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Clinician Referral vs. Linkage Navigation for Hepatitis C Care (DETECT HCV Trial)
N/A
Waitlist Available
Led By Jason Haukoos, MD, MSc
Research Sponsored by Denver Health and Hospital Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 months from time of hcv diagnosis (for new hcv diagnoses) or ed visit (for existing hcv diagnoses).
Awards & highlights
DETECT HCV Trial Summary
This trial is comparing two ways of linking HCV-positive patients to care. One is referral by a clinician only, and the other is referral by a clinician plus a linkage navigator.
Who is the study for?
This trial is for adults who have tested positive for Hepatitis C in the emergency department (ED), are clinically stable, can consent to participate, and have untreated active HCV. It excludes minors, prisoners, pregnant women, out-of-state residents, those unable to consent due to health issues or language barriers (non-English/Spanish speakers), and previous participants.Check my eligibility
What is being tested?
The DETECT HCV trial is comparing two strategies to help patients with Hepatitis C get the care they need after diagnosis: one group will receive a clinician's referral only while the other group gets both a clinician's referral and additional support from a linkage navigator.See study design
What are the potential side effects?
Since this trial focuses on linkage-to-care interventions rather than medications or treatments directly targeting Hepatitis C itself, there are no direct side effects associated with the interventions being studied.
DETECT HCV Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 6 months from time of hcv diagnosis (for new hcv diagnoses) or ed visit (for existing hcv diagnoses).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6 months from time of hcv diagnosis (for new hcv diagnoses) or ed visit (for existing hcv diagnoses).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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).
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).
Other outcome measures
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).
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).
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).
DETECT HCV Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Clinician Referral + Linkage NavigationExperimental Treatment2 Interventions
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.
Group II: Clinician Referral OnlyActive Control1 Intervention
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.
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Who is running the clinical trial?
Denver Health and Hospital AuthorityLead Sponsor
101 Previous Clinical Trials
400,088 Total Patients Enrolled
2 Trials studying Hepatitis C
147,606 Patients Enrolled for Hepatitis C
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,284 Total Patients Enrolled
46 Trials studying Hepatitis C
22,229 Patients Enrolled for Hepatitis C
Jason Haukoos, MD, MScPrincipal InvestigatorDenver Health
1 Previous Clinical Trials
147,533 Total Patients Enrolled
1 Trials studying Hepatitis C
147,533 Patients Enrolled for Hepatitis C
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I do not speak English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Clinician Referral Only
- Group 2: Clinician Referral + Linkage Navigation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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