NCT06042361

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

July 27, 2023

Last Update Submit

October 17, 2024

Conditions

Keywords

tobaccosecond hand tobacco smoketobacco cessationsmokefree housing

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Ambient second-hand smoke in common indoor areas

    Pre-intervention through 6 months post intervention

  • Residents' self-reported exposure to secondhand smoke

    Pre-intervention through 6 months post intervention

  • Behavior of residents who smoke

    Pre-intervention through 6 months post intervention

Study Arms (1)

Intervention

OTHER

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

Behavioral: Smokefree Implementation Framework and Toolkit

Interventions

Framework and toolkit that includes "Implementation Guide", "Action Plan", and "Implementation Checklist" that supports the needs of Permanent Supportive Housing communities.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Those unable to speak English or Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard TH Chan School of Public Health

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Tobacco UseTobacco SmokingTobacco Use CessationTobacco Use Disorder

Condition Hierarchy (Ancestors)

BehaviorSmokingHealth BehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Vaughan Rees, PhD

    Harvard University School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Two-phased approach: formative first phase, testing second phase. Enrollment based on residential property clusters.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Global Tobacco Control

Study Record Dates

First Submitted

July 27, 2023

First Posted

September 18, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2025

Study Completion

December 31, 2025

Last Updated

October 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations