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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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:
- 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;
- 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;
- 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
- 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 group | Role | What they receive |
|---|---|---|
| Intervention Condition | Experimental | Fourteen communities will be assigned to the intervention. Receives: Behavioral: Intervention Condition |
| Control Condition | No intervention | The 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.
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)
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)
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)
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)
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)
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)
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.
- First posted27 Feb 2018
- Study start1 Oct 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Michelle C. Kegler, Emory University
- Investigators
- Michelle Kegler, DrPH, Principal investigator, Emory University
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 35131832Berg 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 37500602Berg 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoke-free Air Coalitions in Georgia and Armenia: A Community Randomized Trial
- ClinicalTrials.gov ID
- NCT03447912
- Acronym / sponsor ID
- IRB00097093
- Conditions
- Smoking
- Keywords
- Behavioral intervention, Social intervention, Public health, Smoking behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,924 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Posted 14 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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;
- 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
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Behavioral: Intervention ConditionFourteen communities will be assigned to the intervention. |
| Control Condition | No intervention | –The 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Lack of interest of local health care center director
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention ConditionThe 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. | Behavioural | Intervention Condition |
Primary outcome
Secondhand Smoke Exposure
Time frame: Baseline, Follow-up (approximately 44 months post-baseline)
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.
6 secondary outcomes
Attitude Regarding Secondhand Smoke Exposure
Time frame: Baseline, Follow-up (approximately 44 months post-baseline)
Attitude Regarding Smoke-Free Environments
Time frame: Baseline, Follow-up (approximately 44 months post-baseline)
Count of Participants Agreeing With Certain Home Policies
Time frame: Baseline, Follow-up (approximately 44 months post-baseline)
Count of Participants With Certain Workplace Policies
Time frame: Baseline, Follow-up (approximately 44 months post-baseline)
Enforcement of Smoke-Free Policies
Time frame: Baseline, Follow-up (approximately 44 months post-baseline)
Secondhand Smoke Exposure in Various Locations
Time frame: Baseline, Follow-up (approximately 44 months post-baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35131832Hayrumyan 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.
- Background: PubMed 37500602Berg 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.
- Derived from this study: PubMed 38325896Berg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Kegler, DrPH principal investigator
Emory University
2 sites in 2 countries: see every site and its status.
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.