HCV Seek, Test and Rapid Treatment for Young PWID

Not Applicable

Completed

• Conditions: Drug Use; Hepatitis C
• Interventions: Other: Rapid Treatment strategy; Other: Usual Care (facilitated referral)

• Registration Number: NCT03627546
• Lead Sponsor: Weill Medical College of Cornell University

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).

Study Timeline

• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-13
• Study Start: 2018-09-18
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Results First Submitted: 2022-04-12
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-17
• Last Update Submitted: 2023-11-17
• Results First Posted: 2024-04-29
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid Treatment with sofosbuvir/velpatasvir (Intervention arm)	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 followed separately and do not receive intervention. 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.
Usual Care (Control arm)	Usual Care (facilitated referral)	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 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.

Primary Outcome Measures

Name	Time	Method
The Proportion of Participants Who Achieve Sustained Virologic Response 12 (SVR12) With Rapid Treatment Strategy Compared to Usual Care	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.

Secondary Outcome Measures

Name	Time	Method
The Proportion of Participants Who Initiate Treatment for HCV	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.
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
Presence of Resistance Associated Substitutions (RAS) in Treated Patients With Treatment Failure	48 wks
Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors	Baseline and 48 weeks	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

Trial Locations

Locations (1)

Lower East Side Harm Reduction Center; 🇺🇸 New York, New York, United States