Testing Novel Pharmacogenetic and Adherence Optimization Treatments to Improve the Effectiveness of Smoking Cessation Treatments for Smokers with HIV

Project Title: Testing Novel Pharmacogenetic and Adherence Optimization Treatments to Improve the Effectiveness of Smoking Cessation Treatments for Smokers with HIV We will conduct a rigorous two-site randomized controlled trial with 488 HIV+ smokers to evaluate nicotine metabolite ratio (NMR)-tailored treatment and managed problem solving (MAPS) as optimization strategies for treating tobacco dependence among people living with HIV/AIDS (PLWHA). We will use a factorial design to examine: 1) The effects of the NMR-tailored and/or MAPS interventions on end-of-treatment (EOT) and 6-month smoking cessation rates (primary aim); 2) Mediators of the NMR-tailored and MAPS interventions (secondary aim); and 3) Moderators of the NMR-tailored and MAPS interventions (exploratory aim). Our overall approach is consistent with the multiphase optimization strategy which has gained prominence for guiding the evaluation of interventions for enhancing tobacco use treatment effectiveness. Addressing these aims will determine: the efficacy of the use of adherence and pharmacogenetic optimization of smoking cessation treatment for PLWHA, the mechanisms that underlie the effects of these optimization strategies on cessation outcomes, and the variation in the effects of these optimization strategies across subgroups of people living with HIV/AIDS. In the end, this trial will help understand if getting the right medication to the right person and helping to make sure they use that medication optimizes tobacco cessation treatment for this population. Led by Dr. Brian Hitsman, the Northwestern research team will ascertain approximately half (N=244) of the proposed sample and conduct the study according to the agreed upon protocol. Participants will be recruited at Northwestern and at Penn in order to enroll a large and racially diverse sample of HIV+ smokers. In collaboration with Dr. Chad Achenbach, the study physician, Dr. Hitsman will supervise the Northwestern research staff, ensure completion of the project, and participate on manuscript preparation.