Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Hepatitis C
  • Severe Mental Disorder
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The objective of this study is to compare the effectiveness of a nurse-navigation program developed by specialist nurses on mental health, for patients with HCV and SMD, against the usual standard care, regarding the detection of the disease, facilitation of access and adherence to treatment, guides...

The objective of this study is to compare the effectiveness of a nurse-navigation program developed by specialist nurses on mental health, for patients with HCV and SMD, against the usual standard care, regarding the detection of the disease, facilitation of access and adherence to treatment, guides through the healthcare system, and cure from HCV. The null hypothesis that this study will test is that there are no differences in the HCV cure rate in SMD subjects who receive the nurse-navigation model versus those who receive usual care. Additionally, a second hypothesis will be tested regarding to the differences in the adherence to HCV treatment.

Tracking Information

NCT #
NCT04891445
Collaborators
  • University of Malaga
  • Gilead Sciences
  • Instituto de Investigación Biomédica de Málaga (IBIMA).
Investigators
Study Chair: María Magdalena Hurtado, PhD Regional Hospital of Málaga, Spain. Study Chair: Celia Martí-García, PhD Faculty of Health Sciences. University of Málaga, Spain Study Director: José Miguel Morales-Asencio, PhD Faculty of Health Sciences. University of Málaga, Spain. Principal Investigator: Casta Quemada Regional Hospital of Málaga, Spain.