Motivation and Patch Treatment for HIV-positive Smokers
Condition: HIV Infections; Smoking Cessation
MeSH terms: HIV Seropositivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to develop and evaluate a brief, clinic-based smoking cessation
      treatment for an HIV+ population. We compared two treatments, a brief advice and follow-up
      plus nicotine patch treatment(Standard Care; SC) and brief advice and follow-up, nicotine
      patch, with the addition of a tailored motivational intervention and behavioral skills
      counseling for smoking cessation (Motivationally-Enhanced; ME), in a randomized controlled
      trial. We hypothesized that those HIV+ participants receiving the ME will demonstrate greater
      biochemically verified smoking abstinence rates at 6-month follow-up than those receiving the
      SC control treatment. All study participants were offered use of the nicotine patch.
    

Detailed description: 
      Cigarette smoking is highly prevalent among HIV+ individuals, posing unique health risks,
      impacting HAART-therapy effectiveness, and possibly altering the course of the disease. To
      our knowledge, Motivation and Patch Treatment for HIV-Positive Individuals (Positive PATHS)
      was the first NIH-funded smoking cessation intervention designed to motivate HIV+ smokers to
      quit. Participants were referred by physicians at eight Immunology clinics in New England and
      randomized to receive either a brief, two-session intervention (Standard Care; SC) modeled on
      PHS guidelines, or a more intensive, four-session motivational counseling intervention
      (Motivational-Enhancement; ME). All physicians participating in the trial were trained in
      study eligibility criteria, as well as basic smoking cessation counseling strategies (based
      on the PHS guidelines). Interested individuals were then referred to the study, with a study
      researcher explaining the details of the study and obtaining informed consent. Participants
      were then assisted in completing baseline assessments via laptop computer, and then
      randomized to receive either a brief intervention (2-sessions) designed to reflect the
      standard of care in outpatient hospital settings and modeled on PHS guidelines (standard
      care; SC) or a more intensive (4-session) motivational counseling intervention (motivational
      enhancement; ME), with both interventions providing 8-weeks of nicotine replacement (patches;
      NRT) to those participants willing to set a quit date. Follow-up assessments, including
      biochemical verification of self-reported quitters (via carbon monoxide measurement) were
      conducted at 2, 4, and 6 months from baseline. This study is among the first to examine the
      health effects of a delivered smoking cessation intervention to an HIV+ population, with the
      results having implications for treatments in clinical care settings.
    

Intervention name(s): Standard Care; Motivational Enhancement
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Brief advice and follow-up provided a smoking-cessation trained Health Educator PLUS nicotine patch; Brief advice and follow-up, nicotine patch, and the addition of a tailored motivational intervention and behavioral skills counseling for smoking cessation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; HIV positive; AIDS; smoking cessation; smoking; smoking counseling