Clinical trial NCT05582681: HCV Test and Treat Utilizing Simplified HCV Patient Education
Official title: HCV Test and Treat Utilizing Simplified HCV Patient Education
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hepatitis C
Keywords: Hepatitis C Virus
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2022-10-17
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an open label, phase 4 randomized trial to assess test and treat strategy with simplified video-based patient education versus standard of care referral with health care provider delivered patient education.
Primary purpose: TREATMENT

Brief summary: The study hypothesis is that the test and treat model utilizing video-based patient education will have higher rates of hepatitis C virus (HCV) treatment initiation and treatment completion.

Detailed description: Viral hepatitis C (HCV) represents a major public health concern and is associated with significant morbidity and mortality. HCV screening and treatment among people who use drugs is challenging due to barriers leading to loss within HCV care cascades at most centers providing addiction care.

One critical element that would improve access to HCV therapy would be a test, educate and treat system, where people obtain drug on the same day as they are confirmed as Hepatitis C viremic.

Eligibility criteria: Inclusion Criteria:

* Men and women age greater or equal to18 at study entry or emancipated minors over greater or equal to 16 to less or equal 70 years at study entry
* HCV antibody positive
* HCV treatment naïve (no prior treatment with an approved or investigational anti HCV medication)

Exclusion Criteria:

* Current or history of decompensated liver disease (including but not limited to encephalopathy, variceal bleeding, or ascites) prior to study entry
* History of hepatocellular carcinoma (HCC)
* Any history of active Hepatitis B or positive HBsAg positive test
* HCV RNA undetectable

Primary outcomes:
measure: Number of subjects who initiated treatment within 8-week window from enrollment.
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Number of subjects who complete treatment in 8 weeks
timeFrame: Up to 8 weeks
measure: Sustained Viral Response 12 weeks post dosing (SVR12) (<lower limit of quantification (LLOQ) of HCV RNA in at 12 weeks post treatment with window up to 24 weeks after end of treatment)
timeFrame: Up to 24 weeks
measure: SVR12 (<LLOQ of HCV RNA in at 12 weeks post treatment with window up to 24 weeks after end of treatment) from real world evidence post-marketing observational study (RWE PMOS) efficacy G/P9 (compare test and treat arm with PMOS SVR12 result)
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Long Island City
country: United States
facility: Phoenix House
state: New York
city: New York
country: United States
facility: ColumbiaDoctors Midtown
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine Midtown Center for Treatment and Research
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Robert S Brown, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: