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

在南非结核病护理平台内实施循证抑郁症治疗的有效性和成本效益：一项混合有效性与实施试验

• 批准号: 10494127
• 负责人: Annika Claire Sweetland
• 金额: $ 58.46万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-23 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10494127
• 关键词: Address; Adherence; Antidepressive Agents; Behavioral; Brazil; Caring; Cause of Death; Cessation of life; Clinic; Clinical; Clinical Trials; Cluster randomized trial; Communities; Consensus; Cost Analysis; Counseling; Country; Data; Drug resistance; Economics; Effectiveness; Epidemic; Evidence based intervention; Evidence based treatment; Exposure to; Family health status; Goals; HIV; Health system; Household; Hybrids; Incidence; Income; Individual; Intervention; Major Depressive Disorder; Mediator of activation protein; Mental Depression; Mental Health; Mental disorders; Motivation; Mozambique; Outcome; Patients; Persons; Pharmaceutical Preparations; Policies; Prevalence; Provider; Qualitative Methods; Quality-Adjusted Life Years; Research; Research Personnel; Resource-limited setting; Risk; Safety; Self Efficacy; Social Functioning; Social support; South Africa; South African; Specialist; Strategic Planning; Stress; Substance abuse problem; Symptoms; Testing; Time; Treatment outcome; Tuberculosis; base; burden of illness; clinical practice; co-infection; comorbidity; coping; cost; cost effective; cost effectiveness; cost-effectiveness ratio; design; disability; disability-adjusted life years; effectiveness evaluation; effectiveness implementation study; effectiveness implementation trial; effectiveness outcome; evidence base; experience; follow-up; health related quality of life; high risk; implementation cost; implementation evaluation; implementation outcomes; improved; incremental cost-effectiveness; interpersonal therapy; low and middle-income countries; medication compliance; primary care setting; psychologic; psychological distress; skills; social stigma; success; treatment as usual; treatment guidelines; tuberculosis treatment

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.

抽象的 结核病和主要抑郁症（MDD）是主要的感染原因，是主要原因 分别是残疾。此外，它们通常是共同出现的和负相关的。 TB和MDD 合并症与2.85的死亡机会更大，损失损失的风险更高（LTFU） 从治疗中有一系列负面的个人，社区，社会和卫生系统级别的级联 含义。作为可治疗条件，MDD是TB流行病的可补充驱动因素。谁呼吁 TB和心理健康整合的全球政策框架，建议简要的心理干预 解决初级保健环境中的精神障碍。人际咨询（IPC）是一个简短版本 这种基于循证的干预措施已证明在治疗MDD方面的功效和有效性 由包括南非在内的非心脏健康专家提供的。这项研究的目的是评估 将IPC（MDD）集成到结核病平台的有效性和成本效益，以改善结核病和 MD的结果以及减轻与TB相关的灾难性成本。作为结核病负担最高的国家 全世界，近60％与艾滋病毒共同感染了南非，是这项研究的理想环境。我们 在八个诊所（n〜1410个患者 在南非东开普省的TB/MDD）将IPC整合到TB护理中的MDD合并症 具有以下目的的平台： 目的1：评估将IPC处理整合的有效性和实施结果 MDD进入现有的结核病护理平台，以改善结核病和MDD结果 目标2：确定基于理论的干预介质和主持人对结核病的影响 治疗结果 目标3：评估将MDD处理整合到结核病平台中的成本效益 患者和卫生系统的观点 我们的团队将由早期的调查员领导，他是TB和MDD的全球专家，由高级支持 具有丰富经验的调查人员进行结核病和MH相关的有效性，成本效益和 混合试验（包括在南非）。这项研究将提供关键的临床，程序化和经济 数据以告知WHO WHO全球结核病和心理健康整合政策框架以及具有成本效益的临床 练习以改善结核病结果，尤其是在低资源环境中。