[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551942":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":31,"locations":40,"responsibleParty":77,"collaborators":18,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":18,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":18,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Cape Town","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Combined CogSMART and BrainHQ intervention group","EXPERIMENTAL","Intervention: The experimental condition in this trial is a combination of CogSMART and BrainHQ. This integrated intervention helps individuals with cognitive impairment improve daily activities and achieve goals. CogSMART, a compensatory cognitive remediation (C-CR) program, employs techniques to enhance prospective memory, attention, learning\u002Fmemory, and executive functioning. BrainHQ, a restorative cognitive remediation (R-CR) program, provides game-like modules targeting memory, attention, and executive functions. Together, they offer a comprehensive approach, combining C-CR with R-CR to reduce impairment and enhance problem-solving skills.",[13],"Behavioral: Combined Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ©",{"label":15,"type":16,"description":17,"interventionNames":18},"Attention-matched Combined CogSMART and BrainHQ Control group","NO_INTERVENTION","This control-matched approach to the CogSMART group, currently utilized in Dr. Twamley's studies, has been well received by participants, with no significant increase in dropout rates. Additionally, control participants will receive the BrainHQ component, involving Internet Navigation Training previously employed by Dr. Vance consisting of 20 sessions lasting 30 minutes each aimed to provide no therapeutic benefit.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Combined Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ©","The intervention combines Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ. This integrated program helps individuals with cognitive impairment improve daily activities and achieve work, social, and daily living goals. CogSMART uses compensatory techniques to enhance prospective memory (remembering to do things), attention, learning\u002Fmemory, and executive functioning (problem-solving, planning, organization, and cognitive flexibility). BrainHQ complements CogSMART with stimulating, game-like modules focusing on memory, attention, and executive functions. Together, they provide a comprehensive therapeutic tool to support cognitive impairment treatments and can also be used as a brain-training tool to prevent memory loss and maintain cognitive abilities.",[9],[26,29],{"name":27,"affiliation":5,"role":28},"Hetta Gouse, PhD","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":5,"role":28},"John Joska, PhD",[32,36],{"name":27,"role":33,"phone":34,"phoneExt":18,"email":35},"CONTACT","+642102064321","hetta.gouse@uct.ac.za",{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},"Kevin GF Thomas, PhD","+27827748517","kevin.thomas@uct.ac.za",[41,60,66],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Michael Mapongwana Community Health Clinic","RECRUITING","Cape Town","Western Cape","8000","South Africa","ZA",{"type":50,"coordinates":51},"Point",[52,53],18.42322,-33.92584,{"lat":53,"lon":52},[56],{"name":57,"role":33,"phone":58,"phoneExt":18,"email":59},"Khanyisa Jacobs","021 361 3353","khanyisa.jacobs@westerncape.gov.za",{"facility":61,"status":62,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":65,"contacts":18},"TB HIV Care","COMPLETED",{"type":50,"coordinates":64},[52,53],{"lat":53,"lon":52},{"facility":67,"status":43,"city":44,"state":45,"zip":68,"country":47,"countryCode":48,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Nolungile Community Clinic","800",{"type":50,"coordinates":70},[52,53],{"lat":53,"lon":52},[73],{"name":74,"role":33,"phone":75,"phoneExt":18,"email":76},"Nothemba Mbomvu","021 829 0004","Nothemba.mbomvu@westerncape.gov.za",{"type":28,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"KevinThomas","Professor","100551942","brain-in-people-living-with-hiv-study-100551942",false,"NCT06466642","B.R.A.I.N in People Living With HIV Study","Building Resources to Achieve Improvement in Neurocognition (B.R.A.I.N) in People Living With HIV","BRAIN","Inclusion Criteria:\n\n* Aged between 30 and 50 years;\n* ≥ 8 years of schooling;\n* Fluent Xhosa speaking;\n* HIV-positive;\n* on Antiretroviral therapy (ART);\n* ability to sign informed consent;\n* willing to attend: (a) two NP testing sessions, (b) a minimum of 10 hours (twenty 30-minute sessions) of R-CR sessions, and (c) 10 CogSMART sessions over a period of five weeks; and\n* meeting the criteria for NCI (as described further in document).\n\nExclusion Criteria:\n\n* Participants with significant neuro-medical comorbidities (e.g., schizophrenia, epilepsy, bipolar disorder, multiple sclerosis, intellectual disability) necessitate exclusion. These comorbidities will be assessed for during screening.\n* Other conditions (e.g., legally blind or deaf, currently undergoing radiation or chemotherapy, a history of brain trauma with a loss of consciousness greater than 30 minutes) that could impact cognitive functioning, testing or consistent study participation over 7 weeks necessitate exclusion; again, this information is conferred in the screen.",true,"ALL","30 Years","50 Years",{"count":93,"type":94},43,"ESTIMATED","INTERVENTIONAL",[97],"NA","People living with HIV (PLWH) often have memory and thinking problems, which can range from mild to severe. These problems, which are called neurocognitive impairment (NCI), can appear even when PLWH are taking medicine to manage their HIV.\n\nPLWH who are experiencing NCI can have difficulties managing everyday activities. For instance, they might not remember to take their medicine on time, they might struggle to manage their money properly, and they might even be at a higher risk of passing HIV on to other. Ultimately, PLWH who are experiencing NCI might not enjoy life as much as others do.\n\nCurrently, there are no specific medicines designed to treat NCI in PLWH. There are, however, some useful memory and thinking strategies that can help improve cognitive abilities. These strategies are called cognitive remediation (CR).\n\nIn South Africa, there are many PLWH. Unfortunately, the country does not have clear plans for identifying and managing NCI in PLWH. It's difficult to use CR in South Africa because of cultural differences between where the strategies were developed and the patients who might need to use it, limited healthcare resources, and HIV clinics not having enough information about NCI.\n\nThere are, however, some promising ways to deal with these issues. For example, it can be helpful to involve regular counselors and to use simple tests on mobile phones to find people who need assistance. With some effort and creativity, investigators can improve the situation and help PLWH lead better lives.\n\nThe proposed study is a unique opportunity to find new ways to help PLWH and others with brain-related diseases who might be experiencing NCI. Investigators want to explore ways to use cognitive exercises to improve thinking abilities. This study will be the first of its kind because investigators will adapt these exercises to fit the cultures and languages of South Africa, where many people are affected by HIV and NCI.\n\nBy doing this research, investigators hope to make important progress in addressing NCI in HIV and similar conditions. Investigators will learn how to make these cognitive exercises work best in South Africa's public clinics, and this knowledge can help people with NCI live better lives. Our goal is to improve healthcare not only in South Africa but also in other parts of the world that might be facing similar challenges with improving the lives of PLWH.",[100],"HIV-associated Neurocognitive Disorders","2024-08-21",{"date":103,"type":104},"2024-08-23","ACTUAL",{"date":106,"type":104},"2023-01-16",{"date":108,"type":94},"2024-12-31",{"name":5,"class":6},3]