1. Prof. Mufuta Tshimanga Co-Principal Investigator
PrePex Device for Rapid Scale up of Male Circumcision Programmes in Zimbabwe: Results of 3 Studies
Prof. Mufuta Tshimanga
Co-Principal Investigator

2. Background Zimbabwe started VMMC programme in mid 2009
Part of a comprehensive HIV prevention programme
Phased approach with learning phase
Different models of service delivery, integrated, fixed, outreach and mobile services
Target: 1.3 Million , 80% of 13-29 age group by 2015, reached 75,000 since inception
MOHCW interested in innovative models to increase scale up of VMMC
MOVE
Adult male circumcision devices, such as PrePex
To increase the feasibility of accomplishing this target, MOHCW has been interested in a non-surgical circumcision device such as PrePex Device for scaling up male circumcision

3. Trial Phases Each phase examines safety and acceptability
Phase 1 - Safety and Efficacy study
Phase 2- RCT surgery vs device
Phase 3 - Field studies 
Each phase examines safety and acceptability

4. Inclusion Criteria Procedures Above 18 years
Agrees to be circumcised by any of the study methods, PrePex or Surgical, accepts study procedures and requirements
HIV sero-negative
Procedures
Screening
Psychosocial Interview
Deployment of Device
Removal of Device
Follow-up visits to day 90

5. Safety Study
One arm, open label, prospective study to assess safety and efficacy
53 Men
Overall procedure duration was 11 minutes 33 sec (SD=3.19 min) for deployment and removal
Median time for complete healing was 35 days post device removal
No SAE recorded

6. Safety Study-Pain Scores
Time
VAS Scale Pain N
Level 0
Level 2
Level 4
During device Placement 53
48 (90.6%)
5 (9.4)
3 hours post-Placement
53 (100%)
2 days post-Placement
33 (62.3%)
19 (35.8%)
1 (1.9%)
Before device and foreskin removal 52
27 (50.9%)
21 (39.6%)
4 (7.5%)
During device removal
26 (50.0%)
25(48.1%)
1 minute post-device removal
12 (23.1%)
38 (73.1%)
2 (3.8%)
2 week post-device removal 48
43 (89.6%)
4 (8.3%)
1 (2.1%)

7. Safety Study Acceptability
All participants were satisfied with the circumcision procedure and the aesthetic result 90 days post-procedure
55.5% stated the abstinence period as too long

8. Comparative Study - Design
RCT comparing PrePex (n=160) to Forceps Guided Surgery (n=80)
Compare the surgery and PrePex :
Procedure time
Time to complete healing
Costing

9. Comparative Study-Results
Surgical MC
Prepex MC
( placement and removal)
Median Procedure Time*
15.3 Min
(Q1=15.3, Q3=23.9)
4.6 Min
(Q1=4.0, Q3=5.8)
Time to complete healing (Median)
42 days
(Q1=42, Q3=42)
35 days
(Q1=35, Q3=42)
Include timing of each step of the procedure
*p<0.001

10. Ongoing Field Study
One arm, open label, prospective, cohort field study, 600 participants
Assess safety of PrePex when circumcision is performed by nurses
Evaluate PrePex training needs
Evaluate acceptability of PrePex by patients, partners and care givers
Evaluate the effectiveness and cost-effectiveness of the PrePex device

11. Field Study-Preliminary Results
Recruitment started 9th May, 2012 at 3 study sites
750 devices were successfully deployed and removed by Nurses
150 during training phase
Recruitment completed 9th July, 2012
No SAE recorded
Follow up visits, to end on 16 Oct, 2012

12. Conclusions
PrePex device is safe to use for MC delivered by physicians and nurses
Pain related to PrePex appears to be minor
Our findings reaffirm and validate similar clinical studies on PrePex done in Rwanda

13. Investigators
Dr Gerald Gwinji, MBChB, MPH. PS MoHCW, Principal Investigator
Prof Mufuta Tshimanga, MD; Department of Community Medicine, University of Zimbabwe, Co-Principal Investigator
Dr. Tonderai Mangwiro,MMed Urology, Department of Surgery, University of Zimbabwe
Dr. Owen Mugurungi, MBChB, Msc; Director AIDS /TB unit , MoHCW
Dr. Munyaradzi Murwira, MBChB, MPH, Director ZNFPC
Dr. Dan Montano, PhD, Batelle Memorial Institute
Dr. Danuta Kasprzyk, PhD, Batelle Memorial Institute
Mrs. Daisy Nyamukapa, Program Officer, UNFPA
Mr. Sinokuthemba Xaba, MC Program Officer, MOHCW
Dr Karin Hatzold, MD, MPH, Deputy Director SRH, HIV &TB, PSI
Dr Christopher Samkange, Director ICHE, College of Health Sciences, University of Zimbabwe

14. Acknowledgements
MoHCW
ZNFPC
UNFPA
Gates Foundation
PSI
ZiCHIRe

15. Summary of Scientific Validation and Implementation of PrePex for Non-Surgical Adult Male Circumcision MUTABAZI Vincent Rwanda Ministry of Health AIDS 2012 Conference July 22nd-27th , 2012

16. Background
Rwanda has a national goal to significantly decrease its HIV incidence rate, by launching a VMMC to reach 2 million adults in 2 years as part of a comprehensive HIV prevention strategy. 
WHO TAG recommendation to scale up PrePex MC in Rwanda received in March 2012.

17. PrePex Innovation Non Surgical MC No injected anesthesia
Bloodless procedure
No sutures
No sterile settings
FDA approved, CE Mark

18. PrePex Placement Procedure
Disinfection
Measuring
Marking the Circumcision Line
Applying Cream
Apply the Placement Ring
Inserting the Inner Ring
Aligning Placement Ring to the Inner Ring and Adjusting the Foreskin
Elastic Ring Over the Inner Ring – Creates Pressure on the Foreskin

19. PrePex Removal Procedure
Disinfection
Measuring
Marking the Circumcision Line
Applying Cream
Apply the Placement Ring
Inserting the Inner Ring
Aligning Placement Ring to the Inner Ring and Adjusting the Foreskin
Elastic Ring Over the Inner Ring – Creates Pressure on the Foreskin

20. Clinical Roadmap
Clinical studies of PrePex were planned using the WHO Evaluation Framework of Adult MC Devices.
PrePex Safety & Efficacy Study subjects, including first cases of natural detachment by day 15 that was found to be safe Visited onsite by WHO, Gates. Manuscript Published in JAIDS. CROI, AUA
Comparison Study – 144 PrePex/73 Surgery Audited onsite by WHO, USAID. Manuscript accepted (not yet published) to JAIDS
Nurses Feasibility Study – 49 subjects, 6 nurses
Nurses cohort Study – 590 subjects, 10 nurses Oral Presentation in ICASA Dec 2011, IAS 2012

21. PrePex Center of Excellence
6 physicians and 41 nurses were successfully trained as PrePex operators in Rwanda.
Teams from Zimbabwe were trained by Rwanda. Hosted delegations from Uganda, Botswana, USA and more in
1 paper published, 1 accepted, 1 under review and 2 in writing.
PrePex Train the Trainer available to train Sub-Saharan Africa. Gates Foundation to sponsor capacity building for PrePex Center of Excellence.

22. First Steps Towards Scale-up
Hearts & Hands Campaign (June 2012) – Sponsored by Korean NGO, 6 nurses from Byumba hospital (rural),1,000 successful MC within 3 weeks with a total of 7 mild AEs, (0.7%). The campaign was closely supervised by MoH, physicians and nurses from PrePex Center of Excellence, All AEs gathered and analyzed.
Army Week Campaign (July 2012) – Sponsored by the Rwanda Military Hospital, 7 teams of nurses performed 1,500 procedures within two weeks on 8 rural health centers across the Cyangugu district. Closely supervised for AEs, 6 mild AEs, AE rate 0.4%.
Operational Pilot Demonstration (Q3 2012) – Sponsored by Global Fund and Bill & Melinda Gates Foundation. Defining parameters for scale up and studying removal with one nurse and AE monitoring for scale up. 10,000 clients.

23. Key Takeaways
SAFE: Very low AE rate demonstrating high safety of PrePex by nurses. 18 related AES from total of 4166 procedures (0.46%)
EASY TO TRAIN: Nurses with no prior knowledge, can be trained in 3 days course to perform Safe, Effective and Efficient MC. Proper supervision is important to ensure safe implementation before releasing to the field.
NATURAL DETACHMENT – a pre-safety study was conducted in March 2009, to alleviate concerns about men not returning for removal. The outcome assured us that PrePex was safe, and would naturally detach for complete circumcision, if men did not come back to the clinic.

24. Next Steps
Scale up – Q Rwanda plans to initiate scale up program
Pilot of 10,000 to inform scale up (Global Fund, Gates)
2 Million MCs in 2 years
~150 teams of 2 nurses (full time – 8 hours a day)
54 procedures per team per day (Placement +Removal)
4000 MCs Per day (4000 placements 4000 removals)
250 working days per year
Adolescents study – 10 to 17 years old

25. Thank You