VOICES

Dear reader,

Welcome to the eighth edition of IAVI’s VOICES newsletter.

The 24th International AIDS Conference (AIDS 2022) called on the world to come together to ‘re-engage and follow the science.’ The conference sought to define future research agendas, shift latest evidence to action, and chart a new consensus on overcoming the HIV pandemic as a threat to public health and individual well-being.

This issue of the VOICES newsletter aligns to the spirit of AIDS 2022 as communities, researchers, and HIV prevention advocates continue to lend their voices to the call for accelerating access to prevention products that may eventually lead us to overcoming the HIV pandemic. They underscore the need to engage with communities, listen to the messages from advocates, and truly respond to their demands. They emphasize that it is only from that place of listening that the work can move forward to truly ensure everyone who has a part in finding solutions is identified and brought on board, with the voices of the powerful and powerless meeting together as equals around the same tables.

This issue of VOICES also reiterates the need to build on existing platforms and partnerships to address emerging healthcare challenges. It further highlights the roles, responsibilities, and relationships between regulatory bodies, sponsors, and investigators towards accelerating product development, access, and ultimately universal health coverage in their countries.

If you know someone else who would benefit from reading VOICES, please feel free to share it with them. We also encourage you to write to us and let us know how we can improve this newsletter.

Happy reading,

Ethel Makila
Director of Advocacy, Policy, and Communications
IAVI
This email address is being protected from spambots. You need JavaScript enabled to view it.

The views and opinions expressed in this newsletter are those of the authors
and do not necessarily reflect the official policy or position of IAVI.

Reflections on AIDS 2022: Inclusivity, access, and affordability

By Gail B. Broder, MHS, associate director, Social Behavioral Science & Community Engagement Unit, HIV Vaccine Trials Network/COVID-19 Prevention Network

Gail B. Broder, MHS, associate director, Social Behavioral Science & Community Engagement Unit, HIV Vaccine Trials Network/COVID-19 Prevention Network

I was asked to offer my reflections on AIDS 2022, also known as the International AIDS Conference, hosted every two years by the International AIDS Society. Writing such reflections has been challenging; why?

Perhaps because I found the conference to be disappointing, a let-down. While we all expected the conference to be smaller in the emerging-from-COVID liminal space, I could not have imagined what a difference it would feel like to go from 20,000-25,000 who attended conferences prior to the COVID-19 pandemic, down to roughly 9,000 in person in Montreal, and an average of 2,000 online participants. Everything just felt small. It was disappointing to see how few exhibitors there were at the Global Village and Exhibition Hall. It was also disappointing to see the smaller traffic of visitors who came through the Global Village. I saw very few members of the general public visiting, which makes me wonder how the conference was promoted locally; the whole point of the Global Village from its inception was to make the conference accessible to the local public of the host city without having to pay to attend the whole conference. I also missed the live-stream of the morning plenary (now “Prime”) session in the Global Village, which made those important lectures available to the public. That was not offered this year, opting to open the Global Village after the conclusion of the Prime session.

Perhaps it was because it was the near total absence of representatives from the Canadian government, and people from the governments (or even just the Health Ministries) of many other nations. In the same breath, the absence of the Canadian government meant that the protests lacked their usual punch. I am accustomed to the raucous energy of the protesters with their handmade signs and banners, but when those in power are not present to hear the truths being spoken, it all falls a bit flat. It also felt a bit too staged, too choreographed, with professionally pre-printed signs and banners carried by most participants.

Also missing this year was the celebrity factor. In the past, I’ve attended sessions alongside musician Annie Lennox, actors Richard Gere and Charlize Theron, Prince Harry of Great Britain, Archbishop Desmond Tutu, Nelson Mandela, Bill Gates, and former President Bill Clinton, just to name a few. The absence of celebrities made me wonder: is HIV/AIDS no longer worthy of celebrities’ attention? Does this work no longer have celebrity status? Or was this absence just another impact of COVID-19?

This meeting has historically been an opportunity for civil society to hear from the people doing the work on the ground and from the scientists conducting the research, and their absences were notable. To be sure, there were bright points in the science being presented like the news about “Doxy PrEP” to help prevent bacterial STIs [sexually transmitted infections], and the attention focused on rolling out long-acting injectable cabotegravir to global populations who most need it. While much of the vaccine news continued to be about products that did not work as hoped, it was great to see the discussions of new experimental medicine vaccine trials that will dive deeper into early immune responses that may prove to be better predictors of whether a product is even on the right path toward future efficacy. The baseball metaphor of “you can’t score if you don’t get on first base” comes to mind, and it will be interesting to see the data coming out of these smaller trials. Dr. Fauci, never one to disappoint even via streaming technology, laid out a significant body of work that is planned in the coming years on all fronts for prevention, therapeutics, and cure research, and it is great to see him returning his attention to HIV after leading so much of the U.S. COVID-19 efforts.

But my favorite feature of the meeting was the prominent recognition and inclusion of the First Nations Indigenous Peoples of Canada. I deeply appreciated the terminology about being on “unceded lands originally occupied by the Kanien'kehá:ka (Mohawk) nation” as well as the Seneca, Cayuga, Oneida, Onondaga, and Tuscarora peoples (with apologies if I have omitted any others). The prayers offered at the Opening Session were breathtaking, and anyone who hasn’t watched them has my strong recommendation to go back and watch the recording. “The words that must be spoken before any other words” and the blessing for water: if only we could all carry the same sort of gratitude for creation/the world around us, and whatever creator any of us believes in, putting that gratitude first and foremost in our minds.

Looking ahead to Australia in 2024 and beyond, IAS and the local organizing committees have a formidable task. How can work begin to ensure that conference attendees arriving from anywhere in the world have equitable and timely access to receiving their travel visas and any other documents, and that meetings are no longer held in places where anyone is excluded? How can considerations for the great expense of conference attendance be best managed to ensure that those with the least ability to afford to attend are still able to do so? How can solutions for climate responsibility be applied to minimize the carbon impact of so many people flying around the world to these large meetings? How can we better promote the conference to local communities so that they are able to take full advantage of the access that is offered through the Global Village, and make the Village a robust space for sharing ideas and hearing from the greatest diversity of people and cultures?

None of these questions have simple answers, but the answers all share a common starting point: engaging with communities, listening to the messages from advocates, and truly responding to their demands. It is only from that place of listening that the work can move forward to truly ensure everyone who has a part in finding solutions is identified and brought on board, with the voices of the powerful and powerless meeting together as equals around the same tables.

Era of glorifying numbers: Neglecting a link to PLHIV’s quality of life

Inad Quinones Rendon, HIV programming and advocacy officer

By Inad Quinones Rendon, HIV programming and advocacy officer

The significance of being employed cannot be understated. As a source of income, employment allows us to access food, housing, education, and healthcare. As part of our identity, it cultivates within us a sense of worth and purpose. Employment plays a critical role in producing positive health outcomes among people living with HIV.

The global HIV agenda is driven by quantitative data. As we implement HIV interventions, we experience a shift of our priorities into reaching globally accepted goals defined exclusively by numbers. We operate in an era where achievement of high targets is celebrated as a successful HIV response. Quantity indicators must not be equal to and must not define quality. For example, an HIV program is deemed effective and successful if the number of PLHIV linked to antiretroviral therapy constitutes 95% of PLHIV who know their status. In no circumstance do the same numbers describe the effectiveness of a program’s efforts to address social and economic barriers, including employment, the PLHIV face. Hence, in the absence of qualitative indicators, HIV interventions cannot effectively and completely address other factors that contribute to the ongoing epidemic.

The employment rates among us who are living with HIV are lower than the general population. Finding out our HIV status, we are most likely to lose or leave jobs for various reasons. Learning about our HIV diagnosis, we deal with self-stigma and struggle to accept our new identity. This impacts our socio-economic well-being and fundamentally alters the course of our career lives. The sudden and unfair termination of one’s employment can cause significant amount of stress which will place PLHIV to greater risk of poor health. As we face economic challenges such as unemployment and job insecurity, our access to healthcare and to treatment for viral suppression becomes inconsistent. This will result in a sub-optimal treatment adherence and negative health outcomes.

In my case, I have experienced firsthand the detrimental effects of HIV diagnosis to my well-being. Upon diagnosis I discontinued my education, lost my job, and was not able to consistently take antiretroviral therapy. I suffered from anxiety caused by an environment of unstable and inadequate resources. Other psychological problems persisted due to reduced access to food and housing challenges resulting from unemployment. While I can underscore the efficacy of ART [anti-retroviral therapy] in suppressing the virus within me, I cannot ignore the fact that interventions assisting socio-economic barriers were absent.

From my recent engagements in Asia-Pacific region, a significant number of newly diagnosed PLHIV are losing jobs, facing unemployment, or already unemployed. Against this reality, the few PLHIV having obtained even basic employment is considered privileged. In its path towards ending AIDS, the global HIV response has an outstanding obligation not only to fight against the virus, but also to care for the people who are living with it.

Target-driven health interventions and quantitative data are significant to public health programs. Regardless, these does not negate the need for interventions that address socio-economic disparities. To improve quality of life of PLHIV, HIV programs need to acknowledge the relationship between employment and positive health outcomes. Peer support and case management programs need to go beyond ART retention and start supporting eligible PLHIV in the complex process of exploring employment options after diagnosis.

Whose choice? Our choice!

Jim Pickett, advocate. Photo credit: Ryder Kennedy

By Jim Pickett, advocate

Four years ago, I was among global prevention advocates who released a report titled “Whose Choice is it Anyway?” The report focused on an analysis of comments to and responses from the U.S. National Institutes of Health’s 2017 call for input on research priorities.

Every seven years, the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, revisits its HIV prevention and treatment research priorities and competitively renews its funding of the HIV clinical trials networks operating in the United States and across the world. To help determine focus and priorities for the networks from 2021 through 2027, NIAID launched a request for input in early 2017 that it promised would be transparent and meaningful.

Our review of the input, obtained through a request via the Freedom of Information Act, revealed strong global support for drugs and modalities that were short-acting, non-systemic, and user-controlled, in addition to long-acting, systemic, clinically delivered options. This support came from communities impacted by HIV as well as researchers and other stakeholders. Meanwhile, the Microbicides Trial Network is no more, and we have a prevention research and development pipeline that defers mostly to long-acting, systemic products. The collective input was set aside. Whose choice was that?

The monthly vaginal dapivirine ring, a safe and effective prevention choice which has a potentially high demand by women in sub-Saharan Africa, many of whom took part in the clinical trials for this product, could be one of the options. But its future — and availability — is unclear. If it is truly to be one of the options that’s available for women in African countries, it needs more investment and support, including for research to extend its usefulness to three months.

We must have a robust choice agenda, an agenda that considers different drugs and modalities and doesn’t defer to only long-acting and systemic options. We must have an equity-focused agenda that recognizes the diverse needs of a wide array of races, genders, and communities, that recognizes human rights and bodily autonomy, and that truly listens. We need fulsome implementation choices (“differentiated service delivery”) and we need to banish once and for all the magical thinking that seems to come along with any new prevention technology.

We need a robust and delicious choice buffet — a buffet built on equity, cultural literacy, humility, sexual health, holistic wellness, and pleasure. And we need lots of tasty choices on that menu for people to have the best opportunity to find things they like and that work for them, delivered in diverse, tailored ways so access is not theoretical.

When we say “our choice” we mean it. It’s not a performance. It’s our lives.

The role of regulators’, investigators’, and sponsors’ relationships in accelerating access to new prevention products in Africa

Prof. Bartholomew Dicky Akanmori, regional adviser for vaccine research and regulation with the WHO Regional Office for AfricaBy Prof. Bartholomew Dicky Akanmori, regional adviser for vaccine research and regulation with the WHO Regional Office for Africa

The past decade has seen significant improvement in research and development for products to meet public health needs especially in low-and middle-income countries (LMICs). Better prioritization of diseases, good governance, improvements in clarity and transparency of national ethics and regulatory process, consistently shorter and competitive timelines for decisions, and the provision of scientific advice are good examples. Digitalization has also improved efficiency. Africa now has four countries (Egypt, Ghana, Nigeria, and Tanzania) whose national regulatory bodies have attained maturity level 3 as assessed by the World Health Organization. South Africa and a few other countries are not too far behind.

Progress towards local product development and manufacture has been driven by the African Vaccine Regulatory Forum (AVAREF), Regional Economic Communities under the African Medicines Regulatory Harmonization and with the support of the World Health Organization, the AUDA-NEPAD and key strategic partners. Other international regulatory authorities are serving as good models and strengthening peer-learning. The peak of these efforts will be the operationalization of the African Medicines Agency, which is intended to contribute significantly to reduced inequities in access to vaccines and treatment. The early access to vaccines against COVID-19 in high-income countries while LMICs especially African countries waited their turn, further underscored the need for local vaccine manufacture to ensure equity, and saw several countries embark on technology transfer for the manufacture of vaccines on the continent.

To address disease priorities and emerging and re-emerging diseases that threaten global health, new technologies and complex clinical trial designs are being rapidly applied to the remaining. Nouvelle approaches to product development require additional knowledge, expertise, and more resources to meet the competitive timelines required for success. Among the key challenges is the definition of roles, responsibilities, and relationships between regulatory bodies, sponsors, and investigators. While ethics and regulatory authorities see their role as gatekeepers to protect consumers of health products, it is important that they also appreciate their overriding responsibility of accelerating product development, access, and ultimately universal health coverage in their countries. The gatekeeper approach has in some situations slowed down product development, rendering opportunities to address diseases such as HIV/AIDS through new technological platforms unreachable to populations eagerly waiting for new and better interventions.

The relationship between regulators (ethics committee and regulatory authorities) and product developers (funders, sponsors, and investigators) remains vital to successful product development. It is important that the regulatory authorities see themselves as providing guidance that will accelerate the pathway to an end-product. On the other hand, it is expected sponsors and investigators not only meet the requirement of regulators, but also focus on the needs of participants, ensuring the safety and respecting the principles of research ethics in clinical research without any compromise. Africa is in need of better and innovative products to address complex public health needs, and only such a healthy and strong collaboration between these major actors in product development can help to address these needs. The AVAREF model has set the pace in building relationships between regulators and ethics teams on one hand, and research and donors on the other hand. However, there is still more to be done and this model needs to be scaled up to ensure that the gains made are sustained and spread to all countries of the region.

Building on existing platforms and partnerships to address emerging healthcare challenges

Jayanta Bhattacharya, Ph.D., director – Antibody Translational Research Program (ATRP), IAVIBy Jayanta Bhattacharya, Ph.D., director – Antibody Translational Research Program (ATRP), IAVI

Amid the threat to global health from emerging and re-emerging diseases, it is imperative to have in place a mechanism to provide a timely response towards saving lives. Such a mechanism is not just one instrument — rather, it is an amalgamation of a solid grasp of basic sciences and their applications, well-trained scientists working in cutting-edge labs, and a supportive infrastructure for scale-up and commercialization of scientific products and solutions. At the same time, it entails an ecosystem that facilitates the seamless transfer of knowledge into workable commercial solutions that address the needs of the population most in need — be it products or services. All these can be put into four pillars: global partnerships, technology platforms, scientific know-how, and infrastructures.

Partnerships in global health remain essential in transforming health services, particularly in low- and middle-income countries (LMICs). From our experiences with HIV and partner services, we have learnt the crucial role played by public health partnerships in promoting contact tracing and ensuring that people who have been exposed to an infectious illness receive the right counselling, testing, and treatment. Today, we see the learnings from the HIV field being applied to other disease areas, moving global health away from the paradigm of disease-specific silos to a health system strengthening and population well-being model.

Collaborations between private and public sector, or healthcare workers and local governments, have supported the translation of innovations into products and services. Examples include the manufacturing of diagnostics that are crucial in rapid detection of disease, vaccines based on new mRNA and recombinant DNA-based platform technologies, and therapeutics such as monoclonal antibodies that are delivered for rapid intervention at the population level. Lessons learnt from decades of research in HIV have also given way to innovative vaccine designs and their rapid acceptance. Nevertheless, the COVID-19 pandemic has shown us that in order to be prepared for the next pandemic, we must step up investment in basic research and equitable access to products of research.

While there are great examples of how existing and growing global partnerships, advanced technology platforms, scientific know-how, and infrastructure are the building blocks to combat future pandemics, it is important to build capacity and capability at the local levels, particularly in LMICs. This will ensure accessible innovations and help increase the number of collaborative initiatives that yield value at the local level while significantly contributing to making the right to healthcare genuinely universal.

Editorial Team

William Dekker – Communications Specialist – ADVANCE, IAVI
Roger Tatoud – Global Health Consultant
Dr. Morenike Ukpong-Folayan – Coordinator, New HIV Vaccine and Microbicide Advocacy Society
Ethel Makila – Director, Advocacy, Policy, and Communications, IAVI

Questions/comments? Email Ethel Makila at This email address is being protected from spambots. You need JavaScript enabled to view it.

DISCLAIMER:
The views and opinions expressed in this newsletter are those of the authors
and do not necessarily reflect the official policy or position of IAVI.