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.

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.