Trial of Male Circumcision to Reduce HIV Incidence

描述：(申请人提供)自1989年以来，多起流行病学 已有研究报道，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。 这些结果导致了呼吁将男性割礼视为 额外的艾滋病毒预防战略。然而，有一个共识是， 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，并且有已知的 需要调查的与MC相关的风险。的主要目标是 这项研究是为了评估男性包皮环切术在减少艾滋病毒方面的有效性。 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及其生物学机制 包皮可能会增加艾滋病毒的易感性。研究将在#年进行。 肯尼亚Nyanza省，那里的Luo部落是主要民族，而不是 超过10%的成年男性接受了割礼。 18-24岁未割包皮的男性将接受自愿艾滋病毒咨询和 测试。艾滋病毒阴性的男性将被要求知情同意注册。 所有参与者都将接受采访，以获取社会人口信息。 并评估行为风险因素，并将接受体检 条件。同意的男性将被随机分配到治疗中 (割包皮)手臂或未割包皮的手臂。割礼之后，男人将被 手术后每隔几个时间检查一次并发症。他们会 在痊愈完成之前，建议你不要做爱。由以下机构跟进 所有2,000名参与者(1,000名割包皮和1,000名未割包皮)都将举行 两年六个月一次。未受割礼的人将在以下时间接受割礼 随访期结束。所有男性都将接受策略咨询，以减少他们的 有感染艾滋病毒的风险。主要的终点将是艾滋病毒发病率和外科手术 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%的降幅 在两年多的时间里，接受割礼的男性的艾滋病毒发病率有所下降。增设实验室 对包皮组织的研究将评估特化组织的数量和密度 富含HIV受体的细胞，以阐明其生物学机制 哪种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.