Standardised monitoring tool of pre-exposure prophylaxis (PrEP) in the European Union and European Economic Area (EU/EEA)

ECDC is in the final stages of developing operational guidance on pre-exposure prophylaxis (PrEP) in the EU/EEA (to be published in March 2021). The guidance provides practical recommendations to inform the development and implementation of structurally supported and clinically safe PrEP programmes at national and sub-national levels through the EU/EEA. The guidance is structured around 10 core principles. One of the core principles identified in the ECDC operational guidance relates to monitoring and evaluation of PrEP programmes. PrEP programmes should strive to deliver services within a monitored system in which it is possible to measure basic data on e.g. people on PrEP, stopping PrEP, breakthrough infections, new STI infections and transmitted drug resistance, so that effectiveness of the programme can be measured. The Scientific Panel supporting ECDC in developing the operational guidance considered the need for measures of PrEP implementation that are applicable across EU/EEA context, while being feasible to collect and relevant to the varying stages of PrEP implementation. The Scientific Panel agreed that four broad areas should be including in any future monitoring framework:
1. Access and need
2. Uptake and use
3. Continued or persistent use of PrEP
4. Toxicity, drug resistance and seroconversion

Determining the optimal measures of PrEP implementation across different countries and health care settings is challenging and the task is further complicated by a lack of widely accepted definitions for terms such as ‘on PrEP’ and ‘discontinued’. It is acknowledged that an acceptable, feasible and standardised method of monitoring PrEP programmes is important for all EU/EEA Member States and that developing this requires additional consultation with Member States.
ECDC will therefore support the implementation and monitoring of PrEP programmes in the EU/EEA by developing a separate monitoring tool, suitable for all EU/EEA Member States at all stages of PrEP implementation. The PrEP monitoring tool should:
• Identify indicators that are most useful to countries at different stages in PrEP implementation
• Determine the feasibility, costs and benefits of collecting specific indicators
• Recommend a specific minimum dataset for collection and reporting across the EU/EEA.