Trial of Male Circumcision to Reduce HIV Incidence

40多项流行病学研究和一项临床试验发现，男性包皮环切术具有保护作用 (MC)防止男性感染艾滋病毒。对非洲研究的荟萃分析表明， 普通人群中艾滋病毒感染风险降低45%，高危人群中降低70%。一项临床试验 南非证明了60%的保护效果，在符合方案分析中有76%的效果。此外，本发明还提供了一种方法， 未割包皮的男子感染某些性传播感染的风险更高， 反过来增加艾滋病易感性。这些数据促使人们呼吁将男性包皮环切术视为一种 艾滋病毒预防战略，特别是在艾滋病毒高发地区。然而，在艾滋病规划署举行的会议上， 世界卫生组织、联合国儿童基金会和其他机构、研究人员和决策者得出结论， 需要额外的随机对照试验（RCT）提供明确的保护作用证据， MC可用于预防艾滋病毒。 这项申请寻求支持，继续进行一项男性包皮环切术的随机对照试验， 肯尼亚，基苏穆。主要目的是评估MC在降低年轻人艾滋病毒发病率方面的有效性， 性活跃的男人年龄在18-24岁之间的未行包皮环切术的HIV血清阴性男性被随机分为 治疗（包皮环切术）或对照组，并随访两年，定期进行行为和性传播感染 评估以及艾滋病毒检测和咨询。主要终点是HIV发病率， 并发症、STI发病率和行为风险作为次要结局。招收2784名青年男子 于2005年9月完成。这一样本量将提供80%的把握度来检测艾滋病毒减少50% 发病率超过两年。到目前为止，只有11%的人年因参与者未报告而错过 艾滋病毒和性传播感染发病率与最初预测一致。因此，本研究 跟踪，以满足最初的目标，并提供一个明确的答案，是否男性的问题， 包皮环切术降低艾滋病毒感染率。因为MC的任何影响都可能在24个月后被稀释， 包皮环切术与未包皮环切术男性行为的差异变化，我们建议延长随访时间 超过两年的时间。由于在艾滋病高流行率地区， 在非洲的许多地区，这项试验的结果可能对艾滋病毒/艾滋病的流行产生非常重大的影响。

Over 40 epidemiological studies and one clinical trial have found a protective effect of male circumcision (MC) against HIV acquisition in men. A meta-analysis of African studies has demonstrated an adjusted reduction in HIV risk of 45% in the general population and 70% among high risk groups. A clinical trial in South Africa demonstrated a 60% protective effect, with a 76% effect in a per-protocol analysis. In addition, uncircumcised men are at higher risk for acquisition of certain sexually transmitted infections (STIs), which in turn increase HIV susceptibility. These data have led to calls for male circumcision to be considered as an HIV prevention strategy, especially in areas of high HIV prevalence. However, at meetings held by UNAIDS, the World Health Organization, UNICEF and others, researchers and policy makers have concluded that clear evidence of a protective effect from additional randomized controlled trials (RCTs) is required before MC can be advocated for HIV prevention. This application seeks support for continuation of a randomized controlled trial of male circumcision in Kisumu, Kenya. The main objective is to assess the effectiveness of MC in reducing HIV incidence in young, sexually active men. Uncircumcised HIV seronegative men aged 18-24 years are randomized into either the treatment (circumcision) or control arm and followed for two years, with regular behavioral and STI assessments, as well as HIV testing and counselling. The primary endpoint is HIV incidence, with surgical complications, STI incidence, and behavioral risk as secondary outcomes. Enrollment of 2784 young men was completed September 2005. This sample size will provide 80% power to detect a 50% reduction in HIV incidence over two years. So far, just 11% of person-years has been missed due to participants not reporting for study visits; rates of HIV and STI incidence are consistent with original projections. Thus the study is on track to meet the original objectives and to provide a clear answer to the question of whether male circumcision reduces HIV incidence. Because any effect of MC could be diluted after 24 months through differential changes in behavior by circumcised versus uncircumcised men, we propose to extend follow-up beyond two years on a sub-cohort of participants. Since MC is little practiced in the high HIV prevalence regions of Africa, the results of this trial could have a very significant impact on the HIV/AIDS pandemic.