Male Circumcision (MC) Using the ShangRing™ Device in Malawi
Condition: Male Circumcision
Study type: Interventional
Phase: Phase 1

Summary: 
      This prospective study will evaluate the safety and acceptability of the ShangRing device for
      medical male circumcision (MMC) during routine service delivery in Namitete, Malawi
    

Detailed description: 
      Although voluntary medical male circumcision (VMMC) was adopted as a prevention strategy in
      2011, MMC prevalence in Malawi is low with estimates between 2 and 20%. The 5-year national
      VMMC target for Malawi is 80% of men ages 15 - 49, or more than two million procedures. Since
      2011, only 42,700 VMMCs have been done for HIV prevention, about 2% of the target. Of the 29
      healthcare districts in Malawi, only a minority are supported by non-governmental (NGO) and
      U.S. government-funded VMMC programs. Major obstacles include few VMMC service-delivery
      points; few trained service providers; poor availability of prepackaged disposable VMMC kits
      requiring re-use of instruments and supplies; few organized campaigns or community
      mobilization programs; and drop-in services only.

      Scale-up of adult MMC services in Malawi could be accelerated by the availability of
      simplified, bloodless methods. Methods of MMC using devices may also increase safety,
      efficiency and acceptability. Although many devices are available and widely used for infant
      circumcision, fewer devices exist for use in adult male circumcision and there are limited
      data on device use in adults. Small-scale safety studies, randomized controlled trials
      (RCTs), and field demonstration studies are required before the safety, effectiveness,
      acceptability, and feasibility of any device is assured.

      Several devices have recently 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 healthcare providers (i.e.
      non-physician), thereby reducing the strain on healthcare systems by having more healthcare
      workers available to provide MMC services. One such device is the ShangRing.

      In the WHO framework, smaller bridging studies are recommended to address additional
      questions about particular sub-populations and specific conditions of use (WHO 2011). This
      research study will assess the safety and acceptability of the ShangRing within the context
      of routine service delivery in Namitete, Malawi. The investigators will enroll 500
      HIV-uninfected adult men aged 18 to 49 years voluntarily seeking medical male circumcision.
      The men will be scheduled for two follow-up visits at 7 and 42 days after ShangRing placement
      for device removal and a healing check, respectively. Results from this study will inform the
      Malawi Ministry of Health (MOH) as it decides on the integration of MMC devices into its
      national VMMC program.
    

Intervention name(s): ShangRing
Intervention type(s): Device
Intervention description(s): ShangRing administered to males seeking medical male circumcision
Intervention model: Single Group Assignment
Masking: None (Open Label)