1. 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

2. 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.

3. 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.

4. 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

5. 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

6. 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

7. 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.

8. 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