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National Institutes of Health Halts Two Studies on Male Circumcision and HIV

On Wednesday, December 13, the National Institutes of Health (NIH) announced it was stopping two clinical trials in Kenya and Uganda examining potential protective effects of male circumcision against HIV infection.1  According to data released by NIH, male circumcision was found to reduce a man’s risk of acquiring HIV by up to 50%.  Over 6,000 previously uncircumcised men ages 15–49 from Uganda and Kenya were enrolled in the study; half of the participants were randomly assigned to be circumcised and the other half acted as a control group, remaining uncircumcised.  The results of the study were so significant that researchers halted the study early and offered circumcision to all participants.

The results of the Kenyan and Ugandan studies were similar to results of an earlier South African study which found that risk of contracting HIV through sexual intercourse with a woman was reduced by up to 60% for men randomly assigned to be circumcised.  In fact, the South African study was also stopped early because researchers felt it was unethical to proceed given the strong risk reduction offered by circumcision.2

United States organizations focused on global HIV/AIDS were quick to voice their support for the studies’ findings.  Mark Dybul, the United States Global AIDS coordinator who oversees the President’s Emergency Plan for AIDS Relief (PEPFAR) said that, if world health agencies recommend it, PEPFAR “will support implementation of safe medical male circumcision.”  Richard Feachmen, executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, expressed his agency’s excitement at the news and said it was likely that if countries submitted plans to carry out sterile circumcisions, the Global Fund’s technical panel would give full approval. The U.S. Centers for Disease Control and Prevention changed its fact sheet on Male Circumcision and HIV the day after NIH’s announcement to include the study results. 

Although no agencies or governments have publicly embraced male circumcision as a panacea against HIV transmission, the zeal with which the NIH’s news has been greeted makes the need for guidance on implementation even more pressing.  Several organizations and countries have indicated their willingness to modify long-standing prevention policies based on the study findings.  Kenya, for example, announced only four days after NIH publicized the study findings, that government health authorities had already begun devising a national policy to promote male circumcision as an HIV-prevention strategy.3  In addition, on December 20, Peter Piot, UNAIDS chief, recommended that sub-Saharan African countries hardest hit by the AIDS epidemic should “now prepare how to introduce circumcision on a large scale.”4

Piot’s remarks urging implementation of mass male circumcision followed what was initially a guarded welcome of the NIH news by the United Nations Health Agencies.  In a press release issued on December 13, the U.N. said it would draw up a panel of experts to develop guidelines on the implications of the study findings out of concern that it “will be necessary to prevent people from developing a false sense of security and, as a result, engaging in high risk behaviors which could negate the protective effect of male circumcision.”5  The U.N. stressed that any guidelines should “take into account cultural and human rights considerations; the risk of complications from the procedure performed in various settings; the potential to undermine existing protective behaviors and strategies; and the fact that the ideal and well-resourced conditions of a randomized trial are often not replicated in other settings.”6

Of all the new technologies being studied to combat HIV/AIDS—including vaccines, microbicides, and other female barrier methods—circumcision is the only surgical tool that has been shown to reduce risk of contracting HIV.  The fact that circumcision is a surgical method, however, raises biomedical ethics issues when discussing the transition of implementation from a controlled randomized trial environment to everyday use in resource-strapped countries where trained health care workers and sterile medical supplies may be in short supply.   In addition, government development of mass circumcision programs for both infant and adult males revives discussions about bodily integrity and human rights.7

Many advocates of comprehensive HIV-prevention programs are also concerned that promotion of circumcision will give men a false sense of security and undermine other evidenced-based prevention messages, particularly messages about the importance of using condoms.8   Given that condom usage in many of the hardest hit sub-Saharan African countries is already extremely low, developers of prevention messages must be careful to promote circumcision as part of a comprehensive education so as not to increase risky behavior.

“We must be extremely vigilant in ensuring that male circumcision is not presented as a panacea,” said William Smith, vice president for public policy at SIECUS.  “Current U.S.-funded HIV-prevention messages purporting to support a balanced ABC (abstinence, be-faithful and condom use) approach have, in reality, focused on promoting abstinence and be-faithful messages to the detriment of condom promotion.  We must make sure that male circumcision as a method of prevention is included in—but does not overtake—other proven comprehensive sexuality education and HIV-prevention messages. We do not want the C in ABC to stand for circumcision rather than condoms.”

For more information about male circumcision and the implications of the NIH findings, see A New Way to Protect Against HIV? Anticipating Results of Male Circumcision Studies for AIDS Prevention at www.avac.org

For more information about current U.S. funded HIV-prevention programs under the President’s Emergency Plan for AIDS Relief, see SIECUS’ PEPFAR Country Profiles at http://www.siecus.local/inter/pepfar.

References

  1. National Institutes of Health, “Adult Male Circumcision Significantly Reduces Risk of Acquiring HIV:Trials in Kenya and Uganda Stopped Early,” Press Release published 13 December 2006, accessed 22 December 2006, <http://www3.niaid.nih.gov/news/newsreleases/2006/AMC12_06.htm >.
  2. “Routine Male Circumcision Could Reduce a Man’s HIV Infection Risk by about 50 Percent, According to Studies Conducted in Kenya, Uganda,” Kaiser Daily HIV/AIDS Report, 14 December 2006 <http://www.kaisernetwork.org/daily_reports/rep_index.cfm?hint=1&DR_ID=41653>.
  3. “Kenya Seeks to Promote Male Circumcision to Reduce HIV/AIDS Infections,” Xinhua General News Service, 08 December 2006, accessed 21 December 2006,  <www.pushjournal.com>.
  4. Kamil Zaheer, “UN urges circumcision in AIDS-hit southern Africa,” Reuters, 19 December 2006, <www.reuters.com >.
  5. United Nations, “Joint Statement on Kenyan and Ugandan Trial Findings Regarding Male Circumcision and HIV,” Press Release published 13 December 2006, accessed 21 December 2006, < http://www.unfpa.org/news/news.cfm?ID=917 >.
  6. Ibid.
  7. See “Declaration of the International Coalition for Genital Integrity,” 3 September 2006, accessed 21 December 2006, <http://www.icgi.org/declaration/ >.
  8. See A New Way to Protect Against HIV? Anticipating Results of Male Circumcision Studies for AIDS Prevention, (Washington, DC: AIDS Vaccine Advocacy Coalition, 13 December 2006), accessed 21 December 2006, <http://www.avac.org> ; “International AIDS Society Statement on New Studies Showing that Male Circumcision Substantially Reduces the Risk of HIV Infection Among Men,” International AIDS Society, 18 December 2006, accessed 21 December 2006,<www.ias.org >.