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Male Circumcision for HIV Prevention in Rakai, Uganda

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00425984
Recruitment Status : Completed
First Posted : January 24, 2007
Last Update Posted : August 24, 2007
Sponsor:
Collaborator:
Fogarty International Center of the National Institute of Health
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Herpesvirus 2, Human Syphilis Genital Diseases, Male Procedure: Adult male circumcision Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Trial of Male Circumcision for HIV Prevention, Rakai, Uganda
Study Start Date : August 2002
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. HIV acquisition
  2. safety of circumcision

Secondary Outcome Measures :
  1. Sexually transmitted infections
  2. sexual risk behaviors
  3. acceptability

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425984


Locations
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Uganda
Rakai Health Sciences Program, P.O. Box 279
Kalisizo Town, Rakai, Uganda
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Fogarty International Center of the National Institute of Health
Investigators
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Principal Investigator: Ronald H. Gray, MD Department of Population, Family and Reproductive Health Sciences, Bloomberg School of Public Health, Johns Hopkins University
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00425984    
Other Study ID Numbers: U1AI171-1-02
U1 AII 171-01-02
U1 AI 171-1-02
First Posted: January 24, 2007    Key Record Dates
Last Update Posted: August 24, 2007
Last Verified: August 2007
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV
Male circumcision
Sexually transmitted infections
Sexual risk behaviors
Adult males
Haemophilus ducreyi
 Human papillomavirus
Rakai
Uganda
HIV seronegativity
HPV
STI
Additional relevant MeSH terms:
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Syphilis
Genital Diseases
Genital Diseases, Male
Infections
Communicable Diseases
Sexually Transmitted Diseases
Urogenital Diseases
 Treponemal Infections
Spirochaetales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Sexually Transmitted Diseases, Bacterial
Male Urogenital Diseases