Male Circumcision and HIV Rates in Kenya
| Tracking Information | |||||
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| First Received Date ICMJE | April 23, 2003 | ||||
| Last Updated Date | May 28, 2008 | ||||
| Start Date ICMJE | February 2002 | ||||
| Primary Completion Date | October 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| 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 |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE | Procedure: male circumcision | ||||
| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 2887 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | October 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria
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| Gender | Male | ||||
| Ages | 18 Years to 24 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Kenya | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00059371 | ||||
| Other Study ID Numbers ICMJE | 5U01AI050440-02 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Carolyn Williams, Chief Epidemiology, NIAID | ||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Verification Date | September 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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