Conquering Hepatitis C Via Micro-Elimination in Southwest Virginia

NCT ID: NCT03876470

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2020-11-30

Brief Summary

The objective of this protocol is to conduct a comprehensive quantitative and qualitative assessment of the impact of our innovative collaborative telehealth HCV care model on patient treatment experiences and quality of life.

Detailed Description

The investigators will evaluate the proportion of patients at each step of the HCV care cascade before and after implementation of the collaborative care model. Additionally, participants will complete questionnaires at three time points: at the initiation of hepatitis C treatment, at treatment completion, and at the assessment of sustained virologic response. Questionnaires will assess quality of life, mental health, chronic liver disease outcomes, and substance use. A subset of participants will also complete semi-structured interviews at each of the three time points. Then, a smaller subset of participants will be selected for a detailed ethnographic case study focusing on treatment experiences, quality of life, forms of social support, and illness experience.

Conditions

Hepatitis C

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All Participants

All participants will receive HCV treatment as determined by their provider. HCV treatment is not assigned by the study.

Hepatitis C treatment as chosen by provider

Intervention Type: OTHER

Participants' providers will determine the type of HCV treatment as appropriate.

Interventions

Hepatitis C treatment as chosen by provider

Participants' providers will determine the type of HCV treatment as appropriate.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• Detectable HCV viral load
• Attended a clinic appointment at one of our participating sites

Exclusion Criteria

• Cognitive disability such that informed consent cannot be obtained
• Prisoners
• Unable to understand English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Dillingham, MD/MPH

Director of the Center for Global Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Dillingham, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Central Contacts

Rebecca Dillingham, MD

Role: CONTACT

RD8V@hscmail.mcc.virginia.edu

4349820103

Chelsea Canan, PhD

Role: CONTACT

CC4WD@hscmail.mcc.virginia.edu

4349241987

Other Identifiers

21167

Identifier Type: -

Identifier Source: org_study_id