Anatomy of a Collection: Q&A with Emmanuel Njeuhmeli, Author of new PLOS VMMC Collection

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Dr Rhona MacDonald, Senior Editor at PLOS Medicine posed the following questions to Emmanuel Njeuhmeli, Senior Biomedical Prevention Advisor at the US Agency for International Development and lead author of the new PLOS Collection: Voluntary Medical Male Circumcision for HIV Prevention: Improving Quality, Efficiency, Cost Effectiveness, and Demand for Services during an Accelerated Scale-up.

RM: What is Voluntary Medical Male Circumcision and why is it so important?

EN: Voluntary medical male circumcision (VMMC) is a surgical procedure that involves the complete removal of the foreskin by a trained medical professional. Studies show that VMMC reduces female to male HIV transmission by approximately 60 percent. In 2007, WHO and UNAIDS recommended that 14 countries in Southern and Eastern Africa with high HIV and low male circumcision prevalence consider including VMMC as a key intervention in their HIV prevention portfolio. Mathematical modelling suggests circumcising 80 percent of the male population between the ages of 15-49 in these countries and sustaining this level of coverage to avert 3.36 million HIV infections among men and women in the next 15 years.

VMMC Collection Image Collage

Image Credit: (left) Sgt. Adam Fischman, US Army Africa & (right) Sterling Riber, MFDI for Jhpiego/Tanzania

VMMC involves a one-time procedure and offers men life-long benefits, including greatly reducing their risk of acquiring HIV and many other sexually transmitted infections (STIs), such as herpes, syphilis and human papilloma virus (HPV). In addition, female partners of circumcised men also have benefits, including lower rates of cervical cancer (the leading cancer killer among African women) and bacterial vaginosis, a condition that has been associated with pre-term birth. VMMC should be offered as part of a comprehensive package of HIV and reproductive health services. This includes education, HIV testing, counselling and linkages to care and treatment, provision of condoms and screening and treatment for STIs. Because it is only partially protective, men who are circumcised are strongly encouraged to use other precautions to reduce their risk of HIV exposure, including using condoms and reducing their number of sexual partners.

Scale-up of VMMC is critically important to reduce the future burden of HIV, particularly in high prevalence regions, such as Eastern and Southern Africa. HIV infections are happening every day among uncircumcised men in the region and this can easily be prevented. Each day that this proven prevention method is not brought to scale represents a missed opportunity to bring us closer to reaching an AIDS-free generation.

 

RM: What progress has been made since the 2011 PLOS Collection and this latest work?

EN: The first collection was published in November 2011 just before the December launch of the WHO-UNAIDS Joint Strategic Action Framework for Acceleration of the Scale-up of VMMC. On December 1, 2011, President Barack Obama challenged the President’s Emergency Plan for AIDS Relief (PEPFAR) to achieve 4.7 million VMMCs by the end of 2013. PEPFAR programs across the 14 VMMC priority countries in Eastern and Southern Africa had reached approximately 850,000 males over the past four years, and the President’s target called for a four-fold program expansion in half the time.

The good news is that PEPFAR has met the President’s target of 4.7 million VMMCs by doubling its reach year after year. In FY2011, it performed 880,000 VMMCs. In FY2012, it performed 1.7 million VMMCs and in FY2013, it performed 2.8 million VMMCs. To date, the East and Southern Africa regional VMMC program has achieved more than 6 million VMMCs with the support of multiple donors and national resources. This achievement is a testament to the collaborative efforts of policymakers, donors, community leaders, civil society groups and many others who saw the value in a proactive approach to health. Their efforts have improved lives and prevented incalculable human suffering.

Despite our successes to date, we have reached only one-third of the 20.3 million interventions needed to achieve the maximum public health benefit by the end of 2016.

The progress has taught program implementers a great deal about the supply and demand associated with scaling up VMMC to improve quality and efficiency. The initial collection provided the evidence that eventually led to significant increases in funding for VMMC programs as well as the prioritization of VMMC as one of three essential interventions needed to achieve an AIDS-free generation.

 

RM: Can you tell us about the key themes of the Collection?

EN: The PLOS Collection, Voluntary Medical Male Circumcision for HIV Prevention: Improving Quality, Efficiency, Cost Effectiveness, and Demand for Services During an Accelerated Scale-up, includes 13 research papers and an overview of key findings, best practices, challenges and recommendations from several priority countries experiencing high-volume VMMC services. The collection addresses the following themes and a host of other practical concerns faced by governments, donors, and program implementers: quality of services, efficiency, cost effectiveness and demand creation.

Sixty-seven co-authors have contributed to the development and publication of these manuscripts, including experts from country Ministries of Health as well as international donors such as the Bill and Melinda Gates Foundation and PEPFAR implementing agencies and partners.

 

RM: What are the challenges to implementing the VMMC program as identified by the articles in the Collection?

EN: There are many. The goals to accelerate scale up are ambitious and it’s critical that we assure consistent safety and overall quality of services. Currently, the Joint Strategic Action Framework sets an ambitious goal to circumcise 20.3 million men by 2016 (2012–2016) across 14 African countries.

Furthermore, since being circumcised involves deep-seated values, beliefs, and motivational factors that vary with ethnic, religious, and cultural identities, sensitive approaches are required to ethically and responsibly aid boys and men and entire communities in their consideration of VMMC. While, as the studies show at a broad level, the program is increasing its outputs each year, the current growth rate of the program is not sufficient to reach the goal of 80 percent coverage by 2016. Resource and capacity constraints pose a serious challenge for countries hoping to reach their scale-up goals.

 

RM: What would you consider to be the main messages that need to be learned from the scale-up of the program?

EN: The collection shows how systematic, evidence-based management of programs and a dynamic culture of learning can help meet the challenges of VMMC scale-up. Let me elaborate these key points.

It is possible to maintain and even improve service quality, especially surgical performance, as VMMC is scaled up. But, improved provider training is needed to strengthen quality of pre and postoperative care and infection control. It is possible for VMMC programs to increase the number of men who learn their HIV status and enroll in HIV care and treatment with effective referral systems between VMMC and ART services.

3_E Njeuhmeli_Iringa Tanzania External Quality Assurance Site Visit_Oct 2013

Emmanuel Njeuhmeli at Iringa,Tanzania site for Quality Assurance Visit, Oct. 2013

Personnel and consumables are VMMC’s  largest expenses, but costs may be reduced as programs scale up and economies of scale are achieved and by improving service efficiency. Under-utilization of service capacity increases unit costs more than any other variable, highlighting the importance of predictable demand and nimble service platforms so that sites are consistently performing as close to capacity as possible. Responsible public-sector pricing strategies for new VMMC devices have the potential to reduce overall unit costs, and further discounts should be negotiated as procurement volumes increase.

Messaging must be tailored to generate demand among specific age groups and to cultural norms of diverse communities. Men aged 25 and above are generally less inclined to undergo VMMC. Studies suggest the need to go beyond HIV-prevention messaging and include additional VMMC benefits, such as hygiene, aesthetics, attractiveness to partners, peer group norms, leadership, modernity, and benefits to women.

Countries vary in their surgical efficiency levels. Task sharing, bundling of surgical instruments, and electrocautery are associated with improved surgical efficiency. Surgical quality need not be compromised by measures to reduce operating time.

 

RM: Finally, what will the next steps be for the program and who needs to do what?

EN: We need to increase program efficiency by identifying and prioritizing those most at risk of acquiring HIV. We need to focus on program efficiency and quality at all levels and assures a good match between supply and demand.

We need to encourage VMMC programs to further strengthen linkages with ART programs including HIV testing, care and treatment for men, a group that has been under served by ART programs in the region.

We need to explore the role that technologies, especially devices, can play in accelerating scale-up.

We need to rethink demand creation through market segmentation and insights from other disciplines to better encourage VMMC participation.

We need to gather and use standardized, high-quality data for program management and decision-making.

We need to provide technical assistance to governments for strengthening management and coordination of programs at national, provincial and district levels.

And, finally we need to strategize for the sustainability phase of the program and finally.

 Our work is just beginning.

 

Please view the full Collection here: www.ploscollections.org/VMMC2014

 

This Collection is a joint collaboration between PLOS and the U.S. President’s Emergency Plan for AIDS Relief (through the U.S. Agency for International Development, the Centers for Disease Control and Prevention, and the Department of Defense), the Bill & Melinda Gates Foundation, PEPFAR implementing partners, and the Ministries of Health in Kenya, Tanzania, Zimbabwe, and South Africa.

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7 Responses to Anatomy of a Collection: Q&A with Emmanuel Njeuhmeli, Author of new PLOS VMMC Collection

  1. Mark Lyndon says:

    From a USAID report:
    “There appears no clear pattern of association between male circumcision and HIV prevalence—in 8 of 18 countries with data, HIV prevalence is lower among circumcised men, while in the remaining 10 countries it is higher.”
    http://www.measuredhs.com/pubs/pdf/CR22/CR22.pdf

    It seems highly unrealistic to expect that there will be no risk compensation. The South African National Communication Survey on HIV/AIDS, 2009 found that 15% of adults across age groups “believe that circumcised men do not need to use condoms”.
    http://www.info.gov.za/issues/hiv/survey_2009.htm

    It is unclear if circumcised men are more likely to infect women. The only ever randomized controlled trial into male-to-female transmission showed a 54% higher rate in the group where the men had been circumcised:
    http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)60998-3/abstract

    ABC (Abstinence, Being faithful, and especially Condoms) is the way forward. Promoting genital surgery seems likely to cost African lives rather than save them.

    Recent news from Botswana
    “There is an upsurge of cases of people who got infected with HIV following circumcision.”
    http://www.gabzfm.com/circumcised-men-still-run-risk-hiv-infection

    and from Zimbabwe:
    “SOME circumcised men are contracting HIV and Aids after ditching the use of condoms, under a misguided belief that male circumcision (MC) would prevent them from getting infected”
    http://www.thestandard.co.zw/2013/11/10/circumcised-men-indulge-risky-sexual-behaviour/

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    • Victoria Costello says:

      This is a long answer, but for anyone who wants to hear how scientific evidence accrued to demonstrate the definitive link between circumcision and a lower risk of HIV infection, here is that process….

      When researchers first suspect a cause-and-effect relationship between two things (in this case male circumcision and HIV), they look to see whether there are existing correlations that support their hypothesis. Scientists looked at levels of HIV and male circumcision across different populations and found a
      strong correlation: HIV prevalence was often higher in countries where male circumcision was uncommon (and lower in countries or areas where male circumcision was common).20,21,22 This is particularly true in Africa, although not for all countries/areas. If the association had been found across all populations worldwide, then further studies and clinical trials might not have been necessary to prove the cause-and-effect relationship.

      Therefore, to further test the hypothesis that male circumcision provides biological protection against HIV acquisition, observational studies (the next higher level of scientific investigation) were performed. The observational studies followed HIV-negative men over time to see if they developed HIV infection. The infection rates among the circumcised men in the studies were then compared to the rates among the men who were not circumcised. Because men were being followed over time, they could also be asked about their sexual behaviors.

      In this way, the statistical analyses could control for any differences in sexual behaviors, and the level of protection against HIV resulting from circumcision could be separated from the level of protection resulting from differences in behaviors. The data from the observational studies also supported the hypothesis that male circumcision biologically protects men against acquiring HIV.23,24,25

      Despite the ecological and observational evidence, some skepticism remained about whether unmeasured differences between circumcised and uncircumcised men were resulting in lower HIV in circumcised men.

      To conclusively test the hypothesis that male circumcision biologically protects men against acquiring HIV, RCTs were needed. The ecological and observational studies provided the ethical justification needed to randomly assign study participants either to undergo male circumcision or to remain uncircumcised. Because the process of randomization is entirely one of chance, it ensures that men in the circumcised and uncircumcised study arms are/will be different in only one way: the presence or absence of their foreskin. Thus, if the risk of HIV is different between the two groups of men over time, the difference is attributable to circumcision. As with the observational studies, men were also asked about risk behaviors while in the study, in case men randomized to undergo circumcision behaved differently than those randomized to remain uncircumcised. The results of three RCTs revealed that the circumcised men experienced an HIV infection rate that was 60% lower than the infection rate of uncircumcised men.26 It was at this point that WHO and UNAIDS issued recommendations for male circumcision and gave priority to countries with generalized (heterosexual) epidemics, high HIV prevalence and low male circumcision prevalence.27

      Although the scientific evidence that male circumcision provides partial biological protection against HIV acquisition is irrefutable, some researchers still question whether the men who enrolled in the RCTs were similar enough to men in the general population. It stands to reason that if the men in the trials were very different from men in the general population, then scaling up VMMC in the general population might not result in the same reductions in HIV infection that were as seen in the RCTs. However, community-level studies from Uganda and South Africa have since demonstrated that the rate of HIV infection is lower among circumcisedmen compared to uncircumcised men.28,29 In these studies, men who received circumcision did so as part of routine health services and not as part of an RCT. Therefore, it is clear that when men in the general population receive circumcision as a routine service (instead of as a research intervention), their risk of HIV is reduced—a finding that is consistent with the RCT findings. WHO prioritized expansion of VMMC in 14 countries with generalized (heterosexual) epidemics, high HIV prevalence, and low male circumcision prevalence. What about areas within these countries where HIV is more prevalent among circumcised men than uncircumcised men? These data, which seem contradictory to the RCT findings, are from cross-sectional surveys, meaning that the data were collected at a single point in time. It is not possible to know whether men in these populations were circumcised before becoming infected with HIV, or after. Men may have been infected with HIV when they were uncircumcised and later decided to become circumcised for clinical or other reasons. Also, cross-sectional data about circumcision status are based on self-reporting. Studies have revealed that many men report being circumcised when actually they either are not circumcised at all or are only partially circumcised.30,31 For these reasons
      and others, cross-sectional data cannot be used to prove a causal relationship. Nevertheless, skeptics often refer to cross-sectional data to refute the gold standard scientific evidence provided by the RCTs.

      These investigations have been completed and the findings are conclusive. Using cross-sectional data now to refute the conclusive findings demonstrates a lack of understanding of the limits of cross-sectional data and the overall scientific process for testing hypotheses.

      20 Bongaarts J et al. 1989. The relationship between male circumcision and HIV infection in African populations. AIDS 3: 373–377.
      21 Moses S et al. 1990. Geographical patterns of male circumcision practices in Africa: Association with HIV seroprevalence. Int J Epidemiol
      19: 693–697.
      22 Halperin DT and Bailey RC. 1999. Male circumcision and HIV infection: Ten years and counting. Lancet 354: 1813–1815.
      23 Cameron DW et al. 1989. Female to male transmission of human immunodeficiency virus type 1: Risk factors for seroconversion in men.
      Lancet 2: 403–407.
      24 Weiss HA, Quigley MA and Hayes RJ. 2000. Male circumcision and risk of HIV infection in sub-Saharan Africa: A systematic review and
      meta-analysis. AIDS 14: 2361–2370.
      25 Quinn TC et al. 2000. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N
      Eng J Med 342: 921–929.
      26 Gray et al., 2007; Bailey et al., 2007; Auvert et al. 2005.
      27 World Health Organization. 2007. New Data on Male Circumcision and HIV Prevention: Policy and Programme Implications. WHO:
      Geneva.
      28 Kong G et al. 2012. Longer-Term Effects of Male Circumcision on HIV Incidence and Risk Behaviors during Post-Trial Surveillance in
      Rakai, Uganda. Paper #36. 18th Conference on Retroviruses and Opportunistic Infections, February 27–March 2, Boston, Mass.
      29 Auvert BH et al. 2012. Decrease of HIV Prevalence over Time among the Male Population of Orange Farm, South Africa, following a Circumcision Roll-out (ANRS-12126). Presentation at the 2012 International AIDS Conference, July 22–27. Washington, DC. Abstract TUAC0403.

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  2. Ron Low says:

    Most of the US men who have died of AIDS were circumcised at birth. The US has three times the HIV incidence seen in Europe, where circumcision is rare.

    Circumcision alters sex dramatically. HIS body, HIS decision.

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    • Victoria Costello says:

      In populations in which men’s HIV risk is primarily due to injection drug use (exposure to HIV is intravenous) or through receptive anal sex with other men (exposure to HIV is rectal), male circumcision is not expected to be protective because removing the foreskin does not change infection risks that are intravenous or rectal. However, in generalized (heterosexual) epidemics, male circumcision does biologically protect men from acquiring HIV from women through sex.

      In 2005, PLOS Medicine published the first randomized, controlled intervention demonstrating a 60 percent reduction in HIV infections over a two-year period among a trial population of 3,274 young South African men who received a voluntary medical circumcision (VMMC). This level of prevention against contracting the AIDS virus through sex with women is considered equivalent to that of an effective vaccination. Since then two further randomized controlled trials — the “gold standard” for medical or scientific research — have replicated this result. It is based on this evidence that the current VMMC campaign has been designed and implemented.

      On the question of whether circumcision makes sex less enjoyable for men:

      Only men who have had sex both with and without their foreskin can compare the sensation and sexual satisfaction they have felt before and after undergoing circumcision. Initial studies that evaluated sexual satisfaction among African men who had undergone VMMC indicated that VMMC does not have any effect on sexual desire or satisfaction, erectile function, or ability to achieve penetration; nor does it cause pain with intercourse. A study that compared men who had undergone VMMC to a control group showed that 98% of the men in both the intervention group and the uncircumcised control group rated their sexual satisfaction as “satisfied” or “very satisfied” six to 24 months after enrolling in the trial.

      Sources:
      6 Bailey RC et al. 2007. Male circumcision for HIV prevention in young men in Kisumu, Kenya: A randomised controlled trial. Lancet 369(9562): 643–656.
      7 Krieger JJN. 2008. Adult male circumcision: Effects on sexual function and sexual satisfaction in Kisumu, Kenya. Journal of Sexual Medicine 5(11): 2610–2622.

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  5. Stephen Moreton says:

    typo correction: “soppiness” = “sloppiness”.

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