; and conveyed emotion while providing facts on 
the effects of tobacco use. Participants were also asked about communication venues most likely to reach 
them (0-4 Likert scale from very unlikely to very likely). Facebook received the highest mean rating (3.3) 
compared with television (3.0), internet via computer (2.0) or smart phone (2.8), Twitter (0.8), or 
Instagram (0.9). 
The proposed intervention will promote engagement with evidence-based smoking cessation treatment 
including the AK state quitline and tribal cessation programs. Promoting treatment utilization is an 
important issue for the tobacco research field.2,13 In 2015, about 68% of smokers in the U.S. wanted to 
stop smoking and 55% made a past-year quit attempt, but only 7% quit smoking.78 In AK, successful 
quit attempts are strikingly lower for AN adults compared with non-Native smokers (4% vs 10%).9 
Generally, only 4-7% of unaided quit attempts are successful, but evidence-based counseling and 
medication treatments boost quit rates to as high as30-40%.38,79 Individual, group, and telephone 
behavioral counseling as well as 7 FDA approved medications increase smoking cessation. For 
example, free quitlines, now available in 50 states, double smokers’ chances at quitting compared to 
control conditions.38,80 However, there is a reach problem: only 1% of U.S. smokers use quitlines81 with 
utilization especially low among underserved racial/ethnic minority groups.82 A 2015 survey of U.S. 
state quitlines found that of the 313,505 callers receiving coaching and/or medications, only 2.4% were 
AI/AN adults (low given the very high prevalence of smoking among AI/AN adults).81 Less than one- 
third (31%) of U.S. smokers attempting to quit use any type of evidence-based behavioral cessation 
counseling and/or medication.78 Therefore, efforts to prompt more AI/AN and other diverse smokers to 
quit and to use evidence-based treatment methods to increase their success are important steps toward 
reducing tobacco-caused health disparities. 
There is a lack of tobacco cessation interventions tailored for AN people. To address this gap, we 
propose to develop and pilot test a culturally relevant, Facebook delivered intervention to promote 
smoking treatment utilization and cessation that builds on our longstanding tobacco control research 

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partnership with the AN community. 
This proposal addresses 3 of 7 gaps and priorities in tobacco research identified by the Tobacco 
Control Research Priorities Working Group45: (1) targets an underserved tobacco use disparities 
population, (2) develops a novel behavioral intervention using a social media platform, and (3) 
promotes uptake of evidence-based treatment and quitting. If effective, the proposed social media 
intervention has relevance for advancing the science of tobacco treatment for AI/AN communities. 
Smoking and COVID-19 
Underserved populations with a higher prevalence of tobacco, such as ANAI people, may be more 
vulnerable to the physical and mental impacts of COVID-19, enhancing the significance of the 
proposed supplement.83-85 Coronavirus disease 2019 (COVID-19) is mainly a disease of the 
respiratory tract caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).86 As 
of May 05, 2020, there were 3,556,852 COVID-19 infections recorded globally, and 251,237 deaths. 
Tobacco smoke is a major risk factor for lung disease,87 and cigarette smoking substantially increases 
risk for bacterial and viral infections.88 
Smoking is further linked to lung inflammation and lowered immune function, and is likely associated 
with the negative progression and adverse outcomes of COVID-19.89 One study found that the presence 
of the ACE-2 enzyme that facilitates the entry and multiplication of coronavirus into the lung cells is 
higher among patients with chronic obstructive pulmonary disease and in smokers.90 Berlin et al. 
(2020)91 summarized case series reports indicating that the proportion of smokers was greater among the 
severe cases of COVID-19, including deaths, compared with that observed among the non-severe cases. 
Cigarette smoking is associated with anxiety and depressive symptoms,92 as well as psychological 
stress.93,94These symptoms are also reported by populations affected by the COVID-19 pandemic.86,95-98 
In the absence of a medical cure for COVID-19, the global response is a simple public health strategy of 
isolation for those infected or at risk, reduced social contact to slow the spread, and masking and hand 
washing to reduce infection risk. While the primary intervention of isolation may well achieve its goals, 
it can also lead to loneliness, reduce access to and availability of social support, and worsen stress, 
anxiety, and depressive symptoms.95,97-100 Therefore, interventions that address COVID-19 risks 
associated with smoking, and associated impacts including stress and reduced social connections, 
especially among tobacco-use disparity populations, are needed. 
 
 
Methods: Describe, in detail, the research activities that will be conducted under this protocol: 
 
Informed Consent Process 
Screening eligibility and study enrollment for all phases of the research will occur either online via the 
study’s webpage, in person, or by phone or mail. All advertisements will contain the study: toll-free phone 
number, email address, and Qualtric’s website link. Individuals will be provided a brief description of the 
study, and then screened in person or by phone. For further information, they can be sent a link to the study 
website. The website will contain a short description of the study as well as eligibility questions. Qualtrics 
(https://www.qualtrics.com) is a secure, online, HIPAA-compliant survey software that transmits data to and 
from secure firewalled data centers using Transport Layer Security encryption. We successfully used this 
software to obtain informed consent and to administer a tobacco use and health behavior survey study in a 
rural AK region with over 400 adult participants (57% AN persons). The potential research participant will 
be informed of the details of the study and the fact that participation is entirely voluntary and will not affect 
their current or future medical care at the Alaska Native Tribal Health Consortium (ANTHC) or Mayo Clinic 
medical facilities. The potential research participants will be given the opportunity to have any questions 
about the study answered and will have as much time as they need for the consent process. If anyone is 
Study Design and Methods 

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uncomfortable completing their survey via Qualtrics, they will be given the option to complete their surveys 
by email, phone, or in person with assistance from a study team member. 
Verbal Consent: For phases 1, 2 and the supplemental aim, the research presents no more than minimal risk 
to subjects and involves no procedures for which written consent is normally required outside of the 
research context. If the potential participant is eligible and verbally consents to participate they are enrolled. 
 
Written Consent: For phases 3 and 4, if the potential participant is eligible to participate, they will complete 
the informed consent in person, by mail or email, or on-line. If consent is completed on-line, to ensure they 
review the document, their understanding of the consent form will be assessed online through multiple choice 
questions with required answers before being able to proceed with the study. Questions are based on those 
used in studies with potentially vulnerable participants.112 Any wrong answers during the consent will be sent 
to study staff who will contact the potential participant via email or phone for clarification. For those who 
complete their consent by mail, A study team member will mail the consent form to the participant to review, 
sign, and mail back in the enclosed postage-paid return envelope. Those who wish to complete consent by 
DocuSign, but experience difficulty, will be provided support by a study team member to complete the 
DocuSign process. Eligible individuals completing the informed consent process will be enrolled. 
 
The potential research participant will be informed of the details of the study and the fact that 
participation is entirely voluntary and will not affect their current or future medical care at the Alaska 
Native Tribal Health Consortium (ANTHC) or any tribal or Mayo Clinic medical facilities. All screening 
and consent forms/processes are approved by the Alaska Area IRB and are at the eighth grade reading level. 
Computer software programs are used to test the reading level of each document. Individuals will be given 
an opportunity to ask questions and decide whether or not s/he wishes to participate. The consenting 
software is designed to ensure that all participants meet the inclusion/exclusion criteria as stated in the 
study protocol and that the potential participant clearly understands the study procedures and agrees to 
follow them. Prior to survey administration, potential participants will be able to receive a copy of the 
consent information for their records. If they agree to participate they will select to proceed to the web 
survey, or exit if they choose to decline. The consent form will include information on the nature of the 
study and alternatives to taking part, and contact information (toll-free number) for the PIs of the study. 
Participants will be encouraged to phone with concerns or problems that might occur during the study. 
 
Standard language in our consent procedure assures the study participants of the confidential nature 
of the study. Those who participate will be clearly told that they may withdraw from the study at any 
time without adversely affecting their current or future medical care at the Alaska Native Tribal Health 
Consortium (ANTHC) or any tribal or Mayo Clinic medical facilities. These standards are strictly 
adhered to and monitored by the Alaska Area IRB and the Mayo IRB 

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Formative Work to Develop the Intervention: Aim 1 (Phases 1-3) 
Projected Content and Structure for the Facebook Intervention 
Structure and duration. The intervention will consist of a Facebook group moderated by an AN 
facilitator. To address potential concerns about Facebook privacy, 94 we will utilize a closed and secret 
Facebook group and a group policy/guideline that emphasizes confidentiality of all content. A secret 
group is defined as invitation only, with the group and content not visible to anyone on Facebook except 
participants. Thus, anyone searching on Facebook would not find the group nor be able to request to join. 
Also, group membership or postings through newsfeeds will not be visible on the participants’ personal 
Facebook page. 
We chose to use a moderated group based on research indicating that moderators play a critical 
role in directing and tailoring content to the group and enhancing overall social media engagement. 
47,95 Also, the frequency of moderator Facebook postings is associated with increased participant 
engagement. 51 
The Facebook group will be active for 3 months. A content library of moderator postings will be 
developed for posting within the Facebook group for the 3 months that the group is active. The 
moderator will check-in with the group about 3-4 times daily to respond to comments and other user- 
generated content, and to prompt and direct discussions by encouraging participants to share stories 
about their tobacco use journey. Participants will be notified through news feeds when there is new 
Facebook content posted. 
Content for moderator postings. Moderator postings will be developed from two existing sources. 

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First are the CDC Tips™ campaign digital story videos. 3 The 31 stories are based on factual appeals to 
quit smoking and each is about 2.5 minutes long. The stories address different phases of the quitting 
process, specifically: motivation (why to quit), engaging in treatment (how to quit), and relapse 
prevention. We anticipate creating about 8-10 new digital stories featuring AN persons. However, 
based on formative work, we recognize that existing Tips™ stories such as Michael’s story (AN former 
smoker) may be acceptable, and will be included. The digital stories will be embedded in moderator 
postings as YouTube links. 
Second, for additional content for moderator postings, we will tailor existing postings from a recently 
held CDC Facebook event “30 Smoke-free Days” that invited people nationwide to set a quit date and 
targeted adults ages 18-54 years. A moderator posted once daily for 30 days. These general audience 
moderator postings included images combined with text that were inspirational, celebrated quitting 
milestones, and included embedded YouTube links to specific Tips™ videos. The content is consistent 
with clinical practice guidelines for behavioral strategies to motivate, prepare and assist individuals to 
quit smoking, and stay tobacco free. 38 In an uncontrolled evaluation, over a 1-month period, 3,221 
people nationwide received updates and posts from the Facebook page, and of these, 641 (20%) actively 
participated by making a quit attempt or supporting others to quit. The mean total engagement (likes, 
shares, replies, comments) on event content was high (36%) compared to the average monthly 
engagement rate of 4-6% on the CDC main Facebook wall. Moderator postings with the highest level of 
engagement, defined as discussion and participant sharing, were themes related to lack of family support, 
weight gain, and cravings. 
For cultural tailoring, messaging will center on abstinence from all tobacco and nicotine products, 
including ST/iqmik and e-cigarettes. Differentiating ceremonial/traditional tobacco use from commercial 
use is not an issue as prior work documents that AN people do not use tobacco for such purposes. 11 
Our goal is to design a social media intervention that could be delivered on a large-scale population 
basis. The CDC “30 Smoke-free Days” Facebook event and the Tips™ campaign both prompted a call to 
positive action, specifically to use free state quitline services, a scalable approach we will use in this 
study. Quitlines represent a high impact approach to improve access and availability of tobacco 
dependence treatments because of their potential to achieve wide reach into the population, including 
hard-to-reach subgroups. The AK quitline services consist of free coaching calls, web coaching, 
supportive text messaging program, personalized web- based quit plan, a quit guide and other written 
materials, and/or a two week starter supply of free nicotine patches, gum, or lozenges. Quitline coaches 
receive cultural competency training for coaching AN people. 
However, we recognize it is important to also promote other types of treatment resources in the 
event that federal funding for state quitlines diminishes. Thus, we will additionally promote use of 
evidence-based quit smoking website resources (smokefree.gov) along with regional tribal tobacco 
treatment programs which provide phone counseling and access to stop smoking medications. Tribal 
programs vary on the number of counseling sessions and duration of free nicotine replacement 
therapy provided. 
Health Communication Framework 
We will use Dr. Resnicow’s cultural variance and surface/deep structure frameworks4,5 to address the 
influence of culture in designing health messages. Cultural variance framework considers AN cultural 
influences on health behaviors including specific beliefs, norms (i.e., communication styles, social 
acceptance of tobacco use), values (e.g., interdependence), and AN knowledge systems/ways of 
knowing. 11,30,32-34,63 Surface and deep structure inform both content and format of messages. Surface 
structure involves matching materials and messages to observable social and behavioral characteristics 
such as AN people, music, and clothing. The second dimension (deep) incorporates cultural beliefs and 
values. Appropriate surface structure generally enhances receptivity, comprehension, and acceptance of 
messages whereas relevant deep structure conveys salience. Cultural variance framework largely 
addresses deeper level components of tailoring messages. We will use a planning framework based on 

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the NCI115 and CDC116 recommendations for developing social media and other digital health 
communication tools, addressing key components of message construction. This framework is in line 
with researcher recommendations to iteratively develop digital health interventions with user feedback. 
107,108 Thus, as part of our formative work we will conduct two rounds of qualitative (phase 1) then 
quantitative (phase 2) pre-testing to develop message concepts and develop the intervention. Next, the 
intervention prototype will be developed and beta-tested (phase 3). 
 
Phase 1 
Qualitative Pre-Testing using Individual Interviews 
Sample. We will use a stratified purposeful sample119 of AN adult smokers with divisions based on 
audience segment (sex, age group [19-29, 30-49, 50+ years] and region [urban, rural]). Krueger120 
recommends conducting at least 10-15 interviews per major subset before reaching data saturation, 
whereby no new information is being learned. 120 We estimate about 40 individual interviews (20 men, 
20 women; 20 urban, 20 rural; 12-13 within each age group) to achieve data saturation. Eligibility 
criteria for participants are described in Table 1 below. Various stakeholders will also be interviewed 
including AK quitline coaches, tribal cessation program counselors, and Alaska Education Advocacy 
members, with about 10 interviews total. There are no eligibility criteria for stakeholders, other than that 
they must be health professionals; stakeholders will be selected and approached for participation by the 
Mayo study team. The ANTHC Tobacco Cessation Program will obtain names and contact information 
of Tobacco Treatment Specialists and statewide Quitline personnel interested in being contacted for the 
interviews and provide them to the Mayo study team. Priority for stakeholder interviews will be based on 
length of time providing tobacco cessation counseling. Stakeholders will verbally consent and complete 
an interview similar to participants but it will be geared to health care professional views instead of those 
of an AN person who smokes. 
Procedures. Interviews will be done by phone and last about 45 minutes, but may take as long as one 
hour. Participants will receive a $25 Visa gift card as remuneration. Eligible participants who have 
provided verbal consent as described above will be emailed a password-protected link to view the 
materials online. Materials will be available for review online on the study web site and links to the 
materials will also be emailed to the participant. At the end of the interview the participant will be asked 
if he/she would like referral information for programs and services to quit smoking. If the participant is 
interested, the study coordinator will mail the participant information on the Alaska Quitline and local 
tribal tobacco cessation program. 
Moderator guide and training. A semi-structured moderator guide was developed and a project 
coordinator at ANTHC will conduct the interviews. Dr. Sinicrope and Ms. Hughes will provide training 
for the project coordinator in Anchorage including 4 hours of didactic instruction, followed by 4 hours 
of mock interview practice, and a certified completion interview. 120 All sessions will be audiotaped. 
The interview will first cover a brief assessment of socio-demographics such as health literacy, 
age, sex, education, marital status, and tobacco use. The interview also covers: 
(a) Tips™ digital stories: Review 4 stories from Tips™ (each about 30 seconds long) and 
obtain feedback. Participants will view online selected general audience videos (i.e., Terrie Bill, and 
Jessica’s stories) and one video featuring an AN person with COPD (Michael’s story) due to the 
strong emotional appeals about impacts of quitting on family members. 121 
Link to CDC Tips™ videos: https://www.cdc.gov/tobacco/campaign/tips/index.html 
 
 For each story: feedback is obtained on the storyteller and story characteristics, including 
identification and engagement; 122 and cultural congruence (i.e., factual-based appeals from 
former smokers). 
 Compare reactions for general audience stories versus the story featuring an AN person. 

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 Assess preferences for message source for new stories: AN person, sex, age, region, tobacco 
use, and relationship (e.g., grandparent, sibling, spouse or Elder). 
(b) ANTHC digital stories: Participants will view two stories from the 7 videos below that 
feature AN people and are already developed by ANTHC. The research team will select 2 
videos of potential videos listed below. 
 
The video descriptions and online links are as follows: 
1. 
Tania (community health aide, role model), 
time 1:38https://player.vimeo.com/video/55410351 
2. 
Edith (cancer, quit for family), 
time 2:33https://vimeo.com/160043666 
3. 
Casandra (cancer, dad quit, she quit for husband and son), 
time 2:33https://player.vimeo.com/video/55320782 
4. 
Caroline (chew tobacco), 
time 2:25 
https://player.vimeo.com/video/55 
320781 
5. 
Marie (quit smoking for son), 
time 2:21 
https://player.vimeo.com/video/553207 
84 
6. 
Caroline (role as tobacco prevention professional), 
time: 1:48https://player.vimeo.com/video/55320946 
7. 
Aubrey (she didn’t start smoking until college and only smoked for a year, then quit), 
time: 1:38https://player.vimeo.com/video/62102834 
 
(c) Other content for moderator postings (text and images): Four general audience postings 
from the CDC 30 Smoke-Free Days Facebook event will be viewed by participants that represent 
different themes, such as setting a quit date, celebrating milestones, family support, and cravings. 
 The cultural relevance of postings is assessed and ideas for adapted or new content are gathered. 
 Individual and cultural barriers to smoking treatment use or cessation that should be 
addressed; for example, beliefs about quitlines and stress/affective comorbidity123, 124 
are addressed. 
(d) Optimizing Facebook intervention engagement: Finally the interviewer asks participants 
how to make the Facebook group more engaging (i.e., would text message prompts help?) and assess 
cultural need for groups separated by sex/age. 
The stakeholder interview is similar except for brief demographic questions only and the feedback 
elicited is geared to health care professional views instead of those of an AN person who smokes. 
Qualitative analyses. Sample characteristics will be summarized using descriptive statistics. 
Recordings will be transcribed by a professional transcription service. Content analysis125 supplemented 
by QSR NVivo software, version 10 (Doncaster, Victoria, Australia) will be used to generate response 
themes. All transcribed statements will be analyzed. Codes and categories will be developed based on 
moderator guide topics and themes emerging from the data. Two study team members will code 
responses independently for each topic area; inter-rater agreement (kappa coefficient) will be assessed. 
During this open-coding process, themes will be extracted for analysis when there is code endorsement 
or elaboration by several interviews. In addition to open coding, planned comparisons within and across 
sex, age, and region strata will be carried out and connections made between identified categories. 
Coding discrepancies will be resolved through discussion with a third study team member until consensus 
is reached. 

13 of 44 
 
Concept development. From the qualitative results, the research team will develop six test concepts: 
3 storylines for the digital videos with written text and graphics, and 3 image/text moderator postings 
representing different types of appeals and message sources. We will consult with the ANTHC media 
department and Mayo social media department in developing these concepts. 
 
 
Inclusion/Exclusion Criteria: 
Table 1: 
Participant Eligibility Criteria and Rationale for Both the Formative Work and Pilot Trial: Phases 1-4 
Study 
Inclusion/Exclusion 
Criteria 
Rationale 
Alaska Native person 
(based on self-reported 
race/ethnicity) and 
resides in Alaska 
Study targets a population with among the highest prevalence of tobacco use in 
the U.S. We chose to conduct this initial study in AK to reduce sample and 
intervention design heterogeneity. Across the nation, there is immense cultural 
and geographic variability, e.g., urban vs. reservation dwelling, ceremonial vs. 
non-ceremonial tobacco use. Also, AK has highest percentage of AN residents 
vs. all other states (19% vs. 2%).107 If effective, the intervention could be 
adapted for and disseminated to AI/AN adults nationwide. 
Age 19 years or older 
Legal smoking age in AK is 19 years. Different social media venues and content 
may be warranted to address developmental issues among those <18 years. A 
Twitter-based intervention for adult smokers 20-59 years found age was not 
related to engagement or cessation,108 thus, we chose not to restrict the upper age 
limit. 
Both men and women 
will be included 
There are no preliminary data to indicate sex-specific interventions are 
warranted at this stage of the research. We will explore sex differences on 
feasibility and efficacy as a research question. 
Smoked at least 1 
cigarette per day over the 
past 7 day period 
Allows for participation of AN people who smoke who report fewer cigarettes 
per day and are considered “light” smokers, but have cotinine concentrations 
equivalent to “heavy” white smokers, indicating differences in nicotine 
metabolism.109,110 
If other tobacco use, 
cigarettes are the main 
tobacco product used 
Cigarette smoking in combination with other tobacco product use is highly 
prevalent in some AK rural regions;9 thus, results are more generalizable if other 
tobacco use is allowed. 
Considering or willing to 
make a quit attempt 
Intervention promotes treatment utilization and quitting. We will explore 
readiness to quit as a potential moderator of Facebook engagement and efficacy. 
Has access to Broadband 
(high speed) Internet on 
mobile phone, at home, 
work, or other location. 
Facebook can be accessed on a variety of technology devices such as computers, 
iPads, and mobile phones. Broadband internet access is needed to access social 
media and to upload and download videos and other links. 
Has an existing Facebook 
account or willing to set 
up an account prior to 
study enrollment. 
There is already good adoption of Facebook in rural regions of AK. Including 
participants familiar with regular social media interaction enhances participation, 
whereas non-users or those unfamiliar with Facebook are less likely to engage in 
the intervention.108,111 To provide study access to a broader group, we will offer 
an online or paper-based tutorial for those without a Facebook account. 
For past 3 months not 
enrolled in a program or 
using pharmacotherapy 
Study promotes treatment uptake, utilization, and quitting. 

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to stop smoking 
 
Phase 2: Quantitative Pre-Testing of Prototype 
Sample. We will test the concepts developed in Phase 1 using quantitative survey interviews 
conducted with a new sample of 40 AN adult smokers (eligibility criteria described above) via a stratified 
purposeful sample119 with divisions based on audience segment (sex, age group, urban/rural region). 120 
Participants will receive a 
$25 Visa gift card as remuneration. 
Procedures. Respondents will view test concepts online through pictures and text embedded in the 
survey. If preferred, participants will be mailed or emailed the concepts for review in advance of the 
survey. The survey will be done online via Qualtrics survey software or by email or phone if preferred. 
The survey will take about 20- 30 minutes to complete. At the end of the survey the participant will be 
asked to indicate if he/she would like referral information for programs and services to quit smoking. If 
the participant responds Yes, the study coordinator will mail the participant information on the Alaska 
Quitline and local tribal tobacco cessation program. 
Measures. The survey will include items assessing socio-demographics such as health literacy, age, 
sex, education, and marital status; tobacco use, and a validated measure of perceived effectiveness (PE) 
to pre-test each concept. PE is useful for assessing the likelihood of success of potential messages when 
large scale efficacy pretesting for behavioral impact is impractical. 126 Measures of PE have been 
underutilized in the evaluation of message tailoring for subpopulations. We will use a 6-item validated 
measure of PE that was used to evaluate the Tips™ stories121 and similar to PE measures used in other 
smoking cessation research. 127 After viewing each concept, respondents will rate their level of 
agreement on a scale from 1 (strongly disagree) to 5 (strongly agree) with the following statements: (1) 
this was worth remembering, (2) this grabbed my attention, 
(3) this was powerful, (4) this was informative, (5) this was meaningful, (6) this was convincing. 
Participants will also rate each concept for “this fits with my culture.” Statistical analyses. Sample 
characteristics and PE items will be summarized using descriptive statistics including means, 
percentages, and frequencies. The Chi-square goodness of fit test will be used to analyze concepts most 
and least preferred by participants. The association of participant sex, age, and region with message 
concept preferences will be examined using line regression. 
 
Prototype Development 
Mayo Clinic social media department will create the Facebook group page, develop the content library of 
moderator postings, and set up the software to capture participant use data. Existing Tips™ stories 
deemed culturally acceptable in the formative phase will be utilized for moderator postings. Moreover, 
ANTHC will develop new digital stories based on their extensive expertise. 60-62 Two workshops will be 
held in Anchorage by two trainers with about 4-5 AN participants each, with the goal of helping 
individuals to generate compelling stories about their tobacco use journey. Participants will be selected 
from our qualitative work or by the Community Advisory Board (CAB) members and invited to 
participate, representing both sexes and different age groups, as well as residents of urban and rural 
regions. The workshops will be held over 3 days lasting about 4-8 hours each day. Each participant will 
sign a press release and receive a $250 honorarium. Meals and beverages will be provided each day 
during the training. Instructions will be mailed to each participant prior to the workshop to bring a draft 
of their story of 1.5 pages or 250 words in length and photos/music they wish to incorporate. The talking 
circle is an integral part of story development. At the workshop, participants will first share their story in 
a circle to help facilitate dialogue and to obtain feedback to further develop their stories. 
After making revisions, each participant will privately record his or her story. Next, the trainers will edit the 
story with the participant to create an integrated theme consistent with the formative findings. Each story 

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will be2.0-2.5 minutes as social media research indicates that the average duration a user will watch a 
video is 2.7 minutes. 128 
Additional content for moderator postings will consist of images combined with text designed to 
provide information and stimulate participant discussion. All text will be written in the English 
language at a 5th grade reading level using readability analysis software. One study found that text 
combined with images increased Facebook engagement 84% more than text-only posts, 129 consistent 
with other research. 130,131 Facebook postings for optimal engagement are about 120 characters in 
length. 132 
Taglines to all moderator postings will have a call to action for tobacco treatment by providing the: (1) 
AK state toll-free quitline number, (2) web link to regional tribal tobacco cessation programs, and (3) link 
to the smokefree.gov quit smoking resources website. 
We will construct a content library organized similar to a treatment manual. 111 The content library will 
have 30postings to be used by the moderator once per day; and repeated for each month the group is 
active. In a future Stage II efficacy trial, we plan to fully automate these postings to increase intervention 
scalability. 108 
The moderator will also prompt and reinforce user-generated postings and discussion (e.g., sharing of 
stories of tobacco use and quitting) to sustain participant engagement. 133 Moderator guidelines for 
responding to participant questions and handling of inappropriate or misinformation will be included in 
the content library. 
 
Phase 3 
Beta-Testing of the Prototype 
The intervention prototype will be beta-tested with a different sample of 10 participants (eligibility 
criteria above). A Facebook group size of 10 was the minimum number for optimal engagement in 
prior work. 49,134The purpose of this phase will be to expose participants to the 30 days of moderator 
postings and obtain 
feedback, to ensure that the system works as intended, to note any technical issues that need to be 
remedied, and to facilitate any refinements of the program. In the subsequent pilot trial, the Facebook 
group will be active for 3 months, but for this formative phase of the study, participation will be 
completed at the end of the 30-day 
beta-testing period. 
 
An online survey will be administered at baseline to assess socio-demographics such as health literacy, 
age, sex, education, marital status, social media use, and tobacco use. A follow-up survey will also be 
administered at the end of the 30 day intervention period that includes self-reported smoking status and 
treatment utilization, and the Social Media Usability Measure which assesses perceived ease of use, 
usefulness, and satisfaction rated on a 7 point scale (1-strongly disagree, 7-strongly agree); 135 as well as 
open-ended questions for feedback on modifications to the prototype. The baseline and follow-up 
surveys will be done online or by phone, or the survey will be mailed with a postage paid return envelope 
depending on participant preference. These surveys will take about 15-20 minutes each to complete. 
Participants will receive a $25 gift card for completing each assessment. Refinements will be made based 
on user feedback. 
 
Phase 4 
Randomized Controlled Pilot Trial (Aim 2) 
Design Overview and Considerations 
The pilot trial, a two-arm, parallel groups, randomized controlled design, will enroll 60 participants 

16 of 44 
 
Randomized with 1:1 allocation to the intervention or control condition. Participants will be randomized 
within stratified 
blocks based on sex (male, female), age group (19-29, 30-49, 50+ years), and region (urban, rural); 
potential variables related to outcomes. 10,12 Assessments will be conducted for both study groups at 
baseline and at 1, 3,and 6 month follow-up. The primary outcomes are feasibility indicators and the 7 
day, biochemically- confirmed smoking abstinence rate at 6-month follow-up. Secondary endpoints are 
self-reported engagement in smoking cessation treatment and quit attempts. Table 2 compares and 
contrasts the two study conditions. 
 
Table 2: Design Elements of Study Groups 
Intervention 
Components 
Intervention Condition 
Facebook Group + Quitline/Treatment Referral 
Control Condition 
Quitline/Treatment Referral 
Only 
Quitline/ 
treatment 
referral 
(both groups) 
Description of tobacco treatment services, phone numbers and web links sent via postal 
mail (printed materials) and email. Treatment options provide free, professional assistance 
based on U.S. clinical practice guidelines: (1) AK quitline, (2) regional tribal tobacco 
cessation programs, and (3) smokefree.gov resources (e.g., free texting program and 
smartphone application, quit guide) 
Facebook 
Intervention 
(developed in 
formative 
work) 
• Participants join a secret (private), culturally relevant 
Facebook group for 3 months, and moderated by an AN 
tobacco research counselor 
• 3 months of moderator postings; plus 3-4 daily check- 
ins/postings to respond to participant generated content 
and encourage sharing of personal stories/experiences 
relevant to all stages of the quitting process and 
treatment engagement 
• No additional intervention 
provided by research staff 
 
Supplemental Aim: Quantitative 
We will use the information we have learned in our previous phases to adapt existing content on 
COVID-19and smoking, and conduct quantitative testing of PE among a new sample of 40 AN smokers 
using identical procedures and evaluation process as was done in phase 2 of the study. 
Sample. We will enroll 40 AN smokers recruited statewide, with stratifications based on audience 
segment (sex, age, and location – rural or urban). Recruitment procedures and study eligibility criteria 
are described above. Participants meeting the eligibility criteria will be provided with details on the 
study and asked to provide verbal consent. Participants will receive a $25 gift card for their time. 
FB Content. We will use existing content (i.e., text, videos, images) on COVID-19 and smoking for 
adaptation from the ANTHC media department, Tips™ Campaign, and the U.S. FDA Center for 
Tobacco Products social media content. Informed by the cultural variance and surface/deep structure 
health communication frameworks,4,5 the qualitative work completed previously provided insights into 
cultural tailoring for new content on COVID-19 and smoking. Qualitative analyses indicated that 
participants preferred culturally relevant content that included images of AN people, places, and 
activities that told a compelling story and was emotional. Participants tended to have less interest in 
content that was not relatable or that included individuals who were not AN. If a story was not AN, then 
it needed to include AN values, such as including family/children or telling a story in a ‘real’ way, with 
emotion and honesty. Figure 1 below provides an example of how we modified existing content in the 
parent R34 grant to be relevant to the AN culture. 

17 of 44 
 
Figure 1 
 
Existing CDC Tips posting 
Modifications: 
Include AN people, 
include AN activities, 
include family as an 
inspiration 
 
New CANQuit FB posting 
 
We will consider additional COVID-19 relevant adaptations to existing content that may impact 
treatment utilization and quitting, as barriers or facilitators, including stress, anxiety, perceived risks, 
social isolation, and social support. The research team will select 2 videos and 4 text/image postings for 
adaptation and evaluation for PE. We will continue to seek technical assistance from the CDC Health 
Communications Branch and advice from the Community Consultation Committee in selecting new 
content with feedback from our moderators who are interacting with CAN Quit participants daily. 
Procedures. Following verbal consent, we will email each eligible candidate a link to the online survey. 
Participants received a $25 gift card upon survey completion. Respondents will view each of the postings 
then completed a 20-minute online Qualtrics (Provo, Utah, U.S.) survey assessing socio-demographic 
and tobacco use characteristics and an appraisal of PE of each posting using a validated measure of 
PE.120 Participants will report how much they agree with the following 6 statements for each posting: 
“This was worth remembering,” “This grabbed my attention,” “This was powerful,” “This was 
informative,” “This was meaningful,” and “This was convincing” using a 5-point scale from 1 (strongly 
disagree) to 5 (strongly agree). A total PE score is produced summing scores for the 6 items and dividing 
by the number of items in the scale (i.e., possible total score range 1=strongly disagree to 5=strongly 
agree); scores > 3.0 indicate greater PE. We added “This fits with my culture” to assess cultural 
relevance for each posting, with identical response options. 
Statistical Methods. We will summarize sample characteristics, responses to individual items, total 
PE score, and the cultural relevance for each posting, with the Kruskal Wallis test to assess associations 
of the total PE score and cultural relevance item to sex, age group (<30, 30-49, and >50 years), locality 
(urban, rural). P- values ≤ 0.05 will be considered statistically significant. Postings with PE > 3.0, no 
substantive differences across demographic groups, and with elements considered salient to AN people 
who smoke, will be added to the FB intervention content library. 
 
Interventions 
All participants will receive evidence-based38 tobacco treatment referral information by postal mail 
(printed materials) and email, including information on their regional tribal tobacco treatment 
program, state quitline, and smokefree.gov quit smoking resources (see Table 2). 
Control condition will receive no additional intervention provided by research staff. 
Intervention condition will additionally receive the Facebook intervention developed in Aim 1. With 
the enrollment letter, participants will receive instructions for joining the Facebook group. The Facebook 
group will be moderated on a daily basis by an AN tobacco research counselor who will be trained onsite 
in Anchorage by Drs. Prochaska and Resnicow using didactics and mock Facebook postings; a 
“refresher” training will occur 6 months after the initial training. The research team will develop a written 
guide for how often the moderator 

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should log in with expectations for his/her engagement. Moderators will also enhance engagement through 
prompting discussion of cultural identity and how that relates to smoking through various Facebook methods 
(e.g. Facebook poll, comments). A 
potential concern about using social 
media for health interventions is that 
user postings may be of poor quality, 
for example, inconsistent with clinical 
practice guidelines38 or involve 
inappropriate or illegal activities. 136,137 
When participants enter the study they 
will be informed about the policies for 
posting content and that any 
inappropriate postings will be 
removed. In Dr. Prochaska’s Twitter 
trial, less than 1% of postings were 
inappropriate. 48 The moderator will be 
trained to handle inappropriate or 
misinformation and to direct 
information content toward evidence- 
based information exchange and social 
support. A random 
sample of 20% of moderator postings and responses to participant inquiries and discussions will be 
selected every week for the first four weeks and monthly thereafter. 138 These transcripts will be coded 
by Dr. Sinicrope to assess moderator adherence to the proscribed intervention. Feedback will be 
provided to the moderator during weekly research team teleconferences. 
 
Measures 
Assessments (see Table 3) will be completed at baseline and 1, 3, and 6 months follow-up. Missing data 
will be minimized through online assessments. With the exception of obtaining a saliva specimen for 
cotinine analysis, all measures will be administered online using Qualtrics. An email link will be sent 
automatically by the Mayo Clinic Survey Research Center to complete the assessment. If a participant 
does not complete online assessments, he/she will be contacted through email or by phone by the project 
coordinator and prompted to complete the assessment. The baseline and follow-up surveys will be done 
online, by phone, in person, or the survey will be mailed with a postage paid return envelope depending 
on participant preference. These surveys will take about 15-30 minutes each to complete. Participants 
will be mailed a $25 Visa gift card as remuneration for completing each assessment, the intervention 
group will receive their initial $25 Visa gift card after they complete the baseline assessment and join the 
Facebook group. 
 
Socio-demographic and tobacco use characteristics. At baseline, we will assess participants’ health 
literacy, sex, age, tribal group, cultural identity (language, traditionalism),30 region of residence, marital 
status, education, employment, and current frequency of use of Facebook and other social media 
platforms. Tobacco use measures will include cigarettes per day, years of smoking, readiness to quit 
(Contemplation Ladder),139 use of other tobacco and nicotine products, and the time to first cigarette 
after waking <30 minutes vs. >30 minutes,140which is primarily consistent with the 6-item Fagerström 
Test for Cigarette Dependence.141,142 
 
Feasibility measures. To assess feasibility and reach, we will collect data on: # screened, # eligible based 
on the inclusion/exclusion criteria, # of eligible participants enrolled, and reasons for exclusion or non- 
Table 3: Pilot Trial Measures 
Baseline 
1, 3, & 
6 
Months 
Socio-demographics and tobacco use 
X 
Feasibility measures (e.g., retention, 
Facebook use and engagement) 
X 
Self-reported smoking abstinence 
X 
Self-reported tobacco/nicotine product 
use 
X 
X 
Saliva cotinine: to verify smoking 
abstinence 
X 
Self-reported smoking treatment 
utilization 
X 
Communal Orientation Scale (mediator) 
X 
X 

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participation. 
The proportion of 60 participants completing the 6 month follow-up assessment (i.e., retention) 
and the proportion providing a saliva cotinine specimen at each assessment will also be 
summarized. Treatment acceptability will be assessed with brief intervention satisfaction rating 
scales.16 
Data from the Facebook application programming interface143 will be extracted using Sprinklr 
software.144 Foreach week of the study, we will extract for each intervention participant the following 
engagement metrics: # of logins; # digital story downloads; # user-generated posts, comments, questions 
and responses to the moderator or other users; # likes, shares and reactions; and time and date of each. In 
addition, a transcript of all participant postings will be generated for content analysis. 
 
Smoking abstinence. At each follow-up, we will obtain the participant’s self-reported cigarette use in the 
past 7 and 30 days, number of cigarettes smoked per day, and quit attempts. We will also assess current 
use of ST/iqmik, e-cigarettes, and other tobacco/nicotine products. All participants will be mailed a saliva 
kit with a collection tube and postage paid return envelope. Participants returning a saliva specimen will 
receive an additional $25 Visa gift card. The specimen will be shipped to and assayed by Mayo Clinic 
laboratories. This approach has been feasible in several NIH-funded clinical trials conducted in AK (DA 
025156; CA164533; CA153605) and in other studies148; and biochemical verification is recommended in 
randomized trials with sample sizes under 500.146 Point prevalence smoking abstinence will be defined as 
no smoking (not even a puff)for the last 7 days verified with salivary cotinine level <15 ng/ml.146,147 Use 
of nicotine replacement therapy and ST/iqmik use will be assessed at follow-up because its use would 
elevate cotinine concentrations. If participants indicate use of e-cigarettes, saliva cotinine and reported e- 
cigarette use will be recorded and analyzed separately from biochemically verified cigarette smoking 
abstinence. 
 
Smoking Treatment Utilization. As a secondary aim, we will document self-reported use of any evidence- 
based cessation aid during the 6 month study period. For this pilot study, it is not practical to objectively 
verify self- reported treatment use given heterogeneity of potential services/medications used. 
 
Communal Orientation Scale (COS). The 14-item validated COS148-149 will be administered at 
baseline and follow-up to examine interdependence as a culturally relevant mediator of intervention 
efficacy. In the intervention condition, we will also explore association of COS baseline scores with 
Facebook engagement. This measure assesses the extent to which individuals are relationship- 
versus self-oriented. 
 
Coronavirus (COVID-19). At the 6 month follow-up assessment we will obtain information on the 
impacts ofCOVID-19 on smoking treatment and cessation. For those receiving the Facebook 
intervention we will also obtain satisfaction with the COVID-19 content and conversation. 
 
Sample Size Calculation 
The goal of the pilot trial is to obtain effect size estimates to adequately power a larger scale, Stage II 
efficacy trial. A sample size of 60 enrolled will be sufficient to determine the intervention’s feasibility. 
Although not able to detect statistically significant study group differences on smoking abstinence, the 
study can obtain estimates of the intervention effect towards planning a definitive Stage II efficacy trial. 
For the dichotomous variable of point prevalence abstinence, 30 subjects per condition should provide 
relatively stable group proportions for effect size estimates. Effect size estimates will include odds ratios 
for smoking abstinence. In addition to demonstrating feasibility, a doubling of the abstinence rate for the 
intervention vs. control condition at 6 months will be considered to be of clinical significance and 

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warrant proceeding to an efficacy trial.150 This approach is consistent with recommendations for Stage I 
work in behavioral addictions treatment development and for conducting small-scale trials to advance e- 
health interventions.151 Given the small sample size, proposed mediational analyses are exploratory. 
 
 
Data Analysis Plan 
Recruitment data will be summarized, including the number of potential participants screened, number 
excluded for each inclusion/exclusion criteria, and number of eligible individuals agreeing to participate. 
To assess program reach, we will calculate proportion of subjects enrolled to total eligible subjects and 
compare enrollment rates by region (rural or urban) using the chi-square test. Baseline demographics will 
be summarized and compared between study groups using the chi-square test for categorical variables and 
the two-sample t- test/rank sum test for continuous variables. Percentage of enrolled participants 
completing each follow-up assessment (i.e., study retention) and ratings of treatment acceptability will be 
compared between study groups using the chi-square test (Fisher’s exact test). Facebook use and 
engagement will be summarized using descriptive statistics and time effects over the 3 month treatment 
period will be assessed via mixed effects models as appropriate to explore sex, age group, and region 
effects respectively. The association of COS baseline scores and Facebook engagement will be evaluated 
using linear regression. Qualitative (content) analysis125 will be utilized to generate themes in Facebook 
postings and comments. 
Biochemically- confirmed 7-day point prevalence tobacco use rate at 1, 3, and 6 months follow-up will 
be compared between conditions using logistic regression (with odds ratio and 95% confidence interval 
estimates). Using an intent-to-treat approach, we will classify as smoking participants eligible but lost to 
follow-up or not providing biochemical verification of smoking abstinence. We will also explore 
multiple imputation methods1152-154 to classify lost to follow-up as cigarette smokers or non-smokers and 
conduct sensitivity analyses as appropriate. For these analyses, we will adjust for stratification factors 
(sex, age group, urban/rural region) and any baseline differences observed between treatment conditions 
if data allow (i.e., adequate numbers of subjects verified as abstinent). Secondary analyses using logistic 
regression will explore intervention effects on self-reported abstinence from all tobacco/nicotine 
products, quit attempts, and self- reported tobacco treatment utilization. We will follow procedures 
suggested by MacKinnon155,156 to assess mediation, fitting logistic/linear regression models to the data. 
 
Study Dissemination Activities 
After receiving Tribal review and approval, findings relevant to the community will be disseminated 
through presentations at regional and national community events and postings on websites and 
newsletters. Findings relevant for the scientific community will be presented at conferences and 
published in peer-reviewed journals. All manuscripts for publication and all abstracts for presentations 
will be submitted to ANTHC for Tribal review and approval prior to submission to a journal or other 
public venue. 
 
Additionally, after receiving tribal review and approval of the following, findings relevant to the Alaska 
Native communities have been developed into a newsletter. In phases 3 and 4, as part of the consent 
process, we asked participants permission for re-contact after the study ended. We will send the 
newsletter only to those who provided consent for future contact in phases 3 and 4. In phases 1 and 2, 
we did not ask participants for permission to contact them in the future. Because sharing results is an 
important part in the research process, we will send the newsletter to phase 1 and 2 participants only 
with AAIRB approval. The newsletter only shares the results of the CAN Quit study, and does not invite 
people to participate in future research. 
Should any ‘return to sender’ letters occur, we will simply recycle these letters. 

21 of 44 
 
 
 
 
 
 
Project Timeline (Table 4) 
 
Table 4: Timeline 
Tasks 
Year 1 
Year 2 
Year 3 
Month: 
3 
6 
9 
12 
15 
18 
21 
24 
27 
30 
33 
36 
IRB/tribal approvals 
X 
Phase 1-3 
Pre-testing 
X 
X 
X 
Develop/beta test 
prototype 
X 
X 
X 
Phase 4 
Pilot trial 
recruit/intervention 
X 
X 
X 
Follow-up 
X 
X 
X 
X 
Analysis 
X 
X 
Dissemination 
X 
Resources: Describe the available resources to conduct the research (personnel, time, facilities, mentor 
commitment, etc.): 
Research Team 
Collectively, the study team is uniquely suited to conduct the proposed study. Mayo Clinic and ANTHC 
collaborators have established and maintained a successful partnership for the past 16 years. The PI, Dr. 
Patten, is an expert in behavioral tobacco treatment. Other partners include Dr. Sinicrope (Co- 
Investigator, qualitative expert), Ms. Hughes (Research Assistant), and Mr. Decker (Biostatistician) at 
Mayo Clinic; and Dr. Koller (AK site PI), Zoe Merritt (Project Coordinator) and Clara McConnell 
(Facebook Group Moderator) at ANTHC. This team has substantial experience conducting research with 
AN people, including the use of mixed qualitative and quantitative methods to assess tobacco use and 
intervention preferences, along with development of culturally congruent tobacco cessation treatments. 
Dr. Resnicow (Consultant), University of Michigan, Ann Arbor, MI, is an expert in cultural messaging 
and tailoring of health promotion interventions. Since 2013, he has collaborated with the Mayo team and 
partners in rural AK to develop the social marketing campaign messaging to reduce smokeless tobacco 
and other tobacco use among pregnant AN women.65,102 New collaborations were formed through 
developing this proposal. Dr. Prochaska (Co-Investigator), Stanford University, is an expert in designing 
and testing social media platforms for smoking cessation and has an ongoing R01 NHLBI funded trial 
using a telemedicine intervention for smoking/health behavior change among rural AN cardiology 
patients. Dr. Prochaska also consulted with the CDC on the 2016 Tips™ campaign with a focus on 
tailoring messages to smokers with depression. In addition, she was a member of the Tobacco Control 
Research Priorities Working Group.45 Finally, collaborators at the CDC Health Communications Branch 
(that developed Tips™) contributed to this proposal and will provide guidance on intervention content. 
Community Advisory Board (CAB)An existing CAB of AN adults, originally formed for a study on 
tobacco treatment during pregnancy,64,103 provided input on this proposal during three meetings (two in- 
person and one via phone). We will form a study-specific CAB with about 10 members comprised of 
several existing CAB members and new members. The CAB members will be diverse, representing 

22 of 44 
 
various tribal health regions in AK; with experience using social media and some being former smokers. 
Quarterly phone or in-person meetings with CAB members will guide all study activities. Members will 
receive an honorarium and a meal will be provided for in-person meetings. 
General Approach: Stage Model of Behavioral Therapies Development Research 
Our approach follows the three-stage model of behavioral therapies development104 and the proposed aims 
correspond to the two sub-stages characterizing Stage I work. In Stage Ia formative work, we will develop the 
Facebook intervention. In Stage Ib, we will use rigorous design and methodology to evaluate the intervention’s 
feasibility and potential efficacy. Stage Ib results will inform a future R01, Stage II, randomized efficacy trial 
A 3 year timeline is proposed. The formative work will take place in months 1-20 and recruitment 
for the pilot trial will occur in months 21-27, with intervention, follow-up and analyses completed by 
month 33. The remaining months will be spent on dissemination activities. 
The study will be conducted at the ANTHC in Anchorage and at Mayo Clinic. All data collection 
and the intervention will be conducted by study staff at ANTHC and Mayo Clinic. Data will be 
collected and maintained by the Mayo Clinic Survey Research Center via Qualtrics software. Mayo 
Clinic will collect and maintain data electronically in a secure REDCap database. 
 
Mayo Clinic study staff will be engaged in research activity at a non Mayo Clinic site. Description of 
the activity that will be conducted by Mayo Clinic study staff. 
The study will be conducted at the ANTHC in Anchorage and at Mayo Clinic. All data collection and 
the intervention will be conducted by study staff at ANTHC and Mayo Clinic. Several procedures are 
established to monitor the quality assurance of the study. For qualitative data collection, a semi-
structured interviewer guide will be developed and the Anchorage-based Project Coordinator will 
conduct the interviews. Dr. Sinicrope and Ms. Hughes will provide training for the project coordinator 
on-site in Anchorage including 4 hours of didactic instruction followed by 4 practice hours of mock 
interviews and a certified completion interview. All sessions will be audiotaped. These transcripts will be 
coded by Dr. Sinicrope to assess counselor adherence to the proscribed intervention, and feedback will 
be provided during weekly research team teleconferences. 
Mayo Clinic social media department will create the Facebook group page, develop the content 
library of moderator postings, and set up the software to capture participant use data. A random sample 
of 20% of moderator postings and responses to participant inquiries and discussions will be selected 
every week for the first four weeks and monthly thereafter. These transcripts will be coded by Dr. 
Sinicrope to assess moderator adherence to the proscribed intervention, and feedback will be provided 
during weekly research team teleconferences. 
A manual of study procedures will be developed for the project coordinator. Ms. Hughes, a Mayo 
Clinic research assistant and clinical trials coordinator, will travel with Dr. Patten to Anchorage, Alaska, 
to train the study staff on the data collection and other study procedures including monitoring of adverse 
events. We will use the same coordination, communication, and quality control procedures successfully 
utilized in our previous work. For ongoing trials in Alaska, we hold weekly conference calls with study 
staff in AK and at Mayo Clinic to discuss progress and problem solve issues related to recruitment and 
data collection. We also monitor quality control of the data on site through review of participant forms 
and procedures every 3 months. Mr. Paul Decker, Biostatistician on this protocol, will oversee the 
transfer of data forms, electronic data, and data storage. The Mayo Survey Research Center will 
electronically transfer all data to Mr. Decker. The quality of the data (data checks) including missing data 
and presence and frequency of outliers will be monitored once per month by Mr. Decker. For study 
recruitment, Ms. Hughes will track posting of ads through FB and in Alaska local newsletters and 
websites. AK study staff will also recruit in person using flyers and different methods of in person 
recruitment. 
All measures will be administered online using Qualtrics software, a data security service. An email 

23 of 44 
 
link will be sent automatically by the Mayo Clinic Survey Research Center to complete the assessment. 
If a participant does not complete online assessments, he/she will be contacted through email or by 
phone by the project coordinator and prompted to complete the assessment. Data collected from survey 
responses will be handled and maintained by the Mayo Clinic Survey Research Center and a de- 
identified database of responses will be provided to the investigators. Interview forms and audio tapes 
will be labeled with subject ID numbers only; all personal identifiers will be removed before the data 
are sent to Mayo Clinic for analysis. At Mayo Clinic the audio tapes will be stored in a locked file 
drawer accessible only to the PI, Dr. Patten, Co- Investigator, Dr. Sinicrope, and the Research 
Assistant, Christine Hughes. These will be destroyed once the interviews are fully transcribed. 
A trained research assistant at Mayo Clinic will mail the saliva sample kit to the participant; and the saliva 
samples, labeled with a subject ID number only, will be shipped directly back to Mayo Clinic for analysis of 
cotinine. Once the specimen sample is processed and results posted, the sample will be destroyed 
immediately. 
The study staff in Anchorage and Rochester will monitor any reports or observations of medical 
problems or severe depression or other psychiatric symptoms in participants. Drs. Patten and Prochaska, 
licensed clinical psychologists, will be consulted by telephone to consult with the study staff as needed. 
 
 
Target accrual: We will recruit up to a total of 200 Alaska Native (AN) people who smoke (100 in the formative 
phases, 60 for the randomized pilot trial, and 40 for the quantitative supplemental aim). 
Screening for eligibility will occur online via the study’s web page, by phone, or in person; and they can 
also use the study toll free number to answer any questions about the study. Verbal consent is adequate 
for phases 1, 2 and the supplemental aim since we are not collecting any personal health information, but 
written consent is required for phases 3 and 4. For phases 3 and 4, if respondents are eligible, they have 
the option to complete the informed consent in person, mail, e-mail, or on-line (i.e. DocuSign). 
 
ANTHC will also recruit 10 stakeholders (AN and non-AN persons) for phase 1, such as quitline 
coaches, in person or by phone. 
 
Subject population (children, adults, groups): We will recruit AN men and women statewide using 
targeted, paid, Facebook advertisements (i.e., digital targeting) or in person based on: (1) >19 years of 
age, (2) AN race/ethnicity and (3) keywords related to tobacco use. Ads will include an image and short 
text consistent with Facebook’s advertising guidelines. Facebook ads are a successful method of 
recruiting for research studies, especially among hard-to-reach populations.105-106 Using targeted 
Facebook advertisements in a rural region of AK, we have successfully recruited AN adults for studies, 
after learning in formative work that people preferred Facebook for outreach. Similarly, Facebook has 
been successful in promoting recruitment for a telemedicine project focused on smoking/health behaviors 
among cardiology patients in rural Nome, AK. We will partner with organizations that have a large 
Facebook following, such as the Alaska Federation of Natives (AFN), along with village-specific 
Facebook pages to advertise the study. We will also use flyers and advertise in tribal newsletters and 
websites. 
 
X (6) Video audio recording: Plan to maintain subject privacy and data confidentiality, transcription, store or 
destroy, etc. 
 
Phase 1: Digital Videos that will be developed to use in the Facebook intervention - 8-12 Alaska 
Native people will record their tobacco use stories. These individuals will sign a release stating they give 
Subject Information 
Review of medical records, images, specimens 

24 of 44 
 
permission for the study team to share their stories and they will be made aware that their stories will 
become a part of the public domain and will be seen by study participants on a secret Facebook page. 
 
Phase 1: Audio Tapes of qualitative interviews to assess the development of the Facebook 
intervention – No names, voices, or images from the audio tapes from the interviews will be released. 
Permission to audio tape will be part of the verbal consent process. Confidentiality of the audio tapes will 
be maintained by keeping these in a locked drawer in the study office. Only the research team will 
review the audio tapes. Once the audio-tapes are fully transcribed and checked for accuracy, they will be 
destroyed. 
 
 
 
 
 
Power Statement: For the pilot RCT, the goal is to obtain effect size estimates to adequately power a 
larger scale, Stage II efficacy trial. Our recommended sample size, 60 enrolled AN people who smoke, 
will be sufficient to determine the intervention’s feasibility. We recognize that the study is not 
adequately powered to detect statistically significant group differences on smoking abstinence, but we 
seek to obtain estimates of the intervention effect towards planning a definitive Stage II efficacy trial. 
 
Data Analysis Plan: Recruitment data will be summarized, including the number of potential participants 
screened, number excluded for each inclusion/exclusion criteria, and number of eligible individuals 
agreeing to participate. To assess program reach, we will calculate proportion of subjects enrolled to 
total eligible subjects and compare enrollment rates by region (rural or urban) using the chi-square test. 
Baseline demographics will be summarized and compared between study groups using the chi-square 
test for categorical variables and the two-sample t-test/rank sum test for continuous variables. Percentage 
of enrolled participants completing each follow-up assessment (i.e., study retention) and ratings of 
treatment acceptability will be compared between study groups using the chi-square test (Fisher’s exact 
test). Facebook use and engagement will be summarized using descriptive statistics and time effects over 
the 3 month treatment period will be assessed via mixed effects models as appropriate to explore sex, 
age group, and region effects respectively. The association of COS baseline scores and Facebook 
engagement will be evaluated using linear regression. Qualitative (content) analysis125 will be utilized to 
generate themes in Facebook postings and comments. 
Biochemically- confirmed 7-day point prevalence tobacco use rate at 1-, 3-, and 6-months follow-up will be 
compared between conditions using logistic regression (with odds ratio and 95% confidence interval 
estimates). Using an intent-to-treat approach, we will classify as smoking participants eligible but lost to 
follow-up or not providing biochemical verification of smoking abstinence. We will also explore multiple 
imputation methods152-154 to classify lost to follow-up as cigarette smokers or non-smokers and conduct 
sensitivity analyses as appropriate. For these analyses, we will adjust for stratification factors (sex, age group, 
urban/rural region) and any baseline differences observed between treatment conditions if data allow (i.e., 
adequate numbers of subjects verified as abstinent). Secondary analyses using logistic regression will explore 
intervention effects on self- reported abstinence from all tobacco/nicotine products, quit attempts, and self- 
reported tobacco treatment utilization. We will follow procedures suggested by MacKinnon155,156to assess 
mediation, fitting logistic/linear regression models to the data. 
 
Endpoints 
Primary: The primary outcomes will be feasibility (e.g., Facebook engagement) and the biochemically- verified 
smoking abstinence rate at 1, 3, and 6 months follow-up. 
Secondary: Secondary outcomes will include self-reported smoking cessation treatment utilization and 
Data Analysis 

25 of 44 
 
abstinence from all tobacco/nicotine products. We will also explore interdependence (relationship 
orientation and collaborative efforts in lifestyle change) as a culturally relevant mediator of 
intervention efficacy. 

26 of 44 
 
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Protection of Human Subjects Training 
Key personnel identified in this grant application have completed the required education on the 
protection of human research participants at their respective institutions. The Mayo Clinic has established 
a formal program entitled the “Mayo Investigator Training Program” (MITP). The MITP is a web-based 
educational course designed to provide all personnel involved in human subject research with training 
about human subject protection. All Mayo personnel engaged in human subject research are required to 
complete the course. MITP primary objectives are to provide historical context for human subject 
protection regulations and explore the evolving issues for human subjects research. 
The Alaska Area Indian Health Service Institutional Review Board requires completion of an 
educational course on the protection of human subjects for anyone conducting or engaged in Alaska 
Native research. This course is online and entitled the “Collaborative IRB Training Initiative Program 
Protection of Human Subjects 

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(CITI Program), available at: http://www.CITIprogram.org. All investigators and key personnel have 
completed this educational course. Prior to the award of this grant, the study will be reviewed and 
approved by the Mayo Clinic and Alaska Area Institutional Review Boards (IRBs) and Alaska Native 
Tribal Health Consortium (ANTHC) board of directors. Recruitment of study participants will 
commence after approval by all IRBs and Boards. 
 
Recruitment and Study Inclusion/Exclusion Criteria 
We will recruit up to a total of 200 Alaska Native (AN) people who smoke (100 in the formative phase, 
60 for the randomized pilot trial, and 40 for the quantitative supplemental aim). Screening for eligibility will 
occur in person, on the phone, or online via the study’s web page. If respondents are eligible, they will be 
taken to the study’s informed consent web page. If preferred, screening will also be done by phone or in 
person, and they can also use the study toll free number to answer any questions about the study. 
Participants will be recruited using targeted, paid, Facebook advertisements (i.e., digital targeting) or 
in person based on: (1) age 19 years and older, (2) AN race/ethnicity, and (3) keywords related to tobacco 
use. Ads will include an image and short text consistent with Facebook’s advertising guidelines. 
Throughout Alaska, we will advertise in tribal newsletters and web sites. 
Study enrollment for all phases of the research will occur either in person, online or by mail. All 
advertisements will contain the study: toll-free phone number, email address, and Qualtrics’s website 
link. Individuals calling or emailing will be provided a brief description of the study and sent a link to 
the study website. The website will contain a short description of the study as well as eligibility 
questions. Qualtrics (https://www.qualtrics.com) is a secure, online, HIPAA-compliant survey 
software that transmits data to and from secure firewalled data centers using Transport Layer Security 
encryption. 
Eligibility criteria for participants are (1) >19 years of age (legal smoking age), (2) Alaska Native 
race/ethnicity, (3) smoke at least 1 cigarette per day over the past 7-day period, (4) if other tobacco 
use, cigarettes are the main tobacco product used, (5) considering or willing to make a quit attempt, 
(6) access to internet, (7) have an existing Facebook account or willing to set up an account, and (8) 
is not using pharmacotherapy or has not enrolled in a program to stop smoking for past 3 months. 
Each person is only eligible to participate in one part of the study. Remuneration in the form of gift 
cards will be provided to all participants. If the individual is not eligible or not interested, he/she will 
be given tobacco treatment referral information. 
Various stakeholders will also be interviewed including AK quitline coaches, tribal cessation 
program counselors, and Alaska Education Advocacy members, with about 10 interviews total. There 
are no eligibility criteria for stakeholders, other than that they must be health professionals; 
stakeholders will be selected and approached for participation by the Alaska Native Tribal Health 
Consortium (ANTHC) study team. 
 
Sources of Material 
Data collected from interviews, questionnaires and specimen samples (saliva) will be used for 
research purposes. With the exception of obtaining a saliva specimen by mail for verification of smoking 
abstinence, all measures will be administered by phone or online using Qualtrics. For online 
assessments, an email link will be sent automatically by the Mayo Clinic Survey Research Center to 
complete the assessment. The qualitative interviews in the first phase of the research will be audiotaped. 
The content of the Facebook intervention from participant postings and comments will be summarized. 
 
Potential Risks and Procedures to Minimize Risks 
Risks are minimal and include those associated with the inconvenience of completing assessment interviews 
and surveys, of providing saliva samples, nicotine withdrawal symptoms for those who stop smoking, and some 
potential risks related to confidentiality. A trained research assistant will obtain the saliva sample(s) from the 
participant by mail and this should not present a risk to subjects. No medications will be administered as part of 

36 of 44 
 
this study. 
Data collected from survey responses will be handled by the Mayo Clinic Survey Research Center, which uses 
Qualtrics data security service and a de-identified data base of responses will be provided to the investigators. 
Qualtrics meets requirements set by the Federal Information security management Act of 2002, the Health Insurance 
Portability and Accountability Act, and the Health Information Technology for Economic and Clinical Health Act. 
Qualtrics servers are protected by high-end firewall systems, vulnerability scans are performed regularly, and 
complete backups of the data are performed nightly. Qualtrics uses Transport Layer Security (TLS) encryption (also 
known as HTTPS) for all transmitted data. We also protect surveys with passwords and HTTP referrer checking. 
Survey data is hosted by third party data centers that are SSAE-16 SOC II certified. All data are considered 
confidential, and treated as such, with no specific designation (such as medical (PHI), PII, or public). Finally, data 
entered in REDCap uses secure and certified data centers. 
In our moderated Facebook intervention, it is impossible to know in advance what might be posted by 
users, and it is possible that incorrect postings or postings that might cause some emotional discomfort could 
occur. Participants will be encouraged to contact the project coordinator if any issue arises that causes them to 
feel uncomfortable. There are also some minimal risks with respect to confidentiality. As a member of a secret 
Facebook group, participants will be asked to talk about his/her own tobacco use and others’ use of tobacco, and 
participate in discussions about moderated postings regarding AN tobacco use, readiness to quit tobacco, and 
tobacco treatment resources, among others. Thus, it is possible that health information or other personal 
information about study participants or other AN members could be disclosed on Facebook postings. To 
ameliorate concerns, a list of do’s and don’ts for posting on the secret Facebook page will be posted at the front of 
the page so that whenever a participant joins the Facebook group, they will be reminded of these guidelines for 
sharing information, protecting confidentiality, and posting appropriately. Participants will be asked or encouraged 
to not mention specific names of people in their house or community. A trained moderator will monitor user 
postings and guide participants in culturally appropriate postings that do not violate confidentiality or harm 
Facebook group members. If someone is offended by Facebook postings, they can message the moderator to 
resolve any concerns. Any adverse events related to the Facebook group will also be handled by the DSMP, if 
necessary. Despite these arrangements, we do not anticipate any adverse consequences of participating in the 
secret Facebook group. The Facebook group will be secret and closed so no one will be able to join the group, 
locate the group through a Facebook search, or see reactions or postings to the group through Facebook 
notification unless they are an official and invited member of the secret and closed group. 
Information from the participants will not be shared with anyone else except for the research team. The group 
moderator will emphasize confidentiality of the group discussions. Moreover, while data from this study will be 
published, participants will be informed that their name, village and other identifying information will not be 
published. No voices or images from the audio tapes from the interviews will be released. Permission to audio 
tape will be part of the consent form. Confidentiality of the audio tapes will be maintained by keeping these in a 
locked drawer in the study office. Only the research team will review the audio tapes. Once the audio-tapes are 
transcribed, they will be destroyed immediately. 
As part of developing the Facebook intervention, 8-12 Alaska Native people will record their tobacco use 
stories. These individuals will sign a release stating they give permission for the study team to share their stories 
and they will be made aware that their stories will become a part of the public domain and will be seen by study 
participants on a secret Facebook page. 
Screening data will not include any unique identifiers and will be used for descriptive purposes only (i.e., to 
characterize the population of individuals screened who were found to be ineligible or not interested in 
participating). For enrolled participants, confidentiality will be maintained by assigning every participant a 
study number (no identifiers) and by numerically coding all data. All biospecimens will be labeled with the 
subject ID number only. The association of the ID number and the participant will be kept by the Alaska site PI 
and destroyed after completion of the project. All data obtained through interviews and other subject records 
will be kept in locked filing cabinets in offices that are kept locked when unoccupied. Subject files will be kept 
in a secure area, with access only by designated staff members (PIs and study staff). Any computer storage of 
data will be password protected and only available to the PIs and the project coordinator. 

37 of 44 
 
All information connecting study ID numbers to participant names will be destroyed after completion of 
the project. Five years after publication of the results (per standard journal guidelines) all paper copies of 
interview forms, Facebook transcripts and the data base sent to Mayo Clinic for analysis, will be destroyed. 
Only summaries of group data will be reported in any publications or presentations, with no identification of 
individuals or villages. 
All data elements and data transfer activities will be strictly compliant with HIPAA privacy regulatory 
requirements. Saliva samples will be shipped directly to Mayo Clinic for analysis of cotinine. These will be 
labeled with a subject ID number only. Once the specimen sample is processed and results posted, the sample 
will be destroyed immediately. Interview forms and audio tapes will be labeled with subject ID numbers only; 
all personal identifiers will be removed before the data are sent to Mayo Clinic for analysis. Standard security 
measures to store data are in place within the Mayo Clinic. Moreover, at Mayo Clinic the audio tapes will be 
stored in a locked file drawer accessible only to the PI Dr. Patten, Co-Investigator Dr. Sinicrope, and the 
Research Assistant Christine Hughes. 
For participants who stop using tobacco in the pilot randomized trial, although uncomfortable, withdrawal 
symptoms do not pose significant health risks. Smoking cessation may result in: increased irritability, 
depression, anxiety, tension and increased hunger and drowsiness. Participants in both study conditions will 
receive written, self-help materials, which cover potential nicotine withdrawal symptoms and how to manage 
these. In addition, those who call the Alaska quitline, which is the goal of this study, will receive support on 
their quit attempt by a licensed quitline counselor, as well as a bevy of support materials in print and online. All 
pilot trial participants will complete online assessments via Qualtrics at baseline, 1, 3 and 6 months completion; 
and at these times any adverse symptoms will be assessed and those reporting adverse symptoms will be called 
by the project coordinator and be referred for appropriate treatment if necessary. 
Clinical Management 
A detailed plan is in place for clinical management of psychiatric or medical problems that might arise. 
The study staff in Anchorage and Rochester will monitor any reports or observations of medical problems 
or severe depression or other psychiatric symptoms in participants. In the event of such an occurrence, they 
will set into motion standard procedures for management of depression and other psychiatric or medical 
symptoms in research subjects. If necessary, the study staff will arrange for additional assessments of the 
subject’s symptoms by a physician in Anchorage or at a local tribal medical facility. Individuals who report 
suicidal intent or other severe psychiatric or medical problems will be referred for treatment and followed 
throughout the study period. In the event of an emergency (e.g., suicidal plan), Anchorage staff physicians 
will be consulted to refer the subject for treatment at ANMC or a local tribal medical facility. Drs. Patten 
and Prochaska (licensed clinical psychologists) will be consulted by telephone to consult with the study 
staff as needed. Continued participation with the study will be voluntary and in cooperation with the health 
care professional treating the subject’s psychiatric or medical condition. 
 
Potential Benefits of the Proposed Research to Subjects and Others 
The study is designed to evaluate the potential effect of an intervention to promote utilization of tobacco 
treatment and to reduce tobacco use among AN persons. In the first phase of the research, participants 
will be asked for feedback in designing the intervention. All subjects will potentially benefit from 
discussions about tobacco use and quitting and referral information on stop smoking resources. In the 
next phase (randomized pilot trial), all participants will receive written tobacco treatment materials that 
cover cessation advice and strategies for quitting as well as referral information. The participants will 
have the opportunity to benefit by making behavioral changes with respect to quitting smoking or 
stopping their tobacco use and have access to free treatment resources. The participants randomized to 
the Facebook group may also receive support from others to help them quit using tobacco. If the 
Facebook intervention is helpful, then others may benefit if we are able to show that it works. The study 
will help us learn more about helping people quit tobacco. 
 

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Importance of the Knowledge to be Gained 
Developing effective interventions to decrease tobacco use among AN people is a national priority. The 
prevalence of smoking among U.S. adults is highest among Native Americans and there is a lack of 
tobacco cessation interventions developed specific to this disparity group. Social media has promise as a 
scalable intervention strategy to promote engagement in treatment and cessation outcomes for AN 
people. This proposal addresses three of seven gaps and priorities in the tobacco research field identified 
by the Tobacco Control Research Priorities Working Group (2016), namely by: (1) targeting an 
underserved tobacco use disparities population, (2) developing a novel behavioral intervention using a 
social media platform, and (3) promoting uptake of evidence-based treatment and quitting. The proposed 
social media intervention, if effective, has relevance for advancing the science of tobacco treatment for 
Native American communities. If the intervention is found to be effective, the intervention materials and 
strategies could be tested in a larger scale RCT and could be readily transportable for use throughout the 
Alaska Native community. With some modifications, the intervention materials could also be considered 
for use in other Native communities and in populations with a focus on cultural interdependence. 
 
 
Power Calculation and Sample Size 
Sample size for each stage of this research was guided by guidelines for behavioral treatment 
development research. For the formative work we calculated the number of interviews necessary to 
cover the major subsets of interest based on audience segment (gender, age, region) and to achieve data 
saturation, whereby no new information is being gained by adding participants. 
For the pilot RCT, the goal is to obtain effect size estimates to adequately power a larger scale, Stage 
II efficacy trial. Our recommended sample size, 60 enrolled AN people who smoke, will be sufficient to 
determine the intervention’s feasibility. We recognize that the study is not adequately powered to detect 
statistically significant group differences on smoking abstinence, but we seek to obtain estimates of the 
intervention effect towards planning a definitive Stage II efficacy trial. For the dichotomous variable of 
point prevalence abstinence, 30 subjects per condition should provide relatively stable group proportions 
for effect size estimates. Effect size estimates will include odds ratios for smoking abstinence. In addition 
to demonstrating feasibility, a doubling of the abstinence rate for the intervention vs. control condition at 
6 months will be considered to be of clinical significance and warrant proceeding to an efficacy trial. 
This approach is consistent with recommendations for Stage I work in behavioral addictions treatment 
development and for conducting small- scale trials to advance e-health interventions. Given the small 
sample size, proposed mediational analyses are exploratory. 
 
TRIAL MANAGEMENT 
List of Participating Enrolling Clinics or Data Collection Centers 
The study will be conducted at the ANTHC in Anchorage and at Mayo Clinic. All data collection 
and the intervention will be conducted by study staff at ANTHC and Mayo Clinic. Data will be 
collected and maintained by the Mayo Clinic Survey Research Center via Qualtrics software. ANTHC 
will collect and maintain data electronically in a secure REDCap database. 
Projected Timetable 
A 3-year timeline is proposed. The formative work will take place in months 1-20 and recruitment 
for the pilot trial will occur in months 21-27, with intervention, follow-up and analyses completed by 
month 33. The remaining months will be spent on dissemination activities. 
Target Population Distribution 
Nearly all (98%) of participants will be of AN race. All participants will be of legal smoking age, 
19 years of age or older. Both males and females will be enrolled. We expect that about half the sample 
(50%) will be female based on our prior studies. 
Data Safety Monitoring Plan (DSMP) 

39 of 44 
 
 
DATA MANAGEMENT AND ANALYSIS 
Data Acquisition and Transmission 
All data collected by Mayo Clinic study staff will be done via the Qualtrics website, which is 
managed by the Mayo Clinic Survey Research Center. Data collected on paper forms by the ANTHC 
project coordinator will be entered into a secure REDCap database. Confidentiality will be maintained by 
all data containing only a sequentially assigned study number for each subject. The study number will 
not be linked to the subject’s date of birth, village, hospital or any medical record number, initials, social 
security number, or any other identifying information. All hard copies of data will be kept in secure 
locked file drawers. Mr. Paul Decker, Biostatistician on this protocol, will oversee the transfer of 
electronic data and data storage. The quality of the data (data checks) will be monitored once per month. 
Five years after publication of the results (per many journal guidelines) the paper forms and 
electronic databases will be destroyed. Only summaries of group data will be reported in any 
publications or presentations, with no identification of individuals. 
Permission to audiotape the qualitative interviews in the first phase of the research will be included in 
the verbal consent process. Once the interviews are fully transcribed the audiotapes will be destroyed 
immediately. 
All biospecimens for the pilot RCT will be labeled with subject ID number only. Once the result 
from the laboratory analysis is completed at Mayo Clinic, the biospecimen will be destroyed 
immediately. Test results will be posted electronically using subject ID number only. 
The Mayo Clinic Division of Biostatistics has a well-developed structure for data management with 
over 7,000 studies currently under their control. Working data is maintained on a single large file server 
that services the entire section. Inactive files are moved to archival storage under control of an automated 
system, itself controlled by a DBMS (Ingres) based request system which ensures that all data movement 
is appropriately logged and commented. The archival storage is hosted on the institutional mainframe 
computer, which also supports billing and registration. The use of the mainframe ensures several high-
level support functions for the archive system, e.g. storage of media in separate fire zones, regular 
copying of data to new media, guaranteed availability. 
The data management will be governed by standard procedures within the division with regard to 
data security and access. All analyses are logged with respect to IRB authorization, accounting 
information, principal and secondary investigators, statistician, and data analyst involved in the 
analyses. All computer files and systems will be password protected and accessible by authorized 
personnel only. 
Data Entry Methods 
As the Qualtrics website is being utilized through the Mayo Clinic Survey Research Center to 
administer consent as well as assessments, most quantitative data will be automatically entered. Any data 
not automated will be entered by the Anchorage staff using a secure REDCap database. Discrepancies 
will be corrected by Mr. Paul Decker, Biostatistician on this protocol. Mr. Decker will oversee all data 
entry. All qualitative data will be transcribed by a professional transcription service and imported into 
QSR NVivo software, version 10, for analyses. 
 
QUALITY ASSURANCE 
A manual of study procedures will be developed for the project coordinator. Ms. Hughes, a Mayo 
Clinic research assistant, and clinical trials coordinator will travel with Dr. Patten to Anchorage, Alaska 
to train the study staff on the data collection and other study procedures. We will use the same 
coordination, communication and quality control procedures successfully utilized in our previous work. 
For ongoing trials in Alaska, we hold weekly conference calls with study staff in AK and at Mayo Clinic 
to discuss progress and problem solve issues related to recruitment and data collection. We also monitor 
quality control of the data on site through review of participant forms and procedures every 3 months. 

40 of 44 
 
Mr. Paul Decker, Biostatistician on this protocol, will oversee the transfer of data forms and data storage. 
The Mayo Survey Research Center will electronically transfer all data to Mr. Decker. The quality of the 
data (data checks) including missing data and presence and frequency of outliers will be monitored once 
per month by Mr. Decker. For study recruitment, Ms. Hughes will track posting of ads through FB and in 
Alaska local newsletters and websites. 
For qualitative data collection, a semi-structured interviewer guide will be developed and the project 
coordinator in Alaska will conduct the interviews. Dr. Sinicrope and Ms. Hughes will provide training for 
the project coordinator on-site in Anchorage including four hours of didactic instruction followed by four 
practice hours of mock interviews and a certified completion interview (Krueger & Case, 2009). All 
sessions will be audiotaped. 
The moderator for the FB-delivered intervention will report to Dr. Koller, Alaska site PI and work in 
tandem with the project coordinator. The moderator will be trained on-site in Alaska by Drs. Prochaska 
and Resnicow using didactics and mock Facebook postings and a “refresher” training will occur 6 
months after the initial training. The research team will develop a written guide for how often the 
moderator should log in and expectations for his/her engagement. A potential concern about using social 
media for health interventions is that user postings may be of poor quality, for example, inconsistent with 
clinical practice guidelines or involve inappropriate or illegal activities. When participants enter the study 
they will be informed about the policies for posting content and that any inappropriate postings will be 
removed. The moderator will be trained to handle inappropriate or misinformation, and to direct 
information content toward evidence-based information exchange and social support. A process 
evaluation checklist will be developed for the moderator to document delivery of specific intervention 
components based on existing measures. A random sample of 20% of moderator postings and responses 
to participant inquiries and discussions will be selected every week for the first four weeks and monthly 
thereafter. These transcripts will be coded by Dr. Sinicrope to assess counselor adherence to the 
proscribed intervention, and feedback will be provided to the moderator during weekly research team 
teleconferences. 
All study staff and volunteers will be required to complete and pass the CITI HIPPA/confidentiality 
course prior to any subject contact. 
 
Regulatory Issues 
Reporting of Serious Adverse Events (SAEs) 
Any SAE, whether or not it is related to the study intervention and for all participants, will be 
reported to the Mayo Clinic and Alaska Area IRBs and NIDA. A summary of the SAEs that occurred in 
the previous year will be included in the annual progress report to the NIDA. 
Reporting of IRB Actions to the NIDA 
Any action taken by the respective IRBs regarding SAEs or major changes to the protocol will be 
reported to the NIDA. 
Report of Changes or Amendments to the Protocol 
Minor changes to the protocol are allowed without prior approval, however, major design changes 
will be reviewed and approval sought from the NIDA Program Officer prior to seeking IRB approval 
and implementation. 
Trial Stopping Rules 
Specific stopping rules have been developed to protect the safety of our study subjects. In the case of 
any SAE, the study will be stopped and no further enrollment will take place until an investigation of the 
event has taken place by the PI (Dr. Patten), Alaska site PI (Dr. Koller) or the project coordinator. 
Disclosure of Any Conflict of Interest in the DSM 
 
There are no conflicts of interest in the DSM plan that we are aware of. If such conflicts arise 

41 of 44 
 
during the course of the trial, the respective IRBs and the NIDA will be notified immediately. 
 
TRIAL SAFETY 
Potential Risks and Benefits for Participants 
Risks are minimal and include those associated with the inconvenience of completing assessment 
interviews by telephone, of providing saliva samples, and online assessments. A trained research 
assistant at Mayo Clinic will mail the saliva sample kit to the participant; and providing and mailing the 
biospecimen back to Mayo Clinic for analysis (no identifiers) should not present a risk to subjects. No 
medications will be administered aspart of this study. Data collected from survey responses will be 
handled by the Mayo Clinic Survey Research Center which uses Qualtrics data security service and a de- 
identified data base of responses will be provided to the investigators. Qualtrics meets requirements set 
by the Federal Information Security Management Act of 2002, the Health Insurance Portability and 
Accountability Act, and the Health Information Technology for Economic and Clinical Health Act. 
Qualtrics servers are protected by high-end firewall systems, vulnerability scans are performed regularly, 
and complete backups of the data are performed nightly. Qualtrics uses Transport Layer Security (TLS) 
encryption (also known as HTTPS) for all transmitted data. We also protect surveys with passwords and 
HTTP referrer checking. Survey data is hosted by third party data centers that are SSAE-16 SOC II 
certified. All data are considered confidential, and treated as such, with no specific designation (such as 
medical (PHI), PII, or public). Finally, Mayo Clinic uses secure and certified data centers. Some data 
collected by ANTHC study staff will be entered by ANTHC study staff using a secure REDCap and 
transferred electronically to Mayo Clinic. 
In our moderated Facebook intervention, it is impossible to know in advance what might be posted by 
users, and it is possible that incorrect postings or postings that might cause some emotional discomfort 
could occur. 
Participants will be encouraged to contact the moderator and/or project coordinator if any issue arises 
that causes them to feel uncomfortable. There are also some minimal risks with respect to confidentiality. 
As a member of a secret Facebook group, participants will be asked to talk about his/her own tobacco use 
and others ‘use of tobacco, and participate in discussions about moderated postings regarding AN 
tobacco use, readiness to quit tobacco, and tobacco treatment resources, among others. Thus, it is 
possible that health information or other personal information about study participants or other AN 
members could be disclosed on FB postings. To ameliorate concerns, a list of do’s and don’ts for posting 
on the secret FB page will be posted at the front of the page so that whenever a participant joins the FB 
group, they will be reminded of these guidelines for sharing information, protecting confidentiality, and 
posting appropriately. Participants will be asked and encouraged to not mention specific names of people 
in their house or community. A trained moderator will monitor user postings and guide participants in 
culturally appropriate postings that do not violate confidentiality or harm FB group members. If someone 
is offended by FB postings, they can message the moderator to resolve any concerns. Any adverse events 
related to the FB group will also be reported as described if necessary. Despite these arrangements, we do 
not anticipate any adverse consequences of participating in the secret FB group. The FB group will be 
secret and closed so no one will be able to join the group, locate the group through a FB search, or see 
reactions or postings to the group through FB notification unless they are an official and invited member 
of the secret and closed group. 
Information from the group will not be shared with anyone else except for the research team. The FB 
group moderator will emphasize confidentiality of the group discussions. Moreover, while data from this 
study will be published, participants will be informed that their name, village and other identifying 
information will not be published. No voices or images from the audio tapes or from the focus groups 
will be released. Permission to audio tape will be part of the verbal consent process. Confidentiality of 
the audio tapes will be maintained by keeping these in a locked drawer in the study office. Only the 
research team will review the audio tapes. Once the audio tapes are transcribed, they will be destroyed 

42 of 44 
 
immediately. In the formative phase of the research, some participants will be recording their smoking 
cessation stories for the intervention. These individuals (8-12) will sign a release stating they give 
permission for the study team to share their stories and they will be made aware that their stories will 
become a part of the public domain and will be seen by study participants on a secret Facebook page. 
For participants who stop using tobacco in the pilot RCT, although uncomfortable, withdrawal 
symptoms do not pose significant health risks. Smoking cessation can result in increased irritability, 
depression, anxiety, tension and increased hunger and drowsiness. Participants in both study conditions 
will receive resources that address potential nicotine withdrawal symptoms and how to manage these. In 
addition, those who call the Alaska quitline will receive support on their quit attempt by a licensed 
quitline counselor as well as a bevy of support materials in print and online. All phase 4 subjects will 
complete online assessments via Qualtrics at baseline, 1, 3 and 6 months completion; and at these times 
any adverse symptoms will be assessed and those reporting adverse symptoms will be called by study 
staff and referred for appropriate treatment if necessary. 
Screening data will not include any unique identifiers and will be used for descriptive purposes only 
(i.e., to characterize the population of individuals screened who were found to be ineligible or not 
interested in participating). For enrolled participants, confidentiality will be maintained by assigning 
every participant a study ID number (no identifiers) and numerically coding all data. The association of 
the ID-code and the participant will be kept by the research coordinator in a locked file cabinet at all 
times. All data obtained through interviews and other subject records will be kept in locked filing 
cabinets in offices that are kept locked when unoccupied. Subject files will be kept in a secure area, with 
access only by designated staff members (PI sand research coordinator). Any computer storage of data 
will be password protected and only available to the PIs and the study coordinator. 
All information connecting study ID numbers to participant names will be destroyed after completion 
of the project. Five years after publication of the results (per standard journal guidelines), all paper copies 
of interview forms, Facebook transcripts and the data base sent to Mayo Clinic for analysis, will be 
destroyed. Only summaries of group data will be reported in any publications or presentations, with no 
identification of individuals or villages. 
All data elements and data transfer activities will be strictly compliant with HIPAA privacy 
regulatory requirements. Saliva samples will be shipped directly to Mayo Clinic for analysis of 
cotinine. These will be labeled with a subject ID number only. Once the specimen sample is processed 
and results posted, the sample will be destroyed immediately. Interview forms and audio tapes will be 
labeled with subject ID numbers only; all personal identifiers will be removed before the data are sent 
to Mayo Clinic for analysis. Standard security measures to store data are in place within the Mayo 
Clinic. Moreover, at Mayo Clinic the audio tapes will be stored in a locked file drawer accessible only 
to the PI, Dr. Sinicrope, and the research assistant, Ms. Hughes. 
Collection and Reporting of AEs and SAEs 
We will use the FDA definition of adverse events (AEs) and serious adverse events (SAEs). The 
FDA guidelines for anticipated or unanticipated SAEs will be followed. Regarding monitoring 
participant safety, ansae, whether or not it is related to the study intervention, will be reported to the 
Mayo Clinic IRB, the Alaska Area IRB, and NIDA. The project coordinator and FB intervention 
moderator both located in Alaska, and the research assistant located at Mayo Clinic, will evaluate for the 
presence of both SAEs and AEs at each scheduled contact, regardless of whether conducted in person, 
via telephone, or online. Drs. Patten and/or Prochaska and will meet with the research staff via 
teleconference on a bi-weekly basis to review any new or continuing SAEs and AEs. 
Management of SAEs or Other Study Risks 
A plan is in place for clinical management of depression and other psychiatric symptoms or medical 
problems. The study staff will refer participants to the appropriate on-call physician or behavioral health 
clinician at the appropriate Alaska medical facility. The study staff will have a list of contacts as patient 
issues or concerns arise that are in need of medical or psychiatric attention, or when other types of 

43 of 44 
 
referral or assistance are needed. Individuals who report suicidal intent or other severe psychiatric 
symptoms or medical problems will be referred for treatment and followed throughout the study period. 
Continued participation with the study will be voluntary and in cooperation with the health care 
professional treating the subject’s psychiatric or medical condition. 
The study staff will be trained by Drs. Patten and Prochaska, licensed clinical psychologists, to 
observe and monitor depression and psychiatric symptoms. They will be available to consult with the 
study staff as needed. 
If the SAE involves death or a life-threatening event, the PI, Dr. Patten, will be notified immediately 
by the study staff. Dr. Patten will telephone, fax, and/or e-mail the Mayo Clinic IRB chair/vice-chair, 
Chair of the Alaska Area IRB, and the NIDA Program Official within 24 hours of when she learns of 
the event. This telephone contact will be followed up with a standardized report form submitted to both 
the respective IRBs and NIDA within 2 working days of the study staff learning of the SAE. If the SAE 
involves something other than death or a life-threatening event, Dr. Patten will submit a standardized, 
detailed report of the event to the respective IRBs and NIDA within 2 working days of when the SAE 
was reported. Reports of serious adverse events received by the respective IRBs will be reviewed by an 
institutional SAE Board, (the members of these boards are not involved in this study) to make a 
determination of the seriousness of the event and to determine what actions, if any, will be required. If 
the SAE Board determines that suspension or termination of the study is required, this information will 
also be reported to NIDA within 24 hours. 
In the event that a participant withdraws from the study or the PI decides to discontinue a participant 
due to an SAE, the participant will be monitored by the PI via ongoing status assessment until: 
(1) resolution is reached (i.e., the problem requiring treatment has resolved or stabilized with no 
further changes expected) 
(2) the SAE is determined to be clearly unrelated to the study intervention 
(3) the SAE results in death. 
Outcome of SAEs will be reported biannually to NIDA or as otherwise specified by the NIDA 
Program Official. A summary of the SAEs that occurred during the previous year will be included in the 
annual progress report to NIDA and to the respective IRBs. All protocol changes and/or protocol 
amendments will be reported to NIDA, then the IRB. Additionally, a summary of all AEs will be 
reported in an annual progress report to the respective IRBs. 
A determination of the association of the adverse event with the study intervention will be made 
and appropriate modifications to the protocol will be made if an association is suspected. If protocol 
modifications to ensure the safety of future study subjects cannot be made, the study will be terminated. 
TRIAL EFFICACY 
Plans for Interim Analysis 
As part of the ongoing data management and statistical activities conducted by the study 
biostatistician, Mr. Paul Decker, the study groups will be reviewed on a quarterly basis to assess 
differential occurrence of the type and number of SAEs and AEs. If any significant difference is found, 
the relevant covariates will be thoroughly examined in order to understand more completely the 
relationship between the variables of interest and potential impact of the intervention on SAEs and AEs. 
The results of our analyses will be reported to both the respective IRBs and NIDA. 
DSMP Administration 
The Mayo Clinic IRB, Alaska Area IRB, the PI (Dr. Christi Patten), Alaska site PI (Dr. Kathryn 
Koller), and the study staff: project coordinator (Ms. Merritt), FB group moderator (Ms. McConnell) 
and research assistant (Christine Hughes) will all be responsible. 
Responsibility for Data and Safety Monitoring 
The study staff will monitor the safety of research subjects. The study staff will receive ongoing training and 
supervision concerning data collection and management from Drs. Patten and Koller. 

44 of 44 
 
Frequency of DSM Board 
Every two weeks, the PI Dr. Patten, Alaska site PI Dr. Koller, Mr. Decker (study statistician), Ms. 
Merritt(project coordinator), Ms. McConnell (FB group moderator) and Christine Hughes (research 
assistant) will review the following information in detail at a study-specific meeting via 
teleconference: 
(1) Subject accrual rate, retention and the reasons for retention failure 
(2) Subject compliance with the protocol 
(3) Project coordinator questions or concerns 
(4) Adherence to FB protocol for moderator postings and adverse events (AEs/SAEs) and other 
issues reported by participants or the moderator or documented by the research assistant on 
FB transcripts. 
(5) Adverse events (AEs/SAEs) and other issues reported by participants as documented by the 
project coordinator on study forms. 
Decisions concerning changes, modifications, or adaptations will be decided and acted upon 
immediately. Annual Reviews: Protocols must be reviewed annually by the Mayo Foundation IRB and 
the Alaska Area 
IRB. Reports will be generated regarding the study progress. 
Content of DSM Report 
A DSM report will be included as part of our annual progress report to the NIDA and the following 
will be included: 
(1) Brief description of the trial 
(2) Baseline sociodemographic characteristics 
(3) Retention and disposition of study participants 
(4) Quality assurance issues 
(5) Regulatory issues 
(6) AEs 
(7) SAEs 
(8) Efficacy