[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539627":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":12,"centralContacts":61,"locations":67,"responsibleParty":92,"collaborators":96,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":12,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":70,"whyStopped":12,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Oswaldo Cruz Foundation","OTHER",[8,13,16,22,27,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Study I","NO_INTERVENTION","Study I is a population-based cross-sectional screening study (n=30,000 individuals) using rapid tests to determine the prevalence of HCV infection in people attending a Basic Health Care Unit.",null,{"label":14,"type":10,"description":15,"interventionNames":12},"Substudy I","The sub-study associated with Study I is a cross-sectional study to assess the usability of a self-test for the detection of HCV antibodies in oral fluid (n=1,500 participants included in Study I).",{"label":17,"type":18,"description":19,"interventionNames":20},"Study II - Specialist","ACTIVE_COMPARATOR","HCV standard-of-care treatment\"; control arm. Participants randomized for the Standard-of-Care HCV treatment arm will be referred for the usual treatment of hepatitis C by specialists (hepatologists and\u002For infectious disease specialists) at a tertiary center \\[INI\u002FFIOCRUZ or Hospital Universitário Clementino Fraga Filho (HUCFF\u002FUFRJ)\\]. Participants will be treated with the pan-genotypic therapeutic regimen \"single-pill daily,\" at a fixed dose and duration: sofosbuvir\u002Fvelpatasvir 400\u002F100 mg (Epclusa, Gilead Sciences, USA) 1 tablet orally per day for 12 weeks.",[21],"Drug: Specialist - Epclusa 400Mg-100Mg Tablet",{"label":23,"type":18,"description":24,"interventionNames":25},"Study II - Non Specialist","Decentralized hepatitis C treatment (\"DS HCV treatment\"; experimental arm).Participants randomized for the \"Decentralized-and-Simplified HCV treatment\" (DS HCV treatment) arm will be referred for simplified treatment of chronic hepatitis C at the Primary Health Care unit where participants were included in Study I and are registered for care. The treatment will be conducted by a non-specialist physician (general practitioner or family doctor) after training provided by a specialist (hepatologist) on the treatment of patients with hepatitis C using DAAs. Participants will be treated with a pan-genotypic therapeutic regimen, a fixed-dose, single-pill daily: sofosbuvir\u002Fvelpatasvir 400\u002F100 mg (Epclusa, Gilead Sciences, USA), 1 tablet orally per day for 12 weeks.",[26],"Drug: Non- specialist - Epclusa 400Mg-100Mg Tablet",{"label":28,"type":18,"description":29,"interventionNames":30},"Sub-Study III - HCV Self-testing Arm","People randomized for this arm will receive an HCV self-testing kit (oral fluid or blood-based) for HCV testing",[31],"Diagnostic Test: HCV Self-Testing kit (Ora-Quick HCV ST or Wond-Foo HCV ST)",{"label":33,"type":34,"description":35,"interventionNames":36},"Sub-Study III - Standard-of-care: Rapid HCV Testing Arm","PLACEBO_COMPARATOR","People randomized for this arm will receive a prescription for HCV testing",[37],"Diagnostic Test: HCV Rapid Testing kit",[39,46,52,57],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","Specialist - Epclusa 400Mg-100Mg Tablet","HCV-positive participants from study 1 will be randomized to be treated in the specialist arm, which consists of follow-up by a specialized doctor.",[17],[45],"Standard-of-Care (SC) HCV treatment",{"type":40,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Non- specialist - Epclusa 400Mg-100Mg Tablet","HCV-positive participants from study 1 will be randomized to be treated in the specialist arm, which consists of follow-up by non-specialized doctor.",[23],[51],"Simplified-and-Decentralized (SD) HCV treatment",{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":12},"DIAGNOSTIC_TEST","HCV Self-Testing kit (Ora-Quick HCV ST or Wond-Foo HCV ST)","HCV Self-Testing kit (oral fluid or blood-based) for HCV testing",[28],{"type":53,"name":58,"description":59,"armGroupLabels":60,"otherNames":12},"HCV Rapid Testing kit","Standard-of-care: HCV Rapid Test",[33],[62],{"name":63,"role":64,"phone":65,"phoneExt":12,"email":66},"Hugo Perazzo, PhD","CONTACT","+552138659587","hugo.perazzo@ini.fiocruz.br",[68,82],{"facility":69,"status":70,"city":71,"state":71,"zip":12,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Hugo Perazzo","RECRUITING","Rio de Janeiro","Brazil","BR",{"type":75,"coordinates":76},"Point",[77,78],-43.18223,-22.90642,{"lat":78,"lon":77},[81],{"name":63,"role":64,"phone":65,"phoneExt":12,"email":66},{"facility":83,"status":70,"city":71,"state":84,"zip":85,"country":72,"countryCode":73,"cosmosGeoPoint":86,"geoPoint":88,"contacts":89},"Evandro Chagas National Institute of Infectious Diseases","Rio de Janeiro\u002FRJ","21040-360",{"type":75,"coordinates":87},[77,78],{"lat":78,"lon":77},[90],{"name":63,"role":64,"phone":91,"phoneExt":12,"email":66},"+5521 3865-9587",{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Hugo Perazzo Pedroso Barbosa","Principal Investigator",[97],{"name":98,"class":99},"Conselho Nacional de Desenvolvimento Científico e Tecnológico","OTHER_GOV","100539627","phase-4-safety-and-efficacy-of-decentralized-hcv-treatment-vs-standard-of-care-in-rio-de-janeiro-brazil-100539627",false,"NCT06306300","Safety and Efficacy of Decentralized HCV Treatment vs Standard-of-Care in Rio de Janeiro (Brazil)","Randomized Open-label and Non-inferiority Clinical Trial to Evaluate the Safety, Adherence, and Cost-effectiveness of Simplified and Decentralized Hepatitis C Treatment in Primary Health Care Compared to Standard-of-care in the Brazilian Public Health System","HCVPCL05\u002F20","Study I and Sub-Study\n\nInclusion Criteria:\n\n\\- Age between 18-79 years-old\n\nExclusion Criteria:\n\n* Presence of a disease that need urgent\u002Femergency treatment and\u002For acute febrile illness, such as COVID-19, Dengue, Zyca virus infection or Chikungunya\n* Lack of capacity to sign the informed consent or refuse to participate\n\nStudy II\n\nInclusion Criteria:\n\n* Age between 18 and 79 years old.\n* Presence of active\u002Fchronic hepatitis C, defined by a positive HCVab test and detectable HCV-RNA\n\nExclusion Criteria:\n\n* Children and adolescents (\\\u003C 18 years old)\n* Pregnancy, defined by a positive β-HCG urinary test\n* Lactating individuals\n* Co-infection with HBV or HIV\n* Regular use of medications with potential drug interactions or contraindication for co-administration with SOF\u002FVEL\n* Presence of severe acute illness, active neoplasia, solid organ transplant, or use of immunosuppressive medications\n* Presence of clinical signs of decompensated liver cirrhosis (ascites, hepatic encephalopathy, report of a recent episode of gastrointestinal bleeding within the last 12 weeks)",true,"ALL","18 Years","79 Years",{"count":113,"type":114},30000,"ESTIMATED","INTERVENTIONAL",[117],"PHASE4","Up to 650,000 people in Brazil are living with chronic hepatitis c virus (HCV) infection. Hepatitis C is a silent disease, and up to 20% of cases can progress to liver cirrhosis and its complications. Rapid tests for diagnosis of HCV infection and non-invasive methods for detecting liver cirrhosis are available in the Brazilian Public Health System. Additionally, safe and highly effective drugs (direct-acting antivirals, DAAs) have been delivered for free for hepatitis C treatment by the Brazilian Unified Health System (Sistema Único de Saúde, SUS) since 2015. Sustained virological response (SVR) rates with DAAs in studies conducted in Brazil and Latin America were higher than 90%. Despite the availability of rapid tests for early diagnosis and effective drugs, the HCV continuum of care remains deficient in Brazil. It is estimated that only 10% of individuals known to have hepatitis C achieve HCV cure (SVR). This is explained by multiple barriers from diagnosis to treatment access, such as low rates of population screening (HCVST are not available in Brazil) and few available slots in tertiary centers for hepatitis C treatment by specialists. International studies have described that SVR rates by simplified hepatitis C treatment performed by non-specialists in the Primary Care System were similar to those treated in tertiary centers by specialists (standard-of-care). However, the optimal strategy for managing hepatitis C within the Brazilian-SUS remains unclear.This project aims to evaluate the improve of the HCV continuum of care by a implementation of a test-and-treat strategy in the Primary Care System in Brazil. The project consists of two parallel studies (and a sub-study).\n\nThe project consists of two parallel studies (and a sub-study). Study I is a population-based cross-sectional screening study using rapid tests to determine the prevalence of HCV infection in people attending a Basic Health Care Unit. The sub-study associated with Study I is a cross-sectional study to assess the usability of a self-test for the detection of HCV antibodies in oral fluid (participants included in Study I). Study II is a phase IV open-label randomized clinical trial to evaluate the non-inferiority of simplified and decentralized hepatitis C treatment (\"Simplified-and-Decentralized (SD) HCV treatment\"; experimental arm) compared to specialist reference treatment (\"Standard-of-Care (SC) HCV treatment\"; control arm) within the SUS.",[120],"Hepatitis C",[122,123,124],"Hepatitis C virus","Primary health care","Hepatitis C virus self-test","2026-08-13",{"date":127,"type":128},"2026-08-17","ACTUAL",{"date":130,"type":128},"2022-07-04",{"date":132,"type":114},"2026-12-31",{"name":5,"class":6},2]