Framework for Evaluation of Male Circumcision Devices Tim

  • Slides: 5
Download presentation
Framework for Evaluation of Male Circumcision Devices Tim Farley TF_Arusha_Jun 10/1 Department of Reproductive

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 –

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

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

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

Male Circumcision Devices Consultation TF_Arusha_Jun 10/5 Nairobi, March 2009