Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
J Int AIDS Soc. 2020 Feb;23(2):e25452. doi: 10.1002/jia2.25452.
The HPTN 071 (PopART) trial evaluated the impact of an HIV combination prevention package that included "universal testing and treatment" on HIV incidence in 21 communities in Zambia and South Africa during 2013-2018. The primary study endpoint was based on the results of laboratory-based HIV testing for> 48,000 participants who were followed for up to three years. This report evaluated the performance of HIV assays and algorithms used to determine HIV status and identify incident HIV infections in HPTN 071, and assessed the impact of errors on HIV incidence estimates.
HIV status was determined using a streamlined, algorithmic approach. A single HIV screening test was performed at centralized laboratories in Zambia and South Africa (all participants, all visits). Additional testing was performed at the HPTN Laboratory Center using antigen/antibody screening tests, a discriminatory test and an HIV RNA test. This testing was performed to investigate cases with discordant test results and confirm incident HIV infections.
HIV testing identified 978 seroconverter cases. This included 28 cases where the participant had acute HIV infection at the first HIV-positive visit. Investigations of cases with discordant test results identified cases where there was a participant or sample error (mixups). Seroreverter cases (errors where status changed from HIV infected to HIV uninfected, 0.4% of all cases) were excluded from the primary endpoint analysis. Statistical analysis demonstrated that exclusion of those cases improved the accuracy of HIV incidence estimates.
This report demonstrates that the streamlined, algorithmic approach effectively identified HIV infections in this large cluster-randomized trial. Longitudinal HIV testing (all participants, all visits) and quality control testing provided useful data on the frequency of errors and provided more accurate data for HIV incidence estimates.
HPTN 071（PopART）试验评估了包括“普遍检测和治疗”在内的艾滋病毒综合预防方案对 2013 年至 2018 年期间赞比亚和南非 21 个社区艾滋病毒发病率的影响。主要研究终点基于对 48000 多名参与者的实验室基于 HIV 检测结果，这些参与者的随访时间长达三年。本报告评估了 HPTN 071 中用于确定 HIV 状况和识别艾滋病毒新发感染的 HIV 检测和算法的性能，并评估了错误对艾滋病毒发病率估计的影响。
使用简化的算法方法确定 HIV 状况。在赞比亚和南非的中央实验室对所有参与者的所有就诊进行单次 HIV 筛查检测。在 HPTN 实验室中心使用抗原/抗体筛查检测、区分检测和 HIV RNA 检测进行额外检测。进行这些检测是为了调查具有不一致检测结果的病例并确认艾滋病毒新发感染。
HIV 检测确定了 978 例血清转换病例。其中包括 28 例参与者在首次 HIV 阳性就诊时患有急性 HIV 感染的病例。对具有不一致检测结果的病例进行调查，发现了存在参与者或样本错误（混淆）的病例。（所有病例的 0.4%）将血清转换病例（从 HIV 感染状态转变为 HIV 未感染状态的病例）排除在主要终点分析之外。统计分析表明，排除这些病例提高了艾滋病毒发病率估计的准确性。
本报告表明，简化的算法方法有效地在这项大型集群随机试验中识别了艾滋病毒感染。纵向 HIV 检测（所有参与者，所有就诊）和质量控制检测提供了有关错误频率的有用数据，并为 HIV 发病率估计提供了更准确的数据。
