PEPFAR Annual Report to Congress

The 12th Annual Report to Congress is now available at http://1.usa.gov/1SvUgKN.

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.

CROI for the Community

Rob Newells is the newly appointed Executive Director of AIDS Project of the East Bay. He is minister and founder of the the HIV program at Imani Community Church in Oakland and has been an AVAC PxROAR member since 2012. This blog is one in a series written by community scholars who attended CROI 2016.

I have a love-hate relationship with the annual Conference on Retroviruses and Opportunistic Infections (CROI). The 12-hour days of high science can be overwhelming, and even after being deliberate about building down time into my schedule, I still crashed and burned before the end of Day 3. (It took the entire week to adjust to the time difference between East and West coasts, and after the daily 7 am Community Educator Breakfast Updates, I struggled to stay awake and alert for the morning plenary sessions.) But I survived!

There are always major headlines coming out of meetings like CROI. As a biomedical research advocate, my inner nerd gets super-excited about things like Phase 2 study results from MTN 017 (a rectal microbicide study), but at CROI I’m a community educator. I try my best to take off my research nerd hat for a few days and tune my ears to hear what members of my community will find useful right now. (I’ll have plenty of time and dozens of webinars to help me grasp all of the high-level science presented at CROI so that my inner nerd will be ready for additional updates during the International AIDS Conference in July.)

The week after returning to Oakland from Boston, I shared information with the staff working at AIDS Project of the East Bay (APEB) and with community members participating in a series of breakfast discussions coordinated through my ministry at the Imani Community Church in partnership with the East Bay HIV Faith Collaborative. This is what I told them:

  • Vaginal microbicide rings look like they’ll work. Don’t be frightened when you hear that the HIV infection rate was only reduced by about 30 percent. Remember that old 44 percent reduction in the HIV infection rate for pre-exposure prophylaxis (PrEP) when the first iPrEx study results were released just over five years ago? It gets better! With PrEP we saw that when people know the product actually works, they use it more and risk goes down. It works when you use it! Will the same thing hold true for the vaginal ring? There’s a need for open-label studies to see if women will use it more when they know it works.
  • There’s reason to think injectable PrEP might work, but there are questions about how to deal with the “tail” — the period of time after injectable PrEP is terminated but there still may be low (non-protective) levels of drug in the system.
  • People who use oral PrEP are generally people who are already at-risk for STIs, and they should be tested more often than every six months as is currently recommended by the CDC. (Our Medical Director at AIDS Project of the East Bay already screens PrEP clients for STIs quarterly as suggested by the research presented at CROI.)
  • We talked a little about the PrEP failure case from Canada, which occurred when the PrEP user was infected with tenofovir- and emtricitibine-resistant virus. But staff and community members alike were more interested in the HPTN-073 study results showing that, with a little client-centered care coordination (C4), it’s really not so difficult to spark black men’s interest in PrEP. This was the silver lining in the cloud hovering over the community after CDC presented lifetime risk estimates indicating that half of all gay black men in the US will test positive for HIV if we don’t do something about it now. (If my community needed a wake-up call… a new reason for a sense of urgency around this HIV epidemic… a fire lit under its collective ass… This has to be it.)

Then we spent a little time talking about things I heard at CROI that probably won’t make headlines:

  • Do you really understand how much smoking while living with HIV increases risk for opportunistic infections, cardiovascular disease, lung disease and some cancers while decreasing life expectancy? What are we saying to our clients living with HIV about smoking that’s different from what we say to clients not living with HIV? (After checking in with our Medical Director, APEB will be implementing a smoking cessation program through our primary care clinic.)
  • When researchers looked at people’s “Perception of Infectiousness,” the takeaway for me was that black people still don’t believe having an undetectable viral load prevents the transmission of HIV. (There are lots of conversations about medical distrust among African Americans begging to be had over and over and over again until someone figures out how to effectively address the issue.)

Another CROI is in the books (and on webcast). It will likely take months for my inner research advocacy nerd to wrap my head around all of the science, but now that my sleep pattern and weather conditions are closer to California-normal, the community educator in me is very happy.

Context Matters: Key Thoughts from CROI 2016

Josephine Ayankoya works for the San Francisco Department of Health’s Bridge HIV program and is a member of AVAC’s PxROAR program. This blog is one in a series written by community scholars who attended CROI 2016.

Attending the Conference on Retroviruses and Opportunistic Infections (CROI) for the first time was an excellent learning opportunity. In the midst of many of the world’s leading researchers in basic, clinical and translational science, I was excited to be among the first to hear about breaking news in biomedical research. While sitting through sessions, and talking with colleagues, I constantly reflected on what this research meant for my communities. My excitement about the progress in research was matched with a desire to build on the data. With every study that I learned about, I was further inspired to support multidisciplinary approaches to ending the HIV/AIDS epidemic.

This is why I found Dr. Gerald Friedland’s N’Galy-Mann Lecture on confronting HIV and tuberculosis in New York and South Africa to be incredibly encouraging. As Dr. Friedland spoke on his experience working with under-resourced, low-income communities of color, he highlighted the importance of understanding the context in which HIV disparities occur. Two quotes stood out to me as he spoke about overlapping epidemics that people at risk for HIV have always juggled. The first was that, “We have to meet marginalized and stigmatized populations where they are and increase resources where they live.” The second was a reminder that, “Declines in HIV have followed eras of activism that led to an increase of political will.”

Meeting underserved communities where they are, increasing resources where they are needed, and increasing political will are easier said than done. It takes sustained commitment, and strategic planning but these actions are possible. More than anything at CROI, I was reminded that data are powerful and should be used as a foundation for civic engagement efforts.

In the United States, Black men who are gay, bisexual, or same-gender-loving (GBSGL) carry a disproportionate burden of the HIV epidemic. For years, the Centers for Disease Control and Prevention (CDC) have reported that while new infection rates in most populations are stable, they are increasing among Black GBSGL men, especially young ones. At CROI, the CDC released data which estimated that throughout the span of their entire lifetimes, half of Black GBSGL men could be infected with the virus. It is a heartbreaking, yet sadly unsurprising, call to action.

As performer, activist Tim’m T. West stated, “It’s easier to blame victims when you can’t talk about systemic racism… when you can’t talk about institutionalized homophobia… Then Black men become responsible for their own dying. In that sense, ‘It’s something they brought upon themselves.’” We cannot talk comprehensively about the disparities among Black GBSGL men without talking about the effects that oppression and under-representation play on their health. It is impossible to fully understand this disparity without acknowledging how the blockage of Medicaid expansion in the Deep South hinders millions of Black people from accessing basic health care. There is a myriad of social, political, economic and cultural barriers that exacerbate HIV disparities.

The socio-cultural context in which Black men, and all African heritage people around the world, live is complicated. Mitigating the multiple challenges that lead to these disparities will take a lot of work. In the words of Dr. Darryl Wheeler, “It’s difficult, but it’s still worth doing.”

Our work as HIV/AIDS researchers, educators and advocates naturally aligns with the work of colleagues in the legal, health, urban planning and educational sectors of society. The people most at risk for HIV are dealing with a series of challenges outside of maintaining their sexual health.

I was thrilled to hear researchers Darryl Wheeler and Sheldon Fields talk about the results of the study HPTN 073 looking at PrEP uptake in Black GBSGL men, because it demonstrated how research can be used to meet marginalized people where they are. The study enrolled over 200 Black gay and bisexual men in three cities across the United States—Atlanta, Chapel Hill and Los Angeles. These men were engaged in a culturally-competent method of counseling called client-centered care coordination (C4). They were also offered access to PrEP. The study found that with C4, the majority of Black GBSGL men decided to initiate and sustain the use of PrEP. Men who attended more of the C4 sessions tended to use PrEP more often than those who attended less of the C4 sessions.

Not only did this research meet people where they were by responding to psychosocial needs that had not been fulfilled, it increased resources for those who need them most. I have known about this study for years, so I was proud of its outcome. It reiterated what many already know: the context in which HIV disparities occur matters.

We will never end the epidemic without strategically working to change public policy. It is critical to use data from studies like HPTN 073 to increase the political will of our elected officials to implement interventions proven to work. To truly address HIV, we’ll have to build and maintain coordinated advocacy movements with coalitions across different sectors of society.

As Dr. Friedland stated the first day of CROI, activism leads to political will and, in turn, the decline in HIV. Our individual and collective actions will determine what this era of HIV research, prevention and treatment will entail. In a time when we have more tools than ever to prevent HIV, no one should be getting infected and every person with HIV should be able to access treatment. I hope now, more than ever, we use evidence-based approaches to advocate for and with communities most at risk for HIV.

Let’s make this era one to remember. Let’s make this the era where data were used to change the many structures that influence HIV/AIDS disparities.

CROI, For the First Time

Yvette is currently working at the Centre for Communication Impact (formerly JHHESA). She is a founding member of the new Advocacy for Prevention of HIV and AIDS (APHA) in South Africa, a former AVAC Advocacy Fellow and a leader in the country’s HIV prevention movement for young women. This blog is one in a series written by community scholars who attended CROI 2016.

My first CROI and it was not the science that was overwhelming…

When I was presented with the opportunity to apply for a scholarship to attend this very scientific meeting and conference as a community educator I was thrilled and most of all exited that I would be in the presence of all the scientists who’s work I have torn to shreds to get my communities in Mpumalanga, Limpopo and KwaZulu-Natal (KZN) to understand. As a community educator I have had to explain microbicides, PrEP, TasP, HIV vaccines and the BIG one: why we still don’t have a cure. Also, I have had to explain why it is important that we know the new research and why a lot of the HIV research happens in South Africa.

Upon my arrival I was overwhelmed by the beauty of the city; the buildings all looked old but they were a beautiful sight. When I left South Africa, the university students were burning old art and statues because it reminded them of our painful past. As I was driving from the airport upon my arrival in Boston, I saw a few homemade banners of Black Lives Matter in the city attached to these old buildings. They were not torn apart; they looked just like they belonged there. They were not threatening each other—the old building and the new feelings of we matter, black lives matter. I wish I had stopped my driver to take a picture.

I was invited to a pre-conference on cure research, on where we are. Because of my suspicions with cure and quacks, I thought I would only last 30 minutes at the most. How wrong I was. I was intrigued by how much research is happening and the amount of work that researchers were putting in trying to unlock this mystery. I was overwhelmed about how much of this research is happening in South Africa and that one study was actually happening in KZN. Research showed that even with focused interventions of counselling and empowerment skills, there were no differences in the new infection rates of young women in the program and those not in the program. Suffice it to say I was there the whole day and did not want to miss a presentation let alone a slide.

The next day was the first day of the conference and our day started at 7 am. I was jet lagged but did not want to miss anything. Not even the cold could keep me in bed. For the duration of the conference we had an opportunity to interact with the scientists, thanks to a great initiative by the BAI, AVAC and CROI Community Liaison Subcommittee. These morning meetings were a space where we as community advocates could come together and learn from each other. I realised that I knew about 30 percent of the community through our work and most of all our very vocal online presence on Facebook. I did not want to show my anxiety around the pending Ring and ASPIRE results so I would walk around meditating that it works. After all, my girls were hoping it does. The day the results were going to be announced I dressed like a winner—I wanted women to win.

When Dr Annalene Nel, lead researcher on the <Ring Study, mentioned a “significant” efficacy result, I did not know what to feel. I was overwhelmed by the word and I knew it worked. I knew our work was cut out for us as advocates. A lot of questions still remained unanswered for the young women but at least the ring works and we know that now. I was happy, very happy. I immediately announced it on my FB Page and I received so many inboxes from young women— both positive and negative—and most told me there is HOPE. Seeing Annalene made me very emotional because unlike the other researchers at CROI she did not see “subjects”— a word that made be shiver every time it was mentioned at sessions throughout the conference referring to research participants. She saw trial participants as young women, some of whom she had met throughout out the study period. I knew she was counting on support and I walked up to her and I told her what this means to the young women I worked with. Annalene received a standing ovation. I was happy—finally a woman for other women. For a feminist like me it mattered that Dr. Annalene was at the forefront. It mattered that she was OK. I was overwhelmed with pride to be South African at this conference and it mostly mattered that I was a woman at the conference too. The rectal microbicides trial results were also positive news for HIV prevention.

At this conference I learnt that there are more HIV prevention tools than there has ever been before. I was left wondering who these prevention tools are developed for. Why is it that if treatment is prevention are there not more visible TasP campaigns, despite UNAIDS’ 90-90-90 and MSF’s Getting to Undetectable? Why is it taking policy makers so long to implement early treatment when the benefits from the START study are so overwhelmingly positive? The benefits, especially for those living with HIV, are lowered risk of cancer, among other risks. This cannot be rocket science, especially seeing that women living with HIV are at such high risk of cervical cancer. Why is it that if being virally suppressed reduces the risk of passing the virus on to others, we are not including this in mass HIV communications? If PrEP works and can help defeat HIV, why are there only four countries that have approved the use of Truvada as PrEP? (Since CROI, two more countries have approved PrEP.) And why is South Africa not moving any faster with rolling out PrEP to those who need it?

I was also swayed in my initial stance against home testing, thinking pre- and post-testing might get lost in the process. However, if this is not the case and home testing will increase the number of men who test, I am now for it.

It was a week of late nights and early cold mornings, a week of appreciating the science. By including the community educators at CROI 2016 I hope the scientists will appreciate the work done by communities and most of all advocates. We will only appreciate your science if you appreciate our stories. And yes it does matter who delivers the news to whom: Male, Female Gay or Straight.

Thank you for the opportunity, the support and the guidance AVAC, BAI, CROI, Sister Love and all the other sponsors.

SBIR-TT creates opportunity for small businesses to develop NIAID technologies

NIAID is seeking applications from small businesses in support of a funding opportunity announcement focusing on moving vaccines and products developed by NIAID intramural scientists into the marketplace. Vaccine and treatment inventions eligible for this award include, but are not limited to: HIV anti-gp120 env vaccine as a therapeutic or HIV prevention vaccine; HPV virus-like particles as a vaccine delivery system and adjuvant; use of the 10E8 broadly neutralizing antibody for HIV treatment and prevention.

Push

Julie Patterson is an HIV prevention research advocate and public health professional who lives in Northeast Ohio. She is chair of the Case Western Reserve University/University Hospitals AIDS Clinical Trials Unit’s Community Advisory Board, a member of AVAC’s PxROAR program, and a member of the US Women and PrEP Working Group. This blog is one in a series written by community scholars who attended CROI 2016.

Being at CROI is like being inside a scientific tornado—data and results fly by, but they are difficult to catch. There is beauty in the force of it. Everyone is caught up, scientists and advocates alike. Once the dust settles, however, it is time to clean up and make sense of it all.

As I saw it, this year’s CROI was full of HIV prevention research victories.

It was incredibly moving to be a part of a standing ovation for the results of ASPIRE and the Ring study. A dapivirine vaginal ring used for HIV prevention has the potential to save the lives of millions of women around the globe. Also, new forms of PrEP and rectal microbicides are working their way through the research pipeline. They may eventually lead to even more options that increase pleasure during sex, are long-acting, give receptive partners control, and are designed to fit the different seasons of risk throughout one’s lifetime.

As advocates, however, these kinds of results are a beginning, not an endpoint.

Our job now—in light of the range of options noted above—is to demand further clinical research, open-label extensions, regulatory approval and rollout. For example, a ring cannot save a woman’s life if she cannot obtain it. Advocates must support the International Partnership for Microbicides (IPM) as they move forward for regulatory approval, and in the meantime, open-label studies should be funded to offer women who participated in the research the opportunity to continue to use the ring now that they know it’s safe and it works. It is unethical to do otherwise. Shall we tell women that a dapivirine vaginal ring can help to prevent HIV and then take it away? No. As the number of new HIV prevention methods expands, it’s important to keep our eyes on the prize: zero new transmissions.

Also at the conference, the US CDC released newly configured data that highlighted the situation in the US for gay/bisexual/same-gender-loving Black and Latino men who face a devastating lifetime risk for HIV. In the face of these data, we cannot rest. Systemic racism and structural violence are not predestined.

Noticeably, CDC didn’t run the numbers on trans* populations when they were calculating lifetime risk. If we don’t talk about trans* risk in these meetings, if we continue to make trans* people invisible in the data, who will act? We must continue to demand HIV prevention for transwomen, and especially transwomen of color, for whom the lifetime risk can be overwhelming. It was a step forward for the conference to host Dr. Tonia Poteat’s (Johns Hopkins University) brilliant plenary focused on Transgender Populations, but it is not enough. We must fight to keep trans* people in the forefront of prevention.

As AVAC, BAI and Community Educator Scholars, our job is to ask the hard questions, to dig deeper than the numbers, to contextualize the data. As a group, we bring history, anger, passion and wisdom to the research table. We voice the fears, the hopes, and the demands of our communities. Our strength is our presence and our collective effort.

Advocates are also tasked with translating what we’ve learned at CROI into information that people can use. We come home to our loved ones: people living with the virus; communities working to fight HIV; and vulnerable people who need this research and these results. As we share what we heard, we create consumer demand and the push that researchers need to move forward. Hope comes from this dialogue. The research to implementation cycle will continue, but only if we play our part.

Making Space for Community Educators and Activists at CROI

Ntando is the Community Engagement Coordinator at the Desmond Tutu HIV Foundation in Cape Town, South Africa, a co-convener of Advocacy for Prevention of HIV and AIDS (APHA) and an AVAC Fellow Alumni. This blog is one in a series written by community scholars who attended CROI 2016.

“So you see, there’s relevance for community educators and health advocates to be at CROI.”

This was my response to a hepatitis clinical researcher I sat next to on my flight home. Having seen his CROI (Conference on Retroviruses and Opportunistic Infections) backpack, I mentioned that we had been at the same meeting. My travel companion, a Dutch PhD student researching acute Hepatitis C infection, asked how I found the conference. When I responded with approval at the high standards and organisation at CROI, he seemed disappointed to learn why I had been there. After finding out that I am neither a scientist nor researcher, he said, “I do not think there’s space for non-scientists to attend the meeting.” I was amazed by his comment. His comment highlighted that some researchers think that conferences like CROI should be exclusive to scientists and researchers to share and discuss amongst themselves. How is it that some researchers think the problems they are trying to solve can be dealt without input from the very same communities who face these issues first-hand?

It is vital that conferences, such as CROI, continue to provide space so that communities are included in the scientific environment where the problems facing communities and possible solutions are discussed. I feel honoured to be recognized as a community representative because of my community engagement and advocacy work in the field of biomedical HIV prevention. The conference re-emphasised the role of science in seeking solutions for the health problems brought about by retroviruses and opportunistic infections in South Africa and Africa, and how these are a global concern. Updates were given on the many diseases that can devastate communities, including HIV, tuberculosis, Hepatitis B and C, other sexually transmitted infections, cancer and chronic non-communicable diseases in the context of HIV.

As a community worker in the midst of this scientific arena where there is a shared language of complex terms: antibodies, adaptive and/or humoral, other immunity or immunogenicity, gene therapies, pathogenesis and metabolism, reservoirs, relapse, remission, pharmacology and pharmacokinetics, processes from laboratory, via animals to people, I often find myself desperate to hear how this translates to real change for communities. That is a bottom line I yearn for as each passionate scientist presents his or her research as if nothing else matters in the world. And indeed, perhaps in context of wanting a solution to a health problem, nothing else does matter. Many members of my society deal with infinite challenges on a daily basis, which include illness of close family members, crime, unemployment, violence and poverty to name a few. In this context, science is only part of the solution.

At this meeting, I experienced the excitement, emotions and sense of fulfilment of successful research when the dapivirine ring study results were announced. The bottom line for me is: how difficult it is going to be to bring this, or other tools, to benefit the population groups in my society who need these tools the most, including young girls, women, gay men, sex workers and many more?

Part of doing what I do requires that I continually attempt to figure out how much of the science my non-scientifically trained mind should be stretched to understand—why and how a biomedical intervention works or doesn’t as much as expected. I seek to dissect the statistical numbers and to understand how a virus interacts with the body and how it might be stopped or suppressed. This understanding allows me to help my community reach a level of not only physical, but social, mental and emotional state of wellbeing to support all to live productive and fulfilling lives. This is my contribution against a range of social and human injustices that are brought about by diseases, harmful societal belief systems and potentially detrimental policies enacted by governments.

So in the midst of a scientific conference, there are a lot of opportunities to figure out all of this and learn, especially when my hand is held by those who have done this work before me and share my interests. The conference provides the opportunity for community members from all over the world to interact, engage in serious conversation, laugh and share amongst each other. At CROI, many scientists acknowledge the important role of community members like myself and my peers, though they may vary on how they express this acknowledgement (some being better than others at it). This helps remind me why I need to be there: to constantly find and raise my shaking and intimidated voice to be heard to elevate my communities’ interests. I was happy when my fellow traveller, the scientist on the plane, eventually understood the role I have to play in scientific research and at CROI. As we spoke, he saw our conversation as an opportunity to practice a talk he had prepared for a session two days after he got home. It showed me he has the same interest and vulnerabilities as me in the seriousness of his work.

I give thanks to organisations and the passionate people behind them who use their positions to facilitate a platform for people, like me, to have a voice and equip me to prepare a platform for a voice for those who come after me. Thanks to AVAC, Black AIDS Institute and the CROI community liaison sub-committee for this experience, and constantly facilitating in this provided space for a community of likeminded community workers, health advocates and activist who are faced with similar burdens in different parts of the world. Thanks importantly to my home organization, the Desmond Tutu HIV Foundation, where all the science collides on a daily basis with communities, as well as all who seek an end to all the devastation caused by HIV, AIDS and TB.

CROI Round-Up; Post-Conference Webinar Series

News last week from the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston was dominated by new efficacy data from two vaginal ring trials that have implications for HIV prevention for women. Our take on it is here, along with a special page with more background than we could squeeze into a blog post. But, the CROI buzz wasn’t all about vaginal rings, and this update provides some ways to hear more about what happened last week and what it all means.

Post-CROI Webinar Series

We will be convening a series of post-CROI webinars covering a range of topics over the next couple of months. The first webinar in our series explored the ring results with advocates and researchers. Slides, audio and the Flash animation of the webinar are available here. And stay tuned for details about the additional webinars in the series!

In-Depth Analysis

In addition to lots of media reports and publications, our colleagues at NAM/aidsmap, The Body and NATAP all provided in-depth coverage of the myriad studies presented in oral abstract sessions, posters and more. Check out the hyperlinks above for comprehensive coverage.

CROI Program and Webcast

CROI provides a number of ways to review what happened in Boston: check out the full program; taped playbacks of press conferences; webcasts of all sessions; and electronic posters will be available a week after the conference. There was a wealth of information on a wide range of topics, but here is a selection of sessions and presentations you might want to explore:

  • Lifetime HIV risk in the US: New data from the US Centers for Disease Control and Prevention (CDC) projected that 1 in 2 black gay men could be diagnosed with HIV in their lifetime. That number is 1 in 4 for Latino gay men and 1 in 49 for African American women. The figures for white men and women are far lower. These data highlight the ways that race impacts access to healthcare at every point in the treatment cascade. They suggest an urgent need to provide prevention including PrEP at a wider scale and with messages and programs that are community-designed and owned. They also provide another opportunity to examine the ways that alarming statistics do and do not advance a structural analysis of the problems and solutions to public health issues. As one article highlighted—individual risk calculations can lay the burden on individuals to change behavior when the drivers of risk are systemic, embedded and often out of individual control.
  • PrEP in the Real-er World: There was a lot of data on oral PrEP that, as expected, added layers to understanding of what the strategy is, and what it can and cannot do. It started with a presentation by Keith Green (University of Chicago) on Engaging Young Men of Color in Community HIV Prevention Studies and later Darrell Wheeler (SUNY Albany) presented an important PrEP study in Black MSM (HPTN 073), which showed that a culturally anchored “client-centered care coordination” model (C4) was important to getting men into and supported in a PrEP program. Other data gave some insight into additional components of PrEP programming and messaging. Presentations included findings that PrEP use can have a limited impact on renal function—as it can in people living with HIV who use TDF/FTC as part of treatment; an update from a New York City PrEP project where rates of sexually transmitted infections among PrEP users suggest that routine screening—at every clinic visit—should be the norm; and finally, a presentation of HIV infection in an adherent PrEP user who acquired TDF/FTC-resistant HIV. Each of these presentations raises concerns—and thebody.com has developed an excellent resource on the HIV-resistance data—but none are insurmountable or even surprising. Piloting PrEP in the real world is the only way to find out how best do deliver, message and monitor this new strategy to all populations at risk.
  • Long-Acting Injectables for Treatment—and Prevention: Antiretrotival treatment options took a step forward with the first injectable treatment option. 91 percent of patients in a study of the 8-week long-acting injectable cabotegravir and rilpivirine combination regimen maintained virological suppression and also expressed satisfaction with this new option in a new study. Both cabotegravir and rilpivirine are also being explored separately as PrEP agents. Marty Markowitz (Aaron Diamond AIDS Research Center) presented results from the Phase IIa ÉCLAIR study that examined the safety and pharmokinetics of cabotegravir in HIV-uninfected men, setting the stage for a future Phase III efficacy trial.
  • Turning Targets into Treatment: A full abstract-driven session was devoted to Getting to 90/90/90 and included Tendani Gaolathe (Botswana Harvard AIDS Institute Partnership) presenting on how Botswana is approaching the 90-90-90 goal, getting to 83 percent (testing), 87 percent (on treatment) and 96 percent (virally suppressed) representing an overall level of viral suppression of 70 percent as compared to the 73 percent goal of the 90-90-90 goals. Factors predictive of not being virally suppressed included youth, male gender, single status and, interestingly, higher education level. At the same time, there was a presentation on how Malawi is using its Option B+ rollout to prepare for universal treatment. The challenges of Option B+ could be seen in the 25 percent drop off in post-partum adherence by women after six months. And in a separate session, Helen Ayles (London School of Hygiene & Tropical Medicine) presented Missing But in Action: Where Are the Men? raising an emerging discussion of how to reach HIV-positive men with treatment programs. Strategies suggested include taking testing outside antenatal clinics and engagement through men’s clubs and even bars. While reaching these men is important, it remains critical that treatment for all who need it remain a focus.
  • Rectal Microbicides Well Received: Ross Cranston (MTN) presented data from MTN 017, the first Phase II rectal microbicide gel study—it showed no safety risk and both adherence and acceptability were high. The open-label trial looked at a rectal formulation of tenofovir gel inserted via vaginal applicator, comparing its daily use with event-driven (used before and after sex) use. A third study regimen included the use of daily oral Truvada as PrEP. All 195 MSM and transgender women cycled through each of the three regimens for eight weeks. Adherence feedback was provided to participants through daily texts, returned applicators and real-time drug levels reporting. This contributed to high adherence across all study regimens. Overall preference favors Truvada as PrEP slightly over event-driven tenofovir gel, but the difference is not statistically significant. Daily gel application came in a close third. Cranston concluded that due to these results, rectal tenofovir gel is worthy of further study. Research is already underway to expand the pipeline of rectal microbicide products in order to find the right product to move forward into an effectiveness study, said Ian McGowan (MTN), co-author of the study.
  • New Cure Work Discussed at CROI: On the day before CROI officially opened, the AIDS Treatment Activists Coalition, AVAC, European AIDS Treatment Group, Project Inform and TAG co-sponsored a community workshop on scientific, regulatory and community engagement issues in HIV cure research, which included an update on an exciting and emerging area using bNAbs for treatment and acute infection in the FRESH (Females Rising through Education, Support, and Health) cohort in South Africa. Presentations are posted online.

Medical Distrust: The Real Reason for PrEP Misgivings in the Black Community

At this year’s National African American MSM Leadership Summit on HIV/AIDS and Other Health Disparities (#NAESM2016), a white doctor stood before a room filled with hundreds of black men at the opening plenary luncheon and talked about how many people “need” to get on PrEP.

I get it. PrEP is the one of the best biomedical prevention tools available to people at risk for HIV infection today. PrEP is safe and effective. PrEP works if you take it correctly. I get it. What I don’t get is why a white doctor would be invited to stand before a room full of black men and tell them that they need to use this medication. The message may be appropriate, but the messenger (and how the message is delivered) matters.

There are lots of barriers to PrEP uptake among black MSM, but beyond the issues of risk perception, healthcare access, provider and consumer PrEP knowledge, PrEP stigma, and homophobia, the elephant in the room is still the history of medical distrust in the African-American community. Distrust of the medical system has been a barrier to care for African Americans since long before the AIDS epidemic started. Black people in the US have the highest mortality rates due to heart disease, diabetes, and some cancers, partially because of our distrust of medical providers. There is also the lingering legacy of mistreatment by researchers—particularly during the Tuskegee Syphilis Experiment—which left black people in the US wary of medical programs and clinical trials.

Medical distrust existed decades prior to the shocking revelations over the 40-year-long Tuskegee study, wherein black men with syphilis were left untreated in order to observe the natural progression of the disease. Dangerous, involuntary and unethical experiments have been carried out on African American subjects at least since the eighteenth century. Accounts of medical and personal violation were passed down orally, from generation to generation. Medical distrust could contribute to the slow uptake of PrEP among black men.

Beyond the importance of both the message and the messenger, we have to recognize that HIV prevention has been medicalized. After 30 years of abstinence, partner reduction, and condoms, we can’t talk about ending HIV today without talking about research and pills and big pharmaceutical companies that make (and charge) ridiculous amounts of money. That looks suspicious as hell to a whole lot of black folks.

Perceptions of greed and racism in routine medical care all contribute to the distrust of physicians. What other people may see as routine medical care is often perceived by African Americans as experimentation, especially when the message is that a certain number of black men “need” to be on PrEP. (Again, how the message is delivered matters.)

And – in the spirit of Black History Month in the era of #BlackLivesMatter – we don’t trust the police (or any part of the criminal justice system). They will pull you over for driving-while-black, beat you off-camera, and say you did it to yourself. We don’t trust politicians (or any part of government). They will have you drinking water from the Flint River as if it were red Kool-Aid. People who have experienced racism or discrimination from individuals or institutions are less willing to be vulnerable and place trust in a system of unknowns such as medical care.

We’ve been beating around the bush. We’ve been picking the low-hanging fruit because issues of medical distrust are too difficult to deal with head-on.

Solutions such as the recruitment of minority healthcare administrators and executives and the presence of Community Advisory Boards that represents the the people help to change the perceptions of African American patients, but we have to do better. Short of a revolution at the polls or in the streets we need to expand support for efforts like AVAC’s PxROAR and the Black AIDS Institute’s African American HIV University, which aim to develop leadership and expertise in the communities most impacted by the epidemic.

There are all kinds of ways to frame it. The GIPA principle recognizes that personal experiences of people living with HIV and AIDS are important in shaping the response; Abraham Lincoln said that government systems should be “of the people, by the people, for the people”; and the name of 90’s American hip hop clothing company FUBU is an acronym for “For Us By Us”. If gay, black men are the group most at-risk for HIV infection in the United States, then they must be allowed to take lead roles in educating our communities about HIV prevention options.

The messenger matters. Gaining the trust of black men in the health care system is imperative if we are to reduce health disparities including incomparable rates of new HIV infections in young, gay black men.