Second Hand Tobacco SmokeSFHAMGENCT06166433
Implementing a Scalable Smoke-free Home Intervention in Armenia and Georgia
A study testing Smoke-free homes intervention in people with Second Hand Tobacco Smoke, run by George Washington University at 1 site in United States.
Trial summary
Tobacco use and secondhand smoke exposure represent critical health disparities in low- and middle-income countries; Armenia and Georgia represent the 11th and 6th highest smoking rates in men globally (51.5% and 55.5%, respectively), but have low rates of smoking in women (1.8% and 7.8%) and few smoke-free homes… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Second Hand Tobacco Smoke
- What is being tested?
- Smoke-free homes intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be greater than or equal to 18 years old
- smoke in the home and have a child and-or nonsmoker in the home, or be a non-smoker and live with someone who smokes in the home
- speak Armenian or Georgian
- live in a selected community
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
George Washington University
Washington D.C., District of Columbia, 20052
Carla J Berg, PhD, 202-994-0168, carlaberg@gwu.edu
Darcey McCready, MS, 202-994-2474, bergresearch@gwu.edu
About this study
Tobacco use and secondhand smoke exposure represent critical health disparities in low- and middle-income countries; Armenia and Georgia represent the 11th and 6th highest smoking rates in men globally (51.5% and 55.5%, respectively), but have low rates of smoking in women (1.8% and 7.8%) and few smoke-free homes (38.6%), which can reduce secondhand smoke exposure and tobacco use rates. This study builds on ongoing collaborations between George Washington University, Emory, and national public health organizations in Armenia and Georgia and advancements in local public health infrastructure; it aims to adapt an evidence-based smoke-free home intervention for homes in Armenia and Georgia, develop capacity to deliver the intervention via local community partners and the national quitlines, and test the intervention in a hybrid effectiveness-implementation randomized clinical trial. This work will advance the knowledge base informing strategies to reduce global tobacco-related disparities, as well as the implementation and scale-out of evidence-based interventions in low- and middle-income countries.
Read the detailed description
Among the disparities faced by populations in low- and middle-income countries are those related to tobacco use and secondhand smoke exposure. Two countries particularly impacted by tobacco use and secondhand smoke exposure are Armenia and Georgia, which represent the 11th and 6th highest smoking rates in men globally (51.5% and 55.5%, respectively). However, smoking prevalence is much lower among women (1.8% and 7.8%). Notably, a primary source of secondhand smoke exposure among children and most nonsmoking adults in many low- and middle-income countries, including Armenia and Georgia, is the home. Smoke-free homes can reduce secondhand smoke exposure, promote cessation, and possibly disrupt initiation; however, 61.4% of households in Armenia and Georgia allow smoking in the home. Thus, promoting smoke-free homes may be an innovative and relatively untapped strategy for chronic disease prevention in these countries - and in other low- and middle-income countries with high smoking rates. Research focused on implementing evidence-based interventions offers unique opportunities to address the pressing needs in low- and middle-income countries and to examine key barriers in the adoption, scale-up, and sustainment of evidence-based interventions in low-resource settings. This study builds on ongoing collaborations among George Washington University, Emory, the Georgia National Center for Disease Control, the Armenia National Institute of Health, and the American University of Armenia that have established: 1) a strong community-based infrastructure for implementing public health programs using local coalitions in 14 communities, developed in our current Fogarty-funded R01; and 2) a theory-based smoke-free homes intervention, designed to be brief and adaptable and shown to be effective, generalizable, scalable, and cost-effective among low-income households in the US. The current study will strategically capitalize on these partnerships with national public health agencies, local community mobilization infrastructure, and smoke-free homes evidence-based intervention to address the specific aims. Aim 1 involves adapting the smoke-free homes intervention to be culturally appropriate for the Armenia and Georgia populations, using a community-engaged approach and robust adaptation frameworks and methods, and develop in-country capacity for intervention dissemination (via local coalitions) and delivery (via national quitlines). Aim 2 involves examining the effectiveness of the adapted intervention (vs. control) on smoke-free home adoption (primary outcome) among households in Armenia and Georgia, using a type 1 hybrid effectiveness-implementation randomized clinical trial (n=550 participants; 275/country), with follow-up assessments at 3 and 6 months. Aim 3 will assess intervention reach, adoption, implementation, and maintenance potential, as well as related contextual influences, using a mixed-methods process evaluation. The research team (including national public health agencies) will use these findings to develop a sustainability and dissemination plan (e.g., intervention packaging for scale-up). This work will provide a robust model for adapting and implementing this evidence-based intervention for Armenia and Georgia, which could then be used for this intervention in other countries and/or for other behavioral targets and evidence-based interventions in Armenia, Georgia, and elsewhere. This work will advance the knowledge base informing strategies to reduce tobacco-related disparities globally and the implementation and scale-out of evidence-based interventions in low- and middle-income countries.
- Conditions
- Second Hand Tobacco Smoke
- Being tested
- Smoke-free homes intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoke-free homes interventionBehavioural
Theory-based intervention involving 3 mailed sets of educational materials and a brief coaching call using motivational interviewing, delivered over a 6-week period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Theory-based intervention involving 3 mailed sets of educational materials and a brief coaching call using motivational interviewing, delivered over a 6-week period Receives: Behavioral: Smoke-free homes intervention |
| Control | No intervention | Assessment-only control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete smoke-free home rule
"Which statement best describes the rules about smoking inside your home: smoking is not allowed anywhere inside my home; smoking is allowed in some places or at some times; smoking is allowed anywhere inside my home; or there are no rules about smoking inside my home." Participant indicates no smoking allowed in the home (in any place or at any time).
Measured: Current status; assessed at 6-months post baseline
Secondary outcomes (11)
Secondhand smoke exposure in the home
Number of days smoking occurred in the home in the past 7 days
Measured: Past 7 days; assessed at 6 months post baseline
Secondhand smoke exposure in the home
Number of days smoking occurred in the home in the past 7 days
Measured: Past 7 days; assessed at 3 months post baseline
Complete smoke-free vehicle rule
"Which statement best describes the rules about smoking in your household vehicles (cars or trucks)? allowed in all vehicles; sometimes allowed in some vehicles; never allowed in any vehicle; no rules about smoking in the vehicles; don't own a vehicle." Participant indicates no smoking allowed in the household vehicles (at any time).
Measured: Current status; assessed at 6 months post baseline
Complete smoke-free vehicle rule
"Which statement best describes the rules about smoking in your household vehicles (cars or trucks)? allowed in all vehicles; sometimes allowed in some vehicles; never allowed in any vehicle; no rules about smoking in the vehicles; don't own a vehicle." Participant indicates no smoking allowed in the household vehicles (at any time).
Measured: Current status; assessed at 3 months post baseline
Among Smokers: Cigarette consumption
Cigarettes smoked per day; days smoked
Measured: Past 7 days; assessed at 6 months post baseline
Among Smokers: Cigarette consumption
Cigarettes smoked per day; days smoked
Measured: Past 7 days; assessed at 3 months post baseline
Among Smokers: Cigarette consumption
Cigarettes smoked per day; days smoked
Measured: Past 30 days; assessed at 6 months post baseline
Among Smokers: Cigarette consumption
Cigarettes smoked per day; days smoked
Measured: Past 30 days; assessed at 3 months post baseline
Among Smokers: Cessation attempts
Number of quit attempts in the past 3 months
Measured: Past 3 months; assessed at 6 months post baseline
Among Smokers: Cessation attempts
Number of quit attempts in the past 3 months
Measured: Past 3 months; assessed at 3 months post baseline
Complete smoke-free home rule
"Which statement best describes the rules about smoking inside your home: smoking is not allowed anywhere inside my home; smoking is allowed in some places or at some times; smoking is allowed anywhere inside my home; or there are no rules about smoking inside my home." Participant indicates no smoking allowed in the home (in any place or at any time).
Measured: Current status; assessed at 3 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 posted12 Dec 2023
- Study start1 Feb 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second Hand Tobacco SmokeStudies of the same condition, open and under way.
- More trials run by George Washington 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
- Theory-based intervention involving 3 mailed sets of educational materials and a brief coaching call using motivational interviewing, delivered over a 6-week period.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Berg, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166433
- Sponsor's protocol ID
- GW13528
- Acronym
- SFHAMGE
- Status last verified
- Mar 2026
- First submitted
- 1 Dec 2023
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Scalable Smoke-free Home Intervention in Armenia and Georgia
- ClinicalTrials.gov ID
- NCT06166433
- Acronym / sponsor ID
- SFHAMGE / GW13528
- Conditions
- Second Hand Tobacco Smoke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tobacco use and secondhand smoke exposure represent critical health disparities in low- and middle-income countries; Armenia and Georgia represent the 11th and 6th highest smoking rates in men globally (51.5% and 55.5%, respectively), but have low rates of smoking in women (1.8% and 7.8%) and few smoke-free homes (38.6%), which can reduce secondhand smoke exposure and tobacco use rates. This study builds on ongoing collaborations between George Washington University, Emory, and national public health organizations in Armenia and Georgia and advancements in local public health infrastructure; it aims to adapt an evidence-based smoke-free home intervention for homes in Armenia and Georgia, develop capacity to deliver the intervention via local community partners and the national quitlines, and test the intervention in a hybrid effectiveness-implementation randomized clinical trial. This work will advance the knowledge base informing strategies to reduce global tobacco-related disparities, as well as the implementation and scale-out of evidence-based interventions in low- and middle-income countries.
Detailed description
Among the disparities faced by populations in low- and middle-income countries are those related to tobacco use and secondhand smoke exposure. Two countries particularly impacted by tobacco use and secondhand smoke exposure are Armenia and Georgia, which represent the 11th and 6th highest smoking rates in men globally (51.5% and 55.5%, respectively). However, smoking prevalence is much lower among women (1.8% and 7.8%). Notably, a primary source of secondhand smoke exposure among children and most nonsmoking adults in many low- and middle-income countries, including Armenia and Georgia, is the home. Smoke-free homes can reduce secondhand smoke exposure, promote cessation, and possibly disrupt initiation; however, 61.4% of households in Armenia and Georgia allow smoking in the home. Thus, promoting smoke-free homes may be an innovative and relatively untapped strategy for chronic disease prevention in these countries - and in other low- and middle-income countries with high smoking rates. Research focused on implementing evidence-based interventions offers unique opportunities to address the pressing needs in low- and middle-income countries and to examine key barriers in the adoption, scale-up, and sustainment of evidence-based interventions in low-resource settings. This study builds on ongoing collaborations among George Washington University, Emory, the Georgia National Center for Disease Control, the Armenia National Institute of Health, and the American University of Armenia that have established: 1) a strong community-based infrastructure for implementing public health programs using local coalitions in 14 communities, developed in our current Fogarty-funded R01; and 2) a theory-based smoke-free homes intervention, designed to be brief and adaptable and shown to be effective, generalizable, scalable, and cost-effective among low-income households in the US. The current study will strategically capitalize on these partnerships with national public health agencies, local community mobilization infrastructure, and smoke-free homes evidence-based intervention to address the specific aims. Aim 1 involves adapting the smoke-free homes intervention to be culturally appropriate for the Armenia and Georgia populations, using a community-engaged approach and robust adaptation frameworks and methods, and develop in-country capacity for intervention dissemination (via local coalitions) and delivery (via national quitlines). Aim 2 involves examining the effectiveness of the adapted intervention (vs. control) on smoke-free home adoption (primary outcome) among households in Armenia and Georgia, using a type 1 hybrid effectiveness-implementation randomized clinical trial (n=550 participants; 275/country), with follow-up assessments at 3 and 6 months. Aim 3 will assess intervention reach, adoption, implementation, and maintenance potential, as well as related contextual influences, using a mixed-methods process evaluation. The research team (including national public health agencies) will use these findings to develop a sustainability and dissemination plan (e.g., intervention packaging for scale-up). This work will provide a robust model for adapting and implementing this evidence-based intervention for Armenia and Georgia, which could then be used for this intervention in other countries and/or for other behavioral targets and evidence-based interventions in Armenia, Georgia, and elsewhere. This work will advance the knowledge base informing strategies to reduce tobacco-related disparities globally and the implementation and scale-out of evidence-based interventions in low- and middle-income countries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Theory-based intervention involving 3 mailed sets of educational materials and a brief coaching call using motivational interviewing, delivered over a 6-week period.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Smoke-free homes interventionTheory-based intervention involving 3 mailed sets of educational materials and a brief coaching call using motivational interviewing, delivered over a 6-week period |
| Control | No intervention | –Assessment-only control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be greater than or equal to 18 years old
- smoke in the home and have a child and-or nonsmoker in the home, or be a non-smoker and live with someone who smokes in the home
- speak Armenian or Georgian
- live in a selected community
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Smoke-free homes interventionTheory-based intervention involving 3 mailed sets of educational materials and a brief coaching call using motivational interviewing, delivered over a 6-week period. | Behavioural | Intervention |
Primary outcome
Complete smoke-free home rule
Time frame: Current status; assessed at 6-months post baseline
"Which statement best describes the rules about smoking inside your home: smoking is not allowed anywhere inside my home; smoking is allowed in some places or at some times; smoking is allowed anywhere inside my home; or there are no rules about smoking inside my home." Participant indicates no smoking allowed in the home (in any place or at any time).
11 secondary outcomes
Secondhand smoke exposure in the home
Time frame: Past 7 days; assessed at 6 months post baseline
Secondhand smoke exposure in the home
Time frame: Past 7 days; assessed at 3 months post baseline
Complete smoke-free vehicle rule
Time frame: Current status; assessed at 6 months post baseline
Complete smoke-free vehicle rule
Time frame: Current status; assessed at 3 months post baseline
Among Smokers: Cigarette consumption
Time frame: Past 7 days; assessed at 6 months post baseline
Among Smokers: Cigarette consumption
Time frame: Past 7 days; assessed at 3 months post baseline
Among Smokers: Cigarette consumption
Time frame: Past 30 days; assessed at 6 months post baseline
Among Smokers: Cigarette consumption
Time frame: Past 30 days; assessed at 3 months post baseline
Among Smokers: Cessation attempts
Time frame: Past 3 months; assessed at 6 months post baseline
Among Smokers: Cessation attempts
Time frame: Past 3 months; assessed at 3 months post baseline
Complete smoke-free home rule
Time frame: Current status; assessed at 3 months post baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoke-free homes intervention in people with Second Hand Tobacco Smoke, run by George Washington University at 1 site in United States.
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 4 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carla Berg (4045585395, carlaberg@gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete smoke-free home rule (time frame: Current status; assessed at 6-months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2026.