Trial record 1 of 1 for:    NCT00425984
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Male Circumcision for HIV Prevention in Rakai, Uganda

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00425984
First received: January 23, 2007
Last updated: August 23, 2007
Last verified: August 2007

January 23, 2007
August 23, 2007
August 2002
Not Provided
  • HIV acquisition
  • safety of circumcision
Same as current
Complete list of historical versions of study NCT00425984 on ClinicalTrials.gov Archive Site
  • Sexually transmitted infections
  • sexual risk behaviors
  • acceptability
Same as current
Not Provided
Not Provided
 
Male Circumcision for HIV Prevention in Rakai, Uganda
Randomized Trial of Male Circumcision for HIV Prevention, Rakai, Uganda

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infections
  • Herpesvirus 2, Human
  • Syphilis
  • Genital Diseases, Male
Procedure: Adult male circumcision
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5000
December 2006
Not Provided

Inclusion Criteria:

  • HIV uninfected
  • Willing to receive HIV results
  • Willing to be circumcised
  • Parent or guardian willing to provide informed consent if applicable
  • Hemoglobin of 8 grams/dl or less
  • Intend to stay in Rakai, Uganda, for at least 1 year and are available for follow-up for 1 year

Exclusion Criteria:

  • Already circumcised or partially circumcised
  • Anatomical abnormality of the penis (e.g., hypospadias, severe phimosis) that may put the participant at risk if circumcised
  • Medical conditions that require therapeutic circumcision
  • Medical condition that contraindicates surgery or use of local anesthesia
Male
15 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT00425984
U1AI171-1-02, U1 AII 171-01-02, U1 AI 171-1-02
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
John E. Fogarty International Center (FIC)
Principal Investigator: Ronald H. Gray, MD Department of Population, Family and Reproductive Health Sciences, Bloomberg School of Public Health, Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP