PROMise

Why?

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.

What?

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.

With whom?

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.

How?

The next phase of project activities include:

• Research processes with relevant stakeholder to define PROMs domains that are desirable in HIV R&D and literature review to identify existing PROMs instruments that are already used or being planned for use in HIV R&D.
• Consultation and research to develop an overview grid/database of HIV medicines pipeline, including product types that are likely and desirable medicines for HIV and likely to evolve in the next 5 to 10 years with a focus on patient characteristics, type of drug, route of administration, types of drug trials, etc.
• Stakeholder engagement and advocacy activities that include outreach to key stakeholders (g. EMA, EUnetHTA, public payers, other patient groups) via bilateral project introductory meetings, project presentations at community focused events and scientific conferences, and multimedia contents to present the past findings, current objectives, activities, and process and explore potential interests.
• Multistakeholder consultation to discuss to present and discuss the findings and recommendations from the previous activities.
• Publications for a renowned journal to develop a supplement that includes all the results of the PROMise project, including the research paper, consultation reports, and results from the follow-up activities, as well as a project overview/summary written in lay language.
• Recommendations and strategy for possible follow-up work.

For what outcome?

• Awareness, knowledge and visibility are increased among community in Europe on the relevance of Patient Reported Outcomes for quality of life of people living with HIV and community advocates have knowledge on the different Patient Reported Outcome Measures that are being used in HIV R&D.
• Community advocates have assessed whether the current Patient Reported Outcome Measures are adequate to reflect the quality-of-life related needs of people living with HIV and are able to represent their interests on Patient Reported Outcome Measures towards the relevant stakeholders.
• A set of recommendations that reflects community needs in the area of PROMs is agreed upon among key stakeholders in the field and guides the development, selection and implementation of HIV-specific PROMs in in HIV R&D.
• Community representatives are involved in all stages of the development of new HIV-specific PROMs according to the recommendations from this project.

Specifically, the objectives of this new phase of the project are:

• To explore where consensus exists regarding the different applications of PROMs in HIV R&D, namely: 1) To ensure that the quality of life of trial participants does not diminish during a trial, or if PROMs improve quality of life and 2) To identify distinguish benefits of (and challenges with) new medicines for HIV.

• Increase awareness and visibility of community and patient engagement in the development and use of HIV PROMs in R&D and in regulatory and health technology assessment processes.

PROMise Community Activist Toolbox