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NCT04513899 · ClinicalTrials.gov registry record · NA
Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults
A NA study, sponsored by University of California, Irvine.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT04513899 is a NA study that has completed, run by University of California, Irvine. The registered enrollment target is 10 participants.
The verdict
NCT04513899, a NA study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
This randomized controlled trial (RCT) will test the efficacy of a Community Health Worker/Registered Nurse (CHW-RN) HCV intervention for homeless individuals, many who are also drug users. The intervention will be designed during Phase I of the proposal using an iterative process between a Community Advisory Board (CAB) and focus groups. The CHW/RN intervention will occur over a 2 or 3 month (8-12 weeks) period depending on the Direct-Acting Antiviral (DAA) prescribed. Homeless adults assigned to the CHW/RN HCV treatment group will receive culturally-sensitive education, case management, and daily DOT delivery of DAA by an RN-guided CHW. The CHW will run a brief (20 min) weekly 1:1 education and 20 min case management session over the 8 or 12 weeks and will deliver all components of the program (which will be developed and refined during Phase I). The CHW-RN HCV intervention will be compared to a clinic-based standard of care group (cbSOC). Primary outcomes are the completion of the Direct-Acting Agent (DAA) treatment (month 2 or 3) and SVR12 Cure (month 5 or 6). Secondary outcomes are improved mental health status, decrease in substance use, and improved access to health care, and shelter stability at month 5 or 6.
Interventions
- BEHAVIORAL Community health worker (CHW)/ registered nurse (RN) [CHW/RN]
- BEHAVIORAL Clinic-based Standard of Care (cbSOC) Program (control group)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-10-05 |
| Est. Completion | 2022-07-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04513899
The ClinicalTrials.gov registry entry for NCT04513899 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Community health worker (CHW)/ registered nurse (RN) [CHW/RN] is the first listed.
NCT04513899 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04513899 about?
NCT04513899 is a clinical study titled "Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults". This randomized controlled trial (RCT) will test the efficacy of a Community Health Worker/Registered Nurse (CHW-RN) HCV intervention for homeless individuals, many who are also drug users. The intervention will be designed during Phase I of the proposal using an iterative process between a Communit...
What is the current status of trial NCT04513899?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2020-10-05. Estimated completion is 2022-07-20.
What interventions are being tested in trial NCT04513899?
The interventions under investigation include: Community health worker (CHW)/ registered nurse (RN) [CHW/RN] (BEHAVIORAL), Clinic-based Standard of Care (cbSOC) Program (control group) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04513899?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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