HCV Seek, Test and Rapid Treatment for Young PWID

NCT ID: NCT03627546

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-18
• Study Completion Date: 2021-06-30

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).

Conditions

Hepatitis C; Drug Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 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.

Group Type: EXPERIMENTAL

Rapid Treatment strategy

Intervention Type: OTHER

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 (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 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.

Group Type: ACTIVE_COMPARATOR

Usual Care (facilitated referral)

Intervention Type: OTHER

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.

HCV RNA negative

Participants assigned to either group who were found to be HCV RNA-negative at entry. They are not eligible for treatment and thus not part of the analysis. They were asked to return the treatment starter pack. They are followed with HCV RNA measured at Week 24 and 48.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristen Marks

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell MC

Locations

Lower East Side Harm Reduction Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1710018606

Identifier Type: -

Identifier Source: org_study_id