With advances in antiretroviral therapy (ART), people living with HIV (PLWH) are living longer, are more likely to die from non-AIDS-related causes, and are less likely to die from AIDS-related complications. In fact, lung cancer is now the leading cause of cancer death among PLWH. Tobacco use is a major contributing factor to lung cancer incidence and mortality among PLWH since smoking rates among PLWH are approximately 40-50%. Indeed, this is more than double or triple the 15.5% rate of smoking in the general United States population. With several evidence-based tobacco treatment approaches at the patients' disposal, including pharmacotherapy and behavioral counseling, optimizing how those treatments are delivered to patients requires an empirical approach. Routine clinical care through the healthcare system may not be optimized to reach this patient population. Prior research has shown that proactive tobacco treatment increases the likelihood of treatment engagement and downstream cessation. Beyond the method for engaging in the initial contact session, prior studies have demonstrated that there are optimal ways for framing how the tobacco treatment is being provided. That is, presenting smoking cessation in an opt-out fashion results in increased patient reach and likelihood of abstinence. Despite the evidence in support of a proactive, opt-out method for smoking cessation intervention delivery, this strategy has not been evaluated in the context of tobacco treatment for PLWH. Further, because this approach can connect patients with available, evidence-based interventions that can be delivered remotely, it holds promise for implementation in the context of healthcare settings across the country. In the proposed study, we will conduct a type 1 hybrid effectiveness-implementation trial to evaluate the impact of a proactive, opt-out smoking cessation intervention on smoking cessation outcomes and advance understanding of key barriers and facilitators of implementation processes. We propose a comparison of Treatment As Usual [TAU; reactive, opt-in smoking cessation treatment delivered through Infectious Diseases clinical pathways] to Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement (PrOMOTE) and characterization of key determinants of PrOMOTE implementation outcomes. The intervention will consist of a tobacco treatment specialist proactively and remotely contacting a patient to assess smoking status, provide a brief motivational interview and counseling, and provide a mail-order prescription for varenicline (or dual NRT if indicated) in an opt-out fashion. This proposed study will examine this novel approach to optimizing delivery of smoking cessation care for PLWH. Integrating effectiveness and implementation results will help define best practices for engaging PLWH with existing evidence-based smoking cessation interventions. This hybrid effectiveness-implementation trial presents on opportunity to optimize tobacco treatment delivery, and identify barriers and facilitators towards future implementation and dissemination to ambulatory HIV clinics across the country.

PROJECT NARRATIVE Despite the promise of smoking cessation interventions in people living with HIV (PLWH), intervention potential is limited by a lack of understanding about how to best implement evidence-based cessation strategies in this population. Tobacco treatment with first-line pharmacotherapy, delivered remotely in a proactive, opt-out fashion presents an opportunity for PLWH to receive robust, evidence-based tobacco treatment even if they are not currently motivated to quit smoking. By optimizing the delivery of effective tobacco treatments for PLWH, we hope to increase the number of people receiving tobacco treatment, increase tobacco cessation rates, and reduce the risk of morbidity and mortality from smoking-related causes.