[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546453":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":34,"studyPopulation":35,"armGroups":36,"interventions":44,"overallOfficials":63,"centralContacts":68,"locations":76,"responsibleParty":177,"collaborators":179,"id":203,"slug":204,"hasResults":205,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":22,"eligibilityCriteria":209,"healthyVolunteers":210,"sex":211,"minAge":212,"maxAge":22,"enrollmentInfo":213,"targetDuration":22,"studyType":216,"phases":22,"briefSummary":217,"conditions":218,"keywords":222,"overallStatus":79,"whyStopped":22,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":245},{"fullName":5,"class":6},"Médecins du Monde","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Effectiveness of a community values and preferences informed LDSS\u002FN distribution program on increasing LDSS uptake among people who inject drugs","Defined as reported exclusive use of LDSS\u002FN vs not exclusive use of LDSS\u002FN","18 months",[14,17,20,23,25,27,29],{"measure":15,"description":16,"timeFrame":12},"Understanding community values and preferences for LDSS\u002FN in the context of other harm reduction supplies available to people who inject drugs","Identified through focus group discussions",{"measure":18,"description":19,"timeFrame":12},"Barriers and facilitators to access and uptake of LDSS\u002FN among people who inject drugs","Assessed through surveys and focus group discussions",{"measure":21,"description":22,"timeFrame":12},"Differences in blood borne virus (HIV\u002FHCV) incidence between those who exclusively use LDSS\u002FN and those who do not",null,{"measure":24,"description":22,"timeFrame":12},"Model the potential public health impact (HCV and HIV infections averted) and cost-effectiveness of LDSS\u002FN distribution for people who inject drugs within harm reduction settings",{"measure":26,"description":22,"timeFrame":12},"Identifying the enablers and challenges affecting the supply chain for LDSS\u002FN",{"measure":28,"description":22,"timeFrame":12},"Document the legal, social, and regularity enablers and challenges affecting the successful introduction and maintenance of LDSS\u002FN distribution",{"measure":30,"description":22,"timeFrame":12},"Evaluate LDSS\u002FN demand creation approaches",{"allocation":22,"interventionModel":22,"interventionModelDescription":22,"primaryPurpose":22,"observationalModel":32,"timePerspective":33,"maskingInfo":22},"COHORT","PROSPECTIVE","This study will recruit people who inject drugs to inform and evaluate the selection and distribution of low dead-space needles and syringes (LDSS\u002FN) at their existing NSP services.\n\nThe interventions include: low- dead-space needles and syringes; and knowledge mobilisation through Focus Group Discussions (FGDs) and peer education.\n\nSpecifically, in Phase 1, people who inject drugs will be recruited at each study site to participate in FGDs, in which they will be presented with a selection of new LDSS\u002FN products, provided information about their advantages regarding blood borne virus (BBV) transmission risk, and invited to discuss their values and preferences regarding needle- and syringe choice to inform the selection of LDSS\u002FN to be piloted for scaled up distribution at their study sites.\n\nFollowing the FGDs, during Phase 2 people who inject drugs who are registered clients at participating NSP services can enroll in a 6-week pilot period during which they will have access to a small selection of new LDSS\u002FN products alongside the usual services they access at the study site or needle and syringe program (NSP). When the 6 week pilot phase concludes, participants will be invited to participate in a second round of FGDs, where they will be asked reflect on their experiences using the new LDSS\u002FN products and share their opinions on which products to select for scaled up distribution to all clients accessing the study sites.\n\nIn Phase 3, a small selection LDSS\u002FN (2-5) will be made available alongside the usual needles- and syringes and other existing harm reduction services at the study site\u002FNSPs. During this period, two forms of data will be collected, 1) routine programmatic data, and 2) data from a concurrent cohort study.\n\nThe routine programmatic data collected will include information already routinely collected by the sites when individuals attend (site specific client ID, type and quantity of needles\u002Fsyringes (N\u002FS) collected) along with two additional questions 'Did you use a LDSS\u002FN the last time you injected?\" and \"Thinking about the last week, for how many of your injections did you use a LDSS\u002FN?'. No identifiable data will be recorded as part of routine programmatic data collection, therefore individuals included in this process are not considered 'participants' and will not undergo informed consent. This data will be used for the purposes of monitoring and evaluating LDSS\u002FN uptake.\n\nAlongside this distribution period, 240 people per country who inject drugs accessing participating study sites will be recruited into an observational cohort study. Participants will be asked to undergo HIV and HCV antibody testing and to answer surveys on demographic and behavioral activities at four timepoints (baseline, 6-months, 12-months, 18-months).\n\nAt the conclusion of the distribution period, a third round of FGDs will be run to assess the acceptability and impact of the LDSS\u002FN distribution program. Key informant interviews with study staff and key stakeholders will also be completed to explore the feasibility and effectiveness of the LDSS\u002FN program.\n\nFollowing all data collection, mathematical modelling will estimate the impact and cost-effectiveness of scaling up LDSS\u002FN for people who inject drugs at a country-level, including modelling the impact on BBV transmission.","People aged 18+ who report injecting drug use",[37],{"label":38,"type":22,"description":39,"interventionNames":40},"Cohort study","All participants in the cohort study will undergo surveys, HIV, and HCV testing at four possible timepoints (baseline, 6-months, 12-months, and if time permits 18-months).\n\nThey will also have access to the study sites usual services, and the introduced LDSS\u002FN.",[41,42,43],"Device: Low dead-space syringes\u002Fneedles","Device: Hepatitis C Antibody Rapid Diagnostic Test","Device: HIV rapid Diagnostic Test",[45,52,58],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"DEVICE","Low dead-space syringes\u002Fneedles","LDSS\u002FN are a type of syringe\u002Fneedle which retains less residual blood following an injecting event when compared to HDSS\u002FN.",[38],[51],"LDSS\u002FN",{"type":46,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"Hepatitis C Antibody Rapid Diagnostic Test","Administered up to 4 times, at baseline, 6-months, 12-months, and 18-months",[38],[57],"HCV RDT",{"type":46,"name":59,"description":54,"armGroupLabels":60,"otherNames":61},"HIV rapid Diagnostic Test",[38],[62],"HIV RDT",[64],{"name":65,"affiliation":66,"role":67},"Mark Stoové","Burnet","PRINCIPAL_INVESTIGATOR",[69,74],{"name":70,"role":71,"phone":72,"phoneExt":22,"email":73},"Bridget Draper","CONTACT","+61 413 272 698","bridget.draper@burnet.edu.au",{"name":65,"role":71,"phone":22,"phoneExt":22,"email":75},"mark.stoove@burnet.edu.au",[77,93,107,117,127,140,147,157,167],{"facility":78,"status":79,"city":80,"state":22,"zip":22,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Real World Real People","RECRUITING","Yerevan","Armenia","AM",{"type":84,"coordinates":85},"Point",[86,87],44.5126,40.17765,{"lat":87,"lon":86},[90],{"name":91,"role":71,"phone":22,"phoneExt":22,"email":92},"Tamara Ohanjanyan","pm.cutts.armenia@medecinsdumonde.net",{"facility":94,"status":79,"city":95,"state":22,"zip":22,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Step to Future","Gori","Georgia","GE",{"type":84,"coordinates":99},[100,101],44.1129,41.98532,{"lat":101,"lon":100},[104],{"name":105,"role":71,"phone":22,"phoneExt":22,"email":106},"Lasha Abesadze","lashaabes@gmail.com",{"facility":108,"status":79,"city":109,"state":22,"zip":22,"country":96,"countryCode":97,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"New Vector","Rustavi",{"type":84,"coordinates":111},[112,113],44.9787,41.56271,{"lat":113,"lon":112},[116],{"name":105,"role":71,"phone":22,"phoneExt":22,"email":106},{"facility":118,"status":79,"city":119,"state":22,"zip":22,"country":96,"countryCode":97,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Hepa+","Tbilisi",{"type":84,"coordinates":121},[122,123],44.83412,41.69143,{"lat":123,"lon":122},[126],{"name":105,"role":71,"phone":22,"phoneExt":22,"email":106},{"facility":128,"status":79,"city":129,"state":22,"zip":22,"country":130,"countryCode":22,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Mukikute","Dar es Salaam","Tanzania",{"type":84,"coordinates":132},[133,134],39.26951,-6.82349,{"lat":134,"lon":133},[137],{"name":138,"role":71,"phone":22,"phoneExt":22,"email":139},"Damali Kabwali","damalikabwali@gmail.com",{"facility":141,"status":79,"city":129,"state":22,"zip":22,"country":130,"countryCode":22,"cosmosGeoPoint":142,"geoPoint":144,"contacts":145},"Peer 2 Peer",{"type":84,"coordinates":143},[133,134],{"lat":134,"lon":133},[146],{"name":138,"role":71,"phone":22,"phoneExt":22,"email":139},{"facility":148,"status":79,"city":149,"state":22,"zip":22,"country":130,"countryCode":22,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Yovaribe","Ilala",{"type":84,"coordinates":151},[152,153],39.26667,-6.83333,{"lat":153,"lon":152},[156],{"name":138,"role":71,"phone":22,"phoneExt":22,"email":139},{"facility":158,"status":79,"city":159,"state":22,"zip":22,"country":130,"countryCode":22,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Mefada","Kinondoni",{"type":84,"coordinates":161},[162,163],39.2699,-6.78693,{"lat":163,"lon":162},[166],{"name":138,"role":71,"phone":22,"phoneExt":22,"email":139},{"facility":168,"status":79,"city":169,"state":22,"zip":22,"country":130,"countryCode":22,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"STEPS Tanzania","Ubungo",{"type":84,"coordinates":171},[172,173],39.2,-6.78333,{"lat":173,"lon":172},[176],{"name":138,"role":71,"phone":22,"phoneExt":22,"email":139},{"type":178,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[180,182,184,187,189,191,193,195,197,199,201],{"name":181,"class":6},"UNITAID",{"name":183,"class":6},"Burnet Institute",{"name":185,"class":186},"International Network of People who Use Drugs","UNKNOWN",{"name":188,"class":6},"University of Bristol",{"name":190,"class":6},"Frontline AIDS",{"name":192,"class":186},"Caritas",{"name":194,"class":186},"Drug-free and preventitve healthcare organisation Nigeria",{"name":196,"class":186},"National Viral Hepatitis and STI Control Program Nigeria",{"name":198,"class":6},"PATH",{"name":200,"class":6},"Population Services International",{"name":202,"class":6},"London School of Hygiene and Tropical Medicine","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":214,"type":215},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.",[219,220,221],"Drug Use","Hepatitis","Hiv",[223,224,51,225,226,227,228,229,230,231,232,233,234,235],"Low dead-space needles and syringes","Qualitative interviews","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","2025-09-25",{"date":238,"type":239},"2025-10-01","ACTUAL",{"date":241,"type":239},"2024-09-13",{"date":243,"type":215},"2026-12",{"name":5,"class":6},9]