Protocol for the Mobile behavioral support plus varenicline for tobacco cessation among people living with HIV in India (MoVIe): A hybrid implementation-effectiveness randomized trial.

INTRODUCTION

The use of tobacco remains a significant health concern among people with HIV (PWH) in India, exacerbating comorbidities, increasing the risk of HIV-related complications and reducing the effectiveness of antiretroviral therapy. This protocol outlines a randomized trial designed to evaluate the effectiveness, cost and implementation of a tobacco cessation intervention for PWH in India.

METHODS

This is a type 1 hybrid implementation effectiveness study including a clinical trial (n = 400) randomizing adults who smoke 1:1 to varenicline and Positively Smoke Free Mobile (PSF-M), a theory-based, digital, behavioral intervention versus a standard care control of brief cessation advice and Quitline referral. The primary outcome is cotinine-validated 7-day point prevalence abstinence from tobacco at 24 weeks post-randomization. Implementation outcomes of acceptability, adoption, appropriateness, feasibility, fidelity, penetration, and sustainability will be measured by survey and interviews. Cost-effectiveness of the intervention will be calculated using a simulation model of tobacco and nicotine outcomes.

CONCLUSION

This study will test the effectiveness of a scalable and comprehensive tobacco use treatment approach with medication plus digital behavioral support in a low- and middle-income country setting, paired with examination of implementation and cost-effectiveness. This research has the potential to improve the health of PWH by demonstrating the health effects of a tobacco cessation treatment package that aims to reduce the morbidity and mortality associated with smoking. Trial Registration clinicaltrials.gov #NCT05786547, Registered 27 March 2023.