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NCT03987503 · ClinicalTrials.gov registry record · Phase 4
The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study
A Phase 4 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 87
- Enrollment target
NCT03987503 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 87 participants.
The verdict
NCT03987503, a Phase 4 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 87 participants
- Enrollment target
Study Summary
Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) offers a cure to those with chronic HCV infection. For marginalized communities, linkage to care services often aren't enough to overcome barriers to accessing the medical system. For difficult to link populations, offering treatment at the same non-clinical community space may improve uptake and reduce loss-to-follow-up. The purpose of this 2 year study is to assess the feasibility, acceptability and effectiveness of accelerated initiation of commercially available DAA therapy targeting socially marginalized communities (e.g., medically underserved, homeless, people actively injecting drugs). The study will be carried out at two community sites that perform HCV testing: (a) fixed community site and (b) community mobile site via clinical research van. Participants (n=150) who test anti-HCV positive and HCV RNA positive (chronic infection) are invited to enroll into the no one waits (NOW) Study and begin HCV treatment at point of diagnosis. All evaluation, medication dissemination, and follow-up care will take place at the project site. The investigators will estimate the effect of on-site point-of-diagnosis (POD) treatment on (1) time from HCV testing to treatment initiation, (2) completing treatment, and (3) attaining (sustained virologic response) SVR-12; overall and by study site. A secondary product will be a lesson learned guide of recommendations for implementing a POD on-site test and treat program for dissemination beyond San Francisco.
Interventions
- DRUG Standard of care
- DRUG Epclusa (SOF/VEL)
- DEVICE Fibroscan® 430 Mini Plus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2022-12-29 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03987503
The ClinicalTrials.gov registry entry for NCT03987503 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Standard of care is the first listed.
NCT03987503 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03987503 about?
NCT03987503 is a clinical study titled "The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study". Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) offers a cure to those with chronic HCV infection. For marginalized communities, linkage to care services often aren't enough to overcome barriers to accessing the medical system. For difficult to link populations, offering treatment ...
What is the current status of trial NCT03987503?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 87 participants. The study started on 2020-07-01. Estimated completion is 2022-12-29.
What interventions are being tested in trial NCT03987503?
The interventions under investigation include: Standard of care (DRUG), Epclusa (SOF/VEL) (DRUG), Fibroscan® 430 Mini Plus (DEVICE).
Who is sponsoring clinical trial NCT03987503?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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