[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599859":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":19,"studyPopulation":19,"armGroups":27,"interventions":38,"overallOfficials":44,"centralContacts":48,"locations":54,"responsibleParty":72,"collaborators":75,"id":79,"slug":19,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":19,"enrollmentInfo":89,"targetDuration":19,"studyType":92,"phases":93,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":57,"whyStopped":19,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Washington","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":19},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"PrEP screening","Using individual client-level data at clinics, compare proportion of clients completing PrEP eligibility screening in usual care (control) versus intervention time points","Up to 42 months",{"measure":14,"description":15,"timeFrame":12},"PrEP initiation","Using individual client-level data at clinics, compare PrEP initiation in usual care (control) versus intervention time points. PrEP initiation will be measured as the proportion of eligible clients starting PrEP use documented on ministry of health (MOH) tools.",{"measure":17,"description":18,"timeFrame":12},"PrEP continuation","Using individual client-level data at clinics, compare PrEP continuation in usual care (control) versus intervention time points. PrEP continuation among clients initiating PrEP will be determined by clinic visit attendance and pharmacy PrEP refill records obtained by abstraction of MOH clinic records.",null,{"allocation":21,"interventionModel":22,"interventionModelDescription":23,"primaryPurpose":24,"observationalModel":19,"timePerspective":19,"maskingInfo":25},"NA","SINGLE_GROUP","Stepped-wedge cluster randomized trial of 20 public health clinics implementing the intervention of HTS counselor-led PrEP care","PREVENTION",{"masking":26,"maskingDescription":19,"whoMasked":19},"NONE",[28,32],{"label":29,"type":30,"description":31,"interventionNames":19},"Control (Usual care)","NO_INTERVENTION","The control period (usual care) will be when the clinics are still implementing the usual care model, prior to implementing the intervention. Prior to launching the intervention, all facilities will have a baseline phase of 3 months. That time, in conjunction with other periods when the clinics are implementing usual care will serve as the control period.",{"label":33,"type":34,"description":35,"interventionNames":36},"HTS counselor-led PrEP care model","EXPERIMENTAL","During the intervention period, all core components of PrEP delivery - including HIV testing, eligibility assessment, dispensing, adherence counseling, and provision of refills will be conducted by existing facility HTS counselor as part of standard of care.",[37],"Other: HTS counselor-led PrEP care model",[39],{"type":6,"name":33,"description":40,"armGroupLabels":41,"otherNames":42},"PrEP delivery ,including HIV testing, eligibility assessment, dispensing, adherence counseling, and provision of refills, provided by an HTS counselor",[33],[43],"HTS-led PrEP",[45],{"name":46,"affiliation":5,"role":47},"Kenneth Mugwanya, MBChB, MS, PhD","PRINCIPAL_INVESTIGATOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":19,"email":53},"Clare Brown, PhD","CONTACT","206-543-8225","brownce@uw.edu",[55],{"facility":56,"status":57,"city":58,"state":19,"zip":19,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Kenyatta National Hospital","RECRUITING","Kisumu","Kenya","KE",{"type":62,"coordinates":63},"Point",[64,65],34.76171,-0.10221,{"lat":65,"lon":64},[68],{"name":69,"role":51,"phone":70,"phoneExt":19,"email":71},"Daniel Matemo","+254 722 322378","dmatemo@uw.edu",{"type":47,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Kenneth K Mugwanya","Associate Professor: School of Medicine, Global Health",[76],{"name":77,"class":78},"National Institute of Mental Health (NIMH)","NIH","100599859",false,"NCT07089966","HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics","HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics: The HIV Testing Services PrEP Integration (HTS PrEP) Project","HTS PrEP","Inclusion Criteria:\n\n* ≥15 years of age\n* Accessing health services at participating public health facilities.\n* Not known to be living with HIV prior to the visit when their clinical data is first abstracted",true,"ALL","15 Years",{"count":90,"type":91},30000,"ESTIMATED","INTERVENTIONAL",[21],"This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.",[96,97],"Human Immunodeficiency Virus (HIV)","HIV Pre-exposure Prophylaxis",[99,100],"PrEP","HIV Prevention","2026-06-16",{"date":103,"type":104},"2026-06-18","ACTUAL",{"date":106,"type":104},"2025-12-01",{"date":108,"type":91},"2029-06-30",{"name":5,"class":6},1]