Smoke-free Home Intervention in Permanent Supportive Housing

NCT04855357 | Completed

• 2 other identifiers: 216311R37CA248448-01A1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The focus of this proposal is on expanding access to voluntary smoke-free homes to formerly homeless residents residing in permanent supportive housing, and examining the impact of this intervention on reducing tobacco-caused disparities. In this study, the principal investigator will conduct a multi-site, community-based cluster-randomized wait-list controlled trial of the multi-faceted smoke-free home intervention among 400 permanent supportive housing residents residing in 20 permanent supportive housing sites across the San Francisco Bay Area with the goal of increasing voluntary adoption of smoke-free homes.

Conditions

Smoking Cessation; Second Hand Tobacco Smoke

Keywords

Smoke-free home; Smoking cessation; Permanent supportive housing

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who adopt a smoke-free home voluntarily

  Self-reported voluntary adoption of smoke-free homes for \>=90 days at 6 months follow-up

  6 months

Secondary Outcomes (1)

• Proportion of participants who achieve abstinence

  6 months

Study Arms (2)

Smoke-free home permanent supportive housing (PSH) resident intervention + Staff Intervention

EXPERIMENTAL

Study staff will deliver a one hour, one-on-one counseling to PSH residents that includes: (1) a step-by-step guide on how to voluntarily adopt a smoke-free home, (2) information on second hand smoke (SHS) and third-hand smoke, alternative combustible tobacco and nicotine product use, cannabis-tobacco co-use, effects of SHS on kids and pets,(3) a worksheet on calculating personal costs related to tobacco use, and (4) pledges to designate one's home smoke-free. At follow-up assessments, the study team will ask participants whether they had a chance to view the intervention materials in between visits and will offer an opportunity for participants to discuss conflicts that they had experienced around smoke-free home adoption and will provide strategies to address these roadblocks.

Behavioral: Resident counselling; Behavioral: Staff Training

Wait-List Control (Usual Care) then crossover to Smoke-free home PSH resident intervention

OTHER

The current standard of care includes no interventions for smoke-free home adoption or referrals to smoking cessation resources. Wait-list group receives Smoke-Free Home (SFH) intervention after intervention group complete 6-month follow-up

Behavioral: Staff Training

Interventions

Resident counselling BEHAVIORAL

One hour, one-on-one counseling for residents

Smoke-free home permanent supportive housing (PSH) resident intervention + Staff Intervention

Staff Training BEHAVIORAL

A two-hour training for PSH staff on how to provide referrals to smoking cessation programs using materials previously developed from UCSF's 'Rx for change' curriculum for service providers, directed toward empowering PSH staff to provide referrals to local cessation services using the ask, advise, and refer approach. The training will address nicotine addiction, tobacco use among PSH residents, pilot data, brief cessation counseling (ask, advise, and refer), and local resources for cessation. Because PSH resident-PSH staff encounters will take place as part of routine care, the study team will request permission from a random sample of staff and resident dyads (n=40) to record these interactions to assess fidelity.

Smoke-free home permanent supportive housing (PSH) resident intervention + Staff Intervention; Wait-List Control (Usual Care) then crossover to Smoke-free home PSH resident intervention

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Ability to understand study procedures and to comply with them for the entire length of the study.
• Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
• Current smokers \[(smoked at least 100 cigarettes in lifetime, daily or non-daily smoking in the past 7 days and at least 5 cigarettes per day, verified by expired Carbon Monoxide (CO)\>= 8 parts per million (ppm) who smoke in their homes.
• Expect to live in the PSH site for at least 12 months
• English proficient.

You may not qualify if:

• \. Contraindication to any study-related procedure or assessment.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

• Odes R, Alway J, Kushel M, Max W, Vijayaraghavan M. The smoke-free home study: study protocol for a cluster randomized controlled trial of a smoke-free home intervention in permanent supportive housing. BMC Public Health. 2022 Nov 14;22(1):2076. doi: 10.1186/s12889-022-14423-y.

  PMID: 36376812 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Maya Vijayaraghavan, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A cluster-randomized, wait-list controlled designed trial where PSH sites will be randomized into intervention and wait-list control groups. Those in the wait-list control group will receive usual care first and then cross over to the intervention arm.

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: January 24, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)