Evaluation of the Effectiveness of 5A-5R Counselling Services for Tobacco Cessation With or Without Mobile Phone Assisted Remote Support in Rural Primary Healthcare Settings

Background and problem statement:

Tobacco use, encompassing both smoking and smokeless tobacco, constitutes a significant global health risk, contributing to eight million annual deaths and resulting in the loss of 229.77 million disability-adjusted life years (DALYs) worldwide. Despite concerted international efforts to mitigate tobacco consumption, approximately 80% of tobacco use is concentrated in low and middle-income countries, with Bangladesh standing out as a prominent example. The Global NCD Action Plan sets a target of a 30% reduction in tobacco prevalence by 2025; however, recent data indicates that 35.3% of Bangladeshi adults continue to use tobacco. In Bangladesh, the prevalence of tobacco use remains high, with 43.7% of adults reported as tobacco users in 2018, where smoking and smokeless tobacco have prevalence rates of 23.5% and 27.5%, respectively. Men exhibit a higher smoking prevalence than women, but both sexes have similar rates of smokeless tobacco use. Tobacco use is a major risk factor for non-communicable diseases (NCDs), including cardiovascular diseases (CVD), chronic lung disease (CRD), and cancer, contributing to substantial mortality rates in the country. In 2018, the estimated mortality from CVD, CRD, and cancer was 30%, 10%, and 12%, respectively. The Directorate General of Health Services (DGHS) in Bangladesh promotes brief intervention using the 5A-5R counselling technique, which is included in national guidelines for hypertension and diabetes management at the primary healthcare level. In this process, 5A (Ask, Advice, Assess, Assist, and Arrange) counselling approach applies to those people who want to quit tobacco, and 5R (Relevance, risk, reward, roadblock, repetition) applies to people who are not ready to change their behaviour. This WHO 5A-5R model is concise, comprehensive, and effective in improving attitudes toward smoking. Studies have shown that brief intervention counselling can lead to a 15% smoking cessation rate. Several cluster randomized trials, especially on 5A-based counselling have been conducted globally which have demonstrated the effectiveness of this approach on tobacco quitting, however, intervention studies evaluating the 5A-5R-based counselling approach in the South Asian context is scarce. Additionally, a systematic review demonstrated that mobile phone-based call play a crucial role in tobacco cessation, with text messages being more acceptable than application-based interventions. A comprehensive tobacco cessation counselling service using 5A-5R based approach coupled with mobile phone follow-up can be effective in reducing tobacco consumption prevalence, however, the investigators did not find any prior study evaluating such an approach, hence the investigators believe this study will not only generate evidence in Bangladesh context but also will be a global example. This study aims to assess whether phone-assisted culturally appropriate 5A-5R counselling services can enhance the tobacco quitting rate or reduce tobacco consumption among adults in union-level primary health care (PHC) settings in Bangladesh.

Research question/hypotheses and objectives: The 5A-5R-based counselling program following WHO PEN protocol has already been incorporated in the national protocol for diabetes and hypertension prevention in Bangladesh and aimed to be implemented at all care provider levels, however, in reality, implementation of this counselling activity for motivating tobacco user to quit tobacco is absent in primary health care settings. Therefore, the investigators want to assess whether with or without a mobile phone-assisted culturally appropriate 5A-5R counselling intervention program provided to any tobacco user will enhance the tobacco quitting rate among adults in union-level primary health care (PHC) settings in Bangladesh.

Methodology: The proposed study is a small-scale cluster randomized control trial using three arms (intervention arm, control arm), total duration is eight months (in total) (Preparatory phase: first one month, intervention: three months, follow-up: four months, data analysis and report writing phase: one month). The study will be conducted in three community clinics (CC) and their catchment communities in Three Unions (Sator, Mohonpur and Sotogram) in Dinajpur, a border-based district in Bangladesh. This small-scale intervention study will be conducted among men and women aged 18 and above. The investigators will purposefully select three unions of Birganj upazila from Dinajpur district; one union will be selected for providing conventional 5A-5R based counselling service according to the national protocol for prevention of diabetes and hypertension to quit tobacco among current tobacco users, one union will be selected for delivering mobile phone assisted enhanced 5A-5R Based counselling service and the other one union will be selected as control that will continue with usual care without introducing any structured 5A-5R based counselling service for tobacco cessation.

Type of Intervention: 5A-5R Based counselling service according to WHO PEN Protocol with mobile phone assisted remote support.