Background: Circumcision devices make the procedure quicker, simpler and potentially more cost-effective, and have the opportunity to make the provision of VMMC easier to scale-up. The primary aim of the safety component of the study was to monitor clinical Adverse Events (AEs) and device-related adverse incidents.
Methods: The sample included 803 HIV negative men, aged 18 to 49 years, from three sites in Gauteng province. Men were followed for 56 days from day of device placement (Day 0).
Results: A total of 15 865 people went to the clinic to access circumcision services during the study period, however only 5 500 of these were between the ages of 18 and 49 years. Almost half of all participants (44%) were between the ages of 25 and 34 years, and 40% were 18 to 24 years of age. Of the 5 500 clients, 828 (15.1%) people were both eligible and opted to have circumcision done using the PrePex device.
There were 20 AEs, giving an AE rate of 2.5%, mainly due to infection, bleeding, self-removals (resulting in surgical interventions), severe pain, problems voiding, and insufficient skin removal as well as delayed wound healing. The majority of the 23 withdrawals prior to device application were due to “lack of device fitting” (device size was too small or too big), and due to medical conditions (phimosis or genital warts).
In Orange Farm, the greatest number of clients were size A; in Katlehong the greatest number of clients were size B; and in Zola the greatest number of clients were size C.
Conclusions: The AE rate obtained for the current study was 2.5%, 0.5% higher than surgical. This result can be considered “good” as this is the first of many pilot studies examining device-related AEs. Uptake seems to be high with 15% of the total number of males accessing VMMC services opting for PrePex. The relatively low AE rate coupled with the increased uptake of PrePex indicates that men are more likely to opt for device-related circumcision, thus increasing the number of men circumcised and ultimately decreasing the incidence and prevalence of HIV/AIDS cases overall.