Study Report HIV Prevention: One 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 MUTABAZI Vincent Rwanda Ministry of Health ICASA Conference 4-8 th Dec 2011

Background Rwanda done over 1000 PrePex MC according to WHO framework Rwanda PrePex clinical studies to date: 1.Safety study –physician’s PrePex MC 2.Randomized controlled study comparing PrePex MC to surgical MC 3.Nurses PrePex MC cohort study (current) PrePex is used routinely in Rwanda for MC by physicians and nurses Scale up planned to start Q – objective of 2M MC in 2 years

Background PrePex Non Surgical – No sterile settings – No injected anesthesia – Bloodless procedure – No sutures

Study Design 590 adult male subjects 10 nurses with no experience in MC or PrePex were formally trained, and paired to 5 PrePex teams Intervention – PrePex MC Follow up period of up to 8 weeks l

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

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

Secondary Endpoints To validate Efficacy by means of: 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

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

Primary Endpoint: Safety AE Frequency (N=590) SeverityIncidence, 95% CI Device related2Moderate0.34% [0.04% %] Procedure related1Moderate0.17% [0.00% %] Unrelated to device or procedure 2Moderate0.34% [0.04% %] Total AEs5Moderate0.85% [0.28% %] No Severe AE, No Infection All AEs were easily resolved with minimal intervention

AEs Details Subj PrePex date DescriptionSeverity Device Related InterventionFollow up /07/11 Disturbance of urine flowModerateNo Re- placement Resolved 56 01/08/11 Pain VAS 10 at day 6ModerateYesSelf-removalResolved 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

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

Secondary Endpoint: MC time First 125 subjectsLast 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

Side Effects Expected side effects include : Oozing Localized edema Clear exudate Expected Side Effects Number of cases (N=590) Percent of cases (N=590) Oozing18 3.0% Localized edema49 8.3% Clear exudate8 1.3% Total % No intervention required all side effects resolved naturally

Secondary Endpoint: Pain Assessment Visual Analogue Scale (VAS) was used in order to assess the subject’s pain level During Device placement (no 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 rate that demonstrates the high safety of PrePex MC when performed by nurses Training: Nurses with no prior knowledge, can be trained in 3 days course to perform Safe, Effective and Efficient MC, which is most suitable for scale up MC program

Scale up – Q Rwanda plans to initiate scale up program – 2 Million MCs in 2 years – 148 teams of 2 nurses – 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 No injected anesthesia Bloodless procedure No sutures No sterile settings Safe and effective Next Steps

Thank You