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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06042361
Other study ID # IRB23-0415
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date December 31, 2025

Study information

Verified date September 2023
Source Harvard School of Public Health (HSPH)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 480
Est. completion date December 31, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
United States Harvard TH Chan School of Public Health Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Harvard School of Public Health (HSPH) Beacon Communities, The Community Builders

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Pre-intervention through 6 months post intervention
Primary 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. Pre-intervention through 6 months post intervention
Secondary Ambient second-hand smoke in common indoor areas Monitored using passive nicotine dosimetry monitors placed in common areas Pre-intervention through 6 months post intervention
Secondary 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. Pre-intervention through 6 months post intervention
Secondary Behavior of residents who smoke Self-reported behavior of smoking (cigarettes/day in the past 30 days) of residents who smoke Pre-intervention through 6 months post intervention
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