Single-arm evaluation of the AccuCirc device for early infant male circumcision in Botswana.

: Existing devices for early infant male circumcision (EIMC) have inherent limitations. We evaluated the newly developed AccuCirc device by circumcising 151 clinically well, full-term male infants with birth weight ≥2.5 kg within the first 10 days of life from a convenience sample in 2 hospitals in Botswana. No major adverse events were observed. There was 1 local infection, 5 cases of minor bleeding, and 1 case of moderate bleeding. In 3 cases, the device made only partial incisions that were completed immediately by the provider without complications. Parental satisfaction was high: >96% of mothers stated that they would circumcise a future son. The pre-assembled, sterile AccuCirc kit has the potential to overcome obstacles related to supply chain management and on-site instrument disinfection that can pose challenges in resource-limited settings. In our study, the AccuCirc was safe and it should be considered for programmatic EIMC in resource-limited settings.