Presentation on theme: "Prof. Mufuta Tshimanga Co-Principal Investigator"— Presentation transcript:
1 Prof. Mufuta Tshimanga Co-Principal Investigator PrePex Device for Rapid Scale up of Male Circumcision Programmes in Zimbabwe: Results of 3 StudiesProf. Mufuta TshimangaCo-Principal Investigator
2 Background Zimbabwe started VMMC programme in mid 2009 Part of a comprehensive HIV prevention programmePhased approach with learning phaseDifferent models of service delivery, integrated, fixed, outreach and mobile servicesTarget: 1.3 Million , 80% of 13-29 age group by 2015, reached 75,000 since inceptionMOHCW interested in innovative models to increase scale up of VMMCMOVEAdult male circumcision devices, such as PrePexTo 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 studyPhase 2- RCT surgery vs devicePhase 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 requirementsHIV sero-negativeProceduresScreeningPsychosocial InterviewDeployment of DeviceRemoval of DeviceFollow-up visits to day 90
5 Safety StudyOne arm, open label, prospective study to assess safety and efficacy53 MenOverall procedure duration was 11 minutes 33 sec (SD=3.19 min) for deployment and removalMedian time for complete healing was 35 days post device removalNo SAE recorded
7 Safety Study Acceptability All participants were satisfied with the circumcision procedure and the aesthetic result 90 days post-procedure55.5% 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 timeTime to complete healingCosting
9 Comparative Study-Results Surgical MCPrepex 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 StudyOne arm, open label, prospective, cohort field study, 600 participantsAssess safety of PrePex when circumcision is performed by nursesEvaluate PrePex training needsEvaluate acceptability of PrePex by patients, partners and care giversEvaluate the effectiveness and cost-effectiveness of the PrePex device
11 Field Study-Preliminary Results Recruitment started 9th May, 2012 at 3 study sites750 devices were successfully deployed and removed by Nurses150 during training phaseRecruitment completed 9th July, 2012No SAE recordedFollow up visits, to end on 16 Oct, 2012
12 ConclusionsPrePex device is safe to use for MC delivered by physicians and nursesPain related to PrePex appears to be minorOur findings reaffirm and validate similar clinical studies on PrePex done in Rwanda
13 InvestigatorsDr Gerald Gwinji, MBChB, MPH. PS MoHCW, Principal InvestigatorProf Mufuta Tshimanga, MD; Department of Community Medicine, University of Zimbabwe, Co-Principal InvestigatorDr. Tonderai Mangwiro,MMed Urology, Department of Surgery, University of ZimbabweDr. Owen Mugurungi, MBChB, Msc; Director AIDS /TB unit , MoHCWDr. Munyaradzi Murwira, MBChB, MPH, Director ZNFPCDr. Dan Montano, PhD, Batelle Memorial InstituteDr. Danuta Kasprzyk, PhD, Batelle Memorial InstituteMrs. Daisy Nyamukapa, Program Officer, UNFPAMr. Sinokuthemba Xaba, MC Program Officer, MOHCWDr Karin Hatzold, MD, MPH, Deputy Director SRH, HIV &TB, PSIDr Christopher Samkange, Director ICHE, College of Health Sciences, University of Zimbabwe
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 BackgroundRwanda 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 procedureNo suturesNo sterile settingsFDA approved, CE Mark
18 PrePex Placement Procedure DisinfectionMeasuringMarking the Circumcision LineApplying CreamApply the Placement RingInserting the Inner RingAligning Placement Ring to the Inner Ring and Adjusting the ForeskinElastic Ring Over the Inner Ring – Creates Pressure on the Foreskin
19 PrePex Removal Procedure DisinfectionMeasuringMarking the Circumcision LineApplying CreamApply the Placement RingInserting the Inner RingAligning Placement Ring to the Inner Ring and Adjusting the ForeskinElastic Ring Over the Inner Ring – Creates Pressure on the Foreskin
20 Clinical RoadmapClinical 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, AUAComparison Study – 144 PrePex/73 Surgery Audited onsite by WHO, USAID. Manuscript accepted (not yet published) to JAIDSNurses Feasibility Study – 49 subjects, 6 nursesNurses 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 in1 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 TakeawaysSAFE: 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 StepsScale up – Q Rwanda plans to initiate scale up programPilot 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 yearAdolescents study – 10 to 17 years old