Press Release

Data gaps hinder global efforts to reduce HIV infections, AVAC report warns; improved data collection and reporting needed to meet looming global AIDS targets

Contacts

Mitchell Warren, [email protected], +1-914-661-1536
Kay Marshall, [email protected], +1-347-249-6375

In a report issued today, AVAC warned that major gaps in global HIV/AIDS data stand in the way of delivering HIV prevention advances to millions of people who need them most. The report identifies several critical weaknesses of today’s HIV prevention data collection and monitoring systems and offers a concrete roadmap for closing these gaps. The report, Big Data, Real People, was issued ahead of next week’s International AIDS Conference in Durban, South Africa (July 18-22), where advocates will demand action to speed HIV prevention research and delivery.

“In an era in which big data are expected to improve essentially every part of our lives, there’s no excuse for HIV prevention data systems to be so uneven, incomplete and inefficient,” said Mitchell Warren, AVAC’s executive director. “To have any chance of ending the epidemic by 2030, we need to be collecting and accounting for every bit of useful information from every person living with or at risk for HIV.”

The need for improved HIV prevention data systems is particularly pressing given the UNAIDS “fast-track” goal to reduce new annual diagnoses to no more than 500,000 by 2020. Earlier this month, UNAIDS reported that the number of new HIV infections has remained near 2 million per year for the past decade.

Report identifies specific HIV data gaps, recommends solutions

AVAC’s report focuses on four critical data gaps that must be addressed to effectively prioritize, target and measure the impact of efforts to develop and deliver HIV prevention advances.

Specifically, today’s HIV prevention data are:

  • Not sufficiently broken down by age, gender, income status, key population status and other vital categories
  • Missing or incomplete for key populations most in need of prevention, including adolescent girls and young women, men who have sex with men, transgender women, and others
  • Not tied to useful HIV prevention metrics and indicators, so that it is impossible to know whether prevention programs are actually averting infections and improving health
  • Not effectively informing the HIV prevention research agenda

To overcome these weaknesses, the report outlines three critical strategies that should be pursued most urgently:

1. Standardize and systemize data collection and reporting for HIV prevention

Understand, measure and report on the risk level of people testing HIV-negative; create and measure linkages to evidence-based prevention for people at substantial risk; and use a standardized “Prevention Data Dashboard” to continually evaluate progress. Such dashboards would consolidate and arrange available data to illuminate critical prevention gaps and help the global community, governments and funders better conceptualize their HIV prevention programming and evaluation. AVAC’s report provides a model dashboard for decision-makers to adopt.

2. Improve use of data for adolescent girls and young women

Ensure that a growing volume of available data can be applied in a meaningful way. As a first step, funders, implementers and governments need to do a better job of defining and segmenting this population; map who is investing in what and where; put adolescent girls and young women in control of core aspects of the data-collection enterprise; and adopt gender-specific indicators tailored to girls and women.

3. Put research on the “fast-track” and countries at the center

Fit biomedical HIV prevention research into comprehensive prevention plans tied to national targets for incidence reduction. Countries and research institutions must invest time and resources in stakeholder engagement; ensure that research priorities are informed by epidemiological and other quality HIV data; and develop national research plans for meeting the prevention needs of specific, affected populations.

The new report and related resources, including downloadable graphics, are available now at www.avac.org/report2016.

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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.

Microbicides by the Numbers: Science, products, money and more

The term “microbicide” refers to substances being studied that could be used in the vagina and/or rectum to reduce the risk of HIV infection via sexual exposure. There are no licensed microbicides available today. Simple, easy-to-use microbicides would help these individuals take control of their own health—while offering people everywhere an additional, needed option. The graphics below represent key facts about the microbicide field.

What Should the Next US President Do? Advice for Hillary and Donald.

On behalf of IFARA, thebodypro.com recently posted two videos. In the first, Jim Pickett, director of Prevention Advocacy and Gay Men’s Health at the AIDS Foundation of Chicago, spoke with Robert Grant, MD, MPH, Mike Cohen, MD, Ian McGowan, MD, PhD, FRCP, and Mitchell Warren about HIV prevention research presented at this year’s Conference on Retroviruses and Opportunistic Infections (CROI).

New prevention tools, such as a safe and effective vaginal ring and the prospect of long-acting injectable agents are exciting news, panelists agreed. However, these tools are only as good as their implementation — as is the case with already approved methods, such as oral pre-exposure prophylaxis (PrEP). This includes finding and effectively treating people living with HIV, because those with an undetectable viral load do not transmit the virus.

Panelists would advise the next US President to invest in long-term research, including the search for a vaccine, cure, fund open-label studies of the vaginal ring, and provide treatment and prevention services to as many people as possible — especially women and men of color.

Watch the video on thebodypro.com.

In the second video, AVAC Policy Director Kevin Fisher spoke with Steven Wakefield and Ntando Yola about the development of a vaccine for HIV.

Wakefield called antibody-mediated prevention “the next holy grail.” Trials of broadly neutralizing antibodies that are infused every two months will start enrollment across the globe by mid-year, he said. However, a potential vaccine is just one component in a set of HIV prevention methods. Yola described HIV prevention as “a track field where products are racing each other.” Communities pin their hopes on each new prevention modality, but the focus needs to be moved from specific methods to overall prevention science, he believes. To that end, the science behind vaccine research needs to be explained in a way that people in the community can understand.

This video is also available at thebodypro.com.

Women’s Prevention Works If Women’s Realities Are Appreciated and Prioritized

Seventy-five advocates from across Africa—friends, allies, researchers—came together for a one-day meeting in Johannesburg on April 14 to discuss the recent dapivirine ring results, what they mean in the broader context of women’s HIV prevention, what comes next and key milestones to plan for.

The recently released results of the dapivirine vaginal ring for HIV prevention demonstrated, for the first time, that an ARV-containing vaginal ring could prevent HIV acquisition. The trial data caused celebration and immediate conversation about what would happen next given that the trial showed both that the ring works and that there may be real challenges with adherence, particularly in younger women.

With new programs, funding initiatives and research specifically targeted for women and girls, this workshop convening was an important juncture to pause, take stock, consider the next few years and plan key advocacy priorities. The discussions highlighted the exciting and complicated road ahead for rings and for prevention options for women generally.

This meeting provided an opportunity to unpack and interpret the dapivirine ring results, understand and interrogate next steps, situate the next two years for women’s HIV prevention (research, implementation and funding), and identify advocacy opportunities and areas for further engagement.

Two young women living with HIV set the stage for the day with their personal stories and perspectives on where HIV prevention sits in the context of the lives of young African women. Their stories became a frame for the day—recognizing the special needs young people have for contextualized education about HIV and sexuality, but more importantly that young women are the most powerful champions and MUST be involved in designing and delivering any interventions and decision-making processes that impact their lives.

There was rich discussion on advocacy priorities for the next year or so and what is needed to ensure that women’s prevention is prioritized. Two of the issues raised underpin the way forward for women’s HIV prevention and serve as a call to action for those attending this meeting and other communities across Africa: (1) the need to roll out PrEP now as we wait for rings; and (2) the need to revive activism in the HIV prevention movement.

One of the most important takeaways was that as we consider the exciting biomedical prevention interventions to change the trajectory of the epidemic—race, gender and the unique aspects of women’s lives will continue to affect access to care and prevention. It is critical to situate the research and access in the realities of women’s, and especially young women’s lives, and that context is always important.

Please visit www.avac.org/ring-results-and-next-steps to access meeting presentations and materials. 

Px Wire April-June 2016, Vol. 9, No. 2

Px Wire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research, implementation and advocacy. This issue is an advocate’s guide to the past, present and future of the dapivirine ring for HIV prevention. Featuring a timeline of key milestones that could lead to licensure, a simple comprehensive Q & A, and a closer look at where sub-Saharan African women will have access to daily oral PrEP and/or the Ring via open-label extension studies.

Patchwork of Prevention for Women: Oral PrEP and the Dapivirine Ring

Participants in the ring efficacy studies will get extended access to the ring via open-label studies. But will they have access to PrEP? This map shows which sites will provide PrEP and which will not. Excerpted from Px Wire.

Dapivirine Ring Results—A snapshot

This infographic provides detailed study design and result information from The Ring Study (IPM 027) and ASPIRE (MTN-020). The lower portion of the infographic charts additional, related studies and the regulatory process before the ring’s earliest possible introduction. Excerpted from Px Wire.

Dapivirine Ring—Past, Present and Future

AVAC’s new issue of Px Wire is an advocate’s guide to the past, present and future of the dapivirine ring for HIV prevention. It features a timeline of key milestones that could lead to licensure, a simple comprehensive Q & A, and a closer look at where sub-Saharan African women will have access to daily oral PrEP and/or the Ring via open-label extension studies. We hope this resource will be used to spark discussion and guide plans for further engagement.

Click to download the new issue of Px Wire.

The full issue of Px Wire, as well as our archive of old issues and information on ordering print copies, can be found at www.avac.org/pxwire.

New Resources at AVAC.org and Our Webinar Series Continues

There’s lots to digest from the recent 2016 Conference on Retroviruses and Opportunistic Infections, but we’ve got you covered. Here are some new resources on our website. Also our post-CROI webinar series continues. See below for details.

Read — Advocates’ Voices from CROI
CROI was about more than the ring results. In our blog series, read perspectives directly from from advocates and activists in attendance. You won’t want to miss advocates’ frank takes on which scientists walk the walk in community engagement, why research results are just the beginning and what the ring results means to African women.

Listen — Webinar: Exploring Dapivirine Trial Results
In the first of a series, Jared Baeten of the Microbicide Trials Network and Zeda Rosenberg of the International Partnership for Microbicides spoke about the dapivirine ring trial results announced at the conference and fielded questions from webinar participants. (More post-CROI webinars to come!)

Look — Infographic: Evidence for HIV Prevention Options
Given these results, what’s the big picture of ARV-based prevention trial results? This graphic shows the levels of efficacy from each major trial with the confidence intervals around the finding. (Not sure what a confidence interval is? See our one-page Advocates' Guide to Statistical Terms.)

Read — Dapivirine Ring Results
Two trials of a vaginal ring containing the antiretroviral drug dapivirine announced their results at the conference. We compiled press releases, media reaction, provided background materials, linked to the conference webcasts with the results and more.

Post-CROI Webinars Series

Upcoming Webinars

Community Perspectives from CROI 2016
April 6 at 2:30pm EDT

The Well Project and AVAC are proud to present this webinar highlighting findings from the annual conference through community voices. We will be joined by:

  • Kate Borloglou, The Well Project
  • JD Davids, TheBody.com
  • Jessica Salzwedel, AVAC
  • Lisa Diane White, SisterLove

Please join to learn about these important clinical, research and advocacy-related updates as well as a Q&A session. Register here!

Past Webinars

Long-Acting Injectable Antiretrovirals for Treatment and Prevention
March 24, 2016

David Margolis (ViiV Healthcare) and Marty Markowitz (Aaron Diamond AIDS Research Center) spoke about long-acting injectable antiretrovirals for treatment and prevention.

At CROI, Margolis presented findings from the LATTE 2 trial, which tested a pair of long-acting injectables—cabotegravir (from ViiV Healthcare) and rilpivarine (from Janssen)—for HIV maintenance therapy, and Markowitz presented findings from the ÉCLAIR paste 2A study of cabotegravir in HIV-uninfected men.

SLIDES / AUDIO / FLASH

Harnessing Antibodies for HIV Prevention and Treatment
March 17, 2016

John Mascola of the NIH Vaccine Research Center spoke about harnessing antibodies for HIV prevention and treatment. The recording includes discussion with webinar participants. For more background, click here to view his CROI plenary session.

SLIDES / AUDIO / FLASH

Exploring Dapivirine Ring Results
March 1, 2016

In the first webinar of our post-CROI webinar series, Jared Baeten (MTN) and Zeda Rosenberg (IPM) spoke about the dapivirine ring trial results announced at the conference and fielded questions from webinar participants.

SLIDES / AUDIO / VIDEO

Move On Down the Road: The vaginal dapivirine ring will enter open-label extension trial

Over the weekend, the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), announced that it would move forward with an open-label extension (OLE) study of a vaginal ring for HIV prevention. This welcome development is the latest step in the journey of a unique, woman-controlled prevention option.

It’s been almost exactly three weeks since the world got its first look at data from the ASPIRE trial and The Ring Study, both of which found that a vaginal ring containing the antiretroviral dapivirine provided women in the trial with a modest level of protection against HIV. Both trials had similar results: among all women in the ASPIRE study, the ring reduced the risk of transmission by 27 percent; in the Ring Study, the overall reduction was 31 percent; and effectiveness varied by age—with higher levels of protection seen in older women, possibly because of more consistent use in this age group.

The trial data caused celebration and immediate conversation about what would happen next given that the trial showed both that the ring works and that there may be real challenges with adherence, particularly in younger women. These are the kinds of questions that open-label trials are meant to answer (for a description of the types of studies that follow efficacy results, click here). By definition, in an open-label extension (OLE) study, everyone knows that they are receiving the product, and they receive information learned from the previous clinical trials of the product. Women participants in the open-label extension study of ASPIRE, known as HOPE, will be told that the product reduces risk of HIV if it is used correctly and consistently—worn in the vagina for roughly a month at a time. This type of information may lead more women to use the product versus the trial, where they are told at every study visit that they may have received the placebo, and that there is no evidence that the experimental product provides protection.

NIAID reached its decision to move forward after last week’s consultation with a panel of outside experts that included physicians, scientists, advocates, ethicists and statisticians – including two AVAC Advocacy Fellows from Malawi and Zimbabwe.

NIAID announced that they will also fund additional studies to help answer additional questions that the OLE is not designed to answer. One of these is a study with adolescents and young women (ages 16-21) to look at safety, adherence and acceptability of the dapivirine ring and oral PrEP. This is an important development, and one that will help ensure that the world has the information it needs about the ring should it receive regulatory approval. This regulatory approval process, which is being pursued in tandem with the open-label extensions, involves preparation and submission of an extensive dossier of information on the product from the clinical trials. The International Partnership for Microbicides (IPM), the ring’s developer, is expected to submit for approval in about one year’s time.

Now that NIAID has agreed to fund HOPE, the extension of ASPIRE, it is essential that IPM’s donors similarly support the Ring Study’s proposed open-label extension, DREAM. AVAC and our advocacy partners will be working with urgency in the coming weeks to amplify demand for this study, as well as additional research needed to understand the potential role of the ring in women’s lives. At the same time, we continue to emphasize the urgent need to roll out daily oral PrEP as a tool that can be used right now to reduce risk for women and men and to maintain a robust prevention research pipeline of additional options that will, over time, provide a wider range of options from which women and men can choose.