One-arm, Open Label, Phase I (Out of 3 Phases), Pilot Study to Verify the Safety of PrePex™ Device for Screen Failure Subjects (Men With Narrow Foreskin and Phimosis) for Adult Male Circumcision, Performed by Physicians, in a Male Population That is Scheduled to Undergo Circumcision in an Effort to Prevent the Spread of HIV.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Rate of clinical Adverse Events (AEs)
研究概览
简要总结
It is well known from a range of observational and epidemiological studies that the lifetime risk of acquiring HIV among males can be significantly reduced via circumcision by 53%-60% and by up to 73% in post-trial observation. Numerous papers on the topic have been published over the past two decades to elevate HIV prevention awareness, especially in sub-Saharan countries.
Results from the Decision Makers' Program Planning Tool (DMPPT) models, performed in 2011, suggest that scaling up adult voluntary medical male circumcision (VMMC) to reach 80% coverage in the 13 countries by 2015 would entail performing 20.34 million circumcisions between 2011 and 2015 and additional 8.42 million between 2016 and 2025. Such a scale-up would result in averting 3.36 million new HIV infections through 2025. In addition, while the model shows that this scale-up would cost a total of US$2 billion between 2011 and 2025, it would result in net savings (due to averted treatment and care costs) amounting to US$16.51 billion.
To date, there are over 38 million adolescent and adult males in Africa that could benefit from male circumcision (MC) for HIV prevention. The challenge Africa faces is how to safely scale up a surgical procedure in resource limited settings.
详细描述
Rwanda has a national plan to offer a Voluntary Medical Male Circumcision (VMMC) program to 2 million adult men in 2 years as part of a comprehensive HIV prevention strategy.
The PrePex device was granted with pre-qualification approval on May 2013 by the World Health Organization (WHO), for scaling up VMMC in Africa.
The device works by stopping the flow of blood to the distal foreskin, leading to necrosis of the tissue, which is removed with the device after 7 days.
The PrePex device was developed to facilitate rapid scale up of non-surgical adult male circumcision in resource limited settings, and it is the first MC device which was granted with a WHO recommendation in addition to CE and FDA approvals.
Prior studies showed that between 8%-12% of men are contraindicated for the standard PrePex technique due to very narrow foreskin from border cases to severe Phimosis, preventing insertion of the Inner Ring of the PrePex device.
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
- 21 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ages - 21 to 49 years
- •Subject wants to be circumcised
- •Uncircumcised
- •HIV sero-negative
- •Able to understand the study procedures and requirements
- •Agrees to abstain sexual intercourse for 9 weeks
- •Agrees to abstain from masturbation for 2 weeks
- •Agrees to remain in the health care facility for up to 48 hours post procedure as required
- •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
- •Subject that was a medical screen failure in RMC-03 study.
排除标准
- •Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing circumcision according to the study procedure and can only undergo surgical MC
- •HIV sero-positive
- •Known bleeding / coagulation abnormality, uncontrolled diabetes
- •Subject does not agree to anonymous video and photographs of the procedure and follow up visits
- •Refusal to take HIV test
- •Refuse to be hospitalized in the medical center for up to 48 hours post Placement as required
- •Subjects that should be excluded from standard surgical MC, such as warts under the prepuce, hypospadias, epispadias, un treated UTI.
结局指标
主要结局
Rate of clinical Adverse Events (AEs)
时间窗: 11 months
To verify that the incidence of moderate and severe Clinical AEs and device-related Adverse Events are not significantly higher than 2%.
次要结局
- Rate of complete circumcision(11 months)
- Time to complete healing(11 months)
- Device related incidents(11 months)
- Optimal methodology to perform PrePex procedure on subjects with very narrow opening of the foreskin.(11 months)
- Safety and effectiveness of performing PrePex MC for subjects with tight frenulum or torn frenulum(11 months)
研究者
Vincent Mutabazi
Director of the Research Grants Unit
Ministry of Health, Rwanda