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  1. Study ReportOne Arm, Open Label, Prospective, Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Scale Up of Non-Surgical Circumcision when Performed by Nurses in Resource Limited Settings for HIV PreventionMUTABAZI VincentRwanda Ministry of Health AIDS 2012 ConferenceJuly 22nd-27th , 2012

  2. Background • Rwanda national goal: VMMC to 2 million men in 2 years to decrease HIV incidence by 50%; attainable only if task shifting is possible to nurses, as there are not enough physicians. • Rwanda seeks innovation to achieve national goal – surgical MC not possible, known devices require skill & cutting.

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

  4. Background • Rwanda PrePex clinical studies: • Safety (physicians) - published in J-Aids • Randomized controlled study comparing PrePex MC to surgical MC – accepted for publication in J-Aids • Nurses cohort study – in writing process • Planned study - Adolescents (ages 10 to 17)

  5. Background • Rwanda received official recommendation by WHO to scale up with PrePex after visiting and auditing studies in Rwanda, and following precise clinical roadmap required. • Rwanda conducted over 4200 PrePex MC to date, and is now routinely used.

  6. Nurses Study Design • 590 adult male subjects • 10 nurses with no experience in MC or PrePex were formally trained = 5 PrePex teams • Intervention – PrePex MC • Follow up period of up to 8 weeks l

  7. Methods Placement Procedure 7 days later - Removal Procedure

  8. Primary Endpoint • To validate the safety of the PrePex MC when performed by nurses, by means of rate of incidence of Adverse Events and Device-related Adverse Events

  9. Secondary Endpoints Efficacy: • Rate of complete MC (Glans completely exposed) • Evaluation of Training efficacy • Procedure time - first 125 subjects vs. last 125 subjects • Procedure related AEs • Pain assessment • Time to complete healing

  10. Results

  11. Demographics • 590 adult male subjects • Average age : 25, SD 4 • 5 HIV positive

  12. Primary Endpoint: Safety • No Severe AE, No Infection • All AEs were easily resolved with minimal intervention

  13. Efficacy • 100% of subjects fully circumcised • Subjects healed completely on average day 33 after device removal SD 6.79

  14. Secondary Endpoint: MC time

  15. Secondary Endpoint: Pain Assessment • Visual Analogue Scale (VAS) was used in order to assess the subject’s pain level

  16. Conclusions

  17. AEs:Very low AE rate demonstrating high safety of PrePex by nurses • Training:Nurses with no prior knowledge, can be trained in 3 days course to perform Safe, Effective and Efficient MC.

  18. Next Steps • 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 • MC Method – PrePex by nurses • Surgical MC as back up for contraindicated and escalation

  19. Thank You

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