Profile of Adverse Events in the Largest Voluntary Medical Male Circumcision Program in Mozambique

1. Abstract number: A-899-0231-10871 Profile of Adverse Events in the Largest Voluntary Medical Male Circumcision Program in Mozambique 2009–2017 by: Sérgio Ndimande, Alicia Jaramillo, Connie Lee, Ruben Frescas, Mehebub Mahomed, and Humberto Muquingue

2. Outline • Voluntary Medical Male Circumcision Program in Mozambique • Objective and Methods • Results • Conclusions

3. Voluntary Medical Male Circumcision Program in Mozambique • Jhpiego started a voluntary medical male circumcision (VMMC) program in Mozambique in November 2009 with PEPFAR/CDC support. • It currently supports the Ministry of Health to implement VMMC services in 56 sites: • 26 fixed sites • 9 mobile units • 21 temporary sites • VMMC/CDC program operates in five out of eleven provinces in the country • Providers are mid-level nurses

4. Adverse Events in Male Circumcision • An adverse event in male circumcision is defined as follows: • “any injuries, harm, or undesired outcomes occurring during or following male circumcision…that would not have occurred if the client had not undergone the procedure.” • Adverse events are categorized as follows: • Severity (mild, moderate, and severe) • Timing (intraoperative or postoperative) • Nature (bleeding, etc…) • Surveillance (passive or active) • An adverse event is a proxy for quality management and service provision, which influences the acceptability of male circumcisions in a community.

5. Objective and Methods • The objective was to identify adverse events, understand their profile, and monitor them in order to reduce the potential risks involved in the male circumcision procedures • Retrospective evaluation of programmatic data produced routinely by the VMMC/CDC program in Mozambique from 2009 to 2017 • We assessed the number, type, and rate of adverse events that occurred during this period • We categorized our findings by age group, event type (bleeding, etc.), and event severity (moderate or severe).

6. Number of VMMC procedures performed • A total of 737,854 male circumcisions were performed between 2009 and 2017: • 95.6% tested for HIV • 2.1% HIV positive

7. Types of adverse events • 0.25% (1,868/ 737,854) moderate and severe adverse events were observed. • 1,687 (90.3%) were moderate, and 181 (9.7%) were severe. • Most common adverse events were infections (41%), hematoma (21.57%), and excessive bleeding (16%).

8. Males 15 years of age or older are more likely to experience an adverse event

9. Preventive actions taken • Reinforcement of IPC: special team in charge of monitoring IPC practices • Adoption of an expanded screening tool for bleeding disorders • Strengthening of hemostasis technique • Reinforcement of counseling for post-procedure care, including parents and guardians • Enforcement of compliance with notification of adverse events • Promotion of a culture of transparency (not punitive) • Implementation of an automated daily reporting system which included production, by site, by adverse events

10. Daily Report

11. Conclusions • Among the 737,855 male circumcision procedures performed, the adverse event rate was 0.25%—even lower than the 0.8%–0.9%1 cited in the literature • An active collection and monitoring of data help to keep adverse events rate low because it allows to identify causes and implement solutions • The information has to be complete, of good quality, and shared • Implementation of good tools for screening and prevention of adverse is very helpful • Relatively simple corrective measures help to control adverse event • Adoption of technology has to be adapted to levels of competency of staff 1 Centers for Disease Control and Prevention. 2013. Voluntary medical male circumcision—Southern and Eastern Africa, 2010–2012. MMWR. 62(47):953–957.

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