Piloting early infant male circumcision using two devices in Zimbabwe: A randomized trial Mavhu W, Ncube G, Hatzold K, Weiss HA, Mugurungi O, Larke N, Mufuka J, Samkange CA, Sherman J, Madidi N, Cowan FM, Ticklay I, Gwinji G

Background and Methods Zimbabwe MoH piloting safety & acceptability of EIMC using devices Trial randomization 2:1 to either AccuCirc device or Mogen clamp Total sample size 150 (100 AccuCirc; 50 Mogen clamp) EIMC performed by doctors

Mogen clamp and AccuCirc device

Results 13% (150/1,151) of all eligible male infants whose parents were offered EIMC enrolled in the trial 150 infants aged 6-54 days circumcised 9 Jan- 19 June 2013 (23 weeks) 2 moderate AEs in AccuCirc arm (95% CI 0.4-7.7%); none in Mogen clamp arm (95% CI 0.0-8.9%)

Parental Satisfaction Characteristic AccuCirc Device (N=100) Mogen Clamp (N=50) Mothers’ satisfaction (0-10) <=5 1 (1%) 0 (0%) 6-8 2 (2%) 3 (6%) 9 7 (7%) 2 (4%) 10 90 (90%) 45 (90%) Mother would recommend 98 (98%) 50 (100%) Mother would have next son circumcised 99 (99%)

Discussion It is feasible and safe to offer EIMC using devices in Zimbabwe Despite the health benefits of EIMC, actual uptake remains low However, parental satisfaction with the procedure and the outcome is very high Culturally appropriate EIMC demand-creation activities need to be developed and introduced to support scale-up

Acknowledgements Study staff Research participants Study being conducted at Edith Opperman & Mabvuku clinics Study funded by BMGF through PSI-Zimbabwe

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