Abstract: Medical male circumcision could prevent more than 5 million new HIV infections in men in Africa over 20 years and should be a central part of any combination prevention public health strategy. Surgical methods, with systems designed for high volume services, have been used in circumcision scale-up programs in several African countries, but remain limited by the need for high-level health workers, skilled in the surgical techniques, and appropriate facilities. New male circumcision devices such as the Shang Ring and the PrePex device have shown promise in initial trials and may provide innovative ways to improve access to medical male circumcision in the future. The rapid introduction of new and promising biomedical strategies for HIV prevention, including antiretrovirals for HIV prevention, will require early consideration of delivery systems and service design.
*Anova Health Institute, Johannesburg, South Africa
†School of Public Health, University of Cape Town, Cape Town, South Africa
The author has no conflicts of interest to disclose.
Dr. McIntyre is funded in part by PEPFAR through USAID under the terms of Award No. 674-A-00-08-00009-00. The opinions expressed herein are those of the author and do not necessarily reflect the views of USAID. Correspondence to: Dr. James A. McIntyre, MD, Anova Health Institute, 12 Sherborne Rd, Parktown, Johannesburg 2193, South Africa (e-mail: firstname.lastname@example.org).
Received September 5, 2011
Accepted September 13, 2011
The Year 2011 has seen a renaissance of hope in the field of HIV prevention. After several years of disappointing results of HIV prevention strategies, the positive results of recent biomedical prevention trials have engendered new hope for eventual control of the epidemic—trumpeted by a cover page of The Economist which asked: “The end of AIDS?”.1 The prevention efficacy of 40%–60% across several trials of antiretroviral pre-exposure prophylaxis as oral or vaginal gel preparations,2–4 and the highly significant 96% reduction of transmission seen in discordant couples where early antiretroviral treatment was provided for the infected partner,5 have potentially moved HIV prevention into a new era. The successful translation of this new scientific knowledge into program interventions will be extremely challenging not only because of the costs involved but also from the increased demands on the health systems of the most affected countries, which are already overburdened and underfunded.
Against this background, important lessons can be learned from medical male circumcision. The HIV prevention benefits of medical male circumcision have been demonstrated in a wide range of observational data and from 3 randomized trials, showing reductions of around 60% in HIV acquisition in circumcised men.6–8 Some studies have shown a protective effect of circumcision against herpes simplex-2 infection in men9 and additional data have shown that male circumcision reduces the prevalence and incidence of high-risk human papillomavirus infection in men and provides partial protection against human papillomavirus transmission to female partners.10 Although there have been conflicting study data on the potential of male circumcision to protect female partners, recent modelling has suggested that circumcision could confer a 46% reduction in the rate of male-to-female HIV transmission in high prevalence settings.11
The World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS estimate that universal male circumcision in sub-Saharan Africa could prevent 5.7 million new cases of HIV infection and million deaths over 20 years. More than 38 million adolescent and adult males in Africa could benefit from circumcision, which could reduce their lifetime risk of infection by 60%.12 Based on this assessment, the WHO has recommended the scale-up of voluntary medical male circumcision as an HIV prevention intervention since March 2007. Despite this guidance, scale-up of service has been slow and patchy, although 14 African countries have incorporated medical male circumcision in their national plans, with coverage targets of 80% of men for circumcision scale-up.
By mid-2011, only Kenya had achieved more than 60% coverage of circumcision, after an impressive mass medical male circumcision drive, which has circumcised close to 300,000 men since November 2008. In contrast, South Africa and Tanzania have reached 3% and Mozambique, Namibia, and Zimbabwe have each only achieved 1% coverage.13 South Africa is targeting circumcision coverage of 80% of men aged 15–49 (approximately 4.3 million men) by 2015 and had conducted around 238,000 by June 2011.14 Health service, staffing, supply chain, and financing constraints are major barriers to expansion, but lack of political or policy support is also a factor in the implementation gap in some countries.15
The WHO has promoted the use of 3 surgical techniques for adult male circumcision: the forceps guided method, the sleeve resection method, and the dorsal slit method, each of which requires trained personnel and 20–30 minutes of surgical time. To increase the competence and capacity of medical male circumcision services, WHO recommends the use of models for optimizing the volume and efficiency of male circumcision services (The MOVE model).16 There is growing experience that using this approach can deliver high volume medical males circumcision services and impact on HIV transmission. The pioneering Orange Farm, South Africa site, which has provided circumcision since 2007, has demonstrated that circumcision prevalence increased from 15.6% to 49.4% in men aged 15–49 in the area, and HIV incidence rate in this age group was 2.86/100 person-year among uncircumcised men and 0.42/100 person-year among circumcised men.17
One major limiting factor of the MOVE model is the need for doctors and other skilled personnel for these services. In contrast, the use of male circumcision devices could have the potential to expand access to the intervention in low-resource settings. The use of devices could require less highly trained health workers, provide a faster service, which could be decentralized, and may be very acceptable to men.18 Although a number of devices are widely used for circumcision in infants and boys, there is limited data on acceptability, safety, and effectiveness of the use of devices in adults. The WHO has not yet endorsed the use of any circumcision devices for adults, but has established a WHO Technical Advisory Group on Technical Innovations in Male Circumcision, which will issue such guidance, and has established the criteria that they will consider for such an approval.18
Ongoing research into new circumcision devices is providing promising results. The initial trials in Kenya of the Shang Ring device (Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd., Wuhu, China), building on the first studies in China, and reported in this journal in May 2011, demonstrated excellent acceptability of the device, short procedure times, and the ability of nonphysicians to use the device.19 The Shang Ring does, however, require local anaesthesia, standard surgical cleansing, and excision of the foreskin. Large-scale studies are in progress to investigate the use of the device in other settings and its potential to expand circumcision services in countries where implementation challenges remain.
Rwanda provides a perfect example of the challenges of the implementation gap for circumcision services. The country has a national target to circumcise 2 million men within 2 years but has a health service with only 300 doctors to provide all medical care for a population of close to 10 million. The need for innovative approaches which facilitate task shifting of circumcision to other health workers in such a low-resource setting is clear. The safety and feasibility study of the PrePex device (Circ MedTech, Tel Aviv, Israel) conducted by the Rwandan government and reported in this issue of the journal provides a potentially useful solution.
This initial study describes a promising new device, which can be applied in a short procedure without anesthetic, with no cutting or bleeding at the time of application, and which is acceptable to men in the initial trials, with a low adverse event rate. The overall time to complete healing is similar to that from surgical methods. As a nonsurgical procedure, the device could enable scale-up of circumcision services without requiring doctors, other than for referral of complicated cases. Much more work is clearly needed before the device could be recommended by the WHO and used at scale—a second, larger study in Rwanda comparing the PrePex device to surgical circumcision (ClinicalTrials.gov NCT01284088) is reported to be complete, and a similar trial is planned in Zimbabwe.18
Several concerns about PrePex will need to be addressed in larger scale studies. Because the foreskin is not removed at device placement (unlike surgical procedures or other devices), the acceptability and hygiene consequences for the participant of having a necrosing foreskin in place for a week, before it is removed with the device, may be different in other settings. Larger studies will enable more reliable comparisons of clinical outcomes, staff utilization and cost-effectiveness compared with surgical methods at high and low volume circumcision sites.
New approaches which would enable medical male circumcision to be scaled-up and delivered by staff with more limited training and skills could have a major impact on HIV prevention in Africa. As with other new biomedical prevention strategies, research must now address issues of implementation, effectiveness at scale and mechanisms to combine a range of potential prevention interventions. The lessons from medical male circumcision for other prevention strategies are that issues of delivery are fundamental to introduction and that new approaches to providing interventions, new models of provider and innovative delivery mechanisms will be key to being able to move rapidly from proof of efficacy to real world use. Researcher and policymakers need to consider how best to tailor delivery of successful biomedical HIV prevention interventions to populations in need, in parallel with scientific advances in prevention.
1. The Economist. The End of AIDS. The Economist. June 2, 2011 London, United Kingdom The Economist Newspaper Ltd
2. Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363:2587–2599
3. Baeten JM, Celum CPartners PREP Study Team. . Antiretroviral pre-exposure prophylaxis for HIV-1 prevention among heterosexual African men and women: the Partners PrEP Study [MOAX0106] Presented at: 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention; July 17-20, 2011; Rome, Italy
4. Abdool Karim Q, Abdool Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329:1168–1174
5. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011;365:493–505
6. 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:e298
7. Bailey RC, Moses S, Parker CB, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007;369:643–656
8. Gray RH, Kigozi G, Serwadda D, et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007;369:657–666
9. Sobngwi-Tambekou J, Taljaard D, Lissouba P, et al. Effect of HSV-2 serostatus on acquisition of HIV by young men: results of a longitudinal study in Orange Farm, South Africa. J Infect Dis. 2009;199:958–964
10. Wawer MJ, Tobian AA, Kigozi G, et al. Effect of circumcision of HIV-negative men on transmission of human papillomavirus to HIV-negative women: a randomised trial in Rakai, Uganda. Lancet. 2011;377:209–218
11. Hallett TB, Alsallaq RA, Baeten JM, et al. Will circumcision provide even more protection from HIV to women and men? New estimates of the population impact of circumcision interventions. Sex Transm Infect. 2011;87:88–93
12. World Health Organization, UNAIDS. New Data on Male Circumcision and HIV Prevention: Policy and Programme Implications. 2007 Geneva, Switzerland World Health Otrganization
13. Hankins CA. 2007–2011: State of the VMMC scale up [SUSA14] Presented at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention; July 17-20, 2011; Rome, Italy
14. South African National AIDS Council. National Strategic Plan for HIV and AIDS, STIs and TB, 2012–2016. Draft Zero for Consultation. 2011 Pretoria, South Africa South African Department of Health
15. Padian NS, McCoy SI, Karim SS, et al. HIV prevention transformed: the new prevention research agenda. Lancet. 2011;378:269–278
16. World Health Organization. Considerations for implementing models for optimizing the volume and efficiency of male circumcision services. 2010Field testing edition Geneva, Switzerland World Health Organization
17. Auvert B, Taljaard D, Rech D, et al. Effect of the Orange Farm (South Africa) male circumcision roll-out (ANRS-12126) on the spread of HIV [WELBC02] Presented at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention; July 17-20, 2011; Rome, Italy
18. Farley T. Adult MC device update and WHO approval process for medical devices [SUSA14] Presented at: 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention; July 17-20, 2011; Rome, Italy
19. Barone MA, Ndede F, Li PS, et al. The Shang Ring device for adult male circumcision: a proof of concept study in Kenya. J Acquir Immune Defic Syndr. 2011;57:E7–E12