Summarising Male Circumcision Efficacy Results of the three

Summarising Male Circumcision Efficacy: Results of the three randomised clinical trials Neil A Martinson Perinatal HIV Research Unit

Three Randomised Control Trials of Male Circumcision • Orange Farm – South Africa • Kisumu – Kenya Feb 2007 • Rakai – Uganda Feb 2007 Today: Feb 2010 Nov 2005

Efficacy • How well an intervention works when studied in under rigorous conditions of a RCT. • Percentage reduction in disease events by providing the intervention. • Control group/arm– no circumcision • Intervention group/arm- circumcision (but in all other respects groups are v. v. similar)

Conditions of a trial • • Well funded Excellent staff – trained and supervised Adverse events reported immediately Monitors – oversee every aspect of the trial • • Participants in trial ≠ general population Numerous: visits, samples, questions No visit – immediately triggers retrieval More attention than real life (safe sex).

Answers of a trial Under “ideal” conditions • Is circumcision better than not circumcising? • If better, by how much? • Is it safe?

Trial jargon • Male circumcision – removal of virtually all penile foreskin by a trained health worker using sterile surgical techniques. • Randomisation: Subjects allocated to intervention or control group by chance (but in equal numbers). • HIV acquisition: becoming infected with HIV • Adverse event: unwanted side effect of intervention

The three studies: design HIV negative men Randomised Circ No circ Follow up 6 mo Follow up 12 mo Follow up 18 mo Final HIV Assessment @ 24 mo Circ

Results 1: Orange Farm Overall efficacy of male circumcision in preventing HIV acquisition by young men: 60% 3. 6% had an adverse event related to circ Auvert et al PLo. S Medicine 2005

Results 2: Rakai - Uganda Overall efficacy of male circumcision in preventing HIV acquisition: 55% 8% had adverse event related to circ. Time Circ group Uncirc group 0 -6 months 1. 2% 1. 6% 6 -12 0. 4% 1. 2% 12 -24 0. 3% 1. 2% ALL 0. 7% 1. 3% Gray et al Lancet 2007

Results 3: Kisumu - Kenya Overall efficacy of male circumcision in preventing HIV acquisition: 53% 1. 7% adverse events related to circ Time interval Circ group Uncirc group 0 -6 months 0. 8% 1% 6 -12 0. 2% 1. 4% 12 -18 0% 0. 7% 18 -24 1% 1. 2% ALL 2. 1% 4. 2%

Combining all 3 “ The results indicate compelling evidence that male circumcision, when conducted using a medical procedure, reduces the acquisition of HIV by heterosexual men by between 38% and 66% over 24 months. Incidence of adverse events is very low, indicating that male circumcision, when conducted under these conditions, is a safe procedure. “ Siegfried N et al Cochrane Database 2009

Benefits restricted to men! • A trial of circumcising HIV-infected men showed no reduction in HIV acquisition by female partners of circumcised men. • Those who resumed sex early were at higher risk of acquiring HIV from their male partner. Wawer M et al Lancet 2009

What else is there to prevent HIV? • Behaviour changes (ABC) – Condom use – Reduce concurrent partners – Delay sexual debut • • • Vaginal Microbicides Barriers (condoms and diaphragms) Vaccines Pre exposure prophylaxis Treatment as prevention

Thank you for your attention

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