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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Carla Berg contact

4045585395

carlaberg@gwu.edu

United States1 site, 1 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

    Recruiting

Other trials in United States

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.

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 groups in NCT06166433
Study groupRoleWhat they receive
InterventionExperimentalTheory-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
ControlNo interventionAssessment-only control

What is being measured

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

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. Among Smokers: Cigarette consumption

    Cigarettes smoked per day; days smoked

    Measured: Past 7 days; assessed at 6 months post baseline

  6. Among Smokers: Cigarette consumption

    Cigarettes smoked per day; days smoked

    Measured: Past 7 days; assessed at 3 months post baseline

  7. Among Smokers: Cigarette consumption

    Cigarettes smoked per day; days smoked

    Measured: Past 30 days; assessed at 6 months post baseline

  8. Among Smokers: Cigarette consumption

    Cigarettes smoked per day; days smoked

    Measured: Past 30 days; assessed at 3 months post baseline

  9. Among Smokers: Cessation attempts

    Number of quit attempts in the past 3 months

    Measured: Past 3 months; assessed at 6 months post baseline

  10. Among Smokers: Cessation attempts

    Number of quit attempts in the past 3 months

    Measured: Past 3 months; assessed at 3 months post baseline

  11. 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.

  1. First posted12 Dec 2023
  2. Study start1 Feb 2025
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

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
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)
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

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.

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