Tobacco Harm Reduction with Vaporised Nicotine (THRiVe): The Study Protocol of an Uncontrolled Feasibility Study of Novel Nicotine Replacement Products among People Living with HIV Who Smoke.

Stephanie Bell,Lisa Fitzgerald,Peter Baker,Allyson Mutch,Charles Gilks,Judith Dean,Mark Boyd,Coral Gartner,Graham Neilsen

doi:10.3390/ijerph14070799

Abstract

Smoking is a leading cause of morbidity and premature mortality among people living with HIV (PLHIV), who have high rates of tobacco smoking. Vaporised nicotine products (VNPs) are growing in popularity as a quit aid and harm reduction tool. However, little is known about their acceptability and use among PLHIV. Using a pragmatic, uncontrolled, mixed methods design this exploratory clinical trial aims to examine the feasibility of conducting a powered randomised clinical trial of VNPs as a smoking cessation and harm reduction intervention among vulnerable populations, such as PLHIV who smoke tobacco. Convenience sampling and snowball methods will be used to recruit participants (N = 30) who will receive two VNPs and up to 12 weeks’ supply of nicotine e-liquid to use in a quit attempt. Surveys will be completed at weeks 0 (baseline), 4, 8, 12 (end of treatment) and 24 (end of the study) and qualitative interviews at weeks 0 and 12. As far as we are aware, this feasibility study is the first to trial VNPs among PLHIV for smoking cessation. If feasible and effective, this intervention could offer a new approach to reducing the high burden of tobacco-related disease among PLHIV and other vulnerable populations.

Highlights

Antiretroviral therapy has reduced HIV-related morbidity and increased the life expectancy of people living with HIV (PLHIV) [1]
This study aims to test the feasibility of conducting a large randomised clinical trial of a tobacco harm reduction intervention with vaporised nicotine among PLHIV who smoke
The results of this study will assist the planning of a larger, clinical trial to determine the effectiveness of a Tobacco harm reduction (THR) approach using Vaporised nicotine products (VNPs) to achieve long-term cessation and relapse prevention among PLHIV and other vulnerable populations experiencing premature mortality associated with tobacco smoking

Summary

Introduction

Antiretroviral therapy has reduced HIV-related morbidity and increased the life expectancy of people living with HIV (PLHIV) [1]. The potential health gains from advances in HIV treatment have been lessened by increased rates of non-AIDS morbidity and mortality in PLHIV [2]. While some evidence exists that this may, in part, be related to increased rates of inflammation in PLHIV despite full suppression of viral replication in those successfully receiving antiretroviral therapy [3], this increased burden of disease may relate to higher rates of adverse health behaviours in PLHIV, for instance tobacco smoking [4,5,6,7]. With tobacco smoking rates two to three times greater than the general population, smoking is a significant risk factor for premature mortality among PLHIV [7,8,9]. Public Health 2017, 14, 799; doi:10.3390/ijerph14070799 www.mdpi.com/journal/ijerph

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