Smoke-free Home Study in Subsidized Housing

Tobacco Dependence Clinical Trial

Official title:

Healthy Homes Study: A Protocol for a Place-based Smoke-free Home Intervention in Federally Subsidized Housing

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06170437
• Other study ID #: 24631
• Secondary ID: R01MD016898
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: University of California, San Francisco
• Contact: Ana Martinez
• Phone: 415-839-0572
• Email: ana.martinez4[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comprehensive smoke-free policies have the potential to substantially reduce tobacco-related disparities among populations in subsidized housing. This study fills this gap by identifying approaches to increase the implementation of smoke-free policies in all types of subsidized housing by increasing the voluntary adoption of smoke-free homes and promoting access to smoking cessation services.

Description:

OBJECTIVES: The investigators will build on previous studies, where a smoke-free home intervention to increase voluntary adoption of smoke-free homes in permanent supportive housing for formerly homeless adults was developed and evaluated. Aim 1: To estimate the effect of our adapted smoke-free home intervention on the primary outcome of residents' voluntary adoption of smoke-free homes and the secondary outcome of biochemically-verified tobacco abstinence at 6-months follow-up. Aim 2: To determine the cost of our adapted smoke-free home intervention and determine whether it is a cost-effective use of health care resources. Aim 3: To evaluate variation in stakeholders' perspectives on the adapted smoke-free home intervention's adaptability, scalability and sustainability.The proposed intervention can expand access to smoke-free policies and smoking cessation services in subsidized housing, thereby reducing racial/ethnic disparities in tobacco use, tobacco exposure and chronic disease in these populations. OUTLINE: A wait-list cluster randomized controlled trial of the adapted smoke-free home intervention compared to usual care among residents from subsidized housing sites in Northern California. Participants from twenty-four subsidized housing sites will be randomized into intervention and waitlist control arms

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 544
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Eligible resident participants

• Current smokers defined as:
• Smoked at least 100 cigarettes in lifetime
• Smoked daily in the past 7 days, and at least 5 cigarettes per day, verified by expired CO = 5 parts per million [ppm] Smokerlyzer CO+ monitor),
• Smoke in their home
• Expect to live in the subsidized housing site for at least 12 months
• Age = 18 years
• Speak Chinese (Cantonese or Mandarin), English, Spanish, or Vietnamese
• Able to provide informed consent.

Exclusion Criteria:

• Contraindication to any study-related procedures or assessment

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Smoking
• Tobacco Use Disorder

Intervention

Behavioral:
• Smoke-free home resident intervention
Study staff delivered intervention on how to adopt a smoke free home using a pamphlet
• Lay Health Worker coaching
Brief tobacco cessation coaching by lay health worker housing staff with residents within 2 weeks of the smoke-free home resident intervention, and on a monthly schedule as part of their routine encounters with residents (total 6 sessions).

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of participants adopting a cannabis-free home among cannabis users	The percentage of participants who reported to adopt a cannabis-free home in the past 90 days will be reported	6 months
Primary	Percentage of participants adopting a smoke-free home for =90 days	The percentage of participants who reported to adopt a smoke-free home in the past 90 days will be reported	6 months
Secondary	Percentage of participants with point prevalent abstinence (PPA)	The percentage of participants with carbon dioxide (CO)-verified tobacco abstinence will be reported at the 6 month follow-up visit.	6 months