BACKGROUND: Clinical trials showed strong evidence that voluntary medical male circumcision (VMMC) reduces the acquisition of HIV among heterosexual men by up to 60%. However, VMMC uptake in East and Southern Africa remains suboptimal, with safety concerns identified as a barrier to uptake. We investigated the occurrence and severity of adverse events (AEs) in a routine VMMC programme implemented in Gauteng and North West provinces of South Africa. METHODS: We describe the frequency and characteristics of AEs using routinely collected data from a VMMC programme implemented between 01 May 2013 and 31 December 2014. The surgical procedure was provided at fixed clinics and mobile units in three districts. Adult men undertaking the procedure were referred for follow-up appointments where AEs were monitored. RESULTS: A total of 7,963 adult men were offered the VMMC service with 7,864 (98.8%) met the age and consent requirements for inclusion in a research follow-up after the surgical procedure and were followed-up for potential AEs. In total, 37 (0.5%) patients reported AEs post-surgery with infection [11 (29.7%)] and excessive bleeding [11 (29.7%)] commonly reported AEs. In terms of severity, 14 (37.8%) were classified as mild, 13 (35.1%) as moderate, and 10 (27.0%) as severe. Further, 32 (86.5%) of the AEs were classified as definitely related to the surgical procedure, with 36 (97.5%) of all AEs resolving without sequelae. CONCLUSION: The VMMC programme was able to reach adult men at high risk of HIV acquisition. Reported AEs in the programme were minimal, with the observed safety profile comparable to clinical trial settings, suggesting that VMMC can be safely administered in a programmatic setting.

BACKGROUND: Male circumcision confers partial protection against heterosexual HIV acquisition among men. The President's Emergency Plan for AIDS Relief (PEPFAR) has supported > 18,900,000 voluntary medical male circumcisions (VMMC). Glans injuries (GIs) are rare but devastating adverse events (AEs) that can occur during circumcision. To address this issue, PEPFAR has supported multiple interventions in the areas of surveillance, policy, education, training, supply chain, and AE management. METHODS: Since 2015, PEPFAR has conducted surveillance of GIs including rapid investigation by the in-country PEPFAR team. This information is collected on standardized forms, which were reviewed for this analysis. RESULTS: Thirty-six GIs were reported from 2015 to 2018; all patients were < 15 years old (~ 0.7 per 100,000 VMMCs in this age group) with a decreasing annual rate (2015: 0.7 per 100,000 VMMCs; 2018: 0.4 per 100,000 VMMC; p = 0.02). Most (64%) GIs were partial or complete amputations. All amputations among 10-14 year-olds occurred using the forceps-guided (FG) method, as opposed to the dorsal-slit (DS) method, and three GIs among infants occurred using a Mogen clamp. Of 19 attempted amputation repairs, reattached tissue was viable in four (21%) in the short term. In some cases, inadequate DS method training and being overworked, were found. CONCLUSION: Following numerous interventions by PEPFAR and other stakeholders, GIs are decreasing; however, they have not been eliminated and remain a challenge for the VMMC program. Preventing further cases of complete and partial amputation will likely require additional interventions that prevent use of the FG method in young patients and the Mogen clamp in infants. Improving management of GIs is critical to optimizing outcomes.

Countries in Southern and Eastern Africa have the highest prevalence of human immunodeficiency virus (HIV) infection in the world; in 2015, 52% (approximately 19 million) of all persons living with HIV infection resided in these two regions.* Voluntary medical male circumcision (VMMC) reduces the risk for heterosexually acquired HIV infection among males by approximately 60% (1). As such, it is an essential component of the Joint United Nations Programme on HIV/AIDS (UNAIDS) strategy for ending acquired immunodeficiency syndrome (AIDS) by 2030 (2). Substantial progress toward achieving VMMC targets has been made in the 10 years since the World Health Organization (WHO) and UNAIDS recommended scale-up of VMMC for HIV prevention in 14 Southern and Eastern African countries with generalized HIV epidemics and low male circumcision prevalence (3).(dagger) This has been enabled in part by nearly $2 billion in cumulative funding through the President's Emergency Plan for AIDS Relief (PEPFAR), administered through multiple U.S. governmental agencies, including CDC, which has supported nearly half of all PEPFAR-supported VMMCs to date. Approximately 14.5 million VMMCs were performed globally during 2008-2016, which represented 70% of the original target of 20.8 million VMMCs in males aged 15-49 years through 2016 (4). Despite falling short of the target, these VMMCs are projected to avert 500,000 HIV infections by the end of 2030 (4). However, UNAIDS has estimated an additional 27 million VMMCs need to be performed by 2021 to meet the Fast Track targets (2). This report updates a previous report covering the period 2010-2012, when VMMC implementing partners supported by CDC performed approximately 1 million VMMCs in nine countries (5). During 2013-2016, these implementing partners performed nearly 5 million VMMCs in 12 countries. Meeting the global target will require redoubling current efforts and introducing novel strategies that increase demand among subgroups of males who have historically been reluctant to undergo VMMC.