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Cigarette SmokingNCT01035151

Smoking Cessation Intervention in Public Housing

A study testing Experimental in people with Cigarette Smoking, run by Medical University of South Carolina at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cigarette Smoking
What is being tested?
Experimental
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
2 sitesUnited States
Study dates
Jul 2009to 15 May 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 yrs of age and older,
  • female, resident of public housing, daily smoker

Who cannot join

  • pregnant,
  • breastfeeding,
  • no intentions to quit smoking

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Medical College of Georgia

    Augusta, Georgia, 30901

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Social Ecological Based Smoking Cessation Intervention in Public Housing Neighborhoods

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.

Read the 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.

Being tested
Experimental, Control
Keywords
randomized cluster design, tobacco cessation, smoking cessation, African American
Medical subject headings
Cigarette Smoking, Tobacco Use Cessation, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExperimentalBehavioural

    Neighborhood level interventions, peer group (counseling, NRT), and individual level (Coach/CHW)

  • ControlBehavioural

    Written Cessation Materials

Study groups in NCT01035151
Study groupRoleWhat they receive
Delayed ControlActive comparatorWomen 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.
Receives: Behavioral: Control
ExperimentalExperimentalWomen 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
Receives: Behavioral: Experimental

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Abstinent From Smoking

    Reported abstinence validated by exhaled CO and saliva cotinine

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2009 (estimated)
  2. Study startJul 2009
  3. Primary completion15 May 2018
  4. Study completion15 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01035151
Sponsor's protocol ID
MUS08022834
Other IDs
R01HL090951
Status last verified
Nov 2018
First submitted
17 Dec 2009
Last updated
13 Dec 2018
Data monitoring committee
Yes
Individual data sharing
Undecided: Contact the PI

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.

    PubMed 25316192

  • 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;6:10.5130/ijcre.v6i1.2805. doi: 10.5130/ijcre.v6i1.2805. No abstract available.

    PubMed 25364473

  • 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.

    PubMed 22289400

  • 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.

    PubMed 22124619

  • 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.

    PubMed 23698666

  • 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.

    PubMed 21477510

  • 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.

    PubMed 27423320

Questions about this trial

What is this clinical trial studying?

A study testing Experimental in people with Cigarette Smoking, run by Medical University of South Carolina at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Abstinent From Smoking (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01035151, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018; AzTrials last refreshed its copy on 30 Oct 2026.

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