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Male Circumcision and HIV Prevention: Insufficient Evidence and Neglected External Validity

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Background

Recent editorials have asked the global health community to scale up male circumcision for HIV prevention in regions with HIV epidemics following the publication of three randomized controlled clinical trials (RCCTs) in Africa (in South Africa, Uganda, and Kenya).1, 2, 3, 4, 5 One editorial concluded: “The proven efficacy of MC [male circumcision] and its high cost-effectiveness in the face of a persistent heterosexual HIV epidemic argues overwhelmingly for its immediate and rapid adoption.”6

General Population Correlates

Effectiveness in real-world settings rarely achieves the efficacy levels found in controlled trials, making predictions of subsequent cost-effectiveness and population-health benefits less reliable. The following related concerns deserve further scrutiny:

  • 1

    The three RCCTs were terminated early because results had reached significance showing reduced HIV infections in experimental compared with control groups; however, it was too soon to gauge long-term effectiveness.

  • 2

    The results have no relevance

Increased Risk to Women

A recent prospective study19 showed that male circumcision offered no protection to women, and an RCCT20 found that male circumcision actually increased the risk to women, presumably because they resumed sex before their circumcised male partner's open wound had healed. A 2008 WHO study21 found that 24% of ritual circumcisions and 19% of clinical circumcisions had not healed 60 days postsurgery.

Women also are placed at greater risk from unsafe sex practices when they, or their circumcised male

Substantial Complications of Male Circumcision

Traditional circumcisions increase HIV transmission risk because of contaminated equipment.26 A 2008 WHO bulletin21 reports that 35% of traditional male circumcisions in Africa result in complications, as do 18% of clinical circumcisions. Among all clinical neonatal circumcisions in Africa, 20.2% result in complications.27 The RCCTs themselves reported unacceptable levels of complication, even though these trials were conducted under optimal conditions. For example, the Ugandan trial3 reported

Cost–Benefit Considerations

Before circumcising millions of men in regions with high prevalences of HIV infection, it is important to consider alternatives. A comparison28 of male circumcision to condom use concluded that supplying free condoms is 95 times more cost effective. This mathematical modeling analysis, presented at the 2009 International AIDS Society, revealed the cost effectiveness of male circumcision to be a distant third compared to condom use or ART. The mathematical analysis showed that increasing both

Ethical Issues Unresolved

Male circumcision constitutes the removal of healthy, functional, and biologically unique tissue.29 For fully informed consent to occur, men must be educated about the risks and sensory losses from circumcision, as well as made aware that circumcision does not offer full protection. Further, any shift from condom use to reliance on circumcision for HIV prevention places men and their partners at increased risk of HIV infection. Published research30, 31 has delved into the association of

Conclusion

Recommending mass circumcision by generalizing from the particular RCCTs to the diverse populations of Africa highlights problems of external validity identified in several areas of preventive medicine and public health research. Studies published since the RCCTs show that (1) male circumcision is not correlated with lower HIV prevalence in some sub-Saharan populations14, 15; (2) circumcision is correlated with increased transmission of HIV to women20; and (3) male circumcision is not a

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