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Background: The frequency of adverse events (AEs) is a widely used indicator of voluntary medical male circumcision (VMMC) program quality. Though over 9 million male circumcisions (MCs) have been performed, little published data exists on the profile of AEs from mature, large-scale programs. No published data exists on routine implementation of PrePex, a device-based MC method that is being scaled up in the region.
Methods: The ZAZIC Consortium began implementing VMMC in Zimbabwe in 2013, supporting services at 36 facilities. Aggregate data on VMMC outputs are collected monthly from each facility. Detailed forms are completed describing the profile of each moderate and severe AE. Bivariate and multivariable analyses were conducted using log-binomial regression models.
Results: From October 2014 to September 2015, 44,868 clients were circumcised according to their VMMC method choice; 156 experienced a moderate or severe AE. AEs were uncommon: 0.28% (116/41,416) of surgical and 1.16% (40/3,452) of PrePex clients experiencing an AE. After adjusting across the 36 VMMC sites, we found that PrePex was associated with a 3.29-fold (95% CI, 2.04-5.30) increased risk of experiencing an AE compared to surgical procedures. Device displacements, when the PrePex device is intentionally or accidentally dislodged during the 7-day placement period, accounted for 70% of PrePex AEs. The majority of device displacements were intentional self-removals. Infection was the most common AE among VMMC clients. Compared to clients ages 20 and above, clients ages 10-14 were 3.07-fold (95% CI, 1.30-7.26) more likely to experience an infection and clients ages 15-19 were 1.80-fold (95% CI, 0.72-4.48) more likely to experience an infection, adjusted for site.
Conclusions: To the best of our knowledge, this exploratory analysis is the first to show that clients receiving a PrePex MC were more likely to experience an AE than surgical circumcision clients. This is largely attributable to the frequent occurrence of device displacements, most of which could be prevented if client behavior could be modified through counseling interventions. We are also the first to find that infection after MC is more common among younger clients. Young clients may benefit from additional counseling or increased parental involvement to reduce infections.

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