NCT04791722

Brief Summary

This project will be conducted to investigate activities on housing-related health and safety issues. The focus of this project is the development of evidence-based approaches to implement smoke-free policies to reduce harms associated with exposure to secondhand smoke (SHS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
386

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 20, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

2.5 years

First QC Date

February 24, 2021

Last Update Submit

November 12, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Ambient secondhand smoke (SHS) in common indoor areas

    SHS will be monitored using a passive nicotine dosimeter and measured in units of µg/m3 of airborne nicotine. Monitors will be placed in three common areas of each property.

    Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 12 months post smoke-free policy implementation

  • Self-reported exposure to secondhand smoke (SHS)

    Self-reported exposure to secondhand smoke (smell or sight) in the home or around the property using the questions: Over the past month: how many times did you smell cigarette smoke that came from another apartment or hallway?/ how many times did you smell cigarette smoke anywhere on the property? Measured by resident self-report on the survey.

    Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 7 months post smoke-free policy implementation

Secondary Outcomes (3)

  • Resident attitude (support) for the smoke-free policy

    Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 7 months post smoke-free policy implementation

  • Resident knowledge of the smoke-free policy

    Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 7 months post smoke-free policy implementation

  • Smoking behavior (cigarettes/day in the past 30 days).

    Baseline (prior to smoke-free policy implementation); 1 month post smoke-free policy implementation; 7 months post smoke-free policy implementation

Study Arms (3)

Wave 1

ACTIVE COMPARATOR

Properties in Wave 1 (n=4) will implement a smoke-free policy on January 1, 2020.

Behavioral: Adaptive Intervention

Wave 2

EXPERIMENTAL

Properties in Wave 2 (n=4) will implement a smoke-free policy on May 1, 2020.

Behavioral: Adaptive Intervention

Wave 3

EXPERIMENTAL

Properties in Wave 3 (n=4) will implement a smoke-free policy on October 1, 2020.

Behavioral: Adaptive Intervention

Interventions

The investigators will conduct an adaptive intervention using six key implementation strategies identified in earlier research on the experiences of public housing authorities adopting a smoke-free housing policy: resident engagement, smoking cessation support, smoker compliance strategies, smoke-free policy enforcement, staff training and community partnership development. The implementation approach will be tailored for each property by varying the order and intensity of smoke-free policy implementation approaches. The design will determine the optimal plan for utilizing the six implementation strategies by learning from the challenges and successes of other properties (previous waves) and providing support to property managers to refine an implementation plan.

Wave 1Wave 2Wave 3

Eligibility Criteria

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

You may qualify if:

  • Property Manager (or designated appointee) at one of the 12 selected sites implementing a smoke-free policy

You may not qualify if:

  • None
  • Aged 18 and over
  • A resident of the housing development (12 selected sites) implementing the smoke-free policy
  • Unable/unwilling to complete surveys

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 SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco UseHealth Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Global Tobacco Control

Study Record Dates

First Submitted

February 24, 2021

First Posted

March 10, 2021

Study Start

May 20, 2019

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

November 16, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations