肯尼亚基苏木年轻男性包皮环切术预防艾滋病病毒感染的随机对照试验。

Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial.

作者信息

Bailey Robert C, Moses Stephen, Parker Corette B, Agot Kawango, Maclean Ian, Krieger John N, Williams Carolyn F M, Campbell Richard T, Ndinya-Achola Jeckoniah O

机构信息

Division of Epidemiology and Biostatistics, University of Illinois at Chicago, Chicago, IL 60612, USA.

出版信息

Lancet. 2007 Feb 24;369(9562):643-56. doi: 10.1016/S0140-6736(07)60312-2.

DOI:10.1016/S0140-6736(07)60312-2

PMID:17321310

Abstract

BACKGROUND

Male circumcision could provide substantial protection against acquisition of HIV-1 infection. Our aim was to determine whether male circumcision had a protective effect against HIV infection, and to assess safety and changes in sexual behaviour related to this intervention.

METHODS

We did a randomised controlled trial of 2784 men aged 18-24 years in Kisumu, Kenya. Men were randomly assigned to an intervention group (circumcision; n=1391) or a control group (delayed circumcision, 1393), and assessed by HIV testing, medical examinations, and behavioural interviews during follow-ups at 1, 3, 6, 12, 18, and 24 months. HIV seroincidence was estimated in an intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, with the number NCT00059371.

FINDINGS

The trial was stopped early on December 12, 2006, after a third interim analysis reviewed by the data and safety monitoring board. The median length of follow-up was 24 months. Follow-up for HIV status was incomplete for 240 (8.6%) participants. 22 men in the intervention group and 47 in the control group had tested positive for HIV when the study was stopped. The 2-year HIV incidence was 2.1% (95% CI 1.2-3.0) in the circumcision group and 4.2% (3.0-5.4) in the control group (p=0.0065); the relative risk of HIV infection in circumcised men was 0.47 (0.28-0.78), which corresponds to a reduction in the risk of acquiring an HIV infection of 53% (22-72). Adjusting for non-adherence to treatment and excluding four men found to be seropositive at enrollment, the protective effect of circumcision was 60% (32-77). Adverse events related to the intervention (21 events in 1.5% of those circumcised) resolved quickly. No behavioural risk compensation after circumcision was observed.

INTERPRETATION

Male circumcision significantly reduces the risk of HIV acquisition in young men in Africa. Where appropriate, voluntary, safe, and affordable circumcision services should be integrated with other HIV preventive interventions and provided as expeditiously as possible.

摘要

背景

男性包皮环切术可提供对获得HIV-1感染的实质性保护。我们的目的是确定男性包皮环切术是否对HIV感染有保护作用，并评估与该干预措施相关的安全性和性行为变化。

方法

我们在肯尼亚基苏木对2784名年龄在18至24岁的男性进行了一项随机对照试验。男性被随机分配到干预组（包皮环切术；n = 1391）或对照组（延迟包皮环切术，1393），并在1、3、6、12、18和24个月的随访期间通过HIV检测、医学检查和行为访谈进行评估。在意向性分析中估计HIV血清阳转率。该试验已在ClinicalTrials.gov注册，编号为NCT00059371。

结果

在数据和安全监测委员会进行第三次中期分析后，该试验于2006年12月12日提前终止。随访的中位时间为24个月。240名（8.6%）参与者的HIV状态随访不完整。研究停止时，干预组有22名男性和对照组有47名男性HIV检测呈阳性。包皮环切术组的2年HIV发病率为2.1%（95%CI 1.2 - 3.0），对照组为4.2%（3.0 - 5.4）（p = 0.0065）；包皮环切男性感染HIV的相对风险为0.47（0.28 - 0.78），这相当于获得HIV感染风险降低了53%（22 - 72）。调整对治疗的不依从性并排除4名在入组时被发现血清呈阳性的男性后，包皮环切术的保护作用为60%（32 - 77）。与干预相关的不良事件（1.5%接受包皮环切术的人中有21起事件）迅速得到解决。未观察到包皮环切术后的行为风险补偿。