BRAZILIAN REGISTRY OF CHRONIC NON-COMMUNICABLE DISEASES IN PEOPLE LIVING WITH HIV/AIDS
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: AIDS (Acquired Immunodeficiency Syndrome), Cardiovascular and Cerebrovascular Diseases, Respiratory Comorbidities, Chronic Kidney Disease. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Бразилия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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/AIDS (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.
Подробное описание
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/AIDS (PLWHA).
Adults (≥18 years) with a confirmed HIV/AIDS 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).
Data 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/CD8 counts; vii) Mental health (depression, anxiety, substance use); and viii) Quality of life via WHOQOL-BREF.
Both 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.
The 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.
Statistical Analysis Cross-sectional analysis uses standard tests (Chi-square, t-test, ANOVA, logistic regression) with methods for handling non-normal data and multivariable modeling.
Subgroup analyses are planned for key populations (e.g., transgender, Black individuals, cisgender women).
Challenges 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.
Ethics The protocol has received approval from the Hospital Alemão Oswaldo Cruz ethics committee (CAAE: 7.003.613). Informed consent and participant confidentiality are ensured.
Первичные конечные точки
- Prevelance of chronic non-communicable diseases and mental disorders [Срок оценки: Baseline]
Вторичные конечные точки (3)
- Prevalence of metabolic and behavioral risk factors for chronic non-communicable diseases [Срок оценки: Baseline]
- Prevalence of participants with good adherence to antiretroviral therapy. [Срок оценки: Baseline and 1 year after]
- Profile of Quality of life of participants [Срок оценки: Baseline and 1 year after]
Критерии участия
Критерии включения
- Adults aged 18 or over;
- Confirmed HIV or AIDS diagnosis;
- Signature of consent form.
Критерии исключения
- Indigenous population or those in prison in open or closed regimes;
- Patients hospitalized at the time of signing the Consent Form.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Бразилия · 9 центров
- Hospital das Clínicas da Universidade Federal de Goiás — Goiânia
- Faculdade de Medicina da Universidade Federal de Minas Gerais — Belo Horizonte
- Hospital de Clínicas da Universidade Federal do Paraná — Curitiba
- Hospital Federal dos Servidores do Estado do Rio de Janeiro — Rio de Janeiro
- Hospital Federal de Santa Maria — Santa Maria
- Centro de Pesquisa Clínica Dom Bosco — Araçatuba
- Faculdade de Medicina de Botucatu da UNESP — Botucatu
- Centro Universitário FMABC — Santo André
- … и ещё 1 центр
Идентификаторы
NCT: NCT07118683 · CAAE: 81912924.9.1001.0070