E. African Male Circumcision Trials Halted for Ethical Reasons
Today from the National Institute of Allergy and Infectious Diseases
“Trials in Kenya and Uganda Stopped Early”
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced an early end to two clinical trials of adult male circumcision because an interim review of trial data revealed that medically performed circumcision significantly reduces a man’s risk of acquiring HIV through heterosexual intercourse. The trial in Kisumu, Kenya, of 2,784 HIV-negative men showed a 53 percent reduction of HIV acquisition in circumcised men relative to uncircumcised men, while a trial of 4,996 HIV-negative men in Rakai, Uganda, showed that HIV acquisition was reduced by 48 percent in circumcised men.
“These findings are of great interest to public health policy makers who are developing and implementing comprehensive HIV prevention programs,” says NIH Director Elias A. Zerhouni, M.D. “Male circumcision performed safely in a medical environment complements other HIV prevention strategies and could lessen the burden of HIV/AIDS, especially in countries in sub-Saharan Africa where, according to the 2006 estimates from UNAIDS, 2.8 million new infections occurred in a single year.”
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Both trials reached their enrollment targets by September 2005 and were originally designed to continue follow-up until mid-2007. However, at the regularly scheduled meeting of the NIAID Data and Safety Monitoring Board (DSMB) on December 12, 2006, reviewers assessed the interim data and deemed medically performed circumcision safe and effective in reducing HIV acquisition in both trials. They therefore recommended the two studies be halted early. All men who were randomized into the non-intervention arms will now be offered circumcision.
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For more information on the Kenyan and Ugandan trials of adult male circumcision, see the NIAID Questions and Answers document at http://www3.niaid.nih.gov/news/QA/AMC12_QA.htm.
Filed under: Epidemiology
Amy Patterson in her new book says that this technical solution won’t confront the problem of male domination and forced sex in Africa. This is true, but in my view, it’s still a good thing to have a technical means to reduce HIV while trying to change long-run patterns of male domination. If people are not going to be regular wearers of condoms and still engage in some risky behavior and if women are not in a position to demand that their partners use a condom, then if this prevents transmission to women, then that is good news.
Male circumcision is a much better option than any prophylaxis that requires constant conscious rededication to healthy behavior change. There simply is a much smaller margin for error in an high prevalence HIV population. Large-scale circumcision may be the most effective biologic mechanism, short of a highly efficacious vaccine, to reduce the HIV rate of transmission across the board allowing policymakers to focus other more resource intensive interventions on high risk groups.
[…] Yesterday, the NIH announced that it was suspending male circumcision trials. Because the trials were so successful, the NIH determined it was unethical to continue with additional rounds of treatment and control groups. The trial in Kisumu, Kenya, of 2,784 HIV-negative men showed a 53 percent reduction of HIV acquisition in circumcised men relative to uncircumcised men, while a trial of 4,996 HIV-negative men in Rakai, Uganda, showed that HIV acquisition was reduced by 48 percent in circumcised men. […]
I find it quite sad and peculiar that even though HIV is a plague in Africa, the cathlitc church still advocates sex without condoms 🙁
Tel Aviv
“The trial in Kisumu, Kenya, of 2,784 HIV-negative men showed a 53 percent reduction of HIV acquisition in circumcised men relative to uncircumcised men”
This is good news. Any idea why this is? Is it because circumcision prevents the trapping of bacteria, etc?
HIV is a real problem there and if stats show 53 percent of decreasing – thats a hope for all!