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

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.

Cost and Impact of Voluntary Medical Male Circumcision in South Africa: Focusing the Program on Specific Age Groups and Provinces.

BACKGROUND: In 2012, South Africa set a goal of circumcising 4.3 million men ages 15-49 by 2016. By the end of March 2014, 1.9 million men had received voluntary medical male circumcision (VMMC). In an effort to accelerate progress, South Africa undertook a modeling exercise to determine whether circumcising specific client age groups or geographic locations would be particularly impactful or cost-effective. Results will inform South Africa's efforts to develop a national strategy and operational plan for VMMC. METHODS AND FINDINGS: The study team populated the Decision Makers' Program Planning Tool, Version 2.0 (DMPPT 2.0) with HIV incidence projections from the Spectrum/AIDS Impact Module (AIM), as well as national and provincial population and HIV prevalence estimates. We derived baseline circumcision rates from the 2012 South African National HIV Prevalence, Incidence and Behaviour Survey. The model showed that circumcising men ages 20-34 offers the most immediate impact on HIV incidence and requires the fewest circumcisions per HIV infection averted. The greatest impact over a 15-year period is achieved by circumcising men ages 15-24. When the model assumes a unit cost increase with client age, men ages 15-29 emerge as the most cost-effective group. When we assume a constant cost for all ages, the most cost-effective age range is 15-34 years. Geographically, the program is cost saving in all provinces; differences in the VMMC program's cost-effectiveness across provinces were obscured by uncertainty in HIV incidence projections. CONCLUSION: The VMMC program's impact and cost-effectiveness vary by age-targeting strategy. A strategy focusing on men ages 15-34 will maximize program benefits. However, because clients older than 25 access VMMC services at low rates, South Africa could consider promoting demand among men ages 25-34, without denying services to those in other age groups. Uncertainty in the provincial estimates makes them insufficient to support geographic targeting.