Tobacco DependenceNCT06170437
Smoke-free Home Study in Subsidized Housing
A study testing Smoke-free home resident intervention and Lay Health Worker coaching in people with Tobacco Dependence and Tobacco Smoking, run by University of California, San Francisco at 1 site in United States.
Trial summary
Comprehensive smoke-free policies have the potential to substantially reduce tobacco-related disparities among populations in subsidized housing. This study fills this gap by identifying approaches to increase the implementation of smoke-free policies in all types of subsidized housing by increasing the voluntary… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence, Tobacco Smoking
- What is being tested?
- Smoke-free home resident intervention and Lay Health Worker coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Eligible resident participants
- Current smokers defined as:
- Smoked at least 100 cigarettes in lifetime
- Smoked daily in the past 7 days, and at least 5 cigarettes per day, verified by expired CO ≥ 5 parts per million [ppm] Smokerlyzer CO+ monitor),
- Smoke in their home
- Expect to live in the subsidized housing site for at least 12 months
Show all 9Show fewer
- Age ≥ 18 years
- Speak Chinese (Cantonese or Mandarin), English, Spanish, or Vietnamese
- Able to provide informed consent.
Who cannot join
- Contraindication to any study-related procedures or assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Weijie Wang contact
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Ana Martinez, ana.martinez4@ucsf.edu
Weijie Wang, weijie.wang@ucsf.edu
About this study
Official title: Healthy Homes Study: A Protocol for a Place-based Smoke-free Home Intervention in Federally Subsidized Housing
Comprehensive smoke-free policies have the potential to substantially reduce tobacco-related disparities among populations in subsidized housing. This study fills this gap by identifying approaches to increase the implementation of smoke-free policies in all types of subsidized housing by increasing the voluntary adoption of smoke-free homes and promoting access to smoking cessation services.
Read the detailed description
OBJECTIVES:
The investigators will build on previous studies, where a smoke-free home intervention to increase voluntary adoption of smoke-free homes in permanent supportive housing for formerly homeless adults was developed and evaluated.
Aim 1: To estimate the effect of our adapted smoke-free home intervention on the primary outcome of residents' voluntary adoption of smoke-free homes and the secondary outcome of biochemically-verified tobacco abstinence at 6-months follow-up.
Aim 2: To determine the cost of our adapted smoke-free home intervention and determine whether it is a cost-effective use of health care resources.
Aim 3: To evaluate variation in stakeholders' perspectives on the adapted smoke-free home intervention's adaptability, scalability and sustainability.The proposed intervention can expand access to smoke-free policies and smoking cessation services in subsidized housing, thereby reducing racial/ethnic disparities in tobacco use, tobacco exposure and chronic disease in these populations.
OUTLINE:
A wait-list cluster randomized controlled trial of the adapted smoke-free home intervention compared to usual care among residents from subsidized housing sites in Northern California. Participants from twenty-four subsidized housing sites will be randomized into intervention and waitlist control arms
- Conditions
- Tobacco Dependence, Tobacco Smoking
- Being tested
- Smoke-free home resident intervention, Lay Health Worker coaching
- Medical subject headings
- Tobacco Use Disorder, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoke-free home resident interventionBehavioural
Study staff delivered intervention on how to adopt a smoke free home using a pamphlet
Lay Health Worker coachingBehavioural
Brief tobacco cessation coaching by lay health worker housing staff with residents within 2 weeks of the smoke-free home resident intervention, and on a monthly schedule as part of their routine encounters with residents (total 6 sessions).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The study's investigators will train bilingual study staff to deliver the intervention to residents using a script that matches the content in the smoke-free home intervention pamphlet. The in-person delivery of the intervention and pamphlet will be the primary modes of intervention delivery to residents. The pamphlet will include: (1) the harms of tobacco, e-cigarette use, cannabis use and exposure (secondhand and thirdhand), (2) an exercise to calculate personal cost of tobacco use, (3) benefits of a smoke-free home, (4) skill-building on how to adopt a smoke-free home, and (5) motivational language on smoke-free home adoption. The study staff will qualitatively assess participants' knowledge by prompting questions on the topics covered and will refer participants to lay-health workers (LHWs) for one-on-one coaching. Participants will receive a pledge to designate their homes smoke-free. Receives: Behavioral: Smoke-free home resident intervention; Behavioral: Lay Health Worker coaching |
| Waitlist Control Group | No intervention | The current standard of care does not include any interventions for smoke-free home adoption or referrals to tobacco treatment resources. At the end of the primary endpoint (6 months), control participants will be offered the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants adopting a smoke-free home for ≥90 days
The percentage of participants who reported to adopt a smoke-free home in the past 90 days will be reported
Measured: 6 months
Secondary outcomes (1)
Percentage of participants with point prevalent abstinence (PPA)
The percentage of participants with carbon dioxide (CO)-verified tobacco abstinence will be reported at the 6 month follow-up visit.
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 posted14 Dec 2023
- Study start12 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies 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
- Cluster randomized controlled groups
- Masking
- None (open label)
- Enrolment
- 544 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Maya Vijayaraghavan, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170437
- Sponsor's protocol ID
- 24631
- Other IDs
- R01MD016898
- Status last verified
- Feb 2025
- First submitted
- 6 Dec 2023
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified datasets may be provided to other researchers upon request and approval by the investigator
Publications
Hawes MR, Chakravarty D, Cheng J, Handley MA, Tsoh JY, Lin TK, Hiatt RA, Vijayaraghavan M. The Healthy Homes Study: Protocol for a cluster randomized trial of a place-based smoke-free home intervention in affordable housing. PLoS One. 2025 Jul 29;20(7):e0328786. doi: 10.1371/journal.pone.0328786. eCollection 2025.
PubMed 40729126
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Homes Study: A Protocol for a Place-based Smoke-free Home Intervention in Federally Subsidized Housing
- ClinicalTrials.gov ID
- NCT06170437
- Acronym / sponsor ID
- 24631
- Conditions
- Tobacco Dependence, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 544 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comprehensive smoke-free policies have the potential to substantially reduce tobacco-related disparities among populations in subsidized housing. This study fills this gap by identifying approaches to increase the implementation of smoke-free policies in all types of subsidized housing by increasing the voluntary adoption of smoke-free homes and promoting access to smoking cessation services.
Detailed description
OBJECTIVES:
The investigators will build on previous studies, where a smoke-free home intervention to increase voluntary adoption of smoke-free homes in permanent supportive housing for formerly homeless adults was developed and evaluated.
Aim 1: To estimate the effect of our adapted smoke-free home intervention on the primary outcome of residents' voluntary adoption of smoke-free homes and the secondary outcome of biochemically-verified tobacco abstinence at 6-months follow-up.
Aim 2: To determine the cost of our adapted smoke-free home intervention and determine whether it is a cost-effective use of health care resources.
Aim 3: To evaluate variation in stakeholders' perspectives on the adapted smoke-free home intervention's adaptability, scalability and sustainability.The proposed intervention can expand access to smoke-free policies and smoking cessation services in subsidized housing, thereby reducing racial/ethnic disparities in tobacco use, tobacco exposure and chronic disease in these populations.
OUTLINE:
A wait-list cluster randomized controlled trial of the adapted smoke-free home intervention compared to usual care among residents from subsidized housing sites in Northern California. Participants from twenty-four subsidized housing sites will be randomized into intervention and waitlist control arms
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled groups
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Smoke-free home resident intervention, Behavioral: Lay Health Worker coachingThe study's investigators will train bilingual study staff to deliver the intervention to residents using a script that matches the content in the smoke-free home intervention pamphlet. The in-person delivery of the intervention and pamphlet will be the primary modes of intervention delivery to residents. The pamphlet will include: (1) the harms of tobacco, e-cigarette use, cannabis use and exposure (secondhand and thirdhand), (2) an exercise to calculate personal cost of tobacco use, (3) benefits of a smoke-free home, (4) skill-building on how to adopt a smoke-free home, and (5) motivational language on smoke-free home adoption. The study staff will qualitatively assess participants' knowledge by prompting questions on the topics covered and will refer participants to lay-health workers (LHWs) for one-on-one coaching. Participants will receive a pledge to designate their homes smoke-free. |
| Waitlist Control Group | No intervention | –The current standard of care does not include any interventions for smoke-free home adoption or referrals to tobacco treatment resources. At the end of the primary endpoint (6 months), control participants will be offered the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eligible resident participants
- Current smokers defined as:
- Expect to live in the subsidized housing site for at least 12 months
- Age ≥ 18 years
- Speak Chinese (Cantonese or Mandarin), English, Spanish, or Vietnamese
Key exclusion criteria (1 listed)
- Contraindication to any study-related procedures 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 |
|---|---|---|
| Smoke-free home resident interventionStudy staff delivered intervention on how to adopt a smoke free home using a pamphlet | Behavioural | Intervention |
| Lay Health Worker coachingBrief tobacco cessation coaching by lay health worker housing staff with residents within 2 weeks of the smoke-free home resident intervention, and on a monthly schedule as part of their routine encounters with residents (total 6 sessions). | Behavioural | Intervention |
Primary outcome
Percentage of participants adopting a smoke-free home for ≥90 days
Time frame: 6 months
The percentage of participants who reported to adopt a smoke-free home in the past 90 days will be reported
1 secondary outcome
Percentage of participants with point prevalent abstinence (PPA)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Derived from this study: PubMed 40729126Hawes MR, Chakravarty D, Cheng J, Handley MA, Tsoh JY, Lin TK, Hiatt RA, Vijayaraghavan M. The Healthy Homes Study: Protocol for a cluster randomized trial of a place-based smoke-free home intervention in affordable housing. PLoS One. 2025 Jul 29;20(7):e0328786. doi: 10.1371/journal.pone.0328786. eCollection 2025.
- Individual participant dataSharing planned: Yes. De-identified datasets may be provided to other researchers upon request and approval by the investigator
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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.
Weijie Wang contact
Maya Vijayaraghavan, MD 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 Smoke-free home resident intervention and Lay Health Worker coaching in people with Tobacco Dependence and Tobacco Smoking, 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 9 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: looking for participants now, as of the sponsor's last update on 24 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Martinez (415-839-0572, ana.martinez4@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants adopting a smoke-free home for ≥90 days (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 NCT06170437, which also lists 1 linked publication.
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 24 Feb 2025.