Feasibility randomised controlled trial of face-to-face counselling and mobile phone messages compared to usual care for smokeless tobacco cessation in Indian primary care: Project CERTAIN

Rajmohan Panda; Rumana Omar; Rachael Hunter; Supriya Lahoti; Rajath R Prabhu; Victoria Vickerstaff; Durga Madhab Satapathy; Sangeeta Das; Irwin Nazareth

doi:10.1093/ntr/ntae038

Feasibility randomised controlled trial of face-to-face counselling and mobile phone messages compared to usual care for smokeless tobacco cessation in Indian primary care: Project CERTAIN

Nicotine Tob Res. 2024 Apr 27:ntae038. doi: 10.1093/ntr/ntae038. Online ahead of print.

Authors

Rajmohan Panda¹, Rumana Omar², Rachael Hunter³, Supriya Lahoti¹, Rajath R Prabhu¹, Victoria Vickerstaff⁴, Durga Madhab Satapathy⁵, Sangeeta Das⁵, Irwin Nazareth³

Affiliations

¹ Research division, Public Health Foundation of India, New Delhi, India.
² Department of Statistical Science, University College London, London, UK.
³ Department of Primary Care and Population Health, University College London, London, UK.
⁴ PRIMENT Clinical Trials Unit, Research Department of Primary Care and Population Health, University College London, London, UK.
⁵ Department of Community Medicine, MKCG Medical College, Berhampur, Odisha, India.

PMID: 38676604
DOI: 10.1093/ntr/ntae038

Abstract

Introduction: Smokeless tobacco (SLT) use in low- and middle-income countries (LMICs) has adverse health consequences. We hypothesize that it is feasible to test an intervention of mobile phone messages and face-to-face counselling session for SLT cessation in India.

Methods: We conducted an exploratory, individual parallel two group, randomised controlled trial (RCT), with baseline -and end-point (three months from randomisation) assessments in urban primary health centres in Odisha, India. A total of 250 current (i.e., users in the last three months) SLT users or dual users (i.e., smokers and SLT users) were recruited to the trial (125 in each group). Participants were randomised to either routine care, face-to-face counselling, and reminder mobile messages or routine care only. The primary outcomes were to assess the feasibility of running a full RCT including recruitment, compliance, and retention.

Results: A total seven (77.8%) out of nine primary care centres took part in the trial. Out of the 315 SLT users invited to participate, 250 provided consent and were randomised [79.4% (95% CI: 74.5, 83.7)]. Out of the 250 randomised SLT users, 238 [95% (95% CI: 91.8, 97.5)] were followed up at three months (117 in the intervention group and 121 in the control group). Of the participants in the intervention group, 74 (63.8%) reported that they received the mobile messages.

Conclusions: This exploratory trial demonstrated the feasibility of delivering and evaluating an intervention of mobile phone messages and face-to-face counselling for SLT users in Indian primary care in a full randomised trial.

Implications: This study found that combining mobile messages with face-to-face counselling for smokeless tobacco users visiting primary health care settings in India is feasible in terms of recruitment of users, compliance with the intervention, and retention of study participants within the trial.The biochemically verified smokeless tobacco abstinence rate was higher in the intervention group compared with the control groupThere was poor agreement between self-reported tobacco cessation and the measured salivary cotinine in smokeless tobacco users.The findings support the feasibility and acceptability of the intervention signalling the need for a larger clinical trial to test effectiveness of the intervention.

Keywords: Smokeless tobacco; cessation; feasibility study; low- and- middle income countries (LMIC); primary health care.

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