Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT ID: NCT06953479

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-11
• Study Completion Date: 2027-08-31

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.

Detailed Description

This is a hybrid effectiveness-implementation pilot study testing a simplified model of hepatitis C virus (HCV) treatment called MINMON-J, based on the successful "minimal monitoring" approach used in community settings. The study takes place at the Rhode Island Department of Corrections (RIDOC), a statewide unified jail and prison system. The goal is to assess whether low-barrier HCV treatment can be feasible, acceptable, and effective when started in jail, especially for individuals who inject drugs.

Participants will receive a full 12-week course of sofosbuvir/velpatasvir (Epclusa) with no lab monitoring required during treatment. Those released before completing treatment will be given take-home medication and supported by Community Health Workers (CHWs) post-release. CHWs will check in with participants, support medication adherence, and help coordinate follow-up testing.

The study will enroll 40 adults with active HCV who are awaiting trial and meet other medical and safety criteria. Implementation outcomes will be assessed using the PRISM/RE-AIM framework. These include:

Feasibility: Can the treatment be delivered as planned in the jail setting? Acceptability: Do participants and providers find the program acceptable? Fidelity: Do participants take the medication as prescribed? Effectiveness: Are participants cured of HCV (measured by SVR12)? Maintenance: Do participants remain engaged in care or avoid reinfection 6 months later?

Additional data will include participant demographics, adherence rates, and program costs (via the COINS framework). Participants and staff will also take part in qualitative interviews to understand their experience and identify ways to improve implementation. Results will inform a future larger trial and contribute to efforts to scale up HCV treatment in carceral settings as part of national HCV elimination efforts.

Conditions

HEPATITIS C (HCV); Incarceration; Injection Drug Use; Implementation Science

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MINMON-J

Individuals in this arm will be provided the full-course treatment of sofosbuvir / velpatasvir for treatment of hepatitis C virus. They will also receive support from a Community Health Worker (CHW) to assist with community re-entry, medication adherence, and lab follow-up.

Group Type: EXPERIMENTAL

Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]

Intervention Type: DRUG

Individuals will receive a full course (i.e., 84 tablets) of Sofosbuvir / Velpatasvir 400/100mg tablets.

Community Health Worker

Intervention Type: OTHER

Participants will receive support from a Community Health Worker which may include assistance with basic needs (transportation, housing, employment, vital documents, insurance re-activation) as well as medication adherence, patient navigation, and peer recovery support.

Interventions

Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]

Individuals will receive a full course (i.e., 84 tablets) of Sofosbuvir / Velpatasvir 400/100mg tablets.

Intervention Type: DRUG

Community Health Worker

Participants will receive support from a Community Health Worker which may include assistance with basic needs (transportation, housing, employment, vital documents, insurance re-activation) as well as medication adherence, patient navigation, and peer recovery support.

Intervention Type: OTHER

Other Intervention Names

CHW

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Lifespan

OTHER

Sponsor Role: lead

Responsible Party

Justin Berk

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rhode Island Department of Corrections

Cranston, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Jessica Migliaccio

Role: primary

doc.planning@doc.ri.gov

(401) 462-3921

References

Berk J, Fu ES, Murphy M, Akiyama MJ, Sulkowski M, Rich JD, Frank HE. MINMON-J: a hybrid implementation pilot study evaluating a low-barrier hepatitis C treatment model in a jail setting. BMJ Open. 2025 Sep 30;15(9):e104839. doi: 10.1136/bmjopen-2025-104839.

Reference Type: DERIVED

PMID: 41027703 (View on PubMed)

Other Identifiers

R34DA061732

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB 2240400

Identifier Type: -

Identifier Source: org_study_id