Hepatitis C
Conditions
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.
Interventions
OTHERLinkage Navigation
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.
OTHERClinician Referral
The Clinician Referral arm will serve as an active control and baseline standard of care.
Sponsors
National Institute on Drug Abuse (NIDA)
Denver Health and Hospital Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or 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
| Measure | Time frame | Description |
|---|---|---|
| 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). | Within 6 months from time of HCV diagnosis (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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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). | Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses). | Measured by indication of a completed visit with a substance use treatment provider. This will be verified via electronic medical record review. |
| 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). | Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses). | 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. |
| 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). | Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses). | 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. |
Countries
United States
Outcome results
None listed