Overview

Background

The efficacy and safety of oral pre-exposure prophylaxis (PrEP) to prevent HIV acquisition has been demonstrated through several high-quality clinical trials [1-3]. Subsequently, in 2015, ECDC recommended that the EU/EEA countries should consider integrating PrEP into their existing HIV-prevention packages for those most at risk of HIV infection [4]. As of the end of 2021, 22 countries in the WHO European Region have made PrEP available and fully reimbursed (see Figure 1).

Status of the formal implementation of PrEP in the WHO European Region, 2021

Coloured map of Europe - Status of the formal implementation of PrEP in the WHO European Region, 2021

Source: European Centre for Disease Prevention and Control. Monitoring implementation of the Dublin Declaration. Stockholm: ECDC; 2021 (unpublished data)

To translate the clinical efficacy of PrEP into comprehensive programmes that can effectively reach and support those who benefit from using it, ECDC has undertaken several actions to guide EU/EEA countries in their PrEP implementation efforts. These actions culminated in the development of an operational guidance, entitled ‘HIV PreExposure Prophylaxis in the EU/EEA and the UK: implementation, standards and monitoring’ [5]. In this guidance, 10 core principles were outlined that define and represent effective PrEP programmes.

In addition, quality statements and minimum standards were included to guide the operationalisation of these principles and track their progress and implementation in real-world settings. The final core principle for PrEP programmes described in this guidance pertained to the need of delivering services in a monitored system, wherein some basic data on the performance and effectiveness of the programme are gathered and reported on.

An effective PrEP programme is one in which people at substantial risk of HIV are adequately identified, are offered PrEP, and then receive continued support to use it as needed [6]. To achieve this, PrEP programmes need to be appropriately focused on the epidemiological profile of potential PrEP candidates within their specific organisational context (e.g. relying on available infrastructure and resources to deliver appropriate services). Scientific experts consulted for the ECDC operational guidance agreed that EU/EEA countries would benefit from a more harmonised approach towards PrEP programme monitoring, to track national and regional progress in this regard. The experts also identified the need for well-defined and relevant indicators, that could be useful for countries in different phases of PrEP implementation, while being feasible to collect and report on.

Therefore, a practical tool was developed as an additional guidance to:

  • support EU/EEA countries in identifying meaningful indicators for PrEP programme monitoring, sensitive to their respective epidemiological and organisational contexts.
  • offer insight into the anticipated benefits and challenges of using certain data sources to report on these indicators.
  • recommend a minimum set of ‘core indicators’ to be collected and reported on in a standardised way across Member States of the EU/EEA, to allow for some comparison at a regional level.

Key considerations

Before an in-depth description of how this tool is organised and can be used, in this section we will highlight some key concepts, definitions and principles that guided the various steps of its development.

Programmatic monitoring approach

The tool is focused on outlining possible ways to measure the performance and implementation of PrEP programmes, with the overarching goal to maximise its impact on the HIV epidemic. Therefore, it focuses on collecting and reporting data that can inform and guide actions towards achieving this goal on a programmatic level. We define a PrEP programme as, ‘a coherent set of activities as part of routine services that aim to identify, reach, and provide PrEP to the target population (however defined)’. This is different from a purely clinical-monitoring approach, where the main aim is to ensure the safe and effective use of PrEP among individual clients. Nevertheless, individual-level data could be used, and are even vital, to report on programmatic indicators for PrEP.

HIV prevention cascade

As a basic, monitorable framework to organise and synthesise different components that are key to the successful implementation of PrEP, we relied on the concept of the ‘HIV prevention cascade’ [7]. Complementary to the HIV treatment cascade, this approach focuses on outlining the different steps in the continuum of implementing preventive interventions (such as PrEP), and aims to display points where inefficiencies (or ‘bottlenecks’) occur. In the spirit of its initial conceptualisation, we distinguished between two perspectives to look at the case of PrEP:

  • The user perspective: Here, the cascade explores the trajectory of people at risk of HIV infection, and how the acquisition of HIV could be successfully prevented through perceiving their risk well and undertaking action to adopt and adhere to PrEP.
  • The provider perspective: This cascade focuses on programme staff identifying a ‘target population’ who could benefit from PrEP, making PrEP available and accessible to them, and tracking uptake and effective use of PrEP in the target population.

Both perspectives offer complementary insights relevant to the monitoring of PrEP programmes, and may even partially overlap. For the development of this tool, we included both provider-oriented and user-oriented indicators that may inform progress along different steps of the HIV prevention cascade for PrEP (see later).

Core principles for the tool

Pragmatism and applicability

This tool, first and foremost, aims to serve as a practical guidance to support Member States of the EU/EEA in their efforts to implement a monitoring system for PrEP. The focus is on the sharing of knowledge and valuable experiences, both informed by available evidence and current practice, in a way that is useful for programme implementers working in different contexts (e.g. resources, infrastructure and data systems).

Therefore, we opted not to standardise the indicator requirements towards data collection and reporting methods, as this would limit their generalisability across the region. We did ensure indicators contain uniform and clear definitions, and present numerators and denominators for their reporting if relevant and applicable, to allow for some comparison (especially for the ‘core indicators’). In addition, to ensure feasibility of data collection, we refer to existing routine health information systems as the first option. For questions that routine monitoring systems cannot answer, we highlight synergies with research efforts (e.g. through special surveys). Lastly, using routine monitoring data, we present alternative proxy measures for indicators that could be particularly challenging to report on.

Relevance

All indicators in this tool have undergone thorough review by an international expert panel, and were included based on their perceived level of importance and feasibility. The indicators reflect different aspects of PrEP implementation and will hopefully contribute, in conjunction with other data, to a better understanding of a PrEP programme’s overall performance. However, we do acknowledge that certain types of information might be more relevant in certain settings compared to others, or at different time points of PrEP roll-out, as reflected in the tool.

Person-centredness

During the process of developing this tool, we were sensitive to the principles of ‘person-centred monitoring’ as outlined in existing WHO guidelines [6]. This implies an approach that does not merely focus on measuring the service ‘output’ (e.g. the number of HIV tests or people on treatment), but places the person at the centre of measuring the access to and performance of health services [6]. A key priority applied throughout the tool is that of, ‘first of all, do no harm’. During data collection, management and reporting, individuals’ privacy must be ensured and protected at all times. All data collection activities must therefore adhere to the European Union General Data Protection Regulation 2016/679 (GDPR) [8]. Moreover, active reflection on unintended yet potential consequences of monitoring activities on the perpetuation of stigma and discrimination towards certain population groups must be undertaken. We have included relevant guidance in those sections of the tool that particularly warrant such active consideration.

Target audience

This tool aims to add value complementary to existing reporting frameworks of either local or global initiatives focused on monitoring data related to PrEP (e.g. ECDC Dublin Declaration monitoring framework, WHO and UNAIDS reporting). To this end, the tool addresses the following groups of audience:

  • PrEP programme managers, monitoring and evaluation specialists, and public health authorities concerned with PrEP programme design and implementation at national and/or sub-national levels.
  • Additionally, (health) professionals and practitioners tasked with the delivery of PrEP services and/or data collection both at the facility-level and community-level, will benefit from its use.
  • Lastly, researchers focusing on certain aspects relevant to the monitoring of PrEP might also turn to this tool for inspiration and/or guidance.