Feasibility Randomized Controlled Trial of Face-to-Face Counseling and Mobile Phone Messages Compared to Usual Care for Smokeless Tobacco Cessation in Indian Primary Care: Project CERTAIN.

ABSTRACT

INTRODUCTION: Smokeless tobacco (SLT) use in low- and middle-income countries has adverse health consequences. We hypothesize that it is feasible to test an intervention of mobile phone messages and face-to-face counseling sessions for SLT cessation in India. AIMS AND METHODS: We conducted an exploratory, individual parallel two group, randomized controlled trial (RCT), with baseline and end-point (3 months from randomization) assessments in urban primary health centers in Odisha, India. A total of 250 current (i.e., users in the last 3 months) SLT users or dual users (ie, smokers and SLT users) were recruited to the trial (125 in each group). Participants were randomized to either routine care, face-to-face counseling, 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 of seven (77.8%) out of nine primary care centers took part in the trial. Out of the 315 SLT users invited to participate, 250 provided consent and were randomized [79.4% (95% CI 74.5, 83.7)]. Out of the 250 randomized SLT users, 238 [95% (95% CI 91.8, 97.5)] were followed up at 3 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 counseling for SLT users in Indian primary care in a full randomized trial. IMPLICATIONS This study found that combining mobile messages with face-to-face counseling 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 group. There 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 signaling the need for a larger clinical trial to test the effectiveness of the intervention.