NCT01956370

Comparing the PrePex™ Device to Surgical MC for Rapid Scale Up of MC in Resource Limited Setting

Phase II - Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult Male Circumcision Programs in Zimbabwe (Comparative Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Ministry of Health and Child Welfare, Zimbabwe · Academic / Other
• Sex: Male
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• HIV

Interventions

Type	Name	Description
DEVICE	PrePex™ device for adult male circumcision	The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.
PROCEDURE	Surgical circumcision	The penis will be surgically circumcised according to one of the WHO recommended circumcision methods as described in the Manual for Male Circumcision under Local Anaesthesia Version 2.5C January 2008

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2013-10-08
• Last updated: 2013-10-08

Locations

1 site across 1 country: Zimbabwe