Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Male Circumcision and HIV Rates in Kenya

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00059371
First received: April 23, 2003
Last updated: May 28, 2008
Last verified: September 2007

April 23, 2003
May 28, 2008
February 2002
October 2006   (final data collection date for primary outcome measure)
  • HIV incidence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • surgical complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00059371 on ClinicalTrials.gov Archive Site
  • incidence of other sexually transmitted diseases [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • behavioral risks [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Male Circumcision and HIV Rates in Kenya
Trial of Male Circumcision to Reduce HIV Incidence

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
Procedure: male circumcision
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2887
December 2006
October 2006   (final data collection date for primary outcome measure)

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
Male
18 Years to 24 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT00059371
5U01AI050440-02
No
Carolyn Williams, Chief Epidemiology, NIAID
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Robert C. Bailey, PhD, MPH University of Illinois at Chicago
National Institute of Allergy and Infectious Diseases (NIAID)
September 2007

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