Reporting from Living 2024 Community Workshop ‘Why people living with HIV must be included in non-HIV clinical trials’

On Saturday, July 20, 2024, as part of the Living 2024 conference and ahead of the International AIDS Society’s AIDS 2024 conference in Munich, Germany, the European AIDS Treatment Group (EATG) hosted a community-led workshop focusing on the critical need for including people living with HIV in non-HIV clinical trials.

Building upon EATG’s ongoing work within the framework of the Belong project and position paper, the workshop aimed to address the current lack of data on treatments for non-HIV conditions and the existing barriers preventing people living with HIV from participating in clinical trials designed to ensure equitable access to healthcare advancements.

During the session, EATG members and Belong Community Advisory Group (CAG) representatives Brian West, Alain Volny-Anne, Memory Sachikonye, and Luís Mendão shared community perspectives on the current exclusion criteria for people living with HIV in clinical research and discussed the implications of these practices.

“Wherever we have access to antiretroviral therapy and good HIV care, we, people with HIV, are living longer. It is almost like being part of the general population, which we are anyway. But then, with our specificities, we are confronted with health conditions that often fall in the process of ageing, just like in the general population. And we need to know if new therapeutic approaches to such diseases will be efficient. Not making sure that we can participate in research on these new treatments illustrates the extra – ultra! – caution taken by researchers but ends up being terribly unfair to us. In my culture of activism, it is up to the individual to decide if they want to join a clinical trial after being adequately informed of potential risks. Without being a disease, pregnancy is a good example: it was for long – too long! – an exclusion criterion for HIV clinical research. Now, we have come a long way. Many HIV clinical trials do not exclude women who become pregnant anymore and, as a matter of fact, include them in specific sub-studies (for which they sign a different informed consent sheet). Why not do the same in other areas? For example, in cancer research, why not allow in people with HIV and dedicate resources to their specific situation? The community of people with HIV/AIDS has always cooperated with HIV researchers. Now it is just a matter of having researchers from other disease areas listen to us and invite us to review the design of their clinical trial protocols, the informed consent forms, etc. Something – our experience, probably – is telling me that we are ready for this” shares Alain Volny-Anne.

Noting the urgency of this issue, Brian West adds: “The exclusion of people living with HIV from non-HIV drug trials had been a longstanding problem, which came to a head during the Covid-19 pandemic, when it was brought to our attention that in Italy, some people had been excluded from Covid-19 vaccine trials. That encouraged us to set up the Belong project with community representatives, academia, and pharmaceutical companies to see how we could address this. It produced a position paper demanding that all people living with another health condition have the right to be part of clinical research whose outcomes may benefit their treatment and care. The discussion at the Living Conference focused at the end on how that could best be achieved and a big focus on regulatory issues emerged as a priority.”

One of the key objectives of the Belong project is advocating for more inclusive and representative research protocols, with specific attention dedicated to the inclusion of women and other underrepresented groups in clinical trials. In this regard, Memory Sachikonye emphasises that “Including women in clinical trials is crucial in ensuring that medical research and treatments are comprehensive, equitable, and effective for all populations. This is essential for developing safe, effective and equitable medical treatments. It ensures that the unique health needs of women are addressed, leads to better health outcomes, and aligns with ethical standards in medical research”.

As part of the workshop, EATG also presented “What We Wanted was What We Needed – Rebuilding a Community of Memories and Inclusive Advocacy”, a feature documentary on the Sitges Meetings released in January 2024. Documenting experiences and lessons learned from the Sitges meetings, EATG’s documentary presented The Sitges Model, a successful community-led advocacy approach to promote more inclusive research trials.

EATG intends to replicate and apply the Sitges Meetings Model specifically to the development of guidelines for the inclusion of people living with HIV in non-HIV clinical trials. According to Luís Mendão, “The Sitges meetings on research, development and access to new drugs to treat and cure Hepatitis C proved that good, clear and fair community objectives – access for people with HIV and HCV co-infection to participate in studies and clinical trials – involving all relevant stakeholders changed the course of the research and saved hundreds of thousands of people. Let’s do it again!”.

Since 2022, the Belong project has worked to develop and build consensus among all the relevant stakeholders on a set of recommendations for European guidelines and regulations for the inclusion of people living with HIV in non-HIV clinical trials. By engaging all relevant stakeholders, the project aims to raise awareness on why this systematic exclusion can no longer be justified and dismantle systemic barriers to create more inclusive, representative trials.

Collaborative efforts are key to driving change in clinical practices and ensuring that everyone has access to the benefits of healthcare innovations.

*Join us in advocating for inclusion in clinical trials—endorse our position paper here!*

Session description on Living 2024 platfrom

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