PEPFAR

Introduction to Devices for VMMC:Potential to Accelerate Scale-up, Approval Processes, and

Status of Clinical Trials

Jason Reed, MD, MPHSr. Technical Advisor for Male Circumcision Programming

Office of the Global AIDS Coordinator

AIDS 2012 - Turning the Tide Together

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ChallengesSurgical 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

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The ‘Ideal’ Medical Device for MC

• 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 useStudy 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

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Currently Undergoing WHO Pre-Qualification Process

Shang Ring

http://www.youtube.com/watch?v=-0s5nVgn7-Ahttp://www.prepex.com/procedure_video

http://www.youtube.com/watch?v=-j3SoMiwRHI

Pre-Qualification StatusPrePex

Application: Approved to proceed with process

Dossier Review: Ongoing

Manufacturing Site Audit: First completed, follow-up scheduled [Fall 2012]

Clinical Trials for TAG Recommendation:

Rwanda Zimbabwe

Safety Case Series Published1 Completed

Comparison Study(randomized)

Accepted for Publication

Completed

Field Study Presented2 Enrollment Completed

1Bitega, JAIDS, 20112Mutabazi, 16th ICASA Ethiopia, 2011

Pre-Qualification StatusShang Ring

Application: Conditionally approved to proceed with process

Dossier Review: Not yet available

Manufacturing Site Audit: TBD

Clinical Trials for TAG Review:

Kenya Zambia

Safety Case Series Published1

Comparison Study(randomized)

Presented2 Presented2

Field Study Enrollment Completed

Enrollment Completed

1Barone, JAIDS, 20112Awori, 16th 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!