%0 Journal Article
%T Randomized Two-Arm Parallel Clinical Trial Protocol Assessing THR Product Effectiveness in LMICs
%A Madeeha Malik
%A Azhar Hussain
%A Ayisha Hashmi
%A Waleed Khan
%J International Journal of Social and Psychological Aspects of Healthcare
%@ 3108-4818
%D 2023
%V 3
%N 1
%R 10.51847/k7feFG828H
%P 55-61
%X 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.
%U https://smerpub.com/article/randomized-two-arm-parallel-clinical-trial-protocol-assessing-thr-product-effectiveness-in-lmics-1feyyemgyu1u3sz