Trial of Male Circumcision to Reduce HIV Incidence

描述：（申请人提供）自1989年以来， 研究表明，缺乏男性 包皮环切术（MC）和通过异性性交感染艾滋病毒的风险。 这些结果导致呼吁将男性包皮环切术视为一种 艾滋病毒预防战略。然而，在这些国家中有一个共识， 国际卫生界认为，MC的随机对照试验（RCT） 需要控制可能的混杂因素，并且已知 需要调查的与MC相关的风险。的主要目标 这项研究旨在评估男性包皮环切术在减少艾滋病毒感染方面的有效性 发生率;我们还将评估MC手术的并发症， 包皮环切术后的性行为，以及 包皮可能会增加艾滋病毒的易感性。本研究的开展将 肯尼亚尼扬扎省，那里的罗部落是主要民族， 超过10%的成年男子接受了割礼。 18-24岁未割包皮的男性将获得自愿艾滋病毒咨询， 试验.将要求HIV阴性男性提供入组的知情同意书。 所有参与者将接受采访，以获得社会人口统计信息 并评估行为风险因素，并将进行医疗检查 条件接受治疗的男性将被随机分配到 （受割礼的）手臂或未受割礼的手臂。受割礼后，男人将 在手术后的几个时间间隔检查并发症。他们将 建议在完全治愈之前禁欲。后续访问 所有2，000名参与者（1，000名包皮环切术和1，000名未包皮环切术）将发生 两年来每半年一次未受割礼的男子将在 后续行动的结束。所有的男人都将被建议采取策略， 艾滋病毒的风险。主要终点将是HIV发病率和手术 并发症其他结果将是性病发病率和行为风险。 参与者的数量将足以检测到50%的减少 在两年多的时间里，额外的实验室 包皮组织的研究将评估专门的数量和密度， 细胞中富含HIV受体，以阐明生物机制， 包皮的存在可能会增加艾滋病毒的易感性。

DESCRIPTION: (provided by applicant) Since 1989, numerous epidemiological studies have reported a significant association between lack of male circumcision (MC) and risk for HIV infection through heterosexual intercourse. These results have led to calls for male circumcision to be considered as an additional HIV prevention strategy. However, there is a consensus among the international health community that a randomized controlled trial (RCT) of MC is needed to control for possible confounding factors, and there are known risks associated with MC that need investigation. The principal objective of this study is to assess the effectiveness of male circumcision in reducing HIV incidence; we will also evaluate complications of the MC procedure, changes in sexual behavior following circumcision, and the biological mechanisms by which the foreskin may increase HIV susceptibility. The study will be conducted in Nyanza Province, Kenya, where the Luo tribe is the main ethnic group, and less than 10 percent of adult men are circumcised. Uncircumcised men aged 18-24 years will be offered voluntary HIV counseling and testing. HIV negative men will be asked to give informed consent for enrolment. All participants will be interviewed to obtain socio-demographic information and to assess behavioral risk factors, and will be examined for medical conditions. Consenting men will be randomly assigned to the treatment (circumcised) arm or the uncircumcised arm. After circumcision men will be checked for complications at several intervals after the procedure. They will be counseled to abstain from sex until healing is complete. Follow-up visits by all 2,000 participants (1,000 circumcised and 1,000 uncircumcised) will occur six-monthly for two years. Uncircumcised men will be offered circumcision at the end of follow-up. All men will be counseled in strategies to reduce their risk for HIV. The primary endpoints will be HIV incidence and surgical complications. Additional outcomes will be STD incidence and behavioral risk. The number of participants will be sufficient to detect a 50 percent reduction in HIV incidence among circumcised men over two years. Additional laboratory studies of foreskin tissue will evaluate the number and density of specialized cells rich in HIV receptors in order to illuminate the biological mechanisms by which presence of foreskin may increase HIV susceptibility.