Today, HIV is increasingly being considered as a chronic condition with near-average life-expectancy. Consequently, the well-being and health-related quality of life of people living with HIV are gaining increasing importance. Evidence suggests that even with effective treatment, people living with HIV have a significantly lower quality of life than the general population.
Reasons for this are grounded in the physical, psychological and social domains that are likely to be overseen by traditional clinical measures focusing mainly on viral load suppression, that determine the choice of treatment and drive the development of new drugs. Patient Reported Outcome Measures (PROMs) can be a tool to address this issue. Defined as “data reported directly by a patient on his or her own health condition, without interpretation by a doctor or anyone else”, PROMs can help assess the implications of a disease and the applied treatment on how the patient feels and functions and compare the clinical outcome to what the patient expects from the treatment.
In addition, PROMs, usually in the form of standardised questionnaires, constitute a unique means of capturing the personal and social context of the patient’s experience in terms of the disease and treatment that might not necessarily be captured by biomarker measures or adverse events.
PROMs are used in clinical research to ensure that the quality of life of trial participants does not diminish due to the new product and to differentiate new products based on specific characteristics that cannot be measured with lab tests and other clinical diagnostic tools. Guidelines for PROMs use in research and development (R&D) trials exist but they are old and do not address HIV R&D specifically.
Since 2020, EATG has commissioned research under the scope of the PROMise project to analyse the role of PROMs in HIV R&D and to explore potential contributions by community-based organisations. The results and recommendations from the research can be read here.
After holding a session at the European AIDS Conference in London in October 2021, EATG conducted a consultation process with involved stakeholders (community, academia/clinicians, and pharmaceutical companies) that reviewed recommendations from the research paper. Many of the original recommendations in the research paper were endorsed. As a follow up, EATG convened a stakeholder workshop on PROMs in HIV Research and Development in Brussels in June 2022, that aimed to explore a methodology for discussion and consensus on various aspects of PROMs in HIV R&D.
The involved stakeholders then identified the tasks required for the next stage of the project, including further research in to developing desirable PROMs domains and how these can be incorporated into current PROMs use.
The project is mainly addressed to 1) community organisations and people living with HIV advocating for stronger consideration of quality of life aspects in HIV R&D, treatment and care; 2) industry, academia or research institutions working in the field of HIV R&D; 3) researchers and clinicians developing PROMs; 4) regulatory agencies in charge of drug approval and registration at European level (EMA) and at national level; 5) international organisations and institutions working in the HIV response in the WHO Europe region; 6) health policy decision-makers at EU level and national level; and 6) Health Technology Assessment bodies.
The next phase of project activities include:
Specifically, the objectives of this new phase of the project are:
|EATG contact person(s):||Fiona Greenhalgh – email@example.com|
|Duration of the project/initiative:||February 2020 – ongoing|
|Project/initiative Main Partner(s):||n/a|
|Budget:||2020: 10.000 €, 2021: 50,000 €|
|Main Funding Sources:||Merck Sharp and Dohme (MSD)|
|Communication Disclaimer:||This initiative has been independently developed by EATG and is supported by a grant from Merck Sharp and Dohme (MSD).|
Are you living with HIV/AIDS? Are you part of a community affected by HIV/AIDS and co-infections? Do you work or volunteer in the field? Are you motivated by our cause and interested to support our work?
Stay in the loop and get all the important EATG updates in your inbox with the EATG newsletter. The HIV & co-infections bulletin is your source of handpicked news from the field arriving regularly to your inbox.