AVAC on World AIDS Day: We’re 20. We’re not giving up.

When AVAC was founded in 1995, we were called the AIDS Vaccine Advocacy Coalition. Our singular goal was to advance swift, ethical research for a vaccine that was then — and is today — essential to bring the epidemic to a conclusive end.

Twenty years later, AVAC is still focused on swift and ethical research, but our scope has expanded. Along with vaccines, we advocate for PrEP, microbicides, voluntary medical male circumcision and more.

Through it all, our message has been the same: prevention is the center of the AIDS response. Not just any prevention but smart, evidence-based, community-owned, rights-based strategies.

We do this work because it’s essential. We are able to do it because of our robust partnerships worldwide. We will keep doing it — with your help — until the epidemic has, finally, come to an end.

We’ve experienced 20 years of breakthroughs and disappointments in prevention research. A vaccine that many had given up on was the first to provide modest protection. One microbicide everyone hoped for didn’t pan out. Male circumcision and PrEP studies overcame skepticism and, together with antiretroviral therapy, paved the way for a prevention revolution.

Through it all, AVAC has worked with partners to maintain the field’s focus and press for continued research into an AIDS vaccine, a cure and more.

When AVAC was founded, the only biomedical HIV prevention options for adults were male and female condoms. The pathway for introducing any new strategy was largely unmapped. No one knew where the gaps would be—between trial result and country action, between guidance and financial support. Now we do.

Over two decades, AVAC has not only identified the gaps; we’ve worked to bridge them, so that products reach people in programs that work — without delay.

Twenty years ago, advocacy for HIV prevention hardly existed. So AVAC helped build a global network of advocates equipped with effective advocacy strategies and the latest evidence.

With our support, they are putting prevention on the agenda in countries and communities around the globe.

When the world lacked a plan for ending AIDS, we helped create one.

Now we’re holding global leaders accountable for results — demanding the resources, policies and evidence-based plans needed to deliver all of today’s prevention options to the people who need them, and to plan for the rapid rollout of new options as they emerge.

Communities’ support for prevention research can never be taken for granted — it has to be earned. For 20 years, we’ve helped build trust between researchers, funders and communities to speed the ethical development and rollout of new prevention options.

And when controversy threatened to derail those efforts, AVAC provided leadership and resources to help get them back on track.

Your gift to AVAC will support our efforts to accelerate the development and delivery of HIV prevention options to men and women worldwide. With your help, we can continue to convene, collaborate and communicate a strong, clear and cohesive vision for HIV prevention today, tomorrow and to end the epidemic.

It will take all of us working together to end AIDS. Please join us.

Anatomy of a Target – VMMC

In Px Wire, our quarterly newsletter, we looked at the strengths and limitations of new PEPFAR targets, new UNAIDS targets, new guidelines on ART and PrEP from the WHO and new Sustainable Development Goals.

In this excerpt from our centerspread graphic, we take a closer look at VMMC.

The New Context for HIV Prevention: Is the world on target?

In this issue of Px Wire, our centerspread graphic looks at the sum total of the new targets and guidelines and gives our “take” on whether the current context is on target.

No Circ, No Sex: Women withhold sex, sending men to get circumcised first

It’s been documented that women generally have better health service seeking behaviors than men. It’s therefore not surprising that a new study by Jhpiego and the Ministry of Health and Social Welfare on the role of women in uptake of VMMC in the Njombe and Tabora regions of Tanzania has revealed that women there are playing a significant role in influencing males in uptake of voluntary medical male circumcision (VMMC) for HIV prevention.

In this study, whose results have recently been published in PLoS One, participants reported that mothers and female partners influence boys’ and men’s decisions to seek VMMC. The women use both direct and indirect means to achieve this – from persuasive discussions, pressuring friends, sons, siblings or partners to denying partners sex.

This study confirms what’s been known but has not been adequately documented. As such, many programs in the different VMMC priority countries can take advantage of the influence that women have on the males in their lives to find ways to meaningfully engage them so as to help scale up roll out of services. Also, messaging on benefits of VMMC to women should be part of these conversations to ensure that women and men know that while VMMC is an intervention for men, its benefits go to women as well, at the individual and community levels.

For additional background about the benefits VMMC can have for women’s health as well as ways women can advocate and support the implementation of this HIV prevention method, check out Making Male Circumcision Work for Women, which AVAC and partners published in 2010.

Interview with an Advocate: Fearless leader of Uganda’s Voluntary Medical Male Circumcision (VMMC) Program speaks of momentum, motivation and maintaining success

Uganda has made tremendous progress in its VMMC (also known as Safe Male Circumcision or SMC in Uganda) scale-up over the past two years, with over 1.7 million men were circumcised in 2013 and 2014 alone. A cumulative total of 2.1 million circumcisions have been done in Uganda since 2008 according to WHO’s recent Progress Brief. As Coordinator of the National Safe Male Circumcision, Dr. Barbara Nanteza has led the Uganda program during this critical period of scale-up. Dr. Nanteza talked to the coordinators of the VMMC Truth-tellers Initiative about leadership, collaboration with the Ministry of Health and implementing partners, the unmet need for sustainable funding, best practices and loving her work.

Truth-tellers (TT): What is your role as the head of the National Safe Male Circumcision (SMC) program in Uganda?

Dr. Barbara Nanteza (BN): My roles are really many and broad. I’m responsible for management of the program – in other words providing coordination, leadership, and ensuring that the program has the infrastructure, logistics and supplies to keep it running smoothly. I’m also responsible for maintaining standards of the program on a range of issues including policy, capacity building, training, supervision and quality improvement. As head of the program, I also mobilize resources and lead its strategic planning.

TT: What was the program’s biggest challenge when you took over in 2012, and what’s the biggest challenge today?

BN: Much as Uganda spearheaded the clinical trials in 2005, the country didn’t take on safe male circumcision immediately. It wasn’t until 2010 that some SMC work started. The US President’s Emergency Plan for AIDS Relief (PEPFAR) had already started funding the program directly through the implementing partners (IPs), but the entire management system was down. It took a lot of courage and effort to streamline both management and maintaining the standards given that IPs had been given a lot of money by PEPFAR. It’s rather ironic that our biggest challenge today is funding.

Unfortunately, the funding challenges are coming at the back of three years of our biggest scale-up. Demand for SMC services is very high at the moment. Last year our target was one million circumcised, but we had funding for 750,000. We ended the year with 878,109 males circumcised. Our target for 2015 is still one million, but I have funding for only 330,000 procedures. That’s a huge funding gap, which without a doubt, will slow down the program.

TT: Some issues came up around tetanus and SMC in Uganda last year; can you tell me about them? [Editor’s note: In 2014, nine cases of tetanus were reported across multiple country national VMMC programs—six resulted in death. Consequently, WHO and partners assessed tetanus risk associated with VMMC and different circumcision methods. To minimize tetanus risk, WHO now advises a dual approach of clean care (emphasis on clean wound care and standard surgical protocols for sterility) and tetanus vaccine interventions. For more information go to WHO Informal Consultation on Tetanus and VMMC.]


BN: In 2014, we faced another unforeseen challenge – tetanus. There were reported cases of tetanus among five males [in Uganda] who had undergone circumcision [with either surgical or device methods]. The reality is that the SMC program helped Uganda realize that as a country we have high background tetanus. The SMC program should be strengthened to help save many Ugandans from this immunizable disease. Through the SMC program we can reach many Ugandans, both men and women. If funds are available, we can make the SMC program become proud of vaccinating Ugandans against tetanus, which has a mortality of more than 56 percent.

TT: The program has made tremendous progress since you took over—from about 80,000 circumcisions in 2011 to a cumulative total of 2.1 million by 2014—about 80 per cent of which were accomplished in 2013–14. What are your plans to maintain this pace of scale-up or even surpass it?


BN: I attribute the achievements to hard work and focus. A few individuals and institutions stand out – including those at PEPFAR, the Ministry of Health (MoH), the AIDS Control Program, the National SMC task force, the implementing partners and many others.

The plan to maintain this scale-up is very simple—we need stable funding. We have proven that we have the desire and ability to get the results. We can even surpass the targets if every stakeholder can play their role.

TT: How did your approach change from when you first took over the program?


BN: Management has been very instrumental to this. I made sure that all IPs operated under MoH guidance. This was very difficult in the beginning but with time most IPs have realized that they offer services to Ugandans and it’s MoH that is answerable to their health.

My approach is straight and candid. I never want anyone to use me as an excuse for his/her failure. I focus on the ultimate goal of averting HIV infections through the SMC program.

TT: If another program manager in another country wanted to achieve what you’re achieving in Uganda, what would you advise he/she to do?


BN: I have always wanted to share Uganda’s best practices but have never had an opportunity. Though I can talk till the cows come home, I’ll give a few pieces of advice:

  • Love your work: We should love our work even in the absence of money. Since childhood I have liked to make a difference in another person’s life so when I was given this job (initially I started as a volunteer) I was very happy. Today, my accomplishments speak volumes. I know my daughter will be happy to know that I did something for my country when the opportunity came.
  • Be in control: MoH leadership is key. Through my years at the MoH, it has been tough simply because it’s the IPs with the money. This puts MoH officers in a very tricky situation. But when you know your role, everything else doesn’t count. I have been able to tell IPs to follow MoH even though they have lots of money. Those who didn’t follow can tell you that I have had to communicate to them in a way many have not liked, but in the end, I’m sure the IPs are also enjoying our success.
  • Data: All mangers should ensure that they have and control data for their programs. That way they are able to analyze and make informed decisions to improve their programs.
  • Research: Nothing beats scientific evidence. I really like to do research or implementation science. This improves programs and helps formulate better policies.
  • Results dissemination: I always want to share what I do with others such that we can learn from each other. This can be through meetings, workshops, and conferences, though as MoH we always have limited resources to do all this.

TT: You’re a vocal advocate for the program yourself, what’s your message to your own government? And funders? And other advocates like you?


BN: First, I would like to thank the government for the support and guidance they offer to the program though I am requesting that they allocate more funds to the SMC program since it’s an important piece of combination prevention.

To the funders – if they want value for their money, I can assure them that Uganda is currently the country that can give the much-needed results in a very short time. My only caution though would be for them to respect the MoH, and let the MoH take leadership.

To my fellow advocates – they should keep the fire burning. Despite the challenges we face, no condition is permanent and all good things are worth fighting for. Every infection is worth our sweat!

VMMC at IAS 2015: Cause for celebration and concern

Advocates tracking the pace and coverage of voluntary medical male circumcision have a new, concise resource in the form of a two-page “progress brief” from the World Health Organization. The document was launched in time for the International AIDS Society’s meeting in Vancouver and reports a “remarkable expansion to nearly 9.1 million voluntary medical male circumcisions (VMMC) performed for HIV prevention through 2014 in priority countries of East and Southern Africa.” Even more remarkable: among the 9.1 million, more than 3 million were performed in 2014 alone.

The report also states that, “Sufficient resources to reach at least 80% VMMC coverage must be available for this one-time, long-term efficacious intervention for both individual and public health HIV prevention, while preparing for VMMC sustainability within broader prevention programming.” As AVAC has covered in recent months, funding for VMMC has dropped at the precise moment that these gains in numbers and coverage are being made (for background, see our VMMC section in AVAC Report 2014/15: Prevention on the Line and this year’s Resource Tracking Report, HIV Prevention Research & Development Funding Trends, 2000–2014).

The bold consensus statement released at the Vancouver meeting by the International AIDS Society and signed by many leaders in the field calls for expanded access to ART for treatment and prevention. Unfortunately, the statement does not mention VMMC as a critical strategy for sustained funding and ambitious targets–an omission also found in the Declaration from the 2012 World AIDS Conference.

In the three years between these meetings, tremendous progress—captured in the new brief—has been made. But to sustain this momentum, VMMC needs to be specifically identified as central to bringing epidemic levels of new infections to an end. Rhetoric, funding and programming all need to follow, or else the progress brief in one or two year’s time may be far less encouraging than it is today.

 

New Report on HIV Prevention R&D Investment Highlights 2014 Global Funding Trends

The recent UN Report on the Millennium Development Goals (MDGs) calls out the 40 percent reduction in new HIV infections since the MDGs were established in 2000 as a singular MDG achievement1. That progress reflects 15 years of HIV research in many forms—from female condoms and voluntary medical male circumcision, to new strategies for preventing vertical transmission to the scale-up of ART. Over the years, this progress has been supported by investments from many government, philanthropic and private sector funders of HIV prevention research.

The 11th annual report on the state of HIV prevention research investment, HIV Prevention Research & Development Funding Trends 2000–2014: Investment Priorities To Fund Innovation In An Evolving Global Health and Development Landscape, suggests that this work is still on the agenda for funders, albeit with a small cohort supplying the bulk of the resources.

The new report, released in Vancouver at the IAS 2015 conference, was prepared by the HIV Vaccines & Microbicides Resource Tracking Working Group (RTWG), led by AVAC, in partnership with the International AIDS Vaccine Initiative and UNAIDS. HIV Prevention Research & Development Funding Trends 2000–2014: Investment Priorities To Fund Innovation In An Evolving Global Health and Development Landscape documents that absolute funding levels have been stable over the past few years. This reflects an overall decline in real spending given biomedical research inflation.

In 2014 funders invested a total of US$1.25 billion in research and development (R&D) for HIV prevention—representing a decrease from the 2013 funding level which totaled US$1.26 billion.

In 2014, the US public-sector and the Bill & Melinda Gates Foundation account for 83 percent of all HIV prevention R&D funding and the number of philanthropic funders engaged in HIV prevention research has continued a steadily decline since 2010. Thus, the report points to the need for a broader funding base.

Despite the slight decline in funding, HIV prevention R&D is still delivering important advances. The 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver July 20-22, will showcase results for a range of groundbreaking research that has been supported over the past several years, including the Strategic Timing of Antiretroviral Treatment (START) trial, the HPTN 052 treatment as prevention trial and several groundbreaking oral PrEP trials.

Results from studies of a vaginal ring containing the antiretroviral dapivirine are expected in the next 12 months. Several different HIV vaccine candidates, neutralizing antibodies and long-acting injectable ARVs are currently in trials that could lead to multiple efficacy trials starting over the next two years.

While the report focuses on financial resources, in also highlights the essential role of individual trial participants. In 2014, there were over a million participants in HIV prevention research trials globally. With continued human and financial investment, the 40 percent reduction in new HIV infections attributed to the MDGs is hopefully only the beginning.

For more information on the HIV Vaccines & Microbicides Resource Tracking Working Group, the full report, executive summary, graphics and slides visit www.hivresourcetracking.org.

1 The MDGs consist of eight global goals, with goal six to combat HIV/AIDS, malaria and other diseases. For more information on the MDGs see: www.un.org/millenniumgoals/aids.shtml.

VMMC: Can the Momentum and Investment be Sustained?

While there has been considerable momentum in the scale up voluntary medical male circumcision (VMMC) over the last 2 to 3 years, many VMMC programs are currently facing serious financial resource challenges.

Many priority countries are now in a critical place where they are making considerations for transitioning from the “catch up” phase to the sustainability stage in order to maintain the long-term public health gains of VMMC, against the backdrop of declining financial resources.

As part of their ongoing webinar series on VMMC, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) in collaboration with the World Bank Group provided updates on some of these considerations through a webinar titled “Maintaining HIV Prevention Benefits of Male Circumcision by Incorporating VMMC Into Routine Newborn And Adolescent Health Service Delivery”. In this webinar (audio and slides are available at this link), speakers covered several issues including integrating VMMC into existing health systems, human resources needs, long-term client age scenarios, sustainable financing options among other considerations.

These are important conversations to have now, and advocates, implementers, funders and policy makers need to focus on sustained investment in VMMC and particularly close monitoring to keep programs on track.

VMMC Device Developments: PrePex price drops and ShangRing gets WHO green light

In May, Circ MedTech, the makers of the PrePex device for adult voluntary medical male circumcision (VMMC), announced it would sell its non-surgical device at US$12 per unit to the 14 WHO-designated priority VMMC countries. The World Health Organization (WHO) prequalified PrePex in 2013, rendering it the first alternative to surgery available for purchase by PEPFAR and other public health providers.

For advocates following VMMC device rollout, this may sound familiar. The US$12 price has been mentioned, without written commitment, since ICASA 2013. So what does this change? Well, it means that organizations in priority countries won’t be faced with the US$20 price tag that’s been attached to the device in some pilot programs and for private purchase.

A second device, the ShangRing, was prequalified by WHO this month for VMMC in healthy males aged 13 years and older. (In contrast, PrePex is currently only officially prequalified for males 18 and older, although efforts are already underway by WHO and the company to recommend PrePex for adolescents and update the official instructions for use. Circ MedTech is also in advanced stages of adapting PrePex technology for use in infants and children.)

A VMMC “device” is an alternative to the conventional surgical methods. PrePex and ShangRing are both ring-based designs worn for a week with the aim of cutting off the blood supply through pressure, resulting in the death of the foreskin tissue. These devices eliminate the need for sutures and take less time than surgery, but the device must remain in place for a week and wound healing takes slightly longer than with surgery. Devices may be desirable for some men, could potentially simplify the VMMC experience for some and reduce the burden of labor for healthcare workers in resource-limited settings.

These device developments, however, come as VMMC programs generally are facing unexpected challenges in terms of global rollout. As AVAC covered in Prevention on the Line, the pace of VMMC is expected to drop this year in part because of scaled-back resources available from the PEPFAR program, which to-date has funded the bulk of VMMC procedures worldwide. Even with the official price reduction for PrePex and the prequalification of ShangRing, a device is only one component of any VMMC program. Whether devices will roll out depends on available funding for the overall expenses for comprehensive VMMC programs, surgical and non-surgical alike.

In terms of what a full-scale device-oriented VMMC program might look like, Rwanda continues to lead in scale-up. The country aims to circumcise 800,000 men with the PrePex device by 2016. Rwanda began routine implementation of the device in 2014 and a study presented at CROI 2015 showed 63 percent of men selected PrePex over conventional surgery. If not for stock outs of the device, study presenter and implementer Eugene Rugwizangoga (Jhpiego) posited that this number would have been higher. Overall uptake of VMMC has increased in Rwanda, aided by efficiencies such as task-shifting and mobile teams. According to Rugwizangoga, introduction of PrePex has accelerated this trend.

Zimbabwe recently included the PrePex device as part of its Accelerated VMMC Operational Plan 2014-2018 with a target of circumcising 1.3 million men by 2018. It is critical that overall funding for VMMC programming in the final PEPFAR Country Operating Plan for Zimbabwe, Global Fund and in national government investments supports the ambitious country plan.

Other countries prioritizing VMMC scale-up are in varying stages of PrePex implementation and monitoring for the type and frequency of complications that could occur outside a controlled study setting. In the VMMC device context, these two stages are referred to as active and passive surveillance. Active surveillance involves performing 1,000 non-experimental, routine device procedures and providing active follow-up for clients who fail to return for device removal. Men are monitored through home visits, in-depth interviews and genital exams. Passive surveillance is the monitoring and reporting of adverse events seen in the clinic as part of ongoing, routine service delivery.

The ShangRing device is made by Wuhu Snnda Medical Treatment Appliance Technology Company, which has marketed the device in China since 2006. More recently it was assessed in Kenya, Uganda and Zambia. Similar to its guidance on PrePex, WHO recommends that training resources for health providers are made available and that men (and adolescents) and caregivers receive accurate information on its use. WHO also endorses a one- to two-year safety data follow-up on ShangRing use in non-research settings.

It has been suggested that the ShangRing device will sell for around US$8 per unit in priority VMMC countries as part of comprehensive HIV prevention programming. With this new device entering into programs, it will be important to watch both the donors and the manufacturers to understand how procurement volumes and pricing evolve for both devices, as well as other devices in development.

It also remains unclear what role devices will play in VMMC programs in general. Though the pace of VMMC scale-up has doubled each year since 2011, exceeding targets and reaching over 9 million circumcisions, funding commitments have begun to decline. VMMC in sub-Saharan Africa is experiencing a contraction. PEPFAR, the primary underwriter of VMMC, has not set new targets and its funding has shrunk. Furthermore, reports suggest that countries are not seeking funds through Global Fund grants to fill the gap left by PEPFAR. And UNAIDS prevention targets, including for VMMC, have yet to see the light of day.

The big lift now is to ensure political will to support the continuation and even expansion of VMMC programming in its entirety. If not, we could soon see clinics shuttered and newly invested infrastructure come undone. New cases of HIV that might have otherwise been prevented will occur. This makes little financial or public health sense. Countries should be resourced to perform at current or even expanded capacity – with strategic investments in devices as well as overall VMMC programs.

Clearinghouse on Male Circumcision for HIV Prevention Redesigned

FHI 360 in collaboration with WHO, UNAIDS and AVAC have announced the upgrade of the Clearinghouse on Male Circumcision for HIV Prevention website — a collaborative effort between these organisations. The new design comes with enhanced form and functionality that will ensure more user-friendly navigation, a modern look, an enhanced search function, an interactive map and a new resources library among other things. Please visit www.malecircumcision.org!

Since its creation in 2009, the Clearinghouse has been an important platform for the generation and sharing of information and resources with the international public health community, civil society groups, health policy makers and program managers involved in efforts to scale-up voluntary medical male circumcision (VMMC) for HIV prevention.

VMMC is one of the most powerful and cost-effective HIV prevention tools at hand. Studies from 2005 showed that it reduces a man’s risk of acquiring HIV from a female partner by up to 60 percent, increasing to around 75 percent over time. VMMC is now being rolled out for HIV prevention in 14 sub-Saharan African countries with high HIV prevalence and low levels of adult male circumcision with the goal of achieve 80 percent coverage among men in these countries in order to avert 3.4 million new HIV infections and save US$16.6 billion in future healthcare costs.