NCT06953479 Implementing Low-Barrier HCV Treatment in a Jail Setting
| NCT ID | NCT06953479 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Lifespan |
| Condition | HEPATITIS C (HCV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-06-11 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2025-06-11 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Incarcerated individual at RIDOC * Age ≥ 18 years * Awaiting trial (i.e., not sentenced) * English speaking * Diagnosis of active HCV (HCV RNA \>1000 IU/mL within 90 days prior to study entry) * Treatment-naïve for current HCV infection * No cirrhosis (FIB-4 Score \<3.25 within 90 days prior to study entry) * Self-report of injection drug use * Ability and willingness to be contacted after jail release * Verbal commitment to continue medication after discharge * Desire to receive Sofosbuvir/Velpatasvir (Epclusa) Exclusion Criteria: * Cirrhosis (FIB-4 Score \>3.25 within 90 days prior to study entry and/or clinical signs of cirrhosis) * Positive for Hepatitis B surface antigen * Actively pregnant or breastfeeding * Known allergy/sensitivity to study drug components * Acute or serious illness requiring hospitalization at enrollment * Documented severe persistent mental illness (SPMI) by RIDOC * Any clinical history of hepatic decompensation (e.g., ascites, SBP, HE, HRS, variceal bleeding) * HIV-positive with active or acute AIDS-defining opportunistic infection within 90 days
Frequently Asked Questions
Who can join the NCT06953479 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HEPATITIS C (HCV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06953479 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06953479 currently recruiting?
Yes, NCT06953479 is actively recruiting participants. Visit ClinicalTrials.gov or contact Lifespan to inquire about joining.
Where is the NCT06953479 trial being conducted?
This trial is being conducted at Cranston, United States.
Who is sponsoring the NCT06953479 clinical trial?
NCT06953479 is sponsored by Lifespan. The trial plans to enroll 40 participants.