PROMise

Why?

Today, HIV is increasingly being considered as a chronic condition with near-normal 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 Outcomes (PROs) 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”, PROs can help assessing the implications of a disease and the applied treatment on how the patient feels and functions and comparing the clinical outcome to what the patient expects from the treatment.

Therefore, PROs and the corresponding Patient Reported Outcome Measures (PROMs), usually in form of standardized 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 biomarker4 measures or adverse events.

What?

The overall goal of the project is to establish a joint framework for the consideration of HIV-specific Patient Reported Outcome Measures (PROMs) in HIV R&D in collaboration with key stakeholders from community organizations, academia, industry, regulators and Health Technology Assessment (HTA) bodies. The framework will provide guidance to the stakeholders involved in the field of HIV R&D on to what extent the currently used PROMs reflect the quality of life related needs and priorities of people living with HIV and to what extent the development of new HIV-specific PROMs is necessary. Furthermore, the framework will provide guidance for the involvement of patient representatives in all stages of the development process of new HIV-specific PROMs.

With whom?

The project is mainly addressed to 1) community organizations 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 organizations 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 main activities of the project initially will be:

• Identification and outreach to other initiatives working in the area of Patient Reported Outcome Measured (PROMs) and discussion on how to avoid duplications and use synergies of each other’s work
• Identification and reaching out to community-oriented researchers in the area of HIV, quality of life research and PROMs
• Review of scientific literature on existing HIV-specific PROMs in HIV R&D and analysis of their differences.
• Review of clinical trial protocols and abstracts on publicly accessible databases such as PubMed etc. focusing to the question to what extent and how PROMs have been used in HIV R&D. Development of a survey on the use of PROMs to be sent to the HIV community.
• Consultation interviews with key Informants from different stakeholders working in HIV R&D in industry, academia or research institutions, as well as clinicians working in research, and analysis of survey results
• Report containing both, results of the literature review, results of the clinical trial protocol review, stakeholder interviews and community survey.
• One-page factsheet of findings from the research for communications.

Further aims for activities for the project if funding is extended will be:

• Organisation of webinars presenting the results of the community research
• Development of an online resource section containing informational material on the topics, HIV, Quality of Life and Patient Reported Outcomes on the EATG Training Academy website and developing reading recommendations for community advocates attending the Multi-stakeholder meeting
• Implementation of a half-a-day training and strategizing session prior to the Multistakeholder meeting
• Organisation of a consultation meeting with participation of key EATG staff and members, other community representatives and community-oriented researchers
• Organisation of a Multi-Stakeholder meeting with participation of stakeholders from community, community organizations, academia, clinicians, industry, regulators and Health Technology Assessment bodies.
• Organisation of an internal half-a-day meeting for follow-up and planning of the next steps right after the Multi-Stakeholder-Meeting
• Development of a framework document capturing the key principles for the use of HIV specific PROMs in HIV R&D that were discussed at the meeting and providing guidance for the inclusion of community representatives at all stages of the development of HIV-specific PROMs
• Promotion of the framework document for the endorsement of the key stakeholders that were present at the Multi-Stakeholder-Meeting

For what outcome?

• Awareness and knowledge are created among community in Europe on the relevance of Patient Reported Outcomes for quality of life of people living with HIV 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 joint framework 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