Exploratory randomised trial of face-to-face and mobile phone counselling against usual care for tobacco cessation in Indian primary care: a randomised controlled trial protocol for project CERTAIN

Rajmohan Panda,Rumana Omar,Irwin Nazareth,Rajath R Prabhu,Rachael Hunter,Arti Mishra

doi:10.1136/bmjopen-2021-048628

Rajmohan Panda, Rumana Omar + Show 4 more

Open Access

https://doi.org/10.1136/bmjopen-2021-048628

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Abstract

IntroductionDespite widespread use of smokeless tobacco products by people within the Indian subcontinent, there is little awareness among Indians of its health hazards when compared with smoked tobacco. We hypothesise...

Highlights

Despite widespread use of smokeless tobacco products by people within the Indian subcontinent, there is little awareness among Indians of its health hazards when compared with smoked tobacco
► The primary care physicians may get unmasked to the allocation of the participants during the course of the trial as the participants visiting the urban primary health centres may reveal the information to the physicians
To the best of our knowledge, this is the first study evaluating a complex low-cost intervention of two components, that is, face-to-face counselling along with mobile phone messaging counselling delivered to smokeless tobacco (SLT) users in low resource Indian settings

Summary

Introduction

Despite widespread use of smokeless tobacco products by people within the Indian subcontinent, there is little awareness among Indians of its health hazards when compared with smoked tobacco. We hypothesise that mobile phone counselling will be feasible and effective for smokeless tobacco cessation intervention in India. Methods and analysis An exploratory randomised controlled trial will be conducted in urban primary health centres in the state of Odisha, India. Participants in the intervention arm will receive routine care together with a face-to-face counselling intervention followed by advice and reminder mobile messages. The primary outcome of this trial is to assess the feasibility to carry out a full randomised controlled trial. ► Evidence on the effectiveness of smokeless tobacco (SLT) cessation intervention in primary care is scarce. The results of this study will inform on the feasibility of conducting an effectiveness trial in the future. ► Providing training to health professionals will lead to an improved understanding of the delivery of low-c ost tobacco cessation interventions in primary care. As per the Global Adult Tobacco Survey 2 (GATS 2), 28.6% of the adult population in India consumes tobacco (10.7% of smoking and 21.4% of smokeless), making it the second-largest consumer in the world.[3]

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