Smoking CessationNCT04855357
Smoke-free Home Intervention in Permanent Supportive Housing
A study testing Resident counselling and Staff Training in people with Smoking Cessation and Second Hand Tobacco Smoke, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Second Hand Tobacco Smoke
- What is being tested?
- Resident counselling and Staff Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Contraindication to any study-related procedure or assessment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Community-based Trial of a Voluntary Smoke-free Home Intervention in Permanent Supportive Housing for Formerly Homeless Adults
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.
Read the 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:
- 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.
- Conditions
- Smoking Cessation, Second Hand Tobacco Smoke
- Being tested
- Resident counselling, Staff Training
- Keywords
- Smoke-free home, Smoking cessation, Permanent supportive housing
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resident counsellingBehavioural
One hour, one-on-one counseling for residents
Staff TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Smoke-free home permanent supportive housing (PSH) resident intervention + Staff Intervention | Experimental | Study staff will deliver a one hour, one-on-one counseling to PSH resident-participants 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. Staff at various sites will be trained by the study team (staff-participants) to provide support to the resident-participants in tobacco cessation. At follow-up assessments, the study team will ask resident-participants whether they had a chance to view the intervention materials in between visits and will offer an opportunity for resident-participants to discuss conflicts that they had experienced around smoke-free home adoption and will provide strategies to address these roadblocks. Receives: Behavioral: Resident counselling; Behavioral: Staff Training |
| Wait-List Control (Usual Care) | Other | The current standard of care includes no interventions for smoke-free home adoption or referrals to smoking cessation resources. Wait-list group will be given the option to receive Smoke-Free Home (SFH) intervention after intervention group completes the 6-month follow-up. Staff at various sites will be trained by the study team (staff-participants) to provide support to the resident-participants in tobacco cessation. Receives: Behavioral: Staff Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Resident-participants Who Adopt a Smoke-free Home Voluntarily
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.
Measured: 6 months
Secondary outcomes (1)
Proportion of Resident-participants Who Achieve Abstinence
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start24 Jan 2022
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster-randomized, wait-list controlled designed trial where PSH sites will be randomized into intervention and wait-list control groups.
- Masking
- None (open label)
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Maya Vijayaraghavan, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855357
- Sponsor's protocol ID
- 21631
- Other IDs
- 1R37CA248448-01A1
- Status last verified
- Mar 2026
- First submitted
- 19 Apr 2021
- Last updated
- 26 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hawes MR, Alway J, Chakravarty D, Xia F, Kushel M, Max W, Vijayaraghavan M. Smoke-Free Home Intervention in Permanent Supportive Housing: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Sep 1;9(9):e2632697. doi: 10.1001/jamanetworkopen.2026.32697.
PubMed 42714909Odes 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.
PubMed 36376812
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Trial of a Voluntary Smoke-free Home Intervention in Permanent Supportive Housing for Formerly Homeless Adults
- ClinicalTrials.gov ID
- NCT04855357
- Acronym / sponsor ID
- 21631
- Conditions
- Smoking Cessation, Second Hand Tobacco Smoke
- Keywords
- Smoke-free home, Smoking cessation, Permanent supportive housing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Posted 29 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster-randomized, wait-list controlled designed trial where PSH sites will be randomized into intervention and wait-list control groups.
| Arm | Type | Receives |
|---|---|---|
| Smoke-free home permanent supportive housing (PSH) resident intervention + Staff Intervention | Experimental | Behavioral: Resident counselling, Behavioral: Staff TrainingStudy staff will deliver a one hour, one-on-one counseling to PSH resident-participants 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. Staff at various sites will be trained by the study team (staff-participants) to provide support to the resident-participants in tobacco cessation. At follow-up assessments, the study team will ask resident-participants whether they had a chance to view the intervention materials in between visits and will offer an opportunity for resident-participants to discuss conflicts that they had experienced around smoke-free home adoption and will provide strategies to address these roadblocks. |
| Wait-List Control (Usual Care) | Other | Behavioral: Staff TrainingThe current standard of care includes no interventions for smoke-free home adoption or referrals to smoking cessation resources. Wait-list group will be given the option to receive Smoke-Free Home (SFH) intervention after intervention group completes the 6-month follow-up. Staff at various sites will be trained by the study team (staff-participants) to provide support to the resident-participants in tobacco cessation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Contraindication to any study-related procedure or assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resident counsellingOne hour, one-on-one counseling for residents | Behavioural | Smoke-free home permanent supportive housing (PSH) resident intervention + Staff Intervention |
| Staff TrainingA 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. | Behavioural | Smoke-free home permanent supportive housing (PSH) resident intervention + Staff Intervention, Wait-List Control (Usual Care) |
Primary outcome
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.
1 secondary outcome
Proportion of Resident-participants Who Achieve Abstinence
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42714909Hawes MR, Alway J, Chakravarty D, Xia F, Kushel M, Max W, Vijayaraghavan M. Smoke-Free Home Intervention in Permanent Supportive Housing: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Sep 1;9(9):e2632697. doi: 10.1001/jamanetworkopen.2026.32697.
- Derived from this study: PubMed 36376812Odes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya Vijayaraghavan, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resident counselling and Staff Training in people with Smoking Cessation and Second Hand Tobacco Smoke, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Resident-participants Who Adopt a Smoke-free Home Voluntarily (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04855357, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.