Evaluation of the AccuCirc Device for Early Infant Male Circumcision in Kisumu, Kenya: Uptake and Safety Irene Nyaboke1, Valentine Pengo1, Mildred Adhiambo1,

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Evaluation of the AccuCirc Device for Early Infant Male Circumcision in Kisumu, Kenya: Uptake and Safety Irene Nyaboke1, Valentine Pengo1, Mildred Adhiambo1, Stella Ojuok1, Erick Okello1, Fredrick Otieno1, Rebeca Plank2, Robert C. Bailey3 1Nyanza Reproductive Health Society, Kisumu, Kenya 2Brigham and Women's Hospital, Division of Infectious Diseases, Massachusetts, USA 3School of Public Health, University of Illinois at Chicago, Chicago, USA AIDS 2016 – Durban, South Africa Poster : WEPDC0102 Contact: Robert Bailey(rcbailey@uic.edu)

Background As countries in sub-Saharan Africa scale up medical male circumcision (MMC), they are considering long term sustainable strategies, including early infant male circumcision (EIMC).

Methods Infant boys are recruited at MNCH clinics and maternity wards Eligibility criteria: Age ≤ 60 days Normal physical and genital exam No history of bleeding Meet weight for age standard (>-2 Z-scores) Questionnaires to mothers assessing knowledge and levels of satisfaction Follow up at 3 days post circumcision or as needed

Results 600 infants circumcised; 596 mothers enrolled Characteristics of mothers: Median age: 26 years (IQR=22,30) Unmarried: 21% Education: 58% had more than primary education Characteristics of infants: Median age: 16 days (IQR=7,33); 28% were ≤7 days and 71% were ≤30 days Median weight: 3.9kg (IQR=3.5, 4.7)

Adverse Events and Device Related Events 17 (2.8%) moderate AEs, all due to bleeding No serious AEs (SAE) No injuries to the glans 16 (2.7%) incomplete cuts, which required completion using surgical scissors or a Mogen Incomplete cuts were reduced to 1.9% after slight modification of the procedure

Conclusions The Accucirc device is a safe alternative to the Mogen clamp which can result in injuries to the glans penis. Restricting procedures to babies ≤30 days may reduce incomplete cuts A complete Accucirc kit is an advantage for large scale implementation of EIMC programs Because of safety and convenience, the AccuCirc should be considered for widespread adoption. These results contribute evidence needed as countries transition from adult toward infant circumcision.

Acknowledgements We are grateful to the following: All the mothers and babies who participated in the research The Nyanza Reproductive Health Society The University of Illinois at Chicago The Division of AIDS, NIAID, NIH Kenya Ministry of Health The AccurCirc Study Team: Irene Nyaboke Evelyne Adoyo Valentine Pengo Caroline Moringa Mary Auma Kentosse Gutu Simon Were Jared Wadeya Erick Okelo Mildred Adhiambo Stella Adhiambo Millicent Ogosi