Computer MI for Tobacco Quitline Engagement in Smokers Living With HIV
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      The long-term goal of this program of research is to disseminate an effective, brief
      computer-based intervention that can be readily integrated into HIV treatment settings to
      motivate tobacco quitline use among smokers living with HIV. The overall objective of this
      application is to develop this computer intervention, modify it based on initial piloting and
      feedback, and obtain preliminary data supporting the efficacy of the intervention. This will
      be accomplished by pursuing three specific aims: 1) to develop and conduct preliminary pilot
      testing (n=16) of a brief, computer-based intervention intended to motivate tobacco quitline
      use among cigarette smokers living with HIV (Computer Intervention to Motivate Engagement in
      Tobacco Quitline treatment; CI-METQ) and to develop and pilot (n=4) a computer-based, time
      matched nutrition education for PLWH control intervention (NC) equated for the offer of a
      tobacco quitline referral and 8 weeks of free nicotine patch for those who engage in quitline
      treatment, 2) to conduct a preliminary smoking cessation, randomized controlled trial (RCT)
      with 100 people living with HIV (PLWH) who smoke cigarettes, comparing CI-METQ vs. NC, with
      predictions that CI-METQ relative to NC will result in increased readiness, higher rates of
      tobacco treatment engagement, more quit smoking attempts and higher rates of 7-day point
      prevalence abstinence rates at 1-, 3- and 6-month follow-ups. Health-related quality of life
      over this period will also be examined, and 3) to examine CI-METQ's effects on key mechanisms
      during the computer session and their associations with tobacco treatment engagement and
      smoking outcomes at 1- and 3-month follow-ups.
    

Detailed description: 
      Cigarette smoking is now a leading cause of morbidity and mortality among people living with
      HIV (PLWH) engaged in highly active antiretroviral therapy (HAART) [2-5]. Between 40-70% of
      PLWH in the U.S. currently smoke [6-14], in comparison to 20.6% of the general population
      [15], and tobacco accounted for nearly 25% of all deaths in a multinational cohort of PLWH
      who used HAART [2]. PLWH who smoke are uniquely vulnerable, moreso than smokers without HIV,
      to developing cardiovascular [2, 16] and lung [2, 17] diseases, and also are at greater risk
      than non-smoking PLWH for a multitude of HIV-associated illnesses [3, 5, 18, 19]. Against
      this backdrop, HIV treatment providers acknowledge the importance of assisting PLWH with
      smoking cessation, but a significant proportion of them lack confidence, training, and/or
      time [10, 12, 20]. Very little research on smoking cessation interventions for PLWH has been
      published, and none has evaluated approaches that could be easily disseminated and integrated
      into standard HIV care. In this context, a sophisticated, efficacious [ORs, 1.4-1.6 in
      meta-analyses [21, 22]] tobacco quitline network is now available in every U.S. state via a
      national quitline portal, 1-800-QUIT-NOW and represents an untapped resource for PLWH.
      Notably, the most positive findings, to date, for smoking cessation in PLWH have involved
      telephone counseling delivered by clinical research staff [1], but no existing studies have
      reported on the efficacy of engaging PLWH with tobacco quitlines or on brief motivational
      approaches to facilitate this process.

      The long-term goal of this research program is to disseminate an effective, brief
      computer-based intervention that can be readily integrated into community-based, HIV
      treatment settings to motivate tobacco quitline use among smokers living with HIV. The
      overall objective of this application, which is the first step in the attainment of our
      long-term goal, is to develop this computer-based intervention, modify it based on initial
      piloting and feedback to insure its feasibility and acceptability, and obtain preliminary
      data supporting the efficacy of the intervention. The rationale for the proposed research is
      that many smokers living with HIV are interested in quitting smoking, and that by exploring
      their smoking-related concerns, providing feedback and enhancing self-efficacy, they can
      become motivated to engage in smoking cessation counseling, utilizing a no-cost, readily
      available treatment option-their local tobacco quitline. We plan to accomplish the objective
      of this application by pursuing the following three specific aims:

      1. To develop a brief, computer-based intervention, the CI-METQ - Computer Intervention to
      Motivate Engagement in Tobacco Quitline treatment in PLWH who smoke. Also, to develop a
      computer-based, time matched nutrition education for PLWH control intervention (NC).

      1a. Following the development of the prototype, we will conduct a preliminary pilot test of
      the CI-METQ with 8 smokers living with HIV, followed by in-depth interviews with each
      individual to develop an understanding of the strengths and limitations of the intervention.
      We will then utilize the interview feedback to guide the modification and refinement of the
      CI-METQ, after which we will repeat the process with another 8 smokers living with HIV.

      1b. The data collected from these 16 interviews regarding feasibility, acceptability and
      barriers that would limit effectiveness will guide the investigators in making the
      appropriate modifications to finalize the CI-METQ prior to preliminary testing in a small,
      randomized controlled trial (RCT).

      1c. A similar iterative process will occur with 4 PLWH who smoke in developing the NC
      condition.

      2. To conduct a preliminary RCT with 100 smokers living with HIV, comparing CI-METQ to a
      computer-based, time matched nutrition control (NC) equated for the offer of a tobacco
      quitline referral and if engaged with quitline, 8 weeks of nicotine patch at no cost. We
      expect: 2a. CI-METQ relative to NC will result in increased readiness for smoking cessation
      post-intervention and higher rates of engagement in smoking cessation treatment.

      2b. CI-METQ relative to NC will result in a greater proportion of participants making at
      least one 24 hour quit attempt over the six months post-intervention and in higher rates of
      7-day point prevalence abstinence at 1-, 3- and 6- month follow-ups.

      2c. To examine the effect of CI-METQ vs. NC on health-related quality of life over 6-month
      follow-up.

      3. To explore potential mechanisms that may underlie the efficacy of CI-METQ: 3a. We will
      examine CI-METQ's effects on key mechanisms self-reported during the computer session:
      concerns about cigarette smoking, likelihood of reducing or quitting smoking, health benefits
      of quitting, and satisfaction with the brief intervention content.

      3b. We will examine the associations of these dynamic changes with smoking cessation
      treatment engagement and smoking outcomes at 1-, 3- and 6-month follow-ups.

      With regard to expected outcomes, the work proposed in aims 1 - 3 is expected to result in
      the development of a brief, computer-based intervention that will produce preliminary data
      showing increased tobacco quitline utilization and smoking cessation in smokers living with
      HIV. Such results are expected to have an important positive impact, moving us closer to the
      long-term goal of dissemination and integration of a cost-effective, CI-METQ into
      community-based, HIV treatment settings, to motivate tobacco quitline use in PLWH who smoke.
    

Intervention name(s): Brief Computer MI for Smoking Cessation; Nutrition Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Brief computer MI intervention to motivate tobacco quitline use; Computer delivered nutrition education control condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Tobacco; Nicotine; Dependence; Quitline