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采用多方面方法分析美国女性队列研究中的 HIV 发病率:HIV 预防试验网络 064 研究。

Use of a multifaceted approach to analyze HIV incidence in a cohort study of women in the United States: HIV Prevention Trials Network 064 Study.

机构信息

Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.

出版信息

J Infect Dis. 2013 Jan 15;207(2):223-31. doi: 10.1093/infdis/jis658. Epub 2012 Nov 5.

Abstract

BACKGROUND

Reliable methods for estimating the incidence of human immunodeficiency virus (HIV) infection are needed to monitor the epidemic, identify at-risk populations, and evaluate HIV prevention strategies. We used a multifaceted approach to estimate HIV incidence in the HIV Prevention Trials Network (HPTN) 064 study.

METHODS

The HPTN 064 study enrolled 2067 HIV-seronegative women and 32 HIV-seropositive women with no prior HIV infection diagnosis. Women were followed for up to 12 months. HIV incidence estimates were based on (1) detection of acute HIV infection, (2) documentation of HIV seroconversion, and (3) detection of recent HIV infection, using a multiassay algorithm (MAA).

RESULTS

Two women had acute HIV infection at enrollment, 4 seroconverted, and 2 were identified as recently infected at enrollment using the MAA. The annual HIV incidence estimate based on acute infection at enrollment (2.52% [95% confidence interval {CI}, .17%-9.33%], using a 14-day window period) was higher than the estimate based on seroconversion (0.24% [95% CI, .07%-.62%]; P = .027). Incidence estimates obtained using the MAA at enrollment and at the end of study were 0.25% (95% CI, .03%-.93%) and 0.13% (95% CI, .006%-.76%), respectively.

CONCLUSIONS

We detected a high frequency of acute infection at enrollment. Cross-sectional HIV incidence estimates obtained using the MAA were similar to the longitudinal estimate based on HIV seroconversion.

CLINICAL TRIALS REGISTRATION

NCT00995176.

摘要

背景

需要可靠的方法来估计人类免疫缺陷病毒(HIV)感染的发病率,以监测疫情、识别高危人群,并评估 HIV 预防策略。我们采用多方面的方法来估计 HIV 预防试验网络(HPTN)064 研究中的 HIV 发病率。

方法

HPTN 064 研究纳入了 2067 名 HIV 血清阴性的妇女和 32 名之前未感染 HIV 的 HIV 血清阳性的妇女。妇女随访时间最长达 12 个月。HIV 发病率估计基于以下三种方法:(1)检测急性 HIV 感染,(2)记录 HIV 血清转换,(3)使用多检测算法(MAA)检测近期 HIV 感染。

结果

两名妇女在入组时患有急性 HIV 感染,4 人血清转换,2 人在使用 MAA 时被确定为入组时新近感染。基于入组时急性感染的年度 HIV 发病率估计值(2.52%[95%置信区间{CI},0.17%-9.33%],使用 14 天窗口期)高于基于血清转换的估计值(0.24%[95% CI,0.07%-0.62%];P=0.027)。在入组时和研究结束时使用 MAA 获得的发病率估计值分别为 0.25%(95% CI,0.03%-.93%)和 0.13%(95% CI,0.006%-.76%)。

结论

我们在入组时检测到急性感染的高发率。使用 MAA 获得的横断面 HIV 发病率估计值与基于 HIV 血清转换的纵向估计值相似。

临床试验注册

NCT00995176。

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