Development, Implementation, and Evaluation of a Tobacco Cessation Intervention Tailored to Persons Living with HIV (PLWH) in Brazil: A Feasibility Study

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Abstract Persons Living with HIV (PLWH) are considered an underserved population with regard to tobacco cessation given the high prevalence of tobacco use compared to the general population and the lack of evidence-based tobacco cessation programs tailored to PLWH, particularly in low- and middle-income countries (LMICs). Although it has been well established that a combination of cognitive behavioral therapy (CBT) and pharmacological management is efficacious in promoting tobacco cessation across diverse populations, these evidence-based treatments have not proven to be effective/efficacious (or even accessible) among these patients. Our preliminary data among PLWH with or without a prior/current diagnosis of tuberculosis attending the public health system in Brazil identified multiple barriers faced by this population with regard to tobacco cessation, including limited literacy, habitual behavior, tobacco use as mood management, lack of social support, cost, distance to care, and reluctance to attend the available tobacco cessation program offered through the primary care clinics due to confidentiality concerns. The overall goal of this feasibility study is to make adaptations to these evidence-based approaches in collaboration with PLWH and health care providers working with this population, and develop, implement, and evaluate the feasibility and scalability of a theory- based, culturally relevant tobacco cessation intervention for PLWH receiving care through the public health system in a southern town in Brazil (Londrina). Our formative assessments point to a mixed approach: CBT (delivered by a Clinical Psychologist) + pharmacotherapy (delivered by a Pulmonologist) augmented by a virtual social support group. This proposal will focus on the intervention development, pretesting, and feasibility testing. The primary outcome will be a 7-day point prevalence abstinence (defined as no tobacco use in the past 7 days and verified through measurement of salivary cotinine and exhaled carbon monoxide levels) at 6- month follow-up. We will also conduct detailed treatment fidelity and scalability assessments (acceptability, feasibility, potential reach and adoption, alignment with the strategic context) to inform a full-scale efficacy trial.