HCV Group Evaluation and Treatment Uptake (HCV GET-UP) Intervention

March 19, 2021 updated by: Montefiore Medical Center

Adaptation and Testing of a Primary Care HCV Group Medical Treatment Intervention

People who inject drugs (PWID) represent the overwhelming majority of both HCV and HIV/HCV infected people in the United States. Though new, direct-acting HCV medications are highly efficacious and have the potential to end the HCV epidemic, few PWIDs ever initiate treatment. This study seeks to improve HCV treatment uptake and cure among HCV and HIV/HCV+ PWIDs by testing a primary care based HCV Group Evaluation and Treatment UPtake (GET-UP) intervention. If efficacious, this innovative care intervention could provide a means to reduce the growing mortality from HCV, as well as decrease the current reservoir for HCV transmission.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this proposal is to improve HCV (hepatitis C virus) treatment uptake among current and former injection drug users (IDUs) by testing an innovative, primary care based HCV Group Evaluation and Treatment UPtake (HCV GET-UP) intervention. IDUs make up the majority of the 4 million Americans chronically infected with HCV, and up to 90% of HIV+ IDUs are infected with HCV. In the U.S., HCV is the leading cause of end-stage liver disease and hepatocellular carcinoma, and the most common indication for liver transplantation. Without imminent action, mortality from HCV-related disease is projected to triple over the next decade and HCV-related deaths have already surpassed deaths related to HIV.

While past HCV therapies have been relatively ineffective, new oral treatment regimens with direct-acting antivirals are substantially more efficacious, with few side effects, and cure rates as high as 100% for both HCV+ and HIV/HCV+ individuals. Importantly, successful HCV treatment has been associated with decreased mortality. Unfortunately, there are significant gaps along the HCV care cascade that prevent patients from ever realizing the benefits of these revolutionary medications. Approximately 10% of all HCV+ patients, and even fewer IDUs, have ever initiated HCV treatment.

Given the ease and efficacy of the new HCV medications, investigators have an unprecedented opportunity to treat IDUs within medical settings that they are already accessing, such as primary care clinics. Community-based primary care clinics, such as Federally Qualified Health Centers (FQHCs), are abundant throughout the US and serve populations at high risk for HCV, such as IDUs; studies show an HCV prevalence rate of approximately 8% in FQHCs almost 5 times greater than the general population. Over the past year at Montefiore Medical Center, investigators have piloted onsite HCV treatment at one FQHC and treated nearly 50 patients (81% former or current IDUs) with direct-acting antivirals, with 93% cure rates.

Despite high HCV cure rates for those treated in primary care at our FQHC, only a small minority of eligible patients has initiated treatment. Though onsite treatment reduces obstacles related to specialty referral, patient level barriers to HCV evaluation and treatment uptake still exist. IDUs in particular often have limited HCV knowledge, as well as low perceived vulnerability to poor HCV-related health outcomes, low self-esteem and poor self-efficacy, high levels of perceived stigma, and mistrust of healthcare providers. These, as well as other barriers, prevent many IDUs from ever initiating HCV evaluation or starting the treatment uptake process. Investigators therefore propose to test an HCV Group Evaluation and Treatment UPtake (HCV GET-UP) intervention to improve HCV medical evaluation and treatment uptake for HCV and HCV/HIV IDUs within an FQHC. Group-based interventions, often familiar to IDUs, provide social support and encourage behavior change, which together promote enhanced engagement in care. Group-based care can also allow efficient delivery of health-education and medical treatment. Informed by the Information-Motivation-Behavior (IMB) model. Investigators hypothesize that a group-based HCV intervention, HCV GET-UP, delivered in an FQHC already accessed by patients, will improve HCV treatment uptake by: (1) providing HCV education; (2) increasing motivation by minimizing stigma, and addressing competing priorities and social norms; and (3) increasing self-efficacy and related behavioral skills. Investigator propose the following specific aims:

Aim 1: To assess the feasibility and acceptability of HCV GET-UP. Investigators will pre-test HCV GET-UP by conducting two group interventions (each consisting of 4 weekly sessions; 8 participants in each intervention group). Investigators will assess feasibility by examining process measures, and acceptability using a brief, self-administered questionnaire after each of the 4 sessions. Investigators will also conduct focus groups after the entire 4-session intervention. Investigators will then refine HCV GET-UP based on these findings.

Aim 2: To conduct a pilot randomized controlled trial of the efficacy of HCV GET-UP for improving HCV treatment uptake in an FQHC. Investigators will enroll 96 HCV+ or HIV/HCV+ IDUs and randomize them 1:1 to HCV GET-UP plus onsite treatment in primary care (intervention) versus onsite treatment alone (control). Our primary outcome is HCV treatment uptake, and secondary outcomes will include HCV medical evaluation, HCV treatment completion, and HCV cure.

Aim 3: To determine potential moderators and mediators of the impact of HCV GET-UP on HCV treatment uptake, using a sequential explanatory design. First, Investigators will perform exploratory quantitative analyses to determine if there are specific patient characteristics (demographic, clinical) that moderate the intervention effect, and if there are mediators (reduced stigma, peer support, increased self-efficacy) of HCV GET-UP's impact on treatment uptake. Second, investigators will perform semi-structured interviews with 20 participants randomized to HCV-GET UP to explore potential moderators/mediators deduced from quantitative analyses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • United States
    • New York
      • Bronx, New York, United States, 10451
        • Comprehensive Health Care 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HCV Ab+ with detectable HCV viral load
  • greater than fifth grade reading level
  • English proficiency
  • current or former IDUs
  • willingness to be randomized to a group intervention.

Exclusion Criteria:

  • short life-expectancy, such that HCV treatment would not be beneficial (e.g. end-stage cancer)
  • decompensated liver disease

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HCV GET-UP (Group Intervention)
HCV GET-Up (Group Evaluation and Treatment Uptake)
Behavioral: HCV GET-Up (Group Evaluation and Treatment Uptake)
Groups will meet for 4 weekly 1-hour sessions facilitated by the PI and focused on providing education, motivation, and behavior change skills, along with an HCV medical evaluation. Patients will then be offered HCV treatment by individual provider after 4-week group evaluation and education intervention.
No Intervention: Control
Individual onsite HCV treatment at a primary care center

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hepatitis C Virus (HCV) Treatment Uptake
Time Frame: within 6 months after HCV medical Evaluation Visit
First HCV medication prescription filled
within 6 months after HCV medical Evaluation Visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hepatitis C Virus (HCV) medical evaluation
Time Frame: within 6 months after Baseline Research visit
Sustained Virological Response at 12 weeks post-treatment (SVR12)
within 6 months after Baseline Research visit
Hepatitis C Virus (HCV) treatment completion
Time Frame: 8 or 12 weeks depending on medication
Completion will be tracked via pharmacy records
8 or 12 weeks depending on medication
Hepatitis C Virus (HCV) cure
Time Frame: 12 weeks after treatment completion
Sustained Undetectable HCV Viral Load at least 12 weeks post-treatment (SVR12)
12 weeks after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Montefiore Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brianna L Norton, DO, MPH, Montefiore Medical Center/Albert Einstein College of Medicine

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-6948
  • K23DA039060-03PD (U.S. NIH Grant/Contract)

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

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Hepatitis C

Clinical Trials on HCV GET-Up (Group Evaluation and Treatment Uptake)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings