HCV Seek, Test and Rapid Treatment for Young PWID
| Status: | Recruiting |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 29 |
| Updated: | 10/13/2018 |
| Start Date: | September 18, 2018 |
| End Date: | July 10, 2021 |
| Contact: | Melinda Smith |
| Email: | mjs4001@med.cornell.edu |
| Phone: | 212-746-7166 |
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
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
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
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).
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).
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
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