BRAZILIAN REGISTRY OF CHRONIC NON-COMMUNICABLE DISEASES IN PEOPLE LIVING WITH HIV/AIDS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: AIDS (Acquired Immunodeficiency Syndrome), Cardiovascular and Cerebrovascular Diseases, Respiratory Comorbidities, Chronic Kidney Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Primary outcome measures
- Prevelance of chronic non-communicable diseases and mental disorders [Time frame: Baseline]
Secondary outcome measures (3)
- Prevalence of metabolic and behavioral risk factors for chronic non-communicable diseases [Time frame: Baseline]
- Prevalence of participants with good adherence to antiretroviral therapy. [Time frame: Baseline and 1 year after]
- Profile of Quality of life of participants [Time frame: Baseline and 1 year after]
Eligibility criteria
Inclusion criteria
- Adults aged 18 or over;
- Confirmed HIV or AIDS diagnosis;
- Signature of consent form.
Exclusion criteria
- Indigenous population or those in prison in open or closed regimes;
- Patients hospitalized at the time of signing the Consent Form.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Brazil · 9 centers
- 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
- … and 1 more center
Identifiers
NCT: NCT07118683 · CAAE: 81912924.9.1001.0070