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

Summary

The main goals of the CARE-C study are to demonstrate the effectiveness of HCV models of care in a rural state (A) to overcome barriers to HCV treatment uptake, (B) to increase retention in care, and (C) to broaden access to care. To achieve these goals the following two systems interventions will be separately implemented: (1) Implementation of the Psychosocial Readiness Evaluation and Preparation for hepatitis C treatment (PREP-C) and related standard of care best practice PREP-C related interventions facilitated by a social worker-patient navigator team, and (2) implementation of a modified ECHO model (with one patient visit at specialty center to include PREP-C and fibrosis assessment in contrast to standard ECHO model). To test the effectiveness of our two systems interventions 600 patients will be equally distributed into three study arms representing 3 care models: Arm 1: Current Care Model (management with current interdisciplinary team); Arm 2: PREP-C Model (management with expanded interdisciplinary team (social worker, patient navigator, PREP-C); and Arm 3: Modified ECHO Model (management with expanded team in collaboration with community providers). An additional Arm 4 was started January 2021 to follow subjects experience with HCV management and treatment via telemedicine.

Conditions

• Hepatitis C

Interventions

BEHAVIORAL

PREP-C

The Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) is an interactive online tool that enables providers to provide a thorough assessment of a patient's psychosocial readiness to begin Hepatitis C treatment, and make a treatment plan to improve treatment readiness.

BEHAVIORAL

Modified ECHO

The heart of the ECHO (Extension for Community Health Outcomes) model is its hub-and-spoke knowledge-sharing networks, led by expert teams who use multi-point videoconferencing to conduct virtual clinics with community providers. The key modification is one patient visit in the specialty center resulting in co-management of patients with data sharing.

BEHAVIORAL

Patient Telemedicine Questionnaire

The patient questionnaire includes questions about patient experiences with telemedicine visits with providers

Sponsors & Collaborators

• Gilead Sciences

  collaborator INDUSTRY

• Jens Rosenau

  lead OTHER

Principal Investigators

• Jens Rosenau, MD · University of Kentucky

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-21

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• United States

Study Locations