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Community health worker (CHW)/ registered nurse (RN) [CHW/RN] for Hepatitis C

N/A
Waitlist Available
Led By ADELINE M NYAMATHI, PhD
Research Sponsored by University of California, Irvine
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 2 or 3- and 5 or 6-month follow-up
Awards & highlights

Study Summary

This trial will test a Community Health Worker/Registered Nurse (CHW-RN) intervention for homeless individuals with Hepatitis C over a 2 or 3 month period. The CHW/RN will provide culturally-sensitive education, case management, and daily DOT delivery of medication. The intervention will be compared to a clinic-based standard of care group (cbSOC). Primary outcomes are the completion of the treatment and SVR12 Cure. Secondary outcomes are improved mental health status, decrease in substance use, and improved access to health care, and shelter stability.

Eligible Conditions
  • Hepatitis C

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 or 3- and 5 or 6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 or 3- and 5 or 6-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Attaining SVR12 (Sustained Viral Response at 12 Weeks After Treatment Completion)
Number of Participants Completing HCV Treatment
Secondary outcome measures
Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
CAGE Substance Abuse Screening Scale
Mental Depression
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Community Health Worker/Registered Nurse (CHW/RN)Experimental Treatment1 Intervention
Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment.
Group II: Clinic-based Standard of Care (cbSOC)Active Control1 Intervention
Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Community health worker (CHW)/ registered nurse (RN) [CHW/RN]
2020
N/A
~10

Find a Location

Who is running the clinical trial?

National Institute on Minority Health and Health Disparities (NIMHD)NIH
383 Previous Clinical Trials
1,216,201 Total Patients Enrolled
3 Trials studying Hepatitis C
2,205 Patients Enrolled for Hepatitis C
University of California, IrvineLead Sponsor
544 Previous Clinical Trials
1,923,033 Total Patients Enrolled
1 Trials studying Hepatitis C
20,000 Patients Enrolled for Hepatitis C
University of California, Los AngelesOTHER
1,530 Previous Clinical Trials
10,278,192 Total Patients Enrolled
12 Trials studying Hepatitis C
3,645 Patients Enrolled for Hepatitis C

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults
Adeline Nyamathi 2020. "Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04513899.
~2 spots leftby Apr 2025
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