Supporting Smoke-Free Policy Compliance in Public Housing

February 8, 2023 updated by: Diana Hernandez, PhD, Columbia University

A Randomized Controlled Trial to Support Smoke-Free Policy Compliance in Public Housing

This project seeks to determine the effectiveness of two types of interventions to reduce exposure to secondhand smoke in residential buildings. One intervention is geared toward all building residents (resident endorsement) and the other targets smokers (smoking reduction via relocation and reduction in personal smoking/cessation) with the goal of reducing personal smoking and secondhand smoke exposure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Smoke-free housing policies in multi-unit housing are promising and increasingly widespread interventions to reduce smoking and secondhand smoke exposure. Little research has identified factors that improve compliance with smoke-free housing policies in low-income multi-unit housing and test corresponding solutions.

The proposed randomized controlled trial (RCT) addresses key gaps in knowledge and capitalizes on key scientific opportunities by: 1) leveraging the federal mandate to ban smoking in a public housing system of more than sufficient size to conduct an adequately powered RCT; 2) expanding our understanding of smoke-free policy compliance beyond policy implementation by testing two novel treatments: a) in-residence smoking cessation and b) resident endorsement, while 3) addressing population and location-specific tobacco-related disparities.

The investigators hypothesize that the relocation/cessation plus resident endorsement intervention will yield significantly larger reductions in personal smoking and secondhand smoke exposure, compared to standalone interventions and the standard approach.

Study Type

Interventional

Enrollment (Anticipated)

512

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Building Inclusion Criteria:

  • NYCHA buildings in Manhattan & the Bronx (stratified evenly by borough) with more than 50 units, not undergoing major renovations.

Building Exclusion Criteria:

  • Buildings in a borough that is not in Manhattan or the Bronx
  • Buildings smaller than 50 units
  • Buildings undergoing major renovations
  • Buildings that are or will be part of Rental Assistance Demonstration (RAD) or Permanent Affordability Commitment Together (PACT)
  • Buildings that are mixed finance
  • Buildings that are exclusively for elderly
  • Buildings that are privately managed
  • Buildings that have other research studies ongoing

Participant Inclusion Criteria:

  • Recruit NYCHA residents via door knocking and lobby intercepts until we reach our targeted number per group (4 smokers, 4 non-smokers in each building).
  • Residents will be screened for smoking status. Both smokers and non-smokers to be recruited but only one participant- smoker or a non-smoker- will be recruited per apartment.
  • Smoking will be defined as those that report using a cigarette or other combustible tobacco product (e.g., little cigar, cigarillo) at least 5 days in the past month. Non-smokers include never smokers and former smokers who had quit 12 months ago or earlier.
  • Additional eligibility criteria include individuals above 18 years old living in the building at least 5 days/week and 9 months/year, not planning on moving in the next 2 years.

Participant Exclusion Criteria:

  • Individuals with severe physical or mental medical conditions (i.e. cognitive disability) or other factors that could limit participation or ability to give informed consent in the study at baseline or during follow-ups.
  • Individuals who participated in the earlier focus groups.
  • Individuals who only smoke non-tobacco products (e.g., marijuana).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Compliance through reduction (relocation and reduction of personal smoking) and cessation
Smokers will be referred by the survey team to peer educators from a community-based organization trained to provide peer to peer health education including tobacco cessation support. The peer educator will coordinate smoking cessation support, including serving as a liaison between participant and research team, providing information regarding the smoke-free policy and opportunities for relocation, and connecting participant to access to tobacco replacement therapy and/or physician support if deemed appropriate.
Behavioral: Reduction (relocation and reduction of personal smoking) and cessation
Individual-level. Peer educator to provide reduction/cessation and/or relocation support.
EXPERIMENTAL: Compliance through resident endorsement
Buildings assigned will be targeted for a series of 2 in-residence programs that involve community forums and the creative arts to garner resident endorsements of smoke-free living environments. Premised on resident engagement, this arm seeks to impact social and physical dimensions of the residential environment to achieve compliance. The sessions will: 1) inform residents of risks associated with smoking and secondhand smoke; 2) identify reasons to have a smoke-free home, 3) ask residents to sign a pledge on paper and/or virtually; 4) display smoke-free signage on doors and/or social media pages with an original hashtag (#Smokefree[building address]); and 5) refer residents to the Smoke-free NYCHA website for information on the policy and existing cessation resources.
Behavioral: Resident Endorsement
Building-level. Peer educator to conduct building-level sessions.
EXPERIMENTAL: Compliance through reduction/cessation plus resident endorsement (combined)
The combined intervention will be carried out in the buildings assigned to this RCT arm, which will provide in-residence programs based on the resident endorsement treatment and the smoking relocation/cessation treatment. Both will occur simultaneously with one geared toward all building residents (resident endorsement) and the other targeting smokers (smoking relocation/cessation) with the goal of reducing both personal smoking and secondhand smoke exposure.
Behavioral: Resident Endorsement
Building-level. Peer educator to conduct building-level sessions.
Behavioral: Reduction (relocation and reduction of personal smoking) and cessation
Individual-level. Peer educator to provide reduction/cessation and/or relocation support.
NO_INTERVENTION: Standard NYCHA approach (control)
Buildings and study participants assigned to this arm will be recruited and followed over a 12-month period to assess outcomes. No additional programs or services will be delivered to the buildings or residents assigned to this arm beyond standard programs that NYCHA may provide to support the smoke-free mandate. Field staff will document any policy-related signage, activities or information to which these participants are exposed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of cigarettes smoked per day
Time Frame: Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Self-reported average number of cigarettes smoked per day among smokers
Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Change in salivary cotinine
Time Frame: At baseline and at the 12-month follow-up
Salivary cotinine (saliva collected as passive drool) will be measured for 25% of the sample among smokers and non-smokers alike
At baseline and at the 12-month follow-up
Change in secondhand smoke exposure
Time Frame: Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Self-reported secondhand smoking exposure (hours of secondhand smoke exposure in the building in the past 7 days); among smokers & non-smokers
Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of participants with successful quit attempts
Time Frame: Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Binary; whether smokers have successfully quit
Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Change in number of quit attempts
Time Frame: Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Mean number of quitting attempts among smokers
Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Change in number of participants with secondhand smoke observations
Time Frame: Ever observing someone smoking indoors within the past 7 days measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Binary; whether participant has observed someone smoking indoors in the building; among smokers & non-smokers
Ever observing someone smoking indoors within the past 7 days measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Change in number of hours of secondhand smoke exposure
Time Frame: Number of hours observed someone smoking indoors within the past 7 days measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Counted number of hours of exposure
Number of hours observed someone smoking indoors within the past 7 days measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Change in number of smokers
Time Frame: At each building visit at baseline and 12 months
Counted number of people observed smoking in common areas
At each building visit at baseline and 12 months
Change in number of cigarette butts
Time Frame: At each building visit at baseline and 12 months
Counted number of cigarette butts observed in common areas
At each building visit at baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 3, 2022

Primary Completion (ANTICIPATED)

August 1, 2024

Study Completion (ANTICIPATED)

August 1, 2025

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (ACTUAL)

August 23, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAAT1493
  • R01CA240555-01A1 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from approximately 512 participants will be released to sponsor (NIH) once the final dataset is analyzed and main findings are accepted for publication to support and validate study findings. This will include participant demographics, data from interviews, and laboratory data from saliva samples. Identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies without additional consent from the subject. De-identified participant data may be utilized for the purposes of repeated analyses by other researchers to verify findings, and/or to promote further research with new or alternative hypotheses. The mechanism of distribution will be a data sharing agreement.

IPD Sharing Time Frame

Data will be available once the final dataset is analyzed and main findings are accepted for publication to support and validate study findings.

Access will be granted for researchers, institutions, and/or the broader public for as long as the data is anticipated to be useful. With the data sharing agreement in mind, the data can be made available for the duration of time needed to conduct analyses.

IPD Sharing Access Criteria

Access should be granted to those with a reputable background in the scientific field who have either a scientific or medical degree and/or a relevant position to ask for the data. Individuals should also express their intended use of the data. These requests will be routinely reviewed by the principal investigator [and/or designated team member].

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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