title: Designing a smoking cessation intervention for the unique needs of homeless persons: a community-based randomized clinical trial.
abstract: BACKGROUND
  Although smoking prevalence remains strikingly high in homeless populations (~70% and three times the US national average), smoking cessation studies usually exclude homeless persons. Novel evidence-based interventions are needed for this high-risk subpopulation of smokers.
  
  
  OBJECTIVE
  To describe the aims and design of a first-ever smoking cessation clinical trial in the homeless population. The study was a two-group randomized community-based trial that enrolled participants (n = 430) residing across eight homeless shelters and transitional housing units in Minnesota. The study objective was to test the efficacy of motivational interviewing (MI) for enhancing adherence to nicotine replacement therapy (NRT; nicotine patch) and smoking cessation outcomes.
  
  
  METHODS
  Participants were randomized to one of the two groups: active (8 weeks of NRT + 6 sessions of MI) or control (NRT + standard care). Participants attended six in-person assessment sessions and eight retention visits at a location of their choice over 6 months. Nicotine patch in 2-week doses was administered at four visits over the first 8 weeks of the 26-week trial. The primary outcome was cotinine-verified 7-day point-prevalence abstinence at 6 months. Secondary outcomes included adherence to nicotine patch assessed through direct observation and patch counts. Other outcomes included the mediating and/or moderating effects of comorbid psychiatric and substance abuse disorders.
  
  
  RESULTS
  Lessons learned from the community-based cessation randomized trial for improving recruitment and retention in a mobile and vulnerable population included: (1) the importance of engaging the perspectives of shelter leadership by forming and convening a Community Advisory Board; (2) locating the study at the shelters for more visibility and easier access for participants; (3) minimizing exclusion criteria to allow enrollment of participants with stable psychiatric comorbid conditions; (4) delaying the baseline visit from the eligibility visit by a week to protect against attrition; and (5) regular and persistent calls to remind participants of upcoming appointments using cell phones and shelter-specific channels of communication.
  
  
  CONCLUSIONS
  The study's limitations include generalizability due to the sample drawn from a single Midwestern city in the United States. Since inclusion criteria encompassed willingness to use NRT patch, all participants were motivated and were ready to quit smoking at the time of enrollment in the study. Findings from the self-select group will be generalizable only to those motivated and ready to quit smoking. High incentives may limit the degree to which the intervention is replicable.
  
  
  CONCLUSIONS
  Lessons learned reflect the need to engage communities in the design and implementation of community-based clinical trials with vulnerable populations.
authors.affiliation: Department of Family Medicine and Community Health, University of Minnesota, Medical School, Minneapolis, MN 55116, USA. kgoldade@umn.edu
authors.forename: Kate
authors.initials: K
authors.lastname: Goldade
authors.forename: Guy-Lucien
authors.initials: GL
authors.lastname: Whembolua
authors.forename: Janet
authors.initials: J
authors.lastname: Thomas
authors.forename: Sara
authors.initials: S
authors.lastname: Eischen
authors.forename: Hongfei
authors.initials: H
authors.lastname: Guo
authors.forename: John
authors.initials: J
authors.lastname: Connett
authors.forename: Don
authors.initials: D
authors.lastname: Des Jarlais
authors.forename: Ken
authors.initials: K
authors.lastname: Resnicow
authors.forename: Lillian
authors.initials: L
authors.lastname: Gelberg
authors.forename: Greg
authors.initials: G
authors.lastname: Owen
authors.forename: Jon
authors.initials: J
authors.lastname: Grant
authors.forename: Jasjit S
authors.initials: JS
authors.lastname: Ahluwalia
authors.forename: Kolawole S
authors.initials: KS
authors.lastname: Okuyemi
mesh_terms: D019058:Community Networks; D005260:Female; D006703:Ill-Housed Persons; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D008910:Minnesota; D009042:Motivation; D010349:Patient Compliance / Q000523:psychology; D012107:Research Design; D016540:Smoking Cessation; D061485:Tobacco Use Cessation Devices; D014029:Tobacco Use Disorder / Q000188:drug therapy; D016896:Treatment Outcome