Smoke-Free Homes Intervention for Secondhand Smoke

(SFHAMGE Trial)

Overseen By Carla Berg

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: George Washington University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

550 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 in Armenia and Georgia who either smoke at home with a child or non-smoker present, or are non-smokers living with someone who smokes indoors. Participants must speak Armenian or Georgian and reside in selected communities.

Inclusion Criteria

Live in a selected community

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

I speak Armenian or Georgian.

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Theory-based intervention involving 3 mailed sets of educational materials and a brief coaching call using motivational interviewing, delivered over a 6-week period

6 weeks

3 mailed sets, 1 coaching call

Follow-up

Participants are monitored for smoke-free home adoption and other outcomes

6 months

Assessments at 3 and 6 months

Treatment Details

Interventions

• Smoke-free homes intervention

Trial Overview The study is testing an intervention designed to create smoke-free homes (SFHs) to reduce secondhand smoke exposure. It's being conducted as a hybrid effectiveness-implementation randomized controlled trial (RCT) across selected communities.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Theory-based intervention involving 3 mailed sets of educational materials and a brief coaching call using motivational interviewing, delivered over a 6-week period

Group II: Control Active Control 1 Intervention

Assessment-only control

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+