xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06042361</url>
    </required_header>
    <id_info>
      <org_study_id>IRB23-0415</org_study_id>
      <nct_id>NCT06042361</nct_id>
    </id_info>
    <brief_title>Enhancing Equity in Smoke-free Housing</brief_title>
    <official_title>Enhancing Equity in Smoke-free Housing: Evidence-based Strategies to Support Implementation in Permanent Supportive Housing (PSH) Communities</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Harvard School of Public Health (HSPH)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Beacon Communities</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Community Builders</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Harvard School of Public Health (HSPH)</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to learn about the acceptability, feasibility, and&#xD;
        effectiveness of smoke-free housing policy implementation in Permanent Supportive Housing&#xD;
        communities. The main objective of this study is to identify and refine adaptations for a&#xD;
        smoke-free housing implementation framework that incorporates behavioral health support and&#xD;
        meets the needs of residents living in Permanent Supportive Housing.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study aims are:&#xD;
  &#xD;
        Aim 1): Identify adaptations for a smokefree housing implementation framework and identify&#xD;
        opportunities to integrate these adaptations with ongoing behavioral health support, to meet&#xD;
        the needs of residents living in Permanent Supportive Housing (PSH) (Phase 1).&#xD;
  &#xD;
        Aim 2): The research team will pilot test the adapted implementation framework, including an&#xD;
        implementation toolkit, to assess the acceptability, feasibility and effectiveness of the&#xD;
        primary intervention provided to Property Managers (Phase 2).&#xD;
  &#xD;
        Aim 3): Based on a synthesis of qualitative and quantitative evidence, the research team will&#xD;
        further refine the smokefree implementation framework and toolkit, comprising modified&#xD;
        versions of the &quot;Implementation Guide&quot;, &quot;Action Plan&quot; and &quot;Implementation Checklist&quot;, to&#xD;
        support future needs of Permanent Supportive Housing communities (Phase 3).&#xD;
  &#xD;
        The research team seeks to use the opportunity provided by smokefree housing implementation&#xD;
        to minimize indoor smoking and encourage smoking cessation, and thus help move communities&#xD;
        with a history of profound health disparities towards a more equitable, tobacco-free future.&#xD;
        The impact of this project will be evident not only among smokers, but also non-smokers,&#xD;
        children and the elderly who share residential communities with people supported by PSH&#xD;
        programs.&#xD;
  &#xD;
        If successful, the results of this work will be used to promote broader and more effective&#xD;
        use of the smokefree PSH implementation framework in federally-assisted public and affordable&#xD;
        housing communities nationally.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Two-phased approach: formative first phase, testing second phase. Enrollment based on residential property clusters.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Acceptability of Intervention Measure (AIM)</measure>
      <time_frame>Pre-intervention through 6 months post intervention</time_frame>
      <description>The Smokefree Implementation Framework and Toolkit is acceptable to implement in Permanent Supportive Housing communities. Measured using 4-items from the AIM.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of Intervention Measure (FIM)</measure>
      <time_frame>Pre-intervention through 6 months post intervention</time_frame>
      <description>The Smokefree Implementation Framework and Toolkit is feasible to implement in Permanent Supportive Housing communities. Measured using 4-items from the FIM.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Ambient second-hand smoke in common indoor areas</measure>
      <time_frame>Pre-intervention through 6 months post intervention</time_frame>
      <description>Monitored using passive nicotine dosimetry monitors placed in common areas</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Residents' self-reported exposure to secondhand smoke</measure>
      <time_frame>Pre-intervention through 6 months post intervention</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Behavior of residents who smoke</measure>
      <time_frame>Pre-intervention through 6 months post intervention</time_frame>
      <description>Self-reported behavior of smoking (cigarettes/day in the past 30 days) of residents who smoke</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">480</enrollment>
    <condition>Tobacco Use</condition>
    <condition>Tobacco Smoking</condition>
    <condition>Tobacco Use Cessation</condition>
    <condition>Tobacco Use Disorder</condition>
    <condition>Second Hand Tobacco Smoke</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All participants will receive the intervention of the Smokefree Implementation Framework and Toolkit</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Smokefree Implementation Framework and Toolkit</intervention_name>
      <description>Framework and toolkit that includes &quot;Implementation Guide&quot;, &quot;Action Plan&quot;, and &quot;Implementation Checklist&quot; that supports the needs of Permanent Supportive Housing communities.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          The study setting is 6 affordable housing communities that include Permanent Supportive&#xD;
          Housing (PSH) in Massachusetts, Maryland and New York (USA).&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult residents of the six affordable housing communities who smoke or do not smoke&#xD;
               tobacco, who receive or do not receive Permanent Supportive Housing services, and can&#xD;
               complete a survey in English or Spanish.&#xD;
  &#xD;
            -  Adult residents of the six affordable housing communities who smoke or do not smoke&#xD;
               tobacco, who receive or do not receive Permanent Supportive Housing services, and can&#xD;
               participate in a focus group discussion in English.&#xD;
  &#xD;
            -  Property Managers (or their designated appointees) of the six affordable housing&#xD;
               communities where the research will be conducted and able to receive the intervention&#xD;
               and participate in the qualitative interviews in English.&#xD;
  &#xD;
            -  Caseworkers who are dedicated health workers who provide behavioral health support&#xD;
               (mental health and substance use support interventions) to residents at each of the&#xD;
               six properties and who can receive the intervention and participate in the qualitative&#xD;
               interviews in English.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those unable to speak English or Spanish.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Vaughan Rees, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Harvard University School of Public Health</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Harvard TH Chan School of Public Health</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02115</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Harvard School of Public Health (HSPH)</investigator_affiliation>
      <investigator_full_name>Vaughan Rees</investigator_full_name>
      <investigator_title>Director, Center for Global Tobacco Control</investigator_title>
    </responsible_party>
    <keyword>tobacco</keyword>
    <keyword>second hand tobacco smoke</keyword>
    <keyword>tobacco cessation</keyword>
    <keyword>smokefree housing</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tobacco Use Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06042361
  org study id: IRB23-0415
  nct id: NCT06042361
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  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.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Acceptability of Intervention Measure (AIM)
  time frame: Pre-intervention through 6 months post intervention
  description: The Smokefree Implementation Framework and Toolkit is acceptable to implement in Permanent Supportive Housing communities. Measured using 4-items from the AIM.
  measure: Feasibility of Intervention Measure (FIM)
  time frame: Pre-intervention through 6 months post intervention
  description: The Smokefree Implementation Framework and Toolkit is feasible to implement in Permanent Supportive Housing communities. Measured using 4-items from the FIM.
  measure: Ambient second-hand smoke in common indoor areas
  time frame: Pre-intervention through 6 months post intervention
  description: Monitored using passive nicotine dosimetry monitors placed in common areas
  measure: Residents' self-reported exposure to secondhand smoke
  time frame: Pre-intervention through 6 months post intervention
  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.
  measure: Behavior of residents who smoke
  time frame: Pre-intervention through 6 months post intervention
  description: Self-reported behavior of smoking (cigarettes/day in the past 30 days) of residents who smoke
  arm group label: Intervention
  arm group type: Other
  description: All participants will receive the intervention of the Smokefree Implementation Framework and Toolkit
  intervention type: Behavioral
  intervention name: Smokefree Implementation Framework and Toolkit
  description: Framework and toolkit that includes "Implementation Guide", "Action Plan", and "Implementation Checklist" that supports the needs of Permanent Supportive Housing communities.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Vaughan Rees, PhD
  role: Principal Investigator
  affiliation: Harvard University School of Public Health
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Harvard School of Public Health (HSPH)
  investigator full name: Vaughan Rees
  investigator title: Director, Center for Global Tobacco Control
  mesh term: Tobacco Use Disorder
  sharing ipd: No