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Male Circumcision and HIV Rates in Kenya

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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)

Tracking Information
First Submitted Date  ICMJE April 23, 2003
First Posted Date  ICMJE April 24, 2003
Last Update Posted Date May 30, 2008
Study Start Date  ICMJE February 2002
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2008)
  • HIV incidence [ Time Frame: 2 years ]
  • surgical complications [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00059371 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2008)
  • incidence of other sexually transmitted diseases [ Time Frame: 2 years ]
  • behavioral risks [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Male Circumcision and HIV Rates in Kenya
Official Title  ICMJE Trial of Male Circumcision to Reduce HIV Incidence
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE Procedure: male circumcision
Study Arms  ICMJE
  • Active Comparator: Circumcised immediately
    Intervention: 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.
    Intervention: Procedure: male circumcision
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
Actual Enrollment  ICMJE
 (submitted: May 28, 2008)
2887
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
3000
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 24 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00059371
Other Study ID Numbers  ICMJE 5U01AI050440-02( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carolyn Williams, Chief Epidemiology, NIAID
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert C. Bailey, PhD, MPH University of Illinois at Chicago
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date September 2007

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