Clinical trial NCT04855357: Smoke-free Home Intervention in Permanent Supportive Housing
Official title: A Community-based Trial of a Voluntary Smoke-free Home Intervention in Permanent Supportive Housing for Formerly Homeless Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Second Hand Tobacco Smoke
Keywords: Smoke-free home
Smoking cessation
Permanent supportive housing
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-04-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants who adopt a smoke-free home voluntarily
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of participants who achieve abstinence
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Maya Vijayaraghavan, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.