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NCT06953479 · ClinicalTrials.gov registry record · Phase 4
Implementing Low-Barrier HCV Treatment in a Jail Setting
A Phase 4 study of Implementation Science and Injection Drug Use, sponsored by Lifespan.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06953479: Recruiting Phase 4 study of Implementation Science and Injection Drug Use, sponsored by Lifespan.
NCT06953479 is a Phase 4 study of Implementation Science and Injection Drug Use that is actively recruiting participants, run by Lifespan. The registered enrollment target is 40 participants, below the 1,741-participant average among 13 other Implementation Science trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06953479, a Phase 4 study of Implementation Science and Injection Drug Use, is actively recruiting participants, sponsored by Lifespan.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to learn whether a low-barrier treatment program can help people with hepatitis C virus (HCV) who are in jail start and complete treatment more easily. This study focuses on adults at the Rhode Island Department of Corrections who have active HCV and are awaiting trial. The study asks: * Can a simplified, low-barrier HCV treatment program work in a jail setting? * Do participants finish treatment and get cured using this approach? All participants will receive a 12-week course of the HCV medication sofosbuvir/velpatasvir (Epclusa). If they are released before completing treatment, they will take the remaining doses with them. Community Health Workers (CHWs) will help support participants after release, including reminding them to take medications and helping them get follow-up lab work. Researchers will measure: * Whether participants are cured of HCV * Whether the treatment approach is easy to use (feasible), acceptable, and followed correctly (fidelity) * Whether the program could be used in other jails or expanded in the future This study may help bring HCV treatment to more people in jail, reduce community spread of the virus, and support national goals to eliminate HCV.
Primary Outcome
HCV Cure Rate will be defined as achieving a Sustained Virological Response at 12 weeks after treatment completion (SVR12), assessed by an undetectable HCV RNA viral load measured via standard laboratory assay. An undetectable result indicates that the virus is no longer present in the blood and is considered the clinical definition of virologic cure.
Conditions Studied
Interventions
- DRUG Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]
- OTHER Community Health Worker
Study Locations (1)
Rhode Island
- Rhode Island Department of Corrections - Cranston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-06-11 |
| Est. Completion | 2027-08 |
| Phase | Phase 4 |
What NCT06953479 shows while recruiting
NCT06953479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,741-participant average among 13 other Implementation Science trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Implementation Science appearing as the primary indexed condition, and to 2 interventions - of which Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] is the first listed.
NCT06953479 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT06953479 about?
NCT06953479 is a clinical study titled "Implementing Low-Barrier HCV Treatment in a Jail Setting". The goal of this clinical trial is to learn whether a low-barrier treatment program can help people with hepatitis C virus (HCV) who are in jail start and complete treatment more easily. This study focuses on adults at the Rhode Island Department of Corrections who have active HCV and are awaiting t...
What is the current status of trial NCT06953479?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2025-06-11. Estimated completion is 2027-08.
What conditions does trial NCT06953479 study?
This clinical trial studies the following conditions: Implementation Science, Injection Drug Use, Hepatitis C (HCV), Incarceration.
What interventions are being tested in trial NCT06953479?
The interventions under investigation include: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] (DRUG), Community Health Worker (OTHER).
Who is sponsoring clinical trial NCT06953479?
This trial is sponsored by Lifespan, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06953479 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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participants (enrollment target), bucketed by value
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