Samuelson, Julia BSN, MPH; Baggaley, Rachel MBBS, MSc; Hirnschall, Gottfried MD, MPH
Department of HIV/AIDS, World Health Organization, Geneva, Switzerland
The authors have no funding or conflicts of interest to disclose.
Compelling evidence from 3 randomized controlled clinical trials in Africa showing a 60% reduction of female-to-male HIV transmission1–3 led the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS in 2007 to recommend voluntary medical male circumcision (VMMC) as part of a comprehensive HIV prevention package (a comprehensive HIV prevention package includes at a minimum: HIV testing and counseling; counseling on safer sex practices including the correct and consistent use of condoms, and screening and treatment of sexually transmitted infections) in settings with a high prevalence of HIV infection and a low prevalence of male circumcision.4 Fourteen countries in East and Southern Africa have identified this intervention as priority for scaling-up. Modeling has demonstrated that by reaching an 80% coverage of medical male circumcision among males 15–49 years during 2011–2015 in those countries, the public health impact by 2025 would include the prevention of 3.4 million HIV infections and a savings of USD 16.5 billion in HIV treatment costs.5 Thus, rapid scale up of safe VMMC as part of a comprehensive package of HIV prevention services for men could have a major impact on the HIV epidemic and save resources.
Other primary prevention interventions to reduce heterosexual HIV transmission, such as male and female condoms6 and preexposure prophylaxis,7 have shown variable efficacy in many settings due to inconsistent use and/or low adherence.8–10 VMMC does not suffer this limitation because it is a 1-time intervention. Because of its efficacy and potential impact on the HIV epidemic, VMMC is an important part of the US President's Emergency Plan for AIDS Relief blueprint for an “AIDS-free generation”11 and the Global Fund is increasing its support of VMMC.12
However, to date, the scale up of VMMC has been limited, reaching 12% of the number of circumcisions, to achieve the impact noted above, by the end of 2012. One challenge to achieve scale is the limited number of surgically trained providers and the time required for the current conventional surgical method of male circumcision. Another challenge is acceptance of the procedure, which is influenced by social and cultural norms and personal perceptions and preferences. Insufficient and unstable funds are another challenge.13
Innovations in service provision and male circumcision methods have been prioritized to expand coverage and maximize prevention impact. The acknowledgment that an innovative male circumcision device could potentially reduce procedure time, expand the cadre of providers who may perform male circumcision, and increase acceptability led to the identification of characteristics and criteria to evaluate a male circumcision device. These characteristics focus on safety, ease of use, acceptability to men and providers, and cost advantages compared with surgery.14 Recognizing the need for a systematic, objective, and evidence-based approach to policy making on use of adult devices, WHO formed a Technical Advisory Group on Innovations in Male Circumcision and established a Programme on Prequalification of Male Circumcision Devices to assess the efficacy, safety, and quality of devices for use in public sector programmes.
WHO led the development of a “Framework for clinical evaluation of devices for male circumcision”14 to guide a unified approach to the evaluation of efficacy and safety. It defines pathways for clinical research that are rigorous, systematic, and independent. It also addresses aspects of research methods such as sample sizes, priority outcomes, and the need for clear definitions including for adverse events and procedure times that account for placement and removal of a device.
As of early 2013, the requisite data for WHO review of clinical efficacy and safety15 were available on 2 devices for adult male circumcision—the ShangRing (5 studies conducted in 3 eastern and southern African countries) and the PrePex (8 studies conducted in 3 eastern and southern African countries). All studies were conducted by a team of researchers with device procedures performed by several physicians, clinical officers, or nurses. Key differences between device (ShangRing and PrePex) and surgical male circumcision methods are the required wearing of the device for 1 week, healing by secondary intention rather than primary intention, and a longer estimated time to healing with these device methods.
Authors of a study conducted on the ShangRing in southwestern Uganda and published recently in Journal of Acquired Immune Deficiency Syndrome, reported several results that were quite different from our review of findings on the ShangRing.16 Although the investigators found the ShangRing to be safe and require less time than conventional surgery, they reported a higher percent of adverse events than was reported in the 5 other high-quality ShangRing research studies conducted in Africa. The reported occurrence of infections with use of the ShangRing in this single Ugandan study was 27.3% (n = 66) in the as-treated analysis compared with 0.2% (n = 1983) in the 5 studies that were reviewed by WHO and, respectively, device slippages were reported among 6.1% (n = 66) compared with 0.15% (n = 1998).
The differences between this recently published study and those reviewed by the WHO Technical Advisory Group on Innovations in Male Circumcision suggest some important lessons regarding the use of an in situ device method in public health programmes where VMMC is being implemented. Appropriate provider training that imparts adequate knowledge about device circumcision and adverse events, and competency in device use, as determined through observation, is essential. In the Ugandan study, the type and extent of training of the single locally trained surgeon was not clearly described in the study report. For men who have complications or device failures such as slippages, at or after device placement, appropriate surgical resources are required. Monitoring needs to be based on standardized adverse event definitions and an understanding of the healing process by secondary intention so that quality and safety assessments are accurate and lead to appropriate action. A sufficient supply of the range of device sizes is important to ensure availability and use of correct sizes.
These male circumcision devices provide a simpler method with a shorter procedure time compared with conventional circumcision surgery; however, acceptability to men, their partners, providers, and programmes needs to be further evaluated beyond research settings. For example, the acceptability of wearing a device for 1 week, a required second visit at 7 days for device removal, and a longer time required for healing are not yet clear.
Optimal service delivery models to provide both a device method and a conventional surgery need to be developed and evaluated. As no data are yet available on device use among males less than 18 years and as not all men above 18 years of age will be eligible for a device method due to other medical contraindications, conventional surgery needs to be available.
There are many competing priorities for the limited resources for public health interventions. The 2 devices noted above are simple designs and likely inexpensive to manufacture. Public sector prices have not yet been announced. Pricing for programmes in low-resource settings, which are in the great majority funded through government or international development assistance resources, should be fair while recognizing appropriate return for innovation and development costs. Donors and countries supporting the implementation of HIV programmes will have to negotiate acceptable prices for devices.
With WHO prequalification of 1 or more devices (products listed as prequalified may be found at this referenced link17) and decisions on use by national programmes, particularly in priority countries of East and Southern Africa, the introduction and use of these devices in nonresearch settings will likely expand. The resources required for planning and management of quality services in all settings should not be underestimated, including the availability of appropriate surgical equipment and skills to manage device failures such as slippage and to prevent potentially serious adverse events with displacement of the PrePex device.
Current pilot studies, operations, and implementation research in local settings along with experience will further inform the optimal use of a device method in medical male circumcision for HIV prevention services in East and Southern Africa. As one, or more, new devices are introduced by national programmes, competency-based training, monitoring of adverse events and device failures, and maintaining sufficient supplies, along with an accelerated uptake of adult medical male circumcision for HIV prevention, are needed.
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2. 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.
3. 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.
4. World Health Organization/United Nations Programme on HIV/AIDS. WHO/UNAIDS Technical Consultation on Male Circumcision and HIV Prevention: Research Implications for Policy and Programming. Conclusions and Recommendations. Geneva, Switzerland: World Health Organisation; 2007.
5. Njeuhmeli E, Forsythe S, Reed J, et al.. Voluntary medical male circumcision: modeling the impact and cost of expanding male circumcision for HIV prevention in eastern and southern Africa. PLoS Med. 2011;8:e1001132.
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11. President's Emergency Plan for AIDS Relief. PEPFAR Blueprint: Creating an AIDS-Free Generation. The Office of the Global AIDS Coordinator, November 2012. Washington DC, USA: Department of State; 2012.
12. The Global Fund. Strategic Investments for Impact: Global Fund Results Report 2012. Geneva, Switzerland: The Global Fund to Fight AIDS, Tuberculosis and Malaria; 2012.
13. World Health Organization. Progress in Scaling up Voluntary Male Circumcision for HIV Prevention in East and Southern Africa: January-December 2011. Geneva, Switzerland: World Health Organization; 2012.
14. World Health Organization. Framework for the Clinical Evaluation of Devices for Male Circumcision. Geneva, Switzerland: World Health Organisation; 2012.
15. World Health Organization. WHO Technical Advisory Group on Innovations in Male Circumcision: Evaluation of Two Adult devices. Geneva, Switzerland: World Health Organization; 2013.
16. Kanyago S, Riding DM, Mutakooha E, et al.. Shang Ring versus forceps-guided adult male circumcision: a randomized, controlled effectiveness study in southwestern Uganda. J Acquir Immune Defic Syndr. 2013;64:130–133.
17. World Health Organization. WHO List of Prequalified Male Circumcision Devices May 2013. Geneva, Switzerland: WHO; 2013.