 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.

 Non Surgical MC ◦ No sterile settings ◦ No injected anesthesia ◦ Bloodless procedure ◦ No sutures ◦ FDA approved, CE Mark

 Rwanda PrePex clinical studies: 1.Safety (physicians) - published in J-Aids 2.Randomized controlled study comparing PrePex MC to surgical MC – accepted for publication in J-Aids 3.Nurses cohort study – in writing process 4.Planned study - Adolescents (ages 10 to 17)

 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.

 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

Placement Procedure 7 days later - Removal Procedure a - Sizingb – Applying Anesthetic cream c – Marking Line d – Placing Devicee - Discharging a – Removing Necrotic foreskin b – Piercing Elastic Ring c – Extracting Inner Ring d – Dressing the wound

 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

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

Results

 590 adult male subjects  Average age : 25, SD 4  5 HIV positive

AE Frequency (N=590) SeverityIncidence, 95% CI Device related 2Moderate0.34% [0.04% %] Procedure related 1Moderate0.17% [0.00% %] Unrelated to device or procedure 2Moderate0.34% [0.04% %] Total AEs5 Moderate 0.85% [0.28% %]  No Severe AE, No Infection  All AEs were easily resolved with minimal intervention

Subj. PrePex date DescriptionSeverity Device Related Intervention Follow up /07/ 11 Partial disturbance of urine flow ModerateNo Re- placement Resolved 56 01/08/ 11 Pain VAS 10 at day 6ModerateYes Self- removal Resolved 56 02/08/ 11 Bleeding due to self- removal of foreskin ModerateNo Pressure on site Resolved /08/ 11 Moving of Elastic Ring by subject during masturbation ModerateNo Re- Placement Resolved /09/ 11 Bleeding post RemovalModerateYes1 sutureResolved

 100% of subjects fully circumcised  Subjects healed completely on average day 33 after device removal SD 6.79

First 125 subjects Last 125 subjects Procedure time (Placement + Removal) 4min 58sec SD 2min 46sec 2min 51sec SD 42sec Preparation time (Placement + Removal) 2min 48sec SD 1min 17sec 1min 48sec SD 46sec Total MC time (Procedure + Preparation) 7 min 46 sec SD 4min 3 sec 4min 39 sec SD 1min 26 sec

 Visual Analogue Scale (VAS) was used in order to assess the subject’s pain level During Device placement (no injected anesthesia) within 1 hour after placement During erection with device Before device removal During removal After removal Average Pain 1 SD SD SD SD0.8 3 SD 1.9 (For 5 sec) 0.9 SD 1.3

Conclusions

 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.

 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  MC Method – PrePex by nurses ◦ Surgical MC as back up for contraindicated and escalation Next Steps

Thank You