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The DETECT HCV Linkage to Care Trial (DETECT HCV)

Primary Purpose

Hepatitis C

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Linkage Navigation
Clinician Referral
Sponsored by
Denver Health and Hospital Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ED patients who test positive for HCV antibodies
  • ED patients who have discharged and confirmatory RNA result is positive
  • Clinically stable per screening nurse or physician assessment
  • Able to provide consent
  • ED patients with untreated active HCV confirmed by the electronic medical record

Exclusion Criteria:

  • Younger than 18 years of age
  • Prisoners
  • Pregnant women
  • Individuals that live out of state
  • Unable to consent for care (e.g., altered mentation, critical illness or injury)
  • Non English or Spanish speaking
  • Have already participated in the trial

Sites / Locations

  • Denver Health Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Clinician Referral Only

Clinician Referral + Linkage Navigation

Arm Description

The Clinician Referral arm will serve as an "active control" and baseline standard of care. All individuals who test positive for HCV antibodies or are identified with untreated, active HCV will be informed of their result and receive the following information from their clinical care teams in the ED: (a) explanation of process and rationale for follow-up RNA testing; (b) delivery of simple posttest counseling (e.g., risk for liver disease, risks of transmission); and (c) provision of a list of insurance enrollment resources, as needed, along with (d) a list of HCV treatment providers and their contact information as provided in aftercare instructions. For new HCV diagnoses, patients will be instructed to access their electronic patient portal (MyChart) for their RNA test results or to call a designated results line. Post-testing counseling messages and follow-up instructions will be included on the patient discharge papers.

The Linkage Navigation arm will consist of an additional service layered onto clinician referral and will incorporate protocols from Antiretroviral Treatment and Access Studies (ARTAS). Individuals randomized to this intervention will be contacted by a linkage navigator either during the ED visit (if during business hours) or the following business day (if during non-business hours). If the navigator does not contact the patient at the time of ED visit, they will offer to meet with the patient in person or over the phone. For all individuals in this arm, a structured linkage navigation process will include motivational interviewing and (a) reiteration of posttest counseling messages, (b) assessment of the patient's needs for medical insurance and substance abuse treatment, c) assistance scheduling and/or rescheduling appointments for HCV treatment, and d) follow-up phone call after the first HCV treatment appointment and thereafter as needed up to 6 months after ED visit.

Outcomes

Primary Outcome Measures

Number of individuals who fill a prescription for Direct-Acting Antivirals (DAAs) for hepatitis C within 6 months of positive HCV RNA test (for new HCV diagnosis) or presenting at ED visit (for those identified with untreated, active HCV).
The primary outcome will be the number of individuals with positive HCV RNA test who initiate HCV treatment within 6 months from the time of ED diagnosis (for new HCV diagnoses) or from time of ED visit (for those identified with untreated, active HCV). This will be verified by electronic medical record review.

Secondary Outcome Measures

Number of individuals who attend an appointment with an HCV treatment provider within 6 months of positive HCV RNA test (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).
Measured by indication of a completed visit with an HCV treatment provider among those identified with active HCV. This will be verified by electronic medical record review.

Full Information

First Posted
June 27, 2019
Last Updated
May 10, 2023
Sponsor
Denver Health and Hospital Authority
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04026867
Brief Title
The DETECT HCV Linkage to Care Trial
Acronym
DETECT HCV
Official Title
Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for HCV
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Denver Health and Hospital Authority
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This aim of the DETECT HCV linkage trial compares two linkage to care intervention strategies among (1) newly diagnosed HCV positive patients from the emergency department (ED) and (2) those patients who present to the ED with untreated active HCV. Patients who are positive for HCV and agree to be part of the study will be randomized to either clinician referral alone or clinician referral plus a linkage navigator.
Detailed Description
The investigators will perform a prospective pragmatic randomized effectiveness trial to compare 2 linkage-to-care strategies. Permuted block randomization with 2 strata (i.e., <40 years of age or active IDU [defined as IDU within 30 days], or ≥40 years of age without active IDU) and varying block sizes will be used to minimize imbalance, ensure appropriate numbers of patients in subgroups, and allow for efficient analyses. Allocation will be concealed by blinding block sizes and using the REDCap Randomization Module, a web-based platform to assign patients to arms (REDCap, Vanderbilt University, TN). Although patients will not be blinded to the interventions, they will be blinded to the outcomes. Also, a trained research assistant will perform all enrollment, including stratification and randomization. Clinical staff will not be blinded, however, to assignment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
309 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinician Referral Only
Arm Type
Active Comparator
Arm Description
The Clinician Referral arm will serve as an "active control" and baseline standard of care. All individuals who test positive for HCV antibodies or are identified with untreated, active HCV will be informed of their result and receive the following information from their clinical care teams in the ED: (a) explanation of process and rationale for follow-up RNA testing; (b) delivery of simple posttest counseling (e.g., risk for liver disease, risks of transmission); and (c) provision of a list of insurance enrollment resources, as needed, along with (d) a list of HCV treatment providers and their contact information as provided in aftercare instructions. For new HCV diagnoses, patients will be instructed to access their electronic patient portal (MyChart) for their RNA test results or to call a designated results line. Post-testing counseling messages and follow-up instructions will be included on the patient discharge papers.
Arm Title
Clinician Referral + Linkage Navigation
Arm Type
Experimental
Arm Description
The Linkage Navigation arm will consist of an additional service layered onto clinician referral and will incorporate protocols from Antiretroviral Treatment and Access Studies (ARTAS). Individuals randomized to this intervention will be contacted by a linkage navigator either during the ED visit (if during business hours) or the following business day (if during non-business hours). If the navigator does not contact the patient at the time of ED visit, they will offer to meet with the patient in person or over the phone. For all individuals in this arm, a structured linkage navigation process will include motivational interviewing and (a) reiteration of posttest counseling messages, (b) assessment of the patient's needs for medical insurance and substance abuse treatment, c) assistance scheduling and/or rescheduling appointments for HCV treatment, and d) follow-up phone call after the first HCV treatment appointment and thereafter as needed up to 6 months after ED visit.
Intervention Type
Other
Intervention Name(s)
Linkage Navigation
Intervention Description
The Linkage Navigation arm will consist of an additional service layered onto clinician referral and will incorporate protocols from Antiretroviral Treatment and Access Studies (ARTAS), the most influential studies of HIV linkage-to-care to date.
Intervention Type
Other
Intervention Name(s)
Clinician Referral
Intervention Description
The Clinician Referral arm will serve as an "active control" and baseline standard of care.
Primary Outcome Measure Information:
Title
Number of individuals who fill a prescription for Direct-Acting Antivirals (DAAs) for hepatitis C within 6 months of positive HCV RNA test (for new HCV diagnosis) or presenting at ED visit (for those identified with untreated, active HCV).
Description
The primary outcome will be the number of individuals with positive HCV RNA test who initiate HCV treatment within 6 months from the time of ED diagnosis (for new HCV diagnoses) or from time of ED visit (for those identified with untreated, active HCV). This will be verified by electronic medical record review.
Time Frame
Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for those identified with untreated, active HCV).
Secondary Outcome Measure Information:
Title
Number of individuals who attend an appointment with an HCV treatment provider within 6 months of positive HCV RNA test (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).
Description
Measured by indication of a completed visit with an HCV treatment provider among those identified with active HCV. This will be verified by electronic medical record review.
Time Frame
Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses)
Other Pre-specified Outcome Measures:
Title
For individuals who self-identify as a person who injects drugs (PWID), the number of individuals who initiate substance use disorder services within 6 months of positive HCV RNA test (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).
Description
Measured by indication of a completed visit with a substance use treatment provider. This will be verified via electronic medical record review.
Time Frame
Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).
Title
Number of individuals who complete their full course of HCV treatment with DAAs within 6 months of positive HCV RNA test (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).
Description
Measured by indication of completion of treatment with DAAs among those individuals identified with active HCV. This will be verified by electronic medical record review.
Time Frame
Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).
Title
Number of individuals who have documented sustained virologic response 12 weeks after completing treatment with DAAs within 6 months of positive HCV RNA test (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).
Description
Rates of sustained virologic response within 12 weeks (SVR12) will be measured by report of undetectable HCV RNA Nucleic Acid Amplification Test (NAAT) 12 weeks after completion of DAAs among those identified with active HCV. This will be verified by electronic medical record review.
Time Frame
Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ED patients who test positive for HCV antibodies ED patients who have discharged and confirmatory RNA result is positive Clinically stable per screening nurse or physician assessment Able to provide consent ED patients with untreated active HCV confirmed by the electronic medical record Exclusion Criteria: Younger than 18 years of age Prisoners Pregnant women Individuals that live out of state Unable to consent for care (e.g., altered mentation, critical illness or injury) Non English or Spanish speaking Have already participated in the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Rowan, MD
Organizational Affiliation
Denver Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason Haukoos, MD, MSc
Organizational Affiliation
Denver Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The DETECT HCV Linkage to Care Trial

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