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 5,052 adult participants in each country from community pharmacies. Participants will be randomly assigned to one of three groups: (1) GHW-only intervention, (2) combined GHW and pharmacist-led counseling, or (3) standard care (control). The intervention includes twice-yearly counseling sessions-delivered both in-person and digitally-supported by educational booklets and leaflets. Primary outcomes are smoking cessation rates and blood pressure reduction. Secondary outcomes include improved hypertension and diabetes management, medication adherence, lifestyle modification, reduced hospitalizations and mortality, and incremental cost-effectiveness. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
5,052
This group will receive only graphical health warnings (GHWs) featuring images proposed by the Bangladesh Tobacco Control Cell, explicitly illustrating smoking-related harms, such as mouth diseases, damaged teeth and gums, lung diseases and cancer, heart diseases and cardiovascular damage, and throat and oral cancer. Additionally, these warnings will clearly highlight the benefits of quitting smoking-including improved overall health, reduced disease risks, financial savings, and enhanced quality of life-as well as practical cessation techniques. Participants will receive these GHW materials at baseline and again at the six-month follow-up to reinforce these critical health messages; however, this intervention group will not receive any counselling services. Monthly SMS reminders will also be sent to participants, prompting them to review the GHW leaflet and reinforcing the negative health impacts of smoking and the benefits of quitting.
Participants in this group will receive graphical health warnings (GHWs) featuring Bangladesh Tobacco Control Cell-approved images clearly depicting smoking-related harms (e.g., mouth diseases, damaged teeth and gums, lung cancer, heart disease, and oral cancer). Additionally, they will receive personalized counselling from community pharmacists, focused on the specific health and financial benefits of quitting, practical cessation techniques, strategies for overcoming barriers, and relapse prevention. This combined intervention will be provided at baseline and reinforced at a six-month follow-up. Monthly SMS reminders will also be sent, reinforcing key messages on the harmful effects of smoking and benefits of cessation.
Participants in this group will receive only routine pharmacy services based on standard pharmacy practice guidelines applicable in each country. They will not receive any additional graphical health warnings or counselling interventions. Outcomes will be assessed at baseline, 6 months, and 12 months, consistent with the intervention groups.
Global Public Health Research Foundation
Dhaka, Bangladesh
RECRUITINGVerified smoking cessation rates
Percentage of participants who report smoking cessation
Time frame: Baseline, 6 months, and 12 months post-intervention.
Change in Systolic Blood Pressure (SBP)
Mean change in systolic blood pressure (mmHg) from baseline to 6 and 12 months. Changes in Blood pressure in the target intervention group (Whose SBP\<140 mmHg and DBP\<90 mmHg were in the baseline) Changes in SBP and DBP of the patients at baseline, at 12 months and 18 months post-intervention. Changes in Blood pressure in the target intervention group (Whose SBP\<140 mmHg and DBP\<90 mmHg were in the baseline)
Time frame: Baseline, 6 months, and 12 months.
Change in Diastolic Blood Pressure (DBP)
Mean change in diastolic blood pressure (mmHg) from baseline to 6 and 12 months.
Time frame: Baseline, 6 months, and 12 months.
Change in Quality-Adjusted Life Years (QALYs)
Incremental QALYs gained from baseline to 12 months, based on health utility measures (e.g., EQ-5D).
Time frame: Baseline, 6 months, and 12 months.
Improvement in Knowledge About Smoking Harms
Percentage increase in correct responses to questions on the health effects of smoking.
Time frame: Baseline, 6 months, and 12 months.
Improved Hypertension Management
Proportion of hypertensive participants achieving BP \<140/90 mmHg or reporting medication adherence.
Time frame: 6 and 12 months.
Improved Diabetes Management
Proportion of participants with diabetes reporting glucose monitoring, medication adherence, or controlled HbA1c (if available).
Time frame: 6 and 12 months.
Hospital Admissions
Number of participants reporting hospital admission related to NCDs (e.g., hypertension, stroke, cardiac events).
Time frame: 6 and 12 months.
All-Cause Mortality
Number of deaths (any cause) among enrolled participants during the study period.
Time frame: Up to 12 months.
Increase in Physical Activity
Increase in days per week with at least 30 minutes of moderate activity.
Time frame: 6 and 12 months.
Incremental Cost-Effectiveness Ratio
Cost per QALY gained comparing intervention arms to control.
Time frame: At 12 months.
Image-Based Biomarker Assessment (Exploratory Secondary Outcome)
Quantitative features extracted from facial photographs, eye photographs, and chest X-rays will be analyzed to examine associations with smoking exposure, blood pressure, and cardiometabolic risk markers.
Time frame: Time Frame: Baseline and 12 months.
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