Safety and Acceptability of the PrePex™ Device for Male Circumcision in Zambia
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will measure the incidence of moderate and severe adverse events (AEs) associated
      with PrePex procedures among 500 men, including both procedural and post-procedure events,
      and all device-related incidents such as dislodgment. To assure complete ascertainment of
      AEs, study-specific forms will be used to collect standardized data from the circumcision
      visit and all follow-up visits. Follow-up will be more intensive for the first 50 cases, and
      will transition to follow-up at two visits (7 and 42 days) for the remaining 450 cases.
    

Detailed description: 
      The World Health Organization, the Joint United Nations Programme on HIV/AIDS (UNAIDS), and
      other global reproductive health organizations have recognized the protective effect of male
      circumcision in HIV acquisition. Male Circumcision(MC) is one of the few biomedical methods
      to demonstrate consistent effectiveness as an HIV prevention intervention in randomized
      controlled trials (WHO and UNAIDS, 2007): three randomized controlled trials (RCTs) in Kenya,
      Uganda, and South Africa reported a protective effect up to 60% of circumcision against HIV
      infection. Subsequent studies have confirmed the value and persistence of MC's protection
      against HIV infection and have demonstrated that MC also reduces the acquisition and
      transmission of human papillomavirus.

      A wide variety of instruments, devices, and techniques are used around the world for male
      circumcision. In 2008, WHO, UNAIDS and JHPIEGO released a draft document entitled Manual for
      Male Circumcision under Local Anesthesia, which includes step-by-step instructions for
      performing adult male circumcision using three different surgical procedures: the
      forceps-guided, dorsal slit, and sleeve resection methods. Procedure times for these
      techniques are approximately 20-30 minutes excluding anesthesia, involve control of bleeding
      and considerable suturing, and can be associated with a variety of complications.

      Demand for MC, even in non-circumcising communities, is substantial when offered at no cost
      in a safe setting (WHO and UNAIDS, 2007). In most African settings, only surgical
      circumcision is available for most adults.

      This is a prospective observational study of the PrePex device, which will be conducted with
      the aim of ascertaining moderate and severe adverse events. This study will be conducted
      within the context of routine service delivery in Lusaka, Zambia to identify potential issues
      that must be addressed as MC services are scaled up. PrePex circumcision procedures will be
      offered as part of the minimum package of HIV prevention services recommended by the Zambian
      Ministry of Health (MOH), including HIV testing and counseling, provision of Sexually
      Transmitted infection (STI) syndromic treatment, provision and promotion of condoms, and
      counseling on risk-reduction and safer sex. This study will be conducted in collaboration
      with the Zambia MOH and will follow recommendations for introductory study of devices as laid
      out in the WHO's Framework for Evaluation of Circumcision Devices.

      This study is a prospective study of adult male circumcision procedures conducted with the
      PrePex MC device at two sites in Lusaka, Zambia. The investigators will enroll a total of 500
      men aged 18 to 49 who are seeking voluntary medical male circumcision. The first 50 men will
      undergo intensive follow-up with six scheduled visits, while the remaining 450 men will be
      scheduled for two follow-up visits at 7 and 42 days after PrePex placement.
    

Intervention name(s): PrePex
Intervention type(s): Device
Intervention description(s): PrePex is a sterile device for adult male circumcision, consisting of an inner ring, elastic ring, placement ring, and verification thread. Proper sizing is facilitated by a sizing accessory. The elastic ring is loaded on to the placement ring, which is then placed at the base of the penis. The inner ring is placed inside the foreskin. The elastic ring is then deployed around the foreskin, clamping the foreskin against the inner ring. PrePex is manufactured by Circ MedTech Limited, is certified CE - Class IIa in the European Union, and has been approved by the U.S. Food and Drug Administration.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Prevention, PrePex, voluntary medical circumcision, non-surgical,; medical device, wound healing, Zambia