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 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 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.

Therefore, PROs and the corresponding Patient Reported Outcome Measures (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.



The overall goal of the project is to establish a guidance document and recommendations for the consideration of HIV-specific Patient Reported Outcome Measures (PROMs) in HIV R&D in collaboration with key stakeholders from community organisations, academia, industry, regulators and Health Technology Assessment (HTA) bodies. The document and recommendations 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 guidance document 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 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.



Project activities include:

  • Research to establish community recommendations based on a literature review, community survey, outreach and 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.
  • Developing materials and training around basic literacy on PROMs within the context of improving quality of life to develop knowledge and awareness.
  • Continued consultation with a variety of relevant stakeholders to discuss and develop ways to implement the set of recommendations to improve community involvement in PROMs development and use.


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 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


EATG contact person(s):Fiona Greenhalgh – fiona.greenhalgh@eatg.org
Duration of the project/initiative:February 2020 – ongoing
Project/Initiative Leader:EATG
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 & Dohme.


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