Framework for Evaluation of Male Circumcision Devices Tim Farley TF_Arusha_Jun 10/1 Department of Reproductive Health and Research World Health Organization Geneva
The Challenge Male circumcision devices have potential to accelerate programme scale up Potentially – Faster, simpler procedure – Less highly-trained providers – More acceptable TF_Arusha_Jun 10/2 Several devices used and well-documented in infants and boys, but safety, effectiveness, acceptability among adults in Africa not known
Progression of Clinical Studies TF_Arusha_Jun 10/3 Clinical studies by skilled surgeons in the country of origin or manufacture, Clinical studies by skilled surgeons in the country of intended use, Comparative clinical study by skilled surgeons in a low resource setting, and Field studies by trained clinical personnel in a low resource setting, reflecting anticipated conditions of intended use.
Framework for Evaluation of Devices Compilation of manufacturing, performance and clinical experience in country of origin – Case-series plus comparative study – Safety, effectiveness, document potential advantages, generate data independent of developer or manufacturer Studies in country of intended final use TF_Arusha_Jun 10/4 – Case series, comparative study, acceptability, field study, post-marketing surveillance
Male Circumcision Devices Consultation TF_Arusha_Jun 10/5 Nairobi, March 2009