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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04855357
Enrollment
452
Registered
2021-04-22
Start date
2022-01-24
Completion date
2025-03-31
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Second Hand Tobacco Smoke, Smoking Cessation

Keywords

Smoke-free home, Smoking cessation, Permanent supportive housing

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALResident counselling

One hour, one-on-one counseling for residents

BEHAVIORALStaff Training

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.

Sponsors

University of California, San Francisco
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

A cluster-randomized, wait-list controlled designed trial where PSH sites will be randomized into intervention and wait-list control groups.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Resident-participants Who Adopt a Smoke-free Home Voluntarily6 monthsThe 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

MeasureTime frameDescription
Proportion of Resident-participants Who Achieve Abstinence6 monthsThe 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMaya Vijayaraghavan, MD, MAS

University of California, San Francisco

Participant flow

Pre-assignment details

This study is designed as an intent-to-treat model so all resident-participants who completed the baseline assessment will be included in the outcome measures. Trained location staff-participants who were enrolled in the study were not included in any analysis but were consented to participate in the study and included in Participant Flow, Baseline, and Adverse Event tables.

Baseline characteristics

Characteristic
Age, Continuous
Resident-Participants
54.53 Years
STANDARD_DEVIATION 10.69
Age, Continuous
Staff-Participants
43.29 Years
STANDARD_DEVIATION 12.41
Ethnicity (NIH/OMB)
Resident-Participants
Hispanic or Latino
29 Participants
Ethnicity (NIH/OMB)
Resident-Participants
Not Hispanic or Latino
179 Participants
Ethnicity (NIH/OMB)
Resident-Participants
Unknown or Not Reported
4 Participants
Ethnicity (NIH/OMB)
Staff-Participants
Hispanic or Latino
3 Participants
Ethnicity (NIH/OMB)
Staff-Participants
Not Hispanic or Latino
14 Participants
Ethnicity (NIH/OMB)
Staff-Participants
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
Resident-Participants
American Indian or Alaska Native
3 Participants
Race (NIH/OMB)
Resident-Participants
Asian
2 Participants
Race (NIH/OMB)
Resident-Participants
Black or African American
73 Participants
Race (NIH/OMB)
Resident-Participants
More than one race
79 Participants
Race (NIH/OMB)
Resident-Participants
Native Hawaiian or Other Pacific Islander
4 Participants
Race (NIH/OMB)
Resident-Participants
Unknown or Not Reported
6 Participants
Race (NIH/OMB)
Resident-Participants
White
62 Participants
Race (NIH/OMB)
Staff-Participants
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Staff-Participants
Asian
3 Participants
Race (NIH/OMB)
Staff-Participants
Black or African American
29 Participants
Race (NIH/OMB)
Staff-Participants
More than one race
1 Participants
Race (NIH/OMB)
Staff-Participants
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Staff-Participants
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
Staff-Participants
White
10 Participants
Region of Enrollment
United States
452 participants
Sex/Gender, Customized
Resident-Participants
Female
68 Participants
Sex/Gender, Customized
Resident-Participants
Male
111 Participants
Sex/Gender, Customized
Resident-Participants
Not Reported
12 Participants
Sex/Gender, Customized
Staff-Participants
Female
20 Participants
Sex/Gender, Customized
Staff-Participants
Male
13 Participants
Sex/Gender, Customized
Staff-Participants
Not Reported
2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
7 / 1910 / 356 / 2090 / 17
other
Total, other adverse events
0 / 1910 / 350 / 2090 / 17
serious
Total, serious adverse events
0 / 1910 / 350 / 2090 / 17

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026