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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: Completed Phase 4 study, sponsored by University of California, San Francisco.
NCT03987503 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 87 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number and percent attaining SVR12 after POD HCV treatment, overall, using an intention to treat (participants taking one or more doses of SOF/VEL) and per-protocol analysis (participants completing treatment). Test Details: Blood serum was collected by venipuncture to quantitatively test for HCV RNA. The lower limit of quantification for this polymerase chain reaction test was 15 IU/mL (1.18 log IU/mL) and the minimum level of blood plasma needed was 1.8 mL.
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 |
What the finished NCT03987503 record still lists
NCT03987503 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Standard of care is the first listed.
NCT03987503 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03987503's enrollment target sits among peer trials
87 923rd of 2000 higher than 1,075 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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