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

Outline Voluntary Medical Male Circumcision Program in Mozambique Objective and Methods Results Conclusions ended in August 2014 (transitioned to another USG partner)

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 ended in August 2014 (transitioned to another USG partner)

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.

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).

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

Types of adverse events Type of adverse event Number Percentage Infection 774 41.43% Hematoma 403 21.57% Excessive bleeding 305 16.33% Damage to the penis 110 5.89% Pain 107 5.73% Suture dehiscence 80 4.28% Suppuration 48 2.57% Excessive swelling 19 1.02% Appearance 15 0.80% Excessive skin removal 7 0.37% Total 1,868 100% 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%). Infections were the most common among moderate adverse event (44.2%). Hematomas were the most common among severe adverse event (59.1%).

Males 15 years of age or older are more likely to experience an adverse event peaking at 2.3%, in the first month

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

Daily Report

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.

THANK YOU