Breakthroughs Blog: HIV/AIDS

In this guest post, Elisabeth Wilhelm, senior media specialist at the International AIDS Vaccine Initiative (IAVI), writes about the need to invest in the next generation of researchers and scientists in sub-Saharan Africa. Young people in countries suffering most from the AIDS epidemic want to have their say in development decisions to fight the disease. That’s what Sydney Hushie from the Global Youth Coalition on HIV and AIDS and fellow youth panelists stressed repeatedly during a United Nations’ General Assembly side event at the end of September in New York. And discussions at this year’s AIDS Vaccine Conference in Barcelona reinforced the insight that it will be the young scientists of today who will drive the innovation toward vaccines—among other new prevention technologies—that will help get to zero new HIV infections tomorrow. Access to quality education not only can help prepare tomorrow’s HIV and AIDS scientists—it can also help them beat the odds of becoming tomorrow’s patients. Nearly half of all new HIV infections globally occur in young adults of 15 to 24. The more education, the lower is the risk that young people will contract HIV. They want to learn: In a study in Zimbabwe, home to the world’s seventh-highest HIV prevalence, boys and girls were very interested in health-related issues such as HIV and sex. It will be the young scientists of today who will drive the innovation toward vaccines—among other new prevention technologies—that will help get to zero new HIV infections tomorrow. Photo: IAVI/Sokomoto The opportunities for young people to take an active role in this global fight remain as limited as their access to health care and to secondary education—as well as their countries’ investments in science, technology, and math (STEM), especially in sub-Saharan Africa. Tanzania and Kenya have the lowest post-secondary education rankings among 61 countries. Ghanaian students’ performance in the Trends International Mathematics and Science Study, for example, ranked second-to-last out of 45 countries surveyed in 2003. South Africa was ranked last by the World Economic Forum in quality of math and science education out of 62 countries. For those students in sub-Saharan Africa who beat the odds of completing a secondary education, many end up working or studying somewhere else—and the developing world can ill afford this “brain drain.” The World Economic Forum ranked 62 countries by their post-secondary graduation rates—Kenya came in 41st and Tanzania 50th. Their departures aren’t surprising. The World Bank estimated that skilled workers account for only 4 percent of the total workforce in sub-Saharan Africa, but 40 percent of those who leave their home countries. Scientists pick up and leave, too; indexes of published peer-reviewed articles show sub-Saharan Africa’s contribution to world science production hovers below 1 percent of total global output. IAVI and partners, such as the Kenya Vaccine Initiative and the Uganda Virus Research Institute, collaborate to help establish research centers and implement training programs and encourage the adoption of Good Clinical Practice. In Rwanda, the First Lady partnered with us to train young scientists in vaccine research, and across sub-Saharan Africa, we support fellowships that help local labs, local clinicians, and scientists become experts in their fields. Their vital research propels us closer to finding an AIDS vaccine. These scientists, together with the members of communities, offer guidance on designing clinical studies and developing vaccines that meet local needs. They also help ensure supportive local policies and sustained local funding—because we’re in it for the long haul, too. IAVI and partners, such as the Kenya Vaccine Initiative and the Uganda Virus Research Institute, collaborate to help establish research centers and implement training programs and encourage the adoption of Good Clinical Practice. Photo: IAVI/Courbet Other organizations are also paying attention to young scientists and advocates, whom they see as an investment in the future. The Global HIV Vaccine Enterprise has taken the lead in engaging and connecting Young and Early Career Investigators at scientific conferences, and other product development partnerships and research organizations, such as the European & Developing Countries Clinical Trials Partnership have made expanding young scientists’ research opportunities a priority. AVAC, a global advocacy prevention group, also builds an advocacy network to build in-country support for youth AIDS advocates. We cannot succeed in overcoming the challenges to developing a vaccine without our many partners, representing the best homegrown talent in sub-Saharan Africa and India. But we look to the next generation to help finish the job. Local perspectives will spur local innovations and foster new approaches to work in the lab and in the field. We can help by promoting more in-country innovation, supporting robust STEM education, and engaging young people earlier in academic settings throughout the Global South. The next generation of AIDS researchers could successfully bring one of human history’s most devastating and long-lasting pandemics to a close. Let’s give them a boost.

In this guest post, Dr. Judy Manning from the US Agency for International Development (USAID) and Dr. Zeda Rosenberg from the International Partnership for Microbicides (IPM) discuss the need for new and improved contraceptive options for women worldwide. The post was written to mark World Contraception Day. The picture could not be clearer: A woman's health and livelihood are threatened when modern family planning methods are out of her reach. On World Contraception Day (September 26), we are reminded that unintended pregnancy is a major contributor to maternal and infant death and disability around the world, and a recognized obstacle to global development. Forty percent of pregnancies worldwide are unintended, but that number is not so surprising when you consider that 222 million women have an unmet need for modern contraceptive methods. Access to such methods would enable women to plan and space their pregnancies, leading to improved health, educational, and economic outcomes for themselves and their families. New sexual and reproductive health innovations have the potential to revolutionize women's options by diversifying delivery forms, varying product duration, and targeting multiple health risks simultaneously. Photo: PATH. According to the Guttmacher Institute, 70 percent of the unmet need stems from method-related concerns. These include concerns about the safety and potential side effects of hormonal methods; appropriate options for women who have infrequent sex, or who are postpartum or breastfeeding; and opposition from their partners to specific approaches. Geography and access to health services are also barriers to modern contraception. Last year at the London Summit on Family Planning, the global community made an unprecedented pledge to reach 120 million more women with contraception by 2020. The upcoming International Conference on Family Planning in Ethiopia will map out additional steps required to make contraception available for all women. Efforts will focus on expanding access to existing methods as well as prioritizing the development of new innovative technologies. New sexual and reproductive health innovations have the potential to revolutionize women's options by diversifying delivery forms, varying product duration, and targeting multiple health risks simultaneously. Unfortunately, there is no magic bullet. When it comes to sexual and reproductive health, women face obstacles that are unique to their circumstances. But experience has taught us that if women have a range of affordable and appropriate products to pick from, they may use them more consistently, which in turn will allow them to better protect their health. We are excited about a number of cutting-edge technologies now in development. For instance, USAID is investing in the early-stage development of a biodegradable contraceptive implant that does not require removal. This product from FHI 360 could fill a critical gap in low-resource settings where women may not have access to trained health workers. Alongside contraceptive-only products, multipurpose prevention technologies (MPTs) can help address women's overlapping health needs in a single product. For example, women in areas with high rates of HIV often have the greatest unmet need for family planning, creating a double burden of risk. With support from USAID and other funders, IPM is developing a 60-day MPT ring to offer dual protection against HIV and unintended pregnancy that women could use discreetly. The self-initiated ring is being designed to provide sustained release of an antiretroviral (ARV) drug called dapivirine along with the contraceptive hormone levonorgestrel. USAID and other funders also recognize that, in many regions of the world, sexually transmitted infections (STIs) such as herpes simplex virus, human papillomavirus, and bacterial vaginosis are of greater public health concern than HIV. As a result, USAID is supporting CONRAD (in partnership with PATH) to develop an MPT that combines the new one-size-fits-most SILCS diaphragm with tenofovir gel—the first ARV drug shown to help prevent both HIV and herpes (a confirmatory trial of tenofovir's effectiveness is under way). This could provide women with a non-hormonal product that could be used "on demand," appealing to women who would like a product that is used at the time of sex. MPTs could result in significant health gains for women by broadly addressing their sexual and reproductive health needs, and reducing rates of maternal and newborn death associated with both unintended pregnancy as well as STIs. In fact, there is reason to believe that MPTs may have another added benefit: Combining two or more products into one may make protection more appealing and acceptable to women, and therefore increase its use. To fully realize the immense promise of up-and-coming innovations, we need continued investment in the development pipeline and in full access to the final products. No single product will address every woman's sexual and reproductive health needs, so it will take a portfolio of methods to ensure that women have options to choose from that are appropriate for their individual circumstances. New tools are not developed overnight—they take time, effort, and dedicated resources. But it is an investment that will help make modern contraception a reality for the 222 million women whose lives, health, and development depend on it. Originally posted by the Policy Innovations blog, a publication of Carnegie Council.

In this guest post, Regina McEnery from IAVI Report writes about the planned closure of the New England Primate Research Center and its effects on the community of HIV researchers who conduct primate studies. As animal facilities go, the New England Primate Research Center (NEPRC) had attained a legendary status on the roster of US biomedical research institutions. A good number of important discoveries have been made within its walls in the half century it has been around. Researchers working there generated some of the earliest evidence that AIDS is a viral disease, and subsequently discovered the simian immunodeficiency virus (SIV), which causes the monkey version of AIDS. It was there, as well, that scientists demonstrated that a vaccine can prevent the transmission of SIV, suggesting that an HIV vaccine is possible. Nor were the NEPRC’s contributions to science confined to HIV and AIDS. The facility has hosted research of profound relevance to everything from cancer to neurological disease and addiction. But lately it had become increasingly clear that this storied institution’s best days were behind it—so far behind it, in fact, that the Harvard Medical School (HMS), which oversees the center, decided it should be shut down. Its decline was slow and fueled largely by management and money problems, rather than the quality of its research. The NEPRC has, for example, been cited at least four times since 2010 by the US Department of Agriculture (USDA) for failure to comply with the requirements of the Animal Control Act. The most recent citation, issued last year, related to a cotton-top tamarin found dehydrated after an employee neglected to provide sufficient water to the squirrel-sized monkey. After examining its recent health history, the NEPRC veterinarian decided to euthanize the monkey, according to the USDA report. The New England Primate Research Center, which had attained a legendary status on the roster of US biomedical research institutions, will be closing. Photo courtesy of IAVI Report. John Harding, acting director of the Division of Comparative Medicine within the Office of Research Infrastructure Programs (ORIP)—the National Institutes of Health arm that provides the core grants for all national primate research centers—notes that it is “ very uncommon to find violations of the sort where animals died.” Still, HMS’s decision to wind down the facility by 2015 has upset the close-knit community of primate researchers. “We were all shocked,” says Ron Veazey, a professor of pathology at the Tulane National Primate Research Center in Louisiana. “Very few people can say, ‘we saw this coming.’ In an ideal world, all those [NEPRC] investigators will be able to transfer projects to other primate centers and everything will go on. But we can’t be sure.” The NEPRC decision to phase out its research also raises serious questions about the future of the approximately 130 projects it hosts—many of which relate to AIDS. Ditto for the 2,000 or so primates housed at the facility in Southborough, MA. The closure is likely to be widely felt throughout the field of HIV research, especially in the areas of vaccine and drug development. “Literally every class of HIV drug, with the exception of protease inhibitors, was first tested in monkeys,” noted Veazey. Louis Picker, a professor of pathology/molecular microbiology and immunology affiliated with the Oregon National Primate Research Center, says he was upset by the decision to shut down the NEPRC—where he did research during his laboratory and pathology medicine residency at Beth Israel Deaconess Medical Center in Boston. But he wasn’t surprised. “You could see the writing on the wall when this first started, two to three years ago, with the mishandling of the animal issues.” Picker says that Harvard’s response to the animal care issues—replacing NEPRC director Ron Desrosiers and two on-site veterinarians—served to drive investigators away rather than fix the problem. HMS, however, did not single out the animal care issues in explaining its decision. In evaluating its long-term needs, HMS says, it concluded that closing NEPRC would be more beneficial and efficient than pouring more resources into maintaining and renewing its supporting grant. “We were surprised,” says Harding. Yet Harvard’s decision, he says, should not be viewed as a signal that interest in funding nonhuman primate research is waning. “In fact, we see a continued need for this.” If anything, says Harding, the recent termination of the large HVTN 505 trial suggests more nonhuman primate research is needed. Still, even researchers personally unaffected by the closure of the NEPRC find its disappearance from the HIV research map hard to take in. “Personally, I see it as a loss for Harvard and for the New England research committee,” said Ana Aldovini, a scientist at Boston Children’s Hospital who once used the NEPRC, but now collaborates with Tulane. “I can’t imagine it not being a loss.” A longer version of this article is available at www.iavireport.org.

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.