[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589366":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":21,"locations":28,"responsibleParty":52,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":9,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":21,"enrollmentInfo":68,"targetDuration":21,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":31,"whyStopped":21,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Lifespan","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MINMON-J","EXPERIMENTAL","Individuals in this arm will be provided the full-course treatment of sofosbuvir \u002F 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.",[13,14],"Drug: Sofosbuvir \u002F Velpatasvir Oral Tablet [Epclusa]","Other: Community Health Worker",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Sofosbuvir \u002F Velpatasvir Oral Tablet [Epclusa]","Individuals will receive a full course (i.e., 84 tablets) of Sofosbuvir \u002F Velpatasvir 400\u002F100mg tablets.",[9],null,{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],[27],"CHW",[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Rhode Island Department of Corrections","RECRUITING","Cranston","Rhode Island","02920","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-71.43728,41.77982,{"lat":41,"lon":40},[44,49],{"name":45,"role":46,"phone":47,"phoneExt":21,"email":48},"Jessica Migliaccio","CONTACT","(401) 462-3921","doc.planning@doc.ri.gov",{"name":50,"role":51,"phone":21,"phoneExt":21,"email":21},"Justin Berk, MD MPH MBA","PRINCIPAL_INVESTIGATOR",{"type":51,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Justin Berk","Assistant Professor",[56],{"name":57,"class":58},"National Institute on Drug Abuse (NIDA)","NIH","100589366","phase-4-implementing-low-barrier-hcv-treatment-in-a-jail-setting-100589366",false,"NCT06953479","Implementing Low-Barrier HCV Treatment in a Jail Setting","MINMON-J: An Effectiveness Implementation Pilot Study Evaluating a Low-barrier Hepatitis C Treatment Model in a Jail Setting","Inclusion Criteria:\n\n* Incarcerated individual at RIDOC\n* Age ≥ 18 years\n* Awaiting trial (i.e., not sentenced)\n* English speaking\n* Diagnosis of active HCV (HCV RNA \\>1000 IU\u002FmL within 90 days prior to study entry)\n* Treatment-naïve for current HCV infection\n* No cirrhosis (FIB-4 Score \\\u003C3.25 within 90 days prior to study entry)\n* Self-report of injection drug use\n* Ability and willingness to be contacted after jail release\n* Verbal commitment to continue medication after discharge\n* Desire to receive Sofosbuvir\u002FVelpatasvir (Epclusa)\n\nExclusion Criteria:\n\n* Cirrhosis (FIB-4 Score \\>3.25 within 90 days prior to study entry and\u002For clinical signs of cirrhosis)\n* Positive for Hepatitis B surface antigen\n* Actively pregnant or breastfeeding\n* Known allergy\u002Fsensitivity to study drug components\n* Acute or serious illness requiring hospitalization at enrollment\n* Documented severe persistent mental illness (SPMI) by RIDOC\n* Any clinical history of hepatic decompensation (e.g., ascites, SBP, HE, HRS, variceal bleeding)\n* HIV-positive with active or acute AIDS-defining opportunistic infection within 90 days","ALL","18 Years",{"count":69,"type":70},40,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","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.\n\nThe study asks:\n\n* Can a simplified, low-barrier HCV treatment program work in a jail setting?\n* Do participants finish treatment and get cured using this approach?\n\nAll participants will receive a 12-week course of the HCV medication sofosbuvir\u002Fvelpatasvir (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.\n\nResearchers will measure:\n\n* Whether participants are cured of HCV\n* Whether the treatment approach is easy to use (feasible), acceptable, and followed correctly (fidelity)\n* Whether the program could be used in other jails or expanded in the future\n\nThis study may help bring HCV treatment to more people in jail, reduce community spread of the virus, and support national goals to eliminate HCV.",[76,77,78,79],"HEPATITIS C (HCV)","Incarceration","Injection Drug Use","Implementation Science",[81,82,83,84,85,86,87],"hepatitis c","incarceration","jail","injection drug use","minimal monitoring","MINMON","implementation science","2026-02-26",{"date":90,"type":91},"2026-02-27","ACTUAL",{"date":93,"type":91},"2025-06-11",{"date":95,"type":70},"2027-08",{"name":5,"class":6},1]