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PREP-C for Hepatitis C (CARE-C Trial)

N/A

Waitlist Available

Led By Jens Rosenau, MD

Research Sponsored by Jens Rosenau

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

CARE-C Trial Summary

Community Access, Retention in Care, and Engagement for Hepatitis C Treatment

Eligible Conditions

Hepatitis C

CARE-C Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HCV treatment completion

HCV treatment initiation

Sustained Virologic Response (SVR)

Secondary outcome measures

Appointment adherence

Clinic visit consistency

Gaps in clinical care

+2 more

CARE-C Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Telemedicine ArmExperimental Treatment1 Intervention

The telemedicine Model will track outcomes and record patient experiences with HCV management and treatment with telemedicine.

Group II: PREP-C ModelExperimental Treatment1 Intervention

The PREP-C care model will provide Hepatitis C care with the standard interdisciplinary team expanded by a social worker and a patient navigator team. The social worker/ patient navigator team will use the standardized Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C) tool and will guide PREP-C related interventions to overcome barriers to HCV treatment uptake and completion.

Group III: Modified ECHO ModelExperimental Treatment2 Interventions

The modified Extension for Community Healthcare Outcomes (ECHO) Model will provide patient care through collaboration of the expanded interdisciplinary team (including social worker patient navigator team) with community providers.

Group IV: Current Care Model (Control)Active Control1 Intervention

The Current Care Model will not have any intervention beyond the standard of care for Hepatitis C provided by an interdisciplinary team at the University of Kentucky.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Modified ECHO

2018

N/A

~660

PREP-C

2017

N/A

~760

Patient Telemedicine Questionnaire

2018

N/A

~660

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Jens RosenauLead Sponsor

1 Previous Clinical Trials

150 Total Patients Enrolled

1 Trials studying Hepatitis C

150 Patients Enrolled for Hepatitis C

Gilead SciencesIndustry Sponsor

1,084 Previous Clinical Trials

847,822 Total Patients Enrolled

186 Trials studying Hepatitis C

225,232 Patients Enrolled for Hepatitis C

Jens Rosenau, MDPrincipal Investigator - University of Kentucky

University of Kentucky, University of Kentucky Albert B. Chandler Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the scope of this study include individuals aged 35 or older?

"This clinical study is open to patients aged 18-99. Separately, there are 27 studies designed for minors and 237 specifically tailored towards those over 65 years of age."

Answered by AI

What is the goal of this experiment?

"This trial will last for 12 months and it's primary aim is to assess Sustained Virologic Response (SVR). Secondary objectives include assessing Gaps in clinical care, Clinic visit consistency, as well as Appointment adherence. Data concerning these metrics will be calculated and presented with the mean amount of time +/- SEM., number of participants maintaining an appointment interval less than six months divided by the total number of participants., and ratio of attended/scheduled appointments respectively."

Answered by AI

What criteria must be met to participate in this experiment?

"This clinical trial seeks 657 volunteers with hepatitis c that are aged 18 or older. To be eligible, the patient must have been either referred to the Hepatology Outpatient Clinic at University of Kentucky in Lexington, KY or a local healthcare provider collaborating with them as part of their ECHO program."

Answered by AI

Are any new patients being admitted to this research program?

"Clinicaltrials.gov provides evidence that, as of October 11th 2022, this medical trial is not admitting new patients. However, there are 281 other studies actively seeking participants right now which were initially posted on August 21st 2018."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Community Access, Retention in Care, and Engagement for Hepatitis C Treatment

Jens Rosenau 2018. "Community Access, Retention in Care, and Engagement for Hepatitis C Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03581383.