Modelling studies suggest that voluntary medical male circumcision (VMMC) for HIV prevention will have the greatest public health impact in 14 priority countries in eastern and southern Africa if scaled up rapidly, averting up to 3.4 million HIV infections through 2025 at a cost savings of USD 16.5 billion. Conventional surgical circumcision methods pose challenges because they require surgical skills and infrastructure that are in short supply in priority countries.
Innovations in adult male circumcision, such as devices, have the potential to make the procedure easier, faster, and safer to perform in a wider variety of settings. Alternatives to conventional surgery may also influence the acceptability of the procedure among men, their partners, and the parents of uncircumcised youth and infant boys. A number of different types of devices for adult male circumcision are available in the market, but until recently evidence on their clinical safety and efficacy was lacking, particularly in African settings.
WHO prequalification of devices
The World Health Organization (WHO) established a Prequalification Programme for Devices for Male Circumcision for HIV Prevention to promote and facilitate equitable access to safe, appropriate, and affordable male circumcision devices. Prequalification indicates that a device meets international standards for three components: 1) the regulatory dossier, 2) the inspection of the quality management system under which the product is manufactured, and 3) clinical studies on efficacy and safety in settings of intended use. WHO prequalification does not replace countries’ own regulatory processes but paves the way for procurement of the devices by United Nations agencies, WHO member states, donors, and other interested purchasers. Current information on the status of the applications for prequalification is available on the WHO website.
Framework for evaluation
WHO, through its Technical Advisory Group on Innovations in Male Circumcision, developed the Framework for the Clinical Evaluation of Devices for Male Circumcision, which stipulates a pathway of clinical studies to provide the data for WHO to evaluate the clinical safety and efficacy of a device for use in VMMC programmes in resource-limited settings. The framework also provides suggestions for a phased introduction of male circumcision devices within national programmes.
Guideline on use
WHO published the Guideline on the Use of Devices for Adult Male Circumcision for HIV Prevention in October 2013, offering an evidence-based recommendation on the use of such devices in public health programmes in resource-limited settings with high HIV prevalence. The recommendation states that “WHO prequalified male circumcision devices are efficacious, safe and acceptable as additional methods of male circumcision for HIV prevention among healthy men 18 years of age and older in high HIV prevalence, low resource settings.” It applies in settings where the devices are used by health-care providers, including physicians and mid-level providers, who are appropriately trained and competent in the use of the specific device and where the necessary surgical backup facilities and skills are available.
By June 2015, two devices had been prequalified by WHO: the PrePex™ device and the ShangRing.™ A current list of prequalified devices is available on the WHO website.
In September 2016, WHO published updated recommendations on preventing tetanus, a rare but serious complication, following VMMC. The new recommendations call for different risk mitigation measures by circumcision method.