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.
AVAC Playbook 2013–2014: Global goals and priorities
ARV-Based Prevention Pipeline (December 2013)
Planned PrEP Demonstration Projects in Resource-Poor Settings
Clinical Trial Evidence for Oral and Topical Tenofovir-Based Prevention
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.
Association of Nurses in AIDS Care PrEP Fact Sheet
This fact sheet can be used for all those interested in PrEP. It provides background and efficacy information on what PrEP as well as the CDC’s recommendations on who should take PrEP.
Taking it to the Streets: Engaging in-country stakeholders to plan for possible PrEP implementation
A poster presentation that goes through the steps advocates need to prepare their local community for PrEP.
Rwandan Civil Society Organizations Learn about PrEP and Combination Prevention
On June 19-20 in Kigali, 15 civil society organizations (CSOs) completed a two-day training on HIV prevention with a focus on pre-exposure prophylaxis (PrEP). The meeting was organized by 2013 AVAC Prevention Research Advocacy Fellow Josephine Kamarebe and her host organization, the Health Development Initiative. 2013 Fellow Peter Michira from Kenya helped convene the meeting, building on his recent experience with a similar gathering in Kenya. Resource people included the UNAIDS Country Coordinator for Rwanda, Dr. Dludlu Sibongile and Dr. Patrick Ndase, Regional Physician for the Microbicide Trials Network.
The CSOs in attendance represented women, youth, sex workers, men who have sex with men, people living with AIDS and more. The session began by gauging participants’ knowledge of new biomedical HIV prevention tools. The meeting was the first time any of the CSO representatives in attendance had ever heard of PrEP. At the end of the session, after learning more about the intervention, everyone agreed PrEP could be a useful tool for those most at risk.
In her remarks, Dr. Sibongile emphasized the continued importance of other prevention options such as condom use and voluntary medical male circumcision. “No single HIV strategy stands alone. They should all be incorporated in order to reach the goal of zero new HIV infections and deaths.”
To follow up, meeting participants agreed to create a CSO steering committee to coordinate future advocacy. Those in attendance committed to passing along what they had learned to other members of civil society who were not present.
The New Times Rwanda wrote a piece about the workshop. And for the latest on PrEP, visit www.avac.org/prep.
Press Release
New PrEP trial results among injecting drug users underscore that PrEP works when taken consistently; AVAC calls for accelerated action to get PrEP to those who can benefit from it
New York, NY – Results from the Bangkok Tenofovir Study published online today in The Lancet provide additional evidence that daily oral tenofovir-based pre-exposure prophylaxis (PrEP) reduces HIV infection risk when taken consistently. The results from the study—the first conducted among people who inject drugs—are consistent with previous studies among men and women primarily at risk of acquiring HIV through sex. They provide additional support for moving forward to ensure that people who can benefit from PrEP have access to it.
“These results underscore what we’ve learned in a range of studies—daily tenofovir-based PrEP works when you take it,” said Mitchell Warren, AVAC executive director. “Although there is more to learn about how this or other PrEP strategies work in men and women who inject drugs, this study offers the first indication that oral PrEP may reduce the risk of HIV infection via needle exposure. Comprehensive harm reduction, along with human rights protections, are the fundamental HIV prevention tools for injecting drug users. We need to continue to roll out proven prevention and find out more about how this oral PrEP strategy might work in a group that is at very high risk for HIV infection and has too often been ignored.”
“We now need to get serious about making PrEP available to those who can benefit. More than two and a half years after the first positive results from a PrEP trial, little has been done to answer critical questions about the best ways to roll out daily oral PrEP to key populations worldwide. Within the next year, a comprehensive package of demonstration projects should be planned, funded and launched in countries around the world,” Warren said.
Data from previous oral PrEP studies showed varying levels of effectiveness of tenofovir-based prevention for heterosexual men and women, and for men and transgender women who have sex with men. In July 2012, the US Food and Drug Administration (FDA) approved daily oral TDF/FTC (marketed as Truvada) for HIV prevention for all adults at risk of HIV from sexual transmission based on data from several PrEP trials that evaluated TDF/FTC for PrEP. Only one other PrEP study—Partners PrEP, which enrolled serodiscordant couples—evaluated daily oral tenofovir disoproxyl fumarate (TDF, marketed as Viread), as well TDF/FTC. It will be critical to examine the cost and feasibility of both daily TDF and TDF/FTC in light of these new data.
The Bangkok Tenofovir Study, which was conducted by the US Centers for Disease Control and Prevention (CDC), the Bangkok Metropolitan Administration and the Thailand Ministry of Public Health, found that a daily dose of the drug tenofovir reduced the risk of HIV infection by 49 percent overall and at a higher rate (up to 74 percent) among trial participants who had detectable tenofovir in their blood, an indication that they were taking the drug consistently. The study, which began in 2005, enrolled more than 2,400 men and women who were part of a drug treatment program run by the city of Bangkok.
The trial team states the conclusion that the HIV infections that occurred were primarily the result of injection drug use, rather than sexual exposure. The team also reports consistent decreases in reported risk behaviors including injection drug use, needle sharing and unprotected sex in both study arms; also of note, the preventive benefit was only observed after the first three years of follow-up.
“People who use drugs also have sex, and there is no way of distinguishing between infection acquired via sex versus drug use. This is one reason why this PrEP strategy cannot be viewed as a replacement for proven prevention such as syringe exchange and drug substitution programs that specifically reduce risk of HIV via drug use. All countries need to offer these services without criminalizing, stigmatizing or infringing on the rights of those who need them,” Warren said. “However, this is the first trial to provide evidence for a prevention option that could protect against HIV infection through both sexual contact and injecting drug use—and this is an exciting finding that must be followed up. PrEP could be a powerful additional tool for some people who inject drugs,” Warren added.
CDC’s new interim guidelines also released Wednesday include important guidance for how PrEP can best be used to help people who inject drugs protect themselves. Consolidated US Public Health Service Guidelines on PrEP use for all risk groups, which will include more detailed guidance on PrEP use for injecting drug users, are expected to be released later this year.
“We commend the CDC for acting quickly to put these interim guidelines in place to help individuals and their health care providers make informed decisions about PrEP use in the context of comprehensive HIV prevention. PrEP is not a silver bullet or a simple solution, but it is an option that can be life-saving for some individuals,” Warren added.
“PrEP using tenofovir-based drugs is a niche product that cannot and will not replace other options that are part of combination prevention. Yet it is an intervention with the real possibility of preventing infections, especially where other prevention options aren’t enough,” Warren said.
“Now, policy makers, regulators, advocates, WHO, UNAIDS and Gilead Sciences—the manufacturer of both TDF and TDF/FTC—must work together to determine how best to move forward to ensure that PrEP is included where appropriate in comprehensive harm reduction programs for people who inject drugs. PrEP must complement, not replace, harm reduction programs everywhere, and especially in countries and communities with significant HIV epidemics driven by injecting drugs,” Warren added.
“AVAC recognizes the altruism and commitment of the more than 2,400 trial volunteers who made this effort possible,” Warren said. “These volunteers and their communities have made an inestimable contribution to HIV prevention research and to the eventual development of new ways for men and women to protect themselves from HIV.”
More information about PrEP is available at www.avac.org/prep and www.prepwatch.org.
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.