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Male Circumcision and HIV Rates in Kenya

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: NCT00059371
Recruitment Status : Completed
First Posted : April 24, 2003
Last Update Posted : May 30, 2008
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Brief Summary:
The Luo tribe of Kisumu, Kenya, does not traditionally practice male circumcision (MC). This study will work with the Luo tribe to test the effectiveness of MC on reducing the risk of HIV infections in young men.

Condition or disease Intervention/treatment Phase
HIV Infections Procedure: male circumcision Phase 3

Detailed Description:

Since 1989, numerous epidemiological studies have reported a significant association between lack of male circumcision (MC) and risk for HIV infection through heterosexual intercourse. These results have led to calls for male circumcision to be considered as an additional HIV prevention strategy. However, there is a consensus among the international health community that a randomized controlled trial of MC is needed to control for possible confounding factors. Additionally, known risks associated with MC need further investigation. This study will assess the effectiveness of male circumcision in reducing HIV incidence and will evaluate complications of the MC procedure, changes in sexual behavior following circumcision, and the biological mechanisms by which the foreskin may increase HIV susceptibility. The study will be conducted in Kisumu, Kenya, where the Luo tribe is the main ethnic group and less than 10% of adult men are circumcised.

Uncircumcised men aged 18 to 24 years old will be offered voluntary HIV counseling and testing. HIV negative men will be asked to enroll in the study. All study participants will be interviewed to obtain socio-demographic information and assess behavioral risk factors. Participants will be examined for significant medical conditions. All men will be counseled in strategies to reduce their risk for HIV infection. Consenting men will be randomly assigned to either the treatment (circumcised) arm or the control (uncircumcised) arm of the study. After circumcision, men will be monitored for complications. They will be counseled to abstain from sex until healing is complete. Follow-up visits will occur every 6 months for 2 years. Uncircumcised men will be offered circumcision at the end of follow-up.

The primary study endpoints will be HIV incidence and surgical complications. Additional outcomes will be the incidence of other sexually transmitted diseases and behavioral risks. Additional laboratory studies of foreskin tissue will evaluate the number and density of specialized cells rich in HIV receptors in order to illuminate the biological mechanisms by which presence of foreskin may increase HIV susceptibility.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2887 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Trial of Male Circumcision to Reduce HIV Incidence
Study Start Date : February 2002
Actual Primary Completion Date : October 2006
Actual 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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Arm Intervention/treatment
Active Comparator: Circumcised immediately Procedure: male circumcision
Placebo Comparator: Delayed Circumcision
Men who were randomized to delayed circumcision were scheduled to be offered male circumcision 2 years after their randomization.
 Procedure: male circumcision


Outcome Measures
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Primary Outcome Measures :
  1. HIV incidence [ Time Frame: 2 years ]
  2. surgical complications [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. incidence of other sexually transmitted diseases [ Time Frame: 2 years ]
  2. behavioral risks [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • HIV uninfected and willing to be tested
  • Live in Kisumu District, Kenya
  • Uncircumcised but willing to be circumcised
  • At least one sexual partner in the 12 months prior to study entry
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): NCT00059371


Locations
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Kenya
UNIM Clinic
Kisumu, Kenya
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Robert C. Bailey, PhD, MPH University of Illinois at Chicago
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Carolyn Williams, Chief Epidemiology, NIAID
ClinicalTrials.gov Identifier: NCT00059371    
Other Study ID Numbers: 5U01AI050440-02 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2003    Key Record Dates
Last Update Posted: May 30, 2008
Last Verified: September 2007
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Male circumcision
HIV acquisition
Sexually transmitted infection
HIV Seronegativity
Additional relevant MeSH terms:
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HIV Infections
Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases