Background: As countries in sub-Saharan Africa (sSA) scale up male circumcision, they are considering long term sustainable strategies, including early infant male circumcision (EIMC). An important aspect of introducing EIMC in sSA settings is safety. We present AE rates associated infant circumcisions achieved during the Mtoto Msafi Study.
Methods: A standard delivery package (SDP) included training health providers in four facilities to deliver safe EIMC and all health facility staff to educate, promote and mobilize mothers in antenatal, maternal neonatal child health (MNCH) and immunization clinics and surrounding communities. A SDP-PLUS model included all SDP activities in four facilities plus provision of EIMC services in the community by trained domiciliary midwives (DM). Infant boys were recruited through informational talks at MNCH and maternity wards, during post-natal visits and in the community by the DMs. Mothers ≥16 years and their healthy infants aged ≤60 days with no genital abnormalities nor history of bleeding disorder and meeting weight-for-age criteria were eligible. They were circumcised using the Mogen clamp after a dorsal penile block. Follow-up to assess the wound occurred three days after circumcision or as needed.
Results: Among 1681 babies screened, 1598 (95%) were eligible and circumcised: 561 in the SDP and 1037 in the SDP-PLUS community. Reasons for ineligibility were: under weight-for-age (34%), rashes or infections (18%), fever (15%) genital abnormalities (12%), jaundice (8%) and other (13%). Median age of mothers was 24 years (IQR=20,28); median age of infants was 8 days (IQR=1,36) and median weight was 3.6kg (IQR=3.1,4.4). Follow-up occurred in 72% of babies. There were 6 moderate (0.3%) and 5 severe (0.3%) adverse events (AEs). Among SAEs, 3 were in the context of training. Three were deaths, two of which were unrelated to EIMC, one possibly related. One was intra-operative bleeding requiring suturing, and one was a post-operative hematoma. No AEs were associated with procedures done in the community by DMs.
Conclusions: EIMC can be provided in a sSA community setting safely with low occurrence of AEs. SAEs possibly related or unrelated to the procedure may occur, requiring emergency response. These results contribute evidence needed as countries transition from adult toward infant circumcision.