HCV Seek, Test and Rapid Treatment for Young PWID

Hepatitis C Clinical Trial

— HCV ST&RT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627546
• Other study ID #: 1710018606
• Status: Completed
• Phase: N/A
• Start date: September 18, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Use
• Hepatitis C

Intervention

Other:
• Rapid Treatment strategy
The intervention arm receives same-day medical evaluation and treatment for hepatitis C. They receive medical evaluation, laboratory assessment , baseline questionnaire/interview, and distribution of a medication (sofosbuvir/velpatasvir) "starter pack" on the day of enrollment. Participants who are HCV RNA negative are discontinued from the study. Other participants start medications and receive weekly text messages during 12 weeks of provided sofusbuvir/velpatasvir treatment.
• Usual Care (facilitated referral)
articipants in the control arm will be provided facilitated referral to community HCV providers by an on-site care coordinator already facilitating care at the community site. HCV RNA negative participants will be called to inform them of these results, and then followed separately. HCV RNA positive participants will be asked during the semi-structured interviews as at 12, 24, 36 and 48 week if they engaged in HCV treatment to assess whether their HCV referral has been filled, and to record their current HCV treatment status. They will also receive repeat HCV RNA testing at week 12, 24, and 48. Participants that have started treatment will be asked to sign consent for release of medical records pertaining to HCV-related laboratory testing to determine achievement of treatment response.

Locations

Country	Name	City	State
United States	Lower East Side Harm Reduction Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Proportion of Participants Who Achieve Sustained Virologic Response 12 (SVR12) With Rapid Treatment Strategy Compared to Usual Care	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.	Week 48
Secondary	The Proportion of Participants Who Initiate Treatment for HCV	The proportion of participants who initiate treatment for HCV in the intervention arm compared to the usual care arm by study week 48.	Week 48
Secondary	Presence of Resistance Associated Substitutions (RAS) in Treated Patients With Treatment Failure		48 wks
Secondary	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
Secondary	Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors	Change in substance use frequency or injection risk behaviors will be defined as percent of participants in each arm that injected alone and the percent of participants who injected with 3 or more individuals	Baseline and 48 weeks