[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602067":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":28,"studyPopulation":29,"armGroups":24,"interventions":24,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":159,"collaborators":162,"id":166,"slug":24,"hasResults":167,"nctId":168,"briefTitle":169,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":167,"sex":172,"minAge":173,"maxAge":24,"enrollmentInfo":174,"targetDuration":177,"studyType":178,"phases":24,"briefSummary":179,"conditions":180,"keywords":186,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},{"fullName":5,"class":6},"Hospital Alemão Oswaldo Cruz","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Prevelance of chronic non-communicable diseases and mental disorders","Prevalence of cardiovascular diseases, non-infectious respiratory diseases, chronic kidney disease and cancers, depression, dependence on alcohol and illicit substances, self-harm and physical violence.","Baseline",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"Prevalence of metabolic and behavioral risk factors for chronic non-communicable diseases","History of hypertension, diabetes mellitus, dyslipidemia, smoking, physical activity, use of illicit drugs, alcoholism, dietary risk and continuous use medications, measurement of blood pressure, weight, height, abdominal and hip circumference, CD4, CD8, fasting blood glucose, HbA1C, total cholesterol and fractions, triglycerides, apolipoprotein A and B, serum and urinary creatinine, cystatin-C, urine 1, urinary albumin, serum and urinary phosphorus, urinary macroglobulin, urinary retinol-binding protein, AST, AST, Hepatitis A, B and C serologies, bone densitometry parameters, carotid ultrasound and spirometry.",{"measure":18,"description":19,"timeFrame":20},"Prevalence of participants with good adherence to antiretroviral therapy.","Adherence to antiretroviral therapy will be assessed using the 8-item Morisky-Green tool adapted for patients with HIV\u002FAIDS.\n\nThe instrument consists of eight dichotomous items. The questions were formulated to avoid a 'yes-saying' bias, so one point is assigned to each 'no' answer, except in item 5, which is reversed. At the end, patients are classified according to the score obtained as low adherers (score \\\u003C6), medium adherers (score 6 to \\\u003C8) and high adherers (score 8). The original authors also proposed a dichotomous cut-off of low (score \\\u003C6) vs. high\u002Fmedium adherence (score ≥6) to facilitate statistical analysis.","Baseline and 1 year after",{"measure":22,"description":23,"timeFrame":20},"Profile of Quality of life of participants","Quality of life will be assessed by WHOQOL-BREF. The WHOQOL-BREF, a shortened version of the WHOQOL-100, is a 26-item questionnaire used to assess an individual's quality of life. It categorizes responses into four domains: Physical Health, Psychological Health, Social Relationships, and Environment. Each domain, along with the overall quality of life and general health questions, is scored on a 5-point Likert scale, which is then transformed to a 0-100 scale. A score of 100 represents the best possible quality of life within that domain.",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":26,"timePerspective":27,"maskingInfo":24},"CASE_ONLY","CROSS_SECTIONAL","The BRAVO is a multicenter observational study. It includes a cross-sectional baseline assessment to evaluate cardiometabolic health, mental health, and quality of life among people living with HIV\u002FAIDS (PLWHA).\n\nAdults (≥18 years) with a confirmed HIV\u002FAIDS diagnosis from across Brazil will be recruited in 2025 and 2026. Participation requires informed consent. The study captures data on risk factors, diseases, anthropometrics, and biological samples, ART adherence, mental health status, and quality of life (WHOQOL-BREF).\n\nData are collected using REDCap©, covering: i) Demographics and socioeconomic indicators; ii) Clinical and lab tests (cholesterol, HbA1c, triglycerides); iii) Physical measures (BMI, blood pressure, waist-hip ratio); iv) Respiratory (spirometry), renal, hepatic, and bone assessments (DXA); v) STIs, cancer risk, and CIMT (carotid ultrasound); vi) ART adherence (Morisky-Green), viral load, CD4\u002FCD8 counts; vii) Mental health (depression, anxiety, substance use); and viii) Quality of life via WHOQOL-BREF.\n\nBoth validated and project-developed instruments will assess risk factors and outcomes. While validated tools improve reliability, the use of unvalidated questionnaires in certain domains (e.g., interpersonal violence) may introduce bias.\n\nThe target sample size is 743 participants, calculated to estimate a 12% prevalence of depression (the condition with the lowest expected prevalence among the non-communicable conditions of interest, derived from a systematic review in low- and middle-income countries) with 20% relative precision and 95% confidence, accounting for 5% refusals or incomplete data.\n\nStatistical Analysis Cross-sectional analysis uses standard tests (Chi-square, t-test, ANOVA, logistic regression) with methods for handling non-normal data and multivariable modeling.\n\nSubgroup analyses are planned for key populations (e.g., transgender, Black individuals, cisgender women).\n\nChallenges No retention strategies are currently outlined, which could affect the study's internal validity due to participant attrition over time. Best practices like reminders and engagement initiatives are recommended.\n\nEthics The protocol has received approval from the Hospital Alemão Oswaldo Cruz ethics committee (CAAE: 7.003.613). Informed consent and participant confidentiality are ensured.","People living with HIV or Aids.",[31],{"name":32,"affiliation":5,"role":33},"Victor Sato","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":24,"email":38},"CONTACT","5511","victorhsato@gmail.com",{"name":40,"role":36,"phone":24,"phoneExt":24,"email":41},"Rosa Lucchetta","rosa.lucchetta@haoc.com.br",[43,61,71,84,97,110,123,136,148],{"facility":44,"status":45,"city":46,"state":47,"zip":24,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Hospital das Clínicas da Universidade Federal de Goiás","RECRUITING","Goiânia","Goiás","Brazil","BR",{"type":51,"coordinates":52},"Point",[53,54],-49.25389,-16.67861,{"lat":54,"lon":53},[57],{"name":58,"role":36,"phone":59,"phoneExt":24,"email":60},"Moara Alves","55","moarasb@ufg.br",{"facility":62,"status":63,"city":64,"state":65,"zip":24,"country":48,"countryCode":49,"cosmosGeoPoint":66,"geoPoint":70,"contacts":24},"Faculdade de Medicina da Universidade Federal de Minas Gerais","ACTIVE_NOT_RECRUITING","Belo Horizonte","Minas Gerais",{"type":51,"coordinates":67},[68,69],-43.93778,-19.92083,{"lat":69,"lon":68},{"facility":72,"status":45,"city":73,"state":74,"zip":24,"country":48,"countryCode":49,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Hospital de Clínicas da Universidade Federal do Paraná","Curitiba","Paraná",{"type":51,"coordinates":76},[77,78],-49.27306,-25.42778,{"lat":78,"lon":77},[81],{"name":82,"role":36,"phone":24,"phoneExt":24,"email":83},"Monica Gomes, PhD","monica.mgomes@gmail.com",{"facility":85,"status":45,"city":86,"state":86,"zip":24,"country":48,"countryCode":49,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Hospital Federal dos Servidores do Estado do Rio de Janeiro","Rio de Janeiro",{"type":51,"coordinates":88},[89,90],-43.18223,-22.90642,{"lat":90,"lon":89},[93],{"name":94,"role":36,"phone":95,"phoneExt":24,"email":96},"Luiz Passoni, PhD","5521","lfernandopassoni@gmail.com",{"facility":98,"status":45,"city":99,"state":100,"zip":24,"country":48,"countryCode":49,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Hospital Federal de Santa Maria","Santa Maria","Rio Grande do Sul",{"type":51,"coordinates":102},[103,104],-53.80694,-29.68417,{"lat":104,"lon":103},[107],{"name":108,"role":36,"phone":59,"phoneExt":24,"email":109},"Alexandre V Schwarzbold, PhD","alexvspoa@gmail.com",{"facility":111,"status":45,"city":112,"state":113,"zip":24,"country":48,"countryCode":49,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Centro de Pesquisa Clínica Dom Bosco","Araçatuba","São Paulo",{"type":51,"coordinates":115},[116,117],-50.43278,-21.20889,{"lat":117,"lon":116},[120],{"name":121,"role":36,"phone":59,"phoneExt":24,"email":122},"Igor Precinoti, PhD","igorprecinoti@gmail.com",{"facility":124,"status":125,"city":126,"state":113,"zip":24,"country":48,"countryCode":49,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Faculdade de Medicina de Botucatu da UNESP","NOT_YET_RECRUITING","Botucatu",{"type":51,"coordinates":128},[129,130],-48.445,-22.88583,{"lat":130,"lon":129},[133],{"name":134,"role":36,"phone":59,"phoneExt":24,"email":135},"Alexandre Barbosa, PhD","barbosa.an@gmail.com",{"facility":137,"status":45,"city":138,"state":113,"zip":24,"country":48,"countryCode":49,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Centro Universitário FMABC","Santo André",{"type":51,"coordinates":140},[141,142],-46.53833,-23.66389,{"lat":142,"lon":141},[145],{"name":146,"role":36,"phone":59,"phoneExt":24,"email":147},"Olavo Leite, PhD","olavo.leite55@gmail.com",{"facility":149,"status":45,"city":113,"state":113,"zip":24,"country":48,"countryCode":49,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Instituto de Infectologia Emílio Ribas",{"type":51,"coordinates":151},[152,153],-46.63611,-23.5475,{"lat":153,"lon":152},[156],{"name":157,"role":36,"phone":37,"phoneExt":24,"email":158},"Luis C Pereira, PhD","luiz.junior@emilioribas.sp.gov.br",{"type":33,"investigatorFullName":160,"investigatorTitle":161,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Victor Augusto Hamamoto Sato","Principal Investigator",[163],{"name":164,"class":165},"Ministry of Health, Brazil","OTHER_GOV","100602067",false,"NCT07118683","BRAZILIAN REGISTRY OF CHRONIC NON-COMMUNICABLE DISEASES IN PEOPLE LIVING WITH HIV\u002FAIDS","BRAVO","Inclusion Criteria:\n\n* Adults aged 18 or over;\n* Confirmed HIV or AIDS diagnosis;\n* Signature of consent form.\n\nExclusion Criteria:\n\n* Indigenous population or those in prison in open or closed regimes;\n* Patients hospitalized at the time of signing the Consent Form.","ALL","18 Years",{"count":175,"type":176},743,"ESTIMATED","3 Months","OBSERVATIONAL","BRAVO proposes the establishment of a comprehensive registry of chronic noncommunicable diseases (NCDs), providing crucial data for the formulation of effective health policies for people living with HIV\u002FAIDS (PLWHA). BRAVO is a cross-sectional study, that will collect on the study allocation sociodemographic data, risk factors related to the main NCDs, physical examination data and samples for determination of biochemical and metabolic parameters. To this end, the study will include co-participating research centers from the 5 Brazilian geographic macro-regions.",[181,182,183,184,185],"AIDS (Acquired Immunodeficiency Syndrome)","Cardiovascular and Cerebrovascular Diseases","Respiratory Comorbidities","Chronic Kidney Disease","Cancer",[187,188,189,190,191,192,193,194,48,195],"Acquired Immunodeficiency Syndrome","Cardiovascular Diseases","Respiratory Tract Diseases","Renal Insufficiency, Chronic","Neoplasms","Treatment Adherence and Compliance","Quality of Life","Prevalence","Cross-sectional study","2026-05-19",{"date":198,"type":199},"2026-05-22","ACTUAL",{"date":201,"type":199},"2025-08-15",{"date":203,"type":176},"2026-12",{"name":5,"class":6},9]