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

Abstract

Introduction Adverse events (AEs) rates in voluntary medical male circumcision (VMMC) are critical measures of service quality and safety. While these indicators are key, monitoring AEs in large‐scale VMMC programmes is not without challenges. This study presents findings on AEs that occurred in eight years of providing VMMC services in three regions of Tanzania, to provide discussion both on these events and the structural issues around maintaining safety and quality in scaled‐up VMMC services. Methods We look at trends over time, demographic characteristics, model of VMMC and type and timing of AEs for 1307 males who experienced AEs among all males circumcised in Tabora, Njombe and Iringa regions from 2009 to 2017. We analysed deidentified client data from a VMMC programme database and performed multivariable logistic regression with district clustering to determine factors associated with intraoperative and postoperative AEs among VMMC clients. Results and discussion Among 741,146 VMMC clients, 0.18% (1307/741,146) experienced a moderate or severe AE. The intraoperative AE rate was 2.02 per 100,000 clients, and postoperative rate was 2.29 per 1000 return clients. Multivariable logistic regression showed that older age (20 to 29 years) was significantly associated with intraoperative AEs (aOR: 3.51, 95% CI: 1.17 to 10.6). There was no statistical significant difference in AE rates by surgical method. Mobile VMMC service delivery was associated with the lowest risk of experiencing postoperative AEs (aOR:0.64, 95% CI: 0.42 to 0.98). AE rates peaked in the first one to three years of the programme and then steadily declined. Conclusions In a programme with robust AE monitoring methodologies, AE rates reported in these three regions were very low and declined over time. While these findings support the safety of VMMC services, challenges in reporting of AEs in a large‐scale VMMC programme are acknowledged. International and national standards of AE reporting in VMMC programmes are clear. As VMMC programmes transition to national ownership, challenges, strengths and learning from AE reporting systems are needed to support safety and quality of services.

Adverse event profile and associated factors following surgical voluntary medical male circumcision in two regions of Namibia, 2015–2018

“…Bleeding was the most frequent early surgical AE, whereas infection was the most common late onset AE. These results are comparable to those reported in other studies [ 19 , 28 , 30 ]. Bleeding AEs often require surgical exploration to correct and are therefore categorized as severe [ 7 ].…”

Quality of service and continuous quality improvement in voluntary medical male circumcision programme across four provinces in South Africa: Longitudinal and cross-sectional programme data

“…Rate of AEs in VMMC programs is among measurement tools used to assess quality of service and they affect the desire for individuals to undergo medical MC [ 13 , 14 ]. Fear of pain, medical complications and the possibility of other negative outcomes from VMMC program act as a barrier for demand creation [ 15 ].…”

Description of adverse events among adult men following voluntary medical male circumcision: Findings from a circumcision programme in two provinces of South Africa

“…The incidence of adverse events reported in this VMMC programme was low in all age groups and did not differ significantly by marital or employment status. Reported AEs from clinical trials and the VMMC programme data may not be strictly comparable, as clinical trials have more active follow-up procedures that may lack in a routine programme [ 34 ]. However, the low incidence of adverse events reported in this study suggests that the quality of the programme is good and the findings are reassuring for broader implementation efforts.…”