Second Hand Tobacco Smoke Clinical Trial
— SFHAMGEOfficial title:
Implementing a Scalable Smoke-free Home Intervention in Armenia and Georgia
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.
Status | Not yet recruiting |
Enrollment | 550 |
Est. completion date | July 31, 2027 |
Est. primary completion date | June 1, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. be greater than or equal to 18 years old 2. 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 3. speak Armenian or Georgian 4. live in a selected community Exclusion Criteria: N/A |
Country | Name | City | State |
---|---|---|---|
United States | George Washington University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
George Washington University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Current status; assessed at 6-months post baseline | |
Secondary | Secondhand smoke exposure in the home | Number of days smoking occurred in the home in the past 7 days | Past 7 days; assessed at 6 months post baseline | |
Secondary | Secondhand smoke exposure in the home | Number of days smoking occurred in the home in the past 7 days | Past 7 days; assessed at 3 months post baseline | |
Secondary | 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). | Current status; assessed at 6 months post baseline | |
Secondary | 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). | Current status; assessed at 3 months post baseline | |
Secondary | Among Smokers: Cigarette consumption | Cigarettes smoked per day; days smoked | Past 7 days; assessed at 6 months post baseline | |
Secondary | Among Smokers: Cigarette consumption | Cigarettes smoked per day; days smoked | Past 7 days; assessed at 3 months post baseline | |
Secondary | Among Smokers: Cigarette consumption | Cigarettes smoked per day; days smoked | Past 30 days; assessed at 6 months post baseline | |
Secondary | Among Smokers: Cigarette consumption | Cigarettes smoked per day; days smoked | Past 30 days; assessed at 3 months post baseline | |
Secondary | Among Smokers: Cessation attempts | Number of quit attempts in the past 3 months | Past 3 months; assessed at 6 months post baseline | |
Secondary | Among Smokers: Cessation attempts | Number of quit attempts in the past 3 months | Past 3 months; assessed at 3 months post baseline | |
Secondary | 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). | Current status; assessed at 3 months post baseline |
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