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

NCT03242655 | Completed

• 3 other identifiers: 2016-6948K23DA039060-03PDK23DA039060-03
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C; Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• Hepatitis C Virus (HCV) Treatment Uptake

  First HCV medication prescription filled

  within 6 months after HCV medical Evaluation Visit

Secondary Outcomes (3)

• Hepatitis C Virus (HCV) medical evaluation

  within 6 months after Baseline Research visit

• Hepatitis C Virus (HCV) treatment completion

  8 or 12 weeks depending on medication

• Hepatitis C Virus (HCV) cure

  12 weeks after treatment completion

Study Arms (2)

HCV GET-UP (Group Intervention)

EXPERIMENTAL

HCV GET-Up (Group Evaluation and Treatment Uptake)

Behavioral: HCV GET-Up (Group Evaluation and Treatment Uptake)

Control

NO INTERVENTION

Individual onsite HCV treatment at a primary care center

Interventions

HCV GET-Up (Group Evaluation and Treatment Uptake) BEHAVIORAL

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.

HCV GET-UP (Group Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Comprehensive Health Care Center

The Bronx, New York, 10451, United States

Location

MeSH Terms

Conditions

Hepatitis C; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Brianna L Norton, DO, MPH

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Random Controlled Trials (RCT)

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 8, 2017
• Study Start: February 21, 2017
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)