Phase III of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe (Nurses Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 603
- 试验地点
- 1
- 主要终点
- To assess the safety of the PrePex device when circumcision is performed by nurses
研究概览
简要总结
The protocol, approved by the Medical Research Council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in Zimbabwe
详细描述
Models show that to have the highest impact on the HIV epidemic, circumcision of up to 80% of men in high prevalence countries, where MC rates are low, needs to be achieved (UNAIDS 2009; Manicaland HIV/STD Prevention Project, 2008; Bollinger, et al, 2009). Hallett and colleagues in 2008 showed that for Zimbabwe specifically, HIV incidence could be reduced between 25% to 35% if about 50% of men are circumcised. All modelings conducted show that MC programs must be part of a comprehensive HIV prevention package as MC alone will not tip the HIV epidemic into a terminal decline.
The PrePex Device offers hope for rapid scale up of adult male circumcision in resource limited settings.
Once the safety and efficacy have been established, it is important to conduct operations research to determine how best to implement both device and surgical circumcisions in the national program. Thus, the Zimbabwe MOHCW is planning a three phase trial in order to determine the safety of the PrePexTM device, its performance and the ease of use in an implementation roll out.
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
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ages 18 - 30 years
- •Uncircumcised
- •Wants to be circumcised
- •Agrees to be circumcised by any of the study methods ,PrePex or Surgical as appropriate
- •HIV sero-negative
- •Able to understand the study procedures and requirements
- •Agrees to abstain from sexual intercourse and to keep caution not to directly rub the cut area if masturbating, for 8 weeks post removal (9 weeks total)
- •Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 8 weeks post removal (9 weeks total)
- •Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study
- •Subject agrees to anonymous video and photographs of the procedure and follow up visits
- •Agrees to stay overnight at the Hospital in order to follow pain measurements in the first 16 hours
排除标准
- •Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
- •HIV sero-positive
- •Subject with the following diseases/conditions: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
- •Known bleeding / coagulation abnormality
- •Uncontrolled diabetes
- •Subject that to the opinion of the investigator is not a good candidate
- •Subject does not agree to anonymous video and photographs of the procedure and follow up visits
- •Refusal to take HIV test.
结局指标
主要结局
To assess the safety of the PrePex device when circumcision is performed by nurses
时间窗: 9 weeks
To assess the safety of the PrePex device by means of the following parameters: Clinical significant adverse event rate when circumcision is performed by nurses
次要结局
- Evaluate the training needs of PrePexTM deployment using nurses(9 weeks)
- Observation of in-field usability of device(9 weeks)
- Obtain user feedback from nurses(9 weeks)
- Assess safety compared to physician deployment(9 weeks)
- Assess practicality and acceptability among nurses and patients(9 weeks)
- Assess satisfaction of procedure among nurses and patients(9 weeks)
- Determine cost-effectiveness compared to surgical procedure(9 weeks)
研究者
Prof. Mufuta Tshimanga
Public Health Physician, Department of Community Medicine, University of Zimbabwe
Ministry of Health and Child Welfare, Zimbabwe