Innovative Methods of Male Circumcision for HIV Prevention-Getting the Right Evidence.

Julia Samuelson,Tim Farley,Renee Ridzon,Timothy Hargreave

doi:10.1097/qai.0000000000000738

Abstract

:World Health Organization recommends that countries with hyperendemic and generalized HIV epidemics implement voluntary medical male circumcision programs for HIV prevention. Innovative methods of male circumcision including devices have the potential to simplify the procedure, reduce time and cost, increase client acceptability, enhance safety, and expand the numbers of providers who may perform circumcision. We describe work led by World Health Organization and supported by global partners to define a pathway for the evaluation of efficacy and safety of male circumcision devices, to set priority criteria, and to establish a process to guide the use of devices in publicly funded voluntary medical male circumcision programs for HIV prevention. A device classification scheme, an expert Technical Advisory Group on Innovations in Male Circumcision, and a formal prequalification program have also guided considerations on safe use of devices. A rigorous approach was deemed appropriate given the intervention is for use among healthy men for public health purposes. The pathway and processes led to coordinated research, better standardization in research outcomes, and guidance that informed the research, introduction and implementation phases. The lessons learnt from this case study can inform evaluation and use of future public health innovations.

Highlights

Based on compelling evidence,[1,2,3,4,5] World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS recommended in 2007 that countries with hyperendemic and generalized HIV epidemics implement voluntary medical male circumcision (VMMC) programs for HIV prevention.[6]
This article reviews work led by WHO and supported by global partners to define a pathway for the evaluation of efficacy and safety of innovative circumcision methods including devices, to set priority criteria, and to establish a process, including through the WHO Technical Advisory Group on Innovations in Male Circumcision (MC TAG), to guide the use of devices in publicly funded VMMC programs for HIV prevention
Other than the claims by the inventors or manufacturers, were available on their clinical performance and safety for use in adult males, the MC TAG was established to advise on the minimum evidence needed and to review which devices could be considered for adult VMMC for HIV prevention in the priority African countries

Summary

INTRODUCTION

Based on compelling evidence,[1,2,3,4,5] World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS recommended in 2007 that countries with hyperendemic and generalized HIV epidemics implement voluntary medical male circumcision (VMMC) programs for HIV prevention.[6]. Other than the claims by the inventors or manufacturers, were available on their clinical performance and safety for use in adult males, the MC TAG was established to advise on the minimum evidence needed and to review which devices could be considered for adult VMMC for HIV prevention in the priority African countries. The device should be evaluated in a series of studies in countries or settings of intended final use, including case series, randomized comparative studies by skilled surgeons, studies on acceptability by providers and clients, and field studies involving trained mid-level clinical providers to demonstrate their potential to perform circumcision safely (Table 1). These different mechanisms of action have unique risks that inform monitoring

DISCUSSION

Findings

Objective review of clinical data