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SmokingNCT05016505

Supporting Smoke-Free Policy Compliance in Public Housing

A study testing Reduction (relocation and reduction of personal smoking) and cessation and Resident Endorsement in people with Smoking and Smoking Cessation, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking, Smoking Cessation, Smoking Reduction
What is being tested?
Reduction (relocation and reduction of personal smoking) and cessation and Resident Endorsement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
405 participants
Where
1 siteUnited States
Study dates
3 Feb 2022to 31 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Columbia University Irving Medical Center

    New York, New York, 10032

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Reduction (relocation and reduction of personal smoking) and cessation, Resident Endorsement
Keywords
smoking, secondhand smoke
Medical subject headings
Smoking, Smoking Cessation, Smoking Reduction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reduction (relocation and reduction of personal smoking) and cessationBehavioural

    Individual-level. Peer educator to provide reduction/cessation and/or relocation support.

  • Resident EndorsementBehavioural

    Building-level. Peer educator to conduct building-level sessions.

Study groups in NCT05016505
Study groupRoleWhat they receive
Compliance through reduction (relocation and reduction of personal smoking) and cessationExperimentalSmokers 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.
Receives: Behavioral: Reduction (relocation and reduction of personal smoking) and cessation
Compliance through resident endorsementExperimentalBuildings 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.
Receives: Behavioral: Resident Endorsement
Compliance through reduction/cessation plus resident endorsement (combined)ExperimentalThe 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.
Receives: Behavioral: Reduction (relocation and reduction of personal smoking) and cessation; Behavioral: Resident Endorsement
Standard NYCHA approach (control)No interventionBuildings 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in number of cigarettes smoked per day

    Self-reported average number of cigarettes smoked per day among smokers

    Measured: Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)

  2. Change in salivary cotinine

    Salivary cotinine (saliva collected as passive drool) will be measured for 25% of the sample among smokers and non-smokers alike

    Measured: At baseline and at the 12-month follow-up

  3. Change in secondhand smoke exposure

    Self-reported secondhand smoking exposure (hours of secondhand smoke exposure in the building in the past 7 days); among smokers \& non-smokers

    Measured: Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)

Secondary outcomes (6)
  1. Change in number of participants with successful quit attempts

    Binary; whether smokers have successfully quit

    Measured: Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)

  2. Change in number of quit attempts

    Mean number of quitting attempts among smokers

    Measured: Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)

  3. Change in number of participants with secondhand smoke observations

    Binary; whether participant has observed someone smoking indoors in the building; among smokers \& non-smokers

    Measured: 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)

  4. Change in number of hours of secondhand smoke exposure

    Counted number of hours of exposure

    Measured: 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)

  5. Change in number of smokers

    Counted number of people observed smoking in common areas

    Measured: At each building visit at baseline and 12 months

  6. Change in number of cigarette butts

    Counted number of cigarette butts observed in common areas

    Measured: At each building visit at baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2021
  2. Study start3 Feb 2022
  3. Primary completion31 Jul 2025
  4. Study completion31 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
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 New York City Housing Authority (NYCHA) developments. The investigators 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) reduction (relocation and reduction in personal smoking)/cessation, (2) resident endorsement, (3) reduction (relocation and reduction in personal smoking)/cessation plus resident endorsement and (4) the standard approach (128 participants per arm).
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
405 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05016505
Sponsor's protocol ID
AAAT1493
Other IDs
R01CA240555-01A1
Status last verified
Jan 2026
First submitted
20 Jul 2021
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Branas CC, Culhane D, Richmond TS, Wiebe DJ. Novel Linkage of Individual and Geographic Data to Study Firearm Violence. Homicide Stud. 2008 Aug;12(3):298-320. doi: 10.1177/1088767908319756.

    PubMed 20617158
  • Kim S, Apelberg BJ, Avila-Tang E, Hepp L, Yun D, Samet JM, Breysse PN. Utility and cutoff value of hair nicotine as a biomarker of long-term tobacco smoke exposure, compared to salivary cotinine. Int J Environ Res Public Health. 2014 Aug 15;11(8):8368-82. doi: 10.3390/ijerph110808368.

    PubMed 25153466
  • Sims M, Mindell JS, Jarvis MJ, Feyerabend C, Wardle H, Gilmore A. Did smokefree legislation in England reduce exposure to secondhand smoke among nonsmoking adults? Cotinine analysis from the Health Survey for England. Environ Health Perspect. 2012 Mar;120(3):425-30. doi: 10.1289/ehp.1103680. Epub 2011 Dec 12.

    PubMed 22169225
  • Kondo MC, Bream KD, Barg FK, Branas CC. A random spatial sampling method in a rural developing nation. BMC Public Health. 2014 Apr 10;14:338. doi: 10.1186/1471-2458-14-338.

    PubMed 24716473
  • Wong MS, Grande DT, Mitra N, Radhakrishnan A, Branas CC, Ward KR, Pollack CE. Racial Differences in Geographic Access to Medical Care as Measured by Patient Report and Geographic Information Systems. Med Care. 2017 Sep;55(9):817-822. doi: 10.1097/MLR.0000000000000774.

    PubMed 28731892
  • Winickoff JP, Gottlieb M, Mello MM. Regulation of smoking in public housing. N Engl J Med. 2010 Jun 17;362(24):2319-25. doi: 10.1056/NEJMhle1000941. No abstract available.

    PubMed 20554988
  • King BA, Travers MJ, Cummings KM, Mahoney MC, Hyland AJ. Secondhand smoke transfer in multiunit housing. Nicotine Tob Res. 2010 Nov;12(11):1133-41. doi: 10.1093/ntr/ntq162. Epub 2010 Oct 1.

    PubMed 20889473
  • Kraev TA, Adamkiewicz G, Hammond SK, Spengler JD. Indoor concentrations of nicotine in low-income, multi-unit housing: associations with smoking behaviours and housing characteristics. Tob Control. 2009 Dec;18(6):438-44. doi: 10.1136/tc.2009.029728. Epub 2009 Aug 13.

    PubMed 19679890
  • King BA, Babb SD, Tynan MA, Gerzoff RB. National and state estimates of secondhand smoke infiltration among U.S. multiunit housing residents. Nicotine Tob Res. 2013 Jul;15(7):1316-21. doi: 10.1093/ntr/nts254. Epub 2012 Dec 17.

    PubMed 23248030
  • Office on Smoking and Health (US). The Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2006. Available from http://www.ncbi.nlm.nih.gov/books/NBK44324/

    PubMed 20669524
  • Nguyen KH, Gomez Y, Homa DM, King BA. Tobacco Use, Secondhand Smoke, and Smoke-Free Home Rules in Multiunit Housing. Am J Prev Med. 2016 Nov;51(5):682-692. doi: 10.1016/j.amepre.2016.05.009. Epub 2016 Jul 13.

    PubMed 27423656
  • Snyder K, Vick JH, King BA. Smoke-free multiunit housing: a review of the scientific literature. Tob Control. 2016 Jan;25(1):9-20. doi: 10.1136/tobaccocontrol-2014-051849. Epub 2015 Jan 7.

    PubMed 25566811
  • Jamal A, Agaku IT, O'Connor E, King BA, Kenemer JB, Neff L. Current cigarette smoking among adults--United States, 2005-2013. MMWR Morb Mortal Wkly Rep. 2014 Nov 28;63(47):1108-12.

    PubMed 25426653
  • Helms VE, King BA, Ashley PJ. Cigarette smoking and adverse health outcomes among adults receiving federal housing assistance. Prev Med. 2017 Jun;99:171-177. doi: 10.1016/j.ypmed.2017.02.001. Epub 2017 Feb 10.

    PubMed 28192095
  • Brown N, Luckett T, Davidson PM, Di Giacomo M. Interventions to reduce harm from smoking with families in infancy and early childhood: a systematic review. Int J Environ Res Public Health. 2015 Mar 16;12(3):3091-119. doi: 10.3390/ijerph120303091.

    PubMed 25785496

Questions about this trial

What is this clinical trial studying?

A study testing Reduction (relocation and reduction of personal smoking) and cessation and Resident Endorsement in people with Smoking and Smoking Cessation, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05016505, which also lists 105 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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