RT Journal Article T1 Study protocol: a randomised, controlled trial of a nurse navigator program for the management of hepatitis C virus in patients with severe mental disorder A1 Quemada-González, Casta A1 Morales-Asencio, José Miguel A1 Hurtado, María M. A1 Martí-García, Celia K1 Hepatitis C AB BackgroundTo evaluate the impact of a nurse navigation program on treatment adherence and resolution of hepatitis C infection in patients with severe mental disorder.MethodsAn open, randomized, controlled trial with blinded outcome assessment. The intervention group will engage in a nurse navigation program designed by mental health nurses. The program involves active screening for patients with severe mental disorder. The patients and caregivers included in the program will receive information, training, support and guidance throughout the treatment and recovery process, which involves different healthcare professionals and units. The control group will receive the standard of care, which includes follow-up by a family physician, referral to the hepatologist, serological testing, new referral to the hepatologist, onset of treatment, and follow-up. Multidisciplinary care will be provided along a coordinated and seamless clinical pathway led by a nurse navigator.The primary endpoints are total recovery (hepatitis C cure) and treatment adherence. Occurrence of symptoms of schizophrenia and health-related quality of life will be also recorded. Follow-up of patients will be performed three and six months after the administration of antiviral treatment.The study was authorised by the Ethics Committee of Malaga in December 2021. Funding was approved in March 2021.DiscussionIf this intervention is proven to be effective in improving treatment access and adherence, it will represent a step forward in addressing a chronic health issue that is 16 times more prevalent in the population with severe mental disease. Finally, this intervention may lead to the detection of undertreated HCV infection in this population of patients. PB BMC Springer Nature YR 2022 FD 2022 LK https://hdl.handle.net/10630/32837 UL https://hdl.handle.net/10630/32837 LA eng NO Quemada-González, C., Morales-Asencio, J. M., Hurtado, M. M., & Martí-García, C. (2022). Study protocol: a randomised, controlled trial of a nurse navigator program for the management of hepatitis C virus in patients with severe mental disorder. BMC nursing, 21(1), 92. NO This project is funded by GILEAD through a competitive research Scholarship evaluated by the evaluation committee of the Spanish association for the study of the liver, confidentially and independent. DS RIUMA. Repositorio Institucional de la Universidad de Málaga RD 21 ene 2026