Clinical trial NCT05016505: Supporting Smoke-Free Policy Compliance in Public Housing
Official title: A Randomized Controlled Trial to Support Smoke-Free Policy Compliance in Public Housing
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking
Smoking Cessation
Smoking Reduction
Smoking Behaviors
Keywords: smoking
secondhand smoke
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-08-23
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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).
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in number of cigarettes smoked per day
timeFrame: Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
measure: Change in salivary cotinine
timeFrame: At baseline and at the 12-month follow-up
measure: Change in secondhand smoke exposure
timeFrame: Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Secondary outcomes:
measure: Change in number of participants with successful quit attempts
timeFrame: Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
measure: Change in number of quit attempts
timeFrame: Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
measure: Change in number of participants with secondhand smoke observations
timeFrame: 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)
measure: Change in number of hours of secondhand smoke exposure
timeFrame: 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)
measure: Change in number of smokers
timeFrame: At each building visit at baseline and 12 months
measure: Change in number of cigarette butts
timeFrame: At each building visit at baseline and 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Associate Professor
name: Diana Hernández, PhD
role: PRINCIPAL_INVESTIGATOR
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