Mixed Methods Process Evaluation of Behavioral Support and Nicotine Replacement Therapy for Smokeless Tobacco Cessation in Bangladesh, India, and Pakistan

Introduction: Interventions for quitting smokeless tobacco are lacking in South Asia. In a pilot trial, we explored the feasibility of delivering and evaluating a culturally adapted behavioral intervention and/or nicotine replacement therapy in Bangladesh, India, and Pakistan. This article presents the process evaluation. Methods: Mixed methods consisted of interviews with 46 participants and five cessation advisors, a questionnaire completed by 236 trial participants, fidelity assessment of intervention delivery for 38 participants and intervention logs. Data were triangulated across three process evaluation functions (implementation, mechanisms of impact, context) and self-reported abstinence outcomes. Results: After everyone attending the pre-quit behavioral session, attendance dropped to 86.3% (quit session) and 65.9% (>1 post-quit sessions). Abstainers attended more sessions. Advisors were confident in delivering the intervention, favoring face-to-face over remote, yet fidelity scores showed room for improvement. Attendance and fidelity scores were consistently best in Bangladesh. There was high acceptability and perceived usefulness of the behavioral intervention with an important role for the advisor especially among abstainers. Two-thirds perceived nicotine replacement therapy as useful, higher among abstainers. Taste and side effects were barriers; adherence was highest in India. Perceived drivers to cessation were new knowledge leading to positive attitudes, beliefs in capability to quit, and family support. Perceived barriers were nicotine addiction, social pressure, and easy access to smokeless tobacco. Conclusions: This process evaluation affirms the feasibility and acceptability of implementing the Behavioral Intervention to support Smokeless Tobacco Cessation in Adults and nicotine replacement therapy interventions while identifying important areas for improvement prior to a full effectiveness trial. Implications: This study provides detailed insights on the feasibility and acceptability of a culturally adapted behavioral intervention and of nicotine replacement therapy for smokeless tobacco cessation in Bangladesh, India, and Pakistan. They identify important implications for the design and delivery of future effectiveness trials of smokeless tobacco cessation interventions that are lacking in this region.