Italy is ready-extended PrEP cascade, and determinants of intention to use long-acting PrEP and unmet PrEP needs among men who have sex with men, trans* individuals, heterosexual women, and men.

Abstract

Background: Italy has recently expanded access to oral pre-exposure prophylaxis (PrEP) and made rapid progress in long-acting PrEP (LA-PrEP) availability. These developments create a unique opportunity to assess population-level readiness for LA-PrEP and identify gaps that may limit its public health impact.

Aim: To assess an extended PrEP cascade, quantify unmet prevention needs that LA-PrEP could mitigate, and identify determinants of LA-PrEP intention across key populations (KPs) in Italy.

Methods: We analysed data from the PROTECT cross-sectional survey (October 2023-April 2024), including participants without HIV in Italy (n = 2215): 1707 MSM, 32 trans* individuals, 267 cis-men, and 209 cis-women. We described PrEP cascades (oral PrEP awareness, uptake, adherence, discontinuation; LA-PrEP awareness, interest, intention), unmet prevention needs potentially addressable by LA-PrEP ( defined as no current oral PrEP use or suboptimal oral PrEP adherence combined with LA-PrEP intention), and regional differences. Open-ended responses on LA-PrEP perceptions were analysed. Determinants of LA-PrEP intention and unmet PrEP needs were explored using multivariable logistic regression.

Results: Overall, 19.0% (95%CI = 17.3-20.6) reported current oral PrEP use, of whom 19.8% (95%CI = 15.8-24.3) reported suboptimal adherence and 10.0% (95%CI = 8.3-13.9) had discontinued. Nearly half (47.0%, 95%CI = 44.9-49.8) expressed LA-PrEP intention. Unmet prevention needs potentially addressable by LA-PrEP were identified in 34.8% (95%CI = 32.8%-36.8%). MSM showed the highest PrEP engagement, whereas cisgender men had the lowest; unmet needs were greater in less-urbanised areas. Qualitative data reflected a positive outlook, framing LA-PrEP as safe, convenient, and empowering sexual freedom. Among MSM, unmet prevention needs potentially addressable by LA-PrEP were substantial among PrEP-naïve and discontinued users, although intention to use LA-PrEP was comparatively lower in these groups, indicating a mismatch between prevention need and acceptability.

Conclusions: Despite low awareness, LA-PrEP intention is high in Italy, indicating strong readiness for rollout. However, a mismatch between prevention need and intention, particularly among PrEP-naïve individuals, may limit population-level impact. Yet, these findings should be interpreted considering the potential for selection bias associated with online convenience sampling and recruitment through social media and dating applications. Targeted, equity-oriented implementation strategies are required to ensure that LA-PrEP reaches populations experiencing substantial unmet HIV prevention needs.