Smoke-free Home Study in Subsidized Housing

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Smoking; Tobacco Dependence
• Intervention / Treatment: Behavioral: Smoke-free home resident intervention; Behavioral: Lay Health Worker coaching

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

• Study Type: Interventional
• Enrollment (Estimated): 544
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Martinez; Phone Number: 415-839-0572; Email: ana.martinez4@ucsf.edu
• Study Contact Backup: Name: Weijie Wang; Email: weijie.wang@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Weijie Wang; Email: weijie.wang@ucsf.edu
      • Contact: Ana Martinez; Email: ana.martinez4@ucsf.edu
      • Principal Investigator: Maya Vijayaraghavan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The study's investigators will train bilingual study staff to deliver the intervention to residents using a script that matches the content in the smoke-free home intervention pamphlet. The in-person delivery of the intervention and pamphlet will be the primary modes of intervention delivery to residents. The pamphlet will include: (1) the harms of tobacco, e-cigarette use, cannabis use and exposure (secondhand and thirdhand), (2) an exercise to calculate personal cost of tobacco use, (3) benefits of a smoke-free home, (4) skill-building on how to adopt a smoke-free home, and (5) motivational language on smoke-free home adoption. The study staff will qualitatively assess participants' knowledge by prompting questions on the topics covered and will refer participants to lay-health workers (LHWs) for one-on-one coaching. Participants will receive a pledge to designate their homes smoke-free.	Behavioral: Smoke-free home resident intervention; Study staff delivered intervention on how to adopt a smoke free home using a pamphlet; Behavioral: 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).
No Intervention: Waitlist Control Group; The current standard of care does not include any interventions for smoke-free home adoption or referrals to tobacco treatment resources. At the end of the primary endpoint (6 months), control participants will be offered the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Maya Vijayaraghavan, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 24631; R01MD016898 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified datasets may be provided to other researchers upon request and approval by the investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No