Learning about Africa, Looking for Answers for Mississippi: One Advocate’s CROI perspective

Cedric Sturdevant is the co-chair for BTAN Jackson in Jackson, Miss. and has worked in the field of HIV prevention for seven years. Over the past five years, Cedric has worked at My Brother’s Keeper, Inc. and gained a wealth of knowledge and experience in HIV/AIDS, STDs and health-related matters.

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

My feeling at CROI so far has been mixed. There is great information being giving, at such a fast pace that it makes me dizzy. I know we will have access to the information afterward but most of the studies being talked about are all in Africa. I know HIV infection is heavy there but I’m interested in knowing what we can do to get more people living in the US get more involved in these trials.

In my state, Mississippi, more education is desperately needed about the advancements being made around the epidemic. I know we are 30-plus years into the epidemic but Mississippians are still behind on the science of HIV. That could be a result of other issues we have within our state like housing, lack of access to health care and retention in care. When I return to Mississippi from CROI I’m going to meet with My Brother’s Keeper’s (MBK) HIV Prevention Programs Manager and BTAN member to come up with a plan to get this information out to the community and professional people working in the field.

My goal is to use the information I’ve gathered, especially around PrEP, PEP and TasP, and incorporate it into the already planned BTAN training, find some funding and travel across the state doing workshop. Personally, my goal is to do a learning session with MBK’s Empowerment Support Group, MBK’s staff, Open Arms Healthcare Center and BTAN Mississippi members. Getting this information out is not something I cannot do alone; it will take all of us working together to make a change in Mississippi.

The biggest thing thus far for me is learning the different ways PrEP can be used. I plan to read more about some of the trials they have on PrEP especially the on-demand PrEP.

More confirmation for PrEP in gay men—now what about the ladies?

Nichole Little is the Founder and Executive Director at Sexual Health Education Research & Outreach (SHERO) and an AVAC PxROAR member. She is also part of the first cohort of the CROI Community Delegate Program, which provides an opportunity for additional community representatives to attend the meeting. She writes about how despite the new PrEP trial results, there needs to be more focus on women’s health and prevention needs.

On Tuesday, during the 2015 Conference on Retroviruses and Opportunistic Infections (CROI), findings from the iPERGAY PrEP trial were released. The results were exciting and determined that “on demand” or intermittent use of TDF/FTC (Truvada) led to an 86 percent reduction in HIV risk in the trial participants—all of whom are gay men. Absolutely awesome news.

Now… How do I go home and proudly deliver this information to a room full of women who have been waiting for the trial that tells them that their lives and sexual health matter. Us advocates, activists, educators and researchers know the nuances of who and how to fill a clinical trial. We know that women in sero-discordant relationships have done very well in PrEP studies. But, at the end of the day, good news is only good news if it directly impacts your life. These women are waiting for a piece of good news to come out of one of these conferences that will directly impact their lives. They want to hear the words, PrEP WORKS IN WOMEN, especially young women not in serodisordant couples. And since we’ve done such a good job, as community advocates in educating folks about the clinical trials process, they want us to prove women in the US will use PrEP and it will protect them.

During CROI’s opening plenary, Dr. Susan Buchbinder, UCSF, presented a talk titled HIV Prevention 2.0: What’s Next? Dr. Buchbinder discussed the challenges of incorporating the new biomedical prevention interventions with what she called “old interventions,” defined as public health campaigns, testing and condoms. She discussed the data that show post-HIV screening counseling may be a deterrent to those individuals testing negative for HIV. Is it the information we are delivering to them not effective? This concerned me because a number of the women I talk to understand the need for a female initiated HIV prevention strategy but they are no longer interested in being treated like little men or after thoughts. PrEP is indicated for men and women. But honestly, I cannot point them to the pudding where the proof is showing the type of information these iPERGAY results show.

The data around PrEP and women have not always been the most promising—think VOICE and FEM PrEP. The trials showed many women underestimated their HIV risk, which is partly the reason they didn’t use PrEP or gel. During the U.S. Women and PrEP pre-CROI conference face-to-face meeting, advocates from across the country convened to review the current biomedical prevention agenda with the goal to ensure that women are properly included in the work toward the end game. One point that threaded its way into every discussion we had during the day-long meeting was how do we determine what a high-risk woman is.

It was pointed out by Marsha Jones, from The Afiya Center, that we often don’t know that something is a risk until it is happening. The idea that the complexities of the lives of women put us in the position where it is difficult to place a target where we can then deliver effective advocacy. The idea that to identify a person as MSM is probably not offensive if you are gay or a man who has sex with other men. It makes moving into that population with a little more ease of motion because you know who you are looking for and have effective ways to reach them. With a woman, her husband may be her risk. For another woman, the stress of single-handedly having to financially provide for family may be her risk. Hell, for a great number of women… walking down the street with breasts puts us at a level of risk that men just cannot understand.

So where I am super excited that the IPERGAY results were so promising… I am challenged with how I take this information back into the community I serve. I can hear the question “What about us?” I’ve heard it year after year. All women want to know is that they are going to be able to have an HIV prevention option that is not going to interfere with the reproductive process, make them gain weight and WILL REALLY PROTECT THEM. I guess, where biomedical interventions are concerned, that is too much to ask at least at this current moment in time. But what I can tell them is that I’m a member of an army of women and men who place women in high priority. I can tell them that we are at the table and we are bringing their concerns back to the folks who control the dollars as well as those who control the science and we are letting them know that women matter.

And one day we will be sitting in a huge conference room and hear the good news that women across the globe have been waiting to hear. The kind of good news that men have been getting for the last few years. I will also reassure the women in my community that microbicides are going to change the game for us—maybe not gels but there is a lot of promise in the work that is currently being done to develop numerous other delivery methods. Now that’s AWESOME news. And until then, my sisters and I will continue to attend conferences, continue to occupy a seat at the table and continue to keep women’s health high on the list of prevention priorities.

FACTS 001 and Me

This post was written by Morenike Folayan, Coordinator with the New HIV Vaccine and Microbicide Advocacy Society and member of the CROI Community Liaison Subcommittee. This is the third in a series of community voice posts from CROI 2015. Read the others here and here.

I sat in the meeting room today listening to the results of the FACTS 001 study. I am sure a number of you must have received mails about what the FACTS study was and what the result of the study is.

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

I felt extremely disappointed with the results. I ask myself, where do we go from here? How come the FACTS study has no similitude of efficacy? Why does the result of this study not show any complimentary to the CAPRISA 004 study? How can the IRR be 1.0? How can that be if the women used it even some of the time?

I still remain very unclear about the answers to these questions. I think the answers may come as we move into the future. I know some answers may never come also. I hear that repeatedly during this meeting that FACTS, VOICE and Fem-PrEP studies seem to tell us something. I no longer hear that CAPRISA 004 told us something.

As the researchers meet and think about the interpretation of the results, I have one question for them as someone concerned about ethics? Why were study participants recruited from only (that is what it seems to me) from the low socio-economic strata? The PI seem to imply that the study participants were majorly unemployed (she noted this in a response to a question doing the session) and live in shacks and so may have had challenges with using the gel discretely. Microbicides would be used by women from all socioeconomic strata if found effective. Why is it that the livelihood of the young girls recruited from the study a reason to explain poor adherence. Why are studies not designed to fit into the lives of people; rather we expect the lives of people to fit into our research? Why does the recruitment of study participants into these trials not respect the principle of justice?

More questions I guess. I hope to look for answers as I move forward today. I hope my search does not generate more questions also as I face FACTS.

ACT UP, Eat Hors d’oeuvres?: Strange days, missing histories at CROI 2015

Cassie provides client-centered, low-threshold, sex-positive, gender affirming care at the Broadway Youth Center. The BYC is a one-stop shop for LGBTQIA youth experiencing housing instability (drop-in, GED, health clinic, talking support, and programming). Cassie’s approach to their work is two-fold: to provide young people with health literacy, support navigating the medical industrial complex, enrollment in health insurance, and know your medical rights information to young people. He also supports provider trainings on how to work with and support young people, be gender affirming, and provide trauma informed care in clinical settings. She also supports AfterHours, an all ages, trans and gender-non-conforming drop-in night (clinical, legal, social support) at Howard Brown Health Center, and is a member of AVAC’s PxROAR program.

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

How’d we go from ACT UP to Nordstrom? No, it wasn’t a protest against capitalism, consumerism or classism. It was the Conference on Retroviruses and Opportunistic Infections’ 2015 reception. Against my best gut reaction, I went for the free champagne and “food” (aka: tiny trays of deviled eggs, mini chicken salad sandwiches, and truffle popcorn—if I hadn’t moved from Kentucky 6 years ago, I wouldn’t even know what a truffle was). Champagne in hand, I stiffly shuffled around without direction. Afraid I’d spill it on a dress that cost more than three of my paychecks combined, I decided to down it quickly. Unsure where to walk, where to sit or what I was even doing there. I felt strange, yet looking around that didn’t seem to be the sentiment reflected by anyone else.

Anxiety, and anger—which I do a good job of turning into sadness, started rising up my throat. I might cry in front of all these people I thought to myself. Cry for a movement that feels separated from people’s experiences. For the 23 year old girl with a CD4 count less than 200 and her three beautiful children, for the 22 year old who was almost murdered by a date but who’s only need at the moment was trying to replace her ID, for the 19 year old boy who told me he didn’t need to start PrEP because soon his parents would accept him, invite him back home, and stop withholding his health insurance, and for the man I encountered three hours earlier who was roughly rejected by asking for spare change. I had to stop myself. All their stories were running through my head. You’re close to the entrance, I told myself. All you have to do is walk down the escalator, past the Jimmy Choo’s and then you’ll be out.

Out front I took a deep breath. Exhaled my roots into the ground and called love into my heart. A man walked up to the entrance. “This is a private party, you can’t come in” Nordstrom’s security stated. Man walks 200 yards away. The security follows him. “This is private property. You have to leave. Go on now, get out of here.” The streets are private property. I threw up in my mouth. Swallowed it. But I did nothing else. I was/am ashamed.

Is this what the movement looks like from cutting edge science and biomedical interventions? Fancy meals on pharma money while we drop comments in our speeches about “social determinants” and “resource poor areas” and “racial disparities”. Erasing queertories with comments like, “CROI has always been a place that accepts community.” Forgetting that folks busted through the conference doors in DC in the early 1990s, demanding to be included. I asked one presenter why they didn’t include transgender populations in their data and they said there isn’t any data, and we have very limited slides. They added that we need that data because transgender populations are at the highest risk. Don’t tell me in the same breath that they are the most vulnerable population and that you couldn’t include one bullet point in one slide about it.

For the record, the data says that the HIV infection rate in the trans community is 30 percent. That’s 1 in 4 people who are HIV positive. Trans people are 49 times more likely to be HIV+ than their cis counterparts. The seropositivty rate in trans people experiencing homelessness is 22%. If we look at other “social determinants” we see that trans people are 1,000 times more likely to be murdered than cis people. That half of the trans population are victims of rape, and a quarter are victims of assault.

There is so much momentum, and it seems we could be so close to ending the epidemic. We certainly have the tools for it. PrEP works if you take it, and you don’t even have to take it everyday. We literally have a pill you can take to prevent HIV, and in the city of Chicago if you’re low income or undocumented, it’s completely free. I was easily swept away by Galit Alter’s engaging and very well articulated presentation on the path to a vaccine (I recommend you watch it), and we have proof of concept for a cure. But if trans folks are the most vulnerable population, and we don’t have trans competent doctors then what does it matter? If we arrest or institutionalize poor, Black young people for attempting to access care at ERs, then what does it matter if we have the best treatment in the world?

If I’ve learned anything this week it’s that science is hard, and humans are even more complicated. This week there has been no shortage of passion, knowledge and energy to end the epidemic, but there are some very clear ways that we are failing. If we want the “most vulnerable” and “most risky” populations to take PrEP, to care about a cure, to get engaged in primary care, to get on treatment then we have to provide gender affirming services, we have to get rid of security guards and police in our health care clinics. We need to affirm people’s consensual pleasures. We need more youth centered healthcare spaces, and insurance companies need to survive on something other than capitalism.

Excitement and Disappointment at CROI as PrEP and Gel Data Break

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

This article was first published in Funders Concerned about AIDS

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

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

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

Why should we be talking about this now?

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

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

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

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

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

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

A clinical trial called HVTN 100 has been launched in South Africa to study an investigational HIV vaccine regimen for safety and the immune responses it generates in study participants. 

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

This blog post first appeared on The Body

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

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

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

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

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

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

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

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

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

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

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

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

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

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