South Africa (2013): [Cohort Study]Assessing the safety, acceptability, and training requirements for Prepex devices in [South Africa]

SFH South Africa conducted a study to assess safety and acceptability of Prepex devices among adult men 14 to 49 years. Primary aims of the study included: Assessing acceptability and reasons for acceptability of PrePex male circumcision; assessing time to final healing following PrePex device removal; and assessing the rate of adverse events Secondary aims of the study included determining and comparing costs of doing male circumcisions using PrePex and using the forceps-guided scalpel-based circumcision method; and ascertaining range of prepex device sizes in the population of men and adolescents in South Africa. A total of 450 adults were recruited (350 adults 18 to 49 years and 100 adolescents 14 to 17 years). In addition accompanying individuals and refusals were interviewed to assess acceptability. The study was a controlled and phased implementation of the PrePex device at several sites in South Africa (Witbank, Tsakane, Piet Retief and Zuzi Mpilo)and used similar operational research strategies and processes at all sites. The sites jointly overseen by The Perinatal HIV Research Unit (PHRU) and the Society for Family Health (SFH).