A Randomized Study of a Rapid HCV Treatment Initiation Strategy (HCV Seek, Test and Rapid Treatment) Compared to Standard Care in Young People Who Inject Drugs
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatitis C
- Sponsor
- Weill Medical College of Cornell University
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- The Proportion of Participants Who Achieve Sustained Virologic Response 12 (SVR12) With Rapid Treatment Strategy Compared to Usual Care
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this randomized study is to determine whether a community-based test and treat model of hepatitis C (HCV) care delivery will be superior to the usual care practice of referral to specialist clinics for the outcomes of sustained virologic response at 12 weeks after treatment and initiation of HCV treatment for persons who inject drugs (PWID) between ages 18 and 29 who are naïve to HCV treatment
Detailed Description
ST\&RT is a randomized open-label clinical trial in which 54 HCV infected PWID between ages 18 and 29 will be randomized to either receive the same-day treatment initiation of the FDA-approved fixed dose combination of sofosbuvir 400mg and velpatasvir 100mg (SOF/VEL) with follow up and medical monitoring at a community site (Intervention arm) or to receive referral to an HCV treatment provider's office (Usual Care Arm).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Persons are eligible for study inclusion if they: (a) are HCV antibody positive, (b) are 18 to 29 years of age, (c) have injected drugs in the past 30 days, (d) are HCV treatment naïve, (e) are English speaking
Exclusion Criteria
- •Persons excluded from the study will be (a) HIV coinfected persons (b) pregnant women, or women planning on becoming pregnant (c) participants with end-stage renal disease (d) participants with decompensated cirrhosis (c) participants on medications with treatment limiting interactions with sofosbuvir/velpatasvir
Outcomes
Primary Outcomes
The Proportion of Participants Who Achieve Sustained Virologic Response 12 (SVR12) With Rapid Treatment Strategy Compared to Usual Care
Time Frame: Week 48
The proportion of participants who achieve sustained virologic response defined as an undetectable HCV RNA viral load 12 weeks after the cessation of treatment (SVR12), in the intervention arm compared to the usual care arm by study week 48.
Secondary Outcomes
- The Proportion of Participants Who Initiate Treatment for HCV(Week 48)
- Number of Participants in Both Arms Who Achieve SVR12, or Are RNA Negative at Baseline, That Have HCV Reinfection by Study Week 48(48 wks)
- Presence of Resistance Associated Substitutions (RAS) in Treated Patients With Treatment Failure(48 wks)
- Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors(Baseline and 48 weeks)