Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial
Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial
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DOI：
10.1016/s0140-6736(07)60313-4
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发表时间：
2007-02-24
期刊：
影响因子：
168.9
通讯作者：
Wawer, Maria J.
中科院分区：
文献类型：
--
作者：
Gray, Ronald H.;Kigozi, Godfrey;Wawer, Maria J.
生态学和观察性研究表明，男性包皮环切术可以降低男性感染艾滋病毒的风险。我们的目的是调查男性包皮环切术对男性艾滋病发病率的影响。方法在乌干达Rakai农村地区，4996名年龄在15-49岁、未行包皮环切术、HIV阴性且同意接受HIV检测和咨询的男性参加了这项随机试验。男性随机分配接受立即包皮环切术（n=2474）或延迟24个月包皮环切术（2522）。在6个月、12个月和24个月的随访中重复艾滋病毒检测、体格检查和访谈。主要结果是艾滋病毒发病率。分析是在改良的意向治疗基础上进行的。该试验已在clinicaltrials .gov注册，注册号为NCT00425984。研究结果：干预组和对照组男性的基线特征在入组时基本相同。两组的留存率基本相同，在所有时间点都有90-92%的参与者留存。在修改后的意向治疗分析中，干预组24个月内的HIV发病率为0.66例/ 100人年，对照组为1.33例/ 100人年（干预的估计疗效为51%，95% Cl 16-72; p=0.006）。治疗后的疗效为55% (95% CI 22-75; p=0.002)；Kaplan-Meier治疗后hiv检测时间分析的有效率为60% （30-77;p=0.003）。在所有社会人口学、行为和性传播疾病症状亚组中，干预组的艾滋病毒发病率低于对照组。84例（3.6%）包皮环切术发生中度或重度不良事件；经过治疗，一切都解决了。在随访期间，两组的行为基本相同。男性包皮环切术降低了没有行为抑制解除的男性的艾滋病毒发病率。包皮环切术可被推荐用于男性艾滋病毒预防。
Background Ecological and observational studies suggest that male circumcision reduces the risk of HIV acquisition in men. Our aim was to investigate the effect of male circumcision on HIV incidence in men.Methods 4996 uncircumcised, HIV-negative men aged 15-49 years who agreed to HIV testing and counselling were enrolled in this randomised trial in rural Rakai district, Uganda. Men were randomly assigned to receive immediate circumcision (n=2474) or circumcision delayed for 24 months (2522). HIV testing, physical examination, and interviews were repeated at 6, 12, and 24 month follow-up visits. The primary outcome was HIV incidence. Analyses were done on a modified intention-to-treat basis. This trial is registered with ClinicaITrials.gov, with the number NCT00425984.Findings Baseline characteristics of the men in the intervention and control groups were much the same at enrolment. Retention rates were much the same in the two groups, with 90-92% of participants retained at all time points. In the modified intention-to-treat analysis, HIV incidence over 24 months was 0.66 cases per 100 person-years in the intervention group and 1.33 cases per 100 person-years in the control group (estimated efficacy of intervention 51%, 95% Cl 16-72; p=0.006). The as-treated efficacy was 55% (95% CI 22-75; p=0.002); efficacy from the Kaplan-Meier time-to-HIV-detection as-treated analysis was 60% (30-77; p=0.003). HIV incidence was lower in the intervention group than it was in the control group in all sociodemographic, behavioural, and sexually transmitted disease symptom subgroups. Moderate or severe adverse events occurred in 84 (3.6%) circumcisions; all resolved with treatment. Behaviours were much the same in both groups during follow-up.Interpretation Male circumcision reduced HIV incidence in men without behavioural disinhibition. Circumcision can be recommended for HIV prevention in men.