protocolSection identificationModule nctId: NCT06306300, orgStudyIdInfo id: 445957/2020-4, briefTitle: Safety and Efficacy of Decentralized HCV Treatment vs Standard-of-Care in Rio de Janeiro (Brazil), acronym: HCVPCL05/20, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-04, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Oswaldo Cruz Foundation, class: OTHER, collaborators name: Conselho Nacional de Desenvolvimento Científico e Tecnológico, descriptionModule briefSummary: 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).The 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., conditionsModule conditions: Hepatitis C, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Study I is a population-based cross-sectional screening study (n=30,000 individuals) 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 (n=1,500 participants included in Study I). Study II is a phase IV open-label randomized clinical trial (1:1) 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., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 30000, type: ESTIMATED, armsInterventionsModule interventions name: Specialist - Epclusa 400Mg-100Mg Tablet, interventions name: Non- specialist - Epclusa 400Mg-100Mg Tablet, outcomesModule primaryOutcomes measure: Prevalence of HCV infection, primaryOutcomes measure: The effectiveness of the HCV treatment with test results., primaryOutcomes measure: Usability of the result of a self-test HCV, secondaryOutcomes measure: Proportion between positive and negative, secondaryOutcomes measure: Participants with fibrosis/cirrhosis, secondaryOutcomes measure: Participants who denied the treatment, secondaryOutcomes measure: cost per detected participant, secondaryOutcomes measure: Unscheduled visits during treatment, secondaryOutcomes measure: Improvement of liver fibrosis stage, secondaryOutcomes measure: Quality of life data, secondaryOutcomes measure: Cost of treatment for participant, secondaryOutcomes measure: Adherence to treatment, otherOutcomes measure: Participant´s Ability to use the test, otherOutcomes measure: Participant preference for types of tests, otherOutcomes measure: Participant understanding to interpret his result, otherOutcomes measure: Test Performance, otherOutcomes measure: Test Accuracy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Evandro Chagas National Institute of Infectious Diseases, status: RECRUITING, city: Rio de Janeiro, state: Rio De Janeiro/RJ, zip: 21040-360, country: Brazil, contacts name: Hugo Perazzo, PhD, role: CONTACT, phone: +5521 3865-9587, email: hugo.perazzo@ini.fiocruz.br, geoPoint lat: -22.90278, lon: -43.2075, locations facility: Hugo Perazzo, status: RECRUITING, city: Rio De Janeiro, country: Brazil, contacts name: Hugo Perazzo, PhD, role: CONTACT, phone: +552138659587, email: hugo.perazzo@ini.fiocruz.br, geoPoint lat: -22.90278, lon: -43.2075, hasResults: False