Abstract Body

Since 2008, Kenya has implemented medical male circumcision for HIV prevention, with passive reporting of moderate and severe adverse events (AE) to monitor program safety. With PEPFAR support, an additional reporting system was introduced in 2014 in which an AE is classified as notifiable if it occurs within 30 days of medical circumcision (MC) and is tetanus or leads to death, complete or partial amputation of the penis, hospitalization for >3 days or probable permanent disability or deformity. We report Kenya’s experiences with reporting notifiable AEs.

Building on PEPFAR’s notifiable AE (NAE) reporting protocol, Kenya has implemented a robust NAE investigation and follow-up system that is reported through standardized forms. The system incorporates taking photographs of AE lesions to monitor healing and evaluate effectiveness of management; these also serve as records of the final outcomes and as case studies for learning. Incidence of penile glans injuries in boys 10-14 years and tetanus are used as proxy indicators of non-compliance as most are preventable by following program guidelines.

Of 661,653 MCs performed in Kenya from August 2014 to August 2017, a total of 25 NAEs were reported. The spectrum of NAEs recognized and reported is growing and includes 4 infant deaths (3-due to non MC conditions); 1 adolescent death (15yrs due to tetanus); 3 non-fatal tetanus (1 related to PrePex); 5 penile glans injuries during forceps guided MC in boys 10-12 yrs; 1 penile glans injury during Mogen clamp infant MC; 3 urethral fistulae in boys 10-12 years; and 8 conditions (including 2 severe bleeding, 1 necrotizing fasciitis, and 5 previously undiagnosed medical conditions) leading to hospitalization for ≥3 days. Cases associated with non-compliance (24%) were 5 penile glans injuries and 1 case of tetanus following MC through PrePex device where the second requisite dose of tetanus toxoid was not given.

NAE reporting system has enhanced understanding of AEs and revealed cases of serious AEs associated with non-compliance or undiagnosed underlying medical conditions. MC programs should implement enhanced NAE reporting systems to monitor lapses in compliance with program safety standards and for learning purposes. Programs introducing new methods of MC should expand their scope of NAEs to include previously undescribed AEs.