Ecological and observational studies suggest that male circumcision reduces the risk
of HIV acquisition in men. Our aim was to investigate the effect of male circumcision
on HIV incidence in men.
4996 uncircumcised, HIV-negative men aged 15-49 years who agreed to HIV testing and
counselling were enrolled in this randomised trial in rural Rakai district, Uganda.
Men were randomly assigned to receive immediate circumcision (n=2474) or circumcision
delayed for 24 months (2522). HIV testing, physical examination, and interviews were
repeated at 6, 12, and 24 month follow-up visits. The primary outcome was HIV incidence.
Analyses were done on a modified intention-to-treat basis. This trial is registered
with ClinicalTrials.gov, with the number NCT00425984.
Baseline characteristics of the men in the intervention and control groups were much
the same at enrollment. Retention rates were much the same in the two groups, with
90-92% of participants retained at all time points. In the modified intention-to-treat
analysis, HIV incidence over 24 months was 0.66 cases per 100 person-years in the
intervention group and 1.33 cases per 100 person-years in the control group (estimated
efficacy of intervention 51%, 95% CI 16-72; p=0.006). The as-treated efficacy was
55% (95% CI 22-75; p=0.002); efficacy from the Kaplan-Meier time-to-HIV-detection
as-treated analysis was 60% (30-77; p=0.003). HIV incidence was lower in the intervention
group than it was in the control group in all sociodemographic, behavioural, and sexually
transmitted disease symptom subgroups. Moderate or severe adverse events occurred
in 84 (3.6%) circumcisions; all resolved with treatment. Behaviours were much the
same in both groups during follow-up.
Male circumcision reduced HIV incidence in men without behavioural disinhibition.
Circumcision can be recommended for HIV prevention in men.