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Conquering Hepatitis C Via Micro-Elimination in Southwest Virginia (CHIME)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03876470
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Rebecca Dillingham, MD/MPH, University of Virginia

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.

Condition or disease Intervention/treatment
Hepatitis C Other: Hepatitis C treatment as chosen by provider

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Micro-elimination of Hepatitis C in a Rural Appalachian Community: The Implementation and Expansion of an Innovative Collaborative Care Model of Telehealth and Knowledge Sharing Focusing on People Who Inject Drugs
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
All Participants
All participants will receive HCV treatment as determined by their provider. HCV treatment is not assigned by the study.
Other: Hepatitis C treatment as chosen by provider
Participants' providers will determine the type of HCV treatment as appropriate.




Primary Outcome Measures :
  1. Cohort-level Hepatitis C Treatment Progress [ Time Frame: 12 months ]
    Change in the proportion of patients at each step of the HCV care continuum (linkage to care, treatment initiation, treatment completion and sustained virologic suppression) before and after program implemenation


Secondary Outcome Measures :
  1. Patient Reported Quality-of-Life [ Time Frame: 12 months ]
    Change in SF-12 scores from treatment initiation to treatment completion and sustained virologic response

  2. Depression [ Time Frame: 12 months ]
    Change in Patient Health Questionnaire-2 (PHQ-2) scores from treatment initiation to treatment completion and sustained virologic response. Scale range: 0 to 6 with a higher score indicative of greater depressive symptoms.

  3. Health-Related Quality-of-Life [ Time Frame: 12 months ]
    Change in Chronic Liver Disease Questionnaire: Hepatitis C version (CLDQ-HCV) scores from treatment initiation to treatment completion and sustained virologic response. Scores range from 1 to 7 with higher scores indicative of better quality of life. CLDQ-HCV includes a total score and 4 sub-scales (activity/energy, emotional, worry, and systemic), each scored from 1 to 7.

  4. Semi-Structured Qualitative Interview about Impact of HCV Treatment [ Time Frame: 12 months ]
    Qualitative assessment of participants' experience with HCV treatment, including its impact on substance use behaviors, activities of daily living, social interactions, and mental and physical health



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A total of 300 subjects will be enrolled. Of these, 20 will be enrolled in the qualitative interviews and 4 will be enrolled in the ethnographic case studies.
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

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): NCT03876470


Contacts
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Contact: Rebecca Dillingham, MD 4349820103 RD8V@hscmail.mcc.virginia.edu
Contact: Chelsea Canan, PhD 4349241987 CC4WD@hscmail.mcc.virginia.edu

Sponsors and Collaborators
University of Virginia
Gilead Sciences
Investigators
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Principal Investigator: Rebecca Dillingham, MD University of Virginia
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Responsible Party: Rebecca Dillingham, MD/MPH, Director of the Center for Global Health, University of Virginia
ClinicalTrials.gov Identifier: NCT03876470    
Other Study ID Numbers: 21167
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rebecca Dillingham, MD/MPH, University of Virginia:
Hepatitis C
Telehealth
Injection Drug Use
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections