Supporting Smoke-Free Policy Compliance in Public Housing

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05016505
• Other study ID #: AAAT1493
• Secondary ID: R01CA240555-01A1
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2022
• Est. completion date: August 2025

Study information

• Verified date: February 2023
• Source: Columbia University
• Contact: Diana Hernández, PhD
• Phone: 2122050245
• Email: e2h2[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 512
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Smoking
• Smoking Behaviors
• Smoking Cessation
• Smoking Reduction

Intervention

Behavioral:
• Reduction (relocation and reduction of personal smoking) and cessation
Individual-level. Peer educator to provide reduction/cessation and/or relocation support.
• Resident Endorsement
Building-level. Peer educator to conduct building-level sessions.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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* Note: There are 103 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of cigarettes smoked per day	Self-reported average number of cigarettes smoked per day among smokers	Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Primary	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	At baseline and at the 12-month follow-up
Primary	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 at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Secondary	Change in number of participants with successful quit attempts	Binary; whether smokers have successfully quit	Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Secondary	Change in number of quit attempts	Mean number of quitting attempts among smokers	Measured at baseline (in person interview), 3 months (phone interview) and 12 months (in person interview)
Secondary	Change in number of participants with secondhand smoke observations	Binary; whether participant has observed someone smoking indoors in the building; among smokers & non-smokers	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)
Secondary	Change in number of hours of secondhand smoke exposure	Counted number of hours of 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)
Secondary	Change in number of smokers	Counted number of people observed smoking in common areas	At each building visit at baseline and 12 months
Secondary	Change in number of cigarette butts	Counted number of cigarette butts observed in common areas	At each building visit at baseline and 12 months

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