Health Warnings and Counseling for Smoking Cessation

Tobacco use remains persistently high across South Asia, despite numerous public health efforts, and continues to significantly contribute to the burden of non-communicable diseases (NCDs) such as cardiovascular disease, hypertension, diabetes, and stroke. Community pharmacists-widely accessible and trusted within their communities-are an underutilized resource for delivering public health interventions. Graphic health warnings (GHWs), recommended by the World Health Organization (WHO), have been shown to promote smoking cessation, but are rarely paired with personalized counseling by healthcare providers. This study aims to evaluate both the effectiveness and cost-effectiveness of integrating GHWs with pharmacist-led personalized counseling at primary healthcare pharmacies in Bangladesh and Pakistan. A cluster randomized controlled trial (RCT) will be conducted, enrolling 3,240 adult participants in Bangladesh and \~160 participants in Pakistan (for feasibility study) from community pharmacies. Participants will be randomly assigned to one of three groups: (1) GHW only (distribution of printed booklets); (2) GHW + counseling (pharmacist-led counselling sessions based on booklets at baseline and six months, with monthly SMS reminders); or (3) standard care (usual pharmacy services with no additional materials). The intervention includes twice-yearly counseling sessions-delivered both in-person and digitally-supported by educational booklets and leaflets. The primary outcome is self-reported 7-day point prevalence abstinence at 12 months (validated where feasible). Secondary outcomes include reduction in cigarettes per day, quit attempts, readiness to quit, awareness of tobacco harms, diet and physical activity scores, quality of life, blood pressure control among hypertensive participants, and cost-effectiveness. Feasibility outcomes in Pakistan include recruitment rate, participant retention, intervention fidelity and acceptability. Bayesian statistical models will be used to assess efficacy, and economic evaluations will determine the cost-effectiveness of the interventions. The findings aim to inform scalable public health strategies for tobacco control and NCD prevention in resource-limited settings.

NCT Number	NCT07098065
Lead Sponsor	Hitotsubashi University Collaborators: Global Public Health Research Foundation
Conditions	Tobacco Cessation, Health Warning Label, Hypertension, Non Communicable Chronic Diseases
Enrollment	3,400 participants
Start Date	2026-02-01
Primary Completion	2027-02-28 (estimated)
Study Completion	2027-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-14