Smoke-free Air Coalitions in Georgia and Armenia

NCT03447912 | Completed Results

• 2 other identifiers: IRB00097093R01TW010664
• Study Type: interventional
• Target: 2,924
• Locations: 2 countries
• Sites: 2

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.

Conditions

Smoking

Keywords

Behavioral intervention; Social intervention; Public health; Smoking behavior

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

• Attitude Regarding Secondhand Smoke Exposure

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

• Attitude Regarding Smoke-Free Environments

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

• Count of Participants Agreeing With Certain Home Policies

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

• Count of Participants With Certain Workplace Policies

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

• Enforcement of Smoke-Free Policies

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

Study Arms (2)

Intervention Condition

EXPERIMENTAL

Fourteen communities will be assigned to the intervention.

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.

Interventions

Intervention Condition BEHAVIORAL

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.

Intervention Condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Lack of interest of local health care center director

Sponsors & Collaborators

• Emory University: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (2)

National Institute of Health

Yerevan, Armenia

Location

National Center for Disease Control

Tbilisi, Georgia

Location

Related Publications (3)

• 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.

  PMID: 35131832 BACKGROUND

• 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.

  PMID: 37500602 BACKGROUND

• 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.

  PMID: 38325896 DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Carla Berg, PhD, MBA, LP
• Organization: George Washington University

carlaberg@email.gwu.edu

202-994-0168

Study Officials

• Michelle Kegler, DrPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: February 27, 2018
• Study Start: October 1, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 17, 2023
• Results First Posted: September 14, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1); GE (1)