AVAC Playbook 2012 includes AVAC’s analysis of what the top strategic goals should be on a global level, and particularly in hard-hit countries, over the year 2012. It also includes AVAC’s organizational priorities for contributing to these goals.
AVAC Playbook 2012
Press Release
AVAC Report Defines Agenda for Ending the Global AIDS Epidemic
New York, NY — AVAC today issued a three-part, science-based agenda for ending the AIDS epidemic within our lifetimes. The new report, titled The End?, is a unique strategic vision encompassing key steps to accelerate impact with existing HIV prevention tools, emerging strategies and longer term research. It identifies critical priorities in each of these areas and advances specific recommendations for both 2012 and for the next decade.
“The past year has seen building excitement about the possibility of ending AIDS in our lifetime. It is an ambitious goal, but a realistic one, provided we have a clear path forward and the will to do what’s needed,” said Mitchell Warren, AVAC executive director. “The science-based agenda in this year’s AVAC Report fills a gap at a critical moment: it describes the full spectrum of actions needed to realize the potential of existing, emerging and long-term biomedical HIV prevention options and change the AIDS response forever.”
The report comes at a pivotal moment for the AIDS response. Just weeks ago, US Secretary of State Hillary Clinton committed the US government to realizing an “AIDS-free generation.” A recent report from UNAIDS mapped a new framework for AIDS investments which are focused on high-impact, evidence-based strategies. Yet at the same time, the Global Fund to Fight AIDS, Tuberculosis and Malaria announced that it has insufficient funds for its next round of grants, effectively delaying any new funding commitments until 2014. Ensuring that the Fund is replenished and continues to support countries worldwide is a top priority for ending AIDS.
“Secretary Clinton and other leaders have put a spotlight on what’s possible. Now, it’s time to agree on a coherent, long-term plan to make it happen,” said Warren. “While our success at ending AIDS is far from assured, the scientific data are speaking loud and clear and expectations are running high. It is essential that funding, implementation and research commitments align. The future of the epidemic hangs in the balance.”
Game-changing research advances fuel optimism
Recent studies have demonstrated that antiretroviral (ARV) medications and other tools can prevent HIV transmission, creating new opportunities to accelerate the global decline in new HIV infections:
- In 2006, trials showed that voluntary medical male circumcision can reduce a man’s risk of infection from a female partner by about 60 percent.
- In 2011, a large US-funded trial released data showing that starting effective HIV treatment earlier reduced individuals’ risk of transmitting HIV by 96 percent.
- In 2009 and 2010, trials of oral and topical pre-exposure prophylaxis (PrEP) using ARV medications in specific populations of HIV-negative people provided proof of concept that PrEP is an effective prevention tool.
- In 2011, scientists identified vaccine-induced immune correlates of risk that help explain the positive finding from the RV144 AIDS vaccine trial—the first to demonstrate that a vaccine can have an impact on HIV transmission—and point the way to discovery of an effective AIDS vaccine.
AVAC Report 2011 outlines priorities for success
The agenda for action in the AVAC Report covers three major priority areas. Each area demands action today, while the dividends in terms of impact on the epidemic will be seen in the short, medium and long term:
- Deliver today’s proven strategies at scale, for immediate impact on the epidemic.Scale up innovative HIV testing programs to identify people who can benefit from prevention and treatment; expand access to treatment to preserve health and prevent transmission; and realize the full potential of voluntary medical male circumcision, a so-far underutilized tool.
For 2012, specific global goals include achieving universal access to ARVs at CD4 counts of 350 or below; and ensuring that relevant countries have long-term plans in place to roll out voluntary medical male circumcision with the goal of achieving 80 percent voluntary circumcision rates.
- Demonstrate and roll out emerging tools, including PrEP and microbicides, for even greater impact in five to 10 years.Quickly establish clear plans to understand how and for whom these promising tools might work; launch pilot projects to determine their best uses in different populations; and then prioritize their use in the populations, and in combinations, where their potential impact is greatest.
For 2012, global goals include swift implementation of pilot projects, establishing a clear pathway for confirmatory research on the tenofovir-based microbicide gel, and building and maintaining a pipeline of longer-acting options.
- Develop long-term solutions, including an effective vaccine and a cure.Sustain funding to capitalize on recent scientific advances that have energized the research field.
A key 2012 goal is to close funding gaps for trials that are needed to pursue leads from the RV144 vaccine trial. Such trials are increasingly threatened by potential research budget cuts in the U.S. and other nations. In addition, it is increasingly important to define how a vaccine could impact combination prevention.
Success hinges on sustained financing, used wisely
The report urges that resources for HIV prevention be allocated for greatest possible impact. Where necessary, funding that supports low-impact activities should be reprogramed, based on evidence, to further reduce infections and save more lives. Moreover, AVAC argues that to end the AIDS epidemic, the field needs to define, evaluate and implement combination prevention in every community affected by HIV.
“If we’re serious about ending the epidemic, then we all need to make certain that precious resources are put where they’re needed most,” said Warren. “And we need to ensure that adequate resources are available. We cannot meet these ambitious goals if the Global Fund, PEPFAR and other essential programs are not adequately funded.”
In launching the report, AVAC called on the United States, global health donors and developing countries to increase funding for scale-up of interventions including HIV testing, treatment and voluntary medical male circumcision. At the same time, renewed promise in the vaccine research field can only be pursued through sustained support from the US and other research sponsors.
“Today’s exciting science comes at one of the most challenging and frustrating economic times,” said Warren. “But the case for investing in the AIDS fight is the strongest it has ever been. If we spend more today—and spend it more wisely—we can save money over the long term and rid the world of one of the most devastating and prolonged epidemics in history.”
The full AVAC Report 2011: The End?, along with AVAC’s Playbook 2012, podcasts, graphics and other materials about ending the epidemic, are available at www.avac.org/report2011.
A PDF version of this press release is available here.
Contact:
Mitchell Warren, mitchell@avac.org, +1-914-661-1536
Kay Marshall, kay@avac.org, +1-347-249-6375
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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.
Press Release
AVAC Applauds Secretary of State Hillary Clinton for Ambitious, Science-Based Vision to End the AIDS Epidemic
New York, NY — AVAC welcomes today’s remarks by U.S. Secretary of State Hillary Rodham Clinton as the first step in an ambitious vision for ending the global AIDS epidemic.
“Secretary Clinton rightly recognized that this is an era of unprecedented opportunity for changing the course of the AIDS epidemic and making an AIDS-free generation a reality. The announcement of an additional US$ 60 million for combination prevention impact evaluation in four countries is a useful first step in terms of realizing the vision. In the coming months, it will be critical for the Obama Administration to build on the plan that she outlined with specific commitments and objectives for the near-, mid- and long-term,” said Mitchell Warren, AVAC executive director.
Secretary Clinton emphasized three core prevention strategies that, if fully implemented, would lead to an AIDS-free generation: prevention of mother-to-child transmission, voluntary medical male circumcision and effective antiretroviral treatment for people who are HIV positive.
“HIV testing and counseling programs are the foundation for each of the interventions Secretary Clinton described, and it will be critical for the Obama Administration to focus on massive scale-up of innovative, ethical testing programs as part of its articulated plan for an AIDS-free generation,” Warren said.
“It is also critical to sustain investments in research and development of additional powerful prevention tools, including pre-exposure prophylaxis (PrEP) using ARVs in HIV-negative people, microbicides, and an AIDS vaccine,” Warren added. “If voluntary medical male circumcision, treatment as prevention and prevention of mother to child transmission are taken to scale, the number of new infections will plummet. Deploying additional tools over the long term,could help realize the greatest achievement of ending the AIDS epidemic in our lifetime.”
“This is truly a new era in the AIDS response, with unprecedented opportunities. Research has brought us a host of new ways to prevent HIV, but we have a long way to go before realizing their full potential. Having identified these key areas, the United States needs to continue to show leadership by articulating a clear plan with milestones for progress. Other developed and developing country governments, communities and donors need to show leadership, ownership and initiative as no single nation can end the epidemic on its own.”
AVAC will release its annual report on the state of global HIV prevention at the end of November, laying out a science-based prescription for the coming decade to realize the end of the AIDS epidemic.
Contact:
Mitchell Warren, mitchell@avac.org, +1-914-661-1536
Kay Marshall, kay@avac.org, +1-347-249-6375
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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.
Modeling the End of the Epidemic
“We need to use modeling to communicate what the possibilities are and what’s been gained from investments to date.” This was the consensus of a small group of advocates, activists, public health leaders and modelers gathered on September 9 by AVAC and amfAR to take a closer look at the state of epidemiological modeling as it relates to the goal of ending the AIDS epidemic. There is scientific evidence for a range of potent prevention strategies including treatment as prevention, male circumcision in the immediate term and, in the future, microbicides, PrEP and vaccines. But decision makers face real challenges about determining priorities and budgets. Models can’t provide the answers, but they can give a sense of the benefits and trade-offs for different scenarios. On October 3, Tim Hallett, a modeler and epidemiologist from Imperial College London, met in Nairobi with AVAC and a small group of East African advocates including several of our Fellows, to discuss how advocates can be what Hallett calls “informed consumers” of HIV models. In the coming weeks and months, AVAC and its allies will be working to help frame the questions and modeling the needs critical to ending AIDS. Watch this space.
A New Tool for Laypeople Serving on Institutional Review Boards
The New HIV Vaccine and Microbicide Advocacy Society (NHVMAS), a partner in AVAC’s work on Good participatory practice for biomedical prevention research, recently published two new training manuals: one for training laypersons serving on ethics committees on how to read and give feedback on protocols, and one on the basics of research ethics. The training manuals and a PowerPoint presentation for training laypersons serving on ethics committees are available for download here. If you have trouble downloading the files or require printed copies, contact us at avac@avac.org.
Epicentro, IRMA and AVAC work to expand the HIV prevention research advocacy community in Latin America
International Rectal Microbicide Advocates (IRMA) and AVAC have partnered with Epicentro gay men’s community center in Lima, Peru to bolster HIV prevention education and advocacy in Latin America. Epicentro is adapting advocacy materials on PrEP and rectal microbicides, conducting community surveys on awareness of recent developments in HIV prevention research and gay men’s concerns and priorities. They held their first advocacy call with their new network, La Red, on August 25. You can follow their work on the IRMA-ALC blog and an active Facebook page. For AVAC materials translated into Spanish, visit www.avac.org/espanol.
2010 AVAC Report: Turning the Page (Thai translation)
The AVAC 2010 Report, Turning the Page, highlights that the biomedical prevention field is entering the next chapter of its development. The past year brought the first evidence, from the Thai Prime-Boost trial, that an AIDS vaccine could prevent HIV in humans, as well as significant preclinical findings around potent, HIV-specific neutralizing antibodies.
At the same time, two microbicide trials testing the candidate PRO 2000 yielded seemingly different, but ultimately disappointing results, and the field now prepares for the release of results from CAPRISA 004, the first ARV-based microbicide effectiveness trial.
Press Release
AVAC Calls for Speedy Funding of Critical Microbicide Follow-Up Studies
New York, NY, – AVAC today issues a call to action to donors, policy-makers, researchers and advocates to ensure that critical follow-up studies to the landmark CAPRISA 004 microbicide trial receive the economic and political support needed to move forward as quickly as possible. The call comes as a group of microbicide and public health experts have agreed upon a plan for further studies, which are expected to cost $100 million over three years, of which only $58 million has been committed.
“We have an imperative to learn about the effectiveness of 1 percent tenofovir gel, the product tested in CAPRISA 004. If the results are confirmed, we now have an incredible opportunity to translate a clinical trial result into public health impact — and we should not miss it” said Mitchell Warren, AVAC executive director.
A group of key decision makers met recently in South Africa to develop a comprehensive research agenda to build on the results of the CAPRISA 004 microbicide gel trial. At that meeting, public health officials, researchers, and regulators moved with remarkable speed to develop a consensus plan that calls for a set of studies aimed at confirming the CAPRISA 004 results and developing implementation strategies.
“A plan is in place to move the research forward, and funders and policy makers must now move quickly ensure that it can be implemented as soon as possible,” Warren added. “Women in South Africa and around the world are calling for access to this product. We have a moral obligation to quickly and efficiently answer the remaining questions that will tell us if this is an intervention that can be used and how it will need to be implemented.”
“These results could lead to one of most exciting breakthroughs in the history of the AIDS epidemic. This microbicide could be an important tool to help women protect themselves from HIV.” said Warren. “At the same time that researchers work to confirm the results, we must also ensure that plans are in place to ensure swift regulatory approvals and implementation programs. A safe and effective microbicide must not follow the same slow route to full implementation as the female condom.”
The microbicide field has been energized by this result, as has the larger field of biomedical prevention research. We must not lose momentum,” Warren added. “There is funding in place for microbicide research and other trials are ongoing, but there is a real risk that the development of 1 percent tenofovir gel will languish without a new infusion of funding specifically targeted to moving this product and dosing strategy forward.”
“Knowing that AIDS treatment and other global health priorities are starved for resources, we do not make the call for additional funds for this research lightly,” Warren added. “But a relatively small investment in this research agenda has the potential to reap huge rewards in the number of new infections that can be prevented if 1 percent tenfovir proves to be even a partially effective microbicide.”
It is critical that as the field moves forward with a research agenda for this strategy, a full and robust HIV prevention research agenda continues and the microbicide pipeline is expanded to ensure the development of additional dosing and delivery methods that will work for more women and men. Several key HIV prevention trials are underway, including other microbicide dosing strategies and formulations, PrEP (testing antiretroviral drugs in oral form), and vaccines. A combination of new HIV prevention interventions, along with scaled up treatment and care programs, are needed to end the AIDS epidemic.
More information about the CAPRISA 004 result and ARV-based prevention is available in AVAC’s new publication A Cascade of Hope and Questions: Understanding the Results of CAPRISA 004 available at www.avac.org.
A UNAIDS press release about the meeting is available at kay@avac.org
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Press Release
New Edition of Guidelines for Communities in HIV Prevention Research Released at International AIDS Conference
GPP Plays Critical Role in Moving HIV Prevention Research Agenda Forward
VIENNA – The draft second edition of The Good Participatory Practice (GPP) Guidelines for Biomedical HIV Prevention Trials were released yesterday at the International AIDS Conference in Vienna by AVAC and UNAIDS. The GPP Guidelines aim to provide trial funders, sponsors, and implementers with systematic guidance on how to effectively work with a range of stakeholders as they design and conduct biomedical HIV prevention trials.
The guidelines were developed by AVAC and UNAIDS in consultation with a broad range of global stakeholders who have provided perspectives since the first edition was published in 2007. AVAC and UNAIDS are now seeking feedback on the draft second edition from those with interest and expertise in HIV prevention research until 31 October, after which the final second edition will be published.
Clinical trials are guided by Good Clinical Practice, Good Laboratory Practice, and other guidelines and regulations that cover scientific and general ethical conduct, but global guidelines had not existed for community engagement before the first publication of GPP.
“Recent breakthroughs, including positive results from the CAPRISA 004 microbicide trial, have reenergized prevention research, and around the world, thousands of research participants and hundreds of researchers and trial site staff are working together find new HIV prevention options. Thousands more will be needed as we work to find new solutions to ending the AIDS epidemic,” said Mitchell Warren, executive director of AVAC.
“The GPP Guidelines were developed to fill an important gap in the conduct of biomedical HIV prevention research and to help research teams, trial sponsors, trial funders, communities, advocates, and other stakeholders plan, implement, and evaluate community engagement in trials, reduce unnecessary conflict and ensure that research is meaningful to both communities and trial implementers,” Warren added.
“AVAC and UNAIDS is pleased to release this new version of the GPP guidelines at the conference at which the groundbreaking results of the CAPRISA tenofovir microbicide gel trial have been presented, recalling that it was the stopping of antiretroviral pre-exposure prophylaxis trials in 2004 that first inspired the development of the GPP guidelines,” said Dr. Catherine Hankins, UNAIDS’ chief scientific adviser.
The GPP guidelines include:
- Guiding Principles of GPP that serve as the foundation of the relationship between trial funders, sponsors, implementers, and other stakeholders.
- GPP Standards that trial funders, sponsors, and implementers should follow when designing, preparing for, conducting, and concluding a biomedical HIV prevention trial.
The GPP Guidelines are available online at: www.avac.org/gppdocuments or www.unaids.org.
AVAC Contact: Kay Marshall, +1-347-249-6375, kay@avac.org
UNAIDS Contact: Saya Oka, +41 22 791 1697, okas@unaids.org
Press Release
Report Warns Flat Funding for HIV Prevention Research May Limit Ability of Researchers to Move Promising Approaches Forward
VIENNA (21 July, 2010) – Following significant advances in vaccine and microbicide research, importantly including results presented today of 39% efficacy in the CAPRISA 004 microbicide gel trial among women in South Africa, a new report released today warns that flat funding for HIV prevention research may limit researchers’ ability to quickly move promising approaches forward.
The report examines investment in HIV prevention research in 2009 and finds that the onset of a global recession did not immediately impact funding levels for biomedical HIV prevention research. Total funding remained stable at approximately US$1.165 billion for preventive vaccines, microbicides, pre-exposure prophylaxis (PrEP) and operations research related to male circumcision.
In the face of an economic crisis that has deeply affected the economies and public-sector budgets of HIV prevention research funders, level funding for HIV prevention is cause for cautious optimism. Yet much of the 2009 funding was likely reflective of resources committed when the global economy was far healthier. As current funding commitments come to an end, the concern will be whether funders will be able to renew commitments at existing funding levels. Furthermore, the report authors argue that flat funding of HIV prevention research could have serious consequences for the field as results from critical prevention trials move the research agenda forward. They warn that researchers could have insufficient resources to advance important opportunities to prevent HIV.
Advancing the Science in a Time of Fiscal Constraint: Funding for HIV Prevention Technologies in 2009, the sixth annual report from the HIV Vaccines and Microbicides Resource Tracking Working Group, was released today at the XVIII International AIDS Conference in Vienna, Austria. It documents investments in biomedical HIV prevention research from public, philanthropic and commercial sectors in 2009. HIV vaccines continued to receive the majority of funding, with a total of US$868 million, which was equal to 2008 funding levels. Investment in microbicides was US$236 million, a decline of 3 percent from 2008 levels. Funding for oral pre-exposure prophylaxis (PrEP) increased by 18 percent over 2008 levels to US$52 million.
The stability in funding is encouraging, given a 10 percent decrease in funding for AIDS vaccine research seen in 2008, but the Working Group identified several areas of concern if funding remains flat, including escalating costs of late-stage clinical research, dependency on a small group of funders and a lack of diversity in funders. In addition, the Working Group stresses that the CAPRISA 004 results, while tremendously exciting, are by no means the definitive answer about antiretroviral-based microbicides and appropriately resourced confirmatory and exploratory research will be needed.
The Working Group has documented an overall trend since 2000 toward increased funding of new funders joining in the effort to support HIV prevention research. Yet in 2009, this funding stability was largely the result of increased or sustained funding by the U.S. National Institutes of Health and the Bill & Melinda Gates Foundation, which together accounted for 79 percent of vaccine funding, 59 percent of microbicide funding and 70 percent of PrEP funding.
“With five new infections, for every two people newly on treatment we cannot give up our quest for new HIV prevention tools,” said Michel Sidibé, Executive Director of UNAIDS. “Investments for HIV prevention must be enhanced and sustained.”
“As we push for expanded funding and political commitments for HIV prevention research and the overall AIDS response, we must also work to find smart and innovative ways to make the best use of available funding to continue to scale up delivery of existing interventions and to look for new ones,” said Mitchell Warren executive director of AVAC. “HIV prevention researchers, advocates and donors must all commit to working together to ensure that we make the best and smartest use of limited resources, while also ensuring that the most promising interventions continue to move forward.”
Recent and upcoming results from several major studies could radically change the trajectory of HIV prevention research and increase the need for funding. These include the results of the RV144 Thai AIDS vaccine trial, which showed modest protection against HIV and scientifically demonstrated for the first time that an AIDS vaccine was possible, results from an important proof of concept microbicide trial CAPRISA 004, released yesterday at the Vienna AIDS conference, and anticipated results from two PrEP trials in the coming year.
“This is a very exciting time in HIV prevention research,” said Seth Berkley, President and CEO of the International AIDS Vaccine Initiative. “As the prevention research field is primed to exploit scientific advances availability and flexibility of funding will be critically important. Our ability to move discoveries into and to undertake even the most critical of these large-scale trials is at risk in the current funding environment.”
“We must work to continuously ensure resources are available to fulfill the promise of new scientific advances that could save millions of lives,” said Dr. Zeda Rosenberg, CEO of the International Partnership for Microbicides. “Microbicides, PrEP, vaccines and treatment-as-prevention are just beginning to show great promise for HIV prevention in large-scale trials. As we work together to develop these tools and transform our global health goals into reality, our success depends on having sufficient resources to keep pace with research developments in the field.”
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