Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27,000
- 试验地点
- 1
- 主要终点
- HIV prevalence in population
研究概览
简要总结
This study is aimed at demonstrating whether or not Male Circumcision can be used as an effective public health prevention tool that will have an impact on HIV prevalence in the South African population.
详细描述
A randomized, controlled trial (ANRS 1265) conducted in Orange Farm (South Africa) has demonstrated that male circumcision (MC) can reduce the risk of HIV acquisition by more than 50% among young men. This result has been confirmed by two similar studies conducted in Uganda and in Kenya.
Giving these findings, the next logical step is to demonstrate whether or not MC can be used as an effective public health prevention tool that will have an impact on HIV in populations as well as among individuals.
This research study aims to establish a MC intervention in the community where the first randomized controlled trial of the impact of MC on men's risk of acquiring HIV infection was carried out in order to evaluate its impact on:
- knowledge, attitudes and practice regarding MC
- existing means of prevention (sexual behavior change, condom use, STI treatment-seeking behavior and VCT (voluntary counseling and testing) attendance)
- the spread of HIV and HSV-2
This research will be carried out over a period of 60 months and will have three major components: (1) the delivery of the intervention, (2) quantitative studies (cross-sectional surveys), and (3) qualitative studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •being uncircumcised
- •living in Orange Farm (South Africa) for more than 3 months
- •agreeing to follow the instructions given by doctors, nurses and/or staff, and in particular to abstain from sex for 6-weeks after being circumcised
- •having understood and sign a consent form written in their own language
- •for those younger than 18 years of age having a written authorization from one parent or guardian and having signed an assent form.
排除标准
- •subjects with contraindications for male circumcision
- •allergy to anesthesia
- •hemophilia or bleeding disorders
- •genital ulceration or other symptoms of sexually transmitted infections
- •signs of infections or AIDS
- •abnormal genital anatomy
- •history of diabetes
结局指标
主要结局
HIV prevalence in population
时间窗: at the end of the study
次要结局
- Sexual behavior, HSV-2 prevalence, circumcision prevalence, knowledge regarding HIV, AIDS and male circumcision(at the end of the study)