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Critique of African RCTs into Male Circumcision and HIV Sexual Transmission

  • Gregory J. BoyleEmail author
Chapter

Abstract

On the basis of three seriously flawed sub-Saharan African randomized clinical trials into female-to-male (FTM) sexual transmission of HIV, in 2007 WHO/UNAIDS recommended circumcision (MC) of millions of African men as an HIV preventive measure, despite the trials being compromised by irrational motivated reasoning, inadequate equipoise, selection bias, inadequate blinding, problematic randomization, trials stopped early with exaggerated treatment effects, and failure to investigate non-sexual transmission. Several questions remain unanswered. Why were the trials carried out in countries where more intact men were HIV+ than in those where more circumcised men were HIV+? Why were men sampled from specific ethnic subgroups? Why were so many men lost to follow-up? Why did men in the intervention group receive additional counselling on safe sex practices? The absolute reduction in HIV transmission associated with MC was only 1.3 % (without even adjusting for known sources of error bias). Relative reduction was reported as 60 %, but after correction for lead-time bias alone averaged 49 %. In a related Ugandan RCT into male-to-female (MTF) transmission, there was a 61 % relative increase (6 % absolute increase) in HIV infection among female partners of circumcised men, some of whom were not informed that their male partners were HIV+ (also some of the men were not informed by the researchers that they were HIV+). It appears that the number of circumcisions needed to infect a woman (Number Needed to Harm) was 16.7, with one woman becoming infected for every 17 circumcisions performed. As the trial was stopped early for “futility,” the increase in HIV infections was not statistically significant, although clinically significant. In the Kenyan trial, MC was associated with at least four new incident infections. Since MC diverts resources from known preventive measures and increases risk-taking behaviors, any long-term benefit in reducing HIV transmission remains dubious.

Keywords

Randomized clinical trials  HIV/AIDS  Sexual transmission  Male to female transmission  Female to male transmission  Researcher bias  External validity  

Notes

Acknowledgments

The author acknowledge the assistance of George Hill, Vice-President for Bioethics and Medical Science, Doctors Opposing Circumcision, Seattle, Washington 98107, USA.

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© Springer Science+Business Media Dordrecht 2013

Authors and Affiliations

  1. 1.Faculty of Humanities and Social Sciences, Bond UniversityQueenslandAustralia

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