Factors Associated with the Safety of Voluntary Medical Male Circumcision in Nyanza Province, Kenya/Facteurs Associes a L'innocuite De la Circoncision Masculine Medicale Volontaire Dans la Province De Nyanza, Kenya/Factores Asociados Con la Seguridad De la Circuncision Medica Masculina Voluntaria En la Provincia De Nyanza, Kenya

Article excerpt

Introduction

Medical male circumcision is the surgical removal of the foreskin of the penis by a trained health professional. The results of three randomized controlled trials (RCTs) have demonstrated that medical male circumcision reduces the incidence of infection with Type 1 human immunodeficiency virus (HIV-1) in heterosexual men by at least one half. (1-3) As a result, the World Health Organization and the Joint United Nations Programme on HIV/AIDS recommend voluntary medical male circumcision (VMMC) as one component of a comprehensive preventive strategy in regions with low male circumcision rates and a high prevalence of HIV-1 infection and where heterosexual sex is the main mode of transmission. (4)

Despite the endorsement of VMMC for the prevention of HIV infection, safety became a concern once mass programmes were implemented in resource-limited settings. In developed countries, adverse events following neonatal circumcision are well documented anal their incidence is very low, from 0.2 to 0.6%. (5) Before the RCTs, outcomes in Africa for male circumcision among adults were poorly documented. In a review, (6) adverse event rates following African male circumcisions ranged from 0 to 24%. The RCTs, which provided services in a clinical trial setting, reported the following adverse event rates: 3.8% in Orange Farm, South Africa; 1.5% in Kisumu, Kenya; and 3.6% in Rakai, Uganda. (1,7,8) Most recently, at the former Orange Farm RCT site, 1.8% of medical male circumcisions offered in one high-volume facility resulted in an adverse event. (9)

Historically, intra- and post-operative adverse events have been detected through passive or active surveillance systems. Passive systems rely on providers to report adverse events on a standardized form. Although passive systems have advantages, such as their low cost, they also have limitations in terms of timeliness, completeness and positive predictive value. (10-12) Active surveillance involves outreach by a provider to identify and report health events. Many believe that active surveillance produces better data than passive systems (11) and is most feasible on a small scale where resources are scarce. (13) Currently, the surveillance of surgical procedures is conducted in developed countries and is primarily passive and restricted to in-patient monitoring of surgical site infections. (14-16) However, the number of surgical procedures being provided on an out-patient basis in resource-limited settings, such as medical male circumcision, is increasing. This creates the need for new approaches to post-discharge surveillance. (17)

To our knowledge, no research has been published to date on clinical outcomes from a large-scale, multi-site VMMC programme in a resource-limited setting. In this study, passive and active surveillance methods were used to monitor factors, including provider characteristics, potentially associated with the incidence of adverse events occurring during and after VMMC procedures provided as part of the national programme for the prevention of HIV infection.

Methods

Study context

The Government of Kenya launched the national VMMC programme in Nyanza province in November 2008 and plans to have circumcised 860000 males by 2013. (18) Nyanza province is the geographic home of the Luo ethnic group. Luo men do not traditionally practice male circumcision and have a relatively high prevalence of HIV infection; 21.5% of Luo men are circumcised and 17.1% are HIV-positive, compared with 85.9% and 4.6% of Kenyan males, respectively. (19)

Study design and participants

The study design and recruitment procedures were detailed in a previous paper. (20) In summary, VMMC clients 12 years of age or older in 16 study facilities in Nyanza province, Kenya, were followed between November 2008 and March 2010 to detect any adverse events occurring during the procedure or within the following 45 days. …