TY - JOUR T1 - Randomized Two-Arm Parallel Clinical Trial Protocol Assessing THR Product Effectiveness in LMICs A1 - Madeeha Malik A1 - Azhar Hussain A1 - Ayisha Hashmi A1 - Waleed Khan JF - International Journal of Social and Psychological Aspects of Healthcare JO - Int J Soc Psychol Asp Healthc SN - 3108-4818 Y1 - 2023 VL - 3 IS - 1 DO - 10.51847/k7feFG828H SP - 55 EP - 61 N2 - Tobacco-related mortality is disproportionately high in LMICs due to increasing consumption, making it essential to explore effective smoking cessation strategies. This study uses a randomized, two-arm parallel design to evaluate the role of THR products, including a 12-week intervention and a follow-up lasting 52 weeks. A total of 258 adult smokers will be recruited and randomly assigned in equal proportions to one of two intervention groups: (1) e-cigarettes (18 mg/ml) with individualized counseling or (2) nicotine patches (21 mg) with individualized counseling. Participants will undergo screening and baseline assessments at the trial site, followed by a total of eight study sessions scheduled over a year at weeks 1, 2, 4, 8, 12, 18, 24, and 52. The trial incorporates in-person and telephone-based follow-ups, with smoking abstinence confirmed by biochemical validation using exhaled carbon monoxide analysis. UR - https://smerpub.com/article/randomized-two-arm-parallel-clinical-trial-protocol-assessing-thr-product-effectiveness-in-lmics-1feyyemgyu1u3sz ER -