Eliminating HCV Infection Among PWUD

Recruiting

• Conditions: Hepatitis C, Chronic; Drug Use

• Registration Number: NCT05474781
• Lead Sponsor: Vancouver Infectious Diseases Centre

Brief Summary

Identify 300 PWUD with chronic, viremic HCV infection and engage them in a multidisciplinary, generalizable model of care and initiate HCV treatment

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-22
• Status Verified: 2022-07
• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-22
• Last Update Submitted: 2022-07-22
• Study First Posted: 2022-07-26
• Last Update Posted: 2022-07-26
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Ability to review, sign and date the IRB/IEC approved informed consent form
2. Age ≥19 years
3. Documented HCV RNA positive for 6 months or more, with any HCV genotype
4. Active PWUD (ongoing drug use or documented use within the previous 6 months) OR active enrolment in an opiate substitution program

Exclusion Criteria

1. Previous DAA-based HCV treatment
2. Pregnant or breast-feeding
3. Indications of decompensated liver disease
4. Diagnosis of active hepatocellular carcinoma
5. Positive test at the time of screening for hepatitis B surface antigen (HBsAg)
6. Frequent injecting drug use that is judged by the treating physician to compromise subsequent HCV treatment safety
7. Inability or unwillingness to provide informed consent or to actively engage in care leading to the initiation of HCV treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of individuals enrolled in the study who initiate HCV treatment	60 months

Secondary Outcome Measures

Name	Time	Method
The proportion of individuals enrolled in the study who achieve sustained virologic response	72 months

Trial Locations

Locations (1)

Vancouver Infectious Diseases Centre; 🇨🇦 Vancouver, British Columbia, Canada