Achieving reimbursable PrEP is insufficient to increase and diversify the users attending community‐based services

OBJECTIVES: The reimbursement of HIV pre-exposure prophylaxis (PrEP) in Italy was expected to increase uptake and diversify users. We assessed changes in PrEP initiation patterns before and after reimbursement at a community-based service. METHODS: We conducted a monocentric retrospective cohort study that included all individuals who initiated PrEP between September 2017 and October 2024. Participants were stratified according to PrEP initiation before and after June 2023, when reimbursed PrEP was made available. Monthly PrEP initiations were analysed using single-group interrupted time series analysis (ITSA) with segmented linear regression, including two intervention points (July 2020 and June 2023) and accounting for autocorrelation. RESULTS: We included 1394 individuals who initiated PrEP: 1019 (73.1%) before and 375 (26.9%) after June 2023. Participants were predominantly cisgender men (96.7%), gay, bisexual and other men who have sex with men (GBMSM) (95.1%) and white (82.1%). After reimbursement, modest differences were observed, including a higher proportion of white individuals (84.0% vs. 81.5%) and fewer lifetime sexual partners (≥30 partners: 73.7% vs. 81.0%), while discontinuation rates remained similar. ITSA showed a marked immediate increase in PrEP initiations after the COVID-19 lockdown (+12.7/month; 95% CI 9.3, 16.1), followed by a flat trend thereafter. PrEP reimbursement was not associated with a significant immediate increase (+4.7/month; 95% CI -1.5, 10.9) and was followed by a negative change in the trend (-0.54/month; 95% CI -0.92, -0.15). CONCLUSIONS: In this community-based setting, reimbursed PrEP was not associated with a substantial increase in uptake or diversification of users, suggesting that additional implementation strategies beyond drug reimbursement may be required to improve equitable access.