Implementing a Scalable Smoke-free Home Intervention in Armenia and Georgia

NCT06166433 | Recruiting DMC

• 1 other identifier: GW13528
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Second Hand Tobacco Smoke

Outcome Measures

Primary Outcomes (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).

  Current status; assessed at 6-months post baseline

Secondary Outcomes (11)

• Secondhand smoke exposure in the home

  Past 7 days; assessed at 6 months post baseline

• Secondhand smoke exposure in the home

  Past 7 days; assessed at 3 months post baseline

• Complete smoke-free vehicle rule

  Current status; assessed at 6 months post baseline

• Complete smoke-free vehicle rule

  Current status; assessed at 3 months post baseline

• Among Smokers: Cigarette consumption

  Past 7 days; assessed at 6 months post baseline

Study Arms (2)

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

Behavioral: Smoke-free homes intervention

Control

NO INTERVENTION

Assessment-only control

Interventions

Smoke-free homes intervention BEHAVIORAL

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

Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University

Washington D.C., District of Columbia, 20052, United States

RECRUITING

Central Study Contacts

Carla Berg

CONTACT

4045585395; carlaberg@gwu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, and outcomes assessors will blind to assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Prevention and Community Health

Model Details: 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 Record Dates

• First Submitted: December 1, 2023
• First Posted: December 12, 2023
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)