P29.02
Background: Voluntary medical male circumcision has been proven to reduce the risk of acquiring HIV by at least 60% in men who are circumcised. South Africa is scaling-up medical male circumcision, and the number of circumcised men is increasing. However, if circumcision could be safely simplified without compromising efficacy, it could potentially allow for more circumcisions to be done. The PrePex device was developed to simplify the circumcision procedure by making sutures, diathermy, scalpels, and local anesthesia unnecessary. However, there is no data available on the assessment of the PrePex device in South Africa.
Methods: A phased, multisite, non-randomised study in which adolescents (14–17 years) and adult (18–45) men underwent circumcision using the PrePex device. Data were collected from 9 visits; application, 2 telephonic follow-ups, removal and 5 follow-up visits. Outcome measures include adverse events, pain and discomfort, procedure time, sexual resumption, healing time, and PrePex sizes. Data presented is of the first 318 participants.
Results: A total of 264 adult men and 54 adolescents were recruited for the PrePex study across the three sites. The overall moderate and severe adverse events (AE) rate was 2.5% with none of the adverse events requiring hospitalisation. Mild AE were predominantly obstructed urine flow. The most commonly used PrePex sizes were size B and C (63%, 197/312). The median resumption for sexual activity was 44 days (IQR: 36.5-53). The device application procedure was quick and caused minor to no pain however the removal procedure was more painful but the pain was temporary.
Conclusions: The preliminary results indicate that the PrePex procedure was easily learned by the staff at the three sites. The device application is quick, safe and less painful however removal causes temporary pain. The AEs encountered were similar in severity to the blade based circumcision with the exception of urinary obstruction.
