Male Circumcision for HIV Prevention: Research Implications for Policy and Programming WHO/UNAIDS Technical Consultation 6–8 March 2007 Conclusions and Recommendations (Excerpts)

Introduction

A number of observational studies indicate that circumcised men have lower levels of HIV infection than uncircumcised men.* On 13 December 2006, the US National Institutes of Health announced that two trials assessing the impact of male circumcision on HIV risk would be stopped on the recommendation of the Data Safety and Monitoring Board. The trials being carried out in Kisumu, Kenya, and Rakai District, Uganda revealed at least a 53% and 51% reduction in risk of acquiring HIV infection, respectively.^†, ** These results support findings published in 2005 from the South Africa Orange Farm Intervention Trial, sponsored by the French National Agency for Research on AIDS, which demonstrated at least a 60% reduction in HIV infection among men who were circumcised.^††

WHO and UNAIDS convened an international consultation to review the results of the three randomised controlled trials and other evidence on male circumcision and HIV prevention, to discuss the policy and programme implications, and to make recommendations regarding public health issues. This document summarizes the principal conclusions and recommendations of the meeting.

The international consultation was attended by experts representing a wide range of stakeholders, including government representatives, researchers, civil society representatives, gender experts, human rights and women's health advocates, young people, funding agencies and implementing partners.

1.	The research evidence is compelling • The efficacy of male circumcision in reducing female-to-male transmission of HIV has been proven beyond reasonable doubt. • Promoting male circumcision should be recognised as an additional, important strategy for the prevention of heterosexually-acquired HIV infection in men.
2.	Male circumcision does not provide complete protection against HIV • Male circumcision does not provide complete protection against HIV infection. Circumcised men can still become infected with the virus and, if HIV-positive, can infect their sexual partners. Promoting and providing safe male circumcision does not replace other interventions to prevent heterosexual transmission of HIV but provides an additional strategy. • In all three randomized controlled trials HIV incidence was considerably lower in the intervention (circumcised men) than in the control group (uncircumcised men), but nevertheless remained high overall (0.7 to 1.0 per 100 person-years in circumcised men). This high incidence persisted in spite of intensive safer sex counselling, condom provision and the management of sexually transmitted infections. This underlines the need to strengthen comprehensive HIV prevention programmes even further. • It is not known whether male circumcision reduces the sexual transmission of HIV from men to women. Although a reduction in HIV incidence among men will eventually result in lower prevalence in men and therefore less likelihood that women will be exposed to HIV, currently there are insufficient data to know whether male circumcision results in a direct reduction of transmission from HIV-positive men to women. • Male circumcision should never replace other known methods of HIV prevention and should always be considered as part of a comprehensive HIV prevention package, which includes: promoting delay in the onset of sexual relations, abstinence from penetrative sex and reduction in the number of sexual partners; providing and promoting correct and consistent use of male and female condoms; providing HIV testing and counselling services; and providing services for the treatment of sexually transmitted infections.
3.	Correct communication and messages on male circumcision are critical • Global, regional and national level communication strategies need to ensure that clear and consistent messages are disseminated and that male circumcision is promoted within the context of comprehensive HIV prevention strategies. • Messages need to be developed to ensure that men opting for the procedure, and where possible, their partners are counselled that male circumcision is only partially protective and therefore they need to continue to use other effective measures of HIV prevention. This will be necessary to prevent men developing a false sense of security and engaging in high-risk sexual behaviours which could undermine the partial protection provided by male circumcision. • Messages and counselling should stress that resumption of sexual relations before complete wound healing may increase the risk of acquisition of HIV infection among recently circumcised HIV-negative men and may increase the risk of HIV transmission to female partners of recently circumcised HIV-positive men. • Men who undergo circumcision should abstain from sexual activity for at least six weeks after the operation. Ideally, medical inspection should be conducted to check that wound healing is complete. Thereafter, other HIV prevention strategies, including the correct and consistent use of male and female condoms, should be promoted and adhered to, as for uncircumcised men.
4.	The socio-cultural context should inform male circumcision programming • There are a wide range of socio-cultural issues to consider in the context of introducing or expanding the availability of male circumcision services. These issues differ according to circumcision history and practice in different communities. • The major determinant of circumcision globally is religion; almost all Muslim and Jewish men are circumcised. In addition, substantial numbers of males are circumcised for cultural reasons. Male circumcision has strong cultural importance in certain communities; it may be performed in different ways with differing results (from a small cut to complete removal of the foreskin), and it frequently forms part of religious and cultural practices surrounding birth or transition of boys to manhood.
5.	Human rights, legal and ethical principles must guide service delivery • Countries should ensure that male circumcision is provided with full adherence to medical ethics and human rights principles. Informed consent, confidentiality and absence of coercion should be assured. • Where male circumcision is provided for minors (young boys and adolescents), there should be involvement of the child in the decision-making, and the child should be given the opportunity to provide assent or consent, according to his evolving capacity. Depending on the local laws, some mature minors may be able to give independent informed consent. Parents who are responsible for providing consent, including for the circumcision of male infants, should be given sufficient information regarding the benefits and risks of the procedure in order to determine what is in the best interests of the child.
6.	The gender implications of male circumcision as an HIV prevention method must be addressed • In all male circumcision programmes, policy makers and programme developers have an obligation to monitor and minimize potential harmful outcomes of promoting male circumcision as an HIV prevention method such as unsafe sex, sexual violence, or conflation of male circumcision with female genital mutilation. • The expansion of safe male circumcision services provides an opportunity to strengthen and expand HIV prevention and sexual health programmes for men, it also provides a means to reach a population that is not normally reached by existing services.
7.	Programmes should be targeted to maximize the public health benefit • The population level impact of male circumcision will be greatest in settings (countries or districts) where the prevalence of heterosexually transmitted HIV infection is high, the levels of male circumcision are low, and populations at risk of HIV are large. A population-level impact of male circumcision on HIV transmission in such settings is not likely until a large proportion of men are circumcised, although benefit to the individual is expected in the short term. • The greatest potential public health impact will be in settings where HIV is hyperendemic (HIV prevalence in the general population exceeds 15%), spread predominantly through heterosexual transmission, and where a substantial proportion of men (e.g. greater than 80%) are not circumcised. • Other settings where public health impact will be considerable include those with generalized HIV epidemics where prevalence in the general population is between 3% and 15%, HIV is spread predominantly through heterosexual transmission and where relatively few men are circumcised. • In high HIV prevalence settings, greatest public health impact will result from prioritizing expansion of male circumcision services for younger males (for example between the ages of 12–30 years), among whom HIV prevalence may still be relatively low but incidence could be high now, or in subsequent years. Priority could also be given to HIV-negative men of any age who have indications of being at higher risk for HIV, such as men presenting with sexually transmitted infections. • The public health benefits of male circumcision will be realized at different time intervals depending on the age group that is prioritized for circumcision; boys and young men before sexual debut are a relatively easy group to reach but measurable impact is not likely to be realized for over 10 years; if older boys and men up to age 30 years are prioritized a more rapid effect can be expected. Circumcision of neonates, in whom the procedure is simpler and less risky, can be considered as a longer-term strategy to promote circumcision in the general population, but impact of this strategy on HIV incidence would not be expected for at least 20 years. • Male circumcision services should not be delivered in isolation, but as part of a recommended minimum package which includes information about the risks and benefits of the procedure, counselling about the need to adopt and maintain safer sex practices, access to HIV testing, condom promotion and provision, and the management of sexually transmitted infections.
8.	Health services need to be strengthened to increase access to safe male circumcision services • The development and expansion of male circumcision services for HIV prevention should not disrupt health systems and the implementation of other health programmes. • The safety of male circumcision depends on the setting, equipment and expertise of the provider. When circumcision is performed in clinical settings under aseptic conditions, by well trained and adequately equipped health care personnel, complication rates are low. High rates of complications have been found when male circumcision is provided by untrained, poorly equipped providers and in some traditional settings. Male circumcision should not be scaled up without assurance of quality and safety of services and appropriate follow-up of clients.
9.	Additional resources should be mobilized to finance the expansion of safe male circumcision services • HIV prevention programmes are still under-resourced and male circumcision requires new and additional investment if it is to be expanded. The financial resources required to rapidly and safely expand male circumcision services for HIV prevention are large and will require efficiency in the use of existing resources and the commitment of additional resources by countries and donors.
10.	Promoting circumcision for HIV-positive men is not recommended • A randomized controlled trial of circumcision among HIV sero-discordant couples in Rakai, Uganda, has recently stopped recruitment on the advice of the Data and Safety Monitoring Board because of concern that numbers would be inadequate to show a protective effect.* The trial was undertaken because prior observational studies suggested that circumcised HIV-positive men might be less likely to transmit HIV to their female partners than uncircumcised HIV-positive men. Preliminary results from the trial showed no significant difference in HIV transmission from circumcised HIV-positive men compared to uncircumcised HIV-positive men. Participants will continue to be followed and it is still possible that a benefit of reduced risk of transmitting HIV infection could be realized several months or years after the operation. Preliminary data from the trial suggested that recently circumcised HIV-positive men who resumed sexual activity before certified wound healing were more likely to transmit HIV than those who waited until complete wound healing, but this observation was based on very small numbers. • All men undergoing male circumcision, regardless of HIV status need to understand the importance of abstaining from sex until complete wound healing. • Based on the current available evidence, male circumcision is not recommended for HIV-positive men as an intervention to reduce HIV transmission to women. • If male circumcision is requested by men with HIV infection following in-depth counselling on the known risks and benefits, it should not be withheld unless it is medically contraindicated. • HIV testing should be recommended for all men seeking male circumcision, but should not be mandatory.
11.	Research is needed to guide programme implementation • Further research should be conducted to clarify the risks and benefits of male circumcision with regard to HIV transmission from HIV-positive men to women, for men who have sex with men and in the context of heterosexual anal sex. The safety of male circumcision in HIV-positive men should be studied further. • Operations research should be conducted as services are scaled up to determine the best models and packages for service delivery in different epidemic settings, for different population groups and at different ages, how to achieve optimum quality services, including effective counselling methods, and to document changes in HIV-related individual and community perceptions and behaviours. • More information should be gathered on the resource needs required to expand safe male circumcision services. • Other potential benefits or risks of male circumcision, including the potential protective effects of male circumcision on other sexually transmitted infections, should be investigated. • Simpler and safer methods for performing male circumcision in resource-limited settings, including the use of suture-less, blood-free procedures and devices, need to be developed and assessed.

Note

The complete document can be found at: <www.who.int./hiv/mediacentre/MCrecommendations_en.pdf>.

Notes

* Weiss HA, Quigley M, Hayes R. Male circumcision and risk of HIV infection in sub-Saharan Africa: a systematic review and meta-analysis. AIDS 2000;14:2361–70.

† Bailey C, Moses S, Parker CB, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomized controlled trial. Lancet 2007;369:643–56.

** Gray H, Kigozi G, Serwadda D, et al. Male circumcision for HIV prevention in young men in Rakai, Uganda: a randomized trial. Lancet 2007;369:657–66.

†† Auvert B, Taljaard D, Lagarde E, et al. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med 2005;2(11):e298.

* Rakai Health Sciences Program. Study presents new information on male circumcision to prevent spread of HIV in Africa. Press release. 6 March 2007.