Monitoring HIV pre-exposure prophylaxis programmes in the EU/EEA

A steady decline in the annual number of new HIV diagnoses has been observed in the European Union (EU) and European Economic Area (EEA) over the last decade. However, there remain considerable disparities in the rate of decline and the burden of new HIV infections between countries and among different population groups. In order to achieve the 95-95-95 targets set out by the Joint United Nations Programme on HIV/AIDS (UNAIDS), a strong and sustained focus on HIV prevention is paramount. This will entail scaling up combination prevention programmes based on scientific evidence, including the implementation of pre-exposure prophylaxis (PrEP) across the EU/EEA region.

In 2015, the European Centre for Disease Prevention and Control (ECDC) recommended that EU/EEA countries consider integrating PrEP into their existing HIV-prevention packages for those most at risk of HIV infection. In 2021, ECDC published an operational guidance that outlined key principles and minimum standards for PrEP programmes and service delivery, to support EU/EEA countries in their PrEP implementation efforts. In order to make evidence-based evaluations of the performance of PrEP programmes, it is imperative to monitor their success in terms of reaching and supporting those who can benefit most from PrEP. This calls for relevant and actionable data that are feasible to collect as well. In addition, a streamlined approach to PrEP monitoring across EU/EEA countries is required to paint a more detailed picture of the regional progress of PrEP roll-out and its impact on the HIV epidemic.

Mindful of the substantial variations in health systems and epidemiological contexts between EU/EEA countries, this publication aims to contribute to a harmonised PrEP-monitoring approach. To this end, a rigorous consensus- building approach was applied, grounded in scientific evidence and informed by inputs from a broad panel of clinical, research and community experts from different EU/EEA countries and organisations.

The result of this consensus-building exercise is a monitoring tool that provides countries with a reference set of commonly agreed indicators for data reporting to improve comparability, while giving practical advice on different options for data collection to allow for sufficient flexibility. It is intended to be used by PrEP programme implementers (e.g. public health authorities, non-governmental and community organisations or researchers) or other stakeholders in the design and implementation of national or sub-national PrEP programmes.

The tool is structured along three key steps of a care continuum adapted to PrEP: pre-uptake, uptake and coverage, and continued and effective use of PrEP.

In addition, based on the input of the expert panel, all indicators are assigned a specific level of priority for reporting:

• ‘core indicators’ (i.e. essential indicators that should be feasible to report on);
• ‘supplementary indicators’ (i.e. indicators that are meaningful to report on, but the feasibility of reporting is context-specific);
• ‘optional indicators’ (i.e. reporting on these indicators is only possible by using additional research efforts).

For all indicators, useful data sources are suggested, and recommendations are made for disaggregation along relevant characteristics to reveal PrEP-related disparities. Possible data sources include routine surveillance data (preferred), population size estimates and special surveys. Anticipated benefits and challenges for data collection and reporting are discussed briefly for each indicator. Users of the tool are encouraged to actively engage with the provided suggestions, and make adaptations where necessary. As such, this document does not set a normative standard, but intends to assist users in making informed decisions on the implementation of measurable indicators adapted to their local contexts.