Analysis of National Lab Database to evaluate the HIV treatment rollout in South Africa

 描述（由申请人提供）：随着南非国家抗逆转录病毒疗法（ART）治疗计划的成熟，它面临着重大挑战，在扩大更难接触到的人群，同时保持对艾滋病毒已成为可管理的慢性疾病的人的护理质量。鉴于这些挑战，监测和评估治疗方案对于持续改进至关重要。然而，当决策者面临如何改进其计划的决定时，决策所依据的关键国家参数仍然未知。这些问题的答案对于规划国家治疗指南的修改至关重要，但迄今为止，还没有常规的方法在国家一级回答这些问题，而不会受到护理损失的严重影响，这可能是重大的。我们建议使用南非的整个国家公共部门的实验室监测数据库，以创建一个国家的患者水平的队列。我们将利用这一队列来评估国家计划，同时也在南非建立分析大数据的能力，以回答有关艾滋病毒治疗规模扩大的重要问题。这项研究是一项前瞻性队列研究，涉及2000多万例实验室观察和300多万例患者，旨在回答四个问题：1）全国艾滋病毒检测运动对艾滋病毒护理和治疗的影响？2)抗逆转录病毒疗法启动前后的国家保留率是多少？3)全国患者队列的长期治疗结果是什么？和4）在CD4计数为350时，立即与延迟ART资格对保留和临床结果的影响是什么？为了回答这些问题，我们将使用新的方法进行因果推理，包括回归不连续设计和定量偏差分析，并将努力提高南非实施这些方法的能力。这项研究意义重大，因为南非拥有世界上最大的治疗计划，每年投资14亿美元，但尚不清楚在全国范围内的好处。试图评估当地影响的个别队列研究都因艾滋病毒护理和地点之间转移的后续行动损失而蒙上阴影。我们的研究是创新的，因为它将产生一个独特的数据集，将能够评估南非艾滋病毒治疗计划在全国范围内的影响。这也是一种创新，因为它将允许首次全面审视南非境内诊所之间的迁移情况，并首次评估治疗影响，而不受方案损失的影响。最后，它是创新的，因为它将联合收割机的数据与创新的设计和分析方法，使我们能够评估因果关系的影响。

 DESCRIPTION (provided by applicant): As South Africa's national antiretroviral therapy (ART) treatment program matures, it faces significant challenges in expanding access to harder to reach populations while also maintaining quality of care for those for whom HIV has become a manageable chronic disease. In light of these challenges, monitoring and evaluation of the treatment program is critical to its sustained improvement. However as policy makers face decisions on how to improve their program, key national parameters on which to base decisions remain unknown. The answers to these questions are critical for planning for changes to national treatment guidelines, yet to date there has been no routine way to answer these questions at a national level and without being heavily influenced by losses from care, which can be significant. We propose using South Africa's entire national public-sector laboratory monitoring database to create a national patient-level cohort. We will use this cohort to evaluate the national program while also building capacity in South Africa to analyze big data to answer important questions about the HIV treatment scale-up. The study is designed as a prospective cohort study of over 20 million laboratory observations and over 3 million patients designed to answer four questions: 1) What is the effect of the national HIV testing campaign on linkage to HIV care and treatment?; 2) What are national retention rates before and after ART initiation?; 3) What are the long run treatment outcomes for the national patient cohort?; and 4) What are the effects of immediate vs. deferred ART eligibility at a CD4 count of 350 on retention and clinical outcomes? To answer these questions we will use novel methods for causal inference, including regression discontinuity design and quantitative bias analysis, and will work to increase South African capacity for implementing these methods. This study is significant because South Africa has the largest treatment program in the world, and is investing 1.4 billion dollars annually, yet it is not clear what the benefits are on a national scale. Individual cohort studies that have tried to assess local impacts have all been clouded by loss to follow up from HIV care and transfer between sites. Our study is innovative because it will generate a unique dataset that will be able to evaluate the impact of the South African HIV treatment program on a national scale. It is also innovative because it will allow the first ever comprehensive look at migration between clinics within South Africa and the first evaluation of treatment impact without being affected by programmatic losses. Finally it is innovative because it will combine the data with innovative designs and analytic approaches that will allow us to assess causal effects.