Purposes: To support high risk/high impact, early discovery research on HIV vaccine approaches; a Go/No-Go approach to funding high risk research significantly different from most R01 projects; and encourage involvement of investigators new to the HIV vaccine field to build interdisciplinary approaches. For more information, click here.
Funding Opportunity: Innovation for HIV Vaccine Discovery (R01)
Webinar with WHO on hormonal contraception and HIV
[UPDATE:] Slides, audio and the recording is now available on YouTube.
You’re invited to join a webinar with the World Health Organization (WHO) on the newly released guidance on hormonal contraceptive eligibility for women at high risk of HIV.
This webinar builds on a March 10 webinar on this topic, which featured advocates and clinicians putting the guidance in context. A recording of that conversation is available here.
We hope you’ll join for this chance to hear from Dr. James Kiarie, coordinator of the Human Reproduction Team at WHO. Dr. Kiarie will present the new guidance and give updates on next steps, and be available for questions and answers. As always, feel free to send questions in advance to avac@avac.org.
CROI 2017: A View from My Seat at the Table
The annual Conference on Retroviruses and Opportunistic Infections (CROI) is an annual gathering where advocates and researchers learn where the science on HIV is taking us. The findings can be both grand and granular. They answer questions, raise new ones or both. And not all of those questions are strictly about science. Two of AVAC’s partners have been reflecting on what they took away from the conference, insights that inform our thinking long after the sessions end and results are published.
Rob Newells is an Associate Minister at the Imani Community Church in Oakland, California, and serves as Executive Director for AIDS Project of the East Bay—a community-based organization serving the most vulnerable and marginalized communities in Alameda County since 1983. He was a 2011 Fellow of the Black AIDS Institute’s African American HIV University Community Mobilization College and has been a biomedical HIV prevention research advocate with AVAC’s US PxROAR group since 2012.
There are conferences that I attend where I can be “Rob Newells, Executive Director for AIDS Project of the East Bay (APEB).” The Conference on Retroviruses and Opportunistic Infections, more commonly known as CROI, is not one of those conferences. At CROI, the ED hat comes off, and I’m purely a community advocate again. This year, that was even more true than in previous years. As I looked around the room of Community Educator Scholars (a program that supports advocates attending CROI) as we gathered for our first early morning breakfast of the week, I immediately noticed that I was the only African American man at the table. There were two African American women (one Scholar and one member of the Community Liaison Subcommittee) and several Africans (shout out to my brothers Ntando, Simon and Supercharger), but no other Black men from the United States. It wasn’t the first time that I’ve been the only one, and I know it won’t be the last, but—if I’m being honest—I was both disappointed and stressed by it. I felt a lot of pressure to be the eyes and ears for my community in a way that I hadn’t felt in previous years.
From a community perspective, CROI is the most boring meeting I attend. It’s 4,000 science and research geeks talking to each other about what they’ve been doing locked away in their labs for the last few years. Most of the news that gets reported after CROI is for science and research geeks, and those reports usually miss the things that I find interesting or that I think my community would find interesting, useful, and relevant. So, in an attempt to rectify that shortcoming, I attended all of the plenary sessions and a bunch of the oral abstract sessions and even took my time to talk to presenters during the poster sessions. I took lots of notes and pictures of slides, and when I returned home (after another conference the following week) I talked it all through with my staff. It took a while longer for me to organize my thoughts into a coherent presentation that I could use for the community report-back I coordinated at the Alameda County Public Health Department on National Women and Girls’ HIV/AIDS Awareness Day. This is some of what I shared.
CDC’s oral presentation on HIV Incidence, Prevalence and Undiagnosed Infection in Men Who Have Sex with Men gave us good news and bad news. The good news is that the percentage of undiagnosed HIV infections decreased for all racial/ethnic groups between 2008 and 2014. (That tells me we’ve been doing a better job of testing.) The bad news is that there was an increase in HIV incidence among Latino MSM and MSM between the ages of 25 and 34. (Annual infections among Black MSM dropped from 10,100 in 2008 to 10,000 in 2014. I don’t see that as anything to write home about, but a decrease is a decrease, right?)
Anal Cancer
I had my third or fourth high resolution anoscopy (HRA) just before CROI, so I was particularly interested in a few of the abstracts related to anal cancer. (There were seven posters and four oral abstract presentations on anal cancer this year, so I wasn’t the only one interested.) While anal cancer is fairly rare overall, men living with HIV who have sex with men are 60-190 times more likely to get anal cancer than the general population. We know that certain types of HPV are responsible for most anal cancers, and most MSM living with HIV have HPV of one type or another. What we didn’t know was what we should be doing about it. What I took away from CROI 2017 was that anal cancer screening should start at 30 to 35 years old for MSM living with HIV. Insured folks like me should get an annual HRA. Unfortunately, HRA is not the most cost-effective prevention tool, and resources to perform the test are limited worldwide. Additionally, patients who rely on the Ryan White AIDS Program or Medicare for coverage have to settle for a digital rectal exam (exams where the doctor inserts a gloved, lubricated finger into the anus to feel for unusual lumps or growths) to detect anal cancer because an HRA isn’t covered. As fun as a digital rectal exam may sound, it’s not that effective. HRA detects the most cancers. (I know from personal experience. I asked my primary care physician to refer me for an anal pap smear and HRA a few years ago. He didn’t find anything suspicious with the digital rectal exam, but he gave me the referral anyway. The HRA found a stage 4 pre-cancerous lesion which was removed during the procedure. Thank you, Kaiser Permanente.)
Antibodies
Bridge HIV in San Francisco is one of the sites for the AMP (antibody mediated prevention) Study, and I know people in my community who are enrolled so I paid attention. Antibodies are a big deal in HIV research. My takeaway from CROI was that the current study won’t produce a home run that will work for everyone. Researchers hope to have an understanding about whether or not antibodies can work for prevention, but as public health intervention it is cumbersome, involving monthly clinic visits and transfusions. And no matter the results from AMP, vaccines based on neutralizing antibodies are still a long way off.
Cure Research
There were two things I found interesting in the cure research presented this year. The first was that people on effective antiretroviral therapy are not producing new HIV-infected cells. Cells proliferate before they die off. That means that earlier detection and treatment results in fewer proliferating cells with less diversity and smaller reservoirs. That might make HIV easier to target and cure. The other thing that caught my attention was that estrogen blocks RNA replication. That discovery leads to at least two pathways to cure: Can we block estrogen to bring latent cells out of hiding (the “flush and kill” strategy), or can we increase estrogen to keep RNA blocked (the anti-proliferation model)?
Drug Use and MSM
Over the past few years, I have heard from friends in Oakland and Atlanta that there was an increasing problem with crystal meth use among Black MSM. I’ve had conversations with many of my colleagues about the increasing mention of PnP (Party and Play) on dating/hook-up app profiles. For years, the common assumption has been that meth is for white boys, but apparently more and more black men are going that route. There were a couple of posters about drug use and MSM that I totally expected to confirm that for me. The first, from CDC, looked at drug use by MSM in 20 cities across the United States. Surprisingly, they didn’t see an increase in meth use. They saw an increase in prescription opioid use among Black MSM between 2008 and 2014. But just two steps away, the very next poster from George Washington University noted a drastic increase in crystal meth use among Black MSM in Washington, DC, over the same time period. I totally expect to see more research in this area.
Pre-Exposure Prophylaxis (PrEP)
What I heard coming from Seattle about pharmacist-managed PrEP was intriguing. Being able to avoid the cost of a clinic visit could greatly increase access and uptake. I contacted my agency’s pharmacy partner when I got home to find out if they had the ability to order labs and prescribe Truvada for PrEP without patients having a clinic visit. (They can, and we will.)
And there was good news for women. Apparently, there was some confusion after all of the talk about good and bad bacteria in the vaginal microbiome at AIDS 2016. That was in relation to vaginal microbicides. Oral PrEP doesn’t go through the vagina, so the vaginal microbiome has no effect on blood and tissue levels of the drug. Oral PrEP works for women. Period.
There were a few other abstracts dealing with community cohort care for adolescents, HIV testing incentives, and text messaging interventions for PrEP users that were interesting enough for me to mention to the folks at home, but if I’m being honest, I was looking for something else.
CROI 2017 was the first conference in an entire year where I didn’t hear anything from the HPTN-073 team. Instead we heard from a team at Emory University, but what I heard only annoyed me. I don’t need another study that tells me how Black MSM don’t use PrEP. The study led by black men for black men (HPTN-073) showed us what works. Emory presented yet another study that showed us what doesn’t work. They studied Black MSM aged 16 to 29 in Atlanta. Participants were offered risk reduction counseling, condoms and lube, and non-incentivized oral PrEP. After viewing a brief education video from WhatIsPrEP.org, the men who expressed interest were scheduled to see a study clinician to initiate PrEP.
The study results indicated that 56 percent of the men expressed interest but 39 percent of those never showed up for the initiation visit with the clinician. Of the ones that did come back, only 35 percent initiated PrEP. The study team’s conclusion was that, “even after amelioration of structural barriers that can limit PrEP use,” PrEP uptake was suboptimal. What structural barriers, you ask? Only lack of health insurance was addressed. (As if that’s the most pressing structural barrier Black MSM face in the United States.) When I asked about what else was done to engage these men based on what we know from HPTN-073, I was told that there is really “no hard, a priori evidence that more aggressive interventions are needed” for Black MSM.
I sat down so that I wouldn’t come off as the angry Black man, but when 79 percent of the participants in HPTN-073 accepted PrEP after a series of counseling sessions that combined service referral, linkage and follow-up strategies to address unmet psychosocial needs (part of what that team calls C4, or client-centered care coordination), I would argue that the need for more aggressive interventions is obvious. A study led by black men told us how to work with black men. Apparently, someone needs to fund more “For Us, By Us” studies so that we have a body of evidence showing what works because I’m tired of hearing what doesn’t work.
There were no exciting results from large efficacy trials at this year’s CROI like there have been for the last several years. It was back to basic science. That means the conference was even more boring than it normally is. But when I returned to Oakland and put my E.D. hat back on, I realized that I had the power to implement some of what I learned without waiting for studies to be published or government agencies to catch up to the science which could take years. I had the power.
In addition to client-centered care coordination and pharmacist-managed PrEP, we are in the process of adding an optional SMS intervention to the PrEP program at APEB, and we’ve started working with La Clinica de la Raza—a local community-based organization that prioritizes Latino populations—to support efforts to address the increasing HIV infection among Latino MSM. That’s why I go to CROI. That’s why I’m grateful to the scholarship committee for supporting my attendance and to AVAC for always providing what I need in order to stay on top of new developments in biomedical HIV prevention research. That’s why I wish I wasn’t the only African American man at those daily 7am breakfast meetings.
…cue Solange’s “F.U.B.U.”
Setting Advocacy Priorities: PEPFAR Country Operational Plans 2017
This week in Johannesburg, South Africa, MSMGF, Health Gap, and AVAC gathered 15 advocates from Botswana, Cote d’Ivoire, Kenya, Uganda, Unites States, and Tanzania to prepare together to advocate for gay men and other men who have sex with men in their national HIV programs. This workshop came before US President’s Emergency Plan for AIDS Relief (PEPFAR) Country and Regional Operational Plan review meetings where officials from 23 countries will review and finalize PEPFAR-supported programs that will be implemented next year.
PEPFAR is the largest funder of HIV programs for key populations in Africa. The review meetings will be a critical opportunity for activists to voice their concerns and recommendations, and strengthen the way that their countries’ HIV programs respond to the epidemic among gay men and other men who have sex with men and funding to reach the right populations with the right services in the right places, right now. They come at a critical moment as the current US Administration’s proposal could potentially cut PEPFAR’s budget, signaling a dangerous diversion in the global AIDS response that will come at a great cost to human lives.
“The US contribution to PEPFAR and the Global Fund to Fight AIDS, Tuberculosis and Malaria grew to $6.81 billion per year in 2016, making the United States the single largest contributor to the global fight to end AIDS. We all need to advocate tirelessly for the US to maintain its budgetary commitments to foreign assistance, the reversal of which could dismantle over a decade of progress,” said Matthew Kavanagh from Health GAP, United States.
“Over the past three years, PEPFAR country programs, have really improved. There are still gaps that we have to address, but we have seen that being involved early on can really strengthen the plans so that they are more effective at reaching men who have sex with men.” said Nana Gleeson from Bonela, Botswana.
Over one and a half days, participants priorities to advocate for in their own Country Operational Plans (COPs). These priorities will be raised in the next two weeks with their respective PEPFAR country teams. In addition, they identified the following common priorities which will be raised with the U.S Office of the Global Aids Coordinator (OGAC):
- PrEP (Pre-Exposure Prophylaxis) should be included in the minimum package of services for men who have sex with men, and clear targets should be set for PrEP enrollment among this key population.
- Data that describes the HIV treatment and prevention cascade for key populations should be collected and used in programing. Data should be based on reasonable population size estimates: Where population size estimates are implausibly low or unavailable, an estimate of 2-3 percent of the adult male population should be used in program planning.
- There should be increased funding for community-led HIV responses among men who have sex with men.
- Health care professionals should be trained to reduce stigma against gay men and other men who have sex with men, and to provide competent and tailored services to this group.
- There should be increased engagement and participation of key populations such as men who have sex with men at appropriate entry points in PEPFAR processes.
- Size estimate and epidemiology studies are critical, but researchers must recognize that in many countries MSM face criminalization and state-sponsored violence. Protecting human rights during research therefore often means avoiding the use of identifiers like biometrics that require MSM to disclose their identities in order to be counted in these contexts.
Over the next two weeks, MSMGF, Health GAP, AVAC and other global, regional and local civil society organizations will participate in PEPFAR regional review meetings, carrying forward the advocacy priorities that were generated in the meeting, and amplifying the voices of communities in the response to HIV. Together with our partners, we will continue to advocate that PEPFAR ensure that global health investments from the US Government to remain responsive to the unique HIV-related needs of gay men and other men who have sex with men living around the world.
Thai HIV Advocates Drop the PrEP Ball
Udom Likhitwonnawut has been working as a consultant for AVAC in Thailand on community engagement on HIV research for the past 5 years. He has been a member of the first community advisory board (CAB) in Thailand from its conception more than 12 years ago. He promotes community participation in HIV research and advocates for the implementation of GPP implementation in Thailand. He is a member of the National Subcommittee on HIV Vaccine Development and the National Subcommittee on Biomedical HIV Prevention representing the Thai NGO Coalition on AIDS (TNCA), the national umbrella organization for HIV/AIDS-related organizations. He is one of the founders of Thailand national CAB (NCAB) on HIV research.
Since the introduction of combination antiretroviral (ARV) therapy almost 30 years ago, antiretroviral drugs have been a key factor in saving lives and restoring the health of millions of people living with HIV throughout the world. In addition to treatment, antiretroviral drugs have been used successfully to prevent HIV transmission from mother to child. Furthermore, over the last five years or so, scientists around the world have shown that a popular ARV drug, Truvada, is safe and effective as pre-exposure prophylaxis (PrEP) to prevent HIV infections. A number of trials, demonstration projects and implementation studies in real world settings have confirmed the findings. As a result, Truvada as PrEP has been approved for prevention of HIV infection in many countries.
Thailand is a well-known poster child in fight against the HIV epidemic. Thailand is credited for being the first country in Asia to eliminate mother to child transmission. Several HIV research institutes in Thailand have been involved in PrEP research from the beginning. Given all this, it could be assumed that PrEP uptake and scale-up in Thailand would be smooth and trouble free. No serious objection was expected, least of all from Thai HIV non-governmental organizations (NGO).
Thai HIV NGOs have been in the forefront of the fight against the HIV epidemic from the early days. They fought for accessible HIV prevention and treatment for marginalized and at-risk populations such as sex workers, injecting drug users, undocumented migrant workers, people living with HIV/AIDS, and women and young people. Thai HIV NGOs were among a core group of civil society organizations that advocated for the establishment of the country’s universal health care program. Because of their advocacy for the universal health care program, ARV treatment and other medical treatment for people living with HIV are free of charge for all Thai citizens as well as migrant workers. With this track record behind them, it is astonishing that strong, albeit subtle, resistance for PrEP scale-up in Thailand comes from a few influential leaders of HIV NGOs. Small in number, these NGOs are vocal and influential. Their opinions are esteemed by government officials and fellow NGOs.
The resistance is not stated in public. Most of the objections to PrEP I have heard from these individuals during backroom talks or various office meetings or private discussions. Concerns, doubts, or cautions against PrEP that are said in public were vague and ambivalent. The objections are couched in cautious, well-intentioned terms such as stigmatization of PrEP users, short and long-term side effects, risk compensation and the possible increase in STI infections, effectiveness in real-world situations, and lastly fairness. At one community meeting on PrEP, I watched as a participant suggested the Thai coalition of AIDS NGOs issue a statement concerning PrEP. A leading PrEP critic, who is a well-known advocate for access to HIV treatment, objected that there was no need since PrEP, in his opinion, was a personal choice. However, he also added that PrEP users should be responsible for the cost and the government should not pay for PrEP. This critic and others are not mentioned by name because they are important figures in the fight against HIV in Thailand. No one wants to jeopardize the response to HIV by alienating them.
Initially, objections centered on concerns that PrEP was a ploy to sell a drug that’s market had plateaued. Then critics shifted their concerns to questions about side effects and risk compensation. They gave voice to a myth that PrEP is a lifelong medication (actually, individuals can choose to use PrEP only during a period of time when the risk of exposure to HIV is high). This purportedly lifelong commitment was contrasted with condoms, which are effective as-needed. Later objections focused on HIV resistance. Finally, the critics talked about fairness and justice. They worried that finite resources would be siphoned off for HIV negative people. People living with HIV need ARV drugs for treatment as a matter of life and death. Wouldn’t they come up short, the thinking goes, while HIV-negative people received Truvada even though condoms would protect them just as well.
Let’s start by addressing this wishful thinking that condoms can do all the work of prevention. PrEP critics are ignoring the fact that some people have no choice; if they insist on using a condom some risk abuse from partners or customers. Some people have to engage in condomless sex in order to earn money for a meal or a place to sleep.
As for costs, the generic version of Truvada (Teno-EM), manufactured by a government agency, is widely available and much cheaper than Gilead’s Truvada. A one-month supply (30 tablets) of Teno-EM is Baht 630 (US$18). Meanwhile, people living with HIV who need ARV drugs for survival get them for free in Thailand, something PrEP critics seem to conveniently disregard. ARV treatment is not only free, it’s available to all people living with HIV at any CD4 level. When it comes to treatment access, the main problem is that a number of people don’t seek treatment due to a variety of reasons or are not aware of their status.
The latest reason cited in objecting to PrEP is that it will lead to HIV drug resistance and HBV drug resistance. Opponents claim that PrEP users will be poorly screened for HIV, will have poor adherence, or that their status will be poorly monitored. Each of these factors could contribute to the development of drug resistance. Finally, the critics assert that PrEP advocates and supporters talk only of the advantages, omitting the damaging effects of Truvada PrEP. Research results on adherence, side effects, and risk compensation, available to the public thru various venues, are snubbed by critics as unsubstantiated or cherry-picked by PrEP advocates.
Instead of Truvada PrEP, critics insist that condom use is the answer to preventing HIV infection. Condoms are cheaper, they say, and suitable to everyone on every occasion. For them, the problem is not that some people don’t or can’t use condoms, the problem is only a shortage of supply. They insist that, with enough condoms, there will be no new HIV infections. Despite their long experience with issues related to the dynamic of the HIV epidemic in the country, they persist in this oversimplified and naïve claim. It verges on chemically-induced hallucination.
They certainly cannot point to a lack of information about PrEP research to justify their apprehension. Information about PrEP research is available in many venues and formats. Though much of it is in English, a substantial amount is available in the Thai language, particularly on a variety of websites and YouTube. Furthermore, many PrEP critics are members of HIV Community Advisory Boards (CAB) and members of a few national committees related to HIV and public health. PrEP critics, if they want, could be well informed about PrEP research.
On several occasions, facts or news about PrEP were reconstructed by PrEP critics to fit their narrative against PrEP. A few examples deserve additional details here.
When the UK National Health Service (NHS) decided not to provide PrEP, the news was celebrated and circulated widely among Thai NGOs. The ensuing discussion never acknowledged that PrEP safety or effectiveness was never challenged by the NHS, only who should pay for it was at issue. Subsequent news, including UK court decisions that NHS can provide PrEP and the launch of a PrEP program that will reach a minimum of 10,000 people over three years, has been ignored by these Thai critics.
When news hit of a rare case of ARV resistant HIV appearing in a PrEP user, critics cited it repeatedly to discredit PrEP. The discussion focused only on one single issue that PrEP could lead to HIV drug resistance and other details were omitted.
A couple months ago, a leading PrEP critic, a well-known HIV activist and human rights advocate, together with a few consumer rights advocates, lodged a formal complaint with the Thai FDA about an educational video on YouTube, produced by an esteemed HIV research institute. They said it was misleading and irresponsible, comparable to false advertising because it explained the benefits of PrEP but not the risks. As a result, the video was removed from YouTube.
PrEP critics are determined to employ any means or tactics to derail PrEP uptake and scale-up. A few prominent PrEP critics who are also members of key national committees related to HIV or public health have declared they will oppose any government plan or HIV prevention budget that includes PrEP delivery.
Could it be that PrEP is guilty only by association? The leading HIV NGOs have been fighting with Gilead and other pharmaceutical companies over access to affordable ARV drugs for many years. The fight still lingers, and it extends beyond ARV drugs to direct acting antivirals for the treatment of hepatitis C infection (HCV) as well. The fight is often confrontational and acrimonious. Gilead, the patent holder and manufacturer of Truvada and several drugs used in HIV and HCV therapies, represents a boogeyman for HIV and hepatitis treatment advocates in Thailand. (It’s worth noting, these PrEP critics stand alongside other critics who had a problem with one PrEP trial in particular, the Bangkok tenofovir study (BTS). BTS was investigating the efficacy of PrEP as HIV prevention among drug users. Advocates for the drug using community had a number concerns about the commitment to harm reduction and the consent process. But the efficacy of PrEP itself was not a chief concern for those criticizing of BTS.)
Then again, maybe a conflict of interest is undermining support for PrEP. A few PrEP critics have been advocating for a national condom fund. PrEP scale-up could weaken or jeopardize their plan. Admitting that PrEP may be an important option for certain populations suggests condoms are not a perfect solution, as they obstinately insist.
Despite the criticism, a number of HIV NGOs have stepped up to support PrEP. Some are involved in demonstration projects or implementation studies. Most of them are less influential NGOs and prefer to remain silent or defer to the more experienced and better-known NGOs on most issues, including PrEP. Some of the silent PrEP supporters are key partners of community-based PrEP projects being implemented in the country now.
It is important to point out that the PrEP critics have done many good works for HIV-affected people and communities. It is unfortunate that they let their prejudice against pharmaceutical companies and their hidden agenda for a national condom fund to override the scientific evidence. Currently, these vocal PrEP critics prefer to throw up obstacles from the sidelines while others to carry the ball forward. It is up to the silent majority to work together with other stakeholders in delivering PrEP to people who need or want additional HIV preventive tools. The discussion related to PrEP should be framed to include PrEP and condoms as well as other prevention options, instead of creating a PrEP-or-condom dichotomy as it is being framed today.
Dear HIV Researchers, To Do Effective Research – Engage Us
The annual Conference on Retroviruses and Opportunistic Infections (CROI) is an annual gathering where advocates and researchers learn where the science on HIV is taking us. The findings can be both grand and granular. They answer questions, raise new ones or both. And not all of those questions are strictly about science. Two of AVAC’s partners have been reflecting on what they took away from the conference, insights that inform our thinking long after the sessions end and results are published.
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 of Cleveland 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.
Recently, I had the opportunity to attend the Conference on Retroviruses and Opportunistic Infections (CROI) as a community educator scholar. It was a grand experience – a gathering of brilliant, hard-working research minds at one of the premier HIV scientific meetings that are held each year. It was truly an honor to be among them.
However, I’m not sure my presence was felt.
A cohort of us came to CROI to give voice to community needs and bring new research back to our communities. We see it as a two-way street.
On the first day of CROI, there is a workshop held for newer researchers called, “Program Committee Workshop for New Investigators and Trainees”. People awarded the Young Investigator and International Delegate Scholarship are required to attend in order to get an introductory overview of the conference, what to expect in the days ahead, and a primer on aspects of the science that may be unfamiliar. The attention is on the science and the scientists—new investigators and clinicians who are actively involved in research. The organizers encourage participants to ask questions because lab scientists aren’t always aware of the issues in epidemiologic research, virologists speak a slightly different tongue than immunologists. You get the idea.
Not surprisingly, community educators are also required to attend the workshop for new investigators. This is a great idea; the nature of these talks is more general than others at the conference, and provides a foundation for understanding key results. Unfortunately, the structure often does not allow the presence of community educators to be known. Sure, we ask questions, but mostly we are like ghosts – ethereal beings with messages from the past. Not quite real. Certainly not equals.
This year, in what I perceived as an attempt to turn this CROI norm on its head, one of the crucial lectures included in the workshop was centered on GPP—Good Participatory Practice. It was led by community activists, grounded in the lives of people living with HIV, and aimed squarely at the new investigators, and with this I agree wholeheartedly. The Martin Delaney Lecture honored his legacy and brought the attention back around to the communities who are struggling with HIV, to the people who are at the heart of this epidemic. The message: listen to community stakeholders, and you will hear what you need to know. Ignore them, and your research results will suffer. We will all suffer.
I was disappointed that this vital talk was held during lunch when many left the room to pursue other food options. Most of the awardees of the Young Investigator and International Delegate Scholarship stayed to eat a free box lunch, but the timing appeared to indicate that this lecture wasn’t as important as the others. It would have been easy to miss it and not be held accountable.
Researchers, I’m here to say that you are accountable to us. We need you on our side and to see this through to the end. Our goals are the same—we want to end this HIV epidemic, to roll out a vaccine that will prevent new infections, to find a cure that works for everyone, to lead happy, healthy and long lives full of purpose and meaning, full of love and adventure. We want to see all of it in our lifetimes, just like you.
I tend to follow HIV prevention and public health research closely, so those were the sessions that I attended. Time and again, I sensed the urgency in the tone of the presentations. For that I am grateful. We must continue to push forward. Yet I also heard something else, even from prominent scientists—a scientific expediency that can leave communities behind.
Two significant HIV prevention clinical trials that are currently being conducted under the umbrella name of the “AMP Studies”—HVTN 704/HPTN 085 and HVTN 703/HPTN 081 are a case in point. I sit on the Community Working Group for these trials that are studying the efficacy of antibody mediated prevention. The HVTN 704/HPTN 085 trial is recruiting cisgender heterosexual women at risk in South Africa. In the US, Peru, Brazil and Switzerland, HVTN 703/HPTN 081 is recruiting cisgender men and transgender people who have sex with men.
Unfortunately, on multiple occasions at CROI, when I heard researchers refer to the AMP Trial, they neglected to mention the involvement of transgender people.
This may seem like a small oversight. Surely it is acceptable to use shorthand amongst fellow researchers? Everyone knows that referring to MSM as the target population for recruitment in this situation includes transgender people, right? Wrong. Transgender and gender non-conforming (TGNC) people don’t necessarily assume it. We all need to see ourselves in HIV prevention research.
Will this study collect data in such a way that we can separately analyze findings that are specific to TGNC participants—if not,we will have lost an invaluable opportunity. Will TGNC people at risk for HIV see results from AMP as applicable to their lives? If our experience with PrEP is any indicator, the answer is no, unless the investment continues to be made in TGNC people. AMP has included TGNC stakeholders early in the research process- from choosing research questions to protocol development, from design of informed consent to rollout of marketing materials. Now advocates are watching to ensure that it continues—from interpreting results to follow-on studies and implementation, all the way to the next trial. Every step of the way. Every step.
The AMP Trial has helped to set a new standard for transgender inclusion in HIV prevention research, but it is only one example of how GPP can be utilized. There are so many more. Community stakeholders have to be involved at every step.
In the end, researchers, my message isn’t to watch your step, it’s to walk alongside us. We can’t do it without you, and you can’t do it without us. As community stakeholders, we bring information to the table that you may never know without our voices. Knowing it up front will make the science more efficient, more ethical, and better in the long run.
For over 30 years, HIV research has been on the cutting edge of engaging affected communities and working together with activists. We need to keep that momentum going. I look forward to it.
Editor’s Note: AVAC’s Stacey Hannah led the presentation during the session on Good Participatory Practice (GPP). GPP is a set of guidelines developed by AVAC and UNAIDS in 2007 to engage affected communities and all other stakeholders in the design and conduct of biomedical HIV prevention trials. GPP has been widely adopted and is instrumental to a research process that yields trusted results.
A Steady Hand of Advocacy in Uncertain Times: HIV Vaccine Awareness Day 2017
[UPDATED] This post now includes recordings of previously held webinars.
This year will mark the 20th anniversary of HIV Vaccine Awareness Day (HVAD). On this May 18, as HIV prevention advocates we find ourselves in new terrain when it comes to vaccine research—both in terms of scientific progress and the challenging political environment. We’ll be highlighting these important issues in an HVAD webinar series leading up to and ending on May 18—read on for full information and to register.
As we look back on the 20 years since President Bill Clinton called for accelerating HIV vaccine development, AVAC recognizes that, now more than ever, we need steady hands and supportive voices to back this long-term, challenging, essential endeavor. Can you help us identify the next HIV vaccine champions? Are you one of them?
This year we are celebrating HVAD, not only on May 18, but throughout the month leading up to it (and beyond). We promise not to inundate you! But we recognize the “breadth and potency” of the current research landscape and the many events that will happen around the globe to mark the momentous day. We want to keep you in the loop.
We’ll provide research literacy tools; share AVAC’s take on developments in the field; and host a series of webinars to discuss key issues in vaccine research and advocacy. Please register, mark your calendars, and have your questions ready.
Recordings of previous webinars available here:
- Ad26 Mosaic Program—Janssen’s Maria Pau discusses preparations for the next efficacy trial
April 28 – YouTube / Audio / Slides - The History—and Future—of the NIH’s Vaccine Research Center with Barney Graham
May 4 – YouTube / Audio / Slides - Building on (and Building!) Success—Status of HVTN 702 with Fatima Laher
May 8 – YouTube / Audio / Slides - “Plan B”-NAb? An Overview of Antibody Research with Lynn Morris
May 11 – YouTube / Audio / Slides - An Overview of Vaccine Development with Julie Ake of MHRP
May 18 – YouTube / Audio / Slides
We hope you’re looking forward to the month ahead as much as we are! Talk soon.
MTN Annual Meeting: Presentations Available
The Microbicides Trials Network (MTN) held its Annual Meeting on March 20-21, 2017 in Bethesda, MD. You can find slides from the presentations on the Annual Meeting page of the MTN website, http://www.mtnstopshiv.org/2017annualmeeting.
Webinar: CDC and WHO Review Current PrEP Guidelines
In February, hundreds of people tuned in to hear researchers discuss the available data on “time to protection” required for effective oral PrEP with TDF/FTC—i.e., how many doses must be taken to build up protective levels of the drug in the blood? The answer is—it varies. Not surprisingly then, so do the guidelines for PrEP use.
As webinar participants learned, the data are varied and subject to interpretation. The World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC) recommend different time frames to reach protection in their respective guidelines for oral PrEP use. Both of these recommendations are based on measurements of the amount of drug that accumulates in blood and/or tissue over a specific period of time. The studies of how drugs are taken into the body and how they leave the body is called “pharmacokinetics” and “pharmacodynamics” or “PK” and “PD” for short, as explained in our primer for advocates. There isn’t a single PK measurement that is associated with PrEP protection—so both WHO and CDC guidelines are based on inference.
In a follow-on webinar presentation and Q&A, representatives from both CDC and WHO reviewed their respective guidance development processes and the role, use, contexts and audience for guidance documents.
The Recording: watch on YouTube, listen to an mp3 version or download the slides. Q&A starts approximately 55 minutes in.