Safety and Acceptability of the PrePex™ Device for Male Circumcision in Zambia
Status:Completed
Phase:IV
Principal Investigator(s):
Objective:The study will measure the incidence of moderate and severe adverse events (AEs) associated with PrePex procedures among 500 men, including both procedural and post-procedure events, and all device-related incidents such as dislodgment.
Prevention Option(s):VMMC
Study Design:Open label
Arms and Assigned Interventions
Description
Mode of Delivery
ARMsExperimental
Official Code:
NCT01844102
Trial Sponsors:
FHI 360, Population Council, Population Services International, Society for Family Health, Zambia Ministry of Health
Start Date
End Date
October 1, 2013
April 30, 2014
Enrollment:500
Age range:
18 Years ↔
49 Years
Population:Cisgender Men