Clinical trial NCT06170437: Smoke-free Home Study in Subsidized Housing
Official title: Healthy Homes Study: A Protocol for a Place-based Smoke-free Home Intervention in Federally Subsidized Housing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Dependence
Tobacco Smoking
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-12-14
Enrollment: 544
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled groups
Primary purpose: PREVENTION

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants adopting a smoke-free home for ≥90 days
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of participants with point prevalent abstinence (PPA)
timeFrame: 6 months
Other outcomes:
measure: Percentage of participants adopting a cannabis-free home among cannabis users
timeFrame: 6 months
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Maya Vijayaraghavan, MD
role: PRINCIPAL_INVESTIGATOR
References: