Smoking, TobaccoNCT04791722
Optimizing Smoke-free Residential Housing Policies
A study testing Adaptive Intervention in people with Smoking, Tobacco and Second Hand Tobacco Smoke, run by Harvard School of Public Health (HSPH) at 1 site in United States.
Trial summary
This project will be conducted to investigate activities on housing-related health and safety issues. The focus of this project is the development of evidence-based approaches to implement smoke-free policies to reduce harms associated with exposure to secondhand smoke (SHS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Tobacco, Second Hand Tobacco Smoke, Smoking Cessation
- What is being tested?
- Adaptive Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2019to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Property Manager Inclusion Criteria:
- Property Manager (or designated appointee) at one of the 12 selected sites implementing a smoke-free policy
Property Manager Exclusion Criteria:
- None
Resident Inclusion Criteria:
- Aged 18 and over
- A resident of the housing development (12 selected sites) implementing the smoke-free policy
Resident Exclusion Criteria:
- Unable/unwilling to complete surveys
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard TH Chan School of Public Health
Boston, Massachusetts, 02115
About this study
Official title: Optimizing the Impact of Smoke-Free Residential Policies Using an Evidence-Informed Implementation Approach
This project will be conducted to investigate activities on housing-related health and safety issues. The focus of this project is the development of evidence-based approaches to implement smoke-free policies to reduce harms associated with exposure to secondhand smoke (SHS).
Read the detailed description
Chronic exposure to secondhand smoke (SHS) is a major health concern for public housing residents. While the prevalence of adult cigarette smoking in the United States has declined to 15.1% in 2015, recent data show that 34% of public housing residents still smoke. A federal rule issued by HUD now requires Public Housing Agencies (PHAs) to adopt a smoke-free policy to reduce SHS exposure. However, no evidence-based approaches are available to support post-adoption implementation by PHAs to ensure that the rule yields optimal benefits for residents. This research gap also applies to the larger population of affordable housing properties that are likely to adopt smoke-free rules in the future. The focus of this research is the development of evidence-based approaches to implement smoke-free policies to reduce harms associated with exposure to secondhand smoke (SHS).
The investigators will use six key implementation strategies identified in earlier research on the experiences of early-adopter PHAs. The investigators will partner with a for-profit affordable housing management company that recently expanded its portfolio with the acquisition of 55 affordable housing properties in Pennsylvania, Ohio, West Virginia, Virginia and Kentucky. This provides a unique opportunity to address the implementation research gap, because these properties are in geographic locations where the smoking rate is close to twice the national smoking rate. The for-profit affordable housing management company has committed to adopting a smoke-free policy in these properties, to go into effect in early 2020.
Using an established implementation science framework to guide the approach, the investigators will work with property managers and staff of properties located in five high-smoking states to strategically incorporate the six implementation strategies to reduce SHS exposure among affordable housing residents. The findings will provide accessible, practical, and effective evidence for property managers and staff to support ongoing efforts to optimize the impact of a smoke-free residential policy. The investigators will test this approach in a geographic region with high smoking rates and a disproportionate burden of tobacco-related mortality, covering western Pennsylvania, southern Ohio, West Virginia, Virginia and Kentucky.
- Being tested
- Adaptive Intervention
- Medical subject headings
- Tobacco Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive InterventionBehavioural
The investigators will conduct an adaptive intervention using six key implementation strategies identified in earlier research on the experiences of public housing authorities adopting a smoke-free housing policy: resident engagement, smoking cessation support, smoker compliance strategies, smoke-free policy enforcement, staff training and community partnership development. The implementation approach will be tailored for each property by varying the order and intensity of smoke-free policy implementation approaches. The design will determine the optimal plan for utilizing the six implementation strategies by learning from the challenges and successes of other properties (previous waves) and providing support to property managers to refine an implementation plan.
| Study group | Role | What they receive |
|---|---|---|
| Wave 1 | Active comparator | Properties in Wave 1 (n=4) will implement a smoke-free policy on January 1, 2020. Receives: Behavioral: Adaptive Intervention |
| Wave 2 | Experimental | Properties in Wave 2 (n=4) will implement a smoke-free policy on May 1, 2020. Receives: Behavioral: Adaptive Intervention |
| Wave 3 | Experimental | Properties in Wave 3 (n=4) will implement a smoke-free policy on October 1, 2020. Receives: Behavioral: Adaptive Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambient secondhand smoke (SHS) in common indoor areas
SHS will be monitored using a passive nicotine dosimeter and measured in units of µg/m3 of airborne nicotine. Monitors will be placed in three common areas of each property.
Measured: Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 12 months post smoke-free policy implementation
Self-reported exposure to secondhand smoke (SHS)
Self-reported exposure to secondhand smoke (smell or sight) in the home or around the property using the questions: Over the past month: how many times did you smell cigarette smoke that came from another apartment or hallway?/ how many times did you smell cigarette smoke anywhere on the property? Measured by resident self-report on the survey.
Measured: Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 7 months post smoke-free policy implementation
Secondary outcomes (3)
Resident attitude (support) for the smoke-free policy
Self-reported attitude on resident survey
Measured: Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 7 months post smoke-free policy implementation
Resident knowledge of the smoke-free policy
Self-reported knowledge on resident survey
Measured: Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 7 months post smoke-free policy implementation
Smoking behavior (cigarettes/day in the past 30 days).
Self-reported smoking behavior on resident survey
Measured: Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 7 months post smoke-free policy implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start20 May 2019
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, TobaccoStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 386 participants (actual)
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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791722
- Sponsor's protocol ID
- MAHHU0041-18
- Status last verified
- Nov 2021
- First submitted
- 24 Feb 2021
- Last updated
- 16 Nov 2021
- 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 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Impact of Smoke-Free Residential Policies Using an Evidence-Informed Implementation Approach
- ClinicalTrials.gov ID
- NCT04791722
- Acronym / sponsor ID
- MAHHU0041-18
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 10 Mar 2021 (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.
This project will be conducted to investigate activities on housing-related health and safety issues. The focus of this project is the development of evidence-based approaches to implement smoke-free policies to reduce harms associated with exposure to secondhand smoke (SHS).
Detailed description
Chronic exposure to secondhand smoke (SHS) is a major health concern for public housing residents. While the prevalence of adult cigarette smoking in the United States has declined to 15.1% in 2015, recent data show that 34% of public housing residents still smoke. A federal rule issued by HUD now requires Public Housing Agencies (PHAs) to adopt a smoke-free policy to reduce SHS exposure. However, no evidence-based approaches are available to support post-adoption implementation by PHAs to ensure that the rule yields optimal benefits for residents. This research gap also applies to the larger population of affordable housing properties that are likely to adopt smoke-free rules in the future. The focus of this research is the development of evidence-based approaches to implement smoke-free policies to reduce harms associated with exposure to secondhand smoke (SHS).
The investigators will use six key implementation strategies identified in earlier research on the experiences of early-adopter PHAs. The investigators will partner with a for-profit affordable housing management company that recently expanded its portfolio with the acquisition of 55 affordable housing properties in Pennsylvania, Ohio, West Virginia, Virginia and Kentucky. This provides a unique opportunity to address the implementation research gap, because these properties are in geographic locations where the smoking rate is close to twice the national smoking rate. The for-profit affordable housing management company has committed to adopting a smoke-free policy in these properties, to go into effect in early 2020.
Using an established implementation science framework to guide the approach, the investigators will work with property managers and staff of properties located in five high-smoking states to strategically incorporate the six implementation strategies to reduce SHS exposure among affordable housing residents. The findings will provide accessible, practical, and effective evidence for property managers and staff to support ongoing efforts to optimize the impact of a smoke-free residential policy. The investigators will test this approach in a geographic region with high smoking rates and a disproportionate burden of tobacco-related mortality, covering western Pennsylvania, southern Ohio, West Virginia, Virginia and Kentucky.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wave 1 | Active comparator | Behavioral: Adaptive InterventionProperties in Wave 1 (n=4) will implement a smoke-free policy on January 1, 2020. |
| Wave 2 | Experimental | Behavioral: Adaptive InterventionProperties in Wave 2 (n=4) will implement a smoke-free policy on May 1, 2020. |
| Wave 3 | Experimental | Behavioral: Adaptive InterventionProperties in Wave 3 (n=4) will implement a smoke-free policy on October 1, 2020. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Adaptive InterventionThe investigators will conduct an adaptive intervention using six key implementation strategies identified in earlier research on the experiences of public housing authorities adopting a smoke-free housing policy: resident engagement, smoking cessation support, smoker compliance strategies, smoke-free policy enforcement, staff training and community partnership development. The implementation approach will be tailored for each property by varying the order and intensity of smoke-free policy implementation approaches. The design will determine the optimal plan for utilizing the six implementation strategies by learning from the challenges and successes of other properties (previous waves) and providing support to property managers to refine an implementation plan. | Behavioural | Wave 1, Wave 2, Wave 3 |
Primary outcome
Ambient secondhand smoke (SHS) in common indoor areas
Time frame: Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 12 months post smoke-free policy implementation
SHS will be monitored using a passive nicotine dosimeter and measured in units of µg/m3 of airborne nicotine. Monitors will be placed in three common areas of each property.
Self-reported exposure to secondhand smoke (SHS)
Time frame: Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 7 months post smoke-free policy implementation
Self-reported exposure to secondhand smoke (smell or sight) in the home or around the property using the questions: Over the past month: how many times did you smell cigarette smoke that came from another apartment or hallway?/ how many times did you smell cigarette smoke anywhere on the property? Measured by resident self-report on the survey.
3 secondary outcomes
Resident attitude (support) for the smoke-free policy
Time frame: Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 7 months post smoke-free policy implementation
Resident knowledge of the smoke-free policy
Time frame: Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 7 months post smoke-free policy implementation
Smoking behavior (cigarettes/day in the past 30 days).
Time frame: Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 7 months post smoke-free policy implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Intervention in people with Smoking, Tobacco and Second Hand Tobacco Smoke, 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?
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 16 Nov 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ambient secondhand smoke (SHS) in common indoor areas (time frame: Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 12 months post smoke-free policy implementation). 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 16 Nov 2021.