Higher risk of loss to follow-up among transgender people with HIV in Italy: findings from the ICONA cohort

Abstract Background Official data on transgender people with HIV (TPWH) in Italy are lacking because gender identity is not recorded in national reports. We aimed to characterize TPWH in Italy and assess retention in care and clinical outcomes. Methods We included PWH enrolled between 2010 and 2023 in 40 Italian Cohort Naive Antiretrovirals (ICONA) centers where gender identity could be reliably ascertained. TPWH were compared with cisgender participants. Univariable and multivariable regression models assessed the association between gender identity and (1) loss to follow-up (LTFU; no visit or exam for ≥18 months) using Fine-Gray models, and (2) a composite clinical endpoint including mortality, major adverse cardiovascular events, cancer, AIDS-defining events, and end-stage kidney and liver disease using Cox models. Sensitivity analyses were restricted to individuals who initiated ART from 2016 onward. Results Overall, 256 transgender and 9,922 cisgender PWH were included. TPWH were younger (median 32 vs 39 years, p<0.0001), more often assigned male at birth (99.6% vs 82.4%, p<0.0001). TPWH had a higher unadjusted risk of LTFU (sHR 1.88, 95% CI 1.60-2.22), confirmed after adjustment (asHR 1.41, 95% CI 1.18-1.68) and in the post-2016 subgroup (asHR 1.39, 95% CI 1.11-1.77). Composite endpoint analyses were inconclusive (TPWH vs cisgender PWH: overall aHR 1.30 [95% CI 0.79-2.14], p=0.293; post-2016 aHR 1.69 [95% CI 0.91-3.16], p=0.098). Conclusions TPWH had a substantially higher risk of LTFU than cisgender participants in this national Italian cohort. Tailored interventions are needed to improve retention and health outcomes.