Hepatitis CDETECT HCVNCT04026867
The DETECT HCV Linkage to Care Trial
A study testing Linkage Navigation and Clinician Referral in people with Hepatitis C, run by Denver Health and Hospital Authority at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Linkage Navigation and Clinician Referral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2019to 12 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health Medical Center
Denver, Colorado, 80204
About this study
Official title: Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for HCV
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.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- Linkage Navigation, Clinician Referral
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linkage NavigationOther
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.
Clinician ReferralOther
The Clinician Referral arm will serve as an "active control" and baseline standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Clinician Referral Only | Active comparator | 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. Receives: Other: Clinician Referral |
| Clinician Referral + Linkage Navigation | Experimental | 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. Receives: Other: Linkage Navigation; Other: Clinician Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for those identified with untreated, active HCV).
Secondary outcomes (1)
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.
Measured: Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start20 Nov 2019
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jason Haukoos, Denver Health and Hospital Authority
- Investigators
- Sarah Rowan, MD, Principal investigator, Denver HealthJason Haukoos, MD, MSc, Principal investigator, Denver Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026867
- Sponsor's protocol ID
- 17-2327
- Other IDs
- R01DA042982
- Acronym
- DETECT HCV
- Status last verified
- Feb 2025
- First submitted
- 27 Jun 2019
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rowan SE, Haukoos J, Kamis KF, Hopkins E, Gravitz S, Lyle C, Al-Tayyib AA, Gardner EM, Galbraith JW, Hsieh YH, Lyons MS, Rothman RE, White DAE, Morgan JR, Linas BP, Sabel AL, Wyles DL; DETECT Hep C Trials Investigators. The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial: rationale and design of an emergency department-based randomized clinical trial of linkage-to-care strategies for hepatitis C. Trials. 2023 Jan 27;24(1):63. doi: 10.1186/s13063-022-07018-w.
PubMed 36707909
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for HCV
- ClinicalTrials.gov ID
- NCT04026867
- Acronym / sponsor ID
- DETECT HCV / 17-2327
- Conditions
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinician Referral Only | Active comparator | Other: Clinician ReferralThe 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. |
| Clinician Referral + Linkage Navigation | Experimental | Other: Linkage Navigation, Other: Clinician ReferralThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linkage NavigationThe 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. | Other | Clinician Referral + Linkage Navigation |
| Clinician ReferralThe Clinician Referral arm will serve as an "active control" and baseline standard of care. | Other | Clinician Referral + Linkage Navigation, Clinician Referral Only |
Primary outcome
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).
Time frame: 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.
1 secondary outcome
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).
Time frame: Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for existing HCV diagnoses)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Derived from this study: PubMed 36707909Rowan SE, Haukoos J, Kamis KF, Hopkins E, Gravitz S, Lyle C, Al-Tayyib AA, Gardner EM, Galbraith JW, Hsieh YH, Lyons MS, Rothman RE, White DAE, Morgan JR, Linas BP, Sabel AL, Wyles DL; DETECT Hep C Trials Investigators. The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial: rationale and design of an emergency department-based randomized clinical trial of linkage-to-care strategies for hepatitis C. Trials. 2023 Jan 27;24(1):63. doi: 10.1186/s13063-022-07018-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Rowan, MD principal investigator
Denver Health
Jason Haukoos, MD, MSc principal investigator
Denver Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linkage Navigation and Clinician Referral in people with Hepatitis C, run by Denver Health and Hospital Authority at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Within 6 months from time of HCV diagnosis (for new HCV diagnoses) or ED visit (for those identified with untreated, active HCV).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04026867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.