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
|Condition or disease||Intervention/treatment|
|Hepatitis C||Other: Hepatitis C treatment as chosen by provider|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
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.
- 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
- Patient Reported Quality-of-Life [ Time Frame: 12 months ]Change in SF-12 scores from treatment initiation to treatment completion and sustained virologic response
- 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.
- 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.
- 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
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
|Contact: Rebecca Dillingham, MD||4349820103||RD8V@hscmail.mcc.virginia.edu|
|Contact: Chelsea Canan, PhD||4349241987||CC4WD@hscmail.mcc.virginia.edu|
|Principal Investigator:||Rebecca Dillingham, MD||University of Virginia|