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Smoking Cessation Intervention in Public Housing

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StatusCompleted
Sponsors
Medical University of South Carolina
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

Keywords

Abstract

The major aim of this study is to test the effectiveness of a bundled, multi-level intervention (Sister to Sister) on smoking cessation outcomes in female smokers residing in public housing neighborhoods.
Hypothesis 1.1: As compared to the control group, women receiving the Sister to Sister Intervention will have higher 7-day point prevalence quit rates at 6- and 12-months as validated by salivary cotinine.
Hypothesis 1.2: As compared to the control group, women receiving the Sister to Sister Intervention will have higher 6- and 12-month prolonged smoking abstinence as validated by salivary cotinine.

Description

This was a cluster randomized controlled study evaluating the effect of a multi-level intervention, Sister to Sister, on the smoking cessation in two Southeastern US metropolitan areas. Fourteen subsidized housing neighborhoods, eight in Charleston, SC and six in Augusta, GA, were pair matched based on size; with one neighborhood in each pair randomized to the intervention to ensure balanced recruitment between groups. Neighborhoods ranged in size from 22 to 33 participants with a total sample size of 409 women; neighborhoods were chosen as the primary sampling unit to prevent contamination of the outcome within neighborhoods, with women in the neighborhoods as secondary sampling unit. All statistical analyses were conducted using SAS 9.2 (SAS Institute, Cary, NC) with statistical significance at an alpha level of 0.05. Comparison between groups at baseline used t-tests for continuous variables and chi-square tests for categorical variables. The primary outcome of interest was smoking status which was dichotomized (smoker/non-smoker) at the 6 and 12 month measurements. Smoking status was determined by cotinine levels in saliva with non-smokers defined as those with cotinine levels of 14 ng/mL or less.

Dates

Last Verified: 10/31/2018
First Submitted: 12/16/2009
Estimated Enrollment Submitted: 12/16/2009
First Posted: 12/17/2009
Last Update Submitted: 11/19/2018
Last Update Posted: 12/12/2018
Date of first submitted results: 05/13/2018
Date of first submitted QC results: 11/19/2018
Date of first posted results: 12/12/2018
Actual Study Start Date: 06/30/2009
Estimated Primary Completion Date: 05/14/2018
Estimated Study Completion Date: 05/14/2018

Condition or disease

Cigarette Smoking

Intervention/treatment

Behavioral: Experimental

Behavioral: Delayed Control

Phase

-

Arm Groups

ArmIntervention/treatment
Active Comparator: Delayed Control
Women in the delayed control condition received culturally sensitive smoking cessation written materials at week 1, and mailed materials at week 6, 12, and 18. At the end of the study (i.e., after the 12 month data collection), participants were offered counseling, nicotine patches, and community health worker contacts.
Behavioral: Delayed Control
Written Cessation Materials
Experimental: Experimental
Women in neighborhoods randomized to the S2S received 24-week bundled multi-level intervention. Individual-led strategies were led by paid community health workers (CHWs). The CHWs provided 1:1 contact to reinforce social support, and enhanced self-efficacy with cessation attempts. A certified smoking cessation counselor led behavioral group sessions using the S2S handbook based on the PHS Guidelines. The weekly group sessions were initiated during the 1st week of the intervention, with a total of 6 group sessions over a 6-week period. Transdermal nicotine patches were offered to participants who set a quit date. Within the 24-week study period, the neighborhood tenant association, in partnership with study staff, implemented at least two neighborhood level anti-smoking activities
Behavioral: Experimental
Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)

Eligibility Criteria

Ages Eligible for Study 18 Years To 18 Years
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersYes
Criteria

Inclusion Criteria:

- 18 yrs of age and older,

- female, resident of public housing, daily smoker

Exclusion Criteria:

- pregnant,

- breastfeeding,

- no intentions to quit smoking

Outcome

Primary Outcome Measures

1. Number of Participants Abstinent From Smoking [12 month]

Reported abstinence validated by exhaled CO and saliva cotinine

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