The Px Wire centerspread from January-March Volume 7, No. 1 lays out the “research-to-rollout” continuum of steps between initial evaluations of a novel concept for HIV prevention and the ultimate introduction of new tool offered in an effective public health program.
A Three-Part Agenda for Ending AIDS 2014
The HIV Prevention Research-to-Rollout Continuum
AVAC Playbook 2013–2014: Global goals and priorities
The AVAC’s Playbook is a concise look at global goals related to ten areas that are critical to ending the AIDS epidemic. The squares contain long-term goals; in the circles we have laid out priorities for 2014. Working with our partners, we develop and implement advocacy strategies to get us closer to these goals.
AIDS Vaccine Research: An overview (2013)
Press Release
AVAC urges HIV prevention research “reality check” in new report
Cape Town, South Africa, December 9, 2013 – In a report released today, AVAC calls on funders and researchers to capitalize on lessons learned from a range of recent HIV prevention trials with better problem solving, more critical thinking and coordinated action around large-scale human trials, faster roll out of proven options and ongoing research for new advances that women and men will want to use.
This year’s AVAC Report, entitled Research and Reality, pays particular attention to the needs of women and girls. Citing recent trials that failed to provide conclusive answers due to low use of products in the studies, the report lays out a broad and ambitious development agenda for female-initiated prevention options including vaginal gels, rings and other emerging biomedical strategies.
The new report also urges researchers, donors and implementers to step up plans for large-scale delivery of recently proven methods for women and men, including pre-exposure prophylaxis (PrEP) and non-surgical male circumcision devices. While pilot studies of these options are in progress, a lack of longer-range plans for program scale-up and roll out means that valuable time, and lives, could be lost.
“Prevention research has had both rough times and revolutionary breakthroughs in the past few years. It’s time to apply lessons from these experiences to work faster and smarter going forward,” said Mitchell Warren, AVAC executive director. “As advocates, we’re looking to make sure that new HIV prevention developments are turned into action—whether that’s delivering new options that work to the people who need them, or revising past assumptions based on trials that didn’t go as planned.”
“We need to keep focused on HIV prevention that’s effective, available and meets the needs of men and women throughout their lives,” Warren said.
Refocusing the Search for New Methods for Women
Research and Reality, released at the 17th International Conference on AIDS and STIs in Africa (ICASA), takes an in-depth, critical look at prevention research for women. There has been a positive, proof of concept finding that a vaginal gel can reduce women’s risk of HIV, as well as positive data on daily oral tenofovir-based PrEP in women. However, there have also been two trials in which participants did not actually use the options being tested regularly enough to answer the study questions.
In the report, AVAC offers recommendations and analysis to move beyond competing interpretations of these data. This is the first advocacy document to provide a full picture of what the trials do and do not reveal about the future of female-initiated prevention. It identifies clear steps to take to address issues from past trials and a core set of questions that need to be answered through strategic research going forward.
“It would be completely unacceptable to throw up our hands and say we don’t know what women want,” said Warren. “With women representing half of the global HIV epidemic, it’s both a practical and a moral imperative to keep up the search for new methods that women can control and want to use.”
“Recent trial results may be puzzling, but one thing we know for sure is that many women at risk want and need new ways to protect themselves from HIV,” said Nono Eland, chairperson of the Women’s Sector of the South African National AIDS Council (SANAC). “The prevention revolution continues. Earlier this year, participants at the SANAC Women’s Sector biennial summit called for better investment in prevention for women. We called for women to be meaningfully involved at all stages—from planning to distribution of HIV prevention products that are developed for us and reiterated the need for prevention research literacy for communities.”
To help resolve questions and challenges about women’s prevention options, Research and Reality recommends that researchers and trial sponsors:
- Continue to explore and measure methods to improve adherence.
- Conduct additional qualitative research to better understand women’s reasons for enrolling in a trial and using (or not using) a study product.
- Use innovative trial designs that would select trial participants who are most likely to adhere to a product regimen so efficacy can be determined – if the trial shows efficacy, bridging studies should be designed to examine how the strategy might work among more diverse populations
“When conventional approaches to science are not working, it’s time to break with convention,” said Dr. Helen Rees, Executive Director of the Wits Reproductive Health and HIV Institute in South Africa and a member of AVAC’s board of directors. “We urgently need to identify a range of prevention options that can work for women – and then we need to know which options will work best for which women.”
Research and Reality also provides four overarching recommendations on issues that lie at the intersection of research goals and real-world conditions.
- Launch complex trials to answer complex questions – Clinical trials remain the only way to answer the most important scientific questions in HIV prevention. Researchers and funders must continue to launch new trials despite the challenges, complexities and costs. This is especially true for AIDS vaccines, as well as to clarify the effect of hormonal contraception on HIV risk, where research is critical and must proceed.
- Plan for roll out beyond pilot projects – Pilot projects are an important first step toward ensuring that promising research results translate into real impact on people’s lives, but pilot projects alone will not end the AIDS epidemic. To realize their full potential, interventions such as daily oral PrEP and non-surgical devices for voluntary medical male circumcision need to be adequately resourced, ramped up, and included in national HIV/AIDS implementation plans.
- Invest and innovate in virologic suppression – In addition to the life-saving benefits of antiretroviral therapy as treatment for people living with HIV, research shows that ARV treatment can dramatically reduce the risk of HIV transmission to others. But treatment works in this way only when it effectively suppresses virus in the body to very low levels. To achieve and sustain HIV suppression and realize the full preventive potential of treatment, it is critical to invest in treatment adherence programs, new antiretroviral therapies, therapeutic vaccines and a cure.
- Align programs, models and funding to stay on track to end AIDS – Countries are developing HIV prevention plans and targets based on modeling that does not fully account for realities on the ground. Models are essential, but they need to be designed with built-in feedback loops – pulling in surveillance data and other information about the impact of prevention programs, so that results can be improved quickly over time.
The new Research and Reality recommendations build on the AVAC Playbook, a long-term agenda for global HIV prevention efforts first issued in 2011. AVAC assesses and reports on the most critical next steps for the development and delivery of new prevention options each year.
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. The full report, AVAC Report 2013: Research and Reality, is available at www.avac.org/report2013.
2013 AVAC Report: Research and Reality [Executive Summary]
This year’s AVAC Report is about the new realities of biomedical HIV prevention research. In the last few years we’ve seen major advances, but also have had sobering realizations about the difficulties of developing new HIV prevention options that can succeed both in trials and programs in the real world. Landmark vaccine, microbicide and PrEP trial results energized the biomedical HIV prevention field. Yet, follow-up work from all these trials has been slower than necessary. In the search for new prevention tools for women two recent trials have found very low rates of adherence. These trials have given rise to important questions, not only about women’s willingness to use the test product, but about the research process itself.
We argue that the field needs to take a fast, focused look at fundamental assumptions and missed opportunities across the HIV prevention research field—and retool its approaches so that the next generation of research delivers advances that women and men want and will use.
Advocacy Fellow Ntando Yola at AIDS Vaccine 2013
On October 7, at the AIDS Vaccine 2013 Conference in Barcelona, AVAC Advocacy Fellow Ntando Yola gave a powerful speech on the continued and urgent need for an HIV vaccine. We hope you’ll all view the webcast here—and read on for highlights. Stay tuned to the Advocates’ Network for a conference wrap-up and webinar announcement.
Ntando worked at the Desmond Tutu HIV Foundation as a Community Engagement Coordinator prior to starting his 2013 Advocacy Fellowship hosted by the Networking HIV/AIDS Community of South Africa (NACOSA). In both of these roles, he’s participated in extensive dialogues with communities engaged in HIV prevention research. In the speech, he told the story of Grace, a South African woman living with HIV. “Brother, in ten years we’ll have a vaccine for HIV, won’t we?” she asked him. “At least when the vaccine comes, my son will be 15 years old and he won’t have to worry about HIV the way I have.” Using Grace’s story, as well as his own experiences growing up with—and witnessing the end of—apartheid, Ntando made a strong case for research and stakeholder engagement that reflects the realities of volunteers’ lives. “Trial participants who face everyday living realities in my country like flooded homes in the winter, may face township fires in the summer, live in shared ablutions, have high rates of unemployment. Yet in all these circumstances, they volunteer.”
HIV Vaccine Awareness Day Commemorated Around the World
Each year on May 18, the global HIV/AIDS community commemorates HIV Vaccine Awareness Day (HVAD). This year, AVAC worked with civil society and research partners from across the globe on a number of community events to mark the date.
From Beijing to Bangkok, through 12 cities in Africa1 around to New York, Oakland and Los Angeles in the United States, HIV prevention advocates organized a range of events to highlight pressing issues facing the vaccine field today. They also took time to recognize the contribution of trial volunteers, advocates, researchers, funders and policy makers working towards a safe and effective HIV vaccine.
Advocates marched. They wrote editorials in newspapers. They spoke on radio and television. They blogged, tweeted and Skyped. Each of the HVAD events included community voices. “One of the highlights from our event in Harare was the conversation on community engagement in research processes. It’s important for us as community advocates to be meaningfully engaged in research at all levels,” said Tendayi Westerhof, organizer of a May 21 event in Zimbabwe, Sensitizing Community on the Value of HIV Vaccine Research.
For a full list of events, visit our HIV Vaccine Awareness Day page, which includes an Advocacy Toolkit with a range of materials breaking down complex AIDS vaccine science.
1 Nairobi, Kisumu and Thika in Kenya; Kampala and Luwero in Uganda; Jos and Lagos in Nigeria; Lusaka in Zambia; Harare in Zimbabwe; and Durban, Cape Town and Johannesburg in South Africa.
Press Release
AIDS vaccine trial results, while disappointing, must guide continuing search; research for vaccine and other new HIV prevention options must continue
New York, NY – The announcement today that immunizations in a large-scale HIV vaccine trial have been stopped early after an independent scientific review board determined that the vaccine being tested is not effective is a reminder of how challenging it is to develop an effective AIDS vaccine, AVAC said. AIDS vaccine research is in its most promising period in decades with breakthroughs in a number of approaches different from that studied in 505. Even though the trial showed no benefit, analysis of these data will help refine the vaccine research pipeline.
The US National Institute of Allergy and Infectious Diseases (NIAID) announced today that the independent Data Safety and Monitoring Board for HVTN 505, a trial testing a two-part vaccine among 2,500 men who have sex with men and transgender women in the United States, recommended that the immunizations be stopped since the data showed that the trial would not be able to show vaccine efficacy. Follow-up of participants will continue.
“This trial has provided a clear, swift answer about a specific vaccine strategy. It’s not the answer we hoped for, but the search doesn’t end here. There are other approaches that must be pursued without delay, and this result will help to focus and guide research efforts,” said Mitchell Warren, AVAC executive director. “Researchers need to unpack the data from this trial to understand more about why this strategy didn’t prevent infection.”
HVTN 505 tested a two-part vaccine strategy including a series of DNA “prime” shots with a vaccine “boost” using a vector based on adenovirus type 5 (Ad5), a common cold virus. While a similar but distinct Ad5-vectored candidate failed to show efficacy in two previous trials, the vaccine tested in HVTN 505 had key differences that researchers hoped would overcome the limitations of earlier candidates.
The adenovirus-based vaccine in HVTN 505 is one of several AIDS vaccine approaches being studied. Vaccine concepts based on the successful RV144 vaccine strategy that showed modest efficacy in a large trial in Thailand in 2009 are moving toward efficacy trials in Thailand and South Africa. Researchers have also recently discovered a number of highly potent neutralizing antibodies and are working to translate these into future vaccine strategies.
“While today’s result is disappointing, we need to look at the bigger picture of AIDS vaccine science. Now more than ever, it is critical to maintain robust funding and establish clear timelines and milestones for the development of an HIV vaccine and other HIV prevention options that can help end the AIDS epidemic,” Warren said.
“At the same time, these results highlight that we must also ensure that all available existing prevention options are offered to those who want and can benefit from them – including male and female condoms, HIV treatment, voluntary medical male circumcision, and daily oral pre-exposure prophylaxis, or PrEP.” Warren said. “While a vaccine remains essential in the long-term fight to end AIDS, we can achieve substantial reductions in new HIV infections in the meantime with fully funded implementation of proven prevention and treatment strategies.”
“There will be many questions and concerns from trial participants, researchers, communities, advocates and others about what the data from HVTN 505 tell us,” Warren said. “NIAID, the trial’s sponsor, has specifically noted the need to understand the finding of slightly higher numbers of infections among vaccine recipients. This finding does not have statistical significance and does not mean that the vaccine increased the risk of HIV. But we do need to understand these data and communicate them clearly. The levels of transparency, urgency and concern that we have seen already from NIAID and HVTN remain crucial as the trial team examines the data and continues to closely monitor trial participants.”
“AVAC also recognizes the enormous contributions of the more than 2,500 volunteers in this trial. Their altruistic involvement makes HIV vaccine research possible. We owe it to them to understand and build on what has been learned here and proceed with further research as rapidly and strategically as possible. The trial staff have also done a huge amount of work and are to be credited for running such a good trial and getting us to an answer.”
“The news today about the halting the trial deeply saddens me as both an HIV vaccine advocate and 505 trial participant,” said Matthew Rose, a member of AVAC’s PxROAR HIV prevention advocacy program. “But I remain hopeful in our search for a vaccine, as this trial showed how researchers and communities can work together to recruit under-represented populations that have not been engaged in AIDS vaccine research. The trial offers a model for how research can be more reflective of the communities that carry the highest burden of HIV and could most benefit from an effective vaccine.”
“These results do not change the fundamental view that an AIDS vaccine remains critical to any long-term strategy to end the AIDS epidemic,” said Rose.
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.
Achieving the End
Recent breakthroughs in HIV prevention research have created unprecedented opportunities to curb new HIV infections, save lives and set the world on a path towards eliminating HIV transmission.