[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528341":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":47,"responsibleParty":66,"collaborators":68,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":26,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Médecins du Monde","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 - simplified care model","ACTIVE_COMPARATOR","Arm 1 will receive DAA medication at the second appointment following the return of RNA HCV results. They will receive sofosbuvir (400mg) and velpatasvir (100mg).",[13],"Drug: sofosbuvir\u002Fvelpatasvir (SOF\u002FVEL)",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2 - short read time","EXPERIMENTAL","Arm 2 will begin DAA treatment after the first appointment following a shortened RDT read time of 5 minutes rather than 20 minutes. They will receive sofosbuvir (400mg) and velpatasvir (100mg).",[13,19],"Diagnostic Test: Shortened read time of rapid diagnostic test for hepatitis C virus.",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","sofosbuvir\u002Fvelpatasvir (SOF\u002FVEL)","400mg of SOF and 100mg of VEL self administered daily as a tablet.",[9,15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIAGNOSTIC_TEST","Shortened read time of rapid diagnostic test for hepatitis C virus.","Administered once during hepatitis C testing. Test is read after 5 minutes rather than its usual time of 20 minutes.",[15],[33],"OraQuick® HCV RDT",[35],{"name":36,"affiliation":37,"role":38},"Margaret Hellard","Burnet","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Bridget Draper","CONTACT","+61 413 272 698","bridget.draper@burnet.edu.au",{"name":36,"role":42,"phone":26,"phoneExt":26,"email":46},"margaret.hellard@burnet.edu.au",[48],{"facility":49,"status":50,"city":51,"state":26,"zip":26,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"National Institute for Infectious Diseases","RECRUITING","Yerevan","Armenia","AM",{"type":55,"coordinates":56},"Point",[57,58],44.5126,40.17765,{"lat":58,"lon":57},[61,64],{"name":62,"role":42,"phone":26,"phoneExt":26,"email":63},"Dr. Sargsyan","sargsyanqn30@gmail.com",{"name":65,"role":38,"phone":26,"phoneExt":26,"email":26},"Knarik Dr. Sargsyan",{"type":67,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[69,71,73,75],{"name":70,"class":6},"UNITAID",{"name":72,"class":6},"Burnet Institute",{"name":74,"class":6},"University of Bristol",{"name":76,"class":77},"International Network of People who Use Drugs","UNKNOWN","100528341","early-phase-1-simplifying-hepatitis-c-pathways-for-people-who-inject-drugs-in-armenia-georgia-and-tanzania-100528341",false,"NCT06159504","Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania","Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania (CUTTS HepC): a Non-randomised, Quasiexperimental, Prospective Comparative Trial","CUTTS HepC","Inclusion Criteria:\n\n* 18 years or older\n* Able and willing to provide informed consent in local language\n* Not currently on or previously had treatment for hepatitis C\n* Attending site for needle \u002F syringe program, OR self-reports ever injecting drugs\n\nExclusion Criteria:\n\n* Self-reported history of decompensate cirrhosis of the liver\n* Women who are pregnant or breast-feeding\n* Self-report other significant co-morbidities such as uncontrolled HIV infection, history of renal dysfunction, tuberculosis infection, or chronic hepatitis B infection\n* Unable \u002F unwilling to stop any contraindicated medications \u002F supplements","ALL","18 Years",{"count":89,"type":90},3040,"ESTIMATED","INTERVENTIONAL",[93],"EARLY_PHASE1","The goal of this non-randomised, quasi-experimental, prospective comparative trial is to trial simplified care pathways for hepatitis C testing and treatment for people who inject drugs in Armenia, Georgia, and Tanzania.\n\nThe main questions it aims to answer are:\n\n1. What is the feasibility of implementing a hepatitis C simplified care and same-day treatment care model in community and harm reduction settings in the three study countries?\n2. Does a same-day treatment initiation model involving only POC antibody tests (with a shortened read-time) increase hepatitis C treatment uptake and SVR12 outcome (cure) among people who inject drugs compared with a simplified care model involving POC antibody followed by a confirmatory RNA test?\n3. What is the comparative cost-effectiveness between a same-day antibody only hepatitis C testing and treatment model and the simplified care model (POC antibody\u002Fconfirmatory RNA test) model?\n\nParticipants will:\n\n* be enrolled in a new simplified model of care in each country (Arm 1). After the enrolment target is met for Arm 1 (approx. 3-9 months into implementation) new participants will be enrolled into a same-day treatment trial, using presumptive treatment after a reactive POC test result at shortened read-time (5minutes) (Arm 2)\n* if in Arm 1, participants will commence SOF-VEL DAA treatment after receiving an RNA test to confirm current hepatitis C infection. They will then continue along the treatment pathway, returning for RNA testing 4-16 weeks after SVR12 to determine cure.\n* if in Arm 2, participants will begin SOF-VEL DAA treatment on the same day as the 5 minute RDT testing. They will then continue along the treatment pathway, returning for RNA testing 4-16 weeks after SVR12 to determine cure.\n\nResearchers will compare cure and participant retention rates between the two groups.",[96,97],"Hepatitis C","RDT",[99,100,101,102,103,104,105],"Point of care (PoC)","Nucleic acid testing","Qualitative interviews","Feasibility","Acceptability","Cost-effectiveness","Modelling","2025-07-15",{"date":108,"type":109},"2025-07-18","ACTUAL",{"date":111,"type":109},"2024-10-03",{"date":113,"type":90},"2026-12",{"name":5,"class":6},1]