[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487896":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":36,"locations":44,"responsibleParty":63,"collaborators":66,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":12,"enrollmentInfo":84,"targetDuration":12,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":12,"overallStatus":47,"whyStopped":12,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Columbia University","OTHER",[8,13,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Enhanced standard of care","NO_INTERVENTION","* Care from trained and supported physicians, nurses, and social workers who have received repeated trainings from study staff on medical and behavioral aspects of DR-TB HIV care, which will be documented in terms of date, attendance, and content\n* All participants who receive care as inpatients will receive an orientation to DR-TB treatment in form of a group session designed to impart key behavioral information and health knowledge about the disease, treatment, and skills to obtain optimal outcome.\n* Discharge counselling session will be conducted prior to discharge.\n* Study participants will complete study assessments at baseline (enrollment) and monthly for the first six months.",null,{"label":14,"type":6,"description":15,"interventionNames":16},"Psychosocial support","* In addition to Arm 1\n* Participants will participate in individual counseling aligned with their monthly clinic visit.\n* Individual counseling will use motivational interviewing (MI) techniques, based on the 4-part engaging, focusing, evoking and planning approach for each participant.\n* Home visits will be conducted (if warranted\u002Fconsented for by the participant) by the same trained counselors known to patients.\n* Adherence support groups will be facilitated by counselors trained in group facilitation methods; group curriculum will include 6 sessions (monthly, gender specific, structured adherence support groups) that focus on practical topics.\n* Discharge planning (if inpatient)\n* Community treatment planning (if outpatient)",[17],"Behavioral: Adherence support intevention",{"label":19,"type":6,"description":20,"interventionNames":21},"mHealth","* In addition to Arm 1\n* Participants will receive x 2 portable Wisepill devices. (x1 for MDR-TB treatment and x1 for ART).\n\nA Wisepill device is an RT2000 cellular-enabled electronic pill boxes using 2G\u002F3G cellular network.\n\n* Participants will select a text message reminder from a guided menu of choices and receive a weekly text message encouraging adherence.\n* Participants will receive a study call to support regular adherence. Participants will be assessed weekly. Less than 85% observed\u002Fexpected doses will be considered at risk for non-adherence and the intervention will be increased.",[17],{"label":23,"type":6,"description":24,"interventionNames":25},"mHealth and Psychosocial support","Combination of Arm 2 and Arm 3.",[17],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":12},"BEHAVIORAL","Adherence support intevention","Compare the effects of adherence support interventions on clinical and biological endpoints using an adaptive randomized platform.",[14,19,23],[33],{"name":34,"affiliation":5,"role":35},"Max O'Donnell, MD, MPH","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":12,"email":41},"Kogieleum Naidoo","CONTACT","+27 31 260 4687","Kogie.Naidoo@caprisa.org",{"name":34,"role":39,"phone":12,"phoneExt":12,"email":43},"mo2130@columbia.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"King DinuZulu Hospital","RECRUITING","Durban","KwaZulu-Natal","4001","South Africa","ZA",{"type":54,"coordinates":55},"Point",[56,57],31.0292,-29.8579,{"lat":57,"lon":56},[60,62],{"name":38,"role":39,"phone":61,"phoneExt":12,"email":41},"+27 31 260 4684",{"name":34,"role":39,"phone":12,"phoneExt":12,"email":43},{"type":35,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Max O'Donnell","Associate Professor of Medicine and Associate Professor of Epidemiology",[67,70],{"name":68,"class":69},"Centre for the AIDS Programme of Research in South Africa","NETWORK",{"name":71,"class":72},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100487896","an-adaptive-randomized-controlled-trial-100487896",false,"NCT05633056","An Adaptive Randomized Controlled Trial","Adaptive Evaluation of mHealth and Conventional Adherence Support Interventions to Optimize Outcome With New Treatment Regimens for Drug-resistant Tuberculosis and HIV in South Africa","ADAP-TIV","Inclusion Criteria:\n\n1. Culture or molecular test positive for MTB\n2. Molecular test positive for HIV or a documented HIV positive history\n3. Drug-susceptibility testing by molecular (i.e. GeneXpert MTB\u002FRIF) or conventional testing consistent with at least rifampicin-resistant TB,\n4. Initiating treatment with a Bedaquiline -containing TB regimen within 4 weeks of enrollment and first-time being treated with BDQ\n5. On treatment with Antiretroviral Therapy (ART) regimen, including dolutegravir-containing combination Antiretroviral Therapy regimen (i.e. Tenofovir-Lamivudine-Dolutergravir), or starting within 4 weeks of enrollment,\n6. Capacity for informed consent in either isiZulu or English\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Prisoners\n3. Discretion of IOR or clinician",true,"ALL","18 Years",{"count":85,"type":86},360,"ESTIMATED","INTERVENTIONAL",[89],"NA","This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment regimens and on ART (integrase strand transfer inhibitor (INSTI)-based fixed dose combination therapy) in KwaZulu-Natal, South Africa. Interventions arms include: enhanced standard of care; psychosocial support; mHealth using cellular-enabled electronic dose monitoring; combined mHealth psychosocial support. Level of support will be adjusted using a differentiated service delivery (DSD)- informed assessment of treatment support needs.",[92,93],"Multi Drug Resistant Tuberculosis","HIV Infections","2026-05-26",{"date":96,"type":97},"2026-05-28","ACTUAL",{"date":99,"type":97},"2023-03-07",{"date":101,"type":86},"2029-04",{"name":5,"class":6},1]