The Stories of HIV Vaccines in 2018—From science to stakeholder engagement

This four-pager explores stories about stakeholder engagement in the current suite of efficacy trials as well as stories around global support for vaccine research in the age of an expanded HIV prevention landscape.

Vaccines Efficacy Trials: A surge of activity

A picture of the status of vaccine trials since 2003: The four trials shown here represent an unprecedented number of late phase trials underway in vaccines research.

Prevention Research & Oral PrEP Rollout: The evolving context for HIV prevention research

Many of the current or planned prevention trials are taking place in countries where daily oral PrEP is available or will be soon. This infographic shows the status PrEP and the location of scheduled trials by country.

Vaccine and Antibody Trial Participant Recruitment, 2018

A global snapshot of total numbers of participants in trials by country.

HIV Vaccine Awareness Day: In May 2018, the story is…

HIV Vaccine Awareness Day (HVAD), May 18, is just a week away. Today, we’re bringing you AVAC’s annual HVAD Toolkit, a new advocacy resource—The Story Is…, and our HVAD webinar announcement!

AVAC’s HVAD 2018 webinar, to be held on Thursday, May 17, 9am ET, will tell the current story of HIV vaccine research from two perspectives. Dr. Sandhya Vasan of the Military HIV Research Program in Thailand will give her take on the world of HIV vaccine research since RV144: from where have we come, and where are we going? Mark Hubbard, a seasoned vaccine advocate and community representative for HIV research in Nashville, Tennessee will tell the story from a community and advocacy perspective: what are today’s current successes and challenges, and how are community members pushing the HIV vaccine agenda? Register now.

We’re especially excited in this year’s HVAD Toolkit to bring you a set of infographics that explain key aspects of vaccine research—trial participant and enrollment numbers, global funding, trials timelines, and more. We also have updated versions of old favorites you’ve come to expect each year, all available online at www.avac.org/hvad.

So, what is the story this year for HVAD? The story is the science, with an unprecedented level of vaccine and antibody clinical activity underway. But it’s not only the science—there are other important stories to tell as well, about global support for vaccine research in a time when there are many priorities in HIV prevention, and about stakeholder engagement in the current trial context. AVAC is publishing a special advocacy document, The Story Is…, which explores all this with an eye on primary prevention and the central role that research must play in it. Download it here.

As always, AVAC hopes these tools prove useful for HVAD events in your communities around the world. We know many of you are hard at work for HVAD, and we can’t wait to hear your stories, too.

Three Perspectives, Two Trials and One Big Goal

With more efficacy trials underway today than ever before in HIV prevention research, this episode of Px Pulse zooms in on two that have most recently launched: one of two trials testing a long-acting injectable antiretroviral called cabotegravir (HPTN 084), and the study of a “mosaic” vaccine developed by Janssen Pharmaceuticals (HVTN 705/HPX2008).

Three Perspectives on Two Big HIV Prevention Trials in Latest Px Pulse Podcast

The February episode of the Px Pulse podcast is up and brings you three perspectives on two recently launched major trials in HIV prevention: HPTN 084 testing a long-acting injectable antiretroviral called cabotegravir and HVTN 705/HPX 2008 testing a “mosaic” vaccine.

  • What opportunities stand out in an advocate’s eyes as these trials enroll?
  • What’s a mosaic vaccine?
  • What’s the status of ethical standards at trial sites?

Explore these issues and more in this episode of Px Pulse, AVAC’s podcast on HIV prevention research today.

You’ll hear from Malawi’s veteran advocate Maureen Luba, Zimbabwe-based bioethicist Paul Ndebele and leading scientist Dan Barouch.

In a hurry? Select among the podcast highlights.

And don’t forget to tell us what you think!

New Px Wire — 2018: Countdowns and counting what matters

The first issue of AVAC’s quarterly newsletter for 2018 is here! It’s designed to help you mark your calendars and make your advocacy plans for critical events in the next 12 months. These include:

  • The upcoming country deadlines for creating roadmaps to implement the priorities laid out by the UNAIDS’ Global Prevention Coalition. This work is supposed to jump-start primary prevention and bring down the rate of new diagnoses by 75 percent by 2020. Will it? Only if you get involved!
  • In the coming weeks, PEPFAR and many stakeholders will gather to develop targets, service delivery approaches and comprehensive plans for testing, prevention, treatment and virologic suppression in PEPFAR countries. It’s a key process for civil society to track. Find out how!
  • In 2019, the ECHO trial is expected to release its results on whether three different contraceptive methods impact women’s risk of HIV—but preparation for these trial results is starting now! Get involved!
  • Seven major efficacy trials of biomedical prevention tools are currently underway—read on to find out where, what and how to learn more.

This issue of Px Wire also includes a detailed infographic showing the status of oral PrEP rollout in the countries where trial sites are located. And don’t miss the infographic explaining the demographics of Africa’s “youth bulge” and its implications for the global response.

Find the full issue of Px Wire and the archive of past issues at www.avac.org/pxwire.

African Advocates Build Platforms and Networks to Push for HIV Prevention Access and Ethical Research Conduct in Africa

Morenike Oluwatoyin Folayan is an Associate Professor at Obafemi Awolowo University and Coordinator of the New HIV Vaccine and Microbicide Advocacy Society (NHVMAS) in Ife, Nigeria. This post first appeared in News Proof.

It was a beautiful sight to behold – the coming together of African advocates for HIV prevention access and conduct of biomedical HIV prevention research that respects the rights and welfare of participants. Acronyms like NHVMAS, AfNHI, VARG, AAVVi.net, APHA, WACIHealth were a delight to hear.

The New HIV Vaccine and Microbicide Advocacy Society (NHVMAS) was the oldest of the pack. It was formed by Advocates in Nigeria to push for the access of Nigerians to biomedical HIV prevention tools as soon as they were available way back in 2004. It is expanding its scope of work to West Africa and liasing with other networks to expand its work to Africa.

One of its chief liaison is WACIHealth. WACIHealth is focused on promoting increased domestic funding for health in Africa. It expanded its scope of work to include advocacy for HIV prevention commodity access, including promoting domestic investment for biomedical HIV prevention research, in 2011 just ahead of the Abuja+12 conference. Its partnership with NHVMAS led to the successful implementation of the biennial Biomedical HIV Prevention Forum since 2013. The forum serves as a platform for networking, sharing, providing updates and motivating for new action to promote access to HIV prevention tools and investment in ethical conduct of biomedical HIV prevention in Africa.

AfNHI is a birth product of the WACIHealth and NHVMAS with ample midwifery from AVAC. AfNHI envisons seeing Africa free of New HIV Infection. It is led by Africans for Africa and largely marries the vision of both WACIHealth and NHVMAS for the purpose of prevention new HIV infection in Africa. The network was launched during the 2017 Biomedical HIV Prevention pre-conference that held on the 3rd of December 2017 in Abidjan.

Also launched was the Vaccine Advocacy Resource Group (VARG). The Group is more global in outlook with members from beyond Africa. The lead of the Group – Tian Johnson – shared the goals and aspiration of the group at the meeting one of which was to be the voice of community advisory boards. The group is largely focused on promoting HIV vaccine research that respects the rights of study participants, and future end users. It tries to address the complex relationship between race, gender, rights and research. One of its most astounding work is the shift it accomplished with respect to PrEP access for all and by all study participants enrolled for HIV vaccine research in South Africa. This landmark shift in the context of designing and implementing HIV prevention research is historical and a huge success worthy of celebration – a proof that the VARG through its members – the VARGers – has the potential to make landmark changes in the way HIV prevention research is designed and implemented in Africa.

Also present at the meeting was Ntando Yola, a founding member of APHA – a group of HIV prevention advocates working in South Africa; and Prince Bahati, a member of AAVVi.net – a group of researchers and advocates who are set to shape the science of HIV vaccine research in Africa.

While it is so heartening to see the evolution of these groups on the continent the hosts the highest number of HIV prevention research, it was clear that more work needs to be done to breed new and many young advocates on the continent. You find the same set of people belonging to the groups. This comes with its challenges – how novel and distinct can the concepts and ideas of these groups be? How do they deal with conflicts of interest? How do the organisations handle the financial resources from funders?

The AVAC Fellowship and PxROAR Africa programmes and the NHVMAS LeNNiB Champion project may be one of the many ways to address this time-limited challenge. Let’s look forward optimistically to what these networks, platforms, organisations, programmes and project is set to do for HIV epidemic on the sub-Saharan continent.

Setting the Standard: New prevention trials in the era of oral PrEP

There’s a lot going on in the world of HIV prevention research right now. The HIV vaccine field has launched a second efficacy trial—HVTN 705/HPX 2008—investigating a mosaic vaccine that could protect against clades of HIV from around the world. HPTN 084, a second trial comparing injectable cabotegravir to oral PrEP as prevention, this one among women, also recently launched across Southern and East Africa. These two trials join five other efficacy trials currently looking to expand the range of new prevention options.

At AVAC, we came out with our annual AVAC Report on December 1–our attempt at trying to untangle the mixed messages that have been circulating, and offer solutions to confront them head on.

The report touches upon an issue that has gained a lot of attention: how participants might access oral PrEP as part of HIV prevention trials. In the midst of all this activity, we thought it necessary to dive deeper into this issue. It may seem simple: trial participants have the right to the highest standard of HIV prevention and care as part of participation. Both the WHO/UNAIDS ethics guidance and the UNAIDS/AVAC Good Participatory Practice Guidelines for biomedical HIV prevention trials clearly outline this point. But the ethics, trial design issues and the mechanisms by which interventions are provided as standard of care are quite complex. Opinions differ and politics abound.

On November 2-3, the South African Medical Research Council (SAMRC) held a summit in Cape Town to discuss this very issue of standard of care in prevention and treatment trials in Southern Africa. Before the summit, members of the Vaccine Advocacy Resource Group (VARG) convened an Imbizo—a South African term for a gathering led by a traditional leader to discuss policy issues—to develop their position on what standard of care should be in prevention trials, and the role that communities and advocates should have in these decisions. AVAC attended both the Imbizo and summit to support the VARG and engage in the discussions.

The topic and tensions–and, for the most part, the players—are not new. Standard of care, and particularly when and how to integrate new interventions into the prevention package, has been discussed and debated for nearly as long as the research itself. What is new is stakeholders across prevention research coming together to reach consensus on not only the package, but on how it should be delivered. Traditionally, these conversations have been siloed. Ethicists made decisions based on their guidelines, statisticians based on trial design considerations, researchers on national context and available resources. Excitingly, there is a way forward from the summit that integrates the different interests of a broad range stakeholders. This is Good Participatory Practice in action!

The summit arrived at some concrete next steps. The SAMRC and the Fred Hutchinson Cancer Research Center (FHCRC and home of the HIV Vaccine Trials Network) will establish a trial-agnostic fund to cover the cost of oral PrEP and HIV testing for HIV prevention trial participants for the duration of the trial; trial sites and their communities will decide how to provide PrEP at their site—and this will likely look different at different sites; sites will be encouraged to work with implementing partners to optimize PrEP access and to support adherence; and South Africa researchers will work with the National Department of Health’s (NDOH) PrEP Technical Working Group to support establishment of demonstration projects closer to trial sites.

These are commendable and essential steps—and advocates, AVAC included, will be following them closely. As we continue to reflect, these are the questions and issues that remain at the fore for AVAC.

How ‘standard’ can standard of care be?

Decisions about provision of oral PrEP in clinical trials as standard of prevention, in particular, are happening as PrEP is being rolled out with great variability in the very countries in which the trials are happening. This creates operational and ethical complications—as well as exciting opportunities. Is there undue incentive if participants are offered PrEP in the trial, but PrEP is not available in the communities? Are researchers filling for the role of government—which is responsible for setting and improving the national standards of care? Within the same country, South Africa being an example, availability of PrEP can differ even between trial sites, potentially creating inequality in how participants in the same trials and in the same country get access.

The consensus from the summit is that rigid standardization is likely impossible; community and trial context have to be taken into account. Some sites do not have the capacity to provide PrEP on site, while some do. Some are close in proximity to demonstration projects and implementation sites and can create efficient linkages, while others cannot. The agreement is that trial sites, in collaboration with communities and local and national advocates, will work together to define a model of provision that ensures all participants who want PrEP can access it. This variability presents an exciting opportunity for sites to be innovative, and for the field to learn from different models of PrEP provision in real time.

But researchers, regulators and communities must also monitor execution of the PrEP plans to ensure that variation does not lead to inequality in access—and stakeholders at all levels must be linked and coordinated so there is constant learning and more efficient collaboration.

How should coordination look different moving forward?

As we move from discussion to action, partnerships are a must. Meaningful coordination will be especially critical among:

  • Advocates and researchers: Civil society is key to the HIV response at national levels. They can, and should, play a concrete role in how to connect prevention programs to trials. As both the ethical guidance and the GPP guidelines highlight, advocates and civil society should have voice in these decisions, and it was good to see that happen in the summit. True engagement, though, doesn’t just mean one meeting. It means a comprehensive, transparent plan for the ongoing role for advocates.
  • Trial sites and governments: Science does not happen in a vacuum; national policies have great impact on trial conduct, and as we have seen with HVTN’s proactive and progressive stance with regards to treatment in HIV prevention trials in 2003—researchers can also have an impact on national policy. SAMRC has committed to working with the South African National Department of Health to set up demonstration projects closer to trial sites.
  • Trial sites and local and national PrEP implementation and research activities: If PrEP cannot be provided onsite, mechanisms must be developed to connect participants to PrEP delivery programs and initiatives. Data and existing capacity from the research and implementation activities should also inform messaging and enhance counseling and adherence support.
  • National advocates and community advisory boards (CABs): To ensure PrEP plans are developed with meaningful and inclusive engagement, that CABs need to be linked to national advocacy agendas, and national advocates, in turn, to the clinical trial objectives and activities. VARG members are planning to follow up with CABs and community engagement personnel to ensure coordination and synergy across sites and communities in South Africa.
  • Regulators, ethics review bodies and funders: The decisions from the summit stand to impact trials happening across Southern and East Africa and those being implemented by multiple clinical trial networks. To promote equity and ensure adherence to core ethical and scientific values, regulators, funders and ethicists need to be coordinated across geographies and networks.

So, what?

AVAC’s position, as we outlined in our new report, is clear: while one research organization, product developer or funder cannot reverse global inequities in HIV prevention or care, researchers have an obligation—and an opportunity—to try to narrow the equity gap. Trialists must grapple with PrEP provision in clinical trials head-on; they should work with program implementers and communities to develop, implement and assess high-quality prevention and treatment models for participants in research programs, and can encourage the development of sustainable community access to good quality, comprehensive HIV prevention.

The summit was a good starting place. As advocates we will be following the implementation of the plans set out by MRC and HVTN—we will be making sure that stakeholders involved and affected by the decisions (from advocates to regulators to trial site staff) are engaged in a sustained manner, that trial sites are communicating with PrEP programs in their contexts, and that there is equity in access across trial sites and across countries.

As we anticipate how the next generation of PrEP products and other HIV prevention modalities will further complicate standard of care conversations, it is partnerships and transparency that will make research smoother and more relevant to the real-world context.

Further resources