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!

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.

Press Release

With future of HIV prevention “on the line,” AVAC calls for sharper, bolder strategy to end the epidemic

Contacts

Mitchell Warren, [email protected], +1-914-661-1536

Kay Marshall, [email protected], +1-347-249-6375

New York — In a report issued today, AVAC warned that global HIV prevention efforts are in jeopardy due to an absence of strategic targets, resources and specific implementation plans to translate science, slogans and goals into action. The report calls for a robust set of global HIV prevention targets tailored to specific interventions and demands action in several key areas of the global AIDS response, including expanded rollout of daily oral pre-exposure prophylaxis, or PrEP, and alignment of science and human rights-based agendas.

“We’re at a make-or-break moment and the future of HIV prevention is on the line,” said Mitchell Warren, AVAC’s executive director. “Advances in HIV treatment and prevention research have made it possible to contemplate ending the AIDS epidemic in our lifetimes, but that will only happen with smarter planning, increased resources and greater accountability.”

The report was released ahead of the Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle (Feb. 23-26), where researchers are expected to present data from several major HIV prevention trials, including studies that could help drive global implementation of PrEP, as well as a key study of a tenofovir-based vaginal gel for women.

Report calls for smart, realistic goals and targets for HIV prevention

Today’s report, entitled Prevention on the Line, takes a close look at global goals for HIV prevention and what it will take to make them a reality. UNAIDS recently adopted the broad goals of reducing new HIV infections worldwide from 2.1 million in 2013 to 500,000 and eliminating stigma and discrimination, both by the year 2020.

Drawing upon lessons from WHO’s “3 x 5” HIV treatment initiative and other case studies, the AVAC Report concludes that ambitious prevention goals are critical – but that they will only work if they’re feasible, well-defined, measurable and supported with adequate resources and political commitment. In the case of the new UNAIDS prevention goals, the report points to a critical need for more specific, interim targets that can be tracked between now and 2020; for better data and monitoring approaches; and for resource allocations that are directly tied to achieving those targets.

“The UNAIDS prevention goals for 2020 are ambitious and inspiring,” said Warren. “But something important is missing from this picture: how to get there. We need a clear path forward, including short-term targets, so we don’t wait five years to see if the world is on track. And new targets won’t be met – and may even be irrelevant – if we fail to close the growing global funding gap for HIV prevention.”

Bold action needed to advance AVAC’s agenda to end AIDS

The report also recommends key actions to advance AVAC’s three-part agenda to end AIDS. First issued in 2011, the agenda calls for sustained efforts to deliver proven prevention tools, demonstrate and roll out new options such as PrEP and develop long-term solutions such as long-acting ARV-based prevention, vaccines and cure strategies.

Key recommendations for 2015 include:

1. Align high-impact HIV prevention with human rights and realities. Research has demonstrated the potential of high-impact prevention strategies, including biomedical approaches like HIV treatment for people living with HIV and voluntary medical male circumcision (VMMC). But these strategies won’t succeed in the real world if we give short shrift to human rights concerns, or if we fail to involve affected communities in designing and implementing prevention programs. Recent experience with treatment and VMMC, in particular, has shown that community buy-in is an essential ingredient of successful rollout and scale-up.

2. Invest now to scale up access to PrEP. Landmark trials have shown that daily oral PrEP is a powerful HIV prevention tool, and studies at next week’s CROI meeting could provide additional support. But the pace of rollout remains far too slow. Demonstration projects are small and disconnected, funding is limited and policy makers are not yet heeding growing demands for access. Funders should invest now in large-scale targeted implementation of PrEP, linked to national programs. National regulatory authorities and health ministries should prioritize licensure and rollout.

3. Accelerate research into long-term solutions. We must sustain and accelerate research on solutions such as an effective AIDS vaccine, long-acting antiretroviral prevention and treatment and a cure. Just like the rest of the AIDS response, this research needs its own short-term targets, aligned to long-term goals.

The new report and related resources, including downloadable graphics, are available now at www.avac.org/report2014-15.

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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.

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.

New Px Wire: Top Ten Things to Watch in 2015

Welcome to the New Year! Wondering where to put your attention and advocacy energy for the next 12 months? We don’t presume to have all the answers, but our new issue of Px Wire includes a highly selective list of ten issues, events and developments to hold attention and spark actions in 2015 — and beyond.

Want to see the bigger picture? Check out our updated timeline of biomedical HIV prevention research in the centerspread!

Download the latest issue of Px Wire here.

Will 2015 be the year for PrEP and women?

In the run-up to the busy holiday season here in New York, a number of great pieces focusing on women and PrEP came out, including new data on PrEP knowledge and attitudes, a video depicting one of our favorite stories of early PrEP use in the Bay Area, another great webinar from the US Women and PrEP Working Group, and a piece from a freelance journalist who took on the question of why so many women are still being infected with HIV when there’s a pill to prevent it. Check it all out below!

In late December 2014, data on knowledge, attitudes and likelihood of PrEP use in US women was published in the journal AIDS Patient Care and STDs. The study was conducted by AIDS United and included focus group discussions with 150+ women from across the United States. Key findings include women’s interest in PrEP as an additional prevention tool and identification of potential barriers that to be addressed to provide access for women in the US. Download the article here.

“This Pill Prevents HIV, So Why Are So Many Women Still Being Infected?” is a piece that features commentary from a range of advocates and PrEP users, including the story of sex-positive advocate Julie Lynn and her decision to begin taking PrEP. The article reminds readers of the need to ensure the conversation on—and implementation of—PrEP in women includes all women at risk, not just those who are part of serodifferent couples and want to use PrEP for safer conception.

The idea of “PrEP-ception” has been pioneered by women’s health and HIV advocates and has been advanced largely due to early efforts from those at the Bay Area Perinatal AIDS Center (BAPAC) in San Francisco, California. One of the first couples to use PrEP to safely conceive worked with BAPAC. The story of “Poppy” and “Ted” (pseudonyms used to protect their privacy) is one of an HIV-serodifferent couple—Poppy is HIV-negative and Ted is HIV-negative—who wanted to get pregnant without the expense of sperm washing, one of the options used by HIV-negative women looking to get pregnant by their HIV-positive partners. Poppy went on PrEP and had condomless sex with her husband for the first time, which happily led to the birth of her adorable—and HIV-negative—daughter Macey. Check out the Fusion TV segment on their wonderful story.

Circling back to the idea of risk and how to do a better job at ensuring all women at risk know about and have access to PrEP, if desired as an HIV prevention option, the US Women & PrEP Working Group recently hosted a webinar: How Do Women Think about HIV Risk? The conversation around women’s perception of HIV risk and how this perception impacts care providers and PrEP as a prevention option is critical. Sign in here to access slides from the webinar and the recording.

Resources, articles and discussions on PrEP are on the rise, and we’ve highlighted just a few of them here. New usage data show that PrEP use in the US among some populations and communities is going up and one has to imagine that it is partly due to increased, accurate coverage and awareness. But, as described in the article above, the conversation around PrEP and women has not experienced the same amplification effect as that of gay men and PrEP over the last year. More women (and men) can benefit from PrEP than are currently accessing it. We—providers, advocates, public health agencies and anyone who talks to a woman about her health—have to do better.

Will 2015 be the year for PrEP and women? And not just in the US but globally? We sure hope so.

Want more information on the US Women and PrEP working group and its activities? Check it out here. Interested in working with us on this issue in 2015? Drop us a line.

Biomedical HIV Prevention Efficacy Trials, 2014–2016

Prepping Gay Men for PrEP

Adebisi Alimi is an LGBT advocate, former AVAC PxROAR Europe member and a 2014 Aspen New Voices Fellow. This article first appeared in Project Syndicate.

In October, two groups researching the effectiveness of a potential breakthrough drug in the fight against HIV did something unusual. They announced that the therapy they were testing, an antiretroviral drug called Truvada, had proved effective enough to end the randomized phases of the trials, and that they were offering the pill to all of the studies’ participants.

The researchers found that gay men who take Truvada, in addition to using condoms when they have sex, were significantly less likely to contract HIV. This is further evidence of the effectiveness of pre-exposure prophylaxis (PrEP), a technique by which people who are HIV-negative use antiretroviral drugs to protect themselves from infection. In 2011, a trial funded by the Gates Foundation found that straight couples using Truvada reduced the risk of transmitting HIV by 73 percent.

Those fighting to prevent the spread of HIV/AIDS thus have a new tool in their arsenal. The question now is how best to deliver it to those who need it most: gay men in developing countries.

This summer, the World Health Organization took an important step to that end, recommending PrEP for all gay men and men who have sex with men, making it the first major international health organization to do so. The WHO estimates that increased use of PrEP could reduce HIV infections by up to 25 percent over the next decade among men who have sex with men (this category includes anyone with elevated risk, not just those who identify as gay).

But an important obstacle remains: the legal predicament of gay men in much of the developing world. In countries like Nigeria, where anti-homosexuality legislation has recently been approved, those following the WHO’s new PrEP guidelines could find themselves subject to imprisonment.

The climate of officially sanctioned homophobia in Nigeria has already set back the fight against AIDS. In 2006, a study found that 13 percent of men who have sex with men in Nigeria were HIV-positive, compared to 4.5 percent of all Nigerians. By 2012, the HIV rate among men who have sex with men had jumped to 17 percent. Meanwhile, an increasing number of men reported encountering homophobia at healthcare centers, making them less likely to seek help.

The consequences could not be more serious. Two years ago, a young HIV-positive Nigerian man contacted me on Facebook to tell me about his monthly ordeal at the clinic. The nurse at the hospital spent more time lecturing him on the evils of homosexuality than telling him about the drugs he was taking and their possible side effects. The man, a third-year medical student, told me that he had decided to stop going to the clinic. When I asked how he would continue treatment, he said that he had a friend abroad who could get him the drugs. Less than two years later, I saw a Facebook update announcing his death.

My Facebook friend is not the only one who has paid the price for Nigeria’s homophobia. A preliminary report from the Solidarity Alliance Nigeria, a coalition of gay, lesbian, bisexual, and transgender (LGBT) organizations, details a huge decrease in the use of HIV services by men who have sex with men in the six months following the enactment of the anti-gay legislation. The decrease ranges from 40 percent in Lagos – Nigeria’s most cosmopolitan city – to 70 percent in Kano, a predominantly Muslim state.

Nigerians living with HIV must do more than just fight the infection; they also must brave social stigma, weather discrimination by secular and religious institutions, and now, potentially, face threats from the legal system. In this environment, the promise of PrEP begins to dim, as the risks of seeking treatment outweigh the potentially life-saving benefits.

The story is similar in Uganda. Last spring, as legal persecution of gays there mounted, the government raided an HIV clinic and withheld its operating license for providing care and support to HIV-positive men who have sex with men.

As an African activist with more than ten years of experience in the fight against HIV, I hope that the WHO will build on its important first step of advising the use of PrEP. That means initiating a public conversation with countries like Nigeria, Uganda, Gambia, and Russia on the importance of inclusion in the battle against HIV.

The WHO should make it clear that while it may not be advocating for LGBT political rights, it is determined to ensure that all those who can benefit from PrEP are able to access the necessary drugs, without fear of legal consequences. Researchers, drug companies, and human-rights campaigners must take up the fight to ensure that PrEP is made available – without risk – to those who need it most.

UNAIDS Report has Bold Vision, Key Messages—But Needs More Precision on HIV Prevention

UNAIDS recently released Fast Track: Ending the AIDS Epidemic by 2030, its report for World AIDS Day (December 1, 2014). Coming nearly two weeks early, the launch was, itself, fast-tracked—and there’s plenty of “we can’t wait” urgency within the pages of the report, starting with the first page (that does more, typographically, with red ribbons than you might believe is possible). It reads:

“We have bent the trajectory of the AIDS epidemic. Now we have five years to break the epidemic or we risk the epidemic springing back even stronger.”

This is on target and a message to convey urgently and with clarity. UNAIDS has its work cut out as an agency that can provide leadership, mobilize resources and push for the shift to community-based service delivery that emerges as one of the core recommendations in the report.

In broad strokes, it’s the right message, with the right vision, at the right time.

But an effective response depends on strategy, details, milestones, resources and specifics—and these are still lacking. This is to be expected, as the UNAIDS Prevention and Non-Discrimination Targets are still in draft form.

The Fast Track World AIDS Day report is clear on what needs to happen to achieve the “90-90-90” goal that calls for 90 percent of people living with HIV to know their status, 90 percent of those to be on antiretroviral therapy (ART) and 90 percent of those to be virologically suppressed by 2020.

It also suggests the components of prevention programming that should also come on line—listing, in various places, male and female condoms, voluntary medical male circumcision, oral pre-exposure prophylaxis (PrEP) for sex workers, men who have sex with men, serodiscordant couples and adolescents, as well as cash transfers for young girls, harm reduction, structural interventions, mass media and behavior change. These prevention elements appear in different subsets throughout the document, leaving some confusion about what, exactly, is essential.

Everything that the UNAIDS report lists is important. But the details of what goes where—which packages, in which places—and what specific terms mean are missing. Cash transfers, for example, can be delivered in a range of ways, with different objectives and different outcomes.

There are also some elements that receive considerably less emphasis. Research and development of more potent ARVs for treatment and prevention, new prevention options for women and other key populations, vaccine and cure strategies, are fundamental to long-term success in “breaking the epidemic”. Within the five-year timeframe set by UNAIDS, there are short-term milestones to set and achieve in each of these areas, even though the ultimate goals may not be reached for many years.

The good news is that this is a solvable problem. We as advocates and activists must use our impatience and collective wisdom to fast-track a process to ensure that clear targets, resources and messages are developed with the same strategy, rigor and urgency as 90-90-90.

AVAC is working with many of our partners to inform this process. This new report adds urgency to this task and clarity to the questions we need to address. As the report stresses, we must all “hold one another accountable for results and make sure no one is left behind.”

In the coming days, AVAC will release “Prevention on the Line”—a briefing paper with core recommendations for effective target-setting across the research-to-rollout continuum. This will summarize core messages and analysis that will be expanded in AVAC Report 2014/15. To receive the Report and other updates in your inbox, please join our Advocates’ Network. Stay tuned—and stay in touch.

Click here to download the new UNAIDS report.

PrEP by the Numbers: Efficacy, regulatory approval and more

PrEP works if you take it. The figures on this graphic show the relationship between PrEP efficacy and adherence and the status of regulatory action on PrEP worldwide. It also shows other potential new formulations of ARV-based prevention being evaluated as additional options in the future.