Adverse event profile of a mature voluntary medical male circumcision programme performing PrePex and surgical procedures in Zimbabwe

Abstract

Introduction: The frequency of adverse events (AEs) is a widely used indicator of voluntary medical male circumcision (VMMC) programme quality. Though over 11.7 million male circumcisions (MCs) have been performed, little published data exists on the profile of AEs from mature, large-scale programmes. No published data exists on routine implementation of PrePex, a device-based MC method. 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 through September 2015, 44,868 clients were circumcised with 156 clients experiencing a moderate or severe AE. 96.2% of clients had a follow-up visit within 14 days of their procedure. AEs were uncommon, with 0.3% (116/41,416) of surgical and 1.2% (40/3,452) of PrePex clients experiencing a moderate or severe AE. After adjusting for VMMC site, we found that PrePex was associated with a 3.29-fold (95% CI: 1.78–6.06) 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. Overall, infection was the most common AE among VMMC clients. Compared to clients aged 20 and above, clients aged 10–14 were 3.07-fold (95% CI: 1.36–6.91) more likely to experience an infection and clients aged 15–19 were 1.80-fold (95% CI: 0.82–3.92) more likely to experience an infection, adjusted for site. Conclusions: This exploratory analysis found that clients receiving PrePex were more likely to experience an AE than surgical circumcision clients. This is largely attributable to the occurrence of device displacements, which require prompt access to corrective surgical MC procedures as part of their clinical management. Most device displacements were self-removals which are preventable if client behaviour could be modified through counselling interventions. We also found that infection after MC is more common among younger clients, who may benefit from additional counselling or increased parental involvement.

Adverse events in a large‐scale VMMC programme in Tanzania: findings from a case series analysis

“…Preventing AEs and making circumcision safer for clients are highest priorities for VMMC programmes . In this VMMC programme, 0.18% of all VMMC clients had a reported moderate or severe AE, similar to the 0.3% rate reported in a VMMC programme in Zimbabwe . These rates of AEs are well below the rate in the landmark research studies conducted in 2007 .…”

“…Without contesting the potential limitation of underreporting, VMMC programmes have reported very low levels of AEs. For example, programmatic data from 44,868 VMMC clients in Zimbabwe showed an AE rate of 0.3% for surgical circumcision and 1.2% for device‐based (PrePex™) circumcision . AEs associated with surgical VMMC programmes tend to be comprise bleeding events in the zero to two day range, and shift to infections in day 3 onwards .…”

Implementing voluntary medical male circumcision using an innovative, integrated, health systems approach: experiences from 21 districts in Zimbabwe

“…Safety of VMMC clients was assured during this period of scale-up and transition with reported rates of adverse events (AE) remaining under 0.5% over the first 3 years (Table 3) [36]. …”

“…According to routine M&E data, ZAZIC’s recent achievements continue to demonstrate excellent progress towards MoHCC targets: by March, 2017, ZAZIC reached 90% of its semi-annual target as compared to 56% of the semi-annual target achieved by the other large-scale partner organization in Zimbabwe [52]. ZAZIC also implemented VMMC safely [36] with reported AE rates lower than the global safety standard of 2% in all 3 years of operation [53–55]. While more logistically challenging than the predominantly vertical approach, and leaders note some weaknesses in program synergies, client access, and VMMC staff training, the progress evidenced by ZAZIC suggests that an integrated or blended approach may positively affect VMMC short-term outputs and supports continued efforts at integration of programs to strengthen local health systems [56].…”

“…ZAZIC routine data collection, including program monitoring and evaluation (M&E) data used for this paper, comes principally from MoHCC VMMC monitoring tools, described in detail previously [35,36]. In brief, quantitative data comes from three sources: (1) the MoHCC Monthly Return Form (MRF) contains aggregated data on monthly VMMC program outputs for each site; (2) VMMC location type (static or outreach) comes from a weekly ZAZIC internal form; and (3) details on adverse events (AEs) are collected using the ZAZIC internal AE Review Tool that includes AE clinical outcomes.…”