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In this guest post, E. Callie Raulfs-Wang –research advisor for the US Agency for International Development’s (USAID) Center for Accelerating Innovation and Impact—writes about the relationship between research and evidence when developing and delivering new global health products. This post is the second in a series highlighting USAID’s new strategy for global health research and development (R&D). It originally appeared on the IMPACT blog. Like strands of human DNA, the genetic underpinnings of life, research and evidence are so closely intertwined they cannot be separated. Whether testing the efficacy of an HIV vaccine or the marketing strategy of a new contraceptive technology, quality research, careful methodology, and rigorous analysis are fundamental for acquiring evidence useful in decision-making. As outlined in USAID’s Report to Congress: Health-Related Research and Development Strategy, the agency supports a range of research activities, including both ‘upstream’ product research and ‘downstream’ implementation research. Along this continuum, USAID places a strong emphasis on evidence for informing development policies, practice, and strategy. As global health products are developed, we need evidence to demonstrate their effectiveness in developing country settings.For example, despite the fact that effective treatments exist for pneumonia, over 1.2 million children die each year from the disease. In the last few years, USAID has supported studies in Pakistan investigating the effectiveness of community-based treatment of severe pneumonia. Results from these studies have shown that oral antibiotics administered at home are as effective as injectable antibiotics administered in a hospital setting. This evidence prompted a 2012 revision of World Health Organization guidelines on outpatient management of severe pneumonia. Beyond effectiveness studies, like the one conducted in Pakistan, we need studies that focus on the implementation and adoption of public health interventions, also known as implementation science. USAID’s 2012 Global Health Strategic Framework: Better Health for Development iterates a commitment to implementation research and the “scale-up of evidence-based, equitable, inclusive, and locally adapted health solutions.” To increase understanding of the ‘what’ and ‘how’ of implementation research, USAID in partnership with Johns Hopkins University and The George Washington University, has launched an open-access peer-reviewed journal called Global Health: Science & Practice. To accelerate product development and the introduction of new technologies, USAID has initiated the Center for Accelerating Innovation and Impact (CII), which engages key experts to identify state-of-the-art ‘best practices’ around product marketing, introduction, and scale. To expand knowledge of interventions that have “high impact,” the Bureau for Global Health has developed several High-Impact Practices (HIPs) in family planning; maternal, newborn, and child health; nutrition; and health systems strengthening. For example High-Impact Practices in family planning are best practices that, when scaled up and institutionalized, will maximize investments in a comprehensive family planning strategy. Since 2011, USAID and partners have hosted three evidence summits addressing critical challenges in global health. Not an ordinary conference, an evidence summit is an organized process that convenes leading scholars and health practitioners to review the latest research and provide evidence-based guidance for improved health performance, an understanding of knowledge gaps, and research agenda recommendations. These summits have addressed: Protecting Children Outside of Family Care, Enhancing Provision and Use of Maternal Health Services through Financial Incentives, and Enhancing Community Health Worker Performance. A fourth evidence summit on Behavior Change Communication for Child Survival will be held later this year. The local adaptation of health solutions is where the rubber meets the road. Each developing country is characterized by its own unique population, culture, health challenges, and infrastructure. To enable the development of local solutions to local problems, USAID is supporting the Partnerships for Enhanced Engagement in Research (PEER) Health program. PEER Health is a capacity-building program which provides research grants to developing country investigators in partnership with National Institutes of Health researchers focused on addressing local health challenges. Asking the right question, at the right time, in the right way, is not easy. As global health moves into the 21st century, more complex health challenges, including non-communicable diseases, the integration of health services, and the strengthening of health systems, present themselves. Solid evidence based on rigorous research is an indispensable ingredient for the successful introduction and scale of health products and services. As the 2012 health research report to Congress attests, USAID remains committed to pursuing an evidence-based agenda in global health.

In this guest post, Molly Schmalzbach—public affairs analyst in the Office of HIV and AIDS at the US Agency for International Development (USAID)—discusses the agency’s support for research to develop new HIV and AIDS and tuberculosis (TB) products. This post is the first in a series highlighting USAID’s new strategy for global health research and development (R&D). It originally appeared on the IMPACT blog. Nearly all great scientific advances can be traced back to methodical R&D. R&D is a critical step in meeting goals and achieving health results that are cost-effective, sustainable, and grounded in evidence. In December 2012, USAID released its new strategy for global health R&D. The report outlines how the agency plans to address some of the world’s most challenging health and development issues through new technologies, research, and evaluation, as well as the scale-up of interventions backed by scientific evidence. HIV and AIDS is a large component of this effort, and the agency—through the US President’s Emergency Plan for AIDS Relief (PEPFAR)—is supporting very promising HIV research in several areas, including microbicides, vaccines, and diagnostic tools to detect TB in HIV-positive patients. Microbicides: Microbicides are substances that can be applied vaginally or rectally to reduce the risk of HIV transmission during sex. Vaginal microbicides are a particularly desirable innovation because women can use these products on their own to protect themselves from HIV infection. Given that women make up almost 60 percent of people living with HIV in sub-Saharan Africa and struggle to negotiate other HIV prevention methods—such as condoms—with their partners, USAID supports microbicide R&D as a key intervention in reaching an AIDS-free generation. Women can use this ARV-based vaginal gel to protect themselves against HIV. Photo credit: International Partnership for Microbicides. In 2010, the CAPRISA 004 clinical trial showed that a vaginal microbicide made up of 1 percent tenofovir gel (a topical form of the antiretroviral drug) protected women against HIV. Following this success, a new public-private joint venture, known as Propreven, is preparing to obtain regulatory approvals, create manufacturing capacity, and support product distribution of tenofovir gel in various African countries. Two additional studies are also underway—the FACTS 001 clinical trial, which is a follow-on to CAPRISA 004 and is currently in year two, and the CAPRISA 008, a study that is examining and addressing implementation issues for future microbicide programs. Both of these studies are supported by a US and South African partnership made up of USAID, the Bill & Melinda Gates Foundation, and the Government of South Africa. Vaccines: While microbicides are an important method in preventing HIV when tailored to specific populations, no single approach is likely to have as dramatic an impact on the HIV pandemic as an effective vaccine. That is why USAID has supported HIV vaccine R&D through the International AIDS Vaccine Initiative (IAVI) since 2001. IAVI is a public-private product development partnership that acts as a virtual pharmaceutical company to accelerate the development and clinical testing of HIV vaccine candidates. On the vaccine design front, IAVI and its partners in the Neutralizing Antibody Consortium (NAC) have designed four new immunogens—the active ingredients of vaccines that stimulate the immune system—and are testing these structures as part of potential HIV vaccines. Two clinical trials involving IAVI’s work are examining new HIV vaccine regimens. One trial nearing completion in East Africa is evaluating a vaccine regimen that uses a new technique called electroporation, and some exciting results are expected in the coming year. Electroporation applies a small charge to effectively distribute the contents of the vaccine in the muscle and enhance uptake of the DNA. Another trial poised to begin within the next few weeks will evaluate new viral vectors carrying HIV antigens. TB Diagnostics: Microbicides and vaccines are critical priorities for USAID’s HIV prevention efforts; however, we must also provide care and support to people already living with HIV. Since TB is the leading cause of death among HIV-positive people, USAID supports the coordination of TB and HIV services to better care for people living with each disease. In recent years the prevention, diagnosis, and treatment of TB has become more complicated because of two factors: HIV-associated TB and multidrug-resistant (MDR) TB. HIV-associated TB often goes undetected because the most common TB diagnostic, called sputum smear microscopy, is not very effective in people infected with HIV. The Cepheid Xpert is a rapid TB diagnostic and sensitive to HIV-associated TB. Photo credit: Cepheid. Fortunately, there is a promising new diagnostic for TB, including HIV-associated TB, on the horizon! This rapid and sensitive test, called the Cepheid Xpert MTB/RIF® assay, has the potential to revolutionize the diagnosis of TB. While Xpert still faces some operational and programmatic barriers, such as high costs and the need for a sustained power supply, USAID has already begun supporting the roll-out of this new tool by helping countries obtain Xpert machines, designing associated policy guidance and strategies, and developing technical approaches to guide implementation. R&D in these three key areas is what keeps USAID at the forefront in the fight against HIV and AIDS. As David Stanton, the director of the Office of HIV and AIDS at USAID said, “These clinical trials and new technologies have the potential to dramatically change the HIV and AIDS landscape and reverse the trajectory of the global HIV pandemic.” To learn more about USAID’s strategy for global health R&D in the coming years, be sure to check out our latest Report to Congress: Health-Related Research and Development Strategy 2011-2015.

  In this guest post, Margie McGlynn, president and CEO of the International AIDS Vaccine Initiative (IAVI), Zeda Rosenberg, chief executive officer of the International Partnership for Microbicides (IPM), and Renate Baehr, executive director of DSW (Deutsche Stiftung Weltbevoelkerung) mark International Women’s Day with a call for continued research to develop new women’s health tools. On this day honoring the political, social, and economic contributions women have made worldwide, nearly 2,000 women will die of AIDS and 790 will perish in pregnancy or childbirth. If we wish to truly advance the health and rights of women globally, we must give them the tools they need to protect their own health. Yet, while the benefits of investing in women—and their health in particular—are well-established and far-reaching, less progress has been made over the past decade toward attaining Millennium Development Goals that address women’s health and gender equality than virtually every other goal.   HIV is a case in point. In the regions hardest hit by the AIDS pandemic, such as sub-Saharan Africa, women bear a disproportionate burden of HIV, accounting for six out of every 10 new infections. A unique combination of factors, having as much to do with biology as with gender inequality, contribute to women’s increased vulnerability. Researchers have made remarkable progress toward developing tools for HIV prevention that could empower women to protect themselves from the virus. Photo credit: PATH/Evelyn Hockstein Fortunately, researchers have in recent years made remarkable progress toward developing tools for HIV prevention that could empower women to protect themselves from the virus. A number of such products and strategies are under development today, including microbicides, AIDS vaccines, multi-purpose prevention technologies (MPTs) and the use of antiretroviral drugs (ARVs) as pre-exposure prophylaxis (PrEP). Take, for example, IPM’s monthly vaginal ring that is currently in the late stages of clinical evaluation. The device slowly releases the ARV dapivirine to prevent HIV. Another product that has already been shown to be partially effective, a microbicide gel containing the ARV tenofovir that is used around the time of sex, is now being tested in a confirmatory trial. And though the latest results from the VOICE trial found that PrEP did not work in that study due to low adherence, a number of other studies have demonstrated that if used consistently, ARVs can do much to prevent HIV. Further, long-acting preventive tools like the dapivirine ring could help address the challenge of adherence for women. IPM and others are also developing MPTs that slowly release ARVs along with a contraceptive to prevent HIV and unintended pregnancy—both leading causes of death for women worldwide. Researchers have also made significant strides toward the development of preventive HIV vaccines. A trial conducted in Thailand four years ago establishes hope that HIV can be prevented by vaccination. Vaccine design too is advancing apace. Scientists around the world have isolated scores of broadly neutralizing antibodies to HIV, uncovering clues to the design of broadly effective vaccines against the highly variable virus. Recent modeling by IAVI suggests that even a partially effective HIV vaccine could significantly reduce the number of new infections among women, if it were deployed in the context of expanded prevention and treatment programs. These models suggest that a vaccine with 50 percent efficacy given to 30 percent of the adult population in low- and middle-income countries would prevent 2.8 million infections in women over 10 years. Vaccines, microbicides and other new preventive technologies could empower women to protect their own health because they could be used discreetly, without the need for negotiation with their sexual partners. Taken together, these new tools and measures could—if deployed with existing methods of HIV prevention—eventually end the AIDS pandemic. Until then, preventing HIV and supporting family planning would improve the health and economic well-being of entire families and advance key development goals. When women are healthy, they have more opportunities for education and employment, which in turn strengthens communities. A paper commissioned by DSW recently reported, for example, that the promotion of HIV prevention and sexual and reproductive health research can help countries make gains toward poverty reduction. This International Women’s Day, we call on the global community to recommit to investing in new preventive tools and health technologies for women. The health of women is, after all, essential to the well-being and economic stability of not only the women themselves and their families—but of entire nations.

Although we’re several days into sequestration, details about the full impact of funding cuts are still hazy. On Friday, the Office of Management and Budget (OMB) released a report to Congress, which details funding cuts required to offset $85 billion in the fiscal year (FY) 2013 budget. In order to reach this goal, the OMB report indicates that global health research and development (R&D) programs will be subjected to cuts of either 5 percent or 7.8 percent. But because the cuts must take place over a seven month period (instead of a full year) to fit within the fiscal year, OMB calculates that these cuts could actually be at a rate of 9 percent and 13 percent with the remaining funding for this year. OMB’s report provides some specific details on how the cuts are calculated. It also provides illustrative examples of what the sequestration cuts might look like if applied equally within federal agency budgets. However, because agency heads will have discretion over how specific cuts affect their agencies, the exact implications of sequestration will be determined in the coming weeks. Estimates are emerging regarding the widespread impact of sequestration on the agencies that support global health R&D. Photo credit: PATH While waiting for these details to come out, we are starting to see some estimates emerge regarding the impact of sequestration on the agencies that support global health R&D. For example: The National Institutes of Health’s discretionary budget will be reduced from $30,899,000 to $29,321,000 for FY13, a cut of over $1.5 billion. The sequester would equate to a $2.6 billion reduction to the State Department and US Agency for International Development (USAID) FY13 budget, translating to a $1.7 billion cut to foreign assistance programs. In particular, sequestration will cut over $400 million from global health initiatives at the State Department and USAID, including R&D initiatives. Global health programs at the Centers for Disease Control and Prevention are likely to be reduced by taking 5 percent from HIV and AIDS initiatives and then taking 5 percent from the remainder of the account. Discretionary spending for the Department of Defense (DoD) is subject to a 7.8 percent reduction, which would include any global health R&D initiatives embedded in DoD programs. Some reports indicate that the US Food and Drug Administration will lose about 9 percent of its budget for FY13. The Obama Administration is urging Congress to allow the agency to spend $41 billion-worth of user fees. In the meantime, the government is currently running on a Continuing Resolution, which expires on March 27. Congressional leaders and President Obama have expressed hopes about successfully negotiating a new spending bill by March 27, in order to avoid a government shut-down. These negotiations may also provide an opportunity to reverse the sequester, before the full impact of the cuts are felt across the government. The President’s budget request for FY14 is also on the horizon, with reports indicating that it might be released on March 25. The House and Senate will begin to take up FY14 budget resolutions, which each Chamber must pass by April 15. It’s becoming increasingly clear that sequestration is the wrong way to reduce the nation’s debt, especially when the impact would set back innovation and devastate global public health. Policymakers should use the upcoming budget negotiations as an opportunity to reverse sequestration and develop a long-term budget solution that protects and—where possible—increases funding for global health product development. Slashing funding will interrupt scientific progress and leave us without the urgent tools we need to address health needs now and in the future.