Smoke-free Home Intervention in Permanent Supportive Housing

A Community-based Trial of a Voluntary Smoke-free Home Intervention in Permanent Supportive Housing for Formerly Homeless Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation; Second Hand Tobacco Smoke
• Intervention / Treatment: Behavioral: Resident counselling; Behavioral: Staff Training

Detailed Description

PSH resident participants (200 each in the intervention and wait-list control arms) and within each site, all resident participants will be informed about the study and invited to participate. Participants will be recruited within blocks of four housing sites per month, with each block containing two intervention and two wait-list control sites, and anticipating roll-out of one such block per month. Anticipated completion of recruitment and enrollment of all participants should occur within 6 months, allowing for a one-to-two-month extension to complete these activities. The intervention will be offered to the wait-list control participants once all participants in the intervention sites from the same block have completed their 6-month follow-up.

400 resident participants will be recruited, with 200 participants each in the intervention and wait-list control arms (~20 participants per site). Within each site, study staff will advertise the study to residents the week prior to enrollment by placing flyers at the study site and making announcements at community meetings. After the informational meeting, study staff will be present at the recruitment sites during designated times to screen interested participants for eligibility and enroll those eligible into the study. These study procedures were successfully employed the pilot study. Participants in the study may be invited to a one-time, voluntary, community advisory board (CAB) meeting.

Specific Objectives:

Aim 1: Conduct a cluster randomized trial to estimate the effect of the smoke-free home intervention on residents' voluntary adoption of smoke-free homes.

Aim 2: Evaluate the cost-effectiveness of the smoke-free home intervention.

Aim 3: Determine characteristics of high and low adopters at the individual level, and social and environmental barriers and enablers of adoption, scalability and sustainability of the intervention.

It will take 6 months for the intervention group participants to complete the study, and 1 year for the wait-list control participants to complete the study.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Alway; Phone Number: 415-839-0572; Email: Jessica.Alway@ucsf.edu
• Study Contact Backup: Name: Maya Vijayaraghavan, MD, MAS; Phone Number: (628) 206-6959; Email: Maya.Vijayaraghavan@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Principal Investigator: Maya Vijayaraghavan, MD, MAS
      • Contact: Jessica Alway; Phone Number: 415-839-0572; Email: Jessica.Alway@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 18 years or older
2. Ability to understand study procedures and to comply with them for the entire length of the study.
3. Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
4. 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.
5. Expect to live in the PSH site for at least 12 months
6. English proficient.

Exclusion Criteria:

1. Contraindication to any study-related procedure or assessment.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smoke-free home permanent supportive housing (PSH) resident intervention + Staff Intervention; 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; One hour, one-on-one counseling for residents; Behavioral: Staff Training; 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.
Other: Wait-List Control (Usual Care) then crossover to Smoke-free home PSH resident intervention; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who achieve abstinence	7-day point prevalence abstinence at 6 months follow-up, measured as self-report of abstinence at the 6-month follow-up and an expired carbon monoxide of <= 5 parts per million (ppm) as abstinence	6 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Maya Vijayaraghavan, MD, MAS, University of California, San Francisco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Smoking cessation; Smoke-free home; Permanent supportive housing
• Other Study ID Numbers: 21631; 1R37CA248448-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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