Validation of population-level HIV-1 incidence estimation by cross-sectional incidence assays in the HPTN 071 (PopART) trial.
Validation of population-level HIV-1 incidence estimation by cross-sectional incidence assays in the HPTN 071 (PopART) trial.
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DOI：
10.1002/jia2.25830
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发表时间：
2021-12
影响因子：
6
通讯作者：
HPTN071 (PopART) study team
中科院分区：
文献类型：
--
作者：
Klock E;Wilson E;Fernandez RE;Piwowar-Manning E;Moore A;Kosloff B;Bwalya J;Bell-Mandla N;James A;Ayles H;Bock P;Donnell D;Fidler S;Hayes R;Eshleman SH;Laeyendecker O;HPTN071 (PopART) study team
横断面发病率测试用于估计人口水平的艾滋病毒发病率，并衡量预防干预措施的影响。在抗逆转录病毒治疗覆盖率和病毒抑制水平较高的情况下，评估估计数准确性的数据有限。了解这些情况下的横断面发病率估计值非常重要，因为病毒抑制可能导致错误的近期检测结果。我们比较了多检测算法（MAA）估计发病率的准确性与社区随机HPTN 071（PopART）试验中观察到的准确性，其中大多数HIV感染受试者的病毒抑制。在研究的第二年评估了HIV发病率，仅包括在研究开始后第1年和第2年（2016-2017年）进行HIV检测的个体。将三种MAA的发病率估计值与第1年和第2年之间观察到的发病率进行比较（MAA-C：LAg-亲合力<2.8 ODn + BioRad亲合力指数<95% + VL >400拷贝/ml; LAg+VL MAA：LAg-亲合力<1.5 ODn + VL >1000拷贝/ml; Rapid+VL MAA：Asanté近期快速结果+ VL >1000拷贝/ml）。用于三种MAA的近期感染（MDRI）的平均持续时间分别为248、130和180天。该研究包括：15，845名HIV阴性个体; 4406名两次访视时HIV阳性; 221名在两次访视之间发生血清转换。在2年访视时，所有HIV阳性受试者的病毒载量（VL）数据均可用。64例（29%）血清转换者和3227例（72%）流行阳性参与者的病毒抑制（<400拷贝/ml）。观察到的HIV发病率为1.34%（95% CI：1.17-1.53）。发生率估计值与观察到的发生率相似，MAA-C为1.26%（95% CI：1.02-1.51），LAg+VL MAA为1.29（95% CI：0.97-1.62）。Rapid+VL MAA估计的发生率显著低于观察到的发生率（0.92%，95% CI：0.69-1.15，p<0.01）。MAA-C和LAg+VL MAA提供了该队列中发生率的准确点估计值，病毒抑制水平较高。Rapid+VL显著低估了发生率，表明制造商推荐的MDRI过长或检测试剂盒无法准确检测足够的近期感染。
Cross‐sectional incidence testing is used to estimate population‐level HIV incidence and measure the impact of prevention interventions. There are limited data evaluating the accuracy of estimates in settings where antiretroviral therapy coverage and levels of viral suppression are high. Understanding cross‐sectional incidence estimates in these settings is important as viral suppression can lead to false recent test results. We compared the accuracy of multi‐assay algorithms (MAA) for incidence estimation to that observed in the community‐randomized HPTN 071 (PopART) trial, where the majority of participants with HIV infection were virally suppressed. HIV incidence was assessed during the second year of the study, and included only individuals who were tested for HIV at visits 1 and 2 years after the start of the study (2016–2017). Incidence estimates from three MAAs were compared to the observed incidence between years 1 and 2 (MAA‐C: LAg‐Avidity <2.8 ODn + BioRad Avidity Index <95% + VL >400 copies/ml; LAg+VL MAA: LAg‐Avidity <1.5 ODn + VL >1000 copies/ml; Rapid+VL MAA: Asanté recent rapid result + VL >1000 copies/ml). The mean duration of recent infection (MDRI) used for the three MAAs was 248, 130 and 180 days, respectively. The study consisted of: 15,845 HIV‐negative individuals; 4406 HIV positive at both visits; and 221 who seroconverted between visits. Viral load (VL) data were available for all HIV‐positive participants at the 2‐year visit. Sixty four (29%) of the seroconverters and 3227 (72%) prevelant positive participants were virally supressed (<400 copies/ml). Observed HIV incidence was 1.34% (95% CI: 1.17–1.53). Estimates of incidence were similar to observed incidence for MAA‐C, 1.26% (95% CI: 1.02–1.51) and the LAg+VL MAA, 1.29 (95% CI: 0.97–1.62). Incidence estimated by the Rapid+VL MAA was significantly lower than observed incidence (0.92%, 95% CI: 0.69–1.15, p<0.01). MAA‐C and the LAg+VL MAA provided accurate point estimates of incidence in this cohort with high levels of viral suppression. The Rapid+VL significantly underestimated incidence, suggesting that the MDRI recommended by the manufacturer is too long or the assay is not accurately detecting enough recent infections.
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影响因子：
6
作者：
Laeyendecker, Oliver;Konikoff, Jacob;Eshleman, Susan H.
通讯作者：
Eshleman, Susan H.
影响因子：
3.7
作者：
Woldesenbet S;Kufa-Chakezha T;Lombard C;Manda S;Cheyip M;Ayalew K;Chirombo B;Barron P;Diallo K;Parekh B;Puren A
通讯作者：
Puren A
影响因子：
3.8
作者：
Longosz, Andrew F.;Mehta, Shruti H.;Laeyendecker, Oliver
通讯作者：
Laeyendecker, Oliver
影响因子：
2.5
作者：
Hayes R;Ayles H;Beyers N;Sabapathy K;Floyd S;Shanaube K;Bock P;Griffith S;Moore A;Watson-Jones D;Fraser C;Vermund SH;Fidler S;HPTN 071 (PopART) Study Team
通讯作者：
HPTN 071 (PopART) Study Team
影响因子：
2.8
作者：
de Wit MM;Rice B;Risher K;Welty S;Waruiru W;Magutshwa S;Motoku J;Kwaro D;Ochieng B;Reniers G;Cowan F;Rutherford G;Hargreaves JR;Murphy G
通讯作者：
Murphy G