Introduction to Devices for VMMC: Potential to Accelerate Scale-up, Approval Processes, and Status of Clinical Trials Jason Reed, MD, MPH Sr. Technical Advisor for Male Circumcision Programming Office of the Global AIDS Coordinator AIDS Turning the Tide Together

Challenges Surgical male circumcision poses some challenges… Fear of pain, complications from surgery, and loss of work as barriers to uptake Surgically skilled providers are limited and difficult to assign to an elective procedure Suitable infrastructure and commodities are scarce and difficult to dedicate to an elective procedure Feasibility of scale-up may be questioned given the resources needed and the scope of the surgical task Ideally, a medical device for VMMC would alleviate these challenges 2

The ‘Ideal’ Medical Device for MC 3 Effective, safe, inexpensive, highly acceptable No injection of local anesthesia Minimal discomfort/pain No sutures (bloodless) Cause minimal disruption in daily activities Does not require physician to place/remove device Single provider could place device; single provider could remove device Sterile environment not required (no cutting of living tissue) Self detaching if left in place beyond recommended time

– Manufacturer applies for pre-qualification – If accepted, manufacturer completes product dossier One element of a dossier is clinical evidence, in line with WHO TAG recommendations. Initial safety and efficacy study Randomized controlled trials in 2 countries comparing device to surgery Field Studies in 2 countries under conditions of final use Study data are reviewed by WHO Technical Advisory Group on Innovations in Male Circumcision and report provided to inform product dossier and pre-qualification decision – Manufacturing site inspection/audit(s) WHO Pre-Qualification Process

– Manufacturer applies for pre-qualification – If accepted, manufacturer completes product dossier One element of a dossier is clinical evidence, in line with WHO TAG recommendations. Initial safety and efficacy study Randomized controlled trials in 2 countries comparing device to surgery Field Studies in 2 countries under conditions of final use Study data are reviewed by WHO Technical Advisory Group on Innovations in Male Circumcision and report provided to inform product dossier and pre-qualification decision – Manufacturing site inspection/audit(s) WHO Pre-Qualification Process

Currently Undergoing WHO Pre-Qualification Process 6 Shang Ring

Pre-Qualification Status PrePex Application: Approved to proceed with process Dossier Review: Ongoing Manufacturing Site Audit: First completed, follow-up scheduled [Fall 2012] Clinical Trials for TAG Recommendation: RwandaZimbabwe Safety Case SeriesPublished 1 Completed Comparison Study (randomized) Accepted for Publication Completed Field StudyPresented 2 Enrollment Completed 1 Bitega, JAIDS, Mutabazi, 16 th ICASA Ethiopia, 2011

Pre-Qualification Status Shang Ring Application: Conditionally approved to proceed with process Dossier Review: Not yet available Manufacturing Site Audit: TBD Clinical Trials for TAG Review: KenyaZambia Safety Case SeriesPublished 1 Comparison Study (randomized) Presented 2 Field StudyEnrollment Completed 1 Barone, JAIDS, Awori, 16 th ICASA Ethjopia, 2011

Funding Governments and donors may determine their own requirements before implementing devices (may be informed by WHO Framework) PEPFAR requires WHO pre-qualification before wide-scale funding of device(s) – Limited funds available now for small acceptability and safety studies of PrePex, given US FDA marketing approval

Thank You!