Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial
Phase: NA
Conditions: Smoking
Sponsor: Emory University

Study Protocol 
 
Title: Smoke-free Air Coalitions in Georgia and Armenia: A Community 
Randomized Trial 
 
NCT Number: NCT03447912 
 
Document Date: May 17, 2022 
 

 
Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial               Date: 05.17.22 
 
 
 
 
 Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial  
 
 
Investigators 
 
Multiple Principal Investigators: Michelle Kegler, PhD; Carla Berg, PhD (external investigator) 
 
Co-Investigators: Regine Haardӧrfer, PhD 
 
Date: 05.17.2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial               Date: 05.17.22 
A. BACKGROUND AND SIGNIFICANCE 
 
Public health efforts in low- and middle-income countries (LMICs) could be catalyzed by developing and 
bolstering ways to optimally leverage local talents and resources. One way to accomplish this is to align civil 
society and governmental public health goals and resources.1 Civil society advocates, builds coalitions, and 
provides evidence-based information.1-6 Local public health protects, assesses, and assures individual, community, 
and environmental health.7 Local public health in many LMICs continue to have a disproportionate focus on 
communicable disease and environmental health, with less attention paid to non-communicable diseases and risk 
factors such as tobacco use. Developing effective models for aligning civil society and governmental public 
health at the local level in LMICs has the potential to impact a range of chronic diseases and risk factors, 
including tobacco. Local coalitions have been a dominant strategy in tobacco control in the US, with well-
documented success in establishing smoke-free policies specifically.8-17 Local public health agencies often serve 
as the lead agency with influential partners from a range of community sectors (e.g., education, health care) 
collaboratively identifying priorities and actions.15 Community-based tobacco control efforts have played a key 
role in shifting social norms and creating community readiness for policy change and enforcement.15 However, 
this approach has not been widely leveraged or well-studied in LMICs or those with less democratic traditions 
than the US. Instead, in many LMICs, smoke-free policy progress has been largely initiated at the national level. 
Parallel civil society movements at the local level may be needed to build support for policies, shift social norms, 
and encourage compliance with new policies.   
Given their sociopolitical histories and high tobacco use and secondhand smoke exposure (SHSe) rates, 
Georgia (GE) and Armenia (AM) are two strategic settings for the proposed work. The smoking prevalence is 
57.7% and 52.3% in men (6th and 11th highest in the world) and 5.7% and 1.5% in women, respectively.18 Despite 
ratifying of the FCTC in 2006 and 2004 in GE and AM, respectively, FCTC-recommended policy implementation 
has been limited, and tobacco use and related diseases have not declined. The sex disparities in tobacco use 
suggests a high proportion of nonusers experience SHSe. Drs. Berg and Kegler (co-PIs) and colleagues in GE 
found that 42% of GE adults report daily SHSe, with 30% reporting past-week SHSe in public places and 54% at 
home.19,20 However, we also found high receptivity to public smoke-free policies.19,20  
 
B. SPECIFIC AIMS 
 
This proposal will build the capacity of GE and AM researchers to conduct high-quality mixed methods 
tobacco research and test the Community Coalition Action Theory (CCAT)21 as a framework for impacting local 
community-driven policy change to inform such processes for the region more broadly. Researchers from the GE 
National Center for Disease Control (NCDC) and AM National Institute of Health (NIH) will collaborate with 
Emory to execute the proposed research, train tobacco control researchers within their organizations and 
partnering universities (Tbilisi State Medical University [TSMU], American University of Armenia [AUA]), and 
train practitioners within local communities to build local coalitions for tobacco control policy. Our team is 
uniquely positioned to conduct this work given our collective expertise in tobacco control, coalition building, and 
evaluation. We will leverage our prior collaborative research findings regarding high SHSe and high receptivity 
for smoke-free policies, particularly in worksites and restaurants,19,20 to develop national and local infrastructure 
to promote local tobacco control policy implementation, specifically related to smoke-free air.19,20  
• 
Aim 1. Conduct a matched-pair community randomized controlled trial in 28 municipalities in GE and 
AM to examine the impact of local coalitions promoting the adoption of smoke-free policies in worksites 
and restaurants. The primary outcome will be reductions in SHSe (per population-level surveys) over 
time.  
• 
Aim 2. Assess how community context and coalition factors influence adoption and implementation of 
organizational and municipal smoke-free policies to provide an evidence-base for public health practice. 
• 
Aim 3. Disseminate research findings regarding both the effectiveness and the process of establishing and 
maintaining coalitions, and consequently increasing smoke-free policies and reducing SHSe, to key 
stakeholders in GE and AM in order to inform future tobacco control research and practice efforts.  

 
Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial               Date: 05.17.22 
• 
Aim 4. Capitalize on proposed research and dissemination opportunities to build tobacco control research 
capacity within the GE NCDC, AM NIH, TSMU, and AUA, as well as practice capacity within local 
public health centers and their civil society partners. 
 
C. DESIGN  
 
Funder 
 
The project is pending funding by the National Institutes of Health Fogarty International Center.  
 
Participants, setting, recruitment, and procedures 
 
We propose to conduct a matched-pairs community randomized controlled trial (CRCT) to examine the impact 
of coalitions promoting smoke-free air policies on individual SHSe. In doing so, we will be able to test the 
CCAT21 and examine the characteristics and processes of community coalitions that effect change. The Emory 
team will lead the oversight of the research design and execution of all components of the research. The GE 
NCDC and AM NIH will oversee the administration of coalition grants to 7 randomly-selected municipalities in 
each country (total of 14), execute population-level surveys in each of the 14 communities per country (total of 
28), and facilitate coalition trainings, in partnership with Emory. TSMU/AUA will execute the evaluation of the 
coalitions by conducting baseline and follow-up assessments, in collaboration with Emory. Dr. Carla Berg, who 
has changed job positions since the start of the study and now is at George Washington University, will also be 
collaborating with Emory in this research study as an external investigator. However, George Washington 
University will not be recruiting any participants of their own or for their own research. The main study site will 
continue to be Emory University. Dr. Berg will be serving as the data collection coordinator at GWU, performing 
tasks such as programming web-based surveys. These activities will lead to the dissemination of significant 
research findings regarding the impact of coalitions on tobacco control and individual SHSe in LMICs and 
evidence-based practices for coalition activity. In conducting and disseminating the research, there will be 
significant research capacity-building within these organizations, as well as practice capacity-building within the 
local communities.  
In brief, throughout the study period, two in-person meetings will be held among the research team each year. 
In Years 1, 2, and 4, these teams will be held in GE and AM, respectively. One meeting per year will coincide 
with training/annual meetings of coalition members. In Years 3 and 5, one meeting will coincide with the annual 
coalition member meeting and one will coincide with an international conference to present baseline and final 
results, respectively. In addition, after the selection of emerging researchers to hire as research personnel and 
assignment to co-mentors in the pursuit of research capacity building, the mentees will meet with the mentors 
semi-annually and deliver annual reports documenting their progress. In terms of research, Year 1 involves 
baseline population-level survey data collection in all municipalities, training of coalition leaders (i.e., the local 
public health center directors) in the municipalities randomly selected for the intervention condition, recruitment 
of coalition members, and the beginning of the coalition member surveys in intervention municipalities. Year 2 
involves the completion of baseline coalition member survey data collection, additional training of coalition 
members, completion of the situational assessment, establishment of coalitions and coalition action plans, 
launching action plans, data entry and analysis, and baseline report development. Year 3 involves full execution 
of coalition action plans in intervention communities and additional baseline data analysis. Year 4 involves final 
execution of coalition action plans and the beginning of the follow-up data collections (i.e., coalition member 
assessments in intervention communities, population-level surveys in all communities). Year 5 involves 
completion of follow-up data collections, data entry and analysis, final report development, and dissemination 
efforts via academic publications and presentations at academic conferences, fact sheets for policymakers, white 
papers, and the regional conference to disseminate the research findings. 
Local public health centers will play a key role in the execution of the proposed intervention – coalition action. 
To provide context for these centers, one of the main priorities of reorienting the health system for GE and AM as 
independent countries was recognition of the need for prevention. The public health system in GE was 

 
Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial               Date: 05.17.22 
established in 1994 to improve and strengthen the processes for managing communicable and non-communicable 
diseases, reorienting the system on preventive services. The Department for Regional Public Health Management 
within the NCDC, directed by Dr. Urushadze (co-I), oversees the 68 local public health centers, which are 
municipal public units. These centers manage programs regarding communicable disease prevention, chronic 
disease management, and healthy living, as well as measures and activities to meet the health needs of the 
population living in particular areas. Public health services in AM evolved from the 1992 Law on Sanitary-
Epidemic Safety. In 2002, the country’s sanitary and epidemiological services were reorganized as the State 
Hygiene and Anti-epidemic Inspection under the Ministry of Health. It consists of a headquarters office and seven 
operations offices in Yerevan as well as 10 regional offices and several additional local public health centers and 
other facilities within the local municipalities. In the proposed study, directors of these local public health centers 
will serve as or identify key leaders to engage in the coalition trainings and lead coalition activities. 
Our study will define a “community” as a distinct municipality, given the division of communities based on 
the coverage area of the local public health centers. We will include communities with small to medium 
populations and local public health centers with sufficient capacity to engage in the proposed research. Our 
partners in GE and AM have identified 14 municipalities within each country fitting these criteria, with 
populations ranging from ~6,000 to 90,000. An example of GE municipalities and their populations, distances 
from Tbilisi, and budgets are listed in Appendix A. After confirming interest with local health center directors, we 
will form matched pairs in each country based on population size, region, and local economy and then randomly 
select one from each pair as an intervention community and the other as a control. We will use block 
randomization by country. Randomization will occur after completion of the baseline population-level survey. 
 
Condition Description. In brief, all 28 communities (14/country) will participate in the population-level tobacco 
survey at baseline and follow-up. Within each country, 7 communities will be randomized to the intervention 
condition and 7 to the control condition (i.e., 14 communities/condition).  
Control Condition. The 14 communities assigned as controls will participate in the population-level survey and 
be provided with a site-specific summary of findings but will not participate in any aspects of the intervention. 
Additionally, to examine potential contamination in the control communities, a follow-up interview will be 
conducted with public health center leaders to assess any local coalition or grassroots actions regarding tobacco 
control that may have naturally occurred or be influenced by coalition activity in other communities. 
Intervention Condition: Coalition Training, Development, and Action. Our intervention will test whether 
creation of local coalitions for 
tobacco control is feasible in 
countries without a grassroots 
community-building tradition such as 
former Soviet Union countries, and if 
established, whether local coalitions 
can shift social norms regarding 
SHSe and promote adoption of 
smoke-free policies in public settings, 
specifically worksites and restaurants. 
Our intervention approach will be 
informed by the CCAT developed by 
Butterfoss and Kegler.21 CCAT posits 
that coalitions form due to a threat, 
opportunity, or mandate. In the 
current project, local public health 
centers will be the lead agency and 
play the role of convener of the 
coalition based on an opportunity 
(e.g., funding and participation in a 
major research project). In the 

 
Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial               Date: 05.17.22 
intervention communities, public health center staff will form a coalition by recruiting partner organizations from 
civil society and other government sectors (e.g., health care, education), conduct situational assessment, and 
develop and implement action plans to promote the adoption and enforcement of smoke-free policies in worksites 
and restaurants, settings selected based on general support for smoke-free policies in these settings19,20 and the 
likelihood of impacting population-level SHSe through widespread reach. The GE NCDC and AM NIH will 
establish subcontracts with the local public health centers in the randomly selected communities to provide 
funding for local staff to develop local coalitions and to support program activities ($2,500 in Yrs 1 and 4, $5,000 
in Yr 2, $7,500 in Yr 3, total=$17,500/municipality).  
Coalition Membership. Per CCAT,21 a lead agency or convening group, in our project the local public health 
center, recruits additional coalition members to ensure diverse community representation. We will ask for a 
minimum of eight members and encourage representation from education, public health, health care, social 
services, civil society (i.e., non-governmental organizations, community groups, women’s organizations, faith-
based organizations, professional associations, trade unions, self-help groups, business associations, registered 
charities, advocacy groups), interested residents affected by cancer and tobacco use, and to the extent possible, 
media, housing, and business. Coalition leadership and staff will develop operating procedures and structures to 
facilitate member engagement in the work of the coalition and to ensure that benefits of participation outweigh the 
costs. We will provide model coalition operating procedures based on our prior work. 
 Coalition Maturation and Maintenance. According to CCAT,21 engaged coalition members pool their 
diverse individual and organizational resources (e.g., connections/access, knowledge of community history, 
tangible resources such as space/equipment, diverse perspectives, creative talents), which creates the collaborative 
synergy that results in comprehensive and appropriately tailored action plans and intervention strategies. In the 
current project, the situational assessment will be combined with coalition member perspectives to develop an 
appropriate action plan for each community that capitalizes on local strengths and acknowledges local politics and 
history. Implementation of well-designed intervention strategies, informed by best practices for policy change and 
enforcement, should result in improved policies, programs, and practices, broadly labeled as community changes 
by CCAT. These community changes, in turn, lead to health and social outcomes of interest – in this case, 
reductions in SHSe. Per CCAT, community changes, in combination with collaborative synergy, also lead to 
increases in community capacity to identify and successfully address other issues of concern to community 
members. We expect the formation of community coalitions and the planning and implementation process will 
develop new skills for tobacco control and allow for the emergence of new tobacco control leaders that increase 
tobacco control capacity at the local level. Changes in policies, practices, programs, and environments; changes in 
capacity; and changes in health and social outcomes are sustained in the institutionalization stage. Additional 
CCAT propositions state that coalitions develop in stages and can cycle through these stages as new issues 
emerge or member composition changes and that community context influences all aspects of coalition behavior. 
Figure 1 above illustrates how CCAT and its constructs will be operationalized for the current project.  
Public health center staff and coalition leaders will attend trainings on skill building in Years 1 and 2 and 
annual meetings in Years 3-5 in order for the practitioners, coalition members, and research team to 
collaboratively guide the project. Table 1 below outlines activities by year. 
Year 1 Training: Situational Assessment. In Year 1, Drs. Kegler and Berg will provide a protocol and 
materials to give an overview of the initiative and conduct training to build skills for how to conduct the 
situational assessment. The delivery of the training will be done by the Georgian NCDC and Armenian NIH staff 
in the respective countries to ensure translation to Georgian and Armenian as appropriate. Dr. Kegler conducted a 
similar training on situational assessment for the China Tobacco Free Cities project.65 See Appendix B for the 
presentation and tools (e.g., interview guide) that will be adapted for this training. 
Year 2 Training: Coalition Building, Action Planning, and Strategy Selection. In Year 2, Drs. Kegler and 
Berg will provide protocols and materials to conduct training regarding coalition building, action planning, and 
selecting intervention strategies. Each public health center will be asked to recruit at least eight coalition members 
and hold monthly meetings to lead the coalition through an action planning and implementation process. 
Situational assessment will inform which worksite and restaurant settings to target, as well as additional strategic 
settings. Action plans will include SMART (specific, measurable, achievable, realistic, and time-based) annual 
objectives, tasks, timelines, and persons responsible for completing each task. The training will include templates 

 
Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial               Date: 05.17.22 
and examples of action plans (Appendix B). We will provide examples of best practices in the US and elsewhere 
for creating policy change in each type of setting. Dr. Kegler has taught community assessment, program 
planning, and evaluation to MPH students for 20 years, and was integrally involved in training CDC practitioners 
in China to conduct similar work.65 The Emory Prevention Research Center, led by Dr. Kegler, also has such 
trainings for practitioners, which can be adapted for this project.   
In addition to engaging partners, steps for policy change include documenting local problems (e.g., 
observations, key informant interviews), formulating policies (e.g., developing/sharing model policies for 
different sectors), building awareness (e.g., creating promotional materials, holding awareness and earned  
media events, developing press releases to media, using 
social media), and persuading decision-makers (e.g., 
meeting with decision-makers, encouraging/supporting 
surveys to assess support for policy change, 
finding/sharing personal stories, making health/cost 
savings arguments).95,96 We will remain sensitive to the 
four step policy-making process:95 1) formulation refers to 
identifying potential solutions or approaches (e.g., drafting 
policies/action plans); 2) enactment includes identifying a 
champion or sponsor and formally approving the policy or 
action; 3) implementation involves developing a plan for 
implementation, communicating the policy or action, 
training relevant staff or volunteers, and actually conducting the required activities and tasks; and 4) maintenance 
refers to ensuring sustained implementation and enforcement of the changes. 
Annual Coalition Meetings. In Years 3 to 5, the coalition members will attend annual meetings with the 
research team in order for local coalition leaders and members to problem-solve challenges and share success 
stories. Training topics will be determined based on needs identified by grantees (e.g., use of media in tobacco 
control, other topics relevant to the policy change process). In Year 5, the coalitions will be offered the 
opportunity to present their research findings within the larger regional meeting open to a broader constituency. 
Technical Assistance (TA) Process. TA will be provided by the GE NCDC, AM NIH, and Emory research 
teams and will consist of monthly check-in e-mails or calls to ensure accountability and assist with challenges that 
arise. Standardized procedures for documenting coalition meetings and activities will be implemented.  
 
Data Collections: One data collections will address Aim 1, and two data collections will address Aim 2.  
Assessment 1: Population-level Survey (addressing Aim 1). The GE NCDC and AM NIH will conduct cross-
sectional population-level surveys in Year 1 (baseline) and in Years 4/5 (follow-up) in the intervention and 
control communities. A multi-stage, clustered sample design will be used to select 50 participants within each 
municipality. Eligible participants will be adults aged 18-65. The most recent census data for each country and the 
respective municipalities will be used to establish the sampling frame. The “random walk” method will be used 
for selecting the households within each municipality. For households with more than two eligible adults, the 
“Kish method” used in the WHO’s STEPS surveys will be applied.104 In the KISH method, all eligible 
participants from the household are first ranked according to age in decreasing orders (males followed by 
females). Then, participants are selected using the KISH table identifying the last digit of household and number 
of eligible participants.104 Using this approach, our prior research resulted in an 89.9% response rate.20 
Assessments 2 & 3: Coalition Assessment (addressing Aim 2): Mixed methods will be used to measure 
constructs in our conceptual model related to Aim 2. Coalition assessments conducted by TSMU/AUA will 
include: 1) coalition member surveys; and 2) semi-structured interviews with coalitions leaders and staff.   More 
detail on specific roles are outlined in the sections below. 
 
We plan to enroll a total of 4,000 participants for all of our assessments over the various data collection periods. 
 
D. MEASURES 
 
Table 1.  Coalition Activities by Year 
Year 
Coalitions Activities 
1 
 
1. Attend situational assessment training 
2. Begin situational assessment: 
-summarize population data 
-review tobacco-related data (new, existing) 
-conduct ≥10 key informant interviews  
2 
 
1. Complete situational assessment 
2. Form a multi-sectoral community coalition  
3. Develop, begin to implement action plan to 
promote policies in worksites, restaurants  
3 
1. Continue to implement action plan  
4 
 
1. Continue to implement action plan 
2. Plan for sustainability 

 
Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial               Date: 05.17.22 
Assessment 1: Population-level Survey. Data will be collected in person by NCDC/NIH staff using hard copy 
and/or technology-assisted procedures. The survey will assess the following primary and secondary outcomes and 
covariates. 
Primary Outcome. Measures of individual-level of changes in SHS exposure will be adapted from the 
Global Adult Tobacco Survey (GATS)105 and CDC’s National Adult Tobacco Survey (NATS).106 The GATS 
assesses SHSe by first asking about locations they came into contact with in the past 30 days (e.g., workplace, 
government buildings/offices). Follow-up questions for those who had been in contact with each location then 
assess SHSe in each location (e.g., “Did anyone smoke inside of any government buildings or government offices 
that you visited in the past 30 days?”) The GATS assesses SHSe in the home by asking, “How often does 
*anyone* smoke inside your home? Would you say daily, weekly, monthly, less than monthly, or never?” While 
we will administer these measures in order to facilitate cross-country comparisons, we will also create a SHSe 
index by assessing frequency of SHSe in the past week, adapting items from CDC’s NATS, which assess number 
of days in the past 7 days one was exposed to SHS in the home, in vehicles, at work, in indoor public places, and 
in outdoor public places.106 As the impact of coalition activities on SHSe may be modest, a continuous measure 
assessing a larger outcome range provides greater sensitivity for detecting changes.  
Secondary Outcomes. Changes in attitudes regarding SHSe will be assessed by adapting the GATS item, 
“Based on what you know or believe, does breathing other people’s smoke cause serious illness in non-
smokers?”105 to assess the degree to which they believe smoke causes illnesses. Changes in attitudes regarding 
smoke-free environments will be assessed by asking, “For each of the following places, indicate how you feel 
about a policy prohibiting smoking in that kind of place (e.g., workplaces, indoor areas on school grounds, 
outdoor events, restaurants, bars; responses are strongly oppose to strongly favor).105 An index score will be 
created from these responses.20 Changes in home policies will be assessed by asking, “Which of the following 
best describes the rules about smoking inside of your home: Smoking is allowed inside of your home, smoking is 
generally not allowed inside of your home but there are exceptions, smoking is never allowed inside of your 
home, or there are no rules about smoking in your home?”105 Because individual workplaces may be affected by 
coalition activity, we will assess changes in workplace policies by asking, “Which of the following best describes 
the indoor smoking policy where you work: Smoking is allowed anywhere, smoking is allowed only in some 
indoor areas, smoking is not allowed in any indoor areas, or there is no policy?”105 We will also measure changes 
in enforcement of smoke-free policies in various settings by asking, “In the past 7 days, how many times have 
you seen someone using tobacco in a location where it is prohibited?” 
Covariates. Sociodemographic characteristics (e.g., age, sex, household income, marital status) will be 
assessed. (Sex as a biological variable: Roughly equal numbers of males and females will be recruited to the 
study, particularly important given the sex differences in tobacco use rates, SHSe, and receptivity to policy 
change.20) Tobacco use and cessation-related factors will be assessed using standardized GATS measures.105 
 
Assessment 2: Coalition Member Survey. The coalition member survey will be conducted in Years 1/2 and 
Years 4/5 by our research partners (AUA, NCDC). Each local coordinator will provide research staff from AUA 
and NCDC with coalition member contact information (email, phone, addresses). The research staff will send 
each coalition member a link to an online survey programmed by the GWU team.  Programming of the survey 
does not require access to personal identifiers such as e-mail addresses.  Two back-up methods will be used to 
increase response rate for those coalition members who may not have reliable access to the internet: 1) A pdf of 
the survey will be emailed or mailed to the coalition member to complete and return to research staff and 2) 
research staff will schedule a phone call with the coalition members to complete the survey. We will send up to 
ten reminders to coalition members to complete the survey. See Appendix C for a sample coalition member 
survey. 
Coalition Membership. Representation will be assessed by the number of community sectors represented on 
the coalition (of 15 sectors). This number will be summed to form a coalition-level measure.27  
Coalition Processes. Communication is defined as the frequency and productivity of communication among 
members and staff, per a 5-point semantic differential scale.11 Four-point Likert scales will assess decision-
making (the extent to which members have influence on decisions such as setting goals and objectives for the 

 
Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial               Date: 05.17.22 
initiative);11,27 task focus (e.g., this is a down to earth, practical coalition);11,27,97 and cohesion (e.g., group spirit 
among members).27,97   
Leadership and Staffing. Leadership will be measured by an 8-item scale assessing skills of the coalition 
leaders in guiding the coalition (e.g., asks you to assist with specific tasks).27 Staffing skill in supporting the 
coalition (e.g., usually available for assistance) will be assessed using an 8-item scale.27  
Coalition Structure. Coalition size will be operationalized as the number of active coalition members.  
Coordinators will provide rosters of members who had attended at least one meeting in the past six months.27 
Coalition complexity is the number of committees per coalition (1=no committees to 3=≥3 committees).27  
Indicators of Member Engagement. Participation will be assessed by asking which of 7 roles they had 
played on the coalition (e.g., helped to assess needs and/or assets of the community).27 We will ask about 10 roles 
in the implementation phase. The number of roles will be averaged for each respondent. Satisfaction will be 
assessed by asking how satisfied members were with 7 aspects of the planning phase (e.g., programs and/or 
activities selected) and 11 aspects in the implementation phase, using a 4-point Likert scale.27 
 
Assessment 3: Key Informant Interviews will be conducted by phone or in person with health center staff 
serving as coordinators, health center directors, and at least one active coalition member not employed by the 
health center. These interviews will take 30-45 mins, and be audio-recorded, transcribed, and analyzed. We will 
adapt interview guides from our prior coalition evaluations and assess progress toward policy change, barriers and 
facilitators to policy change with a focus on community context, new or strengthened partnerships, resources 
mobilized, and opportunities for new tobacco control leaders to emerge.29,98-101   
 
E. RISK OF PARTICIPATION 
 
Study participants may experience risks related to loss of privacy or breach of confidentiality related to responses 
to surveys or interviews. We have put in placed several safeguards to minimize this possibility.  
 
F. BENEFITS TO SUBJECTS OR FUTURE BENEFITS 
 
There are no specific benefits anticipated to individual participants. However, the study has the potential to 
benefit population health in general since the findings can inform health services for immigrant populations.  
 
G. INCENTIVE 
 
No incentives will be offered for participation. 
 
H. DATA ANALYSIS 
 
For Aim 1: Population-level Survey 
Power Calculation. We powered the CRCT on the primary outcome of SHSe per the population-level survey. 
We determined power using closed equations to calculate the minimum number of clusters for a CRCT for a 
specific effect size and intra-class correlation (ICC) and used Moerbeek and Teerenstra’s formulas for CRCTs 
with fixed cluster sizes.107 We assumed a conservatively high ICC of 10% (especially for a matched-pair design), 
50 participants per cluster, and small to medium effect size (d=.35).108 Calculations indicated that 28 communities 
provided adequate power. If the ICC is lower, we are powered to detect smaller effects (.27 or .24 if the ICC’s are 
5% or 3%, respectively).109 Our sample size is larger than one in a comparable study.110   
Analyses. First, we will assess key variables for normality of distributions. For both baseline and follow-up 
samples, we will use PROC GLIMMIX to compare sociodemographics in intervention and control conditions as 
well as the two countries. We will use multilevel modeling to assess intervention impact. Multilevel modeling 
allows to model both individual- and community-level variances, predictors, and cross-level interactions 
simultaneously.111-113 This allows for unbiased estimates of effects. For the primary outcome of SHSe, we will 
assess intervention impact using a two-level model adjusting for individual- and cluster-level covariates while 

 
Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial               Date: 05.17.22 
accounting for unmeasured differences between clusters. Models will be built sequentially, adding first 
individual- and then community-level covariates including country and baseline means, and finally intervention 
assignment.114 Random effects for the intercept and intervention impact will be modeled in all models. This 
allows for differences in the outcome across communities, both due to the intervention and due to other 
unmeasured factors. For secondary outcomes, multilevel models with the appropriate link function (i.e., linear for 
continuous outcomes, Poisson for count outcomes, binary for dichotomous outcomes) will be built similarly to 
those for the main outcome. Additional analyses will model cross-level interaction effects (i.e., community-level 
moderators of the intervention effect). Dr. Berg, from George Washington University, will lead many of the 
analyses. 
 
For Aim 2: Coalition Assessment 
Both qualitative and quantitative analysis will be used. Qualitative analysis will involve a multiple case study 
of six coalitions (a high, medium, and low performer in each country with performance defined by number of 
policies passed). After reviewing a subset of the interview transcripts (translated to English), the evaluation teams 
from the two countries, plus the George Washington University research team, will meet to discuss their general 
findings and to develop a codebook, using the conceptual model as sensitizing constructs. Once the team is coding 
consistently (examining transcripts from across countries), one team member in each country will code 
independently. Any discrepancies in the coding will be discussed and resolved. We will use standard content 
analysis methods to identify themes, as well as site-ordered matrices based on level of implementation to identify 
patterns of factors influencing implementation. Community name and participant roles will be identifiable during 
the analysis phase.  While individual study participant names will not be included, it may be possible to identify 
respondents and/or partners based on information available in the qualitative transcripts. Dr. Kegler has led 
several multiple case studies.29,98,115  
Power Calculation. We will use coalition member survey data to assess the extent to which CCAT 
propositions are supported by our data. Many CCAT constructs are conceptualized at the coalition level, which 
implies a sample size of 14 for these analyses. At the organizational-level, 14 communities will give us sufficient 
power to detect large effects, specifically d≥0.80 in paired t-tests and rho≥0.55 in correlations (α=.10). 
Analyses. We will conduct all analyses for Aim 2 at the community-level (i.e., coalition-level average scores 
will be created for all models). This analysis strategy is preferable over individual analyses that account for 
clustering because we aim to understand the coalition impact, compared to individual impact, on policy.30,33 We 
will report univariate properties first and then assess relationship strengths using t-tests and correlations. Due to 
the small sample size (N=14), we will set alpha at .10 as others have done in coalition research.30,33,116 We will use 
chi-square tests, t-tests, and Spearman correlations to assess bivariate relationships. Based on these analyses, we 
will conduct multivariable regression analyses to identify which contextual (e.g., country) and coalition factors 
from our conceptual model predict intermediate outcomes, such as member participation and satisfaction, action 
plan quality, and number of smoke-free policies passed, with a small set of predictors.  
 
I.  TRAINING 
 
Emory research staff training for the study will review basic principles and focus on procedures specific to the 
protocol. Similar trainings will occur at the GE NCDC, the AM NIH, and AUA for all study staff. Training will 
cover: (1) sampling strategy and recruitment, (2) eligibility confirmation for potential participants, (3) survey and 
interview data collection, (4) adverse event handling and reporting, (5) data safety and monitoring, (6) protocol 
adherence. We will establish security procedures (outlined below in Confidentiality). All study staff members will 
obtain CITI training certificates.  
 
J. PLANS FOR DATA MANAGEMENT AND MONITORING 
 
 
Given the nature of the research, requiring minimal invasive assessments and no interventions, we have 
determined that there is no need for a data safety and monitoring board.  
 

 
Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial               Date: 05.17.22 
K. CONFIDENTIALITY 
 
With regard to minimizing risk of loss of confidentiality or privacy, confidentiality will be protected at all 
times and potential risks minimized systematically.  
Study participants will be assigned a permanent unique study ID number upon enrollment, which will be the 
only identifier associated with any of the survey data and addresses. A key linking personal identifying 
information (name, other household members who are taking the survey, and address) with study ID number will 
be kept in a separate encrypted data file stored secured research shared drives (i.e. not on personal computers that 
are vulnerable to theft) in the study’s data coordinating centers in either the GE NCDC or the AM NIH and then 
transferred to the study’s data coordinating center at Emory University Rollins School of Public Health. Files will 
be accessed only on an as needed basis for the conduct of the study. Physical security of the data center’s servers 
and files is maintained with double-locked keyed doors during all hours.  Only authorized persons are allowed 
access. Identifying information will be kept in a secured folder in encrypted version for the duration of the study 
data management purposes. Once all phases of the study have been conducted, the identifiers will no longer be 
needed and will be deleted from the data sets.  
 
L. INFORMED CONSENT 
 
Regional and local public health and community-based organization leaders will complete a capacity 
assessment.  This capacity assessment survey will be used to ensure comparability across intervention and 
comparison communities.  This will be completed prior to conducting consent for other aspects of the study. 
Statements of consent for each of the data collections are included in this application.  
 
We are asking for waiver of documentation of consent for the coalition member survey. The primary mode of data 
collection for this survey will be via an online platform such as SurveyMonkey or SurveyGizmo. However, to 
ensure a high response rate, the two backup methods of data collection for those with unreliable internet access 
are mailing a PDF of the survey and conducting the survey via a phone call, both of which would make obtaining 
documentation of consent burdensome for the participants. Since the survey does not entail more than minimal 
risk, we believe a waiver of documentation of consent is appropriate. 
 
M. PLANS TO INFORM PARTICIPANTS OF NEW FINDINGS  
 
We will disseminate the research findings through presentations, publications, and other printed materials. Given 
the nature of the study, no immediate health consequences are anticipated. However, any concerns will be 
discussed in a timely matter, and problems or unanticipated implications will be addressed immediately. 
 

 
Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial               Date: 05.17.22 
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Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial               Date: 05.17.22