Smoke-free Air Coalitions in Georgia and Armenia
Condition: Smoking
Study type: Interventional

Summary: 
      This is a matched-pairs community randomized controlled trial (CRCT) to examine the impact of
      coalitions promoting smoke-free air policies on individual secondhand smoke exposure (SHSe).

      This proposal will build the capacity of Georgia (GE) and Armenia (AM) researchers to conduct
      high-quality mixed methods tobacco research and test the Community Coalition Action Theory
      (CCAT) 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, and train practitioners within local communities to build local
      coalitions for tobacco control policy.

      Twenty-eight communities (14 per 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 (14 communities per condition). In
      the 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 primarily in indoor and outdoor public
      places (e.g., worksites, hospitality). 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. 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.
    

Detailed description: 
      Public health efforts in low- and middle-income countries (LMICs) could be catalyzed by
      bolstering ways to optimally leverage local talents and resources, such as civil society.
      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 use. Local coalitions have been a dominant strategy in tobacco
      control in the US, with well-documented success in establishing smoke-free policies
      specifically. 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 is largely initiated at the national level. Parallel civil society movements
      at the local level may be needed to build support for and compliance with 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. Moreover, previous findings indicate extremely high rates of
      SHSe. However, there is also documented high receptivity to public smoke-free policies
      despite high use rates.

      In this matched-pairs community randomized controlled trial (CRCT), the impact of coalitions
      promoting smoke-free air policies on individual secondhand smoke exposure (SHSe) will be
      examined. The Emory team will lead the oversight of the research design and execution of all
      components of the research. This proposal will build the capacity of Georgia (GE) and Armenia
      (AM) researchers to conduct high-quality mixed methods tobacco research and test the
      Community Coalition Action Theory (CCAT) 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,
      American University of Armenia), and train practitioners within local communities to build
      local coalitions for tobacco control policy.

      This study aims to:

        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 public places, with the primary outcome of changes in SHSe over time;

        2. assess how community context and coalition factors influence adoption of organizational
           and municipal smoke-free policies to provide an evidence-base for public health
           practice;

        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; and

        4. capitalize on the proposed research and dissemination opportunities to build tobacco
           control research capacity within the GE NCDC, AM NIH, and partnering universities, as
           well as practice capacity within local public health centers and their civil society
           partners.

      Twenty-eight communities (14 per 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 (14 communities per condition). In
      the 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 primarily in indoor and outdoor public
      places (e.g., worksites, hospitality). 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. 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.

      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. The most recent census data for each country and the respective municipalities
      will be used to establish the sampling frame.
    

Intervention name(s): Intervention Condition
Intervention type(s): Behavioral
Intervention description(s): The intervention approach will be informed by the Community Coalition Action Theory (CCAT) developed by Butterfoss and Kegler. CCAT posits that coalitions form due to a threat, opportunity, or mandate. 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 public indoor and and outdoor spaces.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a matched-pairs community randomized controlled trial. 14 communities will receive the behavioral intervention and 14 will serve as control communities. Enrollment is on the community level rather than individual level.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Behavioral intervention; Social intervention; Public health; Smoking behavior