The Burden of Depression and Stigma Among Individuals With Tuberculosis Within the Integrated Tuberculosis-Mental Health Project: A Multisite Mixed-Methods Study Protocol.

There is a complex bidirectional relationship between tuberculosis (TB), major depressive disorder (MDD), and stigma. Despite the significant burden of these conditions in sub-Saharan Africa, only a few studies have explored their interplay. The primary aim of this study is to determine the burden of MDD and the dimensions of stigma among individuals with TB. The secondary aim is to assess the effectiveness of integrated TB-depression treatment compared to standard TB treatment. This will be a multistage study utilizing a mixed-methods design to address the research questions. Stage 1 will use a cross-sectional design to evaluate the burden of depression and stigma. Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9), and stigma will be measured using Van Rie's TB stigma scales - covering self-stigma, secondary stigma, community stigma, and stigma among healthcare workers. Stage 2 will involve a longitudinal follow-up of all eligible participants diagnosed with both TB and MDD. Participants will receive either integrated TB and MDD treatment or standard TB treatment, depending on their assigned site. Baseline assessments will include depressive symptomatology (PHQ-9) and perceived social support (Oslo Social Support Scale, OSSS). Follow-up assessments will occur at two weeks, eight weeks, and 24 weeks, using the same instruments. TB-related outcomes - including treatment continuation, interruption, default, and mortality - will also be recorded. Stage 3 will use a qualitative approach to explore the experience and dimensions of stigma from the perspectives of service users, their family members, and their communities. Weighted prevalence of MDD will be estimated with 95% CIs. The proportion of participants reporting experiences of stigma will be described using frequency counts and percentages. Changes in depressive symptoms over time between the two treatment groups will be analyzed using mixed ANOVA. Qualitative data will be analyzed thematically.