Our New Year’s Resolution for 2018: Speak up, act up loud and clear

Released a few weeks ago, AVAC’s annual state-of-the-field report calls for an end to mixed messages about key issues affecting HIV prevention research and implementation. As we come to the end of a year that has been filled with challenges and moments of resilience, collaboration and progress, we want to be clear once more: we cannot give up, and we cannot do this alone.

Over the past several days in the US, a law has passed that many analysts say will increase taxes for poor and middle-class people, and make life even easier for the richest of the rich. There’s also been a flurry of news and action triggered by the report that the US government directed the Centers for Disease Control and Prevention (CDC) not to use seven words in its budget requests: diversity, entitlement, evidence-based, fetus, science-based and transgender.

CDC denied the ban, but this hardly matters. A valuable analysis of the last four CDC budget requests—lengthy documents that lay out the agency’s annual plans, priorities and funding needs—shows a dramatic decrease in the number of times CDC used some of the words on the alleged list in its budget requests. In particular, transgender and evidence-based were both nearly erased from these documents, which run hundreds of pages long. This signals worrying programmatic and policy shifts.

Income inequality is a global scourge; censorship is an insidious practice. They are also two facets of the structural violence that drives HIV worldwide. You cannot be an advocate for HIV prevention and accept wealth disparities or any form of silencing as the state of the world.

And so we don’t.

Not today and not ever.

In the past months, AVAC has launched a new program with African transgender rights defenders and activists, and has begun work on a dynamic new phase of coalition-based action aimed at ensuring that people most affected by HIV are at the frontlines of decisions about the HIV response in their communities. Stay tuned for updates about these and all of our activities in the New Year.

In 2018, we’ll keep on working with our partners in these and many other initiatives to speak up, act up and fight back against all of the drivers of the epidemic. Our lives depend on it, and we depend on you as partners in this fight.

In that spirit, we send our great thanks for your partnership and wish you all a holiday season of rest, respite and recharging.

The Weekly NewsDigest will return January 5

There will be no issue next week. The NewsDigest will return on January 5, 2017. Our best wishes for happy holidays and a peaceful new year, and our thanks for reading!

Untangling Mixed Messages in the Newest Episode of AVAC’s Px Pulse!

Last month, AVAC released our annual, opinionated state-of-the-field report—Mixed Messages and How to Untangle Them. It’s filled with information, graphics and in-depth analysis and definitely worth a read! This month, we’re also pleased to offer highlights of the report in the December episode of our podcast Px Pulse, which is now up. Find it on iTunes or click here for Px Pulse on avac.org.

Hear AVAC’s Director of Strategy and Content, Emily Bass—who’s been writing for the AVAC Report for nearly 15 years—give short, sharp summaries of the key “mixed messages” that the report untangles, and review AVAC’s advocacy agenda for the year ahead. In conversation with AVAC’s Web Editor, Jeanne Baron, Bass describes critical issues in the research landscape, the evolving field of PrEP rollout and the unfinished work of scaling up effective HIV prevention worldwide. Tune in to hear what AVAC thinks needs to happen—now and in the year to come.

We can’t wait to hear what you think!

US Agency for International Development/Bureau for Global Health/Office of HIV/AIDS/Research Division, Microbicide Branch (GH/OHA/RES) is recruiting to fill the following position: Senior Advisor for Development of Biomedical HIV Prevention Technologies

For more information, please click here.

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

What Young Women Want

This letter comes from a group of young African women and reflects their HIV prevention research priorities. It was submitted to the National Institutes of Health’s (NIH) Division of AIDS (DAIDS) during the open-comment period concerning the structure and agenda for its next funding cycle (2021-2027).

Dear Dr. Carl Dieffenbach,

We are eight young women from South Africa, Uganda and Zimbabwe who were involved in recent consultations for planned HIV prevention trials with young women. We are interested in HIV prevention research because in each of our countries, young women are at high risk for HIV and we are so excited to hear that finally the needs of protecting young women are at the forefront of studies exploring new prevention tools. We understand that you and DAIDS are considering the research priorities for the next several years and we want to make sure that our voices are heard.

We are:
Sanele Ngulube – Zimbabwe, age 20
Irene Hware – Zimbabwe, age 22
Cleopatra Makura – Zimbabwe, age 21
Shakirah Green – Uganda, age 24
Catherine Nakkide – Uganda, age 22
Charity Twikirize – Uganda, age 22
Sinazo Peter – South Africa, age 24
Anelisa Madalane – South Africa, age 18

Please accept this as our feedback to you as you consider the research agenda that affects our future.

We have arranged our suggestions to you based on the themes we discussed together as a group. Here is what we want.

1) We want choice. The feeling that young women have when we know we have choices on how to protect ourselves, gives us power within and we get confident. The power and confidence means there are less chances that we become reckless about our sexual reproductive health. Choice frees us from slavery of any type because we are able to say yes or no, or even pick from a variety without being judged.

Most of all, we, young women, love experiencing new things and we love pushing boundaries. We want fun and exciting things and we shouldn’t be scared of using other methods because they are not of equal standard. Simply put, choice makes our life better.

2) We want products that are safe for our bodies and discrete. We, young women, are delicate, and you know how sensitive our vagina is. Not only that, but we have to fight social norms and cultures in our communities. We know that social norms should not dictate how we should take care of ourselves, but we also realise that most young women are oppressed by their partners, communities and culture.

We want something that will not attract people’s eyes and judgement. We need something that doesn’t require us to close our eyes, and clench our teeth when we use it. Again, it means we need different choices.

3) We want both systemic and non-systemic options. We have different opinions on what can work for us. Some of us like the idea of having to go to the clinic only once and be protected with a long-acting product—and it would be great if that could be for 6 months. Some of us like the convenience of systemic coverage. But others of us are nervous about side effects and the interaction with our sensitive bodies. We don’t want something that requires constant check-up. We want something that doesn’t stay in our bodies for a long time.

So, if you want to prioritise long-acting systemic methods, please make sure that it is easy and has no side effects for us. But remember our first point, that we want choices—we are all different and we want different tools at the table so we can choose what suits us best. We are all from different environments and cultures.

4) We want something other than injections. Some of us are okay with injections, but for others, injections don’t work and we want something we can take without pain. Some of us think twice about even going to the hospital when we are sick because we are scared of injections. Also, injections mean going to a clinic—and we have to deal with judgmental nurses who think we are too young for sex.

A visit to the clinic is really something else. So, if you plan on only giving us injections, it is not okay with us. We are not all good with the injections—please ensure that the research gives us something else too.

5) We want the ring: We love the idea of the ring. You insert it and you are done. It is like our secret weapon, painless but protective. We would use it because it’s in and doesn’t bother us for a while, and we can watch out for ourselves. We would even love the ring more if you added a contraceptive. We understand that DAIDS is thinking not to put more research into other forms of rings like this and we don’t think that’s a good idea. We have seen it works for some women and that’s okay that it doesn’t work for all because it’s another tool, another choice.

We want to thank you for the research you and your team have done. Thank you for the time you have put in and done for us, so far. However, we want you to know that we want more and we need more from you. We want to challenge you to do more for us and we want you to involve us more. We don’t want to be terrified of the products we are using (and please, if you come up with a new product, make it smell good). We don’t want side effects. And please, don’t forget about the potentially expensive costs of these methods. Most of all, we want products that will be safe and protect us as much as possible.

We hope our views will be heard and considered because we don’t want our issues to go unnoticed. We would love if—in the future—we were asked first about our needs instead of just coming with the products researchers think will be best and then asking us if we would use them. There is a South African saying, “it’s better to hear it from the horse’s mouth.”

—Sanele, Charity, Irene, Cleo, Shakirah, Catherine, Sinazo and Anelisa

New Video Series: Lessons from the field on oral PrEP introduction

AVAC is pleased to share a new series of videos on the introduction of daily oral PrEP in Kenya—Lessons from the Field. The series features lessons on how to fit this newer prevention option into the lives of people who need it through case studies of issues related to supporting Kenyan women who choose to take daily oral PrEP.

Check out the videos here.

A collaboration with LVCT Health in Kenya and AVAC, through the USAID-funded OPTIONS Consortium, this series was filmed at several sites in Kenya where LVCT Health offers oral PrEP to populations at risk of HIV. Each film highlights a different theme or challenge that emerged as PrEP rolled out, and tells the story of how the project responded:

In these videos, women enrolled in LVCT’s oral PrEP project share their experiences and program staff describe tactics they developed to address these issues, such as hotlines, enhanced counseling and support, and engagement with the community.

This series is intended for PrEP stakeholders, including program implementers, policy makers, civil society, advocates and people considering PrEP in Kenya and other countries. Taken together, the full series will increase understanding of specific barriers to delivering oral PrEP and show successful strategies to help people start oral PrEP and use it correctly and consistently.

Check them out at PrEPwatch.org and please tell us what you think at avac@avac.org!