Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Non-Surgical Circumcision When Performed by Nurses
Condition: Male Circumcision; HIV Prevention
Study type: Interventional

Summary: 
      A range of observational and epidemiological studies have shown that the lifetime risk of HIV
      infection can be reduced by 70% through male circumcision.

      Rwanda has a national plan to offer a voluntary male circumcision (MC) program to 2 million
      adult men in 2 years as part of a comprehensive HIV prevention strategy. To achieve this
      goal, the government launched a national study, based on the WHO Framework for Evaluation of
      Adult MC Devices, to assess the safety, efficacy and supremacy of the PrePex™ device when
      compared to surgical circumcision.

      The PrePex device was developed to facilitate rapid scale up of non-surgical adult male
      circumcision in resource limited settings.

      Rwanda validated the aforementioned endpoints via physicians in a Safety and Efficacy Study
      (NCT01150370) and Randomized, Controlled Comparison Study (NCT01284088). The procedure was
      bloodless, required no anesthesia, no sutures and no sterile settings, with 1 AE that was
      managed with minimal intervention.

      Evidence submitted to members of WHO, USAID, UNAIDS and the Bill and Melinda Gates
      Foundation, and WHO audited the study site. The Safety and Efficacy study results were
      published in the JAIDS Journal of Acquired Immune Deficiency Syndromes, Sept 8, 2011, and
      presented in CROI 2011 and AUA 2011.

      To achieve its national "catch up" campaign with minimal burden to the overly strained health
      system, which lacks physicians and surgical infrastructure, Rwanda needs to task shift the
      procedure to nurses. This study is meant to test the Safety and Efficacy in the hands of
      non-surgically trained nurses from the A1 and A2 cadres.
    

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 resource limited settings.

      Rwanda has a national plan to offer a voluntary male circumcision (MC) program to 2 million
      adult men in 2 years as part of a comprehensive HIV prevention strategy. To achieve this
      goal, the government launched a national study, based on the WHO Framework for Evaluation of
      Adult MC Devices, to assess the safety, efficacy and supremacy of the PrePex™ device when
      compared to surgical circumcision.

      The PrePex device was developed to facilitate rapid scale up of non-surgical adult male
      circumcision in resource limited settings.

      Rwanda validated the aforementioned endpoints via physicians in a Safety and Efficacy Study
      (NCT01150370) and Randomized, Controlled Comparison Study (NCT01284088). The procedure was
      bloodless, required no anesthesia, no sutures and no sterile settings, with 1 AE that was
      managed with minimal intervention.

      Evidence submitted to members of WHO, USAID, UNAIDS and the Bill and Melinda Gates
      Foundation, and WHO audited the study site. The Safety and Efficacy study results were
      published in the JAIDS Journal of Acquired Immune Deficiency Syndromes, Sept 8, 2011, and
      presented in CROI 2011 and AUA 2011.

      To achieve its national "catch up" campaign with minimal burden to the overly strained health
      system, which lacks physicians and surgical infrastructure, Rwanda needs to task shift the
      procedure to nurses. This study is meant to test the Safety and Efficacy in the hands of
      non-surgically trained nurses from the A1 and A2 cadres.

      The study will evaluate 75 subjects in training phase, 100 subjects in a pilot group and then
      additional 415 in a pivotal group summing up to 590.

      The 503 subjects assigned to the Pivotal group will undergo standard PrePex procedure and
      follow up and will be the main core of the study. An interim safety report will be prepared
      after 100 subjects (Pilot Group). Up to 75 subjects will be enrolled to the Training group.

      The study will assess the safety and efficacy of the PrePex device when circumcision is
      performed by nurses, among healthy adult men scheduled for voluntary circumcision, in
      preparation for scale up.

      The Study duration per subject will be 8 weeks.
    

Intervention name(s): PrePex™ device
Intervention type(s): Device
Intervention description(s): PrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Male Circumcision; HIV Prevention; HIV Infections