[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654873":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":41,"studyPopulation":33,"armGroups":42,"interventions":49,"overallOfficials":57,"centralContacts":61,"locations":70,"responsibleParty":97,"collaborators":100,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":33,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":33,"studyType":117,"phases":118,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":128,"whyStopped":33,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Virologic Suppression","HIV-1 Plasma RNA level \\\u003C200 copies\u002Fml at 12 months","Baseline to 12 months (+\u002F- 3 months)",[14,18,21,25,29],{"measure":15,"description":16,"timeFrame":17},"Patient Health Questionnaire-9 (PHQ-9)","A 9 item survey with each item scored:\n\n0: Not at all 1: Several days 2: More than half the days 3: Nearly every day Total possible score is between 0-27, with a higher score indicating more symptoms indicative of depression","Baseline to Study End (approximately 18 months)",{"measure":19,"description":20,"timeFrame":17},"HIV Stigma Scale Survey (HIVSS)","A 40 item scale, with each item scored from 1=Strongly agree, 2=Disagree, 3=Agree, 4=Strongly agree. The total score can range from 10-40 with a higher score indicating more stigma",{"measure":22,"description":23,"timeFrame":24},"National Institute of Drug Abuse (NIDA) - Modified ASSIST","A quick screen questionnaire that includes only Question 2 of the NIDA-modified ASSIST regarding substance abuse. 10 substances are included and each is scored depending on use: Never=0, Once or Twice=2, Monthly=3, Weekly=4, Daily or Almost daily = 6. Total scores range from 0-60 with a higher score indicating more frequent substance abuse.","Baseline to study end (approximately 18 months)",{"measure":26,"description":27,"timeFrame":28},"System Usability Survey","This survey is administered at Visits 2 and 3 with 10 structured questions scored from 0=Strongly Disagree, 1=Disagree, 2=Somewhat Disagree, 4=Neither Agree nor Disagree, 5=Somewhat Agree, 6=Agree, 7=Strongly Agree. There are 3 additional free response questions that are not scored. Total scores range from 0-70 with a higher score indicating better system usability.","Month 12 and Month 18",{"measure":30,"description":31,"timeFrame":32},"HIV Care Engagement","At least two clinic visits \\>60 days apart in the prior 12 months","Baseline through end of study, measured at each study time point (baseline, 6mos, 12 mos, 18 mos)",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"NA","SINGLE_GROUP","Type 1 hybrid study. Staircase design is a particular variation of the incomplete stepped-wedge design.It allows for phased implementation of the intervention across all participating clusters in a staggered fashion, ensuring all clusters receive the intervention. A cluster serves both as its control, as it spends time under both control and intervention conditions.","SUPPORTIVE_CARE",{"masking":40,"maskingDescription":33,"whoMasked":33},"NONE","The overall objective of this proposal is to implement and rigorously test an existing mHealth care engagement intervention, PL4Y, in a six clinic network in Texas. The investigators will use the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to inform a type 1 hybrid study, assessing effectiveness of PL4Y alongside measures of acceptability, feasibility, and sustainability. The study has two main components:\n\n* A cluster randomized longitudinal staircase trial across six clinics in Texas\n* Qualitative assessment, using semi-structured interviews and focus groups, of acceptability and feasibility of PL4Y implementation in the clinics",[43],{"label":44,"type":45,"description":46,"interventionNames":47},"mHealth Intervention group","EXPERIMENTAL","18-29yos with HIV who are in care in one of the participating clinics.",[48],"Behavioral: PositiveLinks for Youth Smartphone App",[50],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"BEHAVIORAL","PositiveLinks for Youth Smartphone App","PL4Y, a smartphone application (app), is a clinic-based multimodal intervention designed by and for youth living with HIV, including daily adherence assessment, appointment reminders, secure messaging with clinic providers, and an asynchronous, anonymized virtual support group.",[44],[56],"PL4Y",[58],{"name":59,"affiliation":5,"role":60},"Barbara Taylor, MD, MS","PRINCIPAL_INVESTIGATOR",[62,66],{"name":59,"role":63,"phone":64,"phoneExt":33,"email":65},"CONTACT","210-450-8144","taylorb4@uthscsa.edu",{"name":67,"role":63,"phone":68,"phoneExt":33,"email":69},"Cyrena Cote","210-450-7277","cotec@uthscsa.edu",[71,87],{"facility":72,"status":33,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"University of Texas Health Science Center San Antonio","San Antonio","Texas","78229","United States","US",{"type":79,"coordinates":80},"Point",[81,82],-98.49363,29.42412,{"lat":82,"lon":81},[85],{"name":33,"role":63,"phone":33,"phoneExt":33,"email":86},"TaylorB4@uthscsa.edu",{"facility":88,"status":33,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":89,"geoPoint":91,"contacts":92},"University of Texas San Antonio Health Campus",{"type":79,"coordinates":90},[81,82],{"lat":82,"lon":81},[93,95],{"name":59,"role":63,"phone":94,"phoneExt":33,"email":86},"(210)450-8144",{"name":67,"role":63,"phone":96,"phoneExt":33,"email":69},"(210)567-4661",{"type":60,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Barbara Taylor","Professor",[101],{"name":102,"class":103},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100654873","positivelinks-for-youth-pl4y-for-texas-100654873",false,"NCT07804602","PositiveLinks for Youth (PL4Y) for Texas","PositiveLinks for Youth (PL4Y) for Texas: Effectiveness, Feasibility, and Acceptability of mHealth to Improve Care Outcomes for Young Adults With HIV","Inclusion Criteria:\n\n1. 18-29yo living with HIV\n2. Attending at least one in-person visit in the clinic site of enrollment in the past 12 mos,\n3. English speaking\n4. Able to participate in the informed consent process.\n5. Access to a personal smartphone with a data plan capable of supporting the PL4Y app. The phone must be password protected and not shared with others for confidentiality purposes.\n6. Interviews only- A stakeholder in one of the network clinics\n\n   1. 18 years or older\n   2. able to participate in the informed consent process\n\nExclusion Criteria:\n\n1. They cannot provide consent\n2. Unwilling or unable to complete virtual study visits","ALL","18 Years","29 Years",{"count":115,"type":116},600,"ESTIMATED","INTERVENTIONAL",[35],"The goal of this interventional clinical trial is to test an an app, PL4Y, installed on a mobile smartphone to see if it can help participants aged 18-29 years who have HIV achieve success with their HIV care and feel supported by their clinic community.\n\nThe first 6 months will be standard of care, after which participants will continue to meet virtually with their health care providers and will also be provided with and taught how to use the app. The standard of care clinic visits will continue as before and virtual visits using the app will be started and continue for abot 18 months.\n\nAdherence to medications Appointment reminders Provide secure communication with providers\n\nProvide a support group in \\[describe participant population\u002Fprimary condition; could include any of the following: sex\u002Fgender, age groups, healthy volunteers\\]. The main question\\[s\\] it aims to answer \\[is\u002Fare\\]:\n\n\\[primary hypothesis or outcome measure 1\\]? \\[primary hypothesis or outcome measure 2\\]?\n\nIf there is a comparison group: Researchers will compare \\[arm information\\] to see if \\[insert effects\\].\n\nParticipants will \\[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\\].",[121,122],"Human Immunodeficiency Virus","HIV",[124,125,126,127],"Communication with providers","Smartphone App","Anonymous Virtual chat group","Medication reminders","NOT_YET_RECRUITING","2026-08-31",{"date":131,"type":132},"2026-09-04","ACTUAL",{"date":134,"type":116},"2027-04-01",{"date":136,"type":116},"2031-04",{"name":5,"class":6},2]