Debate This: What do HIV prevention and elections have in common?

In a baseball-obsessed town (see Monday’s round-up) there was competition for TV viewers last night in Chicago as millions of people, including many conference-goers, watched the third and final debate between the two candidates vying to become the next US President. What do political campaigns and HIV prevention have in common? Read on for our (non-partisan) thoughts!

Lesson One: Tell a story, make it personal.

Politicians, advocates and parents—these are all groups that know the power of storytelling. Wednesday’s plenary session featured Noël Gordon Jr. (Human Rights Campaign) who told his unique story of getting on PrEP. He also shared his observations from working with gay men and transgender women, he talked about how their attitude toward HIV prevention, the threats to uptake and what opportunities we have to succeed. In advocacy, the best stories are the ones that (re)connect people to the issues. Gordon showed statistics on who is using PrEP in America—and the racial, age and gender demographics of PrEP users do not match those of people most at risk. Stigma also remains a huge issue.

Also in this plenary session, and available via webcast: two excellent research updates—Dennis Burton (Scripps Research Institute) on broadly neutralizing antibody-based vaccine design and Sharon Hillier (Microbicide Trials Network) on the state of the microbicide field.

Later that morning in the Advocates’ Corner, four advocates—Chilufya Kasanda, current AVAC Fellow at the Treatment Advocacy and Literacy Campaign (Zambia), Chamunorwa Mashoko, a leader of the Advocacy Core Team in Zimbabwe, Morenike Upkong, founder and leader of the Nigerian HIV New HIV Vaccine and Microbicide Advocacy Society and Amaka Enemo, current AVAC Fellow at the Heartland Alliance in Nigeria—shared personal stories about empowerment, advocacy and being human. All participated in a training for advocates earlier this year conducted by The Moth, a US-based organization focused on the art and craft of storytelling. Check back at avac.org to see video from their stories later this year.

Lesson Two: Exercise choice, give consent, show zero tolerance for sexual violence.

Some of the story lines in the American election have been a potent reminder of the fundamental right that all people, women and men, have to exercise choice about their bodies. In her plenary, Sharon Hillier (MTN) showed data that underscored the importance of full, free choice. Among women under 21 in the ASPIRE trial of the dapivirine ring, overall use was very low. But among women in this age range who were invested in using it—indicated by the amount of dapivirine still remaining in used rings, drug levels in samples, and self-report—use levels were stronger. And when they did use it, they were protected. Hillier reported analysis from the ASPIRE data indicating that the ring, used consistently, reduced risk by up to 84 percent compared to women under 25 using a placebo ring. This information complemented findings, also from ASPIRE, presented by Thesla Palanee-Phillips (WHRI) at the Tuesday press conference (and on the conference program today) that found that intimate partner violence—which can be physical and psychological—impeded adherence among ASPIRE trial participants. In this election and prevention season, it bears repeating: no biomedical prevention strategy will eliminate the need to prevent and address sexual, psychological and physical violence against women, sexual minorities and all people under threat because of how they live or what they do.

Lesson Three: Look who’s talking (or being talked about).

Sometimes the candidate who seizes the spotlight is campaigning for the next election. HIV prevention, like American politics, can gravitate towards the next big thing, be it a vaccine candidate or a presidential hopeful. The relatively untested is also relatively untarnished—and it can inspire hope for major change. Much of the vaccine discussion was not on the candidates now in efficacy trials but rather on candidates in earlier phases of development. On Tuesday, Chris Parks (IAVI) discussed the results of a trial in non-human primates of a vaccine that uses Vesicular Stomatitis Virus (VSV) as a vector. VSV is a replicating vector: a virus that has been disabled so that it doesn’t cause disease or carry risk but does have the ability to copy itself. It is thought that replicating vectors could prompt strong and sustained immune responses.

Later on Tuesday, Hanneke Schuitemaker from Janssen said that a decision is expected as early as the 4th quarter of 2016 about whether to move forward with a three-part vaccine strategy known as Ad26/gp140/MVA, which is currently under development in collaboration with a number of organizations including the HIV Vaccine Trials Network (HVTN), International AIDS Vaccine Initiative (IAVI), the US Military HIV Research Program (USMHRP) and Beth Israel Deaconess Center.

Interest in next-generation candidates also showed up in discussions of long-acting antiretrovirals, which could be used for both treatment and prevention. Data were shown on a new compound known as EFdA, which is in early animal studies, and on cabotegravir, the candidate moving toward possible efficacy trials in 2017. Politics remind us—don’t discount or count on any single candidate to get the job done!

Lesson Four: Money talks.

At an afternoon session, we heard that money for HIV prevention R&D has remained essentially flat for over a decade. These data come from a new report, HIV Prevention Research & Development Investments, 2000–2015: Investment priorities to fund innovation in a challenging global health landscape, from the Resource Tracking for HIV Prevention R&D Working Group, which AVAC leads. Read more on the new data in our blog post here.

Lesson Five: People in power can and must listen to and be guided by people “on the ground”.

Who are politicians or trial site staff responsible to—and dependent on—for success? The people in the communities in which they work. Without collaboration, there is no change. No engagement, no chance of making real progress. This is recognized across the field—and there’s expanding data on just how to engage. This contribution to the field is coming from widespread use of the Good Participatory Practice Guidelines (GPP) framework, which has been mentioned throughout the conference. In a presentation by Kenyan researcher Jane Ng’ang’a from the KAVI Institute of Clinical Research, she described how KAVI evaluated and improved its engagement plans using GPP. She credits the GPP framework for fostering community understanding and genuine support for the research. AVAC is proud to be the home of an online course on GPP—be sure to subscribe to the Advocates’ Network for announcements of when the next course will run.

When scientists work with (or as) advocates, or when politicians serve as (or team up with) activists, great things can happen. So one of our favorite moments of yesterday’s dialogues came at a “Meet the Experts Session”. Discussing their respective presentations, antibody expert Dennis Burton, and Noël Gordon, expert on the real world experience of people whose lives are affected by HIV in the US, realized they needed to connect. Business cards were exchanged—and perhaps the next prevention revolution was born.

For those on-site today, be sure to check out the final sessions at the Advocates’ Corner and grab some extra materials to take home! Thursday’s sessions include:

  • 10:00am – 10:30am: PrEP implementation in Chicago’s STI clinics
  • 12:00pm – 1:00pm: “It’s too complicated for them”: Service providers as gatekeepers to PrEP information and access

For the latest from the conference follow in real-time on Twitter and check out meeting coverage on aidsmap. The daily rapporteur summaries also provide report-backs on the conference. Missed a session? Visit here to see the webcasts as they become available.

HIV Prevention Research & Development Investments, 2000–2015: Investment priorities to fund innovation in a challenging global health landscape

This annual accounting of funding for biomedical HIV prevention research tracks trends and identifies gaps in investment. In 2015, reported funding for HIV prevention R&D decreased from US$ 1.25 billion in 2014 to US$1.20 billion. However, overall funding has remained essentially flat for over a decade. While investments towards research for preventive vaccines and female condoms increased from 2014 levels, investments towards microbicides, PrEP, TasP, VMMC and PMTCT declined.

HIV Prevention Research & Development Investments, 2000–2015: Investment priorities to fund innovation in a challenging global health landscape (1-pager)

This annual accounting of funding for biomedical HIV prevention research tracks trends and identifies gaps in investment. In 2015, reported funding for HIV prevention R&D decreased from US$ 1.25 billion in 2014 to US$1.20 billion. However, overall funding has remained essentially flat for over a decade. While investments towards research for preventive vaccines and female condoms increased from 2014 levels, investments towards microbicides, PrEP, TasP, VMMC and PMTCT declined.

Not To Be Missed: New report on funding for prevention research

The span of a decade—that interval that’s neither too long nor too short to bring innovation—is one that’s often used in the HIV prevention research space, usually to convey optimism. Back in 1997, then President Bill Clinton called for a national commitment to develop an AIDS vaccine within ten years. Just this week, Bill Gates said, “With the right leadership and investments over the next decade, we can discover and deliver a vaccine for HIV.”

The success of these forward-looking claims has always depended on sustained funding. Note, in both cases, the emphasis on commitment and leadership. No one is promising a vaccine with anything less. A look back at the last ten years provides a warning on this front. Released today, the Resource Tracking for HIV prevention R&D Working Group’s latest annual report on global investment into biomedical HIV prevention reports that overall funding for HIV prevention research and development (R&D) has remained essentially flat for over a decade.

Close followers of the annual “RT” report take note—a preliminary version was released at AIDS 2016 in Durban in July. The final version contains slightly updated data and the same overall messages: with a slight fall from US$1.25 billion in 2014 to US$1.20 billion in 2015, overall funding for HIV prevention research and development (R&D) has been more or less level for the past ten years.

And what a decade it’s been! Consider the developments in PrEP, the pipeline of injectable ARVs for prevention and treatment, the continued advance of the ARV-containing vaginal dapivirine ring, and the insights and advances that have come from sustained scientific inquiry related to the search for an HIV vaccine. These are exciting times. And the fact that all of this happened in the context of flat funding for research doesn’t mean that flat funding will get us where we need to go next. As Tom Hope, PhD (Northwestern University) stressed at an opening plenary of the HIV R4P conference where the report was launched, the fact that funding is declining concurrent with new discoveries is a major challenge for the field.

The report notes that preventive vaccine research funding constituted the bulk of all investments, followed by investments in microbicides, TasP, PMTCT, PrEP, VMMC and female condoms. With the exception of vaccines and female condoms, every other HIV prevention option tracked by the working group experienced a decline. These trends are somewhat reflective of the cyclical nature of large-scale clinical trials—when trials end, funding drops off. Likewise, as some interventions enter full scale rollout, like VMMC and TasP, research in this arena can be expected to slow down. Nevertheless, the overall trends bear close watching and strong advocacy to ensure that research continues.

The right products need to be tested in the populations who need them most. The report is also a powerful reminder that this isn’t necessarily how research works. It provides information on the demographic breakdown of almost 900,000 participants in ongoing HIV prevention trials in 2015, with the majority of these volunteers residing in sub-Saharan Africa, most notably Uganda, Kenya, and South Africa. Only one in eight trial participants in 2015 belonged to a population most affected by HIV, including MSM and transgender women, injection drug users, and cisgender women.

These sobering facts come in the context of a vigorous period in research and development. It’s a time of growing recognition from the global community that research has to be part of the long-term fight to end the HIV epidemic. Taking stock of all that’s been accomplished with ten years of flat funding, now is the time to support continued progress with additional, well-targeted resources.

The Resource Tracking Working Group hopes that this tool provides strong facts for advocacy and supports efforts to assess public policy and its role in accelerating scientific progress. We thank all of the individuals who contributed data to the report and who gave time and effort as trial participants.

Check out the report, share it with your fellow advocates, and be sure to let us know if your organization is either a funder or recipient of HIV prevention grants or if you have further questions or information about resource tracking at all!

Press Release

A Decade of Flat Funding Could Imperil Progress of the HIV Prevention Research Pipeline

Contacts

AVAC: Kay Marshall, [email protected], +1-347-249-6375
IAVI: Arne Naeveke, [email protected], +1-212-847-1055

A PDF version of this press release is also available.

Report released at HIV Research for Prevention Conference highlights funding trends, opportunities and challenges for HIV prevention R&D

Chicago – A new report released today at the second HIV Research for Prevention Conference in Chicago documents 2015 funding, highlighting a decade of flat funding and its potential impact on continued innovation in the HIV prevention research and development (R&D) field.

The Resource Tracking for HIV Prevention R&D Working Group’s (RTWG) 12th annual report, HIV Prevention Research & Development Investments, 2000-2015 Investment priorities to fund innovation in a challenging global health landscape, finds that funding for R&D of new and emerging prevention options decreased slightly in 2015. This was due in part to decreases from the US public sector and a downswing in global philanthropic funding.

Steady progress in R&D for AIDS vaccines, microbicides, pre-exposure prophylaxis using antiretroviral drugs (PrEP) and treatment as prevention (TasP) confirms science’s critical role in providing solutions to end the HIV/AIDS epidemic. Yet research for these badly-needed solutions is in danger of being slowed or even sidelined by inadequate funding.

“It is critical that investments into HIV prevention innovations, science and technology are scaled up to put us firmly on the Fast-Track to ending AIDS by 2030,” said Luiz Loures, Deputy Executive Director, UNAIDS.

In 2015, funders invested a total of US $1.20 billion across R&D, down from US $1.25 billion in 2014, across eight key areas: preventive AIDS vaccines, microbicides, PrEP using antiretroviral drugs, TasP, HSV-2 vaccines and operations research related to voluntary medical male circumcision, female condoms and prevention of vertical transmission.

The report also finds that investment is being made along all phases of the research pipeline but remains concentrated among a few large investors. A more diverse base of funders would increase the stability of R&D financing and cushion the impact if any of the major funders were to reduce their investments. To improve continuity, RTWG calls for a more balanced funding base, especially through support of new investment by European and low- and middle-income countries. The US public sector (primarily via the National Institutes of Health) remained the largest global contributor at US$850 million, accounting for 70 percent of total funding. Together the US government and the Bill & Melinda Gates Foundation, the largest philanthropic funder, accounted for 81 percent of all funding in 2015.

“There is now very strong momentum in research and development, and we need to expedite the development of vaccine strategies and other new, biomedical prevention options that promise to be safe, accessible and effective for use throughout the world,” said Mark Feinberg, President and CEO of IAVI. “There must be adequate and sustained investment at all stages from early laboratory research and to clinical testing if we are to truly be able to contain the HIV pandemic and approach and end to AIDS.”

This is indeed a time of great optimism for HIV prevention research. Daily oral PrEP is gaining traction as a new prevention option in an increasing number of countries; an antiretroviral-based microbicide ring that showed modest efficacy earlier in 2016 will be further evaluated to determine its viability as a prevention option for women; large-scale efficacy trials of an AIDS vaccine candidate and an injectable form of PrEP are slated to begin soon and a novel proof-of-concept trial of antibody-mediated prevention is underway in several countries. Many more promising candidates in earlier stages are progressing toward pre-clinical and clinical evaluation.

Importantly, 2015 saw increasing investment in the science of delivery – or implementation research – primarily focused on delivery of TasP interventions. Such investments will become even more important to help ensure new prevention options move quickly and efficiently into prevention programs and begin to have an impact on HIV infection rates. There is also an increasing understanding that research must understand and integrate the needs and desires of people who will eventually use new prevention options. Ensuring that the perspective of those for whom new prevention options are being developed is included from the beginning of the research process can help ensure that safe and effective products can be rolled out swiftly and be more fully accepted.

“Innovative science needs innovative funding,” said Mitchell Warren, AVAC Executive Director. “We need an expanded and more diverse global cadre of funders who will be involved in and dedicated to advancing HIV prevention R&D, including product delivery. And these investments need to ensure that new options like daily oral PrEP, and potentially the dapivirine vaginal ring, do not sit on the shelf unused because we don’t know how to effectively deliver them, and that future R&D better meets the needs and wants of those for whom products are developed.”

The report and infographics on prevention research investment are online at www.hivresourcetracking.org and on social media with #HIVPxinvestment.

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Since 2000, the Resource Tracking for HIV Prevention R&D Working Group (formerly the HIV Vaccines & Microbicides Resource Tracking Working Group) has employed a comprehensive methodology to track trends in research and development (R&D) investments and expenditures for biomedical HIV prevention options. AVAC leads the secretariat of the Working Group, that also includes the International AIDS Vaccine Initiative (IAVI) and the Joint United Nations Programme on HIV/AIDS (UNAIDS). This year’s report is additionally made possible by the support of several donors, including IAVI, UNAIDS, the Bill & Melinda Gates Foundation and the American people through the US President’s Emergency Plan for AIDS Relief (PEPFAR) and the US Agency for International Development (USAID). The contents are the responsibility of AVAC and the Working Group and do not necessarily reflect the views of PEPFAR, USAID or the United States Government.

Desperate Times Call for Desperate Measures: DIY PrEP in Europe

Did you know there were more new diagnoses of HIV in Europe in 2014 than at any point since the 1980s? In fact, Europe is home to the fastest growing HIV epidemic on earth. Faced with this fact, many people are taking prevention into their own hands as they begin to seek ways to secure PrEP even though access is highly limited in the region. In a new report by the PrEP in Europe Initiative we tell these stories.

Oral PrEP using TDF/FTC, known to be almost 100 percent effective at preventing HIV infection when taken as prescribed, was recently approved by the European Commission. This allows for the ARV combination of tenofovir and emtricitibine to be marketed as HIV prevention across the European Union.

Yet outside of France, where PrEP is available through the national health system at no charge, it is not available to anyone in a European health system unless they pay full price for the medication and find a doctor willing to write a prescription for it. Costs can reach several hundred euros per month. It has been available in the US through public and private health insurance plans for over four years now.

Gay men and other MSM in Europe are aware of the unacceptably high numbers of new diagnoses in their communities. These rates tell us that condoms alone are simply insufficient to protect all those at risk all of the time. The analogy with birth control is worth considering: women do not solely rely on male condom use to prevent pregnancy. Gay men, and other people at high-risk are therefore desperate to get their hands on the new blue pill, trademarked by the company Gilead as Truvada.

In “PrEP Access in Europe” by the PrEP in Europe Initiative, we set out the ways in which people across the European region are securing PrEP outside of traditional health systems and often outside of medical supervision. These include sharing pills among friends, smuggling pills into Europe from abroad, ordering generic versions on-line, and buying them on the black market. Emergency HIV prevention regimens for the ‘morning after’, formally known as PEP, contain Truvada and are therefore also being mined for the blue pills, with the rest thrown in the bin.

These DIY (Do it Yourself) approaches are worrying to physicians and PrEP advocates alike. One concern is that some people may be taking PrEP without a confirmed HIV-negative test result. Being sure you are HIV-negative when starting PrEP, and going for regular HIV tests are key to safe, successful PrEP use. TDF/FTC can also have side effects, both minor and, in rare instances, severe that can only be dealt with in the context of a health setting—so home-based PrEP might be a risky manoeuvre. Lastly, inadequate dosing or irregular drug supplies are not suitable when it comes to PrEP, just as they aren’t suitable for ART. For example, popping only one pill at the weekend, or a few pills here and there, won’t provide protection.

The Report shows that, in the absence of government and health authority action, DIY PrEP is the outcome. The fault does not lie with people who are seeking to take control of their HIV prevention options but with the national authorities that have failed to act.

The report calls on European governments and health authorities to take immediate action to make PrEP available to populations at imminent risk of HIV as a matter of urgency. Read the full report here.

Rebekah Webb is an HIV advocate and policy analyst with over 20 years of experience. She is a founding member of the PrEP in Europe initiative, currently sits on the Prevention Portfolio Steering Committee of the European AIDS Treatment Group, and is a partner in the management of AVAC’s European ROAR advocacy program.

Trial Participants by Prevention Research Area, 2015

Given the higher rates of acquisition seen across so-called key populations—members of highly burdened and underserved groups—it is critical to provide access to the research process such that they can participate and reap more immediate benefit of scientific progress. Greater efforts must be made to include key populations in this crucial process for the HIV prevention response to be truly impactful.

Global HIV Prevention R&D Investments by Technology, 2000-2015

In 2015, global funding for HIV prevention R&D declined slightly, from US $1.25 billion in 2014 to US $1.20 billion in 2015. This continues a decade of roughly flat funding. The US public sector remained the largest global contributor at US $850 million, and together with the Bill & Melinda Gates Foundation, the largest philanthropic funder, constituted 81 percent of all funding.

PrEP for MSM in Africa: Meeting Summary and Next Steps

Advocates gather in South Africa for the continent’s first PrEP and MSM consultation to chart a path for PrEP access. See the report summary with links to presentations and country plans.

Moving Forward with PrEP and MSM in Kenya and Uganda—And It’s Just the Beginning

It’s been five months since the first ever consultation about PrEP for gay African men was held in South Africa. (Yes, there was consensus at the meeting at the outset to use the term “gay men”, rather than MSM, and also to be clear that we were not addressing the specific needs of transwomen, an urgent and separate agenda.) It’s terrific to be able to share the meeting report from the April consultation, and to provide the first of a series of ongoing updates, in this case from Kenya and Uganda, about work to expand access to oral PrEP to all the Africans who need it!

Kenyan PrEP Ambassador accepts PrEP User of the Year Award

From Kenya, the key population focused organization HOYMAS held their HIV/AIDS Champions’ Day in Nairobi on Monday this week. This year HOYMAS focused their HIV/AIDS Champions’ Day on highlighting the advocacy needs for new prevention options including oral PrEP. The event provided a platform for participants to exchange best practices, strategies for advocacy and ideas that advance the overall goal of prevention of HIV. One highlight from the meeting was when Brandon, who was named Kenyan PrEP ambassador by a Kenyan health organization known as LVCT, won the PrEP User of the Year.

Earlier in September, the Uganda LGBTQ community, led by Sexual Minorities Uganda (SMUG), held a meeting to discuss expanding PrEP access that put gay men at the center.

I am personally intrigued by the resilience of SMUG and of the entire Uganda LGBTQ community, even in the midst of the unrest. In the past six weeks alone, they have endured terrible police brutality at a Pride-related event, cancellation of the main Pride parade and ongoing harassment and stigmatization. In the midst of these rights violations, and their crucial work as human rights’ defenders, SMUG is also helping to ensure that the right to health is upheld. I salute them.

The September 9 meeting, held at a secure location, brought together about 25 participants from civil society organizations, members of Uganda’s LGBTQ community and members of SMUG. Some of the participants were attending a PrEP advocacy strategy meeting for gay men for the first time.

Richard Lusimbo from SMUG, the lead organizer of the meeting, reports that there was a deep sense of urgency within the members of the community who were at the meeting and others who were following on social media. You can get a sense of the lively discussion by searching #PrEP4MSM on Twitter he questions debated by meeting participants included: “Where has PrEP been?”, “Why don’t we have it yet?”, “How do we make this important prevention method available for our community now!?” Lusimbo noted, “The key word is ‘NOW.’” They want it now and they deserve to have access to it now!

The meeting participants stressed that community members need to be empowered with more education and information about PrEP. Many people are still confused about the difference between PrEP and PEP. PrEP stands for pre-exposure prophylaxis. It is an HIV prevention strategy in which HIV-negative people take an oral pill once a day before coming into contact with HIV to reduce their risk of infection. PEP stands for post-exposure prophylaxis. PEP is an HIV prevention strategy in which HIV-negative people take a short course of ARVs after possible exposure to reduce their risk of HIV infection. Basic questions that members of the community might be having about PrEP need to be asked and answered.

Some of the participants expressed the fear of continued stigmatization and homophobia in the country that might be heightened if PrEP is considered only for MSM. They stressed the need for PrEP to be rolled out for all populations at risk, as WHO has recommended, so that the Uganda government can support it without singling out specific populations.

Participants also expressed the need to come up with a clear communications strategy to inform the community about PrEP and to address misconceptions.

Further allies in PrEP advocacy in Uganda such as Health GAP helped members challenge the myth that lack of government funding in the short term should hold back implementation advocacy.

We are very excited about the ongoing PrEP advocacy and the work to create demand for prevention options for all populations in Africa, especially those most at risk. Ongoing collaboration with our Africa partners supports a broad and crucial effort—engage with national governments and other stake holders, advocate for the development of national PrEP guidelines and make sure there is community awareness of PrEP.

Watch this space for how the group moves forward in the weeks to come.