Comparing the PrePex™ Device to Surgical Circumcision for Rapid Scale Up of Male Circumcision in Resource Limited Setting
Condition: HIV
Study type: Interventional

Summary: 
      The World Health Organization and UNAIDS cite that male circumcision can reduce the lifetime
      risk of HIV infection by 60% in high risk areas such as Sub Saharan Africa.

      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.

      The study will enroll one hundred and fifty (150) persons scheduled for voluntary
      circumcision. The subjects will be randomly divided into two unbalanced study arms, PrePex™
      arm which will include about a hundred and twenty (100) subjects and surgical circumcision
      arm which will include about sixty (50) subjects.

      Study duration per subject will be 9 weeks.
    

Detailed description: 
      The World Health Organization and UNAIDS cite that 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™ System, a new device and methodology for
      rapid adult male circumcision in resource limited settings. Evidence showed the safety and
      efficacy of the device, as well as the ability to conduct the procedure with no anesthesia,
      no blood, no sutures and in a standard consultation room.

      The government decided to embark upon a controlled, randomized, two arm study comparing the
      PrePex™ device with the surgical method to have a broader evidence base to support the
      findings in the pivotal study.
    

Intervention name(s): PrePex™ device for adult male circumcision; Surgical circumcision
Intervention type(s): Device; Procedure
Intervention description(s): The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.; The penis will be surgically circumcised according to one of the WHO recommended circumcision methods as described in the Manual for Male Circumcision under Local Anaesthesia Version 2.5C January 2008
Other intervention name(s): The PrePex Device; PrePex; PrePex™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Male Circumcision; HIV Prevention; Medical Device