欧洲疾控中心-艾滋病毒暴露前预防护理标准审计的最终报告（英）-2025.9_27页_1mb

HIV Pre-Exposure Prophylaxis (PrEP) Standards of Care Audit Summary

Core Content

This report presents the findings of a clinical audit conducted by the European Centre for Disease Prevention and Control (ECDC) in collaboration with the European AIDS Clinical Society (EACS) on the HIV pre-exposure prophylaxis (PrEP) Standards of Care module. The audit aimed to assess the implementation of quality standards for PrEP safety, continuum of care, and delivery, integrated services, and combination prevention across 10 clinics in 8 European countries.

The audit followed a two-part process:

• Part One: Evaluation of clinic policies and guidelines.
• Part Two: Review of medical records for up to 40 participants per clinic to assess implementation.

The audit focused on key quality statements and indicators outlined in the PrEP Standards of Care module, which are categorized as structural or process indicators. Structural indicators are monitored annually through the Dublin Declaration monitoring framework, while process indicators require clinical audits to assess service performance.

Main Viewpoints

1. PrEP Safety Standards

• HIV Exclusion Before Initiation: Six out of 10 clinics met the target of 95% HIV test reliability before starting PrEP. However, it was noted that tests should be conducted as close to initiation as possible to ensure accurate results.
• HBV Testing and Vaccination: All clinics except one (Clinic F, 55%) achieved the 80% target for HBV status determination. Additionally, all clinics except one met the 80% target for HBV vaccination among those who tested HBsAb negative.
• Kidney Function Monitoring: Most clinics met the target for annual glomerular filtration rate (eGFR) assessment for individuals over 50, with only two clinics (B and D) failing to meet the standard for all users.
• Rapid HIV Diagnosis and ART Initiation: All clinics reported having clear pathways for rapid HIV diagnosis and timely antiretroviral treatment (ART) initiation. Eight clinics (excluding J and K) also had systems in place for rapid resistance testing for recently infected individuals.

2. Continuum of PrEP Care Standards

• Adherence Assessments: The audit required adherence assessments to be conducted at least twice within 14 months for 80% of PrEP users. All clinics except two (A and J) met this target.
• Remote Assessments: Six clinics reported conducting some adherence assessments remotely, indicating flexibility in service delivery.
• Follow-Up Barriers: Clinic D noted that some PrEP users missed follow-up visits due to the need for a formal referral from a general practitioner (GP), which could be a barrier for those who preferred not to disclose PrEP use to their GP.

3. PrEP Delivery, Integrated Services, and Combination Prevention Standards

• Regular HIV and STI Testing: All clinics had policies for regular HIV and STI testing. The audit required HIV testing every six months and STI testing (syphilis, gonorrhoea, chlamydia) at least annually.
• HIV Testing Rate: All clinics except one (Clinic C, 78%) achieved the 80% target for HIV testing within 14 months of initiation.
• STI Testing Rate: Testing for gonorrhoea and chlamydia was lower, with only five out of 10 clinics meeting the 80% target. This discrepancy may be due to PCR tests being conducted at different clinics or only on symptomatic individuals.

Key Information

Clinic Characteristics

• Total PrEP Users in 2023: 8,311 across 10 clinics.
• Gender Distribution: 99.5% of participants were male, with a small number of trans women and non-binary individuals.
• Age Range: Participants ranged from 19 to 76 years, with an average age of 39.
• Ethnicity: 91.3% of participants were white.
• Geographic Origin: 83.1% were born in the same country as the clinic, while 16.9% were born in other countries.

PrEP Access and Funding

• Eligibility: Gay men, transgender individuals, and those who could benefit from PrEP were the most eligible groups.
• Funding: Seven clinics fully funded PrEP, while all 10 clinics covered HIV testing and eight covered STI testing.
• HBV Vaccination: Eight clinics fully funded HBV vaccination.
• Waiting Lists: Three clinics had waiting lists for PrEP, with delays ranging from two to 12 months.

Audit Outcomes

• Overall Performance: Most clinics met the process indicators and targets outlined in the PrEP Standards of Care module.
• Areas for Improvement:
  • Timing of HIV testing should be optimized.
  • Testing rates for gonorrhoea and chlamydia need improvement.
  • The audit highlighted the need for more detailed questions on PrEP interruptions, HBV testing types, and adjustments to the 12-month assessment timeframe.
• Usefulness of Audit: Clinics found the audit helpful for identifying areas for improvement. Future audits could be automated to streamline the process and ensure continued monitoring.

Conclusion

The audit demonstrated that while most clinics are meeting the PrEP Standards of Care, there are still opportunities for improvement, particularly in testing frequency and accessibility for certain populations. The results serve as a pilot for future audits and highlight the importance of ongoing monitoring and refinement of PrEP services to support the UN Sustainable Development Goal 3.3 of ending the HIV/AIDS epidemic by 2030.