[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583738":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":35,"studyPopulation":27,"armGroups":36,"interventions":52,"overallOfficials":78,"centralContacts":82,"locations":90,"responsibleParty":171,"collaborators":174,"id":178,"slug":27,"hasResults":179,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":185,"sex":186,"minAge":187,"maxAge":188,"enrollmentInfo":189,"targetDuration":27,"studyType":192,"phases":193,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":93,"whyStopped":27,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},{"fullName":5,"class":6},"Northwestern University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":27},[9,13],{"measure":10,"description":11,"timeFrame":12},"Case Finding: HIV-positive serostatus","HIV-positive serostatus based on rapid test with confirmation","48 weeks",{"measure":14,"description":15,"timeFrame":16},"Treatment: Viral suppression","Viral suppression (\\\u003C 200 copies per mL)","48 Weeks",[18,21,24],{"measure":19,"description":20,"timeFrame":16},"Case Finding: Linkage to HIV care","Linkage to HIV care within 30 days of positive HIV test",{"measure":22,"description":23,"timeFrame":12},"Case Finding: PrEP among youth who test HIV-negative","PrEP uptake among youth who test HIV-negative",{"measure":25,"description":26,"timeFrame":16},"Treatment: Adherence to antiretroviral therapy (ART)","\\> 90% adherence to ART",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":32,"observationalModel":27,"timePerspective":27,"maskingInfo":33},"RANDOMIZED","PARALLEL","This is a hybrid effectiveness\u002Fimplementation trial with an HIV Case Finding Intervention \"Arm\" and a parallel HIV Treatment Intervention \"Arm\" that is a randomized controlled trial.","PREVENTION",{"masking":34,"maskingDescription":27,"whoMasked":27},"NONE","Two combination interventions, each with mHealth and Peer Navigation components, will be evaluated in two 48-week parallel hybrid effectiveness\u002Fimplementation trials among youth aged 15-24 in Nigeria:\n\n1. HIV Case Finding Intervention: single arm trial of an HIV case finding and linkage to care intervention targeting young men at risk of HIV infection (n = 6000), particularly young men who have sex with men (YMSM) in Akwa Ibom, Benue, Enugu, Kano, Taraba, and Lagos states who complete HIV testing.\n\n   Objectives: To determine the effectiveness of the intervention to:\n   * identify youth living with HIV, particularly YMSM and\n   * link those who test HIV-positive to HIV care\n   * pre-exposure prophylaxis (PrEP) initiation (uptake) among those who test HIV-negative.\n2. HIV Treatment Intervention: randomized controlled trial of a medication adherence and viral suppression intervention among youth newly diagnosed with HIV and initiating antiretroviral therapy (ART) for the first time (n = 600) at the participating clinical sites.\n\nObjectives: To determine the effectiveness of the intervention on\n\n* viral suppression and\n* adherence to ART\n* success of implementation in the target populations",[37,45],{"label":38,"type":39,"description":40,"interventionNames":41},"HIV Case Finding Intervention","EXPERIMENTAL","Combination HIV case finding and linkage to care intervention",[42,43,44],"Behavioral: Testing Peer navigation","Behavioral: PrEP Intervention","Behavioral: Social Media Outreach",{"label":46,"type":39,"description":47,"interventionNames":48},"HIV Treatment Intervention","Combination HIV treatment intervention vs. standard of care adherence among youth newly diagnosed with HIV and initiating ART",[49,50,51],"Behavioral: Treatment Peer Navigation","Behavioral: SMS Test messaging","Other: Adherence standard of care",[53,58,62,66,70,74],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":27},"BEHAVIORAL","Testing Peer navigation","Peer navigators will promote HIV testing in YMSM and linkage to care if HIV-positive",[38],{"type":54,"name":59,"description":60,"armGroupLabels":61,"otherNames":27},"PrEP Intervention","Motivational-interviewing to promote uptake of PrEP among those who test HIV-negative",[38],{"type":54,"name":63,"description":64,"armGroupLabels":65,"otherNames":27},"Treatment Peer Navigation","Peer navigators will provide assistance and support to youth with HIV to optimize adherence to ART",[46],{"type":54,"name":67,"description":68,"armGroupLabels":69,"otherNames":27},"Social Media Outreach","Social media outreach to identify youth at risk for HIV",[38],{"type":54,"name":71,"description":72,"armGroupLabels":73,"otherNames":27},"SMS Test messaging","Text (SMS) messages to remind and encourage youth to adhere to their ART",[46],{"type":6,"name":75,"description":76,"armGroupLabels":77,"otherNames":27},"Adherence standard of care","Standard of care HIV treatment adherence",[46],[79],{"name":80,"affiliation":5,"role":81},"Robert Garofalo, MD","PRINCIPAL_INVESTIGATOR",[83,87],{"name":80,"role":84,"phone":85,"phoneExt":27,"email":86},"CONTACT","312-227-7740","rgarofalo@luriechildrens.org",{"name":88,"role":84,"phone":85,"phoneExt":27,"email":89},"Lisa M Kuhns, PhD","lkuhns@luriechildrens.org",[91,109,122,135,147,159],{"facility":92,"status":93,"city":94,"state":95,"zip":27,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":104},"University of Uyo Teaching Hospital","RECRUITING","Uyo","Akwa Ibom State","Nigeria","NG",{"type":99,"coordinates":100},"Point",[101,102],7.9335,5.05127,{"lat":102,"lon":101},[105],{"name":106,"role":84,"phone":107,"phoneExt":27,"email":108},"Ofonime Dixon-Umo, MBBS","234","ofonimedixonumo@uniuyo.edu.ng",{"facility":110,"status":93,"city":111,"state":112,"zip":27,"country":96,"countryCode":97,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Federal Medical Center","Makurdi","Benue State",{"type":99,"coordinates":114},[115,116],8.52139,7.73375,{"lat":116,"lon":115},[119],{"name":120,"role":84,"phone":107,"phoneExt":27,"email":121},"Bem Tar, MBBS","drbemtar@gmail.com",{"facility":123,"status":93,"city":124,"state":125,"zip":27,"country":96,"countryCode":97,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Taraba State Specialist Hospital","Jalingo","Taraba State",{"type":99,"coordinates":127},[128,129],11.3596,8.89367,{"lat":129,"lon":128},[132],{"name":133,"role":84,"phone":107,"phoneExt":27,"email":134},"Dashe Dasogot, MBBS","dashedr@gmail.com",{"facility":136,"status":93,"city":137,"state":27,"zip":27,"country":96,"countryCode":97,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"University of Nigeria Teaching Hospital","Enugu",{"type":99,"coordinates":139},[140,141],7.49883,6.44132,{"lat":141,"lon":140},[144],{"name":145,"role":84,"phone":107,"phoneExt":27,"email":146},"Chinwe Chukwuka, MBBS","chinwechukwuka@yahoo.com",{"facility":148,"status":93,"city":149,"state":27,"zip":27,"country":96,"countryCode":97,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Aminu Kano Teaching Hospital","Kano",{"type":99,"coordinates":151},[152,153],8.51672,12.00012,{"lat":153,"lon":152},[156],{"name":157,"role":84,"phone":107,"phoneExt":27,"email":158},"Musa Babashani, MBBS","babashanim@yahoo.com",{"facility":160,"status":93,"city":161,"state":27,"zip":27,"country":96,"countryCode":97,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Lagos University Teaching Hospital","Lagos",{"type":99,"coordinates":163},[164,165],3.39467,6.45407,{"lat":165,"lon":164},[168],{"name":169,"role":84,"phone":107,"phoneExt":27,"email":170},"Sulaimon Akanmu, MBBS","asulaimona@gmail.com",{"type":81,"investigatorFullName":172,"investigatorTitle":173,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Robert Garofalo","Professor",[175],{"name":176,"class":177},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100583738",false,"NCT06880224","Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness\u002FImplementation Hybrid Study","Intensive Combination Approach to Rollback the HIV Epidemic in Nigerian Youth (iCARE) Plus Effectiveness\u002FImplementation Hybrid Study: Aim 2","iCARE Plus","Inclusion Criteria:\n\nHIV Case Finding Intervention:\n\n* Aged 15 to 24\n* Male birth sex of any current gender identity\n* Understand basic English, Yoruba, Hausa, Igbo or Pidgin English For the PrEP component, must also be HIV-negative\n\nHIV Treatment Intervention:\n\n* Aged 15 to 24\n* HIV seropositive\n* Initiating ART for the first time at a Clinical Research Performance Site (CRPS) clinic or satellite clinic\n* Understand basic English, Yoruba, Hausa, Igbo or Pidgin English\n* Intention to remain a CRPS patient during follow-up\n\nExclusion Criteria:\n\n* Unable to provide consent\n* No parental permission if aged 15 and not emancipated",true,"ALL","15 Years","24 Years",{"count":190,"type":191},500,"ESTIMATED","INTERVENTIONAL",[194],"NA","Two combination interventions (HIV Case Finding Intervention and HIV Treatment Intervention), each with mHealth and Peer Navigation components, will be evaluated in two 48-week parallel hybrid effectiveness\u002Fimplementation trials among youth aged 15-24 in Nigeria.",[197],"Adolescent HIV Infection",[199],"Adolescents, HIV Testing, HIV Treatment","2026-04-06",{"date":202,"type":203},"2026-04-08","ACTUAL",{"date":205,"type":203},"2025-02-01",{"date":207,"type":191},"2028-08-31",{"name":5,"class":6},6]