Sexton Connie J, Costenbader Elizabeth C, Vinh Dang Thi Nhat, Chen Pai Lien, Hoang Tran Vu, Lan Nguyen Thi Hoang, Feldblum Paul, Kim Andrea, Giang Le Truong
FHI, Research Triangle Park, North Carolina 27709, USA.
AIDS Res Hum Retroviruses. 2012 Aug;28(8):866-73. doi: 10.1089/aid.2011.0221. Epub 2011 Nov 9.
The primary aim of this study was to estimate HIV incidence within a high-risk population in Ho Chi Minh City (HCMC), Vietnam using both cross-sectional and prospective methodologies. A secondary aim was to develop a local correction factor for the BED and avidity index incidence assays. The research study design consisted of three phases: (1) cross-sectional, (2) prospective, and (3) BED false recent (BED FR). A total of 1619 high-risk, sexually active individuals were enrolled in the cross-sectional phase and 355 of the opiate-negative, HIV-negative women were subsequently enrolled in the prospective phase. Four-hundred and three men and women with known HIV infection duration of greater than 12 months were enrolled in the BED FR phase. The HIV prevalence for all participants in the cross-sectional phase was 15.8%. HIV incidence in the cross-sectional group was estimated using the BED IgG capture assay and AxSYM avidity index assay for recent HIV infection and incidence within the prospective cohort was determined by observations of HIV seroconversion. HIV incidence in opiate-negative women was estimated using the BED assay to be 0.8% unadjusted and 0.5% after applying the locally derived BED false recent rate of 1.7%; no seroconversions were observed in the prospective cohort. We also screened the cross-sectional samples for evidence of acute infection using nucleic acid testing, 4th generation HIV EIA, and SMARTube coupled with Genscreen and Determine diagnostic tests; no confirmed acute infections were identified by any method. HIV incidence within this opiate-negative study population was low and incidence estimates from the two methods compared favorably with each other. Incidence estimates and false recent rates using the AxSYM assay were higher: AI FRR of 2.7% and adjusted incidence of 1.7% per year (95% CI, 0.6, 2.8). By comparison, both HIV prevalence and incidence estimates for the opiate-positive group were higher.
本研究的主要目的是运用横断面研究和前瞻性研究方法，估算越南胡志明市高危人群中的艾滋病毒发病率。次要目的是为BED和亲和力指数发病率检测开发一个本地校正因子。该研究设计包括三个阶段：（1）横断面研究阶段；（2）前瞻性研究阶段；（3）BED假近期感染（BED FR）阶段。共有1619名高危、有性行为的个体参与了横断面研究阶段，随后355名阿片类药物阴性、艾滋病毒阴性的女性参与了前瞻性研究阶段。403名已知艾滋病毒感染持续时间超过12个月的男性和女性参与了BED FR阶段。横断面研究阶段所有参与者的艾滋病毒患病率为15.8%。横断面研究组的艾滋病毒发病率通过BED IgG捕获检测和AxSYM亲和力指数检测估算近期艾滋病毒感染情况，前瞻性队列中的发病率则通过观察艾滋病毒血清转化来确定。阿片类药物阴性女性的艾滋病毒发病率经BED检测估算，未调整时为0.8%，应用本地得出的1.7%的BED假近期感染率后为0.5%；前瞻性队列中未观察到血清转化情况。我们还使用核酸检测、第四代艾滋病毒酶免疫测定法以及结合Genscreen和Determine诊断检测的SMARTube对横断面样本进行急性感染证据筛查；未通过任何方法确定确诊的急性感染病例。该阿片类药物阴性研究人群中的艾滋病毒发病率较低，两种方法得出的发病率估算结果相互比较情况良好。使用AxSYM检测得出的发病率估算和假近期感染率较高：AI FRR为2.7%，调整后的发病率为每年1.7%（95%CI，0.6，2.8）。相比之下，阿片类药物阳性组的艾滋病毒患病率和发病率估算均更高。
