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Enhancing Equity in Smoke-free Housing

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ClinicalTrials.gov Identifier: NCT06042361
Recruitment Status : Enrolling by invitation
First Posted : September 18, 2023
Last Update Posted : September 18, 2023
Sponsor:
Collaborators:
Beacon Communities
The Community Builders
Information provided by (Responsible Party):
Vaughan Rees, Harvard School of Public Health (HSPH)

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Tobacco Use Tobacco Smoking Tobacco Use Cessation Tobacco Use Disorder Second Hand Tobacco Smoke Behavioral: Smokefree Implementation Framework and Toolkit Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Two-phased approach: formative first phase, testing second phase. Enrollment based on residential property clusters.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Enhancing Equity in Smoke-free Housing: Evidence-based Strategies to Support Implementation in Permanent Supportive Housing (PSH) Communities
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
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Arm Intervention/treatment
Intervention
All participants will receive the intervention of the Smokefree Implementation Framework and Toolkit
 Behavioral: Smokefree Implementation Framework and Toolkit
Framework and toolkit that includes "Implementation Guide", "Action Plan", and "Implementation Checklist" that supports the needs of Permanent Supportive Housing communities.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Ambient second-hand smoke in common indoor areas [ Time Frame: Pre-intervention through 6 months post intervention ]
    Monitored using passive nicotine dosimetry monitors placed in common areas

  2. Residents' self-reported exposure to secondhand smoke [ Time Frame: Pre-intervention through 6 months post intervention ]
    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.

  3. Behavior of residents who smoke [ Time Frame: Pre-intervention through 6 months post intervention ]
    Self-reported behavior of smoking (cigarettes/day in the past 30 days) of residents who smoke


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

The study setting is 6 affordable housing communities that include Permanent Supportive Housing (PSH) in Massachusetts, Maryland and New York (USA).

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Those unable to speak English or Spanish.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06042361


Locations
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United States, Massachusetts
Harvard TH Chan School of Public Health
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Harvard School of Public Health (HSPH)
Beacon Communities
The Community Builders
Investigators
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Principal Investigator: Vaughan Rees, PhD Harvard University School of Public Health
More Information
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Responsible Party: Vaughan Rees, Director, Center for Global Tobacco Control, Harvard School of Public Health (HSPH)
ClinicalTrials.gov Identifier: NCT06042361    
Other Study ID Numbers: IRB23-0415
First Posted: September 18, 2023    Key Record Dates
Last Update Posted: September 18, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vaughan Rees, Harvard School of Public Health (HSPH):
tobacco
second hand tobacco smoke
tobacco cessation
smokefree housing
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders