Pharmacist-led education intervention to improve pulmonary tuberculosis treatment adherence through the Health Belief Model in Malaysia: a study protocol for a randomized controlled trial.

Pulmonary tuberculosis (TB) remains a significant global health concern, particularly in low- and middle-income countries, where treatment adherence is critical to improving patient outcomes and mitigating drug resistance. In Malaysia, challenges in adherence to TB treatment regimens continue to hinder disease control efforts. This study protocol outlines a pharmacist-led educational intervention to improve treatment adherence among pulmonary TB patients. This randomized controlled trial will enroll 206 pulmonary TB patients from public healthcare facilities in Penang, Malaysia, divided equally into intervention and control groups. The intervention group will receive tailored educational counseling sessions delivered by pharmacists at baseline and during months 2, 4, and 6, using materials developed by the World Health Organization and the Centers for Disease Control TB treatment guidelines. The control group will receive standard care. The pharmacist-led educational intervention will be structured around the Health Belief Model framework to systematically address psychological determinants of adherence. Adherence will be measured using the Medication Adherence Report Scale-5. Data will be collected at baseline and subsequent intervals to assess changes over time. The primary outcome will be to improve the treatment adherence of the pulmonary TB patients. The secondary outcomes will measure knowledge of the TB disease and health-related quality of life. This protocol describes a novel, theory-driven approach to addressing adherence barriers in TB treatment through pharmacist-led education. The study aims to contribute to the global effort to control TB and improve patient outcomes by providing evidence of the intervention's impact.