Observational Study of Male Circumcision Using PrePex Device
Condition: HIV
Study type: Observational

Summary: 
      The study will measure the incidence of moderate and severe adverse events (AEs) associated
      with PrePex procedures, 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
      revert to routine practice (two follow-up visits) for the remaining 375 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: 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.

      Yet the demand for MC even in non-circumcising communities is substantial when offered at no
      cost in a safe setting. Following Kenyan support of one of the key research studies
      demonstrating the preventive effectiveness of MC, the Kenyan Ministry of Health (MOH) began a
      national voluntary medical male circumcision (VMMC) program in 2008, based on a National
      Guidance document. MC activities in Kenya have been centered in Nyanza Province, where the
      prevalence of circumcision is about 50% compared to about 90% in the rest of the country.
      Based on WHO statistics, Kenya is the African country that has made the most progress in
      implementing large-scale MC activities: to date, there have been over 400,000 VMMC procedures
      in Kenya.

      In the current African setting, only surgical circumcision is available for most adults.
      Recently, devices have been developed that have the potential to simplify and shorten both
      training time and surgical duration by eliminating the need for suturing and hemostasis as
      well as allow for task-shifting to lower level cadres of providers. Small-scale safety
      studies, RCTs, and field demonstration cohort studies are required before the safety,
      effectiveness, acceptability and feasibility of any device is assured.

      This is a prospective observational study of the PrePex male circumcision device, which will
      be conducted with the aims of ascertaining important adverse events or unexpected side
      effects that may not have been observed in other studies. This study will be conducted within
      a routine service delivery system to identify potential issues that must be addressed as MC
      services are scaled up in a variety of Kenyan settings. PrePex circumcision procedures will
      be offered in VMMC services, part of the minimum package of HIV prevention services
      recommended by the Kenyan MOH, including HIV testing and counseling, exclusion of men with
      symptomatic sexually transmitted infection (STI) and provision of syndromic treatment as
      indicated, provision and promotion of condoms, and counseling on risk-reduction and safer
      sex.

      This study is a prospective observational study of adult male circumcision procedures with
      PrePex in sites in Nyanza Province, Kenya. We will enroll a total of 425 men aged 18 to 49
      who seek voluntary medical male circumcision. The first 50 men will undergo intensive
      follow-up with multiple follow-up visits, per secondary objective 2 above. The remaining 375
      men will be scheduled for two follow-up visits at 7 and 42 days after PrePex placement, per
      standard practice in Kenyan MC service delivery.
    

Intervention name(s): PrePex device for male circumcision
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.
Sampling method: Non-Probability Sample
Study population: 
        Men aged 18-49 years
      
Keywords: HIV prevention; PrePex; voluntary medical male circumcision; non-surgical; medical device; wound healing; Kenya