A nurse navigator program for the management of hepatitis C virus in patients with severe mental disorder. A feasibility trial

People with severe mental disorders (SMD) face higher hepatitis C virus (HCV) infection risks and lower treatment adherence compared to the general population. Traditional care pathways often fail due to fragmented coordination and patient-related barriers. This study evaluates the feasibility and acceptability of an individualized nurse navigation program (NNP) designed to facilitate adherence to medical appointments and pharmacological treatment in this population. A feasibility randomized open parallel trial was conducted. The intervention simplified the clinical pathway through intensive nursing support (phone reminders, in-person meetings, home visits) and appointment accompaniment. Primary outcomes included recruitment, retention, refusal rates, cure rate defined as undetectable HCV RNA at 12 weeks post-treatment, and identification of barriers. From 1,916 assessed individuals, 20 were eligible and 13 finally randomized (65% participation, refusal rate 35%). Overall, 69% (9/13) achieved a cure. Notably, the average cure time was nearly 11 months, indicating that standard 6-month follow-up is insufficient. Key facilitators included institutional residency and competent caregivers, while barriers included symptom-related non-attendance and system-level delays, such as deferred treatment prescription by gastroenterologists. The NNP is feasible and enhances HCV outcomes in SMD populations. Definitive trials require extended follow-up periods of 24 months and larger multicenter samples.