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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA061732 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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:
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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] | Drug | Individuals will receive a full course (i.e., 84 tablets) of Sofosbuvir / Velpatasvir 400/100mg tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Implementation: Feasibility of Implementation Measure | The Feasibility of Implementation Measure (FIM) is a validated 4-item Likert-scale tool assessing provider perceptions of the feasibility of implementing a specific intervention. Each item is scored from 1 (completely disagree) to 5 (completely agree), with higher scores indicating greater perceived feasibility. The total score ranges from 4 to 20. Mean FIM scores will be reported across participants. This will be administered to participating stakeholders. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Department of Corrections | Recruiting | Cranston | Rhode Island | 02920 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41027703 | Derived | 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. |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C000604171 | velpatasvir |
| C000611331 | sofosbuvir-velpatasvir drug combination |
| D003150 | Community Health Workers |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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Pilot Single-Arm Hybrid Implementation-Effectiveness Study; adaptation of "Minimal Monitoring" HCV treatment model
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| 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. |
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| Between 4 to 12 weeks post-implementation |
| Fidelity: In-facility Treatment Adherence | Fidelity will be assessed by calculating the percentage of prescribed doses taken during the treatment period, based on in-facility medication dispensation data from the Rhode Island Department of Corrections (RIDOC) electronic medical record (EMR), Adherence will be reported both as a continuous variable (% of doses taken) and as a binary indicator (≥80% of prescribed daily doses taken during treatment). Missing doses will be quantified to assess treatment fidelity across care settings. | From enrollment to the end of treatment at 12 weeks |
| Fidelity: Community Treatment Adherence | Fidelity will be assessed by calculating the percentage of prescribed doses taken during the treatment period, based on community adherence data collected by community health workers (CHWs) using the Brief Adherence Rating Scale (BARS). Adherence will be reported both as a continuous variable (% of doses taken) and as a binary indicator (≥80% of prescribed daily doses taken during treatment). Missing doses will be quantified to assess treatment fidelity across care settings. | From enrollment to the end of treatment at 12 weeks |
| Implementation: Acceptability of Implementation Measure | Acceptability will be assessed using the validated 4-item Acceptability of Intervention Measure (AIM), which evaluates provider perceptions of how acceptable the intervention is. Each item is rated on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). Total scores range from 4 to 20, with higher scores indicating greater acceptability. | Between 4 to 12 weeks post-implementation |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D000488 | Allied Health Personnel |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |