[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rdt\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rdt":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"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":20,"type":21},3040,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Hepatitis C","RDT",[30,31,32,33,34,35,36],"Point of care (PoC)","Nucleic acid testing","Qualitative interviews","Feasibility","Acceptability","Cost-effectiveness","Modelling","RECRUITING","2025-07-15",{"date":40,"type":41},"2025-07-18","ACTUAL",{"date":43,"type":41},"2024-10-03",{"date":45,"type":21},"2026-12",{"name":47,"class":48},"Médecins du Monde","OTHER"]