Contact: Robert Bailey(rcbailey@uic.edu) Safety of a facility-based versus community-based model of early infant male circumcision using the Mogen clamp in western Kenya: Mtoto Msafi Mbili Study Fredrick Adera1, Marisa Young2,Timothy Adipo1, Fredrick Otieno1, Sherry K. Nordstrom3, Supriya D. Mehta4, Robert C. Bailey4 1Nyanza Reproductive Health Society, Kisumu, Kenya; 2Gynecology and Obstetrics, Emory University, Atlanta, GA; 3Obstetrics and Gynecology, Advocate Christ Medical Center, Oak Lawn, IL; 4School of Public Health, University of Illinois at Chicago, Chicago, USA Poster WEPDC0107 Contact: Robert Bailey(rcbailey@uic.edu)

Background As countries in sub-Saharan Africa (sSA) scale up medical male circumcision (MMC), they are considering long term sustainable strategies, including early infant male circumcision (EIMC). A critical aspect of introducing EIMC in sSA settings is safety. We present adverse event (AE) rates associated with infant circumcisions achieved during the Mtoto Msafi Study. EIMC services using the Mogen clamp introduced in both health facility and community settings.

Methods A standard delivery package (SDP) SDP-PLUS model training health providers in four facilities training all health facility staff and Community Health Volunteers (CHV) to educate, promote and mobilize mothers in antenatal, maternal neonatal child health (MNCH) and immunization clinics and in surrounding communities. SDP-PLUS model all SDP activities in four facilities plus provision of EIMC services in the community by trained domiciliary midwives (DM). Eligibility: 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. Circumcised using the Mogen clamp after a dorsal penile block. Follow-up at three days after circumcision and as needed. Data are as of May 31, 2016.

Screening, Eligibility and Enrolment Screened 2076 Eligible 1965 (94.7%) Ineligible 111(5.3%) SDP 716 (36.4%) SDPPlus 1249 (63.6%) Low wt.-for-age (38%) Penis abnormal (14%) Fever (14%) Jaundice (8%) Other infections (16%) Other (10%) Screened 2076 Screened 2076

Characteristics of Parents and Babies MEAN MEDIAN IQR Age of Mother (Years) 27.5 28 22,32 Age of Father (Years) 33.8 34 28, 39 Age of Baby (Days) 17 8 1, 35 Weight of Baby (gms) 3.8 3.6 3.1, 4.3

Adverse Events Total AEs: 15 with 11 related (0.56%) Moderate AEs (0.03%) 5 infections 1 bleeding Severe AEs (0.03%) 4 injuries to the glans 1 hematoma Deaths 2 unrelated 1 possibly related No AEs in the SDPPlus communities

Conclusions EIMC can be performed with low rates of AEs using the Mogen clamp in all levels of health facilities and in the community. However, injury to the glans can occur, requiring emergency procedures to be in place and surgical consult readily available. Infections can be minimized by reinforcing post-operative instructions. For implementation of large-scale EIMC programs, alternatives to the Mogen clamp that avoid injuries to the glans should be considered. These results provide evidence needed as countries transition from adult toward infant circumcision.

Acknowledgements Mothers, babies and fathers who participated in the study Division of AIDS, NIAID, NIH Nyanza Reproductive Health Society University of Illinois at Chicago The Mtoto Msafi Mbili Study Team Kenya Ministry of Health