- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03627546
HCV Seek, Test and Rapid Treatment for Young PWID (HCV ST&RT)
July 27, 2021 updated by: Weill Medical College of Cornell University
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
Study Overview
Status
Completed
Conditions
Intervention / 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).
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10022
- Lower East Side Harm Reduction Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 29 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rapid Treatment with sofosbuvir/velpatasvir (Intervention arm)
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 treatment to record adherence.
They have follow up visits for laboratory tests, medication distribution, and counseling for prevention of reinfection.
They have HCV testing at end of treatment and 12 weeks post treatment, and at 48 weeks to assess for reinfection.
Each study visit will include a brief questionnaire and qualitative interview.
|
Sofosbuvir/velpatasvir (Epclusa) is an FDA-approved treatment for HCV.
It is provided in the intervention arm as part of a rapid treatment strategy,
Other Names:
|
No Intervention: Usual Care (Control arm)
Participants 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 discontinued from the study.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of participants who achieve sustained virologic response 12 (SVR12)
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.
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Week 48
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of participants who initiate treatment for HCV
Time Frame: Week 48
|
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
|
The proportion of participants who complete the prescribed course of treatment for HCV
Time Frame: Week 48
|
The proportion of participants who complete the prescribed course of treatment for HCV in the intervention arm compared to the usual care arm by study week 48
|
Week 48
|
The proportion of participants who achieve SVR 12 that have HCV reinfection
Time Frame: Week 48
|
The proportion of participants in both arms who achieve SVR 12 that have HCV reinfection by Week 48
|
Week 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kristen Marks, Weill Cornell MC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 18, 2018
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
July 20, 2018
First Submitted That Met QC Criteria
August 9, 2018
First Posted (Actual)
August 13, 2018
Study Record Updates
Last Update Posted (Actual)
July 28, 2021
Last Update Submitted That Met QC Criteria
July 27, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepatitis
- Hepatitis C
- Anti-Infective Agents
- Antiviral Agents
- Sofosbuvir
- Sofosbuvir-velpatasvir drug combination
- Velpatasvir
Other Study ID Numbers
- 1710018606
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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