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Male Circumcision Randomized controlled trial Johannesbourg – South Africa

Male Circumcision Randomized controlled trial Johannesbourg – South Africa. Adrian Puren NICD, South Africa Dirk Taljaard Progessus CC, South Africa Bertran Auvert - Emmanuel Lagarde INSERM, Paris, France Paris-Ouest medical school. Objective. Main:

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Male Circumcision Randomized controlled trial Johannesbourg – South Africa

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  1. Male Circumcision Randomized controlled trial Johannesbourg – South Africa Adrian Puren NICD, South Africa Dirk Taljaard Progessus CC, South Africa Bertran Auvert - Emmanuel Lagarde INSERM, Paris, France Paris-Ouest medical school

  2. Objective Main: To measure the effect of medicalized male circumcision on HIV infection in men aged 18-24 years in South Africa Secondary: HSV-2, genital ulceration

  3. Main hypothesis Male circumcision performed by physicians results in a 50% reduction of the incidence of HIV infection relative to the HIV incidence in uncircumcised men.

  4. Study Design RCT 2 arms (control – intervention) 3 centers (same area) 3500 participants Losing rate: 15% HIV incidence 2.2%/Year à 1.1% Initial HIV prevalence: 13% Power 80% (one tail) Follow up: 21 months Visits: M0, M3, M12 and M21 Duration of the study: 3 years

  5. Characteristics of MC in the population • MC Prevalence: 21% • 2/3 initiation school • 1/3 GPs, hospital, clinics • Median age at MC: 17 years • High potential and acceptability • Cross-sectional studies: • No protective effect

  6. Characteristics of MC in the RCT • - By local general practitioners (US$ 30). • Standard protocol developed by the Department of Urology of the University of Witwatersrand. • - Forceps Guided technique.

  7. Other characteristics of this RCT (1/2) Inclusion is independent of the HIV status Counseling at each visit MC will be proposed to each participant at the end of the follow up

  8. Other characteristics of this RCT (2/2) Main reason of participation: free MC 10 randomizations per day à 25? 700,000 US$ August 2002 à August 2005

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