Accepted Abstracts presented at ICASA 2013, Cape Town, South Africa
- Summary of Scientific Validation and Ongoing Use of PrePex Device for Non- Surgical Adult Male Circumcision in Rwanda. Rwanda has completed the roadmap, scientifically validating the safety, efficacy, acceptability and superiority (over dorsal slit, on both measures of time and safety) of PrePex. Data was gathered from 4 clinical studies and 3 local campaigns, from over 10 facilities, including active reporting of Adverse Events (AEs) and their classification. Studies confirmed that PrePex is safe when performed by physicians and when performed by nurses, with a related AE rate of 0.4%, offering a bloodless procedure that requires no needles (no injection of anaesthesia), no knives, no sutures, no sterile settings.
- Cost Analysis of the PrePex Procedure Compared to Surgical Procedure (Rwanda). The objective of this cost-analysis study was to provide an average unit cost and cost-analysis information related to performing male circumcision (MC) using either a surgical method or PrePex, and to determine how the use of PrePex might enhance the delivery of Rwanda national voluntary medical male circumcision (VMMC) targets. The total circumcision cost per person, for surgical MC was found to be $40US/VMMC, while the PrePex MC was found to be $27US/VMMC with the current cost of $20 per device, providing an overall cost saving of more than 36% ($15) versus surgical VMMC.
- Evaluation of Efficacy in Nurses Prepex Training Course (Rwanda). A study was conducted in Rwanda where 10 nurses with no prior experience with the PrePex device and procedure were trained for 3 days. Training efficacy was measured by theoretical exam grades before and after the course, clinical performance on subjects, analysis of AE rate, procedure time and more. The PrePex nurses training course effectiveness was validated for training nurses with no previous experience. The training course was approved and is now used to train new PrePex teams for scaling up MC for HIV prevention in all Sub Sahara Africa.
- HIV Prevention: Male Circumcision with a Nonsurgical Device Evaluation in Nurses Safety Trial (Zimbabwe). A study conducted in Zimbabwe recruited 603 healthy men aged 18-51 years. All procedures were done by 16 registered general nurses who went through 5-days PrePex training course, and who did not have any previous experience with the PrePex device procedure. The safety outcomes were measured by the rate of Adverse events (AEs) and side effects. The PrePex device results were found to be safe in the hands of registered general nurses, and revalidated the findings of the safety nurses study conducted in Rwanda.