The Impact on Linkage-to-care of an Alternative Hepatitis C Screening Method in PWID

HIV Clinical Trial

Official title:

The Impact on Linkage-to-care of an Alternative Hepatitis C Screening Method in PWID

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971488
• Other study ID #: HUIL 15/03
• Status: Completed
• Start date: January 15, 2017
• Est. completion date: May 10, 2019

Study information

• Verified date: August 2019
• Source: Hospital Universitario Infanta Leonor
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Screening, diagnosis and treatment of HCV in PWID, should be part of a harm reduction strategy. Treatment of HCV infected PWID should be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population. More frequent diagnosis, new methods that prevent loss of tracking, and access to antiviral treatment are all strategies that must be implemented jointly if the prevalence of HCV infection in our setting is to be reduced.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 529
• Est. completion date: May 10, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PWID

• >18 years of age

• Signed consent form

Exclusion Criteria:

Related Conditions & MeSH terms

• Drug Users
• Harm Reduction
• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV

Intervention

Other:
• Screening for HCV in PWID and Linkage-To-Care
Screening, diagnosis and treatment of HCV in PWID, will be part of a harm reduction strategy. Treatment of HCV infected PWID will be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitario Infanta Leonor	Fundacion SEIMC-GESIDA, Instituto de Salud Carlos III

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of HCV Infected Paticipants Whom Result of the Test Was Delivered to	Percentage of participants who had a positive HCV test and results of the test was delivered to them.	2 years
Primary	Percentage of Participants Who Were Evaluated at a HCV Clinic.	Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).	2 years
Primary	Percentage of Participants Who Started HCV Antiviral Therapy.	Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).	2 years
Primary	Percentage of Participants Who Achieved a Sustained Virological Response (SVR)	Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).	2 years
Secondary	Percentage of Participants With Active HCV in Screened Population	Screening for HCV using dried blood samples on WhatmanTM cards in subjects from Cañada Real based on the results of the laboratory tests performed in phase I. The percentage of active HCV infections will be calculated from the total population of active drug addicts screened.	2 years
Secondary	Prevalence of Other Chronic Viral Infections in the Population Screened	Other viruses (HIV, HBV, HDV) using dried blood samples on WhatmanTM cards in subjects from Cañada Real based will be analysed. The prevalence of these infections will be calculated base on the total screened population.	2 years