Clinical trial NCT03447912: Smoke-free Air Coalitions in Georgia and Armenia
Official title: Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Behavioral intervention
Social intervention
Public health
Smoking behavior
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2018-02-27
Enrollment: 2924
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Community Level Inclusion Criteria:

* Population size ranging from approximately 6,000 to 90,000

Exclusion Criteria:

* Lack of interest of local health care center director

Primary outcomes:
measure: Secondhand Smoke Exposure
timeFrame: Baseline, Follow-up (approximately 44 months post-baseline)
Secondary outcomes:
measure: Attitude Regarding Secondhand Smoke Exposure
timeFrame: Baseline, Follow-up (approximately 44 months post-baseline)
measure: Attitude Regarding Smoke-Free Environments
timeFrame: Baseline, Follow-up (approximately 44 months post-baseline)
measure: Count of Participants Agreeing With Certain Home Policies
timeFrame: Baseline, Follow-up (approximately 44 months post-baseline)
measure: Count of Participants With Certain Workplace Policies
timeFrame: Baseline, Follow-up (approximately 44 months post-baseline)
measure: Enforcement of Smoke-Free Policies
timeFrame: Baseline, Follow-up (approximately 44 months post-baseline)
measure: Secondhand Smoke Exposure in Various Locations
timeFrame: Baseline, Follow-up (approximately 44 months post-baseline)
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: National Institute of Health
city: Tbilisi
country: Georgia
facility: National Center for Disease Control
Study officials:
affiliation: Emory University
name: Michelle Kegler, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayrumyan V, Harutyunyan A, Torosyan A, Grigoryan L, Sargsyan Z, Bazarchyan A, Petrosyan V, Dekanosidze A, Sturua L, Kegler MC, Berg CJ. Tobacco-related risk perceptions, social influences and public smoke-free policies in relation to smoke-free home restrictions: findings from a baseline cross-sectional survey of Armenian and Georgian adults in a community randomised trial. BMJ Open. 2022 Feb 7;12(2):e055396. doi: 10.1136/bmjopen-2021-055396.
citation: Berg CJ, Dekanosidze A, Hayrumyan V, LoParco CR, Torosyan A, Grigoryan L, Bazarchyan A, Haardorfer R, Kegler MC. Smoke-free home restrictions in Armenia and Georgia: motives, barriers and secondhand smoke reduction behaviors. Eur J Public Health. 2023 Oct 10;33(5):864-871. doi: 10.1093/eurpub/ckad129.