Hepatitis CDETECT HCVNCT04003454
The DETECT HCV Screening Trial
A study testing HCV Screening in people with Hepatitis C, run by Denver Health and Hospital Authority at 3 sites in United States.
Trial summary
The investigators propose to compare the effectiveness of nontargeted rapid opt-out hepatitis C (HCV) screening versus targeted rapid opt-out HCV screening using recommended risk characteristics in multiple urban emergency departments (EDs) across the United States (Aim 1 - "Screening Trial"). 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?
- HCV Screening
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147,533 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Nov 2019to 31 Jan 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
- Present to EDs during study enrollment period
- Clinically stable per screening nurse or physician assessment
- Able to provide consent for medical care
Who cannot join
- Younger than 18 years of age
- Are unable to consent for care (i.e., altered mentation, critical illness, or injury)
- Have already participated in the trial
- Self-Identify as already living with HCV
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21224
Denver Health Medical Center
Denver, Colorado, 80204
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for HCV Trial
The investigators propose to compare the effectiveness of nontargeted rapid opt-out hepatitis C (HCV) screening versus targeted rapid opt-out HCV screening using recommended risk characteristics in multiple urban emergency departments (EDs) across the United States (Aim 1 - "Screening Trial").
Read the detailed description
The investigators will perform a prospective pragmatic randomized effectiveness trial that will allow the investigators to directly compare 2 HCV screening methods while minimizing threats to internal validity. Patients will be screened for HCV infection using 1 of 2 interventions using a balanced patient-level random allocation scheme built into existing electronic health records (EHRs) for each ED. Patients will therefore be offered HCV testing based on the result of the screening arm to which they are assigned, and in the case of the targeted arm, the results of the risk assessment evaluation performed by the intake nurse. All randomization will be completely integrated into electronic medical screening systems and workflow at each site. Integration of randomization into the electronic systems will allow for real-time concealed random allocation. Nurses who perform screening and all other ED staff (e.g. physicians, technicians) will understand the conceptual goals of the project but will be blinded to study hypotheses, and patients will be completely blinded to the purpose of the study.
This study will be performed at multiple sites, including the EDs at Denver Health Medical Center (DHMC) (Denver, Colorado), Johns Hopkins Hospital (JHH) (Baltimore, Maryland), and the University of Mississippi Medical Center (UMMC) (Jackson, Mississippi).
- Conditions
- Hepatitis C
- Being tested
- HCV Screening
- Keywords
- Hepatitis C, Screening, Emergency Department, Risk
- Medical subject headings
- Hepatitis C, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCV ScreeningOther
The investigators will perform a prospective pragmatic randomized effectiveness trial that will allow the investigators to directly compare 2 HCV screening methods while minimizing threats to internal validity. Patients will be screened for HCV infection using 1 of 2 interventions using a balanced patient-level random allocation scheme built into existing EHRs for each ED.
| Study group | Role | What they receive |
|---|---|---|
| Nontargeted Screening | Other | The nontargeted HCV screening arm will consist of implementing non-risk-based rapid opt-out HCV screening. Receives: Other: HCV Screening |
| Targeted Screening | Other | The targeted HCV screening arm will consist of implementation of risk-based rapid opt-out HCV screening using current recommendations for HCV screening by the CDC, USPSTF, and AASLD-IDSA. Targeted HCV screening will consist of offering HCV testing to those identified with the following specific risk characteristics, adapted from the above recommendations: born between 1945 - 1965 ("birth cohort"); injection drug use (IDU); intranasal drug use;tattoo or piercing in an unregulated setting; or blood transfusion or organ recipient before 1992. Receives: Other: HCV Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newly diagnosed active HCV
Confirmed cases of newly diagnosed active HCV, defined as patients who test positive for HCV antibody and measurable HCV RNA, and without a prior HCV diagnosis, stratified by study arm
Measured: 1 day from ED visit
Secondary outcomes (2)
HCV test acceptance
Defined by the proportion of patients who agree to HCV testing, as measured by the proportion of those who consent among patients offered HCV testing, stratified by study arm
Measured: 1 day from ED visit
HCV test completion
Defined by the proportion of patients who complete HCV testing, as measured by the proportion of rapid HCV tests completed among patients who accepted testing, stratified by study arm
Measured: 1 day from ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start20 Nov 2019
- Primary completion31 Jul 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients presenting to the emergency department will be randomized to targeted HCV screening or nontargeted HCV screening
- Masking
- None (open label)
- Enrolment
- 147,533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, University of Mississippi Medical Center, Boston University, Boston Medical Center, University of Cincinnati, Alameda County Medical Center
- Responsible party
- Principal investigator, Jason Haukoos, Denver Health and Hospital Authority
- Investigators
- Jason Haukoos, MD, MSc, Principal investigator, Denver HealthSarah Rowan, MD, Principal investigator, Denver Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003454
- Sponsor's protocol ID
- R01DA042982
- Acronym
- DETECT HCV
- Status last verified
- Nov 2023
- First submitted
- 5 Apr 2019
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haukoos J, Rothman RE, Galbraith JW, Hopkins E, Hsieh YH, Lyle C, Gravitz S, Kamis KF, White DAE, Lyons MS, Gardner EM, Al-Tayyib AA, Sabel AL, Linas BP, Morgan JR, Wyles DL, Rowan SE; DETECT Hep C Screening Trial Investigators. Hepatitis C Screening in Emergency Departments: The DETECT Hep C Randomized Clinical Trial. JAMA. 2025 Aug 12;334(6):497-507. doi: 10.1001/jama.2025.10563.
PubMed 40632510Haukoos JS, Rowan SE, Galbraith JW, Rothman RE, Hsieh YH, Hopkins E, Houk RA, Toerper MF, Kamis KF, Morgan JR, Linas BP, Al-Tayyib AA, Gardner EM, Lyons MS, Sabel AL, White DAE, 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) Screening Trial: rationale and design of a multi-center pragmatic randomized clinical trial of hepatitis C screening in emergency departments. Trials. 2022 Apr 25;23(1):354. doi: 10.1186/s13063-022-06265-1.
PubMed 35468807
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for HCV Trial
- ClinicalTrials.gov ID
- NCT04003454
- Acronym / sponsor ID
- DETECT HCV / R01DA042982
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, Screening, Emergency Department, Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147,533 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- Johns Hopkins University, University of Mississippi Medical Center, Boston University, Boston Medical Center, University of Cincinnati, Alameda County Medical Center
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 1 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.
The investigators propose to compare the effectiveness of nontargeted rapid opt-out hepatitis C (HCV) screening versus targeted rapid opt-out HCV screening using recommended risk characteristics in multiple urban emergency departments (EDs) across the United States (Aim 1 - "Screening Trial").
Detailed description
The investigators will perform a prospective pragmatic randomized effectiveness trial that will allow the investigators to directly compare 2 HCV screening methods while minimizing threats to internal validity. Patients will be screened for HCV infection using 1 of 2 interventions using a balanced patient-level random allocation scheme built into existing electronic health records (EHRs) for each ED. Patients will therefore be offered HCV testing based on the result of the screening arm to which they are assigned, and in the case of the targeted arm, the results of the risk assessment evaluation performed by the intake nurse. All randomization will be completely integrated into electronic medical screening systems and workflow at each site. Integration of randomization into the electronic systems will allow for real-time concealed random allocation. Nurses who perform screening and all other ED staff (e.g. physicians, technicians) will understand the conceptual goals of the project but will be blinded to study hypotheses, and patients will be completely blinded to the purpose of the study.
This study will be performed at multiple sites, including the EDs at Denver Health Medical Center (DHMC) (Denver, Colorado), Johns Hopkins Hospital (JHH) (Baltimore, Maryland), and the University of Mississippi Medical Center (UMMC) (Jackson, Mississippi).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients presenting to the emergency department will be randomized to targeted HCV screening or nontargeted HCV screening
| Arm | Type | Receives |
|---|---|---|
| Nontargeted Screening | Other | Other: HCV ScreeningThe nontargeted HCV screening arm will consist of implementing non-risk-based rapid opt-out HCV screening. |
| Targeted Screening | Other | Other: HCV ScreeningThe targeted HCV screening arm will consist of implementation of risk-based rapid opt-out HCV screening using current recommendations for HCV screening by the CDC, USPSTF, and AASLD-IDSA. Targeted HCV screening will consist of offering HCV testing to those identified with the following specific risk characteristics, adapted from the above recommendations: born between 1945 - 1965 ("birth cohort"); injection drug use (IDU); intranasal drug use;tattoo or piercing in an unregulated setting; or blood transfusion or organ recipient before 1992. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Present to EDs during study enrollment period
- Clinically stable per screening nurse or physician assessment
- Able to provide consent for medical care
Key exclusion criteria (4 listed)
- Younger than 18 years of age
- Are unable to consent for care (i.e., altered mentation, critical illness, or injury)
- Have already participated in the trial
- Self-Identify as already living with HCV
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 |
|---|---|---|
| HCV ScreeningThe investigators will perform a prospective pragmatic randomized effectiveness trial that will allow the investigators to directly compare 2 HCV screening methods while minimizing threats to internal validity. Patients will be screened for HCV infection using 1 of 2 interventions using a balanced patient-level random allocation scheme built into existing EHRs for each ED. | Other | Nontargeted Screening, Targeted Screening |
Primary outcome
Newly diagnosed active HCV
Time frame: 1 day from ED visit
Confirmed cases of newly diagnosed active HCV, defined as patients who test positive for HCV antibody and measurable HCV RNA, and without a prior HCV diagnosis, stratified by study arm
2 secondary outcomes
HCV test acceptance
Time frame: 1 day from ED visit
HCV test completion
Time frame: 1 day from ED visit
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 6 Feb 2025.
- Derived from this study: PubMed 40632510Haukoos J, Rothman RE, Galbraith JW, Hopkins E, Hsieh YH, Lyle C, Gravitz S, Kamis KF, White DAE, Lyons MS, Gardner EM, Al-Tayyib AA, Sabel AL, Linas BP, Morgan JR, Wyles DL, Rowan SE; DETECT Hep C Screening Trial Investigators. Hepatitis C Screening in Emergency Departments: The DETECT Hep C Randomized Clinical Trial. JAMA. 2025 Aug 12;334(6):497-507. doi: 10.1001/jama.2025.10563.
- Derived from this study: PubMed 35468807Haukoos JS, Rowan SE, Galbraith JW, Rothman RE, Hsieh YH, Hopkins E, Houk RA, Toerper MF, Kamis KF, Morgan JR, Linas BP, Al-Tayyib AA, Gardner EM, Lyons MS, Sabel AL, White DAE, 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) Screening Trial: rationale and design of a multi-center pragmatic randomized clinical trial of hepatitis C screening in emergency departments. Trials. 2022 Apr 25;23(1):354. doi: 10.1186/s13063-022-06265-1.
- 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.
Jason Haukoos, MD, MSc principal investigator
Denver Health
Sarah Rowan, MD principal investigator
Denver Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCV Screening in people with Hepatitis C, run by Denver Health and Hospital Authority at 3 sites 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 3 inclusion and 4 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Newly diagnosed active HCV (time frame: 1 day from ED visit). 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 NCT04003454, which also lists 2 linked publications.
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 6 Feb 2025.