Smoking Cessation Intervention in Public Housing

• ClinicalTrials.gov Identifier: NCT01035151
• Recruitment Status: Completed
• First Posted: December 18, 2009
• Results First Posted: December 13, 2018
• Last Update Posted: December 13, 2018
• Sponsor: Medical University of South Carolina
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Medical University of South Carolina

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cigarette Smoking	Behavioral: Experimental; Behavioral: Control	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 420 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Social Ecological Based Smoking Cessation Intervention in Public Housing Neighborhoods
• Study Start Date: July 2009
• Actual Primary Completion Date: May 15, 2018
• Actual Study Completion Date: May 15, 2018

Arms and Interventions

Arm	Intervention/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: 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)

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Abstinent From Smoking [ Time Frame: 12 month ]
   Reported abstinence validated by exhaled CO and saliva cotinine

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Georgia

Medical College of Georgia

Augusta, Georgia, United States, 30901

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Jeannette Andrews, PhD; University of South Carolina

  Study Documents (Full-Text)

Documents provided by Medical University of South Carolina:

Statistical Analysis Plan  [PDF] August 9, 2018

Study Protocol  [PDF] August 9, 2018

More Information

Publications of Results:

Andrews JO, Mueller M, Dooley M, Newman SD, Magwood GS, Tingen MS. Effect of a smoking cessation intervention for women in subsidized neighborhoods: A randomized controlled trial. Prev Med. 2016 Sep;90:170-6. doi: 10.1016/j.ypmed.2016.07.008. Epub 2016 Jul 14.

Other Publications:

Andrews JO, Mueller M, Newman SD, Magwood G, Ahluwalia JS, White K, Tingen MS. The association of individual and neighborhood social cohesion, stressors, and crime on smoking status among African-American women in southeastern US subsidized housing neighborhoods. J Urban Health. 2014 Dec;91(6):1158-74. doi: 10.1007/s11524-014-9911-6.

Spruill IJ, Leite RS, Fernandes JK, Kamen DL, Ford ME, Jenkins C, Hunt KJ, Andrews JO. Successes, Challenges and Lessons Learned: Community-engaged research with South Carolina's Gullah population. Gateways. 2013;6. doi: 10.5130/ijcre.v6i1.2805.

Andrews JO, Newman SD, Heath J, Williams LB, Tingen MS. Community-based participatory research and smoking cessation interventions: a review of the evidence. Nurs Clin North Am. 2012 Mar;47(1):81-96. doi: 10.1016/j.cnur.2011.10.013. Epub 2011 Dec 14. Review.

Andrews JO, Tingen MS, Jarriel SC, Caleb M, Simmons A, Brunson J, Mueller M, Ahluwalia JS, Newman SD, Cox MJ, Magwood G, Hurman C. Application of a CBPR framework to inform a multi-level tobacco cessation intervention in public housing neighborhoods. Am J Community Psychol. 2012 Sep;50(1-2):129-40. doi: 10.1007/s10464-011-9482-6.

Magwood GS, Andrews JO, Zapka J, Cox MJ, Newman S, Stuart GW. Institutionalization of community partnerships: the challenge for academic health centers. J Health Care Poor Underserved. 2012 Nov;23(4):1512-26. doi: 10.1353/hpu.2012.0161.

Newman SD, Andrews JO, Magwood GS, Jenkins C, Cox MJ, Williamson DC. Community advisory boards in community-based participatory research: a synthesis of best processes. Prev Chronic Dis. 2011 May;8(3):A70. Epub 2011 Apr 15.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT01035151
• Other Study ID Numbers: MUS08022834; R01HL090951 ( U.S. NIH Grant/Contract )
• First Posted: December 18, 2009
• Results First Posted: December 13, 2018
• Last Update Posted: December 13, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Contact the PI

Keywords provided by Medical University of South Carolina:

randomized cluster design; tobacco cessation; smoking cessation; African American