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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. - PowerPoint PPT Presentation
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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 SatisfactionCharacteristic 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%) 50 (100%)
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
Thank You!