Safety and Efficacy of the PrePex Device Circumcision When Performed by Nurses

Circumcision Adult Clinical Trial

Official title: Phase III of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe (Nurses Study)

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Circumcision Adult
• HIV CDC Category B2

• NCT number: NCT01956383
• Study type: Interventional
• Source: Ministry of Health and Child Welfare, Zimbabwe
• Status: Completed
• Phase: Phase 3
• Start date: April 2012
• Completion date: September 2012