Funding opportunity: HIV Vaccine Research and Design (HIVRAD) Program

The purpose of this Funding Opportunity Announcement (FOA) is to support multi-component, multi-disciplinary projects that address important scientific questions relevant to AIDS prophylactic vaccine discovery research. Extensive modeling of vaccine concepts in non-human primates may be included.
Details at: http://grants.nih.gov/grants/guide/pa-files/PAR-15-164.html#sthash.4hgMh…

A New CUREiculum Launched

The number of HIV cure-related publications has risen exponentially in recent years. This is due in part to a burst of funding and scientific interest around HIV cure research in the last decade. At the 2014 Conference on Retroviruses and Opportunistic Infection (CROI), it became clear at a community meeting that we needed to provide resources to increase scientific literacy around HIV cure research. These resources to increase understanding can help manage expectations around HIV cure, but can also provide the foundation for ethical research. Scientific literacy is a way to allow community members to meaningfully engage around the research. Potential study participants can be also informed about the risks, benefits and scientific merits of a study. The CUREiculum concept was developed out of this need to make HIV cure science accessible to as many people as possible.

The CUREiculum initiative was launched at CROI 2015, one year later. The CUREiculum is a suite of tools developed by a collaboration between community educators, advocates and research institutions. Each module contains a set of learning tools that is designed to be used by either an individual learner or as part of a training session or workshop. In addition to an annotated PowerPoint slide deck and various participatory activities, each module contains a set of references chosen for their accessible content about specific topic areas.

On February 21st, 2015 the CUREiculum partnered with the defeatHIV Community Advisory Board (CAB) and the Seattle Public Library to hold the first of two kick off events. The meeting at the library had a diverse crowd of individuals simply interested in HIV cure research. Audience members learned about the Basics of HIV Cure Research, Pediatric Research on HIV Cure and Gene Therapy in HIV Cure Research. Audience members asked a range of thoughtful questions about obtaining informed consent from pregnant women and the potential risks of altering genes in the human body. A reception was held on February 22, following the annual Community Cure Workshop. This reception celebrated the involvement of the CUREiculum collaborators.

The complete suite of CUREiculum modules includes:

  • HIV/AIDS and Cure Basics
  • Stakeholder Engagement in HIV Cure Research
  • Regulatory Issues in HIV Cure Research
  • Ethics of HIV Cure Research
  • Informed Consent in HIV Cure Research
  • Participation in HIV Cure Studies
  • Concepts in Basic Sciences and Translational Research – The Main Pathways
  • Measuring the Latent HIV Reservoir
  • Early Antiretroviral Treatment
  • Pediatric HIV Cure Research
  • Latency Reversing Agents
  • Therapeutic Vaccines and Immune-Based Therapies
  • Gene Therapy and Stem Cell Transplant
  • Animal Models in HIV Cure Research
  • Combination Approaches and Conclusions – The Science Looking Forward

For more information about the CUREiculum please contact:

HIV Prevention on the Line: Time to Mobilize — Again

This post first appeared on the Huffington Post.

In 2015, the International AIDS Society (IAS) will hold a conference in Vancouver, returning to the city for a large-scale meeting the first time since the 1996 AIDS Conference that heralded the beginning of the era of highly active antiretroviral treatment. And in 2016, the IAS will convene the large, biennial International AIDS Conference in Durban, South Africa—16 years after the 2000 conference that revolutionized global expectations of AIDS treatment in low-income settings.

The 1996 and 2000 conferences are by many accounts the two most significant global AIDS meetings that have ever taken place. And it is possible, if the right steps are taken, the right funds committed, the right programs implemented and the right partners engaged that the 2015 and 2016 meetings could prove to be watershed moments in the field.

These are big “ifs.”

The most pressing and fundamental question is one of financial resources. If global investment doesn’t match the price tag for expanded, comprehensive prevention, then all the plans and targets in the world are irrelevant.

But if it does, then by 2016, we could begin to see evidence of downward slopes that confirm we’re on track to beginning to end the AIDS epidemic in our lifetime.

AVAC, the HIV advocacy organization that I direct, just released Prevention on the Line, a report in which we talk about target setting and the importance of having specific strategies, clear definitions and strong commitments.

We also talk about the need for short-term action. The world cannot wait until 2020 to find out whether the AIDS response is on track to end the epidemic by 2030. Indicators of progress or problems are already available—and the picture will be even clearer by the time the Vancouver and Durban conferences take place.

There is no better use of these large, costly AIDS meetings than to take honest stock of the global response and galvanize action on a global scale.

Both the 1996 and 2000 conferences are remembered as momentous turning points. They’re also remembered for the grief and urgency of the time. People who lived through the early years of the AIDS epidemic remember the dawn of the HAART era as a moment of exhaustion and grief, as well as celebration.

And while Durban started a revolution in AIDS drugs for Africa, it took four long years—and an unconscionable number of lives—before that revolution realized its goals.

Today the AIDS response is poised at another moment that could be a revolution, providing that it does not dissipate into rhetoric or dissolve into underfunded documents and plans.

Will Vancouver 2015 be the meeting where science, rights and action get in sync and revolutionize the epidemic once again? Will Durban 2016 lead to massive mobilization for decisive action on ending the epidemic?

Let’s use the memories of those who did not live to return to Vancouver and Durban—as well as our own memories and histories—to fuel the continued fight for lasting change.

Funding Opportunity: Methodologies to enhance understanding of HIV-associated social determinants

National Institutes of Health
This Funding Opportunity Announcement (FOA) invites applications that propose to understand social determinants of health as they relate to HIV infection and disease outcomes in order to identify mutable targets for inclusion in structural interventions. Details at: http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-16-200.html

Support the Global Response to HIV/AIDS, Tuberculosis, and Malaria

The United States Congress is currently considering the future budget of the President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Members of Congress are encouraging you to reach out to your representatives and advocate for strong funding.

Barbara Lee, a member of Congress from California, provides more information in a note below, including a call to sign on to her letter to other members of Congress.

Dear Colleague:

I urge you to sign on to the letter below requesting funding to support the President’s Emergency Plan for AIDS Relief (PEPFAR), the Global Fund to Fight AIDS, Tuberculosis, and Malaria in the FY 2016 State and Foreign Operations appropriations bill.

The U.S.’s bipartisan commitment to PEPFAR and the Global Fund not only saves lives, but also contributes directly to stability, security and economic growth worldwide. Our strong support for PEPFAR and the Global Fund, coupled with scientific advances and lessons learned from a decade of implementation, has the potential to turn the tide on HIV/AIDS and help us meet our target of achieving an AIDS-free generation.

These contributions are just a fraction of 1% of the federal budget, yet enable PEPFAR and the Global Fund to continue its critical, life-saving work and influence the organization’s ability to leverage additional resources from other donors. Strong support for both PEPFAR and the Global Fund will enhance U.S. leadership in the world and increase our ability to meet seminal global health goals that are within reach.

A copy of the letter is below. If you need further information or would like to sign on, please contact Monica Pham in Rep. Lee’s office (monica.pham@mail.house.gov).

Sincerely,
Barbara Lee
Member of Congress

Letters to Congress

A letter to members of the United States House of Representatives is below. Click here to download a letter for the United States Senate.

The Honorable Kay Granger
Chairwoman
Appropriations Subcommittee for
State and Foreign Operations
U.S. House of Representatives
Washington, DC 20515

The Honorable Nita Lowey
Ranking Member
Appropriations Subcommittee for
State and Foreign Operations
U.S. House of Representatives
Washington, DC 20515

FACTS 001 Cannot Mean the End for Women: How do we PrEP for this?

This post was written by Yvette Raphael in South Africa a few days following the announcement of the FACTS 001 microbicide gel trial results. Yvette is a 2014 AVAC Fellow working at Johns Hopkins Health and Education in South Africa. She is a leader in South Africa’s HIV prevention movement for young women.

For years women’s failure to protect themselves from HIV was exacerbated by their inability to navigate through young womanhood. I fell into that same cycle: I did not negotiate my first sexual debut and not using a condom was surely not my choice. I now know that I was coerced into not using one. I learnt the hard way that that his compliments on my beauty were to make me feel OK about having unprotected sex with someone who knew he was HIV positive but not virally suppressed.

In 2010 the CAPRISA 004 trial showed a microbicide is possible. It was just the news I wanted to hear even if this news was almost 10 years too late for me and a marketable product would be even much later. A microbicide gel was one of the many prevention methods being tested and all were at different stages but I was particularly excited about this one for many reasons. The research for this was happening in South Africa, my country. The women who were in the trial represented me at the age I got infected and they would have gone through the same struggles as I did. If the gel worked for them, it would work in the South African context and most likely work for woman elsewhere in the world. What was particularly exiting was the regimen, in which the gel is delivered by applicator before and after sex. I thought of this as a power tool for women—something women could put in their handbag, almost like a Taser, and protect themselves. I was excited that our government made an investment in the research and I was excited that the team of lead researchers were women who I looked up to.

I waited for the results of the FACTS 001 trial results like an excited toddler would wait for Santa Clause. Then, in February, the call came directly from fellow advocates attending the session where the long-awaited results were released at the 2015 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle. The results were flat. A microbicide gel in an applicator used before and after sex did not work for women. That was certainly not the news I wanted to hear. My heart sank. I wanted to run away. I wanted to hide. So many women were looking forward to this. The emails started, the press releases, the commentary from all angles. Everyone had something to say except the women.

I was following CROI with keen interest mostly for the FACTS results. But like with soccer, when your team loses, you support your next favourite team. I started to follow what was coming out of CROI about PrEP.

The Partners Demonstration Project among discordant heterosexual couples showed that PrEP and treatment in couples reduced the negative partner’s risk of HIV by 96 percent. Both the PROUD study in the UK and IPERGAY in France, looking at PrEP in gay men, showed an 86 percent reduction in risk.

What does all this mean for women? Would PrEP be the option that will finally liberate young women and girls? How do we advocate for PrEP to be made available to women in South Africa—where HIV prevalence is nearly twice that of men?

The Dangers of False Science Reporting and Our Duty as Communicators

In December 2009, the trial known as MDP 301 released results that the microbicide gel known as PRO 2000 had not shown efficacy among women in Zambia, South Africa, Tanzania and Uganda. These results were not unique as many efficacy trials in HIV prevention and in other arenas have shown flat results, or at times even increased risk. However, what happened after the released results was unique. Blogs and online media framed the trial as “exploitation”, resulting in skepticism about future HIV microbicide trials. Six years later, the effects of that misleading reporting can still be felt. That’s why the recent Toronto Star article caught my eye.

On February 5th the Toronto Star published an investigative article on the HPV vaccine headlined “A wonder drug’s dark side”. The article focused on several young women who became sick after receiving Merck’s HPV vaccine, Gardasil. Although the article stated that the illnesses were not conclusively linked to the vaccine, the photos, front page headline and anecdotes likely led some readers to believe that the Star had uncovered the “truth” about the vaccine.

The Star removed the article a week later but not before it fell under heavy criticism by other media outlets:

The Washington Post quoted Vox Science writer Julia Belluz, “everything wrong with vaccine reporting in one dangerous package. These tales of suffering and death are awful. Stomach turning. But they are just that: stories.” JAMA also wrote “Not all reported events are systematically validated, and many may have only coincidentally followed vaccination,” the study said, adding that underreporting, inconsistency in the quality and completeness of reported data, stimulated reporting due to extensive news coverage and reporting biases could also skew these numbers.”

Global News quoted Dr. Jen Gunter, an OB/GYN, “Paragraph after paragraph is dedicated to detailing the terrible things that happened to these young girls and their families and in an Oprah-esque move the wealth of information detailing the vaccine’s safety was distilled to a few comments easy to ignore in among the trail of destruction allegedly due to the vaccine. It also quoted Julia Belluz, “In medicine, anecdotes are considered the least helpful type of evidence. They are biased, unrepresentative, and, as often as not, misleading,” wrote Belluz. “What’s worse, while the Star cherry-picked damning cases about the vaccine’s alleged harms, they ignored the reams of independent studies we have involving millions of women around the world that show the vaccine is safe.”

CBC quoted John Cruickshank, the Star publisher, from his As it Happens Interview: “”We failed in this case. We let down. And it was in the management of the story at the top,” It also brought to light how two Star staff lashed out at critics: Michael Cooke, editor-in-chief of the Star, responded to Vox’s Julia Belluz: “’Stop gargling our bathwater and take the energy to run yourself your own, fresh tub.’ Cooke also called a reader an ‘idiot’ on Twitter.” Columnist Heather Mallick from the Star also criticized Dr. Jen Gunter by writing: “Here’s a tip: don’t read a website run by a rural doctor whose slogan is ‘wielding the lasso of truth.”

The Los Angeles Times writes: “But has the damage already been done? The article should stay online, as a warning to readers — not of the purported dangers of a life-saving vaccine, but of the real perils of shoddy science reporting.”

After much criticism, the Star printed a commentary titled “Science shows HPV vaccine has no dark side”. They write: “The Star presented the stories of women who have suffered greatly. The article was engaging, dramatic and might have created fear. But study after study has shown that there is no causal link between the events the Star reported and the vaccine. About 169 million doses of the HPV vaccine have been administered worldwide. In any given large population, there will be illness and death. This is a statistical fact. To attribute rare devastating occurrences to a vaccine requires evidence of causation, of which the international scientific community and the Star article have none.”

Thankfully, in this case, there was a swift response to this misleading, “investigative” report that resulted in the take down of the report. Had it not, there could have been serious implications for the future of the HPV vaccine and/or other vaccines. Although my hope is that this is a solitary incident, I know that this is not the last time we will see misreported facts. But this highlights the important role science reporting plays, and especially in sharing new information about health research. The things that we write and say shape public perception — and they have consequences that can have long-lasting effects.

Prevention on the Line Webinar Series

AVAC is putting together a year-long series of web-based dialogues focused on HIV prevention research and implementation. This series, HIV Prevention on the Line, will delve into issues raised in our recent AVAC Report and engage with issues and priorities that emerge over the course of the year.

Slides, audio and animations from the first set of webinars are available below. Stay tuned to this page, or subscribe to our Advocates Network newsletter, for details on future webinars.

Vaccines in Vivo: Advances in AIDS Vaccine Research
This year brought the launch of long-awaited initiation of clinical trials building on positive results from the RV144 “Thai” trial. This effort is led by the Pox-Protein Public-Private Partnership (P5), including the the HIV Vaccine Trials Network, who joined the webinar to provide a status update of their current vaccine research and development program. We also featured Janssen, part of Johnson & Johnson, to provide an overview of the research program they are moving forward that focuses on a cross-clade vaccine product.

May 18, 2015Downloads: Slides (PDF) / Audio (MP3) / Animation (Flash)

New Frontiers in HIV Prevention, Treatment and Cure: An advocate’s webinar on passive immunization
This webinar focused on “passive immunization”—a scientific term for an expanding area of research that’s highly relevant to treatment, prevention and cure work. There are trials in humans happening in many regions of the world—and data are beginning to come in that advocates need to understand, analyze and consider.

This hour-long webinar featured Dr. Sarah Schlesinger (Rockefeller University) who provided an overview of recent developments across the field including new data from Rockefeller.

April 21, 2015Downloads: Slides (PDF) / Audio (MP3) / Animation (Flash)

Demanding Clarity on PrEP: Understanding recent data on oral PrEP

This webinar featured Jean-Michel Molina of the French research agency ANRS and Sheena McCormack of the UK Medical Research Council discussing the data from the IPERGAY and PROUD studies, respectively. Both trials evaluated oral TDF/FTC (brand name Truvada) as PrEP in gay men and other men who have sex with men, and both reported high levels of protection against HIV acquisition. PROUD prescribed a daily pill regimen; IPERGAY asked trial participants to follow an “event driven” regimen that involved a sequence of doses before and after sex. IPERGAY participants took an average of four doses per week—comparable to the estimated protective dose required in trials of daily oral PrEP.

March 12, 2015Downloads: Slides (PDF) / Audio (MP3) / Animation (Flash)

Follow the Money: Knowns and unknowns when it comes to cash transfers and financial incentives to improve health in people living with and/or at risk of HIV
This webinar featured Wafaa El-Sadr, principal investigator of HPTN 065, which evaluated the use of cash incentives in improving outcomes for people living with HIV in the United States.

March 11, 2015Downloads: Slides (PDF) / Audio (MP3) / Animation (Flash)

After FACTS: What’s next for HIV prevention in women?
Helen Rees, principal investigator of the FACTS 001 microbicide trial of vaginal 1% tenofovir gel, spoke of their findings of no evidence of protection overall associated with the vaginal gel. Jared Baeten, co-chair of Partners PrEP, discussed the Partners Demonstration Project finding that serodiscordant couples using oral PrEP and/or ART had ver low levels of HIV transmission. We discussed what these and other data meant for women, including young and adolescent girls.

March 9, 2015Downloads: Slides (PDF) / Audio (MP3)

Women Deserve to Know About HIV Prevention Medication Too

This originally appeared on RH Reality Check.

In 2012, the Food and Drug Administration (FDA) approved the use of the antiretroviral medication Truvada as the first form of PrEP (pre-exposure prophylaxis), a pill to protect against getting HIV. To date, the United States is the only country to give regulatory approval to PrEP for HIV prevention. The Centers for Disease Control and Prevention (CDC) then issued clinical guidelines for prescribing PrEP to adults at risk of HIV. PrEP has been proven to reduce the risk of acquiring HIV equally well in both men and women—with a protection rate of up to 96 percent when taken daily without interruption or missed doses. Yet three years later, PrEP-centric media campaigns and clinical prescriptions continue to primarily target men who have sex with men.

We at the US Women and PrEP Working Group, a national advocacy coalition of more than 100 women’s health advocates, health-care providers, researchers, policymakers and industry partners, believe that everyone has the right to affordable access to the tools they need to implement their sexual and reproductive choices. Full PrEP availability—for both cis and trans women—is both a reproductive justice and human rights issue. March 10 is National Women and Girls HIV/AIDS Awareness Day. So it’s a good time to ask the question: Why are women being excluded from this potentially life-saving medication?

Of the six oral PrEP studies completed to date, only one took place in the United States. It only enrolled men and a few transgender women who have sex with men. Two international studies that only enrolled women did not show PrEP as successful, but researchers attributed this to the fact that most of the participants did not take the pills daily as instructed. In still other studies involving heterosexual couples, women who did take PrEP consistently achieved a high level of protection—showing that PrEP does work well across the gender spectrum.

Even so, the success of the trial involving American men, combined with the lack of positive data from the trials enrolling women, generated domestic press coverage that generally implied PrEP is “for men,” thus making women invisible as potential PrEP users.

In the United States, about one in four people living with HIV is a woman. Black women, who make up only 13 percent of the female population, comprise nearly two-thirds (64 percent) of new HIV infections among US women. Yet when sociologist Judith Auerbach conducted focus groups in six US cities among 144 women at high risk of HIV on their thoughts about PrEP, she discovered they were overwhelmingly unaware of the effectiveness of the medication for women.

Fewer than 10 percent of the women had even heard about PrEP; those who had thought it was only a tool for men, not for women. The remaining 90 percent were “upset, frustrated and even angry that they had not learned of it before.” They saw the failure of health professionals to reach out to them with information about PrEP as a “societal devaluation” of their lives.

In addition to human rights concerns, this kind of low awareness of PrEP’s availability is also highly problematic for practical reasons. Gender-based differences in social and economic power can sometimes make it difficult or impossible for many women to insist on condom use, and consistent condom use is infrequent overall. In a 2010 national probability study, only 22 percent of men and 18 percent of women reported using male condoms during the last ten times they had vaginal intercourse—and cis women are twice as likely to acquire HIV during heterosexual vaginal intercourse without condoms than are their male partners. Finally, women with HIV in the United States are more likely to be living in poverty and have less access to health care than men living with HIV. All of these factors make access to effective HIV prevention, including the option of PrEP, crucial for women.

Advocates are, however, making inroads in ensuring that PrEP becomes part of the narrative for women at risk of HIV. With funding by the CDC Foundation and its partners, the Sustainable Health Center Implementation PrEP Pilot Study (SHIPP) is under way. As the first PrEP study enrolling women in the United States, this demonstration project is designed to show how PrEP provision can be implemented sustainably. SHIPP is enrolling 1,200 volunteers at four federally qualified health centers in Illinois, Pennsylvania, New Jersey and Texas. These volunteers select PrEP as a part of their sexual health and primary care services. SHIPP’s results—including the rates of PrEP uptake, consistency of use, and protection from HIV—are expected in 2017. To date, about 40 percent of enrolled SHIPP participants are women, a victory for the Working Group and other PrEP supporters across the country.

In the meantime, family planning clinics and private OB-GYNs are well situated to educate women about PrEP, since 99 percent of American women, at some point in their lives, have used contraception. Not surprisingly, cost is a key concern among women considering PrEP use; these facilities can also help patients affordably obtain the medication. At this point, Truvada is the only pill approved as PrEP; Truvada Track, an advocates’ project monitoring PrEP access, reports that it is routinely covered by insurers and Medicaid. Gilead, the pharmaceutical company producing Truvada, also has a patient assistance program that supplies the drug to those without coverage and assists with co-pays to cover the testing and other services associated PrEP access and monitoring.

To choose whether or not to use PrEP, women need information about the medication, clinicians need to be educated about its use for women, and the drug needs to be affordable and accessible. While we are monitoring the implementation of SHIPP, we will continue to pressure policymakers, health-care professionals and the CDC to reach out to women. In addition, we will continue to mobilize women to demand more.

Everyone deserves the right to HIV prevention tools that we can use without our partner’s participation—for the sake of our safety, health and well-being. In short, we are tired of asking permission to protect our own lives.

Facing FACTS, and Just Getting On With It

Jim Pickett, Director of Prevention Advocacy and Gay Men’s Health at AIDS Foundation of Chicago and chair of IRMA (International Rectal Microbicide Advocates), is a long-time advocate for new HIV prevention technologies for men, women, and transgender individuals.

I’ve been a microbicide advocate before I could pronounce the term. And while I am associated closely with rectal microbicides, I was a vaginal microbicide advocate well before I had a clue there was any back-door research going on—and I still am.

The microbicide field has a lot of experience with trials that don’t yield the results we’ve all been hoping for, and working so very hard to achieve. We’re used to being sad, disappointed, heartbroken. We’ve learned to manage our expectations—not always an easy task. And we’ve wiped our tears, tended to our bruises and gotten right back in the game. We don’t wallow.

When I heard the FACTS results—I was sad. SAAAAAAAD. I felt heartbroken—reflecting on the 2,000+ African women who volunteered for this study in the hopes they could be part of HIV prevention history, and help change the trajectory in a setting that so, so, so desperately needs new protective strategies for women.

I felt frustrated for the hundreds of clinical trial staff who gave this thing their all. But microbicide researchers and advocates—a pretty fabulous, resilient, hard-core bunch—don’t tend to linger at the pity party. There is no time to wallow. Our communities don’t have the luxury of wallowing—and we don’t either. We’re learning a lot from FACTS, and I look forward to the qualitative research that comes out and helps us better understand the lives of young African women, so we can do better. We have to do better.

Meanwhile, we have Truvada as PrEP—proven to work with women. And we have two Phase III dapivirine ring studies (the Ring Study and ASPIRE) in the field. And a robust pipeline of films, fibers and multi-purpose technologies. We’re not stopping. We’re not giving up. FACTS hurt us—but it didn’t break us. We all have work to do—and we’re getting on with it.