Engagement Matters: Providing New Perspectives on HIV/AIDS from CROI

This blog by DaShawn Usher, Community Education and Recruitment Manager at New York Blood Center-Project ACHIEVE and an AVAC PxROAR member. It is the first in a series written by community delegates attending CROI 2015.

In addition to the CROI Community Educator Scholarship Program, AVAC and the Black AIDS Institute—with support from the CROI Community Liaison Subcommittee—are supporting a pilot program that provides an opportunity for additional community reps to attend the meeting. Delegates are mentored and supported with supplemental programming to help translate big science into accessible language for our communities. Expect daily updates from the meeting.

The first day of the Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle kicked off with a great start, especially for the first cohort of the CROI Community Delegate Program through the Black AIDS Institute, AVAC and the CROI Community Liaison Subcommittee. Community Delegates and Community Education scholarship recipients were welcomed in the morning by Phil Wilson of the Black AIDS Institute and Mitchell Warren of AVAC. The two gave perspectives of why we were selected to be at CROI and reminded us that this particular program has been years in the making. Mr. Wilson, gave an overview of the Black AIDS Institute’s recent report “When We Know Better, We Do Better: The State of HIV/AIDS Science and Treatment Literacy in the HIV/AIDS Workforce in the United States.”

The Program Committee Workshop for New Investigators and Trainees featured a wonderful consortium of research from all fields of HIV prevention and treatment. Dr. Galit Alter’s “A Path to an HIV Vaccine,” provided a very engaging overview of HIV vaccine options that would prevent HIV. The options include two main points: 1) Block infection and 2) Kill fast at the site of infection. Dr. Alter described that any vaccine that will be effective in fighting HIV must work in two days, since by day 3 the virus will have formed enough to replicate and create the HIV reservoir. I thought this was particularly interesting because it aligned with Post Exposure Prophylaxis (PEP) science of attacking HIV before it has the chance to replicate. Dr. Alter then went on to describe how 30% of infected patients generate neutralizing antibodies within 2–3 years. [Editor’s note: Click here for background on this science.] It was stimulating to learn that this process can occur naturally in HIV positive people—even though the antibodies that evolve aren’t usually able to neutralize the virus that’s present in the body at the same time. Instead, the antibodies are effective against virus that existed earlier—and has since evolved. One key take away point, therefore: Vaccines have to act faster, since HIV is faster than the immune response.

Next Dr. Guido Silvestri’s “Animal Models of Prevention and Cure” was most fascinating as it provided understanding of early phase clinical research trials that occur with Non Human Primates (NHP) and humanized mice. Listening to Dr. Silvestri’s speak reinforced the need for continued research that seems promising in animals to be developed for human clinical trials.

Following Dr. Silvestri’s presentation, Dr. Susan Buchbinder, discussed HIV Prevention 2.0: What’s Next. Dr. Buchbinder’s talk highlight the evolution of HIV prevention, which now includes three pillars: 1) Circumcision 2) PrEP, and 3) Treatment as Prevention. While highlighting the advances in HIV prevention, I thought it was interesting to see that new issues continue to emerge. For PrEP, the mixed messaging around adherence (which will be even more complicated when the IPERGAY trial presents its data during CROI about efficacy in gay men and other men who have sex with men who were prescribed a dosing regimen centered on sexual activity, rather than daily dosing), continues to pose concern. Right now there are a lot of ways of talking about PrEP use: including time based and event based, and periodic dosing. But we don’t know who these strategies work for, if they work, and how they are understood in the real world.

Even with current studies underway for addressing adherence to daily oral PrEP, there are ongoing studies of injectable PrEP, which could provide a month or more of protection after a single shot. This poses the question of will people continue to get the shot. Especially when studies of injectable contraceptives show that over time people drop off from receiving their scheduled injections.

One remaining point from Dr. Buchbinder’s talk was how traditional pillars of HIV prevention aren’t enough to curve the epidemic. Condoms, public health campaigns, and HIV testing and counseling each have strengths and areas where they ned to be improved. For HIV testing and counseling, some studies have show that counseling is not effective. I believe that the context of counseling sessions prior to biomedical interventions may not have been the most effective, however, biomedical interventions like PrEP and PEP can now be used in that session time to educate clients about other options of remaining HIV negative.

Finally, Dr. John Coffin, presented on “HIV Cure Research.” He reported on the infamous Berlin patient, now known to be Tim Brown, as the only person truly cured from HIV. I thought it was interesting that he highlighted that although people commonly refer to Tim Brown as being “cured” that their may be lingering HIV cells in Mr. Brown. I liked that he discussed the effectiveness of ART and how these drugs greatly suppress the viral load of HIV but the “rebound reservoir” of HIV keeps these drug from being a cure. Dr. Coffin also mentioned that ART blocks infection, but does not have an effect on infected cells.

Following that session, the Martin Delaney lecture occurred. Appropriated called “How to End the HIV Epidemic: Community Perspectives,” this session featured panelist, Damon Jacobs (PrEP Advocate), Connie Celum (Treatment as Prevention Advocate), and Matthew Sharp (Cure Advocate) and was moderated by Steven Wakefield. This session highlighted the need across the field that more needed to be done. For PrEP, people need to be educated about the benefits of it. Treatment as Prevention (TasP), showcased the need for more focus on getting people into care. Cure research, was highlighted by Matthew Sharp’s personal narrative of his involvement of cure research.

The day continued on with additional presentations and preparations for the full CROI conference. The welcome reception was held at Nordstrom, which was actually a lot more fun then I expected. I had a conversation with a CDC Director that encouraged me to advocate for other young community delegates to attend conferences like this. While at Nordstrom not only did I get a chance to network with colleagues from CROI, but I also got to meet some fascinating Nordstrom employees that were very nice and engaging (Shout out to Lilly, Blake, and Gavin at Nordstrom). I ended up browsing through the store’s latest collection and end of season sales racks. Not only did I get a chance to learn about the latest in HIV research today, I learned a lot of the local history of Seattle (Note: If you’re in Seattle check out Capital Hill and Fremont). This experience continues to add to my continual learning that I will bring back to the communities I serve locally and nationally. I look forward to day two of CROI.

Excitement and Disappointment at CROI as PrEP and Gel Data Break

In the moments leading up to the packed session where new PrEP and gel data were presented, longtime activist and Body editor Julie Davids tweeted that there was an “Oscar-like” atmosphere—referencing the buzz, hum and readiness of the film awards ceremony that completed on Sunday. Unlike the Oscars, which ran three hours and forty minutes, this session was brief—under two hours—and yet the news that it brought will almost certainly change the world. AVAC’s own press release is here. And below is a quick summary of this historic day.

The bottom line from Partners PrEP, PROUD and IPERGAY is that oral PrEP using TDF/FTC provides protection. We knew this already, but the new data add nuance.

  • The Partners Demonstration project among discordant heterosexual couples (where one partner is HIV-positive and one is not) in Kenya and Uganda showed that a program that delivers both PrEP for HIV-negative partners and/or antiretroviral treatment (ART) for HIV-positive partners reduced the risk of HIV infection by 96 percent. These results highlight the potential impact of combining PrEP and ARV treatment to slow the HIV epidemic.
  • The PROUD Study among high risk men who have sex with men (MSM) in the UK showed that daily oral PrEP reduced the risk of HIV infection by 86 percent when delivered in existing public health clinics.
  • IPERGAY, a French study, was the first to examine the efficacy of “event-driven” PrEP – in this case, a three-day dosing strategy involving four pills around the time of sex – among high risk MSM who reported frequent sex. Overall, PrEP reduced the risk of HIV infection by 86 percent in the trial. Based on reported pill use by men in the trial, the regimen that most participants took amounted to at least four doses a week. Previous studies of daily oral PrEP have shown that this may be enough to be protective. However, it is not clear how well the event.

There are a range of press statements, a statement from the US CDC and—starting on 2/25, the webcasts for the sessions will be available. You can find all of those links here.

The PrEP data are terrifically exciting findings insofar as they reinforce that this is a strategy that works when taken as prescribed. In gay men and other men who have sex with men, this means it even works when the instructions for use involve coitally-related dosing. It is really important to remember that the data so far about PrEP, protection and vaginal sex suggest that this type of strategy might not work as well for women. As we discussed in AVAC Report 2014/5, now is the time to invest in an oral PrEP-driven paradigm shift. We made this statement even before the data were out—and now we mean it more than ever.

If anything, emotions ran even higher as the FACTS 001 data were presented. Here, it was news everyone had hoped to avoid.

  • FACTS 001 was a trial of a tenofovir-based vaginal microbicide gel to be used before and after sex among young women in South Africa. FACTS 001 found no effect for 1% vaginal tenofovir gel overall in the trial. While it appeared that most of the participants used the product at some point, there was not enough correct and consistent use in the trial to provide significant levels of protection. There was a trend of modest protection among the small proportion of women in the trial who appeared to have used the product consistently. This was similar to trends seen in previous studies of tenofovir gel among women, but not enough to change the overall outcome of the trial.

Statements and facts sheets from the FACTS consortium, other microbicide stakeholders and CONRAD are all available here.

The world has far more work to do to find additional tools, above and beyond oral PrEP—which should be rolled out to all who want and could benefit from it—to reduce rates of HIV acquisition among women worldwide.

AVAC will be working with partners to convene webinars and in-country discussions in a range of locations to talk through the implications of all of these data. We will announce the schedule in the coming weeks. If you have a specific question or would like support in organizing around these data, please contact us.

Our recently-released AVAC Report: Prevention on the Line provides background and analysis that anticipates and contextualizes these developments.

Women’s Lives on the Line: AVAC’s new report takes on prevention, targets, research and results

AIDS terminology comes and goes. There are short-lived acronyms like MARP (Most-At-Risk Populations) and unpronounceable but universally recognized ones like GFATM. Right now, the way that much of the world is talking about women and girls and their risk of HIV acquisition is as treacherous a field of terms and euphemisms as advocates have seen. Women and their prevention needs are, due to fuzzy rhetoric, left hiding in plain sight.

All of this is going to matter a great deal as the world grapples with the data expected from this week’s Conference on Retroviruses and Opportunistic Infections, which will bring the release of new data on a range of HIV prevention tools including daily oral PrEP in gay men and other men who have sex with men (MSM), serodiscordant couples who were offered PrEP and also offered ART, and PrEP dosed around sex acts (different from the FDA-approved daily Truvada regimen). It will also bring the long-awaited data from the FACTS 001 microbicide trial, which tested a 1% tenofovir gel, applied before and after sex, in South African women.

We don’t know what the data are, but we do know what some of the pitfalls in discussing women’s prevention and treatment needs are. So here are a few points to keep in mind—each of which is expanded upon the recent AVAC Report: Prevention on the Line—as the week unfolds:

Daily oral PrEP is driving a paradigm shift that may mean different things for men and women. The body of evidence on daily oral PrEP shows that it works if taken correctly and consistently. Right now, there is more “real world” evidence of effectiveness in gay men and other MSM—and less is known about how PrEP could be delivered effectively in young women, particularly those who are not in stable partnerships. The data that do exist suggest that women may need to be more adherent to achieve protection against acquisition during vaginal sex, compared to anal sex. So any data on adherence and efficacy from studies in MSM needs to be contextualized—these data will apply to men whose risk is via anal sex and should not be presented as a global indication of what could work for all populations. Check out Part II in AVAC Report 2014/15 for discussion of these nuances and proposals of what global targets for daily oral PrEP could look like, including for young women and adolescent girls.

Many people aren’t saying what they mean when they say “key populations”. The term “key population” came on the scene as MARP shuffled off. It is used to mean many things, and included groups like gay men and other MSM, transgender women, people who inject drug, and sex workers. Sometimes it is used to mean under-served and over-burdened populations, and in this context that includes women and adolescents. Sometimes people say, “key populations and women”. CROI will certainly include information on prevention and treatment services for key populations. Check out our box in AVAC Report 2014/5 on what clarity should look like with this term. Watch closely as data are presented, and keep this question in mind: Where are the women?

Microbicide research is critical to the future of women’s prevention—but no single trial has all the answers. AVAC Report 2013 focused extensively on what recent trials have taught the field about women’s experiences in research. And the upcoming, highly anticipated data from FACTS 001 will provide even more information. Because women’s prevention needs are great, and the current range of available tools is small, each new finding carries enormous weight. Will an efficacy finding trigger a global change in prevention programming? No. Not right away. There are limited quantities of the gel available and much to understand about how it might work in the real world. Will a lack of efficacy signal the end of user-dependent methods? No. Not at all. Each trial has brought a trove of information about how and why women use specific products and how they relate to research, and it’s imperative to act on this information—to listen to women—whatever the outcomes.

Throughout the next few weeks, we’ll cover CROI developments and highlight relevant sections of our recent Report. Bookmark our CROI page and stay tuned!

Gearing up for CROI: What is the state of private funding for HIV/AIDS-related research?

This article was first published in Funders Concerned about AIDS

At the end of February the Conference on Retroviruses and Opportunistic Infections (CROI) will bring together researchers and advocates from around the world to share the latest studies, important developments and best research methods in the ongoing battle against HIV/AIDS and related infectious diseases. According to AVAC, data is expected at CROI on several important trials, including the first data on non-daily use of Truvada as post-exposure prophylaxis (PrEP), and results on the efficacy of 1% tenofovir gel from the FACTS 001 microbicide trial.

Philanthropy – led by the efforts of the Bill & Melinda Gates Foundation and The Wellcome Trust – continues to fund important parts of HIV prevention research & development (R&D), such as the funding of young investigators, or helping to support new research initiatives2. In 2013, FCAA identified roughly $240 mil in funding to support HIV/AIDS-related research efforts[1]. This included support for HIV prevention R&D, as well as supportive research efforts studying trends in behavior, and the impact of such issues as stigma on access to care.

According to HIV Prevention Research & Development Investment in 2013: In a changing global development, economic, and human rights landscape[2] —the most recent annual report by the HIV Vaccines and Microbicides Resource Tracking Working Group – funding for HIV prevention R&D declined by US$50 million in 2013, or four percent, compared to 2012. The US government continues to be the largest funder of HIV prevention R&D efforts, accounting for nearly 70% of the total investment. However, US public-sector support also decreased by nearly $38 million from 2012. The data also show funding declines in nearly every category of HIV prevention R&D underscoring an urgent need to sustain and diversify funding sources through partnerships between governments, philanthropies, and the biopharmaceutical industry. Philanthropic funding represented just 15% of total HIV prevention R&D investment in 2013, an almost 5% decrease from 2012.

Why should we be talking about this now?

With decreased funding for HIV prevention R&D, and the field so heavily reliant on US public sector support, philanthropy is poised to play an important role by funding new and innovative research, and in helping to ensure proven interventions and technologies are successfully rolled out. One opportunity for the philanthropic sector is underscored by data showing that funding for PrEP-related R&D increased by $5 million in 2013, due in part to a number of new demonstration and implementation projects focused on the use of PrEP in different settings3, such as support from the Bill & Melinda Gates Foundation for PrEP demonstration projects in Africa.

As another timely example, FACTS 001 data soon to be presented at CROI will confirm whether tenofovir gel, used before and after sex, can prevent HIV infection. If effective, the conversation turns to how to implement it as a prevention tool in the real world. If not, then focus will turn to other options in the R&D pipeline that will require continued funding to ensure their successful rollout. And both options, of course, require new ideas, new energy and increased funding.

Stay tuned to AVAC (@hivpxresearch #CROI2015) for exciting CROI news and potential opportunities for philanthropic investment in HIV prevention R&D. Please also share your questions on, or examples and impact of, funding research via @FCAA #AIDSfunding or [email protected].

There’s room for all sizes of support and funders. Here are just a few examples of what funders supported in 2013:

  • The Canadian Foundation for AIDS Research (CANFAR) is currently supporting research projects including one focused on behavioral patterns among young men who have sex with men, on male circumcision for prevention in the Caribbean and on the effects of HIV treatment on babies and children.
  • The Fondation de France supports a research project focused on developing new blood tests for tuberculosis (TB) that could be used with an HIV-infected pediatric population.
  • amfAR continues to bring top scientists together through its amfAR Research Consortium on HIV Eradication (ARCHE) to develop collaborative studies that will generate creative ideas and shorten the time it will take to find a cure for HIV.
  • In addition to scientific research projects related to areas such as HIV vaccine and microbicide development and HIV/TB immune response, The Wellcome Trust conducts other wide-ranging research projects, including a project evaluating the impact of scaled-up evidence-based treatment and prevention services in Zimbabwe.

AVAC Report: HIV Prevention on the Line

AVAC’s annual report of the field, the upcoming CROI meeting and why the coming year is the best and worst of times for HIV prevention

Next week, scientists, advocates and clinicians will gather in Seattle for the Conference on Retroviruses and Opportunistic Infections (CROI), a venerable HIV meeting that often triggers media coverage of the AIDS epidemic and the potential for curbing it and preserving health in people living with HIV.

A range of data is expected from CROI including “late-breaker” abstracts that will showcase data from IPERGAY and PROUD, two trials of oral PrEP using TDF/FTC in gay men and other men who have sex with men in Europe and Canada, and another trial of the microbicide 1% vaginal tenofovir gel in South African women. There will also be data from a PrEP “demonstration project” that provided the strategy in a real-life context for Kenyan and Ugandan couples with one HIV-positive and one HIV-negative partner.
We don’t know what the specific headlines will be, but we can say with confidence that one take-away must be this: The future of HIV prevention is on the line.

In our latest report, AVAC Report 2014/15: Prevention on the Line, we provide a clear agenda for what needs to happen, what’s missing, and why it matters now more than ever before.

Specifically, we argue that:

  • Ambitious prevention goals matter. They can galvanize new action, in part by expanding our sense of what’s possible.
  • But these goals will only work if they’re feasible, well-defined, measurable, and backed by adequate resources and political support. The prevention goals issued so far are inspiring but they don’t yet meet those requirements.
  • As the UNAIDS “Fast Track” for 2020 set aspirational goals, clear short-term targets are also urgently needed. We can’t wait for five years to see if the world is on track to end the AIDS epidemic.
  • The global AIDS response is running at a major financial deficit. New targets will not be met—and may even be irrelevant—if we fail to close a growing global funding gap.

Recent breakthroughs in HIV research have transformed the ability to curb new infections, making it possible to contemplate the end of the global AIDS epidemic. But prevention could be left behind if global leadership fails to make it a priority.

Recently, UNAIDS issued broad goals for HIV testing, ART provision and virologic suppression over the next five years. According to the agency, achieving these “90-90-90” goals would put the world on track to effectively end the AIDS epidemic by 2030.

On the prevention front, UNAIDS seeks to reduce new infections worldwide from 2.1 million in 2013 to 500,000 in 2020, and to eliminate stigma and discrimination. These are ambitious goals and worth aspiring to. But something important is missing from the picture—intervention-specific targets with the specificity, strategy and resources to match. The goal is great. What’s missing is how to get there.

In twenty years, we will have ample hindsight as to whether today’s targets mattered in the quest to end AIDS.

But right now, foresight and focus are urgently required. We’re concerned about whether the targets that have been set are the right ones, how much targets matter—particularly in the context of a global response running at a disastrous funding deficit—and where prevention targets other than those focused on the antiretrovirals in HIV-positive individuals—fit in. We’re also cognizant that targets can turn from audacious to absurd in the blink of an eye if financing, political will and community buy-in are missing.

AVAC works in coalitions in many of the countries hardest hit by the epidemic. Targets that are developed Geneva, Washington DC and other corridors of power can bear little resemblance to the realities of AIDS endemic countries and communities. Where there’s no reality, there’s no relevance. It’s essential that countries have the technical and financial resources to make global targets relevant to national context. Otherwise, the loftiest goals will be ignored.

As we argue in this Report, targets have played a critical role in changing the course of the epidemic. Likewise, a poorly-thought out target can have no impact at all. Right now, it’s critical that targets and tactics are matched to the lofty but achievable goal of bringing an end to AIDS. This is why we’ve devoted the first section of the Report to a look at why targets matter, what targets are missing, and how advocates for a comprehensive response need to work together to ensure smart, strategic targets across the spectrum of prevention options.

We also focus on issues that underpin (and, sometimes, undermine) the ability to meet these targets. We identify three specific areas for action:

  • Align high impact strategies with human rights and realities. Biomedical advances of the past eight years have made it scientifically plausible to talk about ending the epidemic. But plausible doesn’t mean possible. Today some scientists and public health professionals are focused on what can be achieved biomedically—without enough attention to the structural and social contexts in which treatment prevention are delivered. At the same time, some rights-focused partners speak of HIV as being exclusively pill-oriented, suggesting that there isn’t any dynamism or action on the rights-based fronts. It need not be a permanent rift—indeed it cannot be. If science does not get synched up with human rights then then there is little hope of bringing the epidemic to a conclusive end.
  • Invest in an oral PrEP-driven paradigm shift. The world is failing to deliver the most effective interventions with smart strategy and at scale. Daily oral PrEP for HIV prevention is just one example. Global targets for PrEP may be released in the coming months, but there aren’t any plans in place to meet them. Demonstration projects are small and disconnected, funding is limited and policy makers aren’t heeding the growing demand from men and women, including young women in Africa. Now is the time to spend and act to fill these gaps.
  • Demand short-term results on the path to long-term goals. It will be years before the world has an AIDS vaccine, cure strategies, long-acting injectable ARVs or multipurpose prevention technologies that reduce the risk of HIV acquisition and provide contraception. But there’s plenty of activity in clinical trials and basic science for these long-term goals. This activity needs to be aligned with short-term goals that can be used to measure progress and manage expectations.

As AVAC Report goes to press this week and as we prepare for CROI next week, the United States is grappling with profound questions about the ways that the lives of Black men and women are valued under the law. The world is trying to understand how the West African Ebola epidemics got out of control—and how to bring them to an end. And there is continued concern and vigilance over anti-homosexuality laws in Nigeria and the Gambia, and in hate-mongering environments and legislation that endanger LGBT individuals and many other marginalized groups around the world.

These events are not separate from the work that we do to fight AIDS. They embody the issues of racism, inequity, poverty and security that drive the epidemic that must be addressed to end it. In addition to the HIV-specific work laid out in these pages, it is essential to work towards fundamental, lasting and positive change in each of these areas. That will be history-making, indeed.

In Childhood Vaccine Controversy, an Indirect Lesson for HIV/AIDS Advocates

This blog post first appeared on The Body

From all the recent attention to parents’ rejection (and some politicians’ naiveté) of vaccines and a possible resurgence of measles in the United States, one welcome theme has emerged: Such a controversy could never occur if vaccines weren’t so powerfully effective in the first place.

Former Secretary of State Hillary Clinton put it best on Twitter, writing, “The science is clear: The earth is round, the sky is blue, and #vaccineswork.”

Melinda Gates spoke for many when, in a widely circulated interview, she said, “We’re incredibly lucky to have that technology and we ought to take full advantage of it.” She prefaced that by saying that people in poorer countries can truly understand the power of vaccines because they’ve experienced the devastation that preventable diseases can bring to their families.

The anti-vaccine movement has gained ground in the U.S. in part because vaccines work so well that many parents have never seen the devastating effect of the diseases that vaccines protect us from.

From the beginning of the HIV/AIDS epidemic we’ve hoped for a vaccine that could help control and eliminate HIV in the same way polio and to a lesser degree measles have been controlled. That hope for and need for a vaccine has stayed with many of us through the rise and spread of HIV treatment, new prevention options and through many setbacks and a few breakthroughs in vaccine research.

It is the power of vaccines — the seeming magic that can keep disease at bay – that keeps us hoping and working toward an HIV vaccine.

But for many in the global community of advocates, researchers, funders and policymakers seeking to end the HIV/AIDS epidemic, an HIV vaccine has slipped off the list of “must haves” to respond to the epidemic, and even sometimes is left out of the equation when they talk about how to end AIDS.

To be fair, recent advances have altered how a vaccine would fit into the HIV/AIDS response. Within just a few years, we’ve learned definitively that antiretroviral treatment not only saves the lives of people living with HIV, but drastically reduces their chances of transmitting the virus. We’ve seen that daily pre-exposure prophylaxis (PrEP) with Truvada (tenofovir/emtricitabine) is highly effective at helping HIV-negative men and women avoid infection. In sub-Saharan Africa, voluntary medical male circumcision is being rolled out widely after studies showed it can greatly reduce heterosexual men’s risk of infection. Other new options for women and men are in clinical trials.

But amidst the drive to scale up these options — enthusiastically supported by this author — are troubling assertions that current tools might be sufficient to end AIDS.

Most advocates know this isn’t true. They realize that today’s treatment and prevention options can get us well on our way toward ending the epidemic, but that our work will never be finished until we have an effective vaccine.

The problem is that knowing it isn’t enough. We need to continually raise our voices in support of the full range of prevention strategies, including those that still remain to be developed. Beyond the clear need, three critical reasons should drive us all to be advocates for HIV/AIDS vaccine research:

  1. An effective vaccine is now more possible than ever. In 2009, a trial showed for the first time that an experimental vaccine modestly reduced the risk of HIV transmission. Now, researchers are testing potentially improved versions of the same approach, known as a pox-protein prime-boost vaccine, while preparing a range of other strategies for clinical trials.
  2. Basic science continues to open whole new areas of vaccine discovery. Over the past six years, a remarkable number of basic science discoveries of new antibodies have presented vaccine researchers with entirely new avenues for research and development.
  3. With advances occurring in other areas of prevention, the impact of an effective vaccine could be even more transformative. As of 2013, some 2.1 million people were becoming infected with HIV annually. But the number has been declining, and the continued scale-up of treatment, PrEP and other options could greatly reduce that figure in the next decade. By the time a vaccine is available, its role could very well be to drive the number of infections close to zero.

My organization AIDS Vaccine Advocacy Coalition (AVAC) was founded 20 years ago with the mission of advocating for AIDS vaccine research. Since then, we’ve expanded our advocacy to include many other critical prevention technologies, but our commitment to the vaccine search remains paramount. We urge you to join us.

In the case of measles, antipathy toward vaccines is an unfortunate but not-too-surprising consequence of their stunning success. With HIV, antipathy is simply not an option.

NIH-supported clinical trials to evaluate long-acting, injectable antiretroviral drugs to prevent HIV infection

NIH
http://www.nih.gov/news/health/feb2015/niaid-19a.htm
A clinical trial called HVTN 100 has been launched in South Africa to study an investigational HIV vaccine regimen for safety and the immune responses it generates in study participants. 

“D” is for Delivery: A new USAID guide to introduction and scale-up of global health innovations

What do getting oral misoprostol approved by national and global regulatory agencies for the treatment of postpartum hemorrhaging, lowering the cost of the HPV vaccine for low and lower-middle income countries by 97 percent and introducing an existing antiseptic to reduce neonatal sepsis as a cause of newborn deaths have in common? Where all of these steps have happened, they have been part of the successful launch of products with the potential to save lives on a global scale.

How were these products successfully launched? What were the steps taken to ensure use, accessibility and affordability? And how can lessons learned be applied to other products that represent major scientific breakthroughs whose main application is in poorer countries?

USAID’s Center for Accelerating Innovation and Impact (CII) developed IDEA to IMPACT: A Guide to Introduction and Scale of Global Health Innovations, dissecting “best practices” for taking innovations to scale and identifying key activities along the research to rollout continuum that need to happen in order to successfully bring a new product to market and into a health system. The guide provides a delivery framework (Figure 1), and a series of case studies highlighting each stage of the process. A companion workbook and toolkit (zipped file) provide practical steps for those coordinating introduction and scale programs (i.e., donors, non-governmental organization implementing partners, or others such as social entrepreneurs and innovators) that can be taken towards product launch.

Many of these “best practices” towards product launch are nothing new. However, what is new are donors and implementing partners thinking along the lines of the pharmaceutical industry model, which dedicates millions of dollars and significant human resources towards these types of product launch activities in close collaboration, and in conjunction with, the research and development stages. The guide ties the time to scale-up of product introduction to an increase in reach (i.e., the faster a product gets offered to those who need it and will use it, the more people will get and use the product). Industry typically takes about five to seven years to reach their intended product users at scale. However, a recent analysis showed that slow product launches are unfortunately norm for products launched to meet the needs of those in poorer counties—meaning that many times life-saving innovations are not reaching all those who are in need (Figure 2). Further, there is a limited window of time during which a product launch needs to happen to be successful, following which achieving scale (i.e., reaching all potential users) becomes very difficult (IMS Health, Launch Excellence IV: A New Launch Environment. 2013).


On Monday, February 2, USAID launched the guide bringing together a panel of global health practitioners with experience delivering a diverse range of products in resource-challenged settings. The delivery framework (Figure 1) outlined in the guide provides steps to address the narrow window of time within which product launch needs to happen so that products (including drugs, devices and vaccines) can get in the hands of those who need them. The panelists named a lengthy list of conditions for a successful product launch, which served to amplify how complex launching a product for populations in developing settings can be. Beyond and within the framework above, a successful product launch requires many elements, including advocacy; the appropriate technology; funding commitments; policy and guideline changes; training of clinicians; clinical effectiveness; partnerships; and alignment among different global health actors.

A big global health need does not equal end user demand or use.

While all of these elements remain important, the panel honed in on one key component that a product launch cannot take place without: the end-user. How product developers and implementers think about the user, and how a product is designed with the user in mind is the key to a successful product. Especially keeping in mind that a big global health need does not equal end user demand or use. When a product does not fully consider the end user, the product may be used for a different purpose, not actually reach the user or simply not be used, for instance: malaria nets used for fishing and wedding dresses; breastfeeding initiatives in clinical settings that don’t work where most births take place outside of hospitals; and in the HIV prevention space when the available prevention methods fail to meet the needs of the user (whether those needs be discretion, control or pleasure). The nonprofit and government agencies involved in developing and delivering global health products need to be “user-obsessed”, not just “user-centric”. And like industry, they need to plan for product launch with the end-user in mind long before a product is ready for launch to ensure the window of time to take a product to scale is maximized.

Wendy Taylor, Director of USAID’s CII, explained that the best outcome is either a product that will be used, or a product that won’t be used, but gets “killed” early in the research and development process. The HIV prevention field needs to ensure that products are not just needed, but that users want them, want to use them and can use them. AVAC’s partners in Africa are doing just this—working on a number of different advocacy fronts to define priorities in HIV prevention. Whether by involving civil society groups focused on women’s health in the processes related to moving a microbicide from trial result to eventual piloting and introduction in South Africa, or advocating for the development of guidelines for tenofovir-based PrEP rollout in Uganda, AVAC’s partners are already undertaking many of the key product launch activities outlined by the panel and in the USAID guide.

(Note: At the recent HIV R4P 2014 conference in October, many of these issues particular to HIV prevention were discussed at a roundtable: Diffusion of Innovation: Accelerating Along the Research to Rollout Continuum. The session included presentations a number of presentations: Moving from Evidence to Demonstration Projects to Policy and Programs in HIV Prevention; Rapid rapid-scale-up of VMMC; Challenges for PrEP Implementation in the US; and From Research Result to Public Health Impact: What Have we Learned and how Can we Do it Better and Faster. Check out the webcast here.

What is PrEP?

Daily, oral pre-exposure prophylaxis (PrEP) using the antiretroviral drugs tenofovir and emtricitabine has been approved by the US FDA since 2012, but not a lot of people know about it. Those who do may be most familiar with more practical aspects, like where to get it and whether it’s covered by insurance, than what PrEP actually does in the body.

This newly released video from the PrEP Audio Visual Representation (PrEP REP) project animates how PrEP protects against HIV and reinforces why adherence is so important.

2015 Adherence Conference

Source: IAPAC

Preliminary program now available for the 10th International Conference on HIV Treatment and Prevention Adherence will take place June 28-30, 2015, at the Eden Roc Miami Beach Hotel in Miami Beach, FL, USA. The conference is sponsored by the International Association of Providers of AIDS Care (IAPAC).