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Enhancing Equity in Smoke-free Housing

Primary Purpose

Tobacco Use, Tobacco Smoking, Tobacco Use Cessation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smokefree Implementation Framework and Toolkit
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tobacco Use focused on measuring tobacco, second hand tobacco smoke, tobacco cessation, smokefree housing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Harvard TH Chan School of Public Health

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention

Arm Description

All participants will receive the intervention of the Smokefree Implementation Framework and Toolkit

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Ambient second-hand smoke in common indoor areas
Monitored using passive nicotine dosimetry monitors placed in common areas
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.
Behavior of residents who smoke
Self-reported behavior of smoking (cigarettes/day in the past 30 days) of residents who smoke

Full Information

First Posted
July 27, 2023
Last Updated
September 13, 2023
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Beacon Communities, The Community Builders
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1. Study Identification

Unique Protocol Identification Number
NCT06042361
Brief Title
Enhancing Equity in Smoke-free Housing
Official Title
Enhancing Equity in Smoke-free Housing: Evidence-based Strategies to Support Implementation in Permanent Supportive Housing (PSH) Communities
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
Beacon Communities, The Community Builders

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use, Tobacco Smoking, Tobacco Use Cessation, Tobacco Use Disorder, Second Hand Tobacco Smoke
Keywords
tobacco, second hand tobacco smoke, tobacco cessation, smokefree housing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Two-phased approach: formative first phase, testing second phase. Enrollment based on residential property clusters.
Masking
None (Open Label)
Allocation
N/A
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
All participants will receive the intervention of the Smokefree Implementation Framework and Toolkit
Intervention Type
Behavioral
Intervention Name(s)
Smokefree Implementation Framework and Toolkit
Intervention Description
Framework and toolkit that includes "Implementation Guide", "Action Plan", and "Implementation Checklist" that supports the needs of Permanent Supportive Housing communities.
Primary Outcome Measure Information:
Title
Acceptability of Intervention Measure (AIM)
Description
The Smokefree Implementation Framework and Toolkit is acceptable to implement in Permanent Supportive Housing communities. Measured using 4-items from the AIM.
Time Frame
Pre-intervention through 6 months post intervention
Title
Feasibility of Intervention Measure (FIM)
Description
The Smokefree Implementation Framework and Toolkit is feasible to implement in Permanent Supportive Housing communities. Measured using 4-items from the FIM.
Time Frame
Pre-intervention through 6 months post intervention
Secondary Outcome Measure Information:
Title
Ambient second-hand smoke in common indoor areas
Description
Monitored using passive nicotine dosimetry monitors placed in common areas
Time Frame
Pre-intervention through 6 months post intervention
Title
Residents' self-reported exposure to secondhand smoke
Description
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.
Time Frame
Pre-intervention through 6 months post intervention
Title
Behavior of residents who smoke
Description
Self-reported behavior of smoking (cigarettes/day in the past 30 days) of residents who smoke
Time Frame
Pre-intervention through 6 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vaughan Rees, PhD
Organizational Affiliation
Harvard University School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard TH Chan School of Public Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhancing Equity in Smoke-free Housing

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