Evaluation of the ShangRing vs. Mogen Clamp for Early Infant Male Circumcision (EIMC) in Sub-Saharan Africa

Male circumcision (MC) has been shown to reduce HIV incidence in men by 50-60% in three randomized trials, and observational studies of men circumcised in infancy or childhood have shown long-term protection from HIV acquisition in adulthood. MC also reduces the risk of human papilloma virus, herpes simplex virus type 2 in men; and Trichomonas vaginalis and bacterial vaginosis infections in their female partners, genital ulcer disease in both sexes, and reduces the risk of cervical and penile cancers. In children, circumcision also provides immediate benefits by protecting against urinary tract infections, phimosis, and balanitis.

Though HIV prevention may be achieved through continued scale-up of MC in adolescents and adults, long-term sustainability will likely be better achieved through early infant male circumcision (EIMC). EIMC is technically simpler, safer, and less expensive compared to MC performed in older children or adults. In addition, EIMC has the benefit of more rapid wound healing and does not carry the risk of premature resumption of sexual activity before complete wound healing that has been reported in 7 to 28% of adult men after circumcision which may increase transmission to female partners. In several African countries, EIMC services have been found to be highly acceptable among parents and other caregivers.The long-term benefits of EIMC have led experts to recommend population-wide neonatal circumcision, as the benefits accrued over a child's life greatly outweigh any short-term risks, and delaying circumcision until adulthood places the child at risk of disease acquisition before the procedure can be performed. Despite these advantages, however, EIMC has not been significantly deployed in African countries. Part of the barrier to wider use of EIMC stems from the scarcity of trained providers and resources in sub-Saharan Africa. Device-assisted MC has therefore been proposed to simplify the procedure, enable safe task-shifting, and reduce the burden on healthcare providers, thus increasing the availability of EIMC services. While several devices are currently in use for patients of various ages, the use of a single device requiring only topical anesthesia across all age ranges would dramatically simplify supply chain logistics, streamline personnel training, and most importantly enhance patient/parent acceptability and demand uptake.

This study seeks to accomplish three major goals. First, the study would evaluate the safety of the ShangRing vs. the Mogen clamp for EIMC. The ShangRing is the only MC device requiring topical anesthesia that is capable of being used across all age ranges from newborns to adults; its use would dramatically simplify supply chain logistics, streamline personnel training, and most importantly enhance patient/parent acceptability and demand uptake. The Mogen clamp is a pre-existing device already in use for EIMC in Africa and will serve as an important comparator. The use of an EIMC device that enables safe task-shifting would allow the integration of circumcision services into pre-existing maternal and child health (MCH) service infrastructure and would thereby further facilitate rapid scale-up of MC services throughout Africa. A penile microbiome study will also be performed to better understand the spectrum of bacteria present at the time of EIMC. Next, the study attempts to ascertain whether device-driven EIMC can be safely and effectively integrated into MCH services as a method to promote demand creation. As sub-Saharan countries have deployed MC services on a national basis, the issue of insufficient patient demand has begun to take greater prominence as a barrier to achieving the goal of 20.8 million MC as proposed by the World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS (UNAIDS). The study will therefore examine the ability of EIMC to stimulate demand for circumcision through MCH services as well as identify potential barriers and strategies for wider scale programmatic roll-out. Finally, the study will also attempt to assess the economic burden of device-driven EIMC. In a context of limited resources, understanding the economic burden of a device-driven EIMC program will be critical in ascertaining its long-term feasibility and sustainability in sub-Saharan Africa.

All subjects will be recruited for the study at the following designated study sites:

Kenya: Homa Bay County Teaching and Referral Hospital, Homa bay; Jaramaogi Oginga Odinga Teaching and Referral hospital, Kisumu County; Nyanza Reproductive Health Society - UNIM Research and Training Centre (URTC) on the grounds of the Lumumba sub-County Hospital, Kisumu County.