Tobacco UseNCT06042361
Enhancing Equity in Smoke-free Housing
A study testing Smokefree Implementation Framework and Toolkit in people with Tobacco Use and Tobacco Smoking, run by Harvard School of Public Health (HSPH) at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about the acceptability, feasibility, and effectiveness of smoke-free housing policy implementation in Permanent Supportive Housing communities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Tobacco Smoking, Tobacco Use Cessation
- What is being tested?
- Smokefree Implementation Framework and Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Dec 2025
- 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
- Adult residents of the six affordable housing communities who smoke or do not smoke tobacco, who receive or do not receive Permanent Supportive Housing services, and can complete a survey in English or Spanish.
- Adult residents of the six affordable housing communities who smoke or do not smoke tobacco, who receive or do not receive Permanent Supportive Housing services, and can participate in a focus group discussion in English.
- Property Managers (or their designated appointees) of the six affordable housing communities where the research will be conducted and able to receive the intervention and participate in the qualitative interviews in English.
- Caseworkers who are dedicated health workers who provide behavioral health support (mental health and substance use support interventions) to residents at each of the six properties and who can receive the intervention and participate in the qualitative interviews in English.
Who cannot join
- Those unable to speak English or Spanish.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Harvard TH Chan School of Public Health
Boston, Massachusetts, 02115
About this study
Official title: Enhancing Equity in Smoke-free Housing: Evidence-based Strategies to Support Implementation in Permanent Supportive Housing (PSH) Communities
The goal of this clinical trial is to learn about the acceptability, feasibility, and effectiveness of smoke-free housing policy implementation in Permanent Supportive Housing communities. The main objective of this study is to identify and refine adaptations for a smoke-free housing implementation framework that incorporates behavioral health support and meets the needs of residents living in Permanent Supportive Housing.
Read the detailed description
The study aims are:
Aim 1): Identify adaptations for a smokefree housing implementation framework and identify opportunities to integrate these adaptations with ongoing behavioral health support, to meet the needs of residents living in Permanent Supportive Housing (PSH) (Phase 1).
Aim 2): The research team will pilot test the adapted implementation framework, including an implementation toolkit, to assess the acceptability, feasibility and effectiveness of the primary intervention provided to Property Managers (Phase 2).
Aim 3): Based on a synthesis of qualitative and quantitative evidence, the research team will further refine the smokefree implementation framework and toolkit, comprising modified versions of the "Implementation Guide", "Action Plan" and "Implementation Checklist", to support future needs of Permanent Supportive Housing communities (Phase 3).
The research team seeks to use the opportunity provided by smokefree housing implementation to minimize indoor smoking and encourage smoking cessation, and thus help move communities with a history of profound health disparities towards a more equitable, tobacco-free future. The impact of this project will be evident not only among smokers, but also non-smokers, children and the elderly who share residential communities with people supported by PSH programs.
If successful, the results of this work will be used to promote broader and more effective use of the smokefree PSH implementation framework in federally-assisted public and affordable housing communities nationally.
- Conditions
- Tobacco Use, Tobacco Smoking, Tobacco Use Cessation, Tobacco Use Disorder, Second Hand Tobacco Smoke
- Being tested
- Smokefree Implementation Framework and Toolkit
- Keywords
- tobacco, second hand tobacco smoke, tobacco cessation, smokefree housing
- Medical subject headings
- Tobacco Use, Tobacco Smoking, Tobacco Use Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smokefree Implementation Framework and ToolkitBehavioural
Framework and toolkit that includes "Implementation Guide", "Action Plan", and "Implementation Checklist" that supports the needs of Permanent Supportive Housing communities.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | All participants will receive the intervention of the Smokefree Implementation Framework and Toolkit Receives: Behavioral: Smokefree Implementation Framework and Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Measure (AIM)
The Smokefree Implementation Framework and Toolkit is acceptable to implement in Permanent Supportive Housing communities. Measured using 4-items from the AIM.
Measured: Pre-intervention through 6 months post intervention
Feasibility of Intervention Measure (FIM)
The Smokefree Implementation Framework and Toolkit is feasible to implement in Permanent Supportive Housing communities. Measured using 4-items from the FIM.
Measured: Pre-intervention through 6 months post intervention
Secondary outcomes (3)
Ambient second-hand smoke in common indoor areas
Monitored using passive nicotine dosimetry monitors placed in common areas
Measured: Pre-intervention through 6 months post intervention
Residents' self-reported exposure to secondhand smoke
Self-reported exposure to secondhand smoke (smell or sight) in the home or around the property, will be assessed with two questions in survey form.
Measured: Pre-intervention through 6 months post intervention
Behavior of residents who smoke
Self-reported behavior of smoking (cigarettes/day in the past 30 days) of residents who smoke
Measured: Pre-intervention through 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Two-phased approach: formative first phase, testing second phase. Enrollment based on residential property clusters.
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vaughan Rees, Harvard School of Public Health (HSPH)
- Investigators
- Vaughan Rees, PhD, Principal investigator, Harvard University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042361
- Sponsor's protocol ID
- IRB23-0415
- Status last verified
- Oct 2024
- First submitted
- 27 Jul 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Equity in Smoke-free Housing: Evidence-based Strategies to Support Implementation in Permanent Supportive Housing (PSH) Communities
- ClinicalTrials.gov ID
- NCT06042361
- Acronym / sponsor ID
- IRB23-0415
- Conditions
- Tobacco Use, Tobacco Smoking, Tobacco Use Cessation, Tobacco Use Disorder, Second Hand Tobacco Smoke
- Keywords
- tobacco, second hand tobacco smoke, tobacco cessation, smokefree housing
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Sep 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.
The goal of this clinical trial is to learn about the acceptability, feasibility, and effectiveness of smoke-free housing policy implementation in Permanent Supportive Housing communities. The main objective of this study is to identify and refine adaptations for a smoke-free housing implementation framework that incorporates behavioral health support and meets the needs of residents living in Permanent Supportive Housing.
Detailed description
The study aims are:
Aim 1): Identify adaptations for a smokefree housing implementation framework and identify opportunities to integrate these adaptations with ongoing behavioral health support, to meet the needs of residents living in Permanent Supportive Housing (PSH) (Phase 1).
Aim 2): The research team will pilot test the adapted implementation framework, including an implementation toolkit, to assess the acceptability, feasibility and effectiveness of the primary intervention provided to Property Managers (Phase 2).
Aim 3): Based on a synthesis of qualitative and quantitative evidence, the research team will further refine the smokefree implementation framework and toolkit, comprising modified versions of the "Implementation Guide", "Action Plan" and "Implementation Checklist", to support future needs of Permanent Supportive Housing communities (Phase 3).
The research team seeks to use the opportunity provided by smokefree housing implementation to minimize indoor smoking and encourage smoking cessation, and thus help move communities with a history of profound health disparities towards a more equitable, tobacco-free future. The impact of this project will be evident not only among smokers, but also non-smokers, children and the elderly who share residential communities with people supported by PSH programs.
If successful, the results of this work will be used to promote broader and more effective use of the smokefree PSH implementation framework in federally-assisted public and affordable housing communities nationally.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two-phased approach: formative first phase, testing second phase. Enrollment based on residential property clusters.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Smokefree Implementation Framework and ToolkitAll participants will receive the intervention of the Smokefree Implementation Framework and Toolkit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult residents of the six affordable housing communities who smoke or do not smoke tobacco, who receive or do not receive Permanent Supportive Housing services, and can complete a survey in English or Spanish.
- Adult residents of the six affordable housing communities who smoke or do not smoke tobacco, who receive or do not receive Permanent Supportive Housing services, and can participate in a focus group discussion in English.
- Property Managers (or their designated appointees) of the six affordable housing communities where the research will be conducted and able to receive the intervention and participate in the qualitative interviews in English.
- Caseworkers who are dedicated health workers who provide behavioral health support (mental health and substance use support interventions) to residents at each of the six properties and who can receive the intervention and participate in the qualitative interviews in English.
Key exclusion criteria (1 listed)
- Those unable to speak English or Spanish.
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 |
|---|---|---|
| Smokefree Implementation Framework and ToolkitFramework and toolkit that includes "Implementation Guide", "Action Plan", and "Implementation Checklist" that supports the needs of Permanent Supportive Housing communities. | Behavioural | Intervention |
Primary outcome
Acceptability of Intervention Measure (AIM)
Time frame: Pre-intervention through 6 months post intervention
The Smokefree Implementation Framework and Toolkit is acceptable to implement in Permanent Supportive Housing communities. Measured using 4-items from the AIM.
Feasibility of Intervention Measure (FIM)
Time frame: Pre-intervention through 6 months post intervention
The Smokefree Implementation Framework and Toolkit is feasible to implement in Permanent Supportive Housing communities. Measured using 4-items from the FIM.
3 secondary outcomes
Ambient second-hand smoke in common indoor areas
Time frame: Pre-intervention through 6 months post intervention
Residents' self-reported exposure to secondhand smoke
Time frame: Pre-intervention through 6 months post intervention
Behavior of residents who smoke
Time frame: Pre-intervention through 6 months post intervention
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 18 Oct 2024.
- 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.
Vaughan Rees, PhD principal investigator
Harvard University School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smokefree Implementation Framework and Toolkit in people with Tobacco Use and Tobacco Smoking, run by Harvard School of Public Health (HSPH) 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 4 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: enrolling by invitation, as of the sponsor's last update on 18 Oct 2024. 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?
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?
Acceptability of Intervention Measure (AIM) (time frame: Pre-intervention through 6 months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2024.