Supporting Smoke-Free Policy Compliance in Public Housing

Sponsor

Columbia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05016505

Collaborator

National Cancer Institute (NCI) (NIH)

512

Enrollment

Location

Arms

42.9

Anticipated Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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 relocation/cessation) with the goal of reducing personal smoking and secondhand smoke exposure.

Condition or Disease	Intervention/Treatment	Phase
Smoking Smoking Cessation Smoking Reduction Smoking Behaviors	Behavioral: Relocation & Cessation Behavioral: Resident Endorsement	N/A

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 Design

Study Type:

Interventional

Anticipated 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 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).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 (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 3, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

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: 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 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: 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.

Outcome Measures

Primary Outcome Measures

Change in number of cigarettes smoked per day [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
Change in salivary cotinine [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
Change in secondhand smoke exposure [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

Change in number of participants with successful quit attempts [Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)]
Binary; whether smokers have successfully quit
Change in number of quit attempts [Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)]
Mean number of quitting attempts among smokers
Change in number of participants with secondhand smoke observations [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
Change in number of hours of secondhand smoke 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)]
Counted number of hours of exposure
Change in number of smokers [At each building visit at baseline and 12 months]
Counted number of people observed smoking in common areas
Change in number of cigarette butts [At each building visit at baseline and 12 months]
Counted number of cigarette butts observed in common areas

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Irving Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

Columbia University
National Cancer Institute (NCI)

Investigators

Principal Investigator: Diana Hernández, PhD, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Diana Hernandez, PhD, Associate Professor of Sociomedical Sciences, Columbia University

ClinicalTrials.gov Identifier:

NCT05016505

Other Study ID Numbers:

AAAT1493
R01CA240555-01A1

First Posted:

Aug 23, 2021

Last Update Posted:

Mar 7, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Diana Hernandez, PhD, Associate Professor of Sociomedical Sciences, Columbia University

smoking

secondhand smoke

Study Results

No Results Posted as of Mar 7, 2022