Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03627546
Other study ID # 1710018606
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Recruiting NCT04510246 - Link Hepatitis C Notifications to Treatment in Tasmania N/A
Completed NCT03413696 - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed NCT03118674 - Harvoni Treatment Porphyria Cutanea Tarda Phase 2
Completed NCT03109457 - Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
Completed NCT01458054 - Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults Phase 1
Completed NCT03740230 - An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
Completed NCT03426787 - Helping Empower Liver and Kidney Patients N/A
Completed NCT03627299 - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors Phase 4
Completed NCT00006301 - Immune Response to Hepatitis C Virus
Active, not recruiting NCT03949764 - The Kentucky Viral Hepatitis Treatment Study Phase 4
Completed NCT03365635 - Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C Phase 4
Recruiting NCT04405024 - Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients N/A
Completed NCT04525690 - Improving Inpatient Screening for Hepatitis C N/A
Completed NCT04033887 - Evaluation Study of RDTs Detecting Antibodies Against HCV
Withdrawn NCT04546802 - HepATocellular Cancer Hcv Therapy Study Phase 3
Active, not recruiting NCT02961426 - Strategic Transformation of the Market of HCV Treatments Phase 2/Phase 3
Completed NCT02992184 - PoC-HCV Genedrive Viral Detection Assay Validation Study N/A
Completed NCT03186313 - A Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus Or Dactavira in Egyptian Adults With Chronic Genotype 4 HCV Infection Phase 3
Completed NCT02705534 - Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 Phase 3