Reduction of HIV Infection Risk RCT published

Randomized, Controlled Intervention Trial of Male Circumcision for
Reduction of HIV Infection Risk: The ANRS 1265 Trial


ABSTRACT

Background

Observational studies suggest that male circumcision may provide
protection against HIV-1 infection. A randomized, controlled
intervention trial was conducted in a general population of South Africa
to test this hypothesis.
Methods and Findings

A total of 3,274 uncircumcised men, aged 18–24 y, were randomized to a
control or an intervention group with follow-up visits at months 3, 12,
and 21. Male circumcision was offered to the intervention group
immediately after randomization and to the control group at the end of
the follow-up. The grouped censored data were analyzed in
intention-to-treat, univariate and multivariate, analyses, using
piecewise exponential, proportional hazards models. Rate ratios (RR) of
HIV incidence were determined with 95% CI. Protection against HIV
infection was calculated as 1 − RR. The trial was stopped at the interim
analysis, and the mean (interquartile range) follow-up was 18.1 mo
(13.0–21.0) when the data were analyzed. There were 20 HIV infections
(incidence rate = 0.85 per 100 person-years) in the intervention group
and 49 (2.1 per 100 person-years) in the control group, corresponding to
an RR of 0.40 (95% CI: 0.24%–0.68%; p 0.001). This RR corresponds to a
protection of 60% (95% CI: 32%–76%). When controlling for behavioural
factors, including sexual behaviour that increased slightly in the
intervention group, condom use, and health-seeking behaviour, the
protection was of 61% (95% CI: 34%–77%).


Conclusion

Male circumcision provides a degree of protection against acquiring HIV
infection, equivalent to what a vaccine of high efficacy would have
achieved. Male circumcision may provide an important way of reducing the
spread of HIV infection in sub-Saharan Africa. (Preliminary and partial
results were presented at the International AIDS Society 2005
Conference, on 26 July 2005, in Rio de Janeiro, Brazil.)


Full text at:
http://medicine.plosjournals.org/per...l.pmed.0020298