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| ID | Type | Description | Link |
|---|---|---|---|
| 1R37CA248448-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resident counselling | Behavioral | One hour, one-on-one counseling for residents |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
1. Contraindication to any study-related procedure or assessment.](streamdown:incomplete-link)
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| Name | Affiliation | Role |
|---|---|---|
| Maya Vijayaraghavan, MD, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36376812 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Smoke-free Home Permanent Supportive Housing (PSH) Resident Intervention + Staff Intervention | Study staff will deliver a one hour, one-on-one counseling to permanent supportive housing (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. |
| FG001 | Wait-List Control (Usual Care) | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||||||||
| Month 6 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Smoke-free Home Permanent Supportive Housing (PSH) Resident Intervention + Staff Intervention | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline data is reported by participant type. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This study is designed as an intent-to-treat model so all resident-participants who completed the baseline assessment will be included in the denominator of the outcome measures. | Posted | Number | proportion of resident-participants | 6 months |
|
Up to 6 months
Resident participants and Staff participants are included in the adverse event data since both groups consented to the study. Adverse events for participants in the wait-list (usual care) who was given the option to engage in the intervention after the 6 month mark was not conducted as part of this study and not included in this analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Smoke-free Home PSH: Resident Participants | 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. |
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Trained location staff-participants who were enrolled in the study were not included in primary and secondary outcome analysis but were consented to participate in the study and are included in the appropriate tables
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maya Vijayaraghavan, MD, MAS | University of California, San Francisco | (415) 476-1000 | maya.vijayaraghavan@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2021 | Feb 12, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 9, 2022 | Jan 14, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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A cluster-randomized, wait-list controlled designed trial where PSH sites will be randomized into intervention and wait-list control groups.
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| Staff Training | Behavioral | 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. |
|
| Staff-Participants |
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| COMPLETED |
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| NOT COMPLETED |
|
| BG001 | Wait-List Control (Usual Care) | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex/Gender, Customized | Baseline data is reported by participant type | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | There were two different participant populations: Resident-participants and Staff-Participants. | Count of Participants | Participants |
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| Race (NIH/OMB) | There were two different participant populations: Resident-participants and Staff-Participants. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Wait-List Control (Usual Care) | 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. |
|
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| Secondary | 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. | This study is designed as an intent-to-treat model so all resident-participants who completed the baseline assessment will be included in the denominator of the outcome measures. | Posted | Number | proportion of resident-participants | 6 months |
|
|
|
| 7 |
| 191 |
| 0 |
| 191 |
| 0 |
| 191 |
| EG001 | Smoke-free Home PSH: Staff Participants | 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. | 0 | 35 | 0 | 35 | 0 | 35 |
| EG002 | Wait-List Control (Usual Care) - Resident Participants | The current standard of care includes no interventions for smoke-free home adoption or referrals to smoking cessation resources. | 6 | 209 | 0 | 209 | 0 | 209 |
| EG003 | Wait-List Control (Usual Care)- Staff Participants | The current standard of care includes no interventions for smoke-free home adoption or referrals to smoking cessation resources. | 0 | 17 | 0 | 17 | 0 | 17 |
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| Not Reported |
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| Male |
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| Not Reported |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|