Assessing Telephone All Nations Breath of Life for Efficacy

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PROJECT SUMMARY AI have the highest smoking rates of all major ethnic groups in the US, at 31.8%, nearly double that of both African Americans and Whites. Despite these high rates of smoking, few researchers have addressed this issue, in part because tobacco is a sacred plant to many AI and cannot be treated completely negatively, as most smoking cessation programs do. Researchers at the University of Kansas Medical Center (KUMC) and Johnson County Community College (JCCC) have been working with regional partners using community- based participatory research (CBPR) to address recreational tobacco since 2003. We have developed a successful culturally tailored program, All Nations Breath of Life (ANBL), that respects tobacco as a sacred plant and promotes honoring it rather than abusing it recreationally. Our in-person, group-based program had an intent-to-treat quit rate of 27.9% versus 17.4% compared to current best practices at end of treatment (12 weeks) in a reservation-based efficacy trial (N=463). Cessation was 20% vs. 12% at 6 months (p=0.02). In a large urban implementation feasibility study (N=312 across five states), the quit rate was 22% at 6-months (p<0.002 compared to the highest previously reported rates for an urban AI population); retention was 71%. Based on a request from the community, we created an individual telephone-based version of the program, tANBL, which was pilot tested with N=33 individuals and had a 24.2% quit rate at 6 months, assuming those lost to follow-up as smokers. The program had an 81.8% retention rate at 6 months. We are now ready to formally test tANBL for efficacy; that is proposed here using a Bayesian Adaptive Design (BAD) and our community-based participatory research (CBPR) framework. We will address the following specific aims: (1) To compare tANBL with an individual non-tailored telephone-based comparison program (CP) using a Bayesian Adaptive Design (n=500); (2) To examine the acceptability and feasibility of implementing an individual telephone-based ANB and (3) To compare individual telephone ANBL with an individual non-tailored telephone-based comparison program using a Bayesian Adaptive Design (N=500). Our primary endpoint will be 7-day point prevalence abstinence from recreational smoking biochemically verified by salivary cotinine level at 6 months post-baseline. Quit rates in the ANBL program will be significantly better than in the non- tailored program (24% versus 10%). We will address the following secondary aims: (1) To compare tANBL and CP 30-day point prevalence and continuous abstinence rates at 6 months and 12 months post-baseline; (2) To examine individual factors such as type of pharmacotherapy (if any), level of addiction, use of other nicotine products such as e-cigarettes, quitting history, motivation, tobacco health literacy, social support, self- efficacy, ethnic identity, psychosocial health and demographic factors for effect on quit rates; (3) To maximize and assess the cultural relevance of the intervention program and all of its components and (4) To identify factors that enhance dissemination of telephone-based ANBL and contribute to program success or failure.