Safety Study of the PrePex Device for Non-Surgical Adult Male Circumcision During Phased in National Implementation in an Effort to Prevent the Spread of HIV
Condition: Male Circumcision
Study type: Interventional

Summary: 
      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. Numerous
      papers on the topic were published in the past two decades to elevate HIV prevention
      awareness, especially in sub-Saharan countries.

      Rwanda has a national plan to offer a voluntary circumcision program to 2 million adult men
      in 2 years as part of a comprehensive HIV prevention package. To achieve this goal, the
      government is continuing to study the PrePex™ device, developed to enable rapid adult male
      circumcision in resource limited settings.

      In February 2012, Rwanda has received WHO recommendation to scale up Adult Male male
      circumcision (MC) using the PrePex device. Based on WHO recommendation (Use of devices for
      adult male circumcision in public health HIV prevention programs: Conclusions of the
      Technical Advisory Group on Innovations in Male Circumcision, March 2012, WHO/HIV/2012.7),
      which recommended that the phased implementation include an active surveillance of the first
      1000 clients to identify and record all adverse events and side-effects based on standardized
      definitions. The active surveillance may change to passive surveillance after the first 1000
      clients, if the incidence of events is reassuringly low, as determined by independent review.
    

Detailed description: 
      Male circumcision can reduce the lifetime risk of HIV infection by 60% in high risk areas
      such as Sub Saharan Africa. In 2009, the US Government (USAID) reported that scaling up male
      circumcision to reach 80 percent of adult and newborn males in 14 African countries by 2015
      could potentially avert more than 4 million adult HIV infections between 2009 and 2025 and
      yield annual cost savings of US$1.4 - 1.8 billion after 2015, with a total net savings of
      US$20.2 billion between 2009 and 2025.

      There are over 38 million adolescent and adult males in Africa that could benefit from male
      circumcision for HIV prevention. The challenge Africa faces is how to safely scale up a
      surgical procedure in resources limited settings.

      The government of Rwanda has a national plan to decrease the incidence rate of HIV by 50%,
      and to support this, needs to conduct 2 million voluntary adult male circumcisions in 2
      years, a nearly impossible goal with surgical methods. Hence, the government embarked upon a
      pre-safety and pivotal study to test The PrePex™ device, a new device and methodology for
      rapid adult male circumcision in resource limited settings.
    

Intervention name(s): PrePex™ device
Intervention type(s): Device
Intervention description(s): PrePex™ device for adult male circumcision programs. The PrePex™ device is designed to enable conducting male circumcision procedure that is bloodless with no anesthesia and no sutures.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Male Circumcision; HIV Prevention; HIV Infections