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Safe and Efficient PrePex Device for Non-Surgical Circumcision by Nurses: Prospective Study in Resource-Limited Settings

This study report presents a prospective cohort field study assessing the safety and efficacy of the PrePex device for non-surgical circumcision when performed by nurses in resource-limited settings for HIV prevention. The study includes background information on the national goal of Rwanda to decrease HIV incidence through VMMC and the innovative PrePex device, along with details of the study design, methods, results, and conclusions. The findings demonstrate the high safety and efficacy of PrePex performed by nurses, paving the way for scale-up programs.

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Safe and Efficient PrePex Device for Non-Surgical Circumcision by Nurses: Prospective Study in Resource-Limited Settings

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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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