Male Circumcision and HIV Rates in Kenya
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Trial of Male Circumcision to Reduce HIV Incidence|
- HIV incidence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- surgical complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- 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 ]
|Study Start Date:||February 2002|
|Study Completion Date:||December 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
|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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059371
|Principal Investigator:||Robert C. Bailey, PhD, MPH||University of Illinois at Chicago|