Development and validation of a health literacy intervention for tuberculosis patients with multimorbidity: A mixed-method study protocol

Background Tuberculosis (TB) multimorbidity, defined as the coexistence of TB with one or more chronic conditions, is an important public health challenge in low- and middle-income countries, particularly India, which accounts for over one-fourth of the global TB burden. Effective chronic disease self-management relies on health literacy, yet our systematic reviews revealed limited health literacy and poor outcomes among TB patients as well as patients with multiple comorbid conditions, highlighting the need for targeted interventions. Thus, we aim to identify the components of an evidence-based intervention to improve health literacy among newly diagnosed TB patients with multimorbidity in India. Methods Following the UK Medical Research Council (MRC) framework, our study includes 3 phases: identifying the evidence base, developing the theory, and modelling processes and outcomes. An umbrella review will identify effective health literacy interventions for chronic diseases. A narrative review will explore knowledge, attitudes, practices, and beliefs associated with TB in India. Primary studies, including a cross-sectional study and qualitative methods (in-depth interviews, focused group discussions, and key informant interviews), will assess health literacy prevalence and its determinants among newly diagnosed TB patients with multimorbidity. Data will be analysed using IBM SPSS version 27.0 (IBM Corporation) and thematic framework analysis. Results We aim to develop and validate a health literacy intervention for TB patients with multimorbidity in India, addressing a critical gap in healthcare. The intervention has the potential to improve patient outcomes, support healthcare practitioners, and promote equity in health access. Conclusion Our study will generate essential evidence on the effectiveness of a health literacy intervention, informing future efforts to enhance healthcare for TB patients with multimorbidity in India.