Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 126 for:    "Viral Infectious Disease" | "Ethanol"

Counseling Hepatitis C Virus (HCV) Positive Patients for Cardiovascular Disease Risk Factors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03402334
Recruitment Status : Enrolling by invitation
First Posted : January 18, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Austin Jones, Tulane University School of Medicine

Brief Summary:
The study aims to compare the effect of a cardiovascular education package intervention on treatment-seeking behavioral outcomes of HCV+ patients. This prospective multicenter trial will compare outcomes between the intervention group (HCV+ patients receiving the enhanced education package) and the control group (HCV+ patients receiving the standard of care, the basic education package). The primary outcome measured will be successful linkage to hepatology for a discussion of HCV treatment options. The secondary outcome measured will be linkage to primary care for chronic disease management.

Condition or disease Intervention/treatment Phase
Hepatitis C Atherosclerosis Behavioral: Patient counseling for HCV associated CVD risk factors Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a two-arm study. Group A will receive the intervention in addition to standard of care counseling while Group B will receive only standard of care counseling.
Masking: Single (Participant)
Masking Description: Single-blinded study. Participants are blinded to their designation in the study arms. Investigators cannot be blinded since the intervention they are providing is patient counseling.
Primary Purpose: Treatment
Official Title: Assessing Healthcare Outcomes of Hepatitis C Virus (HCV) Positive Patients Counseled for Cardiovascular Disease Risk Factors
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : March 10, 2021
Estimated Study Completion Date : May 10, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CVD risk factor counseling

This arm will receive intervention 'Patient counseling for HCV associated CVD risk factors' in addition to standard of care Hepatitis C counseling.

Cardiovascular risk factor counseling will include:

  1. Increased risk for atherosclerosis with chronic HCV infection
  2. Increased risk of heart attack and stroke
  3. Treatment of HCV infection and reduction of viral load reducing risk of stroke and heart attack
Behavioral: Patient counseling for HCV associated CVD risk factors
Patients will be counseled for cardiovascular disease risk factors associated with Hepatitis C infection. Such risk factors include atherosclerosis, heart attack, and stroke. Cardiovascular risk factors can be managed through connection with primary care and reduced through curative HCV treatment.

No Intervention: Standard of care counseling

This arm will receive standard of care Hepatitis C counseling:

  1. HCV infection poses an increased risk for hepatocellular carcinoma
  2. Hepatitis C is a curable disease
  3. Hepatitis C is transmitted through blood to blood contact, primarily through sharing needles
  4. HCV+ individuals should be vaccinated for Hepatitis A (HAV) and Hepatitis B (HBV)
  5. HCV+ individuals should reduce alcohol intake and shellfish consumption



Primary Outcome Measures :
  1. Linkage to HCV Care [ Time Frame: Patient will be assessed for follow up within 6 months post counseling ]
    The percentage of patients attending their subsequent University Medical Center hepatology appointment for the treatment and control groups will be measured, indicating the effectiveness of the "augmented education package" at improving patients' willingness to treat their HCV infection.


Secondary Outcome Measures :
  1. Linkage to Primary Care [ Time Frame: Patient will be assessed for follow up within 6 months post counseling ]
    Patients referred to the primary care provider (PCP) will be tracked to assess the proportion that attended their PCP appointment, measuring the impact of the "augmented education package" at positively influencing HCV+ patients to follow up with primary care for their atherosclerotic comorbidities.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HCV antibody positive tested at one of six locations in New Orleans: Ozanam Inn, New Orleans Mission, Bethel Colony South, Grace House, St. Anna's Mobile Clinic, and Ruth Fertel

Exclusion Criteria:

  • vulnerable populations including children, prisoners, pregnant women
  • non-English speaking patients since effective counseling cannot be provided

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402334


Locations
Layout table for location information
United States, Louisiana
Tulane University HCV Testing Clinics
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Austin Jones
Investigators
Layout table for investigator information
Principal Investigator: Austin T Jones, BA, BS Tulane University

Publications:

Layout table for additonal information
Responsible Party: Austin Jones, MD/MPH&TM candidate, Tulane University School of Medicine
ClinicalTrials.gov Identifier: NCT03402334     History of Changes
Other Study ID Numbers: 2017-610
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be disclosed

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Virus Diseases
RNA Virus Infections
Hepatitis A
Hepatitis C
Hepatitis
Atherosclerosis
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases