prepex device for rapid scale up of male circumcision programmes in zimbabwe: results of 3 studies...
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PrePex Device for Rapid Scale up of Male Circumcision Programmes in Zimbabwe:
Results of 3 Studies
Prof. Mufuta TshimangaCo-Principal Investigator
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
Trial Phases
– Phase 1 - Safety and Efficacy study– Phase 2- RCT surgery vs device– Phase 3 - Field studies
• Each phase examines safety and acceptability
• Above 18 years• Agrees to be circumcised by any of the study methods, PrePex
or Surgical, accepts study procedures and requirements• HIV sero-negative
Inclusion Criteria
Procedures • Screening • Psychosocial Interview• Deployment of Device• Removal of Device• Follow-up visits to day 90
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
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 53 (100%)
2 days post-Placement
53 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
52 1 (1.9%) 26 (50.0%) 25(48.1%)
1 minute post-device removal
52 12 (23.1%) 38 (73.1%) 2 (3.8%)
2 week post-device removal
48 43 (89.6%) 4 (8.3%) 1 (2.1%)
Safety Study-Pain Scores
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
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
Comparative Study-ResultsSurgical 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)
*p<0.001
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
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
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
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
Acknowledgements
• MoHCW• ZNFPC• UNFPA• Gates Foundation• PSI• ZiCHIRe
Summary of Scientific Validation and Implementation of PrePex for Non-Surgical Adult Male Circumcision
MUTABAZI VincentRwanda Ministry of Health
AIDS 2012 Conference July 22nd-27th , 2012
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.
Background
Non Surgical MC
◦ No injected anesthesia
◦ Bloodless procedure
◦ No sutures
◦ No sterile settings
◦ FDA approved, CE Mark
PrePex Innovation
PrePex Placement Procedure
PrePex Removal Procedure
Clinical studies of PrePex were planned using the WHO Evaluation Framework of Adult MC Devices.
PrePex Safety & Efficacy Study - 105 subjects, including first cases of natural detachment by day 15 that was found to be safeVisited onsite by WHO, Gates. Manuscript Published in JAIDS. CROI, AUA
Comparison Study – 144 PrePex/73 SurgeryAudited onsite by WHO, USAID. Manuscript accepted (not yet published) to JAIDS
Nurses Feasibility Study – 49 subjects, 6 nurses
Nurses cohort Study – 590 subjects, 10 nursesOral Presentation in ICASA Dec 2011, IAS 2012
Clinical Roadmap
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 2012.
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.
PrePex Center of Excellence
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.
First Steps Towards Scale-up
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.
Key Takeaways
Scale up – Q3 2012 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
Next Steps
Thank You