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Supporting Smoke-Free Policy Compliance in Public Housing

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ClinicalTrials.gov Identifier: NCT05016505
Recruitment Status : Not yet recruiting
First Posted : August 23, 2021
Last Update Posted : November 29, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Farzana Khan, Columbia University

Brief Summary:

Smoke-free housing policies in multiunit 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 multiunit housing and test corresponding solutions.

The proposed 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.


Condition or disease Intervention/treatment Phase
Smoking Smoking Cessation Smoking Reduction Smoking Behaviors Behavioral: Relocation & Cessation Behavioral: Resident Endorsement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 512 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

The proposed design will be a borough-stratified, four-arm, factorial-design, cluster RCT that will target 64 randomly selected buildings (16 buildings per arm) in separate NYCHA developments.

We will recruit and follow 8 randomly selected residents stratified by smoking status- 4 smokers and 4 non-smokers- per building (n=512 residents) into four arms: (1) relocation/cessation, (2) resident endorsement, (3) relocation/cessation plus resident endorsement and (4) the standard approach (128 participants per arm).

Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial to Support Smoke-Free Policy Compliance in Public Housing
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Compliance through relocation 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: Relocation & Cessation
Individual-level. Peer educator to provide 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 relocation/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: Relocation & Cessation
Individual-level. Peer educator to provide cessation and/or relocation support.

Behavioral: Resident Endorsement
Building-level. Peer educator to conduct building-level sessions.

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.



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Focus Group Inclusion Criteria:

  • For focus groups, we will recruit NYCHA residents via flyers posted in common areas of buildings. We will differentiate eligibility by smoker or non-smoker and maintain database information collected from focus group participants so as not to contaminate interventions by recruiting the same participants later.

Focus Group Exclusion Criteria:

  • Focus groups will be hosted virtually. Internet or dial-in capabilities are necessary for joining online teleconferencing.

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

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:

  • We will exclude those 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.
  • We will also exclude those who participated in the earlier focus groups.
  • We will also exclude those who only smoke non-tobacco products (ie marijuana).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05016505


Contacts
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Contact: Diana Hernández, PhD 2122050245 smokefree@cumc.columbia.edu
Contact: Narine Malcolm, MEd 2123050245 smokefree@cumc.columbia.edu

Locations
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United States, New York
Columbia University Irving Medical Center
New York, New York, United States, 10032
Contact: Diana Hernández, PhD       dh2494@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Diana Hernández, PhD Associate Professor
Additional Information:

Publications:

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Responsible Party: Farzana Khan, Project Coordinator, Department of Sociomedical Sciences (Interim RP), Columbia University
ClinicalTrials.gov Identifier: NCT05016505    
Other Study ID Numbers: AAAT1493
R01CA240555-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 23, 2021    Key Record Dates
Last Update Posted: November 29, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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, qualitative 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.
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.

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].

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Farzana Khan, Columbia University:
smoking
secondhand smoke