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, Judith Dean, Charles Gilks, Mark A. Boyd, Lisa Fitzgerald, Allyson Mutch, Peter Baker, Graham Neilsen, Coral E. Gartner

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.