STEPS, a community initiative to design the pathway to a long-term remission of HIV infection, has reached its 5th edition in Glasgow. This year the theme of the meeting that was held just before the opening of the HIV Drug Therapy Congress was ‘socio-behavioural science and ethics around HIV cure research’.
“This study will not cure you!”
After a brief introduction by Giulio Maria Corbelli, Simon Collins led the discussion around the disconnection between the expectations of researchers and those of the participants: participants are asked to consent to very intense and invasive procedures, while researchers know nobody will be cured in these studies; they are only a piece of a greater part of efforts to make science advance. This disconnection is the main problem in the ethic aspects of HIV cure research trials. Researchers know that participants in HIV cure research studies will get no personal benefit, while participants expect or hope to have personal benefit from participating.There is now very good experience with HIV treatment: life expectancy has been normalised -especially for those who are diagnosed early- and treatment can be personalised. In HIV cure studies participants are asked to do something different from these successful treatment strategies, to veer away from best practices. It may be difficult for some people to understand the importance of guidelines as well as the risks connected to moving away from these procedures. It is also difficult to understand potential risks involved with cure studies, since these are complex studies with new procedures. For example, most HIV cure studies include Analytical treatment interruption (ATI) . But interrupting treatment can represent a risk and participants must fully understand those risks. Usually people sign the informed consent sheet without even reading it and if they read it in many cases they do not understand it. The readability score of most informed consent sheets is good for university graduates, so they are not written in a language that can be easily understood by people from lower educational levels.
Analytical treatment interruption is in contradiction with all treatment guidelines and there are important social and ethical considerations around this intervention, with no evident benefits for the participants. Community organisations and advocates should explain the science and the trials so that people consenting to participate are really informed. Community has a critical role in the development of informed consent forms and other materials that can translate and disseminate reliable information from high level research to be accessible to people with different backgrounds. Suggestions were made for innovative approaches, such as using different tools like videos or new technologies so as to align with advocates from other disease areas -such as cancer communities- facing similar issues.
ATIs are one of the most sensitive issue, calling for clear criteria to minimise risks in treatment interruptions. Richard Jefferys and Simon Collins have drafted a paper that can be a good starting point.
Karine Dubé, in a video presentation, updated the audience of the workshop about the most important psychosocial studies conducted in the field of HIV remission and highlighted the need to advance in this field in order to understand better the perception and ethics of cure research and ATIs, risks and benefits, expectations and motivations that lead to participation to research.
Results from specific surveys about willingness to participate into HIV cure studies and understanding of risks were presented. According to a study, the most important motivator was to feel good contributing to HIV cure research and also the notion of helping find a cure for HIV. Apart from the more altruistic motives, participants also claimed that they would participate into Latency Reversing Agents (LRA) studies to reduce the viral burden in their reservoirs, although it has not been demonstrated yet that any LRA is able to reduce the virus in reservoirs. A lot of data about acceptable and not acceptable risks were also included in the video presentation.
Another survey conducted by Dubé and David Evans looked at how people evaluate an improvement by a potential future HIV cure over currently available HIV treatment. HIV not reproducing itself inside the body was the most important factor estimated by the participants, followed by overcoming the need to take treatment every day. People think that being 1-2 years off treatment without rebound would be enough to be considered cured.
Further to the presentation Dubé illustrated the principles of ethics in clinical research, which may be slightly different from medical ethics or public health ethics. There are several values in research ethics: scientific validity, social value, potential for scalability, acceptability, favourable risk/benefit ratio, informed consent, community involvement and independent review. The importance of the informed consent was again highlighted.
There is a lot of literature on different topics, from ethics of healthy volunteers participation, ethics of ART interruptions, end of life etc. ATI is the most controversial topic. Some papers focus on the issues related to language and its ethical use; for example, is it ethics to talk about HIV cure? Finally, there is the issue of scalability which also has important ethic consequences.
Giorgio Barbareschi presented the HIVACAR study where EATG is the community partner in charge of conducting a survey among people living with HIV on their knowledge about HIV and the possible impact of reaching a solution to control the HIV infection without cART. Community Support for Clinical Trial Participants and Community Targeted Communication Tools were developed in order to support the participation to the study and dissemination of information.
You can find the presentations here:
Ethical and practical considerations in HIV cure research by Simon Collins:
Socio-behavioral sciences/ethics around HIV cure research by Karine Dubé:
Social science research in the HIVACAR project by Giorgio Barbareschi:
This review is based on notes by Giulio and Giorgio. Thank you both.