HCV Treatment in a Low-threshold Clinic

NCT ID: NCT04063839

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2022-12-31

Brief Summary

This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years

Detailed Description

This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years

Inclusion Consenting patients older than 18 years attending the low threshold HCV clinic in Oslo

The primary aims are to assess the efficacy (SVR rate) of DAA treatment among PWID treated in a low-threshold primary care setting (Work Package 1) and to estimate the incidence HCV reinfection f

The secondary aims are to:

• Evaluate adherence to DAA treatment (Work Package 1)
• Identify factors associated with SVR and adherence (Work Package 1)
• Characterize reinfection using next generation sequencing (Work Package 2)
• Identify factors associated with reinfection (Work Package 2)
• Evaluate changes in recent injecting risk behaviours longitudinally (Work Package 2)
• Identify factors associated with changes in risk behaviours (Work Package 2)

The hypothesis is that high SVR rates and good treatment adherence will be achieved in PWID treated for HCV infection in a low-threshold primary health care setting. Further,it is anticipated that the incidence of reinfection will be 5-10/100 PY and associated with younger age, low education level and ongoing injecting risk behaviours.

The study will include 300 patients and are close to achieving that aim the summer of 2019

Conditions

Hepatitis C; Substance Use Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Elbasvir / Grazoprevir Oral Tablet

HCV treatment according to Norwegian guidelines

Intervention Type: DRUG

Other Intervention Names

sofosbuvir; ledipasvir

Eligibility Criteria

Inclusion Criteria

• HCV RNA positive Attending the low-threshold HCV clinic in Oslo

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Akershus

OTHER

Sponsor Role: lead

Responsible Party

Olav Dalgard

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olav Dalgard, MD PhD

Role: STUDY_CHAIR

University Hospital, Akershus

Locations

AkershusUH

Lørenskog, Select A State Or Province, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Olav Dalgard, MD PhD

Role: CONTACT

odalgard@medisin.uio.no

92616800 ext. 47

Kjersti Ulstein, MD

Role: CONTACT

kjersti.ulstein@vel.oslo.kommune

41226162 ext. 47

Facility Contacts

Olav Dalgard, MD PhD

Role: primary

odalgard@medisin.uio.no

92616800

Kjersti Ulstein, MD PhD

Role: backup

kjersti.ulstein@vel.oslo.kommune.no

41226162 ext. 0047

Other Identifiers

17_120

Identifier Type: -

Identifier Source: org_study_id