Male Circumcision for HIV Prevention in Rakai, Uganda
Condition: HIV Infections; Herpesvirus 2, Human; Syphilis; Genital Diseases, Male
MeSH terms: Syphilis; Genital Diseases; Genital Diseases, Male
Study type: Interventional
Phase: Phase 3

Summary: 
      Circumcision in HIV unifected men may reduce the likelihood of becoming infected with HIV,
      reduce sexually transmitted infections (STIs) in men, not engender increases in sexual risk
      behaviors, and be acceptable to men as a procedure for preventing HIV. The purpose of this
      study is to evaluate circumcision in HIV uninfected men in terms of safety and ability to
      prevent HIV infection.
    

Detailed description: 
      South Africa has one of the most severe and fast-growing HIV epidemics in the world. Adult
      male circumcision may be an effective preventive measure to slow the spread of HIV and other
      STIs. This study will assess the efficacy of circumcision in HIV uninfected men in preventing
      HIV and STI acquisition.

      This study will have two stages. In the first stage, 200 men will be enrolled into a study of
      the acceptability, feasibility, and safety of circumcision. Frequent postoperative follow-up
      will occur to determine rates of healing and complications. After assessment of those
      enrolled in Stage 1, Stage 2 enrollment will begin. Stage 2 will determine the efficacy of
      circumcision in preventing HIV acquisition. In both stages, HIV uninfected men will be
      randomly assigned to have either immediate circumcision or possible circumcision 2 years
      following Stage 2 study entry. The participants not receiving immediate circumcision will be
      offered circumcision after completion of 2 years of follow-up study, provided there is
      evidence of the efficacy of this procedure at that time. If efficacy is still unknown after 2
      years of follow-up, participants will be given the option of circumcision at the completion
      of the trial.

      Postoperative follow-up visits will be scheduled between 24 to 48 hours, 5 to 9 days, and 4
      to 6 weeks. At each postoperative visit, participants will be questioned about symptoms
      suggestive of complications, and the area operated on will be inspected. Participants will be
      asked about resumption of sexual intercourse, and those who have resumed sexual intercourse
      will be asked about condom use. Study visits will be also conducted regarding risk behaviors
      and symptoms of STIs, and these will occur sometime between Weeks 4 to 6, and at Months 6,
      12, and 24 post-enrollment. At each study visit, assessment of circumcision status and penile
      pathology; blood, urine, and penile swabs collection; and HIV testing will occur, and
      counseling and health education will be provided.
    

Intervention name(s): Adult male circumcision
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; Male circumcision; Sexually transmitted infections; Sexual risk behaviors; Adult males; Haemophilus ducreyi; Human papillomavirus; Rakai; Uganda; HIV seronegativity; HPV; STI