Counseling Hepatitis C Virus (HCV) Positive Patients for Cardiovascular Disease Risk Factors
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|ClinicalTrials.gov Identifier: NCT03402334|
Recruitment Status : Enrolling by invitation
First Posted : January 18, 2018
Last Update Posted : March 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Atherosclerosis||Behavioral: Patient counseling for HCV associated CVD risk factors||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|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 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.|
|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|
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:
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:
- 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.
- 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.
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
|United States, Louisiana|
|Tulane University HCV Testing Clinics|
|New Orleans, Louisiana, United States, 70112|
|Principal Investigator:||Austin T Jones, BA, BS||Tulane University|