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SmokingNCT03447912

Smoke-free Air Coalitions in Georgia and Armenia

A study testing Intervention Condition in people with Smoking, run by Emory University at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Smoking
What is being tested?
Intervention Condition
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,924 participants
Where
2 sitesin 2 countries
Study dates
1 Oct 2018to 30 Jun 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Lack of interest of local health care center director

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Armenia1 site
  • National Institute of Health

    Yerevan

Other trials in Armenia

Georgia1 site
  • National Center for Disease Control

    Tbilisi

Other trials in Georgia

About this study

Official title: Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial

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.

Read the 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.

Conditions
Smoking
Being tested
Intervention Condition
Keywords
Behavioral intervention, Social intervention, Public health, Smoking behavior
Medical subject headings
Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention ConditionBehavioural

    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.

Study groups in NCT03447912
Study groupRoleWhat they receive
Intervention ConditionExperimentalFourteen communities will be assigned to the intervention.
Receives: Behavioral: Intervention Condition
Control ConditionNo interventionThe 14 communities assigned as controls will participate in the population-level survey and will be provided with a site-specific summary of findings but will not participate in any aspects of the intervention. 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Secondhand Smoke Exposure

    The frequency of secondhand smoke (SHS) exposure in the past 30 days was assessed by asking the respondent to report the number of days they were exposed to SHS.

    Measured: Baseline, Follow-up (approximately 44 months post-baseline)

Secondary outcomes (6)
  1. Attitude Regarding Secondhand Smoke Exposure

    Attitudes regarding Secondhand Smoke Exposure (SHSe) were examined by assessing the degree to which the respondent believes that smoke causes illnesses. Participants were asked "Based on what you know or believe, does breathing other people's smoke cause serious illness in non-smokers?" Possible responses are 1 = "not at all", 2 = "a little", 3 = "somewhat", or 4 = "a lot".

    Measured: Baseline, Follow-up (approximately 44 months post-baseline)

  2. Attitude Regarding Smoke-Free Environments

    To assess attitudes regarding smoke-free environments, respondents were asked whether they think smoking should or should not be allowed in places such as workplaces, indoor areas on school grounds, outdoor events, restaurants, and bars. Participants indicated how much the supported or opposed complete cigarette smoking bans on a 4-point scale where 1 = strongly oppose and 4 = strongly support.

    Measured: Baseline, Follow-up (approximately 44 months post-baseline)

  3. Count of Participants Agreeing With Certain Home Policies

    Smoke-free home policies at baseline and follow-up were assessed by asking about rules about smoking inside of the participant's home. Possible responses included: smoking is allowed, smoking is not allowed but there are exceptions, smoking is never allowed, or there are no rules about smoking in the home.

    Measured: Baseline, Follow-up (approximately 44 months post-baseline)

  4. Count of Participants With Certain Workplace Policies

    Among participants employed in a workplace with an indoor setting, workplace policies at baseline and follow-up were measured 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."

    Measured: Baseline, Follow-up (approximately 44 months post-baseline)

  5. Enforcement of Smoke-Free Policies

    Changes in enforcement of smoke-free policies in various settings will be measured by asking, "In the past 7 days, how many times have you seen someone using tobacco in a location where it is prohibited?"

    Measured: Baseline, Follow-up (approximately 44 months post-baseline)

  6. Secondhand Smoke Exposure in Various Locations

    The frequency of secondhand smoke (SHS) exposure in the past 30 days will be assessed by asking the respondent to report the number of days they were exposed to SHS in the home, in vehicles, at work, in indoor public places, and in outdoor public places. The frequency of exposures is evaluated as the number of days in the past 30 days the participant was exposed to SHS in the home, in vehicles, at work, in indoor public places, and in outdoor public places

    Measured: Baseline, Follow-up (approximately 44 months post-baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2018
  2. Study start1 Oct 2018
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
2,924 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03447912
Sponsor's protocol ID
IRB00097093
Other IDs
R01TW010664
Status last verified
Oct 2023
First submitted
21 Feb 2018
Last updated
17 Oct 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35131832
  • 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.

    PubMed 37500602
  • Berg CJ, Haardorfer R, Torosyan A, Dekanosidze A, Grigoryan L, Sargsyan Z, Hayrumyan V, Sturua L, Topuridze M, Petrosyan V, Bazarchyan A, Kegler MC. Examining local smoke-free coalitions in Armenia and Georgia: context and outcomes of a matched-pairs community-randomised controlled trial. BMJ Glob Health. 2024 Feb 7;9(2):e013282. doi: 10.1136/bmjgh-2023-013282.

    PubMed 38325896

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Condition in people with Smoking, run by Emory University at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Armenia, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Secondhand Smoke Exposure (time frame: Baseline, Follow-up (approximately 44 months post-baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03447912, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.

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