Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: IRB 2240400R34DA061732
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

hepatitis c; incarceration; jail; injection drug use; minimal monitoring; MINMON; implementation science

Outcome Measures

Primary Outcomes (1)

• HCV Cure Rate

  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.

  Between 12 and 24 weeks after completion of HCV treatment

Secondary Outcomes (4)

• Implementation: Feasibility of Implementation Measure

  Between 4 to 12 weeks post-implementation

• Fidelity: In-facility Treatment Adherence

  From enrollment to the end of treatment at 12 weeks

• Fidelity: Community Treatment Adherence

  From enrollment to the end of treatment at 12 weeks

• Implementation: Acceptability of Implementation Measure

  Between 4 to 12 weeks post-implementation

Study Arms (1)

MINMON-J

EXPERIMENTAL

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.

Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]; Other: Community Health Worker

Interventions

Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] DRUG

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

MINMON-J

Community Health Worker 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.

Also known as: CHW

MINMON-J

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lifespan: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Rhode Island Department of Corrections

Cranston, Rhode Island, 02920, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 41027703 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir; velpatasvir; sofosbuvir-velpatasvir drug combination; Community Health Workers

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pilot Single-Arm Hybrid Implementation-Effectiveness Study; adaptation of "Minimal Monitoring" HCV treatment model

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 1, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)