Mailed smoking cessation support for Aboriginal and Torres Strait Islander people who smoke: protocol for a hybrid type 1 effectiveness - implementation trial.

INTRODUCTION

Smoking is the leading preventable cause of death and the single most significant risk behaviour contributing to adverse health conditions among Aboriginal and Torres Strait Islander people. There is an urgent need for innovative approaches to support reductions in smoking prevalence. This study will assess the implementation and effectiveness of a mailed smoking cessation support programme that includes nicotine replacement therapy (NRT) () for Aboriginal and Torres Strait Islander people.

METHODS AND ANALYSIS

A hybrid type 1 effectiveness-implementation trial will be conducted in Australia from 2023 to 2025. A sample of 500 Aboriginal and Torres Strait Islander people aged over 16 who smoke will be recruited using social media. All participants will: (a) receive a mailed that includes pamphlets and resources on quitting, information about quit smoking support options (MyQuitBuddy App) and a selection of merchandise; (b) be offered a referral to Aboriginal Quitline; and (c) be offered a free 12-week mail out course of combination NRT. Outcome data will be obtained using quantitative surveys and qualitative Yarning. Effectiveness outcomes will include assessment of 7-day point prevalence, continuous abstinence and quit attempts at 3- and 6-month follow-up. Implementation outcomes will include assessment of recruitment and retention rates, intervention uptake and adherence, and intervention acceptability.Cessation data will be analysed using an intention-to-treat principle with all individuals lost to follow-up considered as smoking. Yarns will be analysed by Aboriginal and Torres Strait Islander members of the research team privileging Collaborative Yarning, with the support of a reflexive thematic analysis approach that will identify themes while also reflecting potential biases and perspectives of the researcher throughout the analysis process.

ETHICS AND DISSEMINATION

Ethics approvals were obtained from Aboriginal Health and Medical Research Council Ethics Committee of NSW (1894/21) and the University of Newcastle (H-2022-0174). Findings will be disseminated through publications, conference presentations and sharing with relevant government bodies.

TRIAL REGISTRATION NUMBER

Australian New Zealand Clinical Trials Registry (ACTRN12623001021662).