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Completed

NCT Number: NCT04855357

Smoke-free Home Intervention in Permanent Supportive Housing

The focus of this study 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

PSH resident-participants (200 each in the intervention and wait-list control arms) and within each site (~20 participants at 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 resident-participants and staff-participants at the locations 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.

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 eligible resident-participants into the study. These study procedures were successfully employed in the pilot study. Participants in the study may be invited to a one-time, voluntary, community advisory board (CAB) meeting.

Primary Objective:

I. Conduct a cluster randomized trial to estimate the effect of the smoke-free home intervention on resident-participants' voluntary adoption of smoke-free homes.

Exploratory Objectives:

II. Evaluate the cost-effectiveness of the smoke-free home intervention.

III. 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 resident-participants to complete the study, and 1 year for the wait-list control participants to complete the study if resident-participants accept the option to cross over after 6 months and receive the intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Contraindication to any study-related procedure or assessment.

Treatment and study plan

Resident counselling

Behavioral

One hour, one-on-one counseling for residents

Staff Training

Behavioral

A two-hour training for PSH staff-participants 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-participants to provide referrals to local cessation services using the ask, advise, and refer approach. The training will address nicotine addiction, tobacco use among PSH resident-participants, 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-participants and resident dyads (n=40) to record these interactions to assess fidelity.

Primary outcomes

  1. Proportion of Resident-participants Who Adopt a Smoke-free Home Voluntarily

    Time frame: 6 months

    The proportion of resident-participants who self-reported a voluntary adoption of smoke-free homes for >=90 days at 6 months follow-up will be reported.

Secondary outcomes

  1. Proportion of Resident-participants Who Achieve Abstinence

    Time frame: 6 months

    The proportion of resident-participants with 7-day point prevalence abstinence at 6 months follow-up, measured as self-report of abstinence and an expired carbon monoxide of <= 5 parts per million (ppm) as abstinence will be reported.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2021
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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