University of California, San Francisco
San Francisco, California, 94143, United States
NCT Number: NCT04855357
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
San Francisco, California, 94143, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One hour, one-on-one counseling for residents
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.
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.
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.
University of California, San Francisco
Other
A Community-based Trial of a Voluntary Smoke-free Home Intervention in Permanent Supportive Housing for Formerly Homeless Adults
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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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