University of Nairobi, Illinois, and Manatoba (UNIM)

Lumumba Health Center

Ondiek Highway – Off Stadium Road

P. O. Box 1764, Kisumu

Phone: 254 - 057 - 2024065

Fax: 254 - 057 - 2022984

Email: onyango@unimkenya.org

Website: unim.rti.org

UNIM project (representing a partnership between the Universities of Nairobi, Illinois, and Manitoba) was the site of a randomized control trial to assess the protective effect of male circumcision against HIV acquisition in men. Details of the study follow:

Male circumcision could provide substantial protection against acquisition of HIV-1 infection. The purpose of the research was to assess using a randomized, unblinded study design, whether male circumcision can reduce HIV incidence in 18-24 year-old men by 50% or more in the treatment (circumcision) group versus controls. In addition, this research was aimed to assess complication rates due to the circumcision procedure, and whether circumcised men engage in behaviours that expose them to greater risk of HIV infection than controls.

We did a randomised controlled trial of 2784 men aged 18-24 years in Kisumu, Kenya. Men were randomly assigned to an intervention group (circumcision; n=1391) or a control group (delayed circumcision, 1393), and assessed by HIV testing, medical examinations, and behavioural interviews during follow-ups at 1, 3, 6, 12, 18, and 24 months. All men were counselled in strategies to reduce their risk for HIV. The primary endpoints were HIV incidence and surgical complications. Additional outcomes were STD incidence and behavioural risk. The sample size was sufficient to detect a 50% reduction in HIV incidence among circumcised men over two years, assuming 2.5% annual HIV incidence in the control arm and 15% loss to follow-up. HIV seroincidence was estimated in an intention-to-treat analysis.

The trial was stopped early on December 12, 2006, after a third interim analysis reviewed by the data and safety monitoring board. All participants, including controls, were offered male circumcision beginning December 15, 2006. Both circumcision and control group participants currently enrolled in the study will continue coming to the clinic for their regularly scheduled follow up visits until September, 2009.

Male circumcision was found to significantly reduce the risk of HIV acquisition in young men in Kisumu, Kenya. The results of this study were similar to two other published randomized, controlled trials investigating the same association. As a result, where appropriate, voluntary, safe, and affordable circumcision services should be integrated with other HIV preventive interventions and provided as expeditiously as possible.

The results of the RCT were published in the Lancet in February, 2007.

The RCT was stopped by the Data Safety and Monitoring Board (DSMB) in December, 2006. Since that time, a portion of the original cohort (i.e. approximately 1,700 men) continue their follow-up in order to monitor long-term effect of circumcision on HIV acquisition. In addition to research, UNIM is engaged with a number of activities:

1. UNIM now serves as a reproductive health clinic for young men and women in the community. It provides STI diagnosis and treatment, voluntary counselling and testing for HIV, behavioural change counselling, and training of health personnel to offer male circumcision
2. UNIM serves as the Male Circumcision Research and Training Center for the MC Program.