The Effectiveness and Cost-Effectiveness of Implementing Evidence-Based Depression Treatment within the TB Care Platform in South Africa: A Hybrid Effectiveness-Implementation Trial

摘要 结核病和重度抑郁症（MDD）是导致死亡的主要传染性原因， 残疾人，分别。此外，它们通常是共同发生的和负面的协同作用。TB和MDD 合并症与死亡几率增加2.85和失访（LTFU）风险增加8.70相关 从治疗，这有一个负面的个人，社区，社会和卫生系统层面的级联 影响作为一种可治疗的疾病，MDD是结核病流行的一个可治愈的驱动因素。世卫组织呼吁， 结核病和心理健康一体化的全球政策框架，建议进行简短的心理干预 以解决初级保健环境中的精神障碍问题。人际咨询（IPC）是一个简短的版本， 此类循证干预已证明在治疗MDD方面的疗效和有效性， 由非心理健康专家提供，包括在南非。本研究的目的是评估 将IPC（用于MDD）整合到结核病护理平台以改善结核病的有效性和成本效益， MD结果，以及减轻结核病相关的灾难性成本。作为结核病负担最高的国家， 南非是这项研究的理想地点。我们 建议在8个诊所进行为期3年的混合I型有效性实施试验（n~1410例， 在南非东开普省的结核病/MDD）中整合IPC，在结核病护理中治疗MDD合并症 该平台具有以下目标： 目标1：评估整合IPC治疗的有效性和实施结果， 将MDD纳入现有结核病护理平台，以改善结核病和MDD结局 目的2：确定基于理论的干预介质和调节剂对结核病的影响 治疗结果 目标3：评估将MDD治疗纳入结核病护理平台的成本效益 病人和卫生系统的观点 我们的团队将由一位全球结核病和MDD专家的早期研究者领导，并由高级研究人员提供支持。 在结核病和MH相关有效性、成本效益和 杂交试验（包括在南非）。这项研究将提供关键的临床，方案和经济 为世卫组织结核病和精神卫生一体化全球政策框架提供信息的数据， 这是一项旨在改善结核病结果的实践，特别是在资源匮乏的环境中。

ABSTRACT TB and major depressive disorder (MDD) are the leading infectious cause of death and the leading cause of disability, respectively. Furthermore, they are commonly co-occurring and negatively synergistic. TB and MDD comorbidity is associated with a 2.85 greater chance of death and 8.70 higher risk for loss to follow up (LTFU) from treatment, which has a cascade of negative individual-, community-, societal-, and health system-level implications. As a treatable condition, MDD is a remediable driver of the TB epidemic. The WHO has called for a global policy framework for TB and mental health integration, recommending brief psychological interventions to address mental disorders in primary care settings. Interpersonal counseling (IPC) is a brief version of one such evidence-based intervention that has demonstrated efficacy and effectiveness in treating MDD when delivered by non-mental health specialists, including in South Africa. The purpose of this study is to assess the effectiveness and cost-effectiveness of integrating IPC (for MDD) into the TB care platform to improve TB and MD outcomes, as well as mitigate TB-related catastrophic costs. As the country with the highest TB burden in the world, nearly 60% of whom are co-infected with HIV, South Africa is the ideal setting for this study. We propose a 3-year hybrid type I effectiveness-implementation trial in eight clinics (n~1410 individuals with TB/MDD) in the Eastern Cape of South Africa to integrate IPC to treat MDD comorbidity within the TB care platform with the following aims: Aim 1: To evaluate the effectiveness and implementation outcomes of integrating IPC treatment for MDD into the existing TB care platform to improve TB and MDD outcomes Aim 2: To determine the influence of theoretically based intervention mediators and moderators on TB treatment outcomes Aim 3: To assess the cost-effectiveness of integrating MDD treatment into the TB care platform from the patient and health system perspectives Our team will be led by an Early-Stage Investigator who is a global expert in TB and MDD, supported by senior investigators with extensive experience conducting TB and MH-related effectiveness, cost-effectiveness, and hybrid trials (including in South Africa). This research will provide critical clinical, programmatic, and economic data to inform the WHO global policy framework for TB and mental health integration, and cost-effective clinical practice to improve TB outcomes, especially in low-resource settings.