艾滋病毒横断面发病率监测:估计“最近感染的平均持续时间”的基准方法

R. Kassanjee, D. De Angelis, Marian Farah, D. Hanson, J. P. Labuschagne, O. Laeyendecker, S. Le Vu, B. Tom, Rui Wang, A. Welte
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引用次数: 10

摘要

“近期”感染的生物标志物在艾滋病毒感染率监测中的应用需要对关键生物标志物特征进行估计。已经采用了各种方法来使用纵向数据来估计最近感染的平均持续时间(MDRI) -处于“最近”状态的平均时间。在对MDRI估计方法的系统基准测试中,我们使用了一个仿真平台来测量20多种方法在30个场景下的准确性和精度,这些场景捕捉了实践中可能遇到的各种研究设计、受试者行为和测试动态。结果强调,假设在“最近”状态下连续逗留一次会产生很大的偏差。简单的插值提供了有用的MDRI估计,前提是受试者定期接受测试。回归表现最好——当“随机效应”描述数据中的主题聚类时,没有随机效应的回归模型被证明易于实现,稳定,并且在考虑的场景中具有相似的准确性;通过回归“最近”/“非最近”分类而不是连续的生物标志物读数,提高了对参数假设的稳健性。所有方法都容易受到关于受试者(未观察到的)感染时间的错误假设的影响。提供的结果显示了MDRI估计性能与受试者数量、访问间隔、错过访问、随访损失以及生物标志物信号和噪声方面的关系。
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Cross-Sectional HIV Incidence Surveillance: A Benchmarking of Approaches for Estimating the ‘Mean Duration of Recent Infection’
Abstract The application of biomarkers for ‘recent’ infection in cross-sectional HIV incidence surveillance requires the estimation of critical biomarker characteristics. Various approaches have been employed for using longitudinal data to estimate the Mean Duration of Recent Infection (MDRI) – the average time in the ‘recent’ state. In this systematic benchmarking of MDRI estimation approaches, a simulation platform was used to measure accuracy and precision of over twenty approaches, in thirty scenarios capturing various study designs, subject behaviors and test dynamics that may be encountered in practice. Results highlight that assuming a single continuous sojourn in the ‘recent’ state can produce substantial bias. Simple interpolation provides useful MDRI estimates provided subjects are tested at regular intervals. Regression performs the best – while ‘random effects’ describe the subject-clustering in the data, regression models without random effects proved easy to implement, stable, and of similar accuracy in scenarios considered; robustness to parametric assumptions was improved by regressing ‘recent’/‘non-recent’ classifications rather than continuous biomarker readings. All approaches were vulnerable to incorrect assumptions about subjects’ (unobserved) infection times. Results provided show the relationships between MDRI estimation performance and the number of subjects, inter-visit intervals, missed visits, loss to follow-up, and aspects of biomarker signal and noise.
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Study design approaches for future active-controlled HIV prevention trials. The role of randomization inference in unraveling individual treatment effects in early phase vaccine trials. Nonlinear mixed-effects models for HIV viral load trajectories before and after antiretroviral therapy interruption, incorporating left censoring. Estimation and interpretation of vaccine efficacy in COVID-19 randomized clinical trials Sample size calculation for active-arm trial with counterfactual incidence based on recency assay.
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