[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637462":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":44,"centralContacts":49,"locations":58,"responsibleParty":72,"collaborators":35,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":35,"eligibilityCriteria":79,"healthyVolunteers":76,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":35,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":97,"whyStopped":35,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Duke University","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"eSOC (enhanced Standard of Care)","ACTIVE_COMPARATOR","Currently mental health screening is not part of routine care. Youth at all trial clinics who report moderate to severe symptoms will be referred for care within the local standard.",[13],"Other: eSOC",{"label":15,"type":16,"description":17,"interventionNames":18},"eSOC (enhanced Standard of Care) + iSYV (integrated Sauti ya Vijana or The voice of youth)","EXPERIMENTAL","iSYV is an intervention that will be peer-led and group based in six monthly sessions.",[19,13],"Behavioral: iSYV (integrated Sauti ya Vijana; The Voice of Youth)",{"label":21,"type":16,"description":22,"interventionNames":23},"eSOC (enhanced Standard of Care) + iSYV + mHealth (mobile Health)","mHealth will be an additional experimental intervention exploring the boosting effect of gamification of intervention content to boost participant knowledge and understanding of iSYV content",[19,24,13],"Other: mHealth",{"label":26,"type":16,"description":27,"interventionNames":28},"eSOC (enhanced Standard of Care) + mHealth (mobile Health)","mHealth is evaluated as a stand alone experimental intervention in this arm to evaluate if mHealth alone (without in person iSYV content) can improve mental health and\u002For HIV RNA outcomes.",[24,13],[30,36,40],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"BEHAVIORAL","iSYV (integrated Sauti ya Vijana; The Voice of Youth)","Integrated \"i\"SYV is a streamlined version of the original intervention SYV that is adapted for integration into routine clinical care. The original SYV intervention included 10 group weekly sessions (2 incorporating caregivers) and 2 individual sessions with adaptation to fit without routine adolescent HIV care based on Tanzanian National HIV Guidelines for HIV care follow up visits.",[15,21],null,{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"mHealth","A gamified version of iSYV that can be played via SMS or Whatsapp messaging.",[21,26],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"eSOC","mental health screening and referral within the standard of care for moderate to severe symptoms",[9,15,21,26],[45],{"name":46,"affiliation":47,"role":48},"Dorothy Dow, MD, MSc","Duke Universtiy","PRINCIPAL_INVESTIGATOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":35,"email":54},"Stuart T Carr, BA","CONTACT","(919) 668-4849","stuart.carr@duke.edu",{"name":56,"role":52,"phone":35,"phoneExt":35,"email":57},"Sandy Askew, MPh","sandy.askew@duke.edu",[59],{"facility":60,"status":35,"city":61,"state":35,"zip":35,"country":62,"countryCode":35,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Elizabeth Glaser Pediatric AIDS Foundation implementing partner sites in Tanzania","Moshi","Tanzania",{"type":64,"coordinates":65},"Point",[66,67],37.33333,-3.35,{"lat":67,"lon":66},[70],{"name":71,"role":48,"phone":35,"phoneExt":35,"email":35},"Akwila Temu, MD, MMED",{"type":73,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100637462","integrating-isyv-within-hiv-clinical-care-for-youth-living-with-hiv-in-tanzania-100637462",false,"NCT07621510","Integrating iSYV Within HIV Clinical Care for Youth Living With HIV in Tanzania","Inclusion Criteria:\n\n1. youth living with HIV (YLWH) 15-24 years;\n2. have understanding of their HIV status;\n3. able to attend iSYV sessions if site is randomized to the intervention.\n\nExclusion Criteria:\n\n1. inability to provide informed consent\u002Fassent or participate meaningfully in the intervention due to cognitive impairment, psychosis, or other disability;\n2. enrollment in any other MH, stigma-related, or adherence intervention research study.","ALL","15 Years","24 Years",{"count":84,"type":85},5000,"ESTIMATED","INTERVENTIONAL",[88],"NA","Youth living with HIV (YLWH) experience mental health (MH) challenges that compromise their HIV care. Though the MH gap is well described, MH service delivery to YLWH is rare, especially in low resource settings. MH professionals are few and interventions tailored to the needs of this population are scarce. This project proposes a way to bridge the gap by streamlining the Sauti ya Vijana (SYV, The Voice of Youth) intervention redesigned to integrate into the differentiated HIV clinical care model in Tanzania. SYV is a peer-led, group-based treatment designed with and for YLWH to address their self-reported MH challenges and stressors living with HIV.",[91,92],"HIV -1 Infection","Mental Health Issue",[94,95,62,96],"Youth","Adolescents","Cognitive behavioral therapy","NOT_YET_RECRUITING","2026-05-27",{"date":100,"type":101},"2026-06-02","ACTUAL",{"date":103,"type":85},"2027-01-10",{"date":105,"type":85},"2030-09-30",{"name":5,"class":6},1]