- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04791722
Optimizing Smoke-free Residential Housing Policies
Optimizing the Impact of Smoke-Free Residential Policies Using an Evidence-Informed Implementation Approach
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Harvard TH Chan School of Public Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Wave 1
Properties in Wave 1 (n=4) will implement a smoke-free policy on January 1, 2020.
|
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.
|
|
EXPERIMENTAL: Wave 2
Properties in Wave 2 (n=4) will implement a smoke-free policy on May 1, 2020.
|
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.
|
|
EXPERIMENTAL: Wave 3
Properties in Wave 3 (n=4) will implement a smoke-free policy on October 1, 2020.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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)
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.
|
Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 7 months post smoke-free policy implementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Self-reported attitude on resident survey
|
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
|
Self-reported knowledge on resident survey
|
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
|
Self-reported smoking behavior on resident survey
|
Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 7 months post smoke-free policy implementation
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MAHHU0041-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
National University of SingaporeRecruitingSmoking &Amp; Tobacco CessationSingapore
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Sultan Qaboos UniversityCompletedSmoking Cessation | Tobacco Use Cessation | Smoking PreventionOman
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedSmoking &Amp; Tobacco CessationUnited States
-
The University of Hong KongCompletedSmoking Cessation Counseling Ability | Smoking Cessation Counseling PracticeHong Kong
Clinical Trials on Adaptive Intervention
-
Rhode Island HospitalNational Institute of Mental Health (NIMH)RecruitingSuicidal and Self-injurious Behavior | Linkage to CareUnited States
-
Halmstad UniversityVinnovaCompleted
-
Emory UniversityNational Institute of Nursing Research (NINR)RecruitingPsychological Distress | Stigma, SocialUnited States
-
University of South CarolinaCenters for Disease Control and PreventionRecruitingArthritis | Osteoarthritis | Lupus Erythematosus, Systemic | Gout | Rheumatoid Arthritis (RA) | Fibromyalgia (FM)United States
-
Northwestern UniversityCompleted
-
Arizona State UniversityActive Living ResearchCompleted
-
Toronto Metropolitan UniversityMitacsActive, not recruitingStress, Psychological | Loneliness | Emotion Regulation | Well Being | Executive Functions | Functional AbilitiesCanada
-
Wageningen University and ResearchZonMw: The Netherlands Organisation for Health Research and DevelopmentCompleted
-
University of Alabama, TuscaloosaUniversity of Alabama at BirminghamUnknownCancer | Aging | Comorbidities and Coexisting Conditions
-
University of MichiganNational Institute on Drug Abuse (NIDA)Completed