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Trial record 48 of 1948 for:    Sexually Transmitted Diseases | NIH

Male Circumcision for HIV Prevention in Rakai, Uganda

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ClinicalTrials.gov Identifier: NCT00425984
Recruitment Status : Completed
First Posted : January 24, 2007
Last Update Posted : August 24, 2007
Sponsor:
Collaborator:
John E. Fogarty International Center (FIC)
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE January 23, 2007
First Posted Date  ICMJE January 24, 2007
Last Update Posted Date August 24, 2007
Study Start Date  ICMJE August 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2007)
  • HIV acquisition
  • safety of circumcision
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00425984 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2007)
  • Sexually transmitted infections
  • sexual risk behaviors
  • acceptability
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Male Circumcision for HIV Prevention in Rakai, Uganda
Official Title  ICMJE Randomized Trial of Male Circumcision for HIV Prevention, Rakai, Uganda
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV Infections
  • Herpesvirus 2, Human
  • Syphilis
  • Genital Diseases, Male
Intervention  ICMJE Procedure: Adult male circumcision
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 23, 2007)
5000
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 15 Years to 49 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00425984
Other Study ID Numbers  ICMJE U1AI171-1-02
U1 AII 171-01-02
U1 AI 171-1-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE John E. Fogarty International Center (FIC)
Investigators  ICMJE
Principal Investigator: Ronald H. Gray, MD Department of Population, Family and Reproductive Health Sciences, Bloomberg School of Public Health, Johns Hopkins University
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date August 2007

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