Back to resultsHCV Seek, Test and Rapid Treatment for Young PWID (HCV ST&RT)
Primary Purpose
Hepatitis C, Drug Use
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sofosbuvir and Velpatasvir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring PWID
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
Sites / Locations
- Lower East Side Harm Reduction Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rapid Treatment with sofosbuvir/velpatasvir (Intervention arm)
Usual Care (Control arm)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The proportion of participants who achieve sustained virologic response 12 (SVR12)
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 Outcome Measures
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.
The proportion of participants who complete the prescribed course of treatment for HCV
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
The proportion of participants who achieve SVR 12 that have HCV reinfection
The proportion of participants in both arms who achieve SVR 12 that have HCV reinfection by Week 48
Full Information
NCT ID
NCT03627546
First Posted
July 20, 2018
Last Updated
July 27, 2021
Sponsor
Weill Medical College of Cornell University
Collaborators
Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03627546
Brief Title
HCV Seek, Test and Rapid Treatment for Young PWID
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Gilead Sciences
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Drug Use
Keywords
PWID
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rapid Treatment with sofosbuvir/velpatasvir (Intervention arm)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care (Control arm)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir and Velpatasvir
Other Intervention Name(s)
Epclusa
Intervention Description
Sofosbuvir/velpatasvir (Epclusa) is an FDA-approved treatment for HCV. It is provided in the intervention arm as part of a rapid treatment strategy,
Primary Outcome Measure Information:
Title
The proportion of participants who achieve sustained virologic response 12 (SVR12)
Description
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.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
The proportion of participants who initiate treatment for HCV
Description
The proportion of participants who initiate treatment for HCV in the intervention arm compared to the usual care arm by study week 48.
Time Frame
Week 48
Title
The proportion of participants who complete the prescribed course of treatment for HCV
Description
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
Time Frame
Week 48
Title
The proportion of participants who achieve SVR 12 that have HCV reinfection
Description
The proportion of participants in both arms who achieve SVR 12 that have HCV reinfection by Week 48
Time Frame
Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen Marks
Organizational Affiliation
Weill Cornell MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lower East Side Harm Reduction Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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HCV Seek, Test and Rapid Treatment for Young PWID
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