- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05016505
Supporting Smoke-Free Policy Compliance in Public Housing
A Randomized Controlled Trial to Support Smoke-Free Policy Compliance in Public Housing
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Irving Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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Individual-level.
Peer educator to provide reduction/cessation and/or relocation support.
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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.
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Building-level.
Peer educator to conduct building-level sessions.
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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.
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Building-level.
Peer educator to conduct building-level sessions.
Individual-level.
Peer educator to provide reduction/cessation and/or relocation support.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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Self-reported average number of cigarettes smoked per day among smokers
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Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
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Change in salivary cotinine
Time Frame: At baseline and at the 12-month follow-up
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Salivary cotinine (saliva collected as passive drool) will be measured for 25% of the sample among smokers and non-smokers alike
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At baseline and at the 12-month follow-up
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Change in secondhand smoke exposure
Time Frame: Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
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Self-reported secondhand smoking exposure (hours of secondhand smoke exposure in the building in the past 7 days); among smokers & non-smokers
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Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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Binary; whether smokers have successfully quit
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Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
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Change in number of quit attempts
Time Frame: Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
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Mean number of quitting attempts among smokers
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Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
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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)
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Binary; whether participant has observed someone smoking indoors in the building; among smokers & non-smokers
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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)
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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)
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Counted number of hours of exposure
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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)
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Change in number of smokers
Time Frame: At each building visit at baseline and 12 months
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Counted number of people observed smoking in common areas
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At each building visit at baseline and 12 months
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Change in number of cigarette butts
Time Frame: At each building visit at baseline and 12 months
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Counted number of cigarette butts observed in common areas
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At each building visit at baseline and 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Diana Hernández, PhD, Associate Professor of Sociomedical Sciences
Publications and helpful links
General Publications
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- Hernandez D. Understanding 'energy insecurity' and why it matters to health. Soc Sci Med. 2016 Oct;167:1-10. doi: 10.1016/j.socscimed.2016.08.029. Epub 2016 Aug 21.
- Navas-Acien A, Carkoglu A, Ergor G, Hayran M, Erguder T, Kaplan B, Susan J, Magid H, Pollak J, Cohen JE. Compliance with smoke-free legislation within public buildings: a cross-sectional study in Turkey. Bull World Health Organ. 2016 Feb 1;94(2):92-102. doi: 10.2471/BLT.15.158238. Epub 2015 Nov 23.
- Stillman FA, Soong A, Zheng LY, Navas-Acien A. Clear Skies and Grey Areas: Flight Attendants' Secondhand Smoke Exposure and Attitudes toward Smoke-Free Policy 25 Years since Smoking was Banned on Airplanes. Int J Environ Res Public Health. 2015 Jun 4;12(6):6378-87. doi: 10.3390/ijerph120606378.
- Apelberg BJ, Hepp LM, Avila-Tang E, Gundel L, Hammond SK, Hovell MF, Hyland A, Klepeis NE, Madsen CC, Navas-Acien A, Repace J, Samet JM, Breysse PN. Environmental monitoring of secondhand smoke exposure. Tob Control. 2013 May;22(3):147-55. doi: 10.1136/tobaccocontrol-2011-050301. Epub 2012 Sep 4.
- Jones MR, Wipfli H, Shahrir S, Avila-Tang E, Samet JM, Breysse PN, Navas-Acien A; FAMRI Bar Study Investigators. Secondhand tobacco smoke: an occupational hazard for smoking and non-smoking bar and nightclub employees. Tob Control. 2013 Sep;22(5):308-14. doi: 10.1136/tobaccocontrol-2011-050203. Epub 2012 Jan 24.
- Erazo M, Iglesias V, Droppelmann A, Acuna M, Peruga A, Breysse PN, Navas-Acien A. Secondhand tobacco smoke in bars and restaurants in Santiago, Chile: evaluation of partial smoking ban legislation in public places. Tob Control. 2010 Dec;19(6):469-74. doi: 10.1136/tc.2009.035402. Epub 2010 Aug 25.
- Stillman F, Navas-Acien A, Ma J, Ma S, Avila-Tang E, Breysse P, Yang G, Samet J. Second-hand tobacco smoke in public places in urban and rural China. Tob Control. 2007 Aug;16(4):229-34. doi: 10.1136/tc.2006.018333.
- Navas-Acien A, Peruga A, Breysse P, Zavaleta A, Blanco-Marquizo A, Pitarque R, Acuna M, Jimenez-Reyes K, Colombo VL, Gamarra G, Stillman FA, Samet J. Secondhand tobacco smoke in public places in Latin America, 2002-2003. JAMA. 2004 Jun 9;291(22):2741-5. doi: 10.1001/jama.291.22.2741.
- Barnoya J, Navas-Acien A. Protecting the world from secondhand tobacco smoke exposure: where do we stand and where do we go from here? Nicotine Tob Res. 2013 Apr;15(4):789-804. doi: 10.1093/ntr/nts200. Epub 2012 Oct 15.
- Moon KA, Rule AM, Magid HS, Ferguson JM, Susan J, Sun Z, Torrey C, Abubaker S, Levshin V, Carkoglu A, Radwan GN, El-Rabbat M, Cohen JE, Strickland P, Breysse PN, Navas-Acien A. Biomarkers of Secondhand Smoke Exposure in Waterpipe Tobacco Venue Employees in Istanbul, Moscow, and Cairo. Nicotine Tob Res. 2018 Mar 6;20(4):482-491. doi: 10.1093/ntr/ntx125.
- Jones MR, Navas-Acien A, Yuan J, Breysse PN. Secondhand tobacco smoke concentrations in motor vehicles: a pilot study. Tob Control. 2009 Oct;18(5):399-404. doi: 10.1136/tc.2009.029942. Epub 2009 Aug 25.
- Wipfli H, Avila-Tang E, Navas-Acien A, Kim S, Onicescu G, Yuan J, Breysse P, Samet JM; Famri Homes Study Investigators. Secondhand smoke exposure among women and children: evidence from 31 countries. Am J Public Health. 2008 Apr;98(4):672-9. doi: 10.2105/AJPH.2007.126631. Epub 2008 Feb 28.
- Apostolou A, Garcia-Esquinas E, Fadrowski JJ, McLain P, Weaver VM, Navas-Acien A. Secondhand tobacco smoke: a source of lead exposure in US children and adolescents. Am J Public Health. 2012 Apr;102(4):714-22. doi: 10.2105/AJPH.2011.300161. Epub 2011 Dec 1.
- Soong A, Navas-Acien A, Pang Y, Lopez MJ, Garcia-Esquinas E, Stillman FA. A Cross-Sectional Study of Tobacco Advertising, Promotion, and Sponsorship in Airports across Europe and the United States. Int J Environ Res Public Health. 2016 Sep 28;13(10):959. doi: 10.3390/ijerph13100959.
- Branas CC, Cheney RA, MacDonald JM, Tam VW, Jackson TD, Ten Have TR. A difference-in-differences analysis of health, safety, and greening vacant urban space. Am J Epidemiol. 2011 Dec 1;174(11):1296-306. doi: 10.1093/aje/kwr273. Epub 2011 Nov 11.
- Giovenco DP, Spillane TE, Merizier JM. Neighborhood Differences in Alternative Tobacco Product Availability and Advertising in New York City: Implications for Health Disparities. Nicotine Tob Res. 2019 Jun 21;21(7):896-902. doi: 10.1093/ntr/nty244.
- Giovenco DP, Ackerman C, Hrywna M, Delnevo CD. Changes in the availability and promotion of non-cigarette tobacco products near high schools in New Jersey, USA. Tob Control. 2018 Sep;27(5):578-579. doi: 10.1136/tobaccocontrol-2017-053800. Epub 2017 Aug 10. No abstract available.
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Helpful Links
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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Other Study ID Numbers
- AAAT1493
- R01CA240555-01A1 (U.S. NIH Grant/Contract)
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Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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