Grant Number:	1R01CA309123-01A1 Interpret this number
Primary Investigator:	Little, Melissa
Organization:	University Of Virginia
Project Title:	Optimizing Pharmacist-Led Tobacco Treatment for Individuals Who Smoke and Are Not Ready to Make a Quit Attempt in Federally Qualified Health Centers
Fiscal Year:	2026

Despite significant declines in the US cigarette smoking rate over the past 50 years, smoking remains the leading cause of preventable morbidity and mortality. However, only 57% of smokers report receiving advice to quit from a healthcare professional in the past year and 95% of smokers will relapse without the use of evidence-based interventions. Additionally, even though the vast majority of smokers are not ready to quit within the next 30 days, approaches for this population of smokers not ready to quit (SNRTQ) remain largely understudied. To address this gap, we developed VergeRx, a pharmacist-delivered medication therapy management (MTM) intervention for SNRTQ to increase motivation to quit by promoting adherence to nicotine replacement therapy (NRT) during the motivation phase of the quit process. The current study builds upon research we have conducted among treatment-seeking smokers during the pre-cessation and cessation phases of the quit process in independent community pharmacies in rural Appalachia. The current study extends this research by: (1) evaluating the addition of 3 pre-quit modules during the motivation phase to reach SNRTQ, and (2) evaluating VergeRx within Federally Qualified Health Centers (FQHCs) in rural and urban areas. FQHCs are an ideal setting to reach SNRTQ since 30% of FQHC patients currently smoke cigarettes and FQHCs are required to screen for tobacco use and deliver cessation interventions, for which they receive reimbursement. Yet barriers have historically limited the efficacy of FQHC-delivered cessation programs. The current study seeks to overcome these limitations by using a Multiphase Optimization Strategy (MOST) to evaluate the right combination of low-burden components that have varying levels of intensity, different mechanisms of action and act synergistically to reach a tipping-point of success among SNRTQ. In preliminary data collected in preparation for this application, we piloted an EHR-integrated referral process to ask-advise- connect SNRTQ to our novel FQHC-pharmacist delivered VergeRx intervention. SNRTQ receiving VergeRx were more likely to use the majority of their NRT patches (71% vs. 52%), and 82.8% became ready to quit within the first month of treatment. The goal of this study is to build an optimized smoking cessation program for SNRTQ using the Optimization Phase of the MOST framework. In an efficacy trial, we will efficiently identify components that significantly increase smoking cessation among 592 SNRTQ in Virginia and West Virginia in a 2x2x2x2 fully-crossed factorial design with 16 treatment combinations: (1) VergeRx (Yes vs. No); (2) SmokefreeTXT (Yes vs. No), (3) Combination NRT Lozenge + NRT Patch (vs. NRT patch alone), and/or (4) 16 weeks of NRT Patch (vs. standard 8 weeks). Reach, adoption, implementation and maintenance data will be collected from participating pharmacists to inform a future Evaluation Phase trial. The proposed study uses low-burden treatment approaches to inform national guidance on the most efficacious and cost-effective treatment for SNRTQ delivered through existing infrastructure in complex, integrated systems of care.





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