Background

Male circumcision could provide substantial protection against acquisition of HIV-1 infection. Our aim was to determine whether male circumcision had a protective effect against HIV infection, and to assess safety and changes in sexual behaviour related to this intervention.

Methods

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. HIV seroincidence was estimated in an intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, with the number NCT00059371.

Findings

The trial was stopped early on December 12, 2006, after a third interim analysis reviewed by the data and safety monitoring board. The median length of follow-up was 24 months. Follow-up for HIV status was incomplete for 240 (8·6%) participants. 22 men in the intervention group and 47 in the control group had tested positive for HIV when the study was stopped. The 2-year HIV incidence was 2·1% (95% CI 1·2–3·0) in the circumcision group and 4·2% (3·0–5·4) in the control group (p=0·0065); the relative risk of HIV infection in circumcised men was 0·47 (0·28–0·78), which corresponds to a reduction in the risk of acquiring an HIV infection of 53% (22–72). Adjusting for non-adherence to treatment and excluding four men found to be seropositive at enrolment, the protective effect of circumcision was 60% (32–77). Adverse events related to the intervention (21 events in 1·5% of those circumcised) resolved quickly. No behavioural risk compensation after circumcision was observed.

Interpretation

Male circumcision significantly reduces the risk of HIV acquisition in young men in Africa. Where appropriate, voluntary, safe, and affordable circumcision services should be integrated with other HIV preventive interventions and provided as expeditiously as possible.