HIV Infections Clinical Trial
Official title:
Phase I of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe
The protocol, approved by the Medical Research Council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in Zimbabwe
Models show that to have the highest impact on the HIV epidemic, circumcision of up to 80%
of men in high prevalence countries, where MC rates are low, needs to be achieved (UNAIDS
2009; Manicaland HIV/STD Prevention Project, 2008; Bollinger, et al, 2009). Hallett and
colleagues in 2008 showed that for Zimbabwe specifically, HIV incidence could be reduced
between 25% to 35% if about 50% of men are circumcised. All modelings conducted show that MC
programs must be part of a comprehensive HIV prevention package as MC alone will not tip the
HIV epidemic into a terminal decline.
The PrePex Device offers hope for rapid scale up of adult male circumcision in resource
limited settings.
Once the safety and efficacy have been established, it is important to conduct operations
research to determine how best to implement both device and surgical circumcisions in the
national program. Thus, the Zimbabwe MOHCW is planning a three phase trial in order to
determine the safety of the PrePexTM device, its performance and the ease of use in an
implementation roll out.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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