Multimorbidity in tuberculosis (TB) and its impact on patient care (MITICare): a cross-sectional study nested within a prospective cohort study protocol [version 1, awaiting peer review]

Multimorbidity, defined as two or more co-existing long-term health conditions, is increasing in low- and middle-income countries, overlapping with ongoing high tuberculosis (TB) incidence. It is known that there is a high prevalence of multimorbidity in patients with TB in South Africa, but our understanding of how common TB-multimorbidity is in other African countries, and its effect on the trajectories of TB care, is limited. This cross-sectional study nested within a prospective cohort (co-designed between the Infectious Diseases Institute, Uganda and the University of St Andrews, United Kingdom) aims to describe the burden and evaluate the consequences of multimorbidity among patients with TB disease in Kampala, Uganda. The primary objective is to describe the prevalence of multimorbidity at the start of treatment for TB. The secondary objectives are to determine the effect of multimorbidity on clinical characteristics at the start of treatment, progress through TB care, and end of TB treatment outcomes. 254 adults commencing treatment for TB shall be recruited. Multimorbidity shall be assessed using structured questionnaires, simple examination and blood analysis. Th clinical characteristics of TB shall be determined using health and quality of life scores and, in patients with pulmonary TB, the degree of chest X-ray abnormalities and sputum bacillary burden. Patients shall be followed-up at two and six months and their response to treatment determined. The analysis of the prevalence of multimorbidity at baseline shall be reported using a proportion and 95% confidence interval. For the secondary objectives, regression models adjusting for confounders identified through directed acyclic graphs will be used. This study has been developed in close collaboration with a core patient and public involvement group, who will also be actively involved in the dissemination of study results. Ugandan and St Andrews University ethical approval has been prospectively granted (IDI-REC-2023-82, MD17720 and HS3888ES).