[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Médecins du Monde\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":85},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100546453","low-dead-space-injecting-equipment-distribution-program-for-people-who-inject-drugs-in-low--and-middle-income-countries-100546453",false,"NCT06395129","Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries","Implementing a Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries: a Process and Outcome Evaluation","Inclusion Criteria:\n\n* Aged ≥18 years (note that country-specific protocols may include participants aged ≥16 where appropriate and relevant);\n* Reporting a history of recent (past month) injection drug use;\n* Accessing the NSP to receive injecting equipment at either a facility, mobile service or through outreach and have an accompanying assigned program unique ID;\n* Able to understand and communicate in the local language(s);\n* If self-reporting HCV\u002FHIV negative status, interested in and agreeing to undergo HCV and HIV testing; and\n* Willing and able to provide informed consent to take part in the study.\n\nExclusion Criteria:\n\n* N\u002FA",true,"ALL","18 Years",{"count":20,"type":21},2400,"ESTIMATED","OBSERVATIONAL","Implementation and evaluation of a distribution program for low dead-space syringes\u002Fneedles (LDSS\u002FN) in Armenia, Georgia, and Tanzania, Egypt, Nigeria, Vietnam, India, Ukraine, and South Africa. This study aims to generate evidence on best practice LDSS\u002FN distribution programs which will enhance acceptability and sustain high levels of LDSS\u002FN uptake.\n\nPeople who inject drugs and access needle and syringe programs will be invited to attend up to three focus group discussion rounds (with 25 participants in each focus group round) to inform and provide feedback on a concurrent distribution program of LDSS\u002FN.\n\nThroughout distribution, a cohort study will be run alongside distribution with 240 participants enrolled per country (with the exception of Nigeria, where 480 participants will be recruited) who will undergo HIV and HCV testing and answer surveys on their sociodemographic and behavioral status. Key informant interviews will also be held with participating staff and stakeholders to evaluate the feasibility and acceptability of this program.\n\nPrimary outcomes assessed through this study include 1) community values and preferences for LDSS\u002FN, 2) barriers and facilitators to accessing LDSS\u002FN, 3) feasibility and effectiveness of the distribution program on increasing LDSS\u002FN uptake, 4) model the potential public health impact and cost effectiveness of LDSS\u002FN distribution in this setting.",[25,26,27],"Drug Use","Hepatitis","Hiv",[29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Low dead-space needles and syringes","Qualitative interviews","LDSS\u002FN","High dead space needles\u002Fsyringes (HDSS\u002FN)","Rapid diagnostic test (RDT)","Feasibility","Acceptability","Cost effectiveness","Modelling","Focus group discussions","Harm Reduction","Values and preferences","Needle and syringe exchange program","Blood borne virus","RECRUITING","2025-09-25",{"date":46,"type":47},"2025-10-01","ACTUAL",{"date":49,"type":47},"2024-09-13",{"date":51,"type":21},"2026-12",{"name":53,"class":54},"Médecins du Monde","OTHER",9,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":83,"locationsCount":84},"100528341","early-phase-1-simplifying-hepatitis-c-pathways-for-people-who-inject-drugs-in-armenia-georgia-and-tanzania-100528341","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",{"count":65,"type":21},3040,"INTERVENTIONAL",[68],"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.",[71,72],"Hepatitis C","RDT",[74,75,30,34,35,76,37],"Point of care (PoC)","Nucleic acid testing","Cost-effectiveness","2025-07-15",{"date":79,"type":47},"2025-07-18",{"date":81,"type":47},"2024-10-03",{"date":51,"type":21},{"name":53,"class":54},1,""]